U.S. patent application number 17/381988 was filed with the patent office on 2022-01-20 for adjunct materials and methods of using same in surgical methods for tissue sealing.
The applicant listed for this patent is Cilag GmbH International. Invention is credited to Jason L. Harris, Frederick E. Shelton, IV, Bret W. Smith.
Application Number | 20220015764 17/381988 |
Document ID | / |
Family ID | |
Filed Date | 2022-01-20 |
United States Patent
Application |
20220015764 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
January 20, 2022 |
ADJUNCT MATERIALS AND METHODS OF USING SAME IN SURGICAL METHODS FOR
TISSUE SEALING
Abstract
Surgical methods involving cutting and sealing tissue include
affixing a first adjunct material to tissue at a treatment site,
such as by stapling the adjunct to tissue. A second adjunct
material is applied to at least a portion of the first adjunct
material such that the second adjunct material interacts with the
first adjunct material to form a seal in an area of the tissue
covered by at least one of the first and the second adjunct
material. The resulting tissue sealing structure, which includes a
combination of the two adjuncts, is believed to be superior to the
sealing properties of either adjunct alone.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Harris; Jason L.; (Lebanon,
OH) ; Smith; Bret W.; (Kings Mills, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cilag GmbH International |
Zug |
|
CH |
|
|
Appl. No.: |
17/381988 |
Filed: |
July 21, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16806252 |
Mar 2, 2020 |
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17381988 |
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16119292 |
Aug 31, 2018 |
10966722 |
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16806252 |
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14300954 |
Jun 10, 2014 |
10172611 |
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16119292 |
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International
Class: |
A61B 17/072 20060101
A61B017/072; A61B 17/064 20060101 A61B017/064; A61B 17/068 20060101
A61B017/068; A61B 17/00 20060101 A61B017/00 |
Claims
1.-19. (canceled)
20. A method for forming an adjunct, comprising: weaving first
fibers together to form a first layer; and interlocking or knotting
second fibers with the first woven fibers to form a second layer
that is connected to the first layer, wherein the adjunct is
configured to be elastically deformable, to be releasably retained
on a stapling body, and to allow a plurality of staples disposed
within the stapling body to pass therethrough such that the adjunct
can be attached to tissue by the plurality of staples.
21. The method of claim 20, wherein at least one of the first layer
and the second layer are configured to releasably couple to the
stapling body.
22. The method of claim 20, wherein the first fibers are made of a
first bioabsorbable polymer and the second fibers are made of a
second bioabsorbable polymer that is different than the first
bioabsorbable polymer.
23. The method of claim 20, further comprising interlocking or
knotting third fibers with the second fibers to form a third layer,
wherein the second layer is positioned between the first and third
layers.
24. The method of claim 23, wherein the second fibers extend from
the first layer to the second layer, wherein at least a portion of
the second fibers within the second layer are oriented in a
different direction compared to an orientation of at least one of
the first fibers and third fibers.
25. The method of claim 23, wherein the at least one of the first
fibers and third fibers are formed of a first bioabsorbable
polymer, and the second fibers are made of a second bioabsorbable
polymer that is different than the first bioabsorbable polymer
26. The method of claim 20, wherein the first layer has a first
weave density and the second layer has a second weave density that
is different that the first weave density.
27. The method of claim 20, wherein the adjunct is configured to
apply a pressure of at least 3 gf/mm.sup.2 to the captured tissue
for at least 3 days when the adjunct is stapled thereto.
28. The method of claim 20, wherein the first fibers are
multifilament fibers and the second fibers are monofilament
fibers.
29. The method of claim 20, wherein at least one of the first
fibers and the second fibers include oxidized regenerated cellulose
fibers.
30. The method of claim 20, wherein at least one of the first
fibers and the second fibers have a fiber diameter of about 0.024
mm to 0.3 mm.
31. The method of claim 20, further comprising weaving third fibers
into the first layer, wherein the first fibers are formed of a
first bioabsorbable polymer and the third fibers are formed of a
third bioabsorbable polymer that degrades at a rate greater than
that of the first bioabsorbable polymer.
32. The method of claim 20, wherein the first fibers are formed of
a first bioabsorbable polymer, and wherein the first bioabsorbable
polymer is formed of at least one of poly-L-lactic acid, a
copolymer of glycolide and L-lactide, a copolymer of glycolic acid
and lactic acid, poly(lactic-co-glycolic acid), poly(lactic acid),
polyglycolide, and a copolymer of glycolide, caprolactone,
trimethylene carbonate, and lactide.
33. The method of claim 20, wherein the second fibers are formed of
a second bioabsorbable polymer, and wherein the second absorbable
bioabsorbable polymer is formed of at least one of polydioxanone, a
copolymer of polydioxanone and polyglycolide, a copolymer of
lactide and polycaprolactone), a copolymer of glycolide, dioxanone,
and trimethylene carbonate, polyhydroxyalkanoate, and
polyglyconate.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 16/806,252, filed Mar. 2, 2020, and entitled
"ADJUNCT MATERIALS AND METHODS OF USING SAME IN SURGICAL METHODS
FOR TISSUE SEALING," which is a continuation of U.S. patent
application Ser. No. 16/119,292, filed Aug. 31, 2018, now issued as
U.S. Pat. No. 10,966,722, and entitled "ADJUNCT MATERIALS AND
METHODS OF USING SAME IN SURGICAL METHODS FOR TISSUE SEALING,"
which is a continuation of U.S. patent application Ser. No.
14/300,954, filed Jun. 10, 2014, now issued as U.S. Pat. No.
10,172,611, and entitled "ADJUNCT MATERIALS AND METHODS OF USING
SAME IN SURGICAL METHODS FOR TISSUE SEALING," each of which is
incorporated herein by reference in its entirety.
FIELD
[0002] The subject matter disclosed herein relates to surgical
instruments, and in particular to methods, devices, and components
thereof for cutting and stapling tissue.
BACKGROUND
[0003] Surgical staplers are used in surgical procedures to seal,
divide, and/or transect tissues in the body by closing openings in
tissue, blood vessels, ducts, shunts, or other objects or body
parts involved in the particular procedure. The openings can be
naturally occurring, such as passageways in blood vessels, airways
or an internal lumen or organ like the stomach, or they can be
formed by the surgeon during a surgical procedure, such as by
puncturing tissue or blood vessels to form a bypass or an
anastomosis, or by cutting tissue during a stapling procedure.
[0004] Most staplers have a handle with an elongate flexible or
rigid shaft having a pair of opposed jaws formed on an end thereof
for holding and forming staples therebetween. At least one of the
opposed jaws is movable relative to the other jaw. In the case of
laparoscopic surgery, often one jaw is fixed and the other is
movable. In some devices (for example an open linear stapler), the
opposed jaws can be separated by the operator and reassembled
providing the relative motion needed for tissue placement. The
staples are typically contained in a staple cartridge, which can
house multiple rows of staples and is often disposed in one of the
two jaws for ejection of the staples to the surgical site. In use,
the jaws are positioned so that the object to be stapled is
disposed between the jaws, and staples are ejected and formed when
the jaws are closed and the device is actuated. Some staplers
include a knife configured to travel between rows of staples in the
staple cartridge to longitudinally cut the stapled tissue between
the stapled rows. Placement of the device, manipulation of
components or systems of the device, and other actuations of the
device such as articulation, firing, etc. can be accomplished in a
variety of ways, such as electromechanically, mechanically, or
hydraulically.
[0005] There are various types of staplers suited for particular
surgical procedures. For example, linear staplers include a handle
with an elongate shaft having a pair of opposed jaws formed on an
end thereof for holding and forming staples therebetween. At least
one of the opposed jaws is movable relative to the other. The
staples are typically contained in a staple cartridge assembly,
which can house multiple rows of staples and is often disposed in
one of the two jaws for ejection of the staples to the surgical
site. Circular staplers have a handle and an elongate shaft with an
anvil and a cartridge assembly disposed on a distal end of the
elongate shaft, the anvil axially movable relative to the cartridge
assembly and configured to form staples therebetween and deploy the
staples into tissue.
[0006] While surgical staplers have improved over the years, a
number of problems can potentially arise. Although rare, as
illustrated in FIG. 1, one problem is that leaks can occur due to
staples S forming tears H when penetrating a tissue T or other
object in which the staples S are disposed. Blood, air,
gastrointestinal fluids, and other fluids can seep through the
tears H formed by the staples S, even after the staples S are fully
formed. The tissue T being treated can also become inflamed due to
the manipulations and deformations that can occur during stapling.
Still further, staples, as well as other objects and materials
implanted during stapling procedures, generally lack the same
characteristics as tissue in which they are implanted. For example,
staples and other objects and materials can lack the natural
flexibility of the tissue in which they are implanted. A person
skilled in the art will recognize that it is often desirable for
tissue to maintain as much of its natural characteristics as
possible after staples are disposed therein.
[0007] In the particular case of stapling bronchial tubes, such as
during lung resection, it is important for no leaks to be present
after stapling so that air does not inappropriately enter or exit
the lung and/or the thoracic cavity. Air escaping a stapled
bronchial tube through a leak can interfere with breathing and lung
function, such as by preventing full intake of air. Air exiting a
stapled bronchial tube into the thoracic cavity through a leak is
unsterile and can cause infection and/or other complications in the
otherwise sterile environment of the thoracic cavity. However, it
can be difficult to prevent leaks in bronchial tubes for a variety
of reasons. The small size of bronchial tubes can make delivery of
any sealing materials into bronchial tubes difficult, inflammation
due to implanted staples and/or other objects and materials can
cause bronchial tubes to close or nearly close since they have
small diameters, and/or it can be difficult for sealing materials
introduced into a bronchial tube to withstand the repeated
expansion and contraction of the lung without failing and/or moving
within the tube so as to break the seal of the bronchial tube.
[0008] In the particular case of stapling a colon, it is important
that the staple line of the anastomosis is substantially sealed so
that gastrointestinal solids and fluid remain in the organ. Leakage
from the tubular body organ, e.g. a colon, can interfere with
normal digestive function and can introduce bacteria into other
portions of the body, causing infection. However, it can be
difficult to prevent leaks in a tubular body organ for a variety of
reasons. For example, it can be difficult for the tissue disposed
near the staple line to withstand repeated expansion and
contraction that occurs when solids and fluid passes through the
colon. Additionally, it can be difficult to deliver sealant to the
tubular body organ and control the position of the sealant when it
is curing from a liquid state to a solidified state
[0009] Accordingly, there remains a need for improved devices,
materials, and methods for stapling tissue, or other objects or
body parts such that leaking and inflammation is minimized while
substantially maintaining the natural characteristics of the
treatment region.
SUMMARY
[0010] A staple cartridge for use with a surgical stapler is
provided and can include a cartridge body and an adjunct material.
The cartridge body can have a plurality of staple cavities
configured to seat staples therein. The adjunct material can be
mated to the cartridge body and configured to be detached therefrom
as the staples are deployed from the cartridge body and into
tissue. The adjunct material can include a solid central portion
sized and shaped to substantially correspond to the cartridge body,
and a wing portion extending along at least two sides of the solid
central portion such that the wing portion extends beyond a lateral
boundary of the cartridge body in a direction traverse to a
longitudinal axis of the cartridge body.
[0011] The solid central portion of the adjunct material can vary
in any number of ways. For example, the solid central portion of
the adjunct material can be substantially rectangular shaped. In
certain aspects, the solid central portion can include first and
second opposed edges. In other aspects, the wing portion can extend
along the first and second opposed edges of the adjunct material.
In use, the solid central portion can be configured to reinforce a
seal around staples when the adjunct material and the staples are
coupled to tissue.
[0012] The wing portion can have various features. For example, the
wing portion can include rounded corners. For another example, the
wing portion can have a mesh structure. In certain aspects, the
wing portion can have plurality of openings formed therein. In use,
the wing portion can be configured to distribute or otherwise alter
a strain or deformation present in tissue beyond the staple line
when the adjunct material is disposed on tissue.
[0013] The solid and wing portions can be formed from various
materials. In certain aspects, the solid and wing portions can be
formed from a single polymer. In certain aspects, the solid and
wing portions can be formed from more than one material or type of
material. In certain aspects, the solid and wing portions can be
formed from different materials. In other aspects, the wing portion
can be more flexible than the solid central portion of the adjunct
material.
[0014] An end effector for a surgical instrument is provided and
can include first and second jaws, the first jaw having a cartridge
body removably attached hereto and the cartridge body having a
plurality of staple cavities configured to seat staples therein.
The second jaw can include an anvil with a plurality of staples
forming openings formed therein, at least one of the first and
second jaws being movable relative to the other jaw. The end
effector can include a buttress having a width greater than a width
of at least one of the cartridge body and the anvil, the buttress
having a compressible, central region configured to seal around a
staple and a strain relief region adjacent to the compressible
region. The strain relief region can have a plurality of openings
formed therein and the strain relief region can extend from at
least two sides of the central region. In use, the buttress can be
releasably retained on at least one of the cartridge body and the
anvil and can be configured to be released therefrom upon
deployment of staples from the cartridge body and into the
compressible region of the buttress.
[0015] The end effector can vary in a number of ways. In certain
aspects, the plurality of openings include slits. When the buttress
and the staples are deployed into tissue, the plurality of slits
can extend parallel to longitudinal axes of the staples. In other
aspects, the plurality of openings are spaced apart such that the
strain relief region is more flexible along a lateral portion
thereof than a portion of the strain relief region adjacent to the
compressible region. In other aspects, the plurality of openings
are shaped and spaced apart such that the strain relief region is
more flexible along a longitudinal portion thereof than a portion
of the strain relief region adjacent to the compressible
region.
[0016] A method for implanting a tissue reinforcement material onto
tissue is provided and includes engaging tissue between a cartridge
assembly and an anvil of a surgical stapler at a surgical site, at
least one of the cartridge assembly and the anvil having a tissue
reinforcement material releasably retained thereon. The tissue
reinforcement material can include a compressible, central region
configured to seal around a staple and a flexible supportive region
adjacent to the central region and defining an edge of the tissue
reinforcement material. Actuating the surgical stapler can eject
staples from the cartridge assembly so as to form a staple line
through the central region and into the tissue to hold the tissue
reinforcement material at the surgical site.
[0017] The method can vary in any number of ways. For example,
actuating the surgical stapler can eject the staples through the
central region and does not eject the staples through the flexible
supportive region of the tissue reinforcement material. In certain
aspects, the cartridge assembly and the anvil can be inserted into
the surgical site with the flexible supportive region folded around
at least one of the cartridge assembly and the anvil. Actuating the
surgical stapler can advance a cutting member through the tissue
reinforcement material and releases the tissue reinforcement
material from the surgical stapler. In certain aspects, actuating
the surgical stapler advances the cutting member through the
central region of the tissue reinforcement material.
[0018] Methods for implanting a tissue reinforcement material onto
tissue are provided. The method can include engaging tissue between
a cartridge assembly and an anvil of a surgical stapler at a
surgical site, at least one of the cartridge assembly and the anvil
having a tissue reinforcement material retained thereon. The tissue
reinforcement material can include a central region configured to
provide a seal around a staple penetration site (e.g. in the
tissue, in the central region, etc.) and an outer region adjacent
to the central region and defining an edge of the tissue
reinforcement material. Actuating the surgical stapler can eject
staples from the cartridge assembly so as to form a staple line
through the central region and into the tissue to hold the tissue
reinforcement material at the surgical site. After actuating the
surgical stapler, sealant can be delivered to the tissue
reinforcement material when the sealant is in a first, liquid state
such that the sealant solidifies thereon and reinforces a seal of
the tissue at the staple line.
[0019] The method can vary in any number of ways. In certain
aspects, actuating the surgical stapler ejects the staples through
the central region of the tissue reinforcement material. The method
can further include inserting the cartridge assembly and the anvil
into the surgical site with the outer region of the tissue
reinforcement material folded around at least one of the cartridge
assembly and the anvil. Actuating the surgical stapler can release
the tissue reinforcement material from the surgical stapler. In
certain aspects, the surgical stapler advances the cutting member
through the central region of the tissue reinforcement material. In
other aspects, the surgical stapler forms a staple line having at
least two rows of staples.
[0020] The sealant can be delivered to tissue in various ways. In
certain aspects, the sealant is delivered through an applicator
tool positioned adjacent to the tissue reinforcement material.
Delivering the sealant can include depositing the sealant onto both
the central and outer regions of the reinforcement material. In
certain aspects, the sealant is delivered to the tissue
reinforcement material in the first, liquid state, and the sealant
penetrates a space in the tissue at the staple line and solidifies
therein.
[0021] Systems for reinforcing a tissue seal are also provided. The
system can include a sealant, a container, and an applicator tool.
The sealant can be configured to transition from a first liquid
state to a second solid state. The container can be configured to
retain the sealant therein when the sealant is in the first liquid
state, the container having a first port for receiving a gas and a
second port for outputting nebulized sealant. The applicator tool
can be coupled to the second port of the container, the applicator
tool being configured to deliver the nebulized sealant to a
surgical site.
[0022] The system can vary in any number of ways. In certain
aspects, the applicator tool is a trocar. In other aspects, the gas
includes carbon dioxide. In other aspects, the sealant includes a
mixture of collagen, fibrinogen, and thrombin. These biologic
materials may be derived from human and/or animal sources. The
sealant can be configured to transition from the first liquid state
to the second solid state after a predetermined amount of time. The
system can include additional components. For example, a first tube
can extend between the second port of the container and the
applicator for receiving nebulized sealant.
[0023] Methods for delivering sealant to a body of a patient are
also provided. The method can include delivering gas to a container
having a sealant retained therein, thereby transitioning the
sealant from a first, liquid state to a second, nebulized state.
The nebulized sealant can be delivered through an applicator tool
extending through an access port in a patient, the nebulized
sealant solidifying onto tissue and forming a seal thereon.
[0024] The method can be performed in various ways. For example,
the applicator tool can be positioned in a thoracic cavity of a
patient prior to delivering the gas to the container. In certain
aspects, the applicator tool includes a trocar, and nebulized
sealant is delivered directly through the trocar and into the
patient. The method can include positioning a distal end of the
applicator tool adjacent to a staple line in the tissue prior to
delivering the nebulized sealant to the tissue. In certain aspects,
the hardened sealant is absorbed into the body after a
predetermined passage of time.
[0025] Some embodiments relate to a staple cartridge assembly for
use with a surgical stapler. In one embodiment, the staple
cartridge assembly can include a cartridge body having a plurality
of staple cavities configured to seat staples therein, and a tissue
reinforcement construct removably attached to the cartridge body
and configured to be delivered to tissue by deployment of the
staples in the cartridge body. The tissue reinforcement construct
can include a first, absorbable material encompassing a swellable,
hydrophilic second material such that the second material is
maintained within the first material in a constrained
configuration. The second material can have a preconfigured shape
such that, in an unconstrained configuration, the second material
is adapted to expand to the preconfigured shape in which a
peripheral edge portion of the second material has a thickness that
is greater than a central portion of the second material.
[0026] The assembly can have any number of variations. For example,
at least a portion of the first material can be less hydrophilic
than the second material. For another example, the first material
can be brittle. For yet another example, the second material can
include a foam material. For another example, the first material
can be selectively dissolvable such that portions of the first
material encompassing the peripheral edge portions of the second
material are adapted to dissolve at a faster rate than portions of
the first material encompassing the central portion of the second
material. For still another example, the first material can include
at least one first portion and at least one second portion, and the
first material can be selectively dissolvable such that the at
least one first portion is adapted to dissolve at a faster rate
than the at least one second portion. For another example, the
first material can be selectively absorbable such that portions of
the first material encompassing the peripheral edge portions of the
second material are adapted to absorb at a faster rate than
portions of the first material encompassing the central portion of
the second material. For yet another example, the first material
can include at least one first portion and at least one second
portion, and the first material can be selectively absorbable such
that the at least one first portion is adapted to absorb at a
faster rate than the at least one second portion. For another
example, the first material can be selected from the group
consisting of polydioxanon, polyhydroxyalkanoate (PHA),
polyglycerol sebacate (PGS), polyglycolic acid, polylactic acid
(PLA), poliglecaprone 25, polyglactin 910, poly glyconate,
polyglycolide (PGA), polyglycolide-trimethylene carbonate
(PGA/TMC), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP),
poly(vinyl alcohol) (PVA), absorbable polyurethanes, a blend
thereof, and a copolymer thereof. For still another example, the
second material can be selected from the group consisting of
polydioxanon, polyhydroxyalkanoate (PHA), Polyglycerol sebacate
(PGS), polyglycolic acid, polylactic acid (PLA), poliglecaprone 25,
polyglactin 910, poly glyconate, polyglycolide (PGA),
polyglycolide-trimethylene carbonate (PGA/TMC), polyhydroxybutyrate
(PHB), poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA),
absorbable polyurethanes, a blend thereof, and a copolymer thereof.
For yet another example, the assembly can include at least one
therapeutic agent incorporated into at least one of the first
material and the second material, and the at least one therapeutic
agent can be effective to be released upon one of absorption of the
first material and expansion of the second material upon exposure
to moisture. For another example, the tissue reinforcement
construct can be shaped such that a cross-section of the peripheral
edge portion of the tissue reinforcement construct is larger than a
cross-section of the central portion of the tissue reinforcement
construct, and the central portion can be closer to a longitudinal
axis of the tissue reinforcement construct than the peripheral edge
portion. The preconfigured shape can be such that the central
portion of the second material transitions to a large radius at the
peripheral edge.
[0027] In another embodiment, a staple cartridge assembly for use
with a surgical stapler can include a cartridge body having a
plurality of staple cavities configured to seat staples therein,
and an adjunct material releasably retained on the cartridge body
and configured to be delivered to tissue by deployment of the
staples in the cartridge body. The adjunct material can include a
first material encompassing a second material. The adjunct material
can be configured to be penetrated by the staples being delivered
to the tissue such that the first material is penetrated so as to
expose the second material to moisture, and the second material can
be configured to expand to form a seal around at least one staple
of the staples inserted therethrough upon the exposure to
moisture.
[0028] The first material can be formed from a variety of
materials; particularly advantageous are those materials that are
absorbable and capable bearing compressive and bending loads. They
may be present in continuous form so as to fully encapsulate the
materials making up the center of the device, or alternately they
might be present in a non-continuous form. These non-continuous
forms include, but are not limited to, otherwise encapsulating
forms with minute openings allowing water or bodily fluids to
access the materials making up the center of the device to
facilitate rapid hydration to allow expansion of the center
material; melt blend nonwoven forms with controlled porosity;
immiscible polymer blends having a major blend component an
absorbable polymer and a minor component being a biocompatible
water soluble polymer which is capable of rapidly dissolving
creating conduits to the central material allowing for its rapid
hydration to generate an external force on the tissue.
[0029] The absorbable polymer making up the outer layer, although
not limited to, can be selected from the group consisting of
polydioxanone [AKA poly(1,4-dioxan-2-one), or poly(p-dioxanone)];
polyglycolide [AKA polyglycolic acid], polylactide [AKA polylactic
acid] in all its forms based on the ring-opening of the
corresponding lactone monomers, L(-)-lactide, D(+)-lactide, and
meso-lactide, as well as all of its forms based upon
polycondensation of L(+)-lactic acid and D(-)-lactic acid [e.g.
poly(L(-)-lactide), poly(D(+)-lactide), poly(meso-lactide),
poly(racemic-lactide), poly(L-lactic acid), poly(D-lactic acid),
etc.]; the polycaprolactones, especially
poly(epsilon-caprolactone); polyhydroxyalkanoate (PHA); the
absorbable copolymers usually formed by the ring-opening
polymerization of the lactone monomers, L(-)-lactide, (D+)-lactide,
meso-lactide, glycolide, 1,4-dioxan-2-one, trimethylene carbonate,
and the caprolactones, especially epsilon-caprolactone, in any
molar combination or in an sequential distribution. These later
copolymers include, but are not limited to
epsilon-caprolactone/glycolide copolymers such as 25/75
poly(caprolactone-co-glycolide) [AKA poliglecaprone 25], 10/90
poly(L(-)-lacide-co-glycolide) [AKA polyglactin 910],
polyglyconate, polyglycolide-trimethylene carbonate (PGA/TMC). The
absorbable polymer can be a miscible or immiscible blend of the
previously mentioned polymers [and copolymers] in any combination.
It will be clear to one skilled in the art to select a
biocompatible material.
[0030] The second material may be formed from a variety of
materials. Advantageous materials include those that are absorbable
and can undergo a controlled degree of swelling so as to create an
external force on the tissue. Swelling might be accomplished by
hydration based on an influx of water or bodily fluids. One class
of materials that is particularly advantageous are absorbable
dehydrated hydrogels. These include the materials described in U.S.
Pat. No. 5,698,213, entitled "Hydrogels of Absorbable
Polyoxaesters" and crosslinked aliphatic polyoxaesters containing
amine and/or amido groups and blends thereof with other polymers as
described in U.S. Pat. No. 5,700,583, each of which is incorporated
herein by reference in its entirety. Other materials suitable for
the second material include water soluble polymers such as
poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), and
polyethylene glycol (PEG) or the higher molecular weight
polyethylene oxide (PEO). Additionally suitable are absorbable
polyurethanes. It is to be understood that suitable materials
include copolymers that contain a hydrophilic section and an
absorbable polyester section; this would include, by way of
example, the copolymer made by reaction of a relatively low
molecular weight alpha,omega-dihydroxy polyethylene glycol and a
lactone monomer such as L(-)-lactide, (D+)-lactide, meso-lactide,
glycolide, 1,4-dioxan-2-one, trimethylene carbonate, and the
caprolactones, especially epsilon-caprolactone, in any molar
combination or in an sequential distribution. Blends of materials
and copolymers formed from a wide variety of suitable monomers,
some already mentioned above, may be suitable. It will be clear to
one skilled in the art to select a biocompatible material.
[0031] The assembly can have any number of variations. For example,
the adjunct material can be positioned on the cartridge body such
that at least a portion of the adjunct material extends beyond the
cartridge body.
[0032] In another aspect, a method for joining tissue is provided
that in one embodiment can include engaging tissue between a
cartridge assembly and an anvil of a surgical stapler at a surgical
site. At least one of the cartridge assembly and the anvil can have
an adjunct material releasably retained thereon. The adjunct
material can include a first material, at least a portion of which
being configured to dissolve when exposed to bodily fluid, and a
second material constrained within the first material in a
constrained form. The method can further include actuating the
surgical stapler to eject staples from the cartridge into the
tissue such that at least one staple from the staples extends
through the adjunct material to maintain the material at the
surgical site. The second material can be configured to transition
to a predetermined shape upon dissolution of the first material
such that at least a peripheral edge portion of the adjunct
material has a thickness greater than a central portion of the
adjunct material. The method can have any number of variations.
[0033] Adjunct materials for use with end effectors like surgical
stapling devices, and methods for using the same, are generally
provided. In some embodiments a staple cartridge assembly for use
with a surgical stapler can include a cartridge body having a
plurality of staple cavities configured to seat staples therein and
a biocompatible, compressible adjunct material releasably retained
on the cartridge body. The adjunct material can be configured to be
delivered to tissue by deployment of the staples in the cartridge
body. The adjunct material can be a woven matrix such that the
material can have a compressible elastic core layer configured to
compress upon application of a compressive force and expand upon
removal of the compressive force, and at least one flexible
supportive layer coupled to at least one side of the compressible
elastic core layer. In some embodiments, the adjunct material can
contain a therapeutic substance such as a drug or other medicament.
Additionally, in some embodiments the adjunct material can be
selectively strengthened in certain areas.
[0034] The adjunct material can be a woven matrix such that the
adjunct material will provide tissue support for tissue within and
surrounding the staple line. In one embodiment, woven 3-D
structures are created and compressed or otherwise formed into
different shapes that have a higher density and different
mechanical properties. This woven structure allows the adjunct to
have different material characteristics in the compressed and
uncompressed states. The amount of material and degree of
compression can be used to determine the mechanical properties of
the resultant brick. Multiple fiber types can be used in the weave
to give it additional properties of interest including
compressibility, abrasion resistance, bioabsorption profile, fluid
absorption profile, substance elution characteristics, ability to
be cut with a knife, ability to swell.
[0035] In other aspects, an end effector for a surgical instrument
is provided. The end effector can include a first jaw having a
cartridge body removably attached hereto, the cartridge body having
a plurality of staple cavities configured to seat staples therein,
a second jaw having an anvil with a plurality of staples forming
openings formed therein. The adjunct material can be releasably
retained on at least one of the tissue contacting surfaces of the
cartridge body and the anvil so that it can be delivered to tissue
upon deployment of the staples. The adjunct material can be
comprised of a compressible elastic region configured to compress
upon application of a compressive force and expand upon removal of
the compressive force, and at least one flexible supportive region
adjacent to the compressible elastic region.
[0036] In other aspects a method for stapling tissue is provided.
The method can include engaging tissue between a cartridge assembly
and an anvil of an end effector, one of which has an adjunct
material releasable retained thereon, and actuating the end
effector to eject staples from the cartridge assembly into tissue.
The staples can extend through the adjunct material to maintain the
adjunct material at the surgical site.
[0037] Embodiments described herein address these and other
challenges by providing, for example, adjunct materials that seal
punctures made by surgical staples in tissue. The adjunct materials
described herein have a number of embodiments, including
embodiments in which an adjunct is disposed about a single staple
or leg thereof, or about a group of staples. Various embodiments
disclosed herein include adjuncts that seal staples in tissue from
the crown, or staple cartridge, side, or from the anvil or staple
leg side (or both).
[0038] In one aspect, for example, a staple cartridge assembly for
use with a surgical stapler is provided that can include a
cartridge body having a plurality of staple cavities, where each
staple cavity has a surgical staple disposed therein. The assembly
can further include a plurality of adjuncts, where each adjunct can
be disposed around at least one leg of a surgical staple such that
each adjunct forms a seal around the at least one leg of the
surgical staple upon deployment of the surgical staple from the
cartridge body.
[0039] The assembly can have a number of different features and/or
modifications, all of which are considered within the scope of the
invention. For example, the adjuncts can have a number of different
shapes and sizes. In some embodiments, for example, each of the
plurality of adjuncts can be in the form of a plug. In certain
embodiments, for each surgical staple of the assembly, a first
adjunct plug can be disposed around a first leg of the surgical
staple and a second adjunct plug can be disposed around a second
leg of the surgical staple such that the first and second adjunct
plugs form a seal around the first and second legs of the surgical
staple.
[0040] In other embodiments, each of the plurality of adjuncts can
be in the form of a pledget configured to seal around both a first
leg and a second leg of a surgical staple. The pledget itself can
have a number of different shapes and sizes. For example, in some
embodiments the pledget can be in the form of a rectangular box
extending along a length of a crown of a staple. Any of a variety
of other shapes are also possible.
[0041] In still other embodiments, each of the plurality of
adjuncts can be in the form of a coating disposed around a leg of a
surgical staple. The adjuncts can be disposed about solely the legs
of a staple (or a portion thereof), or about the entirety of a
staple.
[0042] In addition to shape and/or size, the plurality of adjuncts
can also be formed from a variety of materials. For example, in
some embodiments each of the plurality of adjuncts can be formed
from a swellable material that expands upon contact with body
fluids. Forming the adjuncts from such a material can enhance the
adjuncts' ability to seal a puncture in tissue created by a staple
leg. Any of a variety of biocompatible swellable materials can be
employed. For example, in certain embodiments, the swellable
material can be a hydrogel. In yet other embodiments, each of the
plurality of adjuncts can be formed from other materials, such as a
foam.
[0043] The plurality of adjuncts can be located at a variety of
positions with respect to the plurality of staples, and can be
configured in certain embodiments to move relative to a staple
during implantation in tissue. For example, in certain embodiments
each of the plurality of adjuncts can be positioned adjacent to a
crown of a surgical staple prior to deployment from the cartridge
body. In other embodiments, each of the plurality of adjuncts can
be positioned at a distal end of the at least one leg of the
surgical staple opposite a crown of the surgical staple prior to
deployment from the cartridge body. In such an embodiment, for
example, each of the plurality of adjuncts can be configured to
slide over the at least one leg of the surgical staple. By way of
further example, if an adjunct is positioned at a distal end of a
staple leg, the action of forcing the staple leg through tissue can
slide the adjunct toward a crown of the staple such that the
adjunct is sandwiched between the tissue and the crown of the
staple, thereby sealing the puncture created by the staple leg. In
other embodiments, adjuncts can be positioned at other locations,
such as on an anvil of a surgical stapler opposite the cartridge
body, as described in more detail below.
[0044] In another aspect, a staple cartridge assembly for use with
a surgical stapler is provided that can include a cartridge body
having a plurality of staple cavities and a plurality of surgical
staples disposed within the plurality of staple cavities and
configured to be ejected therefrom into tissue. The assembly can
also include a plurality of sealing adjuncts disposed within the
plurality of staple cavities and configured to be ejected therefrom
along with the plurality of surgical staples without contacting the
cartridge body. By avoiding contact between the cartridge body and
the sealing adjuncts, the adjuncts can be prevented from
interfering with sliding movement of the staples relative to the
cartridge body.
[0045] The adjuncts can be prevented from contacting the cartridge
body in a number of different ways. For example, in some
embodiments each of the plurality of sealing adjuncts can be
positioned such that a surgical staple shields the sealing adjunct
from contact with the cartridge body during ejection. This can be
accomplished, for example, by coupling one or more sealing adjuncts
to a staple so that the staple leads the adjunct as it is ejected
from the cartridge body, thereby shielding the adjunct from contact
with the cartridge body.
[0046] Other configurations for coupling adjuncts to a staple are
also possible. For example, in certain embodiments, each of the
plurality of sealing adjuncts can be positioned adjacent to a
junction between a leg of a surgical staple and a crown of the
surgical staple.
[0047] In still other embodiments, each of the plurality of staple
cavities can be shaped to accommodate passage of at least one
sealing adjunct coupled to a surgical staple. For example, each of
the plurality of staple cavities includes at least one cut-out
formed on opposing ends of the staple cavity to accommodate the at
least one sealing adjunct.
[0048] As mentioned above, the adjuncts can be formed from a
variety of biocompatible materials and have any of a variety of
shapes and/or sizes. In some embodiments, each of the plurality of
sealing adjuncts can be configured to expand in volume upon contact
with tissue.
[0049] In another aspect, a method for stapling tissue is provided
that can include engaging tissue between a cartridge assembly and
an anvil on a surgical stapler, and actuating the surgical stapler
to eject at least one staple from the cartridge assembly into the
tissue. Further, at least one leg of the at least one staple can
extend through a sealing adjunct such that the adjunct forms a seal
between the tissue and the leg.
[0050] In some embodiments, the sealing adjunct can be coupled to a
distal end of the at least one leg of the at least one staple. In
such an embodiment, actuating the surgical stapler can cause the
adjunct to slide toward a crown of the at least one staple and seal
a hole formed in the tissue by the at least one leg. In other
embodiments, however, the sealing adjunct can be coupled to a crown
of the at least one staple and actuating the surgical stapler can
cause the adjunct to eject from the cartridge assembly with the
crown such that the sealing adjunct is disposed between the crown
of the at least one staple and the tissue.
[0051] As mentioned above, various embodiments described herein can
include sealing adjuncts positioned away from the crown of a
surgical staple, such as on the opposite side of stapled tissue
near staple legs that are deformed by an anvil of a surgical
stapler. And, in some embodiments, adjuncts can be positioned at
both locations to seal punctures from both sides of the tissue
and/or staple.
[0052] In one aspect, a surgical device includes an end effector
that can include first and second jaws, where the first jaw has a
cartridge body removably attached thereto and the second jaw having
an anvil. The cartridge body can have a plurality of staple
cavities configured to seat staples therein and the anvil can have
a plurality of staple forming openings formed therein. Further, at
least one of the first and second jaws can be movable relative to
the other jaw. The end effector can also include a plurality of
sealing adjunct segments coupled to one another and at least one of
the first and second jaws such that a staple ejected from the
cartridge body passes through one of the plurality of sealing
adjunct segments and tissue disposed between the first and second
jaws.
[0053] In some embodiments, each of the plurality of sealing
adjunct segments can span a plurality of staple forming openings.
In other embodiments, however, each of the plurality of sealing
adjunct segments can cover a single staple forming opening.
[0054] The plurality of sealing adjunct segments can be coupled to
one another in a variety of manners. For example, in some
embodiments each of the plurality of sealing adjunct segments can
be coupled to one another by a plurality of connecting branches.
Further, at least one of the first and second jaws can includes a
plurality of features formed thereon that are configured to sever
the plurality of connecting branches when deploying staples into
tissue disposed between the first and second jaws. Destroying the
connecting branches between sealing adjuncts can allow for greater
compliance of tissue between adjacent staples, thereby reducing
forces that can otherwise act to enlarge a puncture surrounding a
staple leg.
[0055] In other embodiments, the plurality of sealing adjunct
segments can be coupled to one another by a plurality of threads,
or by a woven mesh. In still other embodiments, the plurality of
sealing adjunct segments can be coupled to one another by a
connective film extending over a surface of at least one of the
first and second jaws. The connective film can, in some
embodiments, have a first thickness and each of the plurality of
sealing adjunct segments can have a second, greater thickness. In
certain embodiments, the greater thickness of the sealing adjunct
segments can extend into the plurality of staple forming openings.
The plurality of sealing adjunct segments in such an embodiment
does not significantly reduce the available clearance between the
jaws of a surgical stapler, thereby allowing use with thicker
tissue.
[0056] In addition to features that sever connections between
sealing adjunct segments, at least one of the first and second jaws
of the end effector can include one or more features formed thereon
that are configured to at least one of align and secure the
plurality of sealing adjunct segments thereto. Such features can be
configured to mate with complementary features coupled to the
plurality of sealing adjuncts such that the plurality of sealing
adjuncts can be temporarily coupled to the end effector in a proper
position and/or orientation. Examples of such features can include
hooks and loops, plastic retainers, etc.
[0057] In certain embodiments, the plurality of sealing adjunct
segments can have the same shape and can be arrayed in a repeating
pattern over a length of the end effector. In other embodiments,
the plurality of sealing adjunct segments can have a plurality of
shapes and can be arrayed in an alternating pattern over a length
of the end effector. Regardless, the plurality of sealing adjunct
segments can cover each of the plurality of staple cavities such
that each staple ejected into tissue passes through one of the
plurality of sealing adjuncts.
[0058] In another aspect, an end effector for a surgical instrument
is provided that includes first and second jaws, the first jaw
having a cartridge body removably attached thereto and the second
jaw having an anvil with a plurality of staple forming openings
formed therein. The cartridge body can have a plurality of staple
cavities configured to seat staples therein and at least one of the
first and second jaws can be movable relative to the other jaw. The
end effector can further include a viscous sealant disposed within
the plurality of staple forming openings of the anvil, wherein the
viscous sealant within each staple forming opening is retained
therein by a film extending across the staple forming opening. In
such an embodiment, the plurality of discrete pockets of viscous
sealant can be the plurality of sealing adjunct segments described
herein.
[0059] In some embodiments, the film extending across each staple
forming opening can be formed from viscous sealant that is at least
partially cured by exposure to any of a chemical, ultraviolet
light, and heat. In other embodiments, however, the film extending
across each staple forming opening can be formed from a second
material overlaid on the viscous sealant.
[0060] In addition the film extending across each staple forming
opening, in some embodiments each of the plurality of staple
forming openings can include at least one retainer formed thereon
to aid in retaining the viscous sealant within the opening.
Further, while in some embodiments the film can extend solely
across each staple forming opening of the anvil, in other
embodiments the film can also extend between adjacent staple
forming openings.
[0061] In another aspect, a surgical method is provided that can
include filling a plurality of staple forming openings in an anvil
of a surgical stapler with a viscous sealant, and forming a film
over the plurality of staple forming openings in the anvil such
that the film retains the viscous sealant within the staple forming
openings.
[0062] As mentioned above, in certain embodiments forming the film
can include at least partially curing the viscous sealant by
exposure to any of a chemical, ultraviolet light, and heat.
[0063] In other embodiments, however, forming the film can include
overlaying a second material over the viscous sealant disposed
within the staple forming openings.
[0064] In still other embodiments, the method can further include
actuating the surgical stapler to drive a plurality of staples
through tissue and into the plurality of staple forming openings
such that the plurality of staples puncture the film and the
viscous sealant forms a seal around the plurality of staples.
[0065] A surgical device is provided in the form of an applicator
for coupling adjunct material to a surgical stapler. In one aspect,
for example, a surgical device is provided that can include at
least one nozzle formed at a proximal end of the device that is
configured to receive a sealant, and an applicator formed at a
distal end of the device that is configured to deliver the sealant
received by the at least one nozzle. In one aspect, the applicator
can be removably and replacably attached to the nozzle. The
applicator can be configured to interface with at least one of a
first and second jaw of a surgical stapler such that the sealant
delivered from the applicator can be deposited into a plurality of
openings formed in the surgical stapler. The plurality of openings
can be, for example, any of a plurality of staple cavities located
in a cartridge body, or a plurality of staple forming openings
formed in an anvil.
[0066] In some embodiments, it can be desirable to prevent adjunct
material, such as the sealant, from being deposited in certain
areas of a surgical stapler. For example, in some embodiments, it
can be desirable to keep a cutting member guide path free from
sealant. Accordingly, in some embodiments, the surgical device can
include a shield disposed within the applicator such that the
shield prevents the sealant delivered by the applicator from
entering a cutting guide slot formed in at least one of the first
and second jaw of the surgical stapler.
[0067] Still further, it can be desirable to remove any excess
sealant from the surgical stapler prior to use. In some embodiments
then, the surgical device can include a squeegee formed on a
distal-most edge of the applicator to remove excess sealant.
[0068] There are a variety of biocompatible sealants that can be
used with the devices and methods described herein. Certain of
these sealants can be multi-part, such as two-part sealants that
must be mixed before being coupled to the surgical stapler.
Therefore, in some embodiments, the surgical device can include two
nozzles formed at a proximal end thereof, and the applicator can
include a common lumen extending therethrough to allow sealant
received from each nozzle to mix before being delivered from a
distal end of the applicator. In still other embodiments, the two
nozzles can be configured to introduce sealant into the common
lumen at different rates, e.g., for multi-part sealants that
require components at various mixing ratios.
[0069] In some embodiments, the surgical device can further include
a container of sealant coupled to the at least one nozzle. The
container can be sealed for sterility purposes in certain
embodiments, and the at least one nozzle can include a piercing tip
configured to puncture a seal formed on the container. The
container can have any of a variety of shapes and/or sizes. In some
embodiments, however, the container can be a syringe.
[0070] In another aspect, a method for applying sealant to a
surgical device is provided that can include applying a viscous
sealant to a jaw member of a surgical stapler, wherein the jaw
member includes a plurality of openings formed therein that can
receive the sealant. The method can further include removing excess
viscous sealant from the jaw member such that only sealant
deposited within the plurality of openings remains.
[0071] The viscous sealant can be applied to the jaw member in a
variety of manners. For example, in some embodiments applying the
viscous sealant to the jaw member can include sliding an applicator
along a length of the jaw member as sealant is introduced through
the applicator. Further, in certain embodiments removing excess
viscous sealant can include sliding a squeegee along a length of
the jaw member. In some embodiments, the applicator can include a
squeegee formed on a distal-most edge thereof to allow both sealant
application and removal of excess sealant with a single pass over
the jaw member.
[0072] In order to help retain the viscous sealant within the
plurality of openings of the jaw member (e.g., staple cavity
openings in a cartridge body or staple forming openings in an
anvil), the method can further include at least partially curing
the viscous sealant after application to the jaw member. At least
partially curing the viscous sealant can create a hardened layer
extending across the opening that can retain the uncured sealant
within the opening until, for example, ejection of a staple from
the surgical stapler punctures the hardened layer of the sealant.
Curing the viscous sealant can be accomplished in a variety of
manners, including, for example, by exposing the sealant to any of
a chemical, ultraviolet light, and heat.
[0073] In a further aspect, a method for stapling tissue is
provided that can include applying a non-compressible sealant into
a plurality of staple forming openings formed in an anvil of a
surgical stapler, and compressing tissue between the anvil and a
cartridge body of the surgical stapler. The method can further
include actuating the surgical stapler to deliver a plurality of
staples from the cartridge body through the tissue and into the
plurality of staple forming openings containing the
non-compressible sealant. The non-compressible sealant can prevent
tissue compressed between the anvil and the cartridge body from
entering the plurality of staple forming openings upon actuation of
the surgical stapler. This can be beneficial to prevent staples
from being formed within tissue (i.e., without being passed
completely through tissue).
[0074] As in the embodiments described above, applying the
non-compressible sealant can, in certain embodiments, include
sliding an applicator along a length of the anvil. In other
embodiments, applying the non-compressible sealant can include
mixing a multi-part sealant just prior to delivery into the
plurality of staple forming openings. The multi-part sealant can be
mixed at any of a variety of ratios, depending on the type of
sealant used.
[0075] In other embodiments, the method can further include
removing excess sealant from the anvil. This can be accomplished
using a separate squeegee or other scraping implement, or it can be
accomplished in a single pass if an applicator used to deposit the
non-compressible sealant includes a squeegee or scraper
thereon.
[0076] In still other embodiments, the method can further include
at least partially curing the non-compressible sealant after
application to the anvil. Such a curing process can harden at least
a portion of the non-compressible sealant extending across the
plurality of staple forming openings, thereby assisting in
retaining the non-compressible sealant within the plurality of
staple forming openings.
[0077] The devices and methods described herein can be utilized in
a variety of different types of tissue throughout the body. Certain
embodiments described herein can provide a more effective procedure
for forming an anastomosis between two body lumens. Such a
procedure is often employed when, for example, resecting a portion
of a patient's colon.
[0078] A staple cartridge assembly for use with a surgical stapler
is provided that can include a cartridge body having a plurality of
staple cavities, where each staple cavity has a surgical staple
disposed therein. The assembly can also include a plurality of
sealing adjuncts coupled to the cartridge body such that a staple
ejected from the cartridge body passes through one of the plurality
of sealing adjuncts before entering into tissue adjacent to the
cartridge body. Further, the plurality of staple cavities can be
arranged such that a greater density of staple cavities is present
at a proximal end and a distal end of the cartridge body than a
density of staple cavities that is present in a middle portion
extending between the proximal and distal ends. Further still, the
plurality of sealing adjuncts can be positioned at the proximal and
distal ends of the cartridge body. Positioning the plurality of
sealing adjuncts at a proximal and distal end of the cartridge body
can keep the sealing adjuncts from interfering with operation of a
circular stapler that can resect tissue extending along the middle
portion to form an anastomosis.
[0079] In some embodiments, however, the assembly can further
include at least one suture thread coupled to and extending between
the plurality of sealing adjuncts positioned at the proximal and
distal ends of the cartridge body. Furthermore, to prevent
interference of the at least one suture thread with any staples
ejected from the cartridge body, the at least one suture thread can
be offset from any staple cavity positioned in the middle portion
of the cartridge body.
[0080] In other embodiments, the assembly can also include a washer
disposed between the plurality of sealing adjuncts at the proximal
and distal ends of the cartridge body and coupled to the at least
one suture thread extending therebetween. More particularly, in
certain embodiments, a first suture thread can extend between at
least one sealing adjunct at a proximal end of the cartridge body
and the washer, and a second suture thread can extend between the
washer and at least one sealing adjunct at a distal end of the
cartridge body. The first and second suture threads can have
identical or different lengths, depending on the particular
embodiment employed.
[0081] The washer can be formed from a variety of materials and can
have a number of different sizes. In some embodiments, for example,
the washer can be configured to elastically compress when the
cartridge body is compressed against tissue. In other embodiments,
the washer can be rigid and the cartridge body can include a
depression formed therein to accommodate the washer during
actuation of the surgical stapler. In still other embodiments, a
compressible washer can be utilized in combination with a cartridge
body having a recess formed therein such that a required amount of
elastic compression can be reduced.
[0082] Including a connecting suture thread and washer in the
assembly can allow for complete resection of the staple line
including the sealing adjuncts when forming an anastomosis, as
described in more detail below.
[0083] In a further aspect, a surgical method is provided that can
include transecting a body lumen using a linear surgical stapler
that delivers a plurality of sealing adjuncts in combination with a
plurality of surgical staples at a proximal end and a distal end of
a staple line formed by the surgical stapler. Further, the
plurality of sealing adjuncts positioned at the proximal and distal
ends of the staple line can be coupled to one another by at least
one suture thread. The method can further include positioning a
circular surgical stapler to create an anastomosis with a second
body lumen across the staple line. The method can also include
drawing the proximal and distal ends of the staple line into a
central lumen of the circular stapler using the at least one suture
thread extending between the plurality of sealing adjuncts
positioned at the proximal and distal ends of the staple line, and
actuating the circular stapler to form the anastomosis and resect
the staple line.
[0084] In certain embodiments, the linear surgical stapler can also
deliver a washer positioned at a mid-point between the proximal and
distal ends of the staple line, and the washer can be coupled to
the at least one suture thread.
[0085] In some embodiments, positioning the circular stapler to
create an anastomosis can include passing a stapler trocar across
the staple line and through the washer. Still further, in certain
embodiments drawing the proximal and distal ends of the staple line
into the central lumen of the circular stapler can include
retracting the stapler trocar and the washer into the central lumen
of the circular stapler. This can allow the circular stapler to
completely resect the staple line including the sealing adjuncts
when forming the anastomosis, thereby reducing the possibility of
future leakage through the staple line formed by the linear
surgical stapler.
[0086] In still other embodiments, positioning the circular stapler
to create an anastomosis can further include mating an anvil to the
stapler trocar such that the anvil prevents the stapler trocar from
retracting through the washer. In such an embodiment, mating the
anvil to the stapler trocar can trap the washer therebetween, such
that retraction of the trocar into the central lumen of the
circular stapler will pull the washer into the central lumen as
well.
[0087] In another aspect, a surgical method is provided that can
include transecting a body lumen using a linear surgical stapler
that delivers a plurality of sealing adjuncts in combination with a
plurality of surgical staples at a proximal end and a distal end of
a staple line formed by the surgical stapler. Further, the
plurality of sealing adjuncts positioned at the proximal and distal
ends of the staple line can be coupled to a washer positioned at a
midpoint of the staple line by a plurality of suture threads. The
method can further include extending a trocar out of a central
lumen of a circular stapler cartridge disposed within the body
lumen such that the trocar crosses the staple line and passes
through the washer. The method can also include coupling the trocar
to an anvil positioned in a second body lumen such that a portion
of the anvil receives the trocar and the washer is trapped between
the anvil and the trocar. The method can further include retracting
the trocar into the central lumen of the circular stapler cartridge
to draw the anvil toward the circular stapler body while
simultaneously drawing the proximal and distal ends of the staple
line into the central lumen.
[0088] In certain embodiments, the method can also include
actuating the circular stapler cartridge to resect the staple line
and form an anastomosis between the two body lumens. As described
above, actuation can resect the entirety of the staple line formed
by the linear surgical stapler because the proximal and distal ends
of the staple line are drawn into the central lumen of the circular
stapler by their attachment to the washer via the plurality of
suture threads.
[0089] A surgical method is provided that in one embodiment
includes transorally advancing a reinforcement material into a
bronchial tube, and introducing a sealant into the bronchial tube
and applying the sealant to the reinforcement material within the
bronchial tube. The sealant can transition from a first state to a
second, harder state within the bronchial tube so as to secure the
reinforcement material in a fixed position relative to the
bronchial tube.
[0090] The method can vary in any number of ways. For example,
advancing the reinforcement material can includes advancing a
distal end of a scoping device into the bronchial tube and
introducing the reinforcement material into the bronchial tube
through the scoping device. Introducing the sealant can include
introducing the sealant into the bronchial tube through the scoping
device with the sealant in the first state. For another example,
the method can include stapling the bronchial tube and the
reinforcement material that has been introduced into the bronchial
tube. The sealant can be introduced and applied before the stapling
of the bronchial tube and the reinforcement material, or the
sealant can be introduced and applied after the stapling of the
bronchial tube and the reinforcement material. A first component of
the sealant can be introduced and applied before the stapling of
the bronchial tube and the reinforcement material, and a second
component of the sealant can be introduced and applied after the
stapling of the bronchial tube and the reinforcement material.
[0091] In another embodiment, a surgical method is provided that
includes positioning a reinforcement material within a bronchial
tube, stapling the bronchial tube and the reinforcement material so
as to form a staple line extending across the bronchial tube, and
applying a sealant to the reinforcement material within the
bronchial tube. The sealant can move from a first state to a
second, more rigid state within the bronchial tube so as to
facilitate sealing of the staple line.
[0092] The method can have any number of variations. For example,
the method can include expanding an inner diameter of the bronchial
tube with a balloon while at least one of the reinforcement
material is being positioned and the sealant is being applied. For
another example, the method can include, after positioning the
reinforcement material and prior to the stapling, locating the
reinforcement material within the bronchial tube by illuminating a
light. For still another example, the reinforcement material can
include at least one of a mesh, a non-woven matrix, a film, a
melt-blown non-woven material, a felt material, a closed-cell foam,
an open-cell foam, a sponge, a braided suture, poliglecaprone,
polyglactin, polydioxanone, collagen, oxidized regenerated
cellulose, regenerated cellulose, glycerol, glycolide, lactide,
dioxanone, trimethylene carbonate, gut suture, polypropylene,
polyethylene, polybutester fiber, stainless steel, nylon,
polyester, silk, polyvinylidene difluoride, oxidized cellulose, and
polypropylene. For another example, the sealant can include at
least one of an adhesive, fibrin thrombin, a hydrogel, fibronectin,
gelatin, collagen, Factor XIII, transglutaminase, Polyethylene
glycol, alginate, carboxymethylcellulose, methylcellulose,
hydroxypropylmethyl cellulose, pectin, polyvinyl alcohol,
polyvinylpyrrolidone, benzocaine, cyanoacrylate, polyglycolic acid,
hyaluronic acid, magnesium peroxide, 2-octyl cyanoacrylate, and
hydrogen peroxide. For yet another example, the method can include,
after positioning the reinforcement material and prior to the
stapling, locating the reinforcement material within the bronchial
tube by positioning a magnet outside the bronchial tube. The magnet
can magnetically engage a target located within the bronchial tube
adjacent to the reinforcement material. Positioning the
reinforcement material can include introducing the reinforcement
material into the bronchial tube using a delivery device, the
target being attached to a distal end of the delivery device. The
target can include one of a Hall sensor and a second magnet.
[0093] In another embodiment, a surgical method is provided that
includes positioning a reinforcement material within a bronchial
tube, and stapling the bronchial tube and the reinforcement
material so as to form a staple line extending across the bronchial
tube with the reinforcement material engaged within the staple
line. An actuator coupled to the reinforcement material can move
from a first state to a second, harder state after the stapling so
as to facilitate sealing of the staple line.
[0094] The method can vary in any number of ways. For example, the
method can include, after positioning the reinforcement material
and prior to the stapling, locating the reinforcement material
within the bronchial tube by illuminating a light inside the
bronchial tube. For another example, the reinforcement material can
include at least one of a mesh, a non-woven matrix, a film, a
melt-blown non-woven material, a felt material, a closed-cell foam,
an open-cell foam, a sponge, a braided suture, poliglecaprone,
polyglactin, polydioxanone, collagen, oxidized regenerated
cellulose, regenerated cellulose, glycerol, glycolide, lactide,
dioxanone, trimethylene carbonate, gut suture, polypropylene,
polyethylene, polybutester fiber, stainless steel, nylon,
polyester, silk, polyvinylidene difluoride, and polypropylene. For
yet another example, the actuator can include a biologic foam. For
another example, the method can include, after positioning the
reinforcement material and prior to the stapling, locating the
reinforcement material within the bronchial tube by positioning a
magnet outside the bronchial tube. The magnet can magnetically
engage a target located within the bronchial tube adjacent to the
reinforcement material.
[0095] In one embodiment, a surgical kit is provided that includes
a liquid sealant and a sealing cuff. The liquid sealant can be
configured to cure into a solidified state. The sealing cuff can
have a sidewall with first and second ends removably mated to one
another to form an enclosed loop, and the sidewall can define an
interior chamber. In use, the sealing cuff can be configured to be
disposed around a body lumen such that the interior chamber is
sealed between the outer wall and the body lumen to allow the
liquid sealant to be received therein and to directly contact the
body lumen. The surgical kit can further include a tube coupled to
the sealing cuff and configured to deliver the sealant to the
interior chamber of the sealing cuff
[0096] The sealing cuff can vary in any number of ways. For
example, the sidewall can be substantially hemispherical and an
inner surface of the sidewall can be substantially concave. The
sealing cuff can include a plurality of protrusions formed on inner
surface of the sidewall for facilitating distribution of the
sealant within the interior chamber. In certain aspects, the
plurality of protrusions can be spaced evenly about a circumference
of the sidewall. For another example, the sealing cuff can include
sutures coupled to an inner surface of the sidewall. In certain
aspects, the sutures can be disposed in a criss-cross pattern. The
sealing cuff can further include a locking mechanism for removably
mating the first and second ends.
[0097] The surgical kit can further include at least one expandable
member configured to move from a compressed position to an expanded
position and having a shape that substantially corresponds to a
shape of the interior chamber of the sealing cuff when the at least
one expandable member is in the expanded position.
[0098] The sealant can also vary in a number of ways. For example,
the sealant can be selected from the group consisting of fibrin,
thrombin, a hydrogel, benzocaine, cyanoacrylate, polyglycolic acid,
hyaluronic acid, magnesium peroxide, hydrogen peroxide, platelet
rich plasma, and combinations thereof. In certain aspects, the
sealant can be configured to transition from the liquid to the
solidified state after a predetermined amount of time.
[0099] A surgical device is provided that includes a sealing cuff
having a ring-shaped sidewall, the sidewall defining an interior
chamber configured to hold a sealant therein. The sealing cuff can
include a plurality of extensions for distributing the sealant
within the interior chamber, the plurality of extensions being
sized and shaped such that when the sealing cuff is disposed around
a tubular body organ and sealant is delivered thereto, the sealant
is distributing substantially uniformly in thickness within the
interior chamber of the cuff and solidifies substantially
circumferentially around the organ.
[0100] The surgical device can vary in any number of ways. The
sealing cuff can further include a port formed therein and
configured to mate with a delivery tube for delivering a sealant to
the interior chamber of the cuff. The plurality of extensions can
vary in a number of ways. For example, each of the extensions can
be disposed radially around the sealing cuff. For another example,
the plurality of extensions can be spaced along an inner surface of
the interior chamber. In certain aspects, the plurality of
extensions can be substantially cylindrical-shaped.
[0101] Methods for reinforcing an anastomosis of a tubular organ
are also provided and in one embodiment, the method can include
forming an anastomosis in a tubular organ, applying a sealing cuff
around the anastomosis, the sealing cuff including at least one
strand of suture extending along an inner surface of the sealing
cuff and having a woven structure for containing a sealant, and
injecting a sealant into an interior chamber of the sealing cuff
such that the sealant directly contacts and forms a substantial
seal around the anastomosis.
[0102] The method can be performed in various ways. In certain
aspects, the anastomosis can be formed in the tubular organ prior
to delivering the sealant into the interior chamber of the sealing
cuff. In other aspects, the anastomosis can be formed in the
tubular organ after the sealant is delivered into the interior
chamber of the sealing cuff Injecting the sealant into the interior
chamber of the sealing cuff can cause the sealant to solidify
around the at least one strand of suture. In certain aspects, after
the sealant is solidified, the sealant can be released from the
interior chamber of the cuff by detaching the at least one strand
of suture from the sealing cuff.
[0103] In one embodiment a surgical method, comprises affixing a
first adjunct material onto a tissue at a treatment site. A second
adjunct material is applied to at least a portion of the first
adjunct material such that the second adjunct material interacts
with the first adjunct material to form a seal in an area of the
tissue covered by at least one of the first and the second adjunct
material. In one aspect the step of affixing the first and/or the
second adjunct is effected by stapling the first adjunct material
to the tissue. At least one of the first and second adjunct
materials is formed from biocompatible, absorbable suture material,
selected from the group consisting of polydioxanon, Polyglycerol
sebacate, Polyglycolic acid, Polycaprolactone, Polylactic acid,
Polyhydroxyalkanoate, Poliglecaprone 25, polyglactin 910,
polyglyconate, polyglocolide-trimethylene carbonate,
polyhydroxybutyrate, poly(vinylpyrrolidone), poly(vinyl alcohol),
absorbable polyurethanes, and regenerated cellulose. In one
embodiment at least one of the first and second adjunct materials
is oxidized regenerated cellulose. At least one of the adjunct
materials is made of a bioabsorbable material or a biofragmentable
material The first and second adjunct materials can be made of a
single layer of material or multiple layers, and one adjunct can be
different from the other or the same as the other. Further, either
or both of the adjunct materials can include a therapeutic
agent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0104] The invention will be more fully understood from the
following detailed description taken in conjunction with the
accompanying drawings, in which:
[0105] FIG. 1 is a side view of damaged stapled tissue;
[0106] FIG. 2 is a perspective view of one embodiment of an adjunct
material as described herein that is fixed to stapled tissue;
[0107] FIG. 3 is a perspective view of a prior art surgical
instrument which can be used with one or more adjunct
materials;
[0108] FIG. 4 is an exploded perspective view of an end effector
and a distal end of a shaft of the instrument of FIG. 3;
[0109] FIG. 5 is a perspective view of an E-beam component of the
instrument of FIG. 3;
[0110] FIG. 6 is a perspective view of another prior art surgical
instrument which can be used with one or more adjunct
materials;
[0111] FIG. 7 is a perspective view of another prior art surgical
instrument which can be used with one or more adjunct
materials;
[0112] FIG. 8 is a perspective view of the end effector of FIG.
4;
[0113] FIG. 9 is a side view of a prior art end effector having an
implantable staple cartridge therein;
[0114] FIG. 10 is a side view of a prior art staple;
[0115] FIG. 11 is a cross-sectional view of the end effector of
FIG. 9;
[0116] FIG. 12 is a top view of a prior art staple cartridge for
use with the instrument of FIG.
[0117] 7;
[0118] FIG. 13 is a diagrammatic representation of lines of staples
installed using a prior art surgical stapling instrument;
[0119] FIG. 14 is a top view of a prior art staple cartridge having
a staple pattern;
[0120] FIG. 15A is a side view of an end effector with a staple
cartridge loaded with an adjunct material;
[0121] FIG. 15B is a side, cross-sectional view of the end effector
of FIG. 4 having an adjunct material thereon;
[0122] FIG. 16A is a perspective view of adjunct material having a
central portion and a wing portion, the adjunct material being
coupled to a cartridge assembly;
[0123] FIG. 16B is a perspective view of an adjunct material
stapled onto tissue;
[0124] FIG. 17 is a perspective view of another exemplary
embodiment of adjunct material stapled to tissue;
[0125] FIG. 18A is a perspective view of an adjunct material having
edge protrusions configured to distribute a strain to tissue beyond
a staple line;
[0126] FIG. 18B is a perspective view of another adjunct material
having edge protrusions, the adjunct material being stapled to
tissue;
[0127] FIG. 19 is a perspective view of an adjunct material
including an outer region with a plurality of cuts formed
therein;
[0128] FIGS. 20A-20C are side views of adjunct material having
modified outer regions;
[0129] FIG. 20D is a side, cross-sectional view of adjunct material
stapled to a body lumen;
[0130] FIG. 21A is a perspective view of adjunct material having
first and second layers and woven, atraumatic edges;
[0131] FIG. 21B is a side view of the adjunct material of FIG. 21A
showing the first and second layers;
[0132] FIG. 21C is a side view of the adjunct material of FIG. 21A
absorbing fluid in between the first and second layers;
[0133] FIG. 22A is a perspective view of adjunct material having a
variable thickness in a lateral direction;
[0134] FIG. 22B is an end view of an anvil and cartridge assembly
and two variable thickness adjuncts, a first adjunct material
associated with the anvil and a second adjunct material associated
with the cartridge assembly;
[0135] FIG. 22C is an end view of the anvil and cartridge assembly
of FIG. 22B having the first and second adjunct materials coupled
thereto;
[0136] FIG. 22D is a side view of the first and second adjunct
material stapled to tissue;
[0137] FIG. 23A is a side view of an adjunct material having
surface features formed thereon for penetrating and gripping into
tissue;
[0138] FIG. 23B is a side view of another adjunct material having
surface features for penetrating and gripping into tissue;
[0139] FIG. 23C is an end view of four rows of adjunct material,
each row of adjunct material having a surface feature locked in a
tissue;
[0140] FIG. 23D is a side view of an adjunct material having
surface features penetrated into tissue;
[0141] FIG. 24A is a side view of another exemplary adjunct
material having a plurality of pointed surface features for
penetrating into tissue;
[0142] FIG. 24B is a side view of the adjunct material of FIG. 24A
having the pointed surface features piercing into tissue;
[0143] FIG. 25A is a perspective view of a cartridge assembly
having an adjunct material for detachable coupling to a distal end
of the cartridge assembly;
[0144] FIG. 25B is a side view of the cartridge assembly and an
anvil of a surgical stapler grasping tissue with the adjunct
material of FIG. 25A extending beyond a distal end of the cartridge
assembly;
[0145] FIG. 25C is a side view of the cartridge assembly and the
anvil of FIG. 25B deploying staples through the adjunct material
and the tissue;
[0146] FIG. 26A is a perspective view of adjunct material having
protrusions configured to mate with corresponding depressions
formed in a cartridge assembly;
[0147] FIG. 26B is a perspective view of adjunct material having a
single protrusion configured to mate with a corresponding
depression formed in a cartridge assembly;
[0148] FIG. 27A is an end view of an adjunct material extending
around a cartridge assembly and having first and second lateral
edges coupled to the cartridge assembly;
[0149] FIG. 27B is an end view of the adjunct material and the
cartridge assembly of FIG. 27A and a cutting member being advanced
through the cartridge assembly to release the adjunct material from
the cartridge assembly;
[0150] FIG. 28A is a perspective view of a cartridge assembly
including suture coupling an adjunct material to the cartridge
assembly;
[0151] FIG. 28B is a perspective view of the cartridge assembly and
adjunct material of FIG. 28A, the suture detached from the
cartridge assembly to release the adjunct material;
[0152] FIG. 29A is a perspective view of a shaft of a surgical
stapler including an adjunct material coupled thereto;
[0153] FIG. 29B is a side view of the shaft of FIG. 29A showing
attachment points for attaching the adjunct material to the
shaft;
[0154] FIG. 29C is a perspective view of a driver insertable within
the shaft and having a plurality of lateral extension portions;
[0155] FIG. 29D is a perspective view of adjunct material for
attaching to the shaft;
[0156] FIG. 29E is a partial top view of the shaft of FIG. 29A with
a cutting member of the stapler in a first, retracted position;
[0157] FIG. 29F is a partial top view of the shaft of FIG. 29A with
the cutting member in a second, advanced position that releases the
adjunct material from the shaft;
[0158] FIG. 30A is an end view of a cartridge assembly, an adjunct
material, and an insertion tool for attaching the adjunct material
to the cartridge assembly;
[0159] FIG. 30B is an end view of the insertion tool pressing the
adjunct material onto the cartridge assembly of FIG. 30A;
[0160] FIG. 30C is an end view of the cartridge assembly of FIG.
30A having the adjunct material attached thereto and after the
insertion tool has been removed from the cartridge assembly;
[0161] FIG. 31A is an exemplary kit including a retaining tool and
a surgical stapler, the retaining tool being configured for
wrapping the adjunct material around a cartridge
assembly/anvil;
[0162] FIG. 31B is a side view of the retaining tool of FIG. 31A
being advanced proximally along a longitudinal axis of the anvil
and the cartridge assembly;
[0163] FIG. 31C is a perspective view of the retaining tool and
stapler of FIG. 31A, the retaining tool being in a proximal most
position;
[0164] FIG. 32A is a perspective view of an end effector of a
stapler having an adjunct material coupled thereto and positioned
above a trocar;
[0165] FIG. 32B is a perspective view of the end effector of FIG.
32A having the adjunct material wrapped around the end effector as
the end effector is inserted through the trocar;
[0166] FIG. 33A is an end view of a cartridge assembly and an anvil
of a surgical stapler having a multi-layer adjunct material coupled
thereto;
[0167] FIG. 33B is a side view of three adjuncts stapled onto
tissue and having overlapping portions therebetween;
[0168] FIG. 33C is a perspective view of a first adjunct material
and a second adjunct material stapled onto tissue and having first
and second overlapping portions;
[0169] FIG. 34A is a perspective view of first and second adjunct
materials stapled onto tissue and having a sealant delivered onto
an outer surface of the first adjunct;
[0170] FIG. 34B is a side view of the first and second adjunct
materials of FIG. 34A stapled to tissue;
[0171] FIG. 34C is a side view of the first and second adjunct
materials of FIG. 34A having sealant delivered to a space below an
outer surface of the adjunct;
[0172] FIG. 34D is a side view of the first and second adjunct
materials of FIG. 34A in an expanded position;
[0173] FIG. 35A is a perspective view a system for nebulizing a
sealant which includes a container and an applicator tool extending
through a trocar and into a patient;
[0174] FIG. 35B is perspective view of the applicator tool of FIG.
35A delivering sealant to a staple line in tissue;
[0175] FIG. 35C is a perspective view of the nebulized sealant of
FIG. 35A hardened onto the staple line;
[0176] FIG. 36A is a perspective view of another exemplary system
for nebulizing a sealant and delivering a nebulized sealant to a
patient directly through a trocar and into a patient; and
[0177] FIG. 36B is a perspective view of the trocar of FIG. 36A
delivering nebulized sealant onto tissue at and beyond the staple
line;
[0178] FIG. 37A is a perspective view of a staple cartridge
assembly comprising an adjunct material, in accordance with some
embodiments;
[0179] FIG. 37B is a cross-sectional view of a portion of the
adjunct material of FIG. 37A, in accordance with some
embodiments;
[0180] FIG. 38 is a perspective, partially cut-away view of the
adjunct material, in accordance with some embodiments;
[0181] FIG. 39 is a perspective view of an interior hydrophilic,
swellable material included in the adjunct material, in accordance
with some embodiments;
[0182] FIG. 40 is a perspective view of the adjunct material before
penetration by surgical staples, in accordance with some
embodiments;
[0183] FIG. 41A is a side view of tissue and adjunct materials
retained to both the cartridge assembly and anvil of a surgical
stapler, after penetration by the surgical staples, in accordance
with some embodiments;
[0184] FIG. 41B is another side view of tissue and adjunct
materials retained to both the cartridge assembly and anvil of a
surgical stapler, after penetration by the surgical staples, in
accordance with some embodiments;
[0185] FIG. 42A is a perspective view of the adjunct material
including portions of an outer material having different
characteristics, in accordance with some embodiments;
[0186] FIG. 42B is a side view of the adjunct material of FIG. 42A,
in accordance with some embodiments;
[0187] FIG. 43 is a perspective view of the adjunct material
illustrating a peripheral edge portion of the adjunct material
after penetration by the surgical staples, in accordance with some
embodiments;
[0188] FIG. 44 is a perspective view of the adjunct material of
FIG. 43, in accordance with some embodiments;
[0189] FIG. 45 is a perspective view of an adjunct material having
a uniform thickness, in accordance with some embodiments;
[0190] FIG. 46 is a cross-sectional view of tissue and an anvil of
a surgical stapler having an adjunct material retained thereon,
before penetration of the tissue by surgical staples, in accordance
with some embodiments; and
[0191] FIG. 47 is a side view of the tissue penetrated by the
surgical staples and the adjunct material penetrated and retained
by surgical staples, in accordance with some embodiments.
[0192] FIG. 48A is a perspective view of a woven adjunct material
loaded onto a cartridge assembly of a surgical stapler;
[0193] FIG. 48B is a top view of the woven adjunct material of FIG.
48A;
[0194] FIG. 48C is a side view of the woven adjunct material of
FIG. 48A stapled onto tissue;
[0195] FIG. 49A is a side view of a woven adjunct material before a
compressive force is applied thereto;
[0196] FIG. 49B is a side view of a woven adjunct material of
FIG.49A having a compressive force applied thereto;
[0197] FIG. 49C is a side view of the woven adjunct material of
FIG. 49A after the compressive force is released therefrom;
[0198] FIG. 50 is a side view of one embodiment of a woven
structure;
[0199] FIG. 51A is a side, cross-sectional view of a woven adjunct
material having outer support layers woven onto an elastic core
layer;
[0200] FIG. 51B is a detailed view of the woven adjunct material of
FIG. 51A;
[0201] FIG. 52A is a side view of the woven adjunct material of
FIG. 51A in compressed state;
[0202] FIG. 52B is a side view of the woven adjunct material of
FIG. 51A in an expanded state;
[0203] FIG. 53A is a perspective view of an end effector with
partial detail of a fibrous adjunct material loaded onto the
cartridge assembly;
[0204] FIG. 53B illustrates a fiber of the adjunct material of FIG.
53A coated with a drug.
[0205] FIG. 54A is a perspective view of a fleece adjunct
material;
[0206] FIG. 54B is a perspective view of a longitudinal fleece
adjunct material with a compressive force applied thereto.
[0207] FIG. 54C is a perspective view of a rectangular fleece
adjunct material with a compressive force applied thereto.
[0208] FIG. 54D is a perspective view of a polygonal fleece adjunct
material with a compressive force applied thereto.
[0209] FIG. 55 is a perspective view of an adjunct material that
includes a fleece core layer surrounded by woven support
layers;
[0210] FIG. 56A is a perspective view of four adjunct materials for
loading onto an end effector of a stapler;
[0211] FIG. 56B is an end, sectional view of adjunct materials
loaded onto both the anvil and cartridge assembly of a stapler;
[0212] FIG. 57A is a front sectional view of adjunct materials
loaded onto both the anvil and cartridge assembly of an end
effector;
[0213] FIG. 57B is a side sectional view of the adjunct material of
FIG. 57A stapled onto tissue.
[0214] FIG. 58 is a top view of tissue damage that can occur near
staple legs;
[0215] FIG. 59A is a side view of one embodiment of adjuncts
coupled to a staple;
[0216] FIG. 59B is a side view of an alternative embodiment of
adjuncts coupled to a staple;
[0217] FIG. 60 is a cross-sectional view of one embodiment of
adjuncts coupled to a staple;
[0218] FIG. 61 is a perspective view of the adjuncts and staple of
FIG. 60;
[0219] FIG. 62 is a cross-sectional view of the staple of FIG. 60
implanted in tissue;
[0220] FIG. 63A is an illustration of one embodiment of adjunct
operation in non-thoracic tissue;
[0221] FIG. 63B is an illustration of one embodiment of adjunct
operation in thoracic tissue;
[0222] FIG. 64A is a side view of one embodiment of adjunct
operation in tissue;
[0223] FIG. 64B is a top view of the adjunct operation shown in
FIG. 64A;
[0224] FIG. 65 is a perspective view of one embodiment of adjuncts
coupled to a staple;
[0225] FIG. 66 is a perspective view of the staple of FIG. 65;
[0226] FIG. 67A is a side view of one embodiment of adjuncts
coupled to a staple;
[0227] FIG. 67B is a side view of an alternative embodiment of
adjuncts coupled to a staple;
[0228] FIG. 67C is a side view of still another alternative
embodiment of adjuncts coupled to a staple;
[0229] FIG. 68A is a cross-sectional view of the staple of FIG. 65
in a staple cartridge;
[0230] FIG. 68B is a cross-sectional view of the staple of FIG. 65
ejected into tissue;
[0231] FIG. 68C is a cross-sectional view of the adjuncts sealing
the staple of FIG. 65 in tissue;
[0232] FIG. 69A is a side view of an alternative embodiment of a
staple;
[0233] FIG. 69B is a side view of an alternative embodiment of a
staple;
[0234] FIG. 70 is a perspective view of an alternative embodiment
of an adjunct coupled to a staple;
[0235] FIG. 71A is a close perspective view of the adjunct of FIG.
70 before implantation in tissue;
[0236] FIG. 71B is a close perspective view of the adjunct of FIG.
70 after implantation in tissue;
[0237] FIG. 72A is a side view of the staple of FIG. 70;
[0238] FIG. 72B is a cross-sectional view of the staple of FIG. 70
in tissue;
[0239] FIG. 73 is a perspective view of an alternative embodiment
of an adjunct coupled to a staple;
[0240] FIG. 74 is a side view of the staple of FIG. 73 in
tissue;
[0241] FIG. 75 is a perspective view of still another alternative
embodiment of an adjunct coupled to a staple;
[0242] FIG. 76 is a perspective view of one embodiment of a staple
cartridge housing a plurality of staples having adjuncts coupled
thereto;
[0243] FIG. 77 is a perspective view of an alternative embodiment
of a staple cartridge housing a plurality of staples having
adjuncts coupled thereto;
[0244] FIG. 78A is a top view of one embodiment of a staple
cartridge ejection slot that accommodates a staple having an
adjunct coupled thereto;
[0245] FIG. 78B is a top view of an alternative embodiment of a
staple cartridge ejection slot that accommodates a staple having an
adjunct coupled thereto;
[0246] FIG. 78C is a top view of still another alternative
embodiment of a staple cartridge ejection slot that accommodates a
staple having an adjunct coupled thereto;
[0247] FIG. 79 is a top view of one embodiment of a plurality of
adjunct segments coupled to one another;
[0248] FIG. 80 is a perspective view of an alternative embodiment
of a plurality of adjunct segments;
[0249] FIG. 81A is a perspective view of one embodiment of a
surgical end effector having a plurality of adjunct segments
accepting a vessel;
[0250] FIG. 81B is a perspective view of the surgical end effector
of FIG. 81A stapling and transecting the vessel;
[0251] FIG. 81C is a perspective view of the vessel and adjuncts of
FIG. 81A after transection;
[0252] FIG. 81D is a perspective view of the vessel and adjuncts of
FIG. 81A after excess adjuncts are removed;
[0253] FIG. 82 is a perspective view of an alternative embodiment
of a plurality of adjunct segments;
[0254] FIG. 83 is a perspective view of one embodiment of a
surgical stapler anvil having a plurality of staple forming
openings filled with a viscous sealant;
[0255] FIG. 84 is a perspective view of an alternative embodiment
of a surgical stapler anvil having a plurality of staple forming
openings filled with a viscous sealant;
[0256] FIG. 85 is a cross-sectional view of one embodiment of a
staple forming opening having a viscous sealant disposed therein
and retained by a film;
[0257] FIG. 86A is a cross-sectional view of one embodiment of a
staple forming opening with a viscous sealant;
[0258] FIG. 86B is a cross-sectional view of the staple forming
opening of FIG. 86A prior to curing;
[0259] FIG. 86C is a cross-sectional view of the staple forming
opening of FIG. 86A after partial curing;
[0260] FIG. 86D is a cross-sectional view of the staple forming
opening of FIG. 86A after complete curing;
[0261] FIG. 87 is a side view of a surgical staple coupled to the
adjunct of FIG. 85;
[0262] FIG. 88 is a perspective view of one embodiment of a film
connecting a plurality of adjuncts;
[0263] FIG. 89 is a perspective view of one embodiment of a weave
connecting a plurality of adjuncts;
[0264] FIG. 90 is an exploded view of the weave and adjuncts of
FIG. 89;
[0265] FIG. 91A is a perspective view of one embodiment of a
plurality of adjuncts coupled to one another by a film of cured
adjunct material;
[0266] FIG. 91B is a perspective view of an alternative embodiment
of a plurality of adjuncts separated from one another and including
a layer of cured adjunct material;
[0267] FIG. 92 is a cross-sectional view of one embodiment of a
staple in a staple cartridge, tissue, and an adjunct disposed in a
staple forming opening of an anvil;
[0268] FIG. 93 is a cross-sectional view of a staple and the
adjunct of FIG. 85 disposed in tissue;
[0269] FIG. 94 is a cross-sectional view of the staple and adjunct
of FIG. 93 being cured after implantation in tissue;
[0270] FIG. 95 is a perspective view of one embodiment of a
plurality of adjuncts coupled by a plurality of connecting branches
of adjunct material;
[0271] FIG. 96 is an exploded view of the plurality of adjuncts of
FIG. 95 disposed in a plurality of staple forming openings of a
surgical stapler anvil;
[0272] FIG. 97 is a perspective view of one embodiment of a
surgical stapler anvil having features to destroy connecting
branches extending between a plurality of adjuncts;
[0273] FIG. 98 is a cross-sectional view of one embodiment of a
surgical stapler including a staple disposed in a staple cartridge
and a plurality of adjuncts coupled to the anvil of FIG. 97;
[0274] FIG. 99 is a cross-sectional view of the stapler of FIG. 98
ejecting a staple through tissue and into a staple forming opening
of the anvil;
[0275] FIG. 100 is a cross-sectional view of the staple of FIG. 98
implanted in tissue;
[0276] FIG. 101 is a perspective cross-sectional view of one
embodiment of a retainer to hold adjunct material against a
surgical stapler anvil;
[0277] FIG. 102A is a cross-sectional view of the retainer and
anvil of FIG. 101;
[0278] FIG. 102B is a cross-sectional view of an alternative
embodiment of a retainer and anvil;
[0279] FIG. 103 is a cross-sectional view of one embodiment of a
staple forming opening having a retainer formed thereon;
[0280] FIG. 104 is a cross-sectional view of the staple forming
opening of FIG. 103 holding adjunct material therein;
[0281] FIG. 105 is a top view of the staple forming opening of FIG.
103;
[0282] FIG. 106 is a perspective view of one embodiment of a
surgical stapler anvil and staple cartridge having adjunct segments
coupled thereto;
[0283] FIG. 107 is an exploded view of one embodiment of attachment
and alignment features of a surgical stapler anvil;
[0284] FIG. 108 is a perspective view of the anvil of FIG. 107;
[0285] FIG. 109 is a perspective view of one embodiment of a
surgical stapler having a plurality of adjunct segments coupled
thereto and connected to one another by a film;
[0286] FIG. 110 is an exploded cross-sectional view of the surgical
stapler of FIG. 109;
[0287] FIG. 111 is a close cross-sectional view of a staple forming
opening of the surgical stapler of FIG. 109;
[0288] FIG. 112 is a cross-sectional view of one embodiment of a
plurality of adjunct segments connected to one another by a
film;
[0289] FIG. 113A is a cross-sectional view of the surgical stapler
of FIG. 109 prior to actuation;
[0290] FIG. 113B is a cross-sectional view of the surgical stapler
of FIG. 109 after actuation that delivers a staple into tissue;
[0291] FIG. 114A is a perspective view of one embodiment of a
surgical stapler having a plurality of adjunct segments of
differing thicknesses;
[0292] FIG. 114B is a close exploded view of the surgical stapler
of FIG. 114A;
[0293] FIG. 115 is an exploded perspective view of an alternative
embodiment of a surgical stapler having a plurality of adjunct
segments of differing thicknesses;
[0294] FIG. 116 is a cross-sectional view of the surgical stapler
of FIG. 115;
[0295] FIG. 117 is a perspective view of an alternative embodiment
of a surgical stapler having a plurality of adjunct segments of
differing thicknesses;
[0296] FIG. 118A is an exploded view of one embodiment of a
multi-material adjunct;
[0297] FIG. 118B is a perspective view of the adjunct of FIG.
118A;
[0298] FIG. 119A is a perspective cross-sectional view of the
adjunct of FIG. 118A prior to actuation of a surgical stapler;
[0299] FIG. 119B is a perspective cross-sectional view of the
adjunct of FIG. 118A after actuation of a surgical stapler;
[0300] FIG. 120 is a cross-sectional view of one embodiment of a
surgical staple and adjunct formed in tissue;
[0301] FIG. 121 is a cross-sectional view of an alternative
embodiment of a surgical staple and adjunct formed in tissue;
[0302] FIG. 122 is a cross-sectional view of still another
embodiment of a surgical staple and adjunct formed in tissue;
[0303] FIG. 123A is a top view of one embodiment of a plurality of
adjuncts coupled to a surgical stapler anvil;
[0304] FIG. 123B is a top view of an alternative embodiment of a
plurality of adjuncts coupled to a surgical stapler anvil;
[0305] FIG. 123C is a top view of still another embodiment of a
plurality of adjuncts coupled to a surgical stapler anvil;
[0306] FIG. 123D is a top view of yet another embodiment of a
plurality of adjuncts coupled to a surgical stapler anvil;
[0307] FIG. 123E is a top view of still another embodiment of a
plurality of adjuncts coupled to a surgical stapler anvil;
[0308] FIG. 124 is a perspective view of one embodiment of a
plurality of adjuncts;
[0309] FIG. 125 is a top view of one embodiment of adjunct segment
shapes;
[0310] FIG. 126 is a top view of the adjuncts of FIG. 125 coupled
to one another;
[0311] FIG. 127 is a top view of one embodiment of a sheet of
adjunct segments coupled to one another;
[0312] FIG. 128 is a top view of an alternative embodiment of
adjunct segment shapes;
[0313] FIG. 129 is a top view of the adjuncts of FIG. 128 coupled
to one another;
[0314] FIG. 130A is a perspective view of one embodiment of adjunct
segments extending between adjacent surgical staples;
[0315] FIG. 130B is a perspective view of an alternative embodiment
of adjunct segments extending between adjacent surgical
staples;
[0316] FIG. 130C is a perspective view of another embodiment of
adjunct segments extending between adjacent surgical staples;
[0317] FIG. 131 is a perspective view of the adjuncts and surgical
staples of FIG. 130A disposed in tissue;
[0318] FIG. 132 is a cross-sectional view of the adjuncts and
surgical staples of FIG. 131;
[0319] FIG. 133 is a perspective view of an alternative embodiment
of surgical staples and adjuncts in tissue;
[0320] FIG. 134 is a perspective view of another embodiment of
surgical staples and adjuncts in tissue;
[0321] FIG. 135 is a perspective view of still another embodiment
of surgical staples and adjuncts in tissue;
[0322] FIG. 136 is a top view of one embodiment of surgical staples
and adjuncts extending between adjacent staples;
[0323] FIG. 137 is a top view of an alternative embodiment of
surgical staples and adjuncts extending between adjacent
staples;
[0324] FIG. 138A is a side view of the surgical staples and
adjuncts of FIG. 137 in a relaxed state;
[0325] FIG. 138B is a side view of the surgical staples and
adjuncts of FIG. 137 in a tensioned state;
[0326] FIG. 139 is a top view of one embodiment of surgical staples
and adjuncts extending between adjacent staples;
[0327] FIG. 140A is a top view of an alternative embodiment of
surgical staples and adjuncts connected to one another by a
serpentine carrier;
[0328] FIG. 140B is a side view of the surgical staples, adjuncts,
and serpentine carrier of FIG. 140A;
[0329] FIG. 141A is a side view of one embodiment of an
adjunct;
[0330] FIG. 141B is a front view of the adjunct of FIG. 141A;
[0331] FIG. 141C is a top view of the adjunct of FIG. 141A;
[0332] FIG. 141D is a perspective view of the adjunct of FIG.
141A;
[0333] FIG. 142A is a side view of an alternative embodiment of an
adjunct;
[0334] FIG. 142B is a front view of the adjunct of FIG. 142A;
[0335] FIG. 142C is a top view of the adjunct of FIG. 142A;
[0336] FIG. 142D is a perspective view of the adjunct of FIG.
142A;
[0337] FIG. 143 is a side view of one embodiment of a plurality of
adjuncts coupled to a backing material;
[0338] FIG. 144A is a side view of one embodiment of an
adjunct;
[0339] FIG. 144B is a front view of the adjunct of FIG. 144A;
[0340] FIG. 144C is a top view of the adjunct of FIG. 144A;
[0341] FIG. 144D is a perspective view of the adjunct of FIG.
144A;
[0342] FIG. 145A is a side view of an alternative embodiment of an
adjunct;
[0343] FIG. 145B is a front view of the adjunct of FIG. 145A;
[0344] FIG. 145C is a top view of the adjunct of FIG. 145A;
[0345] FIG. 145D is a perspective view of the adjunct of FIG.
145A;
[0346] FIG. 146 is an illustration of one embodiment of an adjunct
applicator;
[0347] FIG. 147 is a cross-sectional view of the applicator of FIG.
146 applying an adjunct to a surgical stapler anvil;
[0348] FIG. 148 is a side view of the applicator of FIG. 146
applying an adjunct to a surgical stapler anvil;
[0349] FIG. 149A is an illustration of an alternative embodiment of
an adjunct applicator;
[0350] FIG. 149B is an illustration of one embodiment of a squeegee
that can remove excess adjunct applied to a surgical stapler;
[0351] FIG. 149C is a cross-sectional view of a surgical stapler
anvil having an adjunct applied thereto;
[0352] FIG. 150 is an illustration of one embodiment of a two-part
adjunct applicator;
[0353] FIG. 151 is an illustration of an alternative embodiment of
a two-part adjunct applicator;
[0354] FIG. 152A is a cross-sectional view of one embodiment of an
applicator nozzle coupled to an adjunct container;
[0355] FIG. 152B is a cross-sectional view of the applicator nozzle
of FIG. 152A piercing a seal formed on the adjunct container;
[0356] FIG. 153 is an illustration of the applicator of FIG. 150
applying an adjunct to a surgical stapler;
[0357] FIG. 154 is a side cross-sectional view of one embodiment of
an applicator applying an adjunct to a surgical stapler;
[0358] FIG. 155 is a front cross-sectional view of one embodiment
of an applicator applying an adjunct to a surgical stapler
anvil;
[0359] FIG. 156 is a front cross-sectional view of one embodiment
of an applicator applying a two-part adjunct to a surgical stapler
anvil;
[0360] FIG. 157 is a cross-sectional view of one embodiment of an
adjunct disposed within a staple forming opening of a surgical
stapler anvil;
[0361] FIG. 158 is a front cross-sectional view of one embodiment
of an applicator applying an adjunct to a surgical stapler
cartridge;
[0362] FIG. 159 is a front cross-sectional view of one embodiment
of an applicator applying an adjunct to a surgical stapler
cartridge;
[0363] FIG. 160 is a cross-sectional view of one embodiment of an
adjunct disposed within a surgical stapler cartridge cavity;
[0364] FIG. 161 is a cross-sectional view of one embodiment of a
surgical staple formed within tissue;
[0365] FIG. 162 is an illustration of one embodiment of an adjunct
applicator and surgical stapler;
[0366] FIG. 163 is a cross-sectional view of one embodiment of a
surgical staple formed so as to trap adjunct material;
[0367] FIG. 164A is an illustration of one embodiment of a surgical
stapler positioned to transect tissue;
[0368] FIG. 164B is an illustration the tissue of FIG. 164A
transected with staples and adjunct segments coupled thereto;
[0369] FIG. 164C is an illustration of the surgical stapler of FIG.
164A having excess staples and adjuncts coupled thereto;
[0370] FIG. 165 is an illustration of one embodiment of a
non-continuous adjunct for use in forming an anastomosis;
[0371] FIG. 166 is an illustration of one embodiment of a surgical
stapler cartridge for use with the adjunct of FIG. 165;
[0372] FIG. 167 is an illustration of one embodiment of a staple
pattern for use with the adjunct of FIG. 165;
[0373] FIG. 168 is an illustration of an alternative embodiment of
a non-continuous adjunct for use in forming an anastomosis;
[0374] FIG. 169 is an illustration of one embodiment of a surgical
stapler cartridge for use with the adjunct of FIG. 168;
[0375] FIG. 170 is an exploded view of the adjunct of FIG. 168 and
surgical stapler cartridge of FIG. 169;
[0376] FIG. 171 is an illustration of one embodiment of a staple
pattern and the adjunct of FIG. 168;
[0377] FIG. 172 is an exploded view of the surgical stapler
cartridge of FIG. 169 and the adjunct of FIG. 171;
[0378] FIG. 173 is an illustration of the surgical stapler
cartridge of FIG. 169 and the adjunct of FIG. 171;
[0379] FIG. 174 is a cross-sectional view of one embodiment of an
adjunct washer before and during actuation of a surgical
stapler;
[0380] FIG. 175 is an illustration of one embodiment of a surgical
stapler cartridge for use in forming an anastomosis;
[0381] FIG. 176 is an illustration of one embodiment of a body
lumen transected by a surgical stapler;
[0382] FIG. 177A is a cross-sectional view of a staple line
including an adjunct with a washer;
[0383] FIG. 177B is a cross-sectional view of a circular stapler
trocar advancing toward the staple line of FIG. 177A;
[0384] FIG. 177C is a cross-sectional view of the circular stapler
trocar of FIG. 177B crossing the staple line of FIG.177A;
[0385] FIG.178 is an illustration of a circular stapler trocar
passing through a washer of the non-continuous adjunct of
FIG.175;
[0386] FIG. 179 is an illustration of a circular stapler anvil
being positioned over the circular stapler trocar of FIG. 177B;
[0387] FIG. 180 is an illustration of an alternative embodiment of
a circular stapler anvil being positioned over the circular stapler
trocard of FIG. 177B;
[0388] FIG. 181 is a cross-sectional view of one embodiment of a
circular stapler anvil trapping an adjunct washer over a circular
stapler trocar;
[0389] FIG. 182 is a close cross-sectional view of the circular
stapler anvil, adjunct washer, and circular stapler trocar of FIG.
181;
[0390] FIG. 183 is a cross-sectional view of the circular stapler
trocar of FIG. 181 being withdrawn into a central lumen of the
circular stapler;
[0391] FIG. 184 is an illustration of one embodiment of forces
exerted on a non-continuous adjunct upon withdrawal of a circular
stapler trocar coupled thereto;
[0392] FIG. 185 is a cross-sectional view of the circular stapler
of FIG. 181 being actuated to resect the staple line including the
non-continuous adjunct; and
[0393] FIG. 186 is a cross-sectional view of an anastomosis
produced by actuation of the circular stapler of FIG. 181.
[0394] FIG. 187 is a perspective, partially transparent view of a
patient with one embodiment of a surgical instrument transorally
advanced into a bronchial tube of the patient;
[0395] FIG. 188 is an exploded perspective view of a distal end of
the surgical instrument of FIG. 187 including a scoping device and
an end cap;
[0396] FIG. 189 is a perspective, partially cross-sectional view of
the scoping device of FIG. 188 advanced into the bronchial tube of
FIG. 187, one embodiment of a grasper advanced through a working
channel of the scoping device and grasping one embodiment of a
reinforcement material, and one embodiment of a stapler having a
distal end positioned outside and adjacent to the bronchial
tube;
[0397] FIG. 190 is a perspective, partially cross-sectional view of
the stapler of FIG. 189 stapling the bronchial tube and the
reinforcement material;
[0398] FIG. 191 is a perspective, partially cross-sectional view of
the scoping device of FIG. 188, with the end cap of FIG. 188
attached thereto, within a portion of the bronchial tube of FIG.
190 stapled and cut by the stapler, and one embodiment of an
applicator advanced through the working channel of the scoping
device and a working port of the end cap, the applicator applying
one embodiment of a sealant, the sealant being in a first
state;
[0399] FIG. 192 is a perspective, partially cross-sectional view of
the scoping device and the end cap of FIG. 6 being removed from the
bronchial tube with the applied sealant being in a hardened
state;
[0400] FIG. 193 is a perspective, partially cross-sectional view of
the scoping device of FIG. 188 disposed within a bronchial tube and
the grasper of FIG. 189 advanced through the working channel of the
scoping device and grasping another embodiment of a reinforcement
material coupled to another embodiment of a sealant;
[0401] FIG. 194 is a perspective, partially cross-sectional view of
the stapler of FIG. 189 stapling the bronchial tube, the
reinforcement material, and the sealant of FIG. 193;
[0402] FIG. 195 is a perspective, partially transparent view of
another patient with another embodiment of a surgical instrument
transorally advanced into a bronchial tube of the patient;
[0403] FIG. 196 is a perspective view of another embodiment of a
stapler with jaws thereof positioned on either side of the
bronchial tube of FIG. 195;
[0404] FIG. 197 is a perspective view of the bronchial tube of FIG.
196 after being stapled and cut by the stapler;
[0405] FIG. 198 is a perspective, partially transparent view of the
instrument of FIG. 195 advanced into the stapled and cut bronchial
tube of FIG. 197 with a distal end of the instrument positioned
adjacent a stapled and cut end of the bronchial tube;
[0406] FIG. 199 is another perspective view of the distal end of
the instrument of FIG. 198 positioned adjacent the stapled and cut
end of the bronchial tube;
[0407] FIG. 200 is a side, cross-sectional view of the stapled and
cut end of the bronchial tube of FIG. 199 having another embodiment
of a sealant disposed therein, the sealant having been advanced
into the bronchial tube from the instrument; and
[0408] FIG. 201 is a side, cross-sectional view of the and cut end
of the bronchial tube of FIG. 200 having another embodiment of a
reinforcement material and additional sealant disposed therein, the
reinforcement material and the additional sealant having been
advanced into the bronchial tube from the instrument.
[0409] FIG. 202A is a perspective view of a sealing cuff, according
to one exemplary embodiment;
[0410] FIG. 202B is a side view of the sealing cuff of FIG.
202A;
[0411] FIG. 202C is a cross-sectional view of the sealing cuff of
FIG. 202A;
[0412] FIG. 203 is another embodiment of a sealing cuff having one
or more extension ports that facilitate positioning the cuff around
a body lumen;
[0413] FIG. 204A is a partial, cross-sectional view of a sealing
cuff having suture woven across an inner surface thereof for
contacting a sealant;
[0414] FIG. 204B is partial, side view of the sealing cuff of FIG.
204A showing a passageway formed in a wall of the cuff and having
suture extending therethrough;
[0415] FIG. 205A is an exemplary embodiment of a foamed
sealant;
[0416] FIG. 205B is a side view of the foamed sealant of FIG. 205A
penetrating into an anastomosis;
[0417] FIG. 206A is a side view of an expandable device including
first and second expandable members;
[0418] FIG. 206B is a side view of another embodiment of an
expandable device having first and second expandable members;
[0419] FIG. 206C is a side view of an expandable device having a
single expandable member;
[0420] FIG. 206D is a side view of another embodiment of an
expandable device having a single expandable member;
[0421] FIG. 207 is a side view of an expandable device having a
lumen for delivering fluid to a space between first and second
expandable members;
[0422] FIG. 208A is a side view of one embodiment of a stent having
first and second expandable portions;
[0423] FIG. 208B is a side view of another embodiment of a stent
having first and second expandable portions;
[0424] FIG. 208C is a side view of yet another embodiment of a
stent having first and second expandable portions;
[0425] FIG. 209A is a perspective view of the sealing cuff of FIG.
202A being positioned over a first section of a tubular body
organ;
[0426] FIG. 209B is a perspective view of a trocar having a tool
extending therethrough and into a positioning port formed on the
sealing cuff;
[0427] FIG. 209C is a cross-sectional view of the organ of FIG.
209A showing an anvil and cartridge assembly of a surgical stapler,
the anvil positioned inside of the first section of the tubular
organ and the cartridge assembly positioned inside of the second
section of the tubular organ;
[0428] FIG. 209D is a cross-sectional view of the stapler and
tubular organ of FIG. 209A, the anvil moved toward the cartridge
assembly and deploying staples to form the anastomosis as the
sealing cuff is positioned away from the anastomosis;
[0429] FIG. 209E is a cross-sectional view of the sealing cuff of
FIG. 209A illustrating the cuff's direction of movement along the
tubular organ and toward the anastomosis;
[0430] FIG. 209F is a cross-sectional view of the sealing cuff of
FIG. 209A showing sealant being delivered to the sealing cuff and
into the anastomosis;
[0431] FIG. 209G is a perspective view of the sealing cuff of FIG.
209A being removed from the tubular organ after the sealant has
cured around the anastomosis;
[0432] FIG. 210A is a perspective, semi-transparent view of an
anvil of a circular stapler positioned inside of a tubular
organ;
[0433] FIG. 210B is a side, semi-transparent view of the anvil and
tubular organ of FIG. 210A, the anvil having first and second
expandable members coupled thereto;
[0434] FIG. 210C is a side, semi-transparent view of the tubular
organ of FIG. 10B formed into an anastomosis and having the first
and second expandable members coupled to a scope;
[0435] FIG. 210D is a side, semi-transparent view of the first
expandable member positioned proximal to the anastomosis, in an
expanded position;
[0436] FIG. 210E is a side, semi-transparent view of the first and
second expandable members disposed on opposite sides of the
anastomosis, in their expanded positions;
[0437] FIG. 211A is a perspective view of an expandable member
disposed on a scope, the scope extending through an anus and moving
toward the sealing cuff;
[0438] FIG. 211B is a partial cross-sectional view of the tubular
organ having the scope of FIG. 211A extending therethrough, the
expandable member being in a first, compressed position adjacent to
the anastomosis and to the sealing cuff;
[0439] FIG. 211C is a partial cross-sectional view of the tubular
organ of FIG. 211B showing the expandable member in a second,
expanded position;
[0440] FIG. 212A is a partial cross-sectional view of an
anastomosis of a tubular organ, along with a scope having a tether
coupled thereto that is attached to a first expandable member;
[0441] FIG. 212B is a partial cross-sectional view of the first
expandable member being positioned proximal to the anastomosis as a
terminal end of the tether is positioned outside of the patient's
body;
[0442] FIG. 212C is a partial cross-sectional view of the first
expandable member being inflated to an expanded position and the
second expandable member being positioned over the tether;
[0443] FIG. 212D is a partial cross-sectional view of the second
expandable member moving toward the anastomosis in a compressed
position;
[0444] FIG. 212E is a partial cross-sectional view of showing the
second expandable member being inflated to an expanded position
through its inflation lumen;
[0445] FIG. 213 is a cross-sectional view of a first and second
expandable members forming a seal inside of the tubular organ and
gas being delivered to the sealed space between the expandable
members so as to test leakage from the anastomosis;
[0446] FIG. 214A is a cross-sectional view of another embodiment of
first and second expandable members with gas delivered to a space
therebetween so as to test leakage from the anastomosis; and
[0447] FIG. 214B is a cross-sectional view of an embodiment of an
expandable member having a central portion configured to support
the anastomosis as fluid is delivered to the space adjacent to the
anastomosis so as to test leakage therefrom.
DETAILED DESCRIPTION
[0448] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those skilled in the
art will understand that the devices and methods specifically
described herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of such
devices and methods is defined solely by the claims. The features
illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the devices and methods described herein.
Further, in the present disclosure, like-numbered components of the
various embodiments generally have similar features when those
components are of a similar nature and/or serve a similar
purpose.
[0449] Reference throughout the specification to "various
embodiments," "some embodiments," "one embodiment," or "an
embodiment," or the like, means that a particular feature,
structure, or characteristic described in connection with the
embodiment is included in at least one embodiment. Thus,
appearances of the phrases "in various embodiments," "in some
embodiments," "in one embodiment," or "in an embodiment," or the
like, in places throughout the specification are not necessarily
all referring to the same embodiment. Furthermore, the particular
features, structures, or characteristics may be combined in any
suitable manner in one or more embodiments. Thus, the particular
features, structures, or characteristics illustrated or described
in connection with one embodiment may be combined, in whole or in
part, with the features structures, or characteristics of one or
more other embodiments without limitation. Such modifications and
variations are intended to be included within the scope of the
methods, apparatus, devices, and systems described herein.
[0450] Additionally, to the extent that linear or circular
dimensions are used in the description of the disclosed systems,
devices, and methods, such dimensions are not intended to limit the
types of shapes that can be used in conjunction with such systems,
devices, and methods. A person skilled in the art will recognize
that an equivalent to such linear and circular dimensions can
easily be determined for any geometric shape. Sizes and shapes of
the systems and devices, and the components thereof, can depend at
least on the anatomy of the subject in which the systems and
devices will be used, the size and shape of components with which
the systems and devices will be used, and the methods and
procedures in which the systems and devices will be used.
[0451] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical," "horizontal," "up," and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0452] It can be desirable to use one or more biologic materials
and/or synthetic materials, collectively referred to herein as
"adjunct materials," in conjunction with surgical instruments to
help improve surgical procedures. These biologic materials may be
derived from human and/or animal sources. A person skilled in the
art may refer to these types of materials as buttress materials as
well as adjunct materials.
[0453] Various exemplary devices and methods are provided for
performing surgical procedures. In some embodiments, the devices
and methods are provided for open surgical procedures, and in other
embodiments, the devices and methods are provided for laparoscopic,
endoscopic, and other minimally invasive surgical procedures. The
devices may be fired directly by a human user or remotely under the
direct control of a robot or similar manipulation tool. However, a
person skilled in the art will appreciate that the various methods
and devices disclosed herein can be used in numerous surgical
procedures and applications. Those skilled in the art will further
appreciate that the various instruments disclosed herein can be
inserted into a body in any way, such as through a natural orifice,
through an incision or puncture hole formed in tissue, or through
an access device, such as a trocar cannula. For example, the
working portions or end effector portions of the instruments can be
inserted directly into a patient's body or can be inserted through
an access device that has a working channel through which the end
effector and elongated shaft of a surgical instrument can be
advanced.
[0454] End effectors of the surgical instruments as described
herein can be configured to deliver one or more synthetic materials
and/or biologic materials, collectively referred to herein as
"adjunct materials," to a surgical site to help improve surgical
procedures. These biologic materials may be derived from human
and/or animal sources. While a variety of different end effectors
can benefit from the use of adjunct materials, in some exemplary
embodiments the end effector can be a surgical stapler. When used
in conjunction with a surgical stapler, the adjunct material(s) can
be disposed between and/or on jaws of the stapler, incorporated
into a staple cartridge disposed in the jaws, or otherwise placed
in proximity to the staples. When staples are deployed, the adjunct
material(s) can remain at the treatment site with the staples, in
turn providing a number of benefits. In some instances, the adjunct
material(s) can be used to help seal holes formed by staples as
they are implanted into tissue, blood vessels, and various other
objects or body parts, and/or can be used to provide tissue
reinforcement at the treatment site. Tissue reinforcement may be
needed to keep the staples from tearing through the tissue if the
tissue is diseased, is healing from another treatment such as
irradiation, medications such as chemotherapy, or other tissue
property altering situation. In some instances, the adjunct
material(s) may minimize tissue movement in and around the staple
puncture sites that can occur from tissue deformation that occurs
after stapling (e.g., lung inflation, gastrointestinal tract
distension, etc.). It will be recognized by one skilled in the art
that a staple puncture site may serve as a stress concentration and
that the size of the hole created by the staple will grow when the
tissue around it is placed under tension. Restricting the tissues
movement around these puncture sites can minimize the size the
holes may grow to under tension. In some instances, the adjunct
material(s) can be configured to wick or absorb beneficial fluids,
e.g., sealants, blood, glues, that further promote healing, and in
some instances, the adjunct material(s) can be configured to
degrade to form a gel, e.g., a sealant, that further promotes
healing. In some instances, the adjunct may carry materials that
when placed into a wet environment (e.g., blood, water, saline, or
other bodily fluids) form a sealant to create a seal (e.g., human
or animal derived fibrinogen and thrombin can be lyophilized into a
powder form that when mixed with water creates a sealant). Still
further, the material(s) can help reduce inflammation, promote cell
growth, and otherwise improve healing.
[0455] FIG. 2 illustrates one embodiment of an adjunct material
that includes a porous buttress 30 that can be fixed to a tissue T
to be treated by a surgical stapler and that remains at the
treatment site with staples 70. The buttress 30 can be made from
one or more absorbent materials and can be stamped, pressed, cut,
molded, woven, melted, blown, comprised from composite structures
and/or methods or otherwise shaped to facilitate absorption,
reinforcement, delivery and/or retention of beneficial fluids such
as sealants, glues, blood, etc. The absorption and/or retention of
beneficial fluids, for example a fibrin sealant 40, at the
treatment site can further help to prevent leaks and to reinforce
the buttress 30.
[0456] In use, the adjunct material can come pre-loaded onto the
device and/or the staple cartridge, while in other instances the
adjunct material can be packaged separately. In instances in which
the adjunct material comes pre-loaded onto the device and/or the
staple cartridge, the stapling procedure can be carried out as
known to those skilled in the art. For example, in some instances
the firing of the device can be enough to disassociate the adjunct
material from the device and/or the staple cartridge, thereby
requiring no further action by the clinician. In other instances
any remaining connection or retention member associating the
adjunct material with the device and/or the staple cartridge can be
removed prior to removing the instrument from the surgical site,
thereby leaving the adjunct material at the surgical site. In
instances in which the adjunct material is packaged separately, the
material can be releasably coupled to at least one of a component
of the end effector and the staple cartridge prior to firing the
device. The adjunct material may be refrigerated, and thus removed
from the refrigerator and the related packaging, and then coupled
to the device using a connection or retention member as described
herein or otherwise known to those skilled in the art. The stapling
procedure can then be carried out as known to those skilled in the
art, and if necessary, the adjunct material can be disassociated
with the device as described above.
[0457] A person skilled in the art will recognize a variety of
other ways by which the adjunct material can be temporarily
retained with respect to the end effector. In various embodiments a
connection or retention member can be configured to be released
from an end effector and deployed along with a piece of adjunct
material. In at least one embodiment, head portions of retention
members can be configured to be separated from body portions of
retention members such that the head portions can be deployed with
the adjunct material while the body portions remain attached to the
end effector. In other various embodiments, the entirety of the
retention members can remain engaged with the end effector when the
adjunct material is detached from the end effector.
[0458] Adjunct materials described herein may be used in any
surgery where a surgical stapler or other instrument creating
tissue punctures is utilized. In some embodiments, adjunct
materials described herein may be used for sealing staple punctures
created when a surgical stapler is used in lung surgery. When
surgery is performed on a lung (e.g., lobectomy, segmentectomy,
wedge resection, lung volume reduction surgery, etc.), the lung is
typically collapsed, and the required procedure, including
application of the stapler to tissue to be removed, is then
performed on the collapsed lung. After the procedure is completed,
the collapsed lung is re-inflated. The re-inflation of the lung
stretches the lung parenchyma, which may result in increased stress
at a junction between the stapled tissue and surrounding tissue
that was not punctured. Furthermore, airtight sealing is required
for the staple punctures of the lung. Such airtight sealing may be
difficult to achieve due to lung tissue movement. While leaks
around staple punctures typically heal within approximately five
days, in some cases, staple punctures may persist for longer
periods of time, such as, for example, up to six months.
[0459] Accordingly, some embodiments provide adjunct material that
may be used to seal staple punctures created by a surgical stapler
used to secure lung tissue. However, it should be appreciated that
the adjunct materials can also be used to seal punctures created by
surgical staplers used to secure any other type of tissue, such as,
for example, blood vessels, intestinal, stomach and esophageal
tissue.
[0460] Various exemplary sealants and methods of sealing a tubular
body organ are provided herein. In general, the sealants can
facilitate sealing around a stapled body lumen, such as around a
colon or around an intestinal anastomosis. A sealant can be
formulated in various ways and can have various properties, but is
generally provided in a first, liquid state and then cures to a
second, solidified state after a predetermined amount of time. For
example, the sealant can be introduced to the tubular body organ
and can help reinforce a seal at the staple line of an anastomosis.
When the sealant is in its liquid state, the sealant can seep into
the staple line and can solidify therein, thereby facilitating a
complete sealing of the tubular body organ at the staple line. The
sealant can facilitate short term sealing of the tubular body organ
and can be formulated so that it is absorbed into the body after
the tubular body organ has healed at the anastomosis. In certain
aspects, a sealing cuff is provided that can act as a mold or form
for holding the sealant at the desired location, e.g. adjacent to a
staple line, when the sealant is in the first, liquid state. One or
more expandable members can be configured to expand the tubular
body organ to further maintain contact between the sealant and the
sealing cuff. In this way, the sealing cuff can be configured to
hold the sealant at the desired location so that the sealant is
more likely to completely seal the staple line and remain sealed as
liquid and solid material passes through the tubular body organ
during normal bodily functions.
[0461] The method can be performed in various ways. For example, at
least one expandable member can be inserted into the tubular organ
within an anastomosis. The expandable member can be inserted in a
first, compressed position and can be moved to a second, expanded
position to increase a diameter of a portion of the tubular organ.
In general, one or more expandable members can be positioned
adjacent to the staple line so that the tissue surrounding the
staple line can be expanded. A sealing cuff can be positioned
around an outer surface of the tubular organ and around the staple
line. When the expandable member is expanded, the tissue can move
toward the sealing cuff. The sealant can be predisposed within or
introduced into the sealing cuff to reinforce a seal at the staple
line of the anastomosis. A method for conducting a leak test of an
anastomosis is also provided and can be performed before or after a
sealant is applied thereto allow a surgeon to visually identify
whether there are openings between the tissue and the staple line
during expansion and contraction of the organ. Liquid or gas can be
delivered into the organ using various techniques and visualization
techniques can be used to allow a user can visually identify
whether the liquid/gas is leaking out of the organ through the
staple line. This can help a user determine whether sealant should
be applied to reinforce the tissue during the surgical procedure,
or if sealant has already been applied, whether additional sealant
or other sealing techniques should be used to reinforce the seal.
As described further below, the sealing cuff and expandable
member(s) can be used in conjunction with the leak test, such as to
reinforce the tissue after a user identifies leakage through the
anastomosis.
Surgical Stapling Instrument
[0462] While a variety of surgical instruments can be used in
conjunction with the adjunct materials disclosed herein, FIG. 3
illustrates one, non-limiting exemplary embodiment of a surgical
stapler 10 suitable for use with one or more adjunct materials. The
instrument 10 generally includes a handle assembly 12, a shaft 14
extending distally from a distal end 12d of the handle assembly 12,
and an end effector 50 at a distal end 14d of the shaft 14. Because
the illustrated embodiment is a surgical stapler, the end effector
50 has jaws 52, 54, although other types of end effectors can be
used with the shaft 14, handle assembly 12, and components
associated with the same. The surgical stapler 10 includes opposed
lower and upper jaws 52, 54 with the lower jaw 52 including a
staple channel 56 (FIG. 4) configured to support a staple cartridge
60, and the upper jaw 54 having an inner surface 58 that faces the
lower jaw 52 and that is configured to operate as an anvil to help
deploy staples 70 of the staple cartridge 60. The jaws 52, 54 are
configured to move relative to one another to clamp tissue or other
objects disposed therebetween, and components of a firing system
can be configured to pass through at least a portion of the end
effector 50 to eject the staples into the clamped tissue. In
various embodiments a knife blade 81 can be associated with the
firing system to cut tissue during the stapling procedure. At least
one of the opposed lower and upper jaws 52, 54 will be movable
relative to the other lower and upper jaws 52, 54. At least one of
the opposed lower and upper jaws 52, 54 may be fixed or otherwise
immovable. In some embodiments, both of the opposed lower and upper
jaws 52, 54 will be movable.
[0463] Operation of the end effector 50 can begin with input from a
clinician at the handle assembly 12. The handle assembly 12 can
have many different configurations designed to manipulate and
operate the end effector 50 associated therewith. In the
illustrated embodiment, the handle assembly 12 has a pistol-grip
type housing 18 with a variety of mechanical and/or electrical
components disposed therein to operate various features of the
instrument. For example, the handle assembly 12 can include a
rotation knob 26 mounted adjacent a distal end 12d thereof which
can facilitate rotation of the shaft 14 and/or the end effector 50
with respect to the handle assembly 12 about a longitudinal axis L
of the shaft 14. The handle assembly 12 can further include
clamping components as part of a clamping system actuated by a
clamping trigger 22 and firing components as part of the firing
system that are actuated by a firing trigger 24. The clamping and
firing triggers 22, 24 can be biased to an open position with
respect to a stationary handle 20, for instance by a torsion
spring. Movement of the clamping trigger 22 toward the stationary
handle 20 can actuate the clamping system, described below, which
can cause the jaws 52, 54 to collapse towards each other and to
thereby clamp tissue therebetween. Movement of the firing trigger
24 can actuate the firing system, described below, which can cause
the ejection of staples from a staple cartridge disposed therein
and/or the advancement the knife blade 81 to sever tissue captured
between the jaws 52, 54. A person skilled in the art will recognize
that various configurations of components for a firing system,
mechanical, hydraulic, pneumatic, electromechanical, robotic, or
otherwise, can be used to eject staples and/or cut tissue, and thus
a detailed explanation of the same is unnecessary.
[0464] As shown in more detail in FIG. 4, the end effector 50 of
the illustrated embodiment is a surgical stapling tool having a
lower jaw 52 that serves as a cartridge assembly or carrier and an
opposed upper jaw 54 that serves as an anvil. The staple cartridge
60, having a plurality of staples 70 therein, is supported in a
staple tray 57, which in turn is supported within the cartridge
channel of the lower jaw 52. The upper jaw 54 has a plurality of
staple forming pockets 66 (FIG. 11), each of which is positioned
above a corresponding staple from the plurality of staples 70
contained within the staple cartridge 60. The upper jaw 54 can be
connected to the lower jaw 52 in a variety of ways, although in the
illustrated embodiment the upper jaw 54 has a proximal pivoting end
54p that is pivotally received within a proximal end 56p of the
staple channel 56, just distal to its engagement to the shaft 14.
When the upper jaw 54 is pivoted downwardly, the upper jaw 54 moves
the anvil surface 58 and the staple forming pockets 66 formed
thereon move toward the opposing staple cartridge 60.
[0465] Various clamping components can be used to effect opening
and closing of the jaws 52, 54 to selectively clamp tissue
therebetween. In the illustrated embodiment, the pivoting end 54p
of the upper jaw 54 includes a closure feature 54c distal to its
pivotal attachment with the staple channel 56. Thus, a closure tube
82, whose distal end includes a horseshoe aperture 82a that engages
the closure feature 54c, selectively imparts an opening motion to
the upper jaw 54 during proximal longitudinal motion and a closing
motion to the upper jaw 54 during distal longitudinal motion of the
closure tube 82 in response to the clamping trigger 22. It will be
appreciated by a person skilled in the art that opening and closure
of the end effector 50 may be effected by relative motion of the
lower jaw 52 with respect to the upper jaw 54, relative motion of
the upper jaw 54 with respect to the lower jaw 52, or by motion of
both jaws 52, 54 with respect to one another.
[0466] The firing components of the illustrated embodiment can
include a firing bar 84, as shown in FIG. 5, having an E-beam 86 on
a distal end thereof. The firing bar 84 is encompassed within the
shaft 14, for example in a longitudinal firing bar slot 14s of the
shaft 14, and guided by a firing motion from the handle 12.
Actuation of the firing trigger 24 can affect distal motion of the
E-beam 86 through at least a portion of the end effector 50 to
thereby cause the firing of staples 70 contained within the staple
cartridge 60. In the illustrated embodiment, guides 85 projecting
from a distal end of the E-Beam 86 can engage a wedge sled 90,
which in turn can push staple drivers 92 upwardly through staple
cavities 68 formed in the staple cartridge 60. Upward movement of
the staple drivers 92 applies an upward force on each of the
plurality of staples 70 within the cartridge 60 to thereby push the
staples 70 upwardly against the anvil surface 58 of the upper jaw
54 and to create formed staples 70'.
[0467] In addition to causing the firing of staples, the E-beam 86
can be configured to facilitate closure of the jaws 52, 54, spacing
of the upper jaw 54 from the staple cartridge 60, and/or severing
of tissue captured between the jaws 52, 54. In particular, a pair
of top pins 87 and a pair of bottom pins 89 can engage one or both
of the upper and lower jaws 52, 54 to compress the jaws 52, 54
toward one another as the firing bar 84 advances through the end
effector 50. Simultaneously, a knife 81 extending between the top
and bottom pins 87, 89 can be configured to sever tissue captured
between the jaws 52, 54.
[0468] In use, the surgical stapler 10 can be disposed in a cannula
or port and disposed at a surgical site. A tissue to be cut and
stapled can be placed between the jaws 52, 54 of the surgical
stapler 10. Features of the stapler 10 can be maneuvered as desired
by the clinician to achieve a desired location of the jaws 52, 54
at the surgical site and the tissue with respect to the jaws 52,
54. After appropriate positioning has been achieved, the clamping
trigger 22 can be pulled toward the stationary handle 20 to actuate
the clamping system. The trigger 22 can cause components of the
clamping system to operate such that the closure tube 82 advances
distally through at least a portion of the shaft 14 to cause at
least one of the jaws 52, 54 to collapse towards the other to clamp
the tissue disposed therebetween. Thereafter, the trigger 24 can be
pulled toward the stationary handle 20 to cause components of the
firing system to operate such that the firing bar 84 and/or the
E-beam 86 are advanced distally through at least a portion of the
end effector 50 to effect the firing of staples 70 and optionally
to sever the tissue captured between the jaws 52, 54.
[0469] Another embodiment of a surgical instrument 100 is
illustrated in FIG. 6. Like surgical instrument 10, surgical
instrument 100 includes a handle assembly 112 with a shaft 114
extending distally therefrom and having an end effector 150 on a
distal end thereof for treating tissue. Upper and lower jaws 154,
152 of the end effector 150 can be configured to capture tissue
therebetween, staple the tissue by firing of staples from a
cartridge 160 disposed in the lower jaw 154, and/or to create an
incision in the tissue. In this embodiment, an attachment portion
116 on a proximal end of the shaft 114 can be configured to allow
for removable attachment of the shaft 114 and the end effector 150
to the handle assembly 112. In particular, mating features 125 of
the attachment portion 116 can mate to complementary mating
features 123 of the handle assembly 112. The mating features 123,
125 can be configured to couple together via, e.g., a snap fit
coupling, a bayonet type coupling, etc., although any number of
complementary mating features and any type of coupling can be used
to removably couple the shaft 114 to the handle assembly 112.
Although the entire shaft 114 of the illustrated embodiment is
configured to be detachable from the handle assembly 112, in some
embodiments the attachment portion 116 can be configured to allow
for detachment of only a distal portion of the shaft 114.
Detachable coupling of the shaft 114 and/or the end effector 150
can allow for selective attachment of a desired end effector 150
for a particular procedure, and/or for reuse of the handle assembly
112 for multiple different procedures.
[0470] The handle assembly 112 can have one or more features
thereon to manipulate and operate the end effector 150. By way of
non-limiting example, a rotation knob 126 mounted on a distal end
of the handle assembly 112 can facilitate rotation of the shaft 114
and/or the end effector 150 with respect to the handle assembly
112. The handle assembly 112 can further include clamping
components as part of a clamping system actuated by trigger 122 and
firing components as part of a firing system that can also be
actuated by the trigger 122. Thus, in some embodiments, movement of
the trigger 122 toward a stationary handle 120 through a first
range of motion can actuate clamping components to cause opposed
jaws 152, 154 to approximate toward one another to a closed
position. Further movement of the trigger 122 toward the stationary
handle 120 through a second range of motion can actuate firing
components to cause the ejection of staples from the staple
cartridge 160 and/or the advancement of a knife to sever tissue
captured between the jaws 152, 154.
[0471] Yet another embodiment of a surgical instrument 200 is
illustrated in FIG. 7 Like surgical instruments 10 and 100,
surgical instrument 200 includes a handle assembly 212 with a shaft
214 extending distally therefrom and having an end effector 250 on
a distal end thereof for treating tissue. The end effector 250 can
include a cartridge assembly 252 and an anvil 254, each having a
tissue-contacting surface 260p, 260d that is substantially circular
in shape. The cartridge assembly 252 and anvil 254 can be coupled
together via a shaft 262 extending from the anvil 254 to the handle
assembly 212 of the stapler 200, and manipulating an actuator 222
on the handle assembly 220 can retract and advance the shaft 262 to
move the anvil 254 relative to the cartridge assembly 252. In one
embodiment, the shaft 262 can be formed of first and second
portions (not shown) configured to releasably couple together to
allow the anvil 254 to be detached from the cartridge assembly 252,
allowing greater flexibility in positioning the anvil 254 and the
cartridge assembly 252 in a body. For example, the first portion of
the shaft can be disposed within the cartridge assembly 252 and
extend distally outside of the cartridge assembly 252, terminating
in a distal mating feature. The second portion of the shaft 214 can
be disposed within the anvil 254 and extend proximally outside of
the cartridge assembly 252, terminating in a proximal mating
feature. In use, the proximal and distal mating features can be
coupled together to allow the anvil 254 and cartridge assembly 252
to move relative to one another. The anvil 254 and cartridge
assembly 252 can perform various functions and can be configured to
capture tissue therebetween, staple the tissue by firing of staples
from a cartridge assembly 252 and/or can create an incision in the
tissue. In general, the cartridge assembly 252 can house a
cartridge containing the staples and can deploy staples against the
anvil 254 to form a circular pattern of staples around a
circumference of a tubular body organ.
[0472] The handle assembly 212 of the stapler 200 can have various
actuators disposed thereon that can control movement of the
stapler. For example, the handle assembly 212 can have a rotation
knob 226 disposed thereon to facilitate positioning of the end
effector 250 via rotation, and/or a trigger 222 for actuation of
the end effector 250. Movement of the trigger 222 through a first
range of motion can actuate components of a clamping system to
approximate the jaws, i.e. move the anvil 254 toward the cartridge
assembly 252. Movement of the trigger 222 through a second range of
motion can actuate components of a firing system to cause the
staples to deploy from the staple cartridge assembly 252 and/or
cause advancement of a knife to sever tissue captured between the
cartridge assembly 252 and the anvil 254.
[0473] The illustrated embodiments of surgical stapling instruments
10, 100, and 200 provide only a few examples of many different
configurations, and associated methods of use, that can be used in
conjunction with the disclosures provided herein. Although the
illustrated embodiments are all configured for use in minimally
invasive procedures, it will be appreciated that instruments
configured for use in open surgical procedures, e.g., open linear
staplers as described in U.S. Pat. No. 8,317,070, can be used in
conjunction with the disclosures provided herein. Greater detail on
the illustrated embodiments, as well as additional exemplary
embodiments of surgical staplers, components thereof, and their
related methods of use, that can be used in accordance with the
present disclosure include those devices, components, and methods
provided for in U.S. Publication No. 2013/0256377, U.S. Pat. Nos.
8,393,514, 8,317,070, 7,143,925, U.S. patent application Ser. No.
14/074,884, entitled "Sealing Materials for Use in Surgical
Procedures, and filed on Nov. 8, 2013, U.S. patent application Ser.
No. 14/074,810, entitled "Hybrid Adjunct Materials for Use in
Surgical Stapling," and filed on Nov. 8, 2013, U.S. patent
application Ser. No. 14/075,438, entitled "Positively Charged
Implantable Materials and Method of Forming the Same," and filed on
Nov. 8, 2013, U.S. patent application Ser. No. 14/075,459, entitled
"Tissue Ingrowth Materials and Method of Using the Same," and filed
on Nov. 8, 2013, U.S. patent application Ser. No. 14/074,902,
entitled "Hybrid Adjunct Materials for Use in Surgical Stapling,"
and filed on Nov. 8, 2013, U.S. patent application Ser. No.
14/226,142, entitled "Surgical Instrument Comprising a Sensor
System," and filed on Mar. 26, 2014, each of which is incorporated
by reference herein in its entirety.
End Effector Variations
[0474] End effectors of the surgical stapling instruments described
herein can have one or more features for adjusting an amount of
compression applied to tissue captured by the end effector. In some
embodiments, the end effector can be configured to create a desired
compression profile in tissue captured therein, for example a
profile that helps to minimize bleeding, tearing, and/or leakage of
the treated tissue. By way of non-limiting example, the desired
tissue compression profile can be obtained using variations in a
gap between upper and lower jaws of the end effector and/or
variations in the orientation, size, and/or shape of staples
applied to tissue by the end effector. As described in detail
herein, adjunct material(s) used in conjunction with such an end
effector can be configured to assist in creating the desired tissue
compression profile and/or to accommodate features used to create
the desired tissue compression profile.
[0475] Any such variations described herein can be used alone or
together to provide the desired tissue compression profile.
Although exemplary end effectors and components thereof are
described in conjunction with a particular surgical instrument,
e.g., instruments 10, 100, and 200, it will be appreciated that the
end effectors and components thereof can be configured for use with
other embodiments of surgical instruments as described herein.
[0476] In some embodiments, a staple cartridge disposed within an
end effector of a surgical stapling instrument can have a first
portion configured to compress tissue captured by the end effector
more than a second portion when the end effector is in a closed
position. The first portion of the cartridge can be spaced
longitudinally and/or laterally from the second portion to create a
desired compression gradient. For example, as shown in FIGS. 4 and
8, the staple cartridge 60 can have a stepped tissue contacting
surface. In particular, the cartridge 60 can have an inner tissue
contacting surface 62 and outer tissue contacting surfaces 64 that
extend upwardly to a taller height than the inner tissue contacting
surface 62. In this way, when the upper jaw 54 is in the closed
position in close approximation with the cartridge 60, the anvil
surface 58 can be configured to compress the outer surfaces 64 more
than the inner surface 62 due to the taller height of the outer
surfaces 64. In some circumstances, including circumstances where
tissue positioned between the anvil surface 58 and the cartridge 60
has a constant, or at least substantially constant, thickness, the
pressure generated within the tissue can be greater at outer
portions of the end effector 50 than at inner portions of the end
effector 50. Whereas a compression gradient generated by the
cartridge 60 varies in a stepped manner, it will be appreciated by
a person skilled in the art that a gradual compression gradient can
be generated within the tissue by a gradual increase in height of
various portions of the cartridge 60. It will also be appreciated
that a compression gradient can be obtained by variations in height
of the anvil surface 58, alone or in combination with height
variations of the cartridge 60, and that height variations can be
spaced laterally and/or longitudinally across the end effector
50.
[0477] In some embodiments, one or more adjunct materials fixed to
an end effector of a surgical stapling instrument can be used to
create a desired compression profile in tissue captured by the end
effector. Referring now to FIG. 9, a compressible, implantable
staple cartridge 360 can be formed from one or more adjunct
materials as described herein and can be configured to be seated
within an end effector of a surgical instrument, e.g., an end
effector 350. The cartridge 360 can have a height that decreases
from a tallest height H1 at a distal end 360d thereof to a smallest
height H2 at a proximal end 360p thereof. In this way, when an
upper jaw 354 of the end effector 350 is in the closed position in
close approximation with the cartridge 360, an upper jaw 354 of the
end effector 350 can be configured to compress the distal end 360d
more than the proximal end 360p. Although the compression gradient
created in the captured tissue by the cartridge 360 decreases
linearly from the distal end 360d to the proximal end 360p, it will
appreciated by a person skilled in the art that any compression
gradient can be created by different shapes of the cartridge 360.
In at least one embodiment, a thickness of the cartridge 360 can
vary across its width, similar to the cartridge 360.
[0478] In some embodiments, staples contained within a staple
cartridge of an end effector can be configured to create a desired
compression profile within tissue captured by the staples. The
desired compression profile can be created in stapled tissue, for
example, where staples within the staple cartridge have different
unformed staple heights. As shown in FIG. 10, an unformed height H
of the exemplary staple 70 can be measured from a base 74 of the
staple 70 to a top, or tip, of legs 72a, 72b of the staple 70.
Referring now to FIG. 11, which illustrates a cross section of the
end effector 350, a first group of staples 370a can have first
staple height H1 that is taller than a second staple height H2 of a
second group of staples 370b. The first group of the staples 370a
can be positioned in a first portion of the staple cartridge 360,
for example in an outer portion, and the second group of staples
370b can be positioned in a second portion of the staple cartridge
360, for example in an inner portion. In the illustrated
embodiment, the cartridge 360, and therefore the compression
gradient, can be configured to be symmetrical about a slot 367
configured to receive a cutting instrument, e.g., the E-beam 86,
therethrough. It will be appreciated by a person skilled in the art
that the first and second groups of staples 370a, 370b can be
arranged in any pattern and can be spaced laterally and/or
longitudinally along the cartridge 360. In certain embodiments, a
plurality of staple groups, each group having different unformed
staple heights, can be utilized. In at least one such embodiment, a
third group having an intermediate staple height can be positioned
in the cartridge intermediate the first group of staples and the
second group of staples. In various embodiments, each staple within
a staple row in the staple cartridge can comprise a different
staple height. In at least one embodiment, the tallest staple
within a staple row can be positioned on a first end of a staple
row and the shortest staple can be positioned on an opposite end of
the staple row. In at least one such embodiment, the staples
positioned intermediate the tallest staple and the shortest staple
can be arranged such that the staple heights descend between the
tallest staple and the shortest staple, for example.
[0479] Similarly, staples within a staple cartridge can have
different crown widths to create a desired compression profile in
the stapled tissue. As shown in FIG. 10, a crown width W of the
exemplary staple 70 can be measured from one side of the base 74 of
the staple 70 to an opposite side. Like the above-described
variations in staple height H, variations in the staple width W can
be spaced throughout the staple cartridge to create a plurality of
staple groups dispersed longitudinally and/or laterally across the
cartridge. By way of non-limiting example, FIG. 12 illustrates a
staple cartridge 260 for use with the surgical instrument 200 and
having staples 270 therein with different crown widths W. The
staple cartridge 260 houses three groups of staples 270a, 270b,
270c, each having different widths W1, W2, and W3, respectively,
although any number of staple groups is possible. As shown, the
groups of staples 270a, 270b, 270c can be arranged in
circumferential rows, with the staples 270c having the largest
width W1 positioned on an outermost edge of the cartridge 260 and
the staples 270a having the smallest width W3 positioned on an
innermost edge of the cartridge 260. In other embodiments, staples
having a larger crown width can be positioned near an inner most
edge of a cartridge and staples having a smaller crown width can be
positioned near an outer edge of the cartridge. In still further
embodiments, staples along the same row can have different crown
widths.
[0480] Additionally or alternatively, it may be possible to create
a desired tissue compression profile by the creation of different
formed (final) staple heights. FIG. 13 illustrates an exemplary
embodiment of lines of formed staples 470' installed using a
surgical stapling instrument as described herein and configured to
apply staples 470' having different formed heights as well as to
cut tissue to thereby create a cut line 494. As shown in FIG. 13,
formed heights F1 of a first group of staples 470a' in a first row
that is the farthest distance away from the cut line 494 are
greater than formed heights F3 of a third group of staples 470c' in
a third row that is closest to the cut line 494. A second group of
staples 470b' in a second row that is formed between the first and
third rows can have staples 470b' with a formed height F2 that is
between the heights F1, F3. In other embodiments, formed heights of
the staples can decrease from an innermost row to an outermost row.
In still further embodiments, formed heights of the staples in a
single row can increase or decrease from staple to staple.
[0481] Referring again to FIG. 11, differences in formed staple
heights can be attained by, for example, altering a staple forming
distance A. Forming distances Al, A2 can be measured from a seat of
staples 370a, 370b, respectively, within the cartridge 360, and an
apex of a corresponding forming pocket 366 of the anvil surface 358
when the upper jaw 354 is in the closed position. In one
embodiment, for example, a first staple forming distance Al is
different from a second staple forming distance A2. Because the
forming distance Al is greater than the forming distance A2, the
staples 370a are not compressed as much as the staples 370b, which
can alter the formed heights of the staples 370a, 370b. In
particular, greater amounts of compression, corresponding to
smaller forming distances, can result in staples with smaller
formed (final) heights. It will be understood that similar results
may be attained in any desired pattern.
[0482] Varied tissue compression gradients can be obtained via
patterns in staple orientation within a staple cartridge, for
example by the patterns illustrated in FIGS. 14 and 15A. In the
embodiment depicted in FIG. 14, staple cartridge 560 can include at
least one first staple cavity 568a and at least one second staple
cavity 568b for housing staples 570 therein. The first cavity 568a
can be situated on first lateral side 563 of the cartridge 560 and
the second cavity 568b can be situated on a second lateral side 565
of the cartridge 560, the first and second lateral sides 563, 565
being separated by a slot 567 configured to receive a cutting
instrument, e.g., the E-beam 86, therethrough. The first cavity
568a can define a first longitudinal axis 569a and the second
cavity 568b can define a second longitudinal axis 569b. In the
illustrated embodiment, the first axis 569a is perpendicular, or
substantially perpendicular, to the second axis 569b. In other
embodiments, the first axis 569a can be transverse to the second
axis 569b such that axes 569a, 569b can create an acute or obtuse
angle therebetween. In still other embodiments, the first axis 569a
can be parallel to, or substantially parallel to, the second axis
569b. In some embodiments, at least a portion of the staple
cavities 568a, 568b can overlap, such that staples 570 therein can
be interlocked when formed. The cartridge 560 can have a plurality
of each of the first and second cavities 568a, 568b, which can be
arranged in any pattern on first and second sides 563, 565 of the
cartridge 560, for example in rows extending along both sides 563,
565 of the cartridge 560 along a longitudinal axis Lc of the
cartridge 560. The staples 570 housed within the cavities 568a,
568b can be implanted into tissue in a pattern determined by the
orientation and positioning of the cavities 568a, 568b. The
cartridge 560, for example, can be used to implant staples 570
having different orientations of the staples 570 on opposite sides
of an incision line created by a surgical instrument carrying the
cartridge 560.
[0483] In other embodiments, for example the embodiment of a
cartridge 660 illustrated in FIG. 15A, staple cavities 668a and
668b having different orientations can both be disposed on a single
lateral side of the cartridge 660. As shown in FIG. 15A, an axis
669a of the first staple cavity 668a is perpendicular, or
substantially perpendicular, to an axis 669b of the second staple
cavity 668b, both of which are disposed on each of first and second
lateral sides 663, 665 of the cartridge 660. In other embodiments,
the axes 669a, 669b can form an acute or obtuse angle therebetween,
or can be parallel to one another. A plurality of the first and
second cavities 668a, 668b can be aligned in adjacent rows along a
longitudinal axis Lc' of the cartridge 660 on each of the first and
second sides 663, 665 of the cartridge 660. In this embodiment,
staples 670 housed within the cavities 668a, 668b can be implanted
into tissue in a symmetrical pattern about an incision line created
by a surgical instrument carrying the cartridge 660. Greater detail
on staple patterns, as well as additional embodiments of such
patterns, can be found in U.S. Publication No. 2011/0192882,
incorporated herein by reference in its entirety.
Exemplary Compositions for Adjunct Materials
[0484] Regardless of the configuration of the surgical instrument,
the present disclosure provides for the use of implantable
materials, e.g., synthetic and/or biological materials,
collectively "adjunct materials," in conjunction with instrument
operations. As shown in FIG. 15B, the end effector 50 can include
at least one piece of adjunct material 30 positioned intermediate
the lower and upper jaw members 52, 54 and it can be releasably
retained to one of the staple channel 56 and/or the anvil surface
58. In use, the adjunct material 30 and patient tissue can be
captured by staples 70 when the staples 70 are fired. Then, the
adjunct material 30 can be separated from the surgical stapler and
can remain in the patient when the stapler is removed from the
patient. Exemplary devices and methods for attaching one or more
adjunct materials to an end effector of a surgical instrument can
be found in U.S. Publication No. 2013/0256377 and U.S. Publication
No. 2013/0153641, incorporated herein by reference in their
entirety.
[0485] Regardless of the configuration of the surgical instrument,
the embodiments described herein can provide for the use of
implantable materials, e.g., synthetic and/or biological materials,
collectively "adjunct materials," in conjunction with instrument
operations. As explained in more detail below, adjunct materials as
disclosed herein can be releasably coupled to the lower and upper
haw members 52, 54 in a variety of manners to allow the adjunct
materials to separate from the jaw members upon actuation of the
end effector 50. More particularly, the adjunct materials can be
captured by staples 70 along with tissue disposed between the jaw
members 52, 54. The adjunct materials can remain in the patient
when the stapler removed from the patient. While a number of
devices and methods for attaching adjunct materials to an end
effector of a surgical instrument are described below, others can
be found in U.S. Pat. Pub. No. 2013/0256377 and U.S. Pat. Pub. No.
2013/0153641, incorporated herein by reference in their
entirety.
[0486] In at least one embodiment, a surface on the adjunct
material 30 can be configured to contact tissue as the tissue is
clamped between the lower and upper jaw members 52, 54. In such an
embodiment, the adjunct material can be used to distribute the
compressive clamping force over the tissue, absorb, reinforce,
and/or retain beneficial fluids at the treatment site, improve the
purchase of the staples, and/or promote improved clinical outcomes
such as hemostasis, pneumostasis, healing, etc. In various
embodiments, one or more pieces of adjunct material can be
positioned within the end effector 50. In some embodiments, one
piece of adjunct material 30 can be attached to the staple
cartridge 60 and a second piece of adjunct material 30' can be
attached to the anvil surface 58; however, any suitable number of
adjunct materials can be situated within the end effector 50.
[0487] Adjunct material used in conjunction with the disclosures
provided for herein can have any number of configurations and
properties. Generally, they can be made from a bioabsorbable
material, a biofragmentable material, and/or a material otherwise
capable of being broken down, for example, such that the adjunct
material can be absorbed, dissolved, fragmented, and/or broken down
during the healing process. In at least one embodiment, the adjunct
material can be configured to degrade over time to form a gel,
e.g., a sealant, to assist in wound healing. In other embodiments,
the adjunct material can include a therapeutic drug that can be
configured to be released over time to aid the tissue in healing,
for example. In further various embodiments, the adjunct materials
can include a non-absorbable and/or a material not capable of being
broken down, for example.
[0488] Some particularly advantageous adjunct materials can include
porous polymer scaffolds that can be configured to be broken down,
for example by exposure to water such that the water attacks the
linkage of a polymer of the material. The degraded material can be
configured to gel over a wound site to thereby coat the wounded
tissue, e.g., wounded soft tissue, which can aid in compressing,
sealing and/or generally creating an environment at the wound site
that promotes healing of the tissue. In particular, such degradable
polymers can allow for the tissue itself to become the
weight-bearing component. In some embodiments, the degraded
material can include chemoattractant agents that attract natural
healing compounds to the wound site. The polymer scaffolds can be
configured to have a desired rate of degradation, for example
within minutes to hours after attachment to tissue, to thereby
assist in the healing process almost immediately after attachment.
For more details on porous polymer scaffolds as described herein,
see Q. Chen et al., Elastomeric biomaterials for tissue
engineering, Progress in Polymer Science 38 (2013) 584-671,
incorporated herein by reference in its entirety.
[0489] In some embodiments, the porous polymer scaffolds described
herein can be physically crosslinked, which can allow for shaping
of the polymer into various complicated three-dimensional shapes,
e.g., fibers, sheets, films etc., having any desired porosity,
surface-to-volume ratio, and mechanical properties. The scaffold
can be shaped into a desired form via a number of methods, for
example by extrusion, wet spinning, electrospinning, thermally
induced phase separation (TIPS), salt leaching/freeze-drying, etc.
Where the scaffold is formed into a film or sheet, the film or
sheet can have any desired thickness, for example in a range of
about 50 to 750 .mu.m or in a range of about 1 to 3 mm, depending
on the desired application.
[0490] One embodiment of a porous polymer scaffold includes
multiple layers, each of which can perform different wound healing
functions. In an exemplary embodiment, the scaffold includes three
layers. The first layer can be made from polyester carbonate
urethane urea (PECUU), the second layer can be made from poly(ester
urethane) urea (PEUU), and the third layer can be made from
poly(carbonate urethane) urea (PCUU) lysine triisocyanate (LTI) or
hexamethylene diisocyanate (HDI). A person skilled in the art will
appreciate that the properties of each layer can be optimized to
achieve desired results and performance. In some embodiments, the
desired properties of the scaffold can be achieved by blending or
copolymerizing the material of the third layer or copolymerized
with various polymers or copolymers. By way of non-limiting
examples, the material of the third layer can be blended with a
polyester copolymer, for example polycaprolactone (PCL),
polyglycolic acid PGA, poly(D,L-lactic acid) (PDLLA), PGA, and/or
polyethylene glycol (PEG). Where the material of the third layer is
blended with both the polyester copolymer and the PEG, a ratio of
the polyester to the PEG in the third layer can be about 50:50. In
another exemplary embodiment, the PCL can be present in a range of
about 60-70% weight/volume, the PGA can be present in a range of
about 20-30% weight/volume, the PEG can be present in a range of
about 50% weight/volume, and the PDLLA can be present in a range of
about 10% weight/volume.
[0491] The three-layered film can be configured to degrade almost
immediately upon attachment to tissue, for example within about 1
to 2 hours after attachment, although each of the three layers can
be configured to degrade differently to have different healing
benefits. The order, number, and thickness of each of the layers
can vary, and can be tailored to create desired degradation and/or
compression ratios. In some embodiments, the first, second, and
third layers can be formed on top of a base material or substrate,
for example on top of PCL, which can be configured to aid in
mechanical compression of the wounded tissue.
[0492] Another exemplary embodiment of a porous polymer scaffold
can be synthesized from polyhydroxyalkanoate (PHA). In an exemplary
embodiment, the PHA can be naturally produced from a variety of
microorganisms, e.g., Gram-negative or Gram-positive bacteria, or
it can be synthesized, e.g., similar to the production of
Biopol.RTM., available from Zeneca of London, United Kingdom.
Because PHAs are very quick to dissolve, scaffolds made from PHA
can begin to degrade within 20 to 30 minutes after attachment to
tissue via contact with heat and/or water. Where the PHA scaffold
has a higher molecular weight, the degradation time can be higher,
for example in a range of about 30 minutes to about 10 hours. The
PHA can be formed into a very thin film, for example a film having
a thickness of less than 0.1 mm, e.g., in a range of between 50 to
750 .mu.m. In some embodiments, the PHA can be copolymerized and/or
blended with one or more additional materials. By way of
non-limiting example, the PHA can be copolymerized with
hydroxlvalerate (HV), hydroxylbutyrate (HB), and/or
hydroxylhexanoate (HH), which can reduce a level or crystallinity
and/or brittleness of the PHA. In other embodiments, the PHA can be
blended with one or more thermoplastics, e.g., poly(lactic acid)
(PLA), PGA, PCL, starch, etc., to thereby customize a molecular
weight and resultant mechanical properties of the scaffold. In
certain aspects, one or more of the polymers can be a thermoplastic
polymer.
[0493] In other embodiments, the scaffold can be synthesized from
poly(polyol sebacate) (PPS), e.g., from poly(glycerol-sebacate)
(PGS). Such scaffolds can be particularly biocompatible and can
provide an additional advantage of reducing a risk of infection in
addition to promoting healing. Other exemplary embodiments can be
synthesized from xylitol-based elastomers, for example polyxylitol
sebacates (PXSs), which can offer structural stability over a
clinically required period and/or can enter the metabolic pathway
slowly without causing rapid fluctuations of blood glucose levels.
Scaffolds made from PXS's can be formed into a thicker film to
thereby provide greater compression to the wound site, and can be
configured to degrade within a range of about 10 hours to 8 days
after attachment. Still other exemplary embodiments can be
synthesized from poly(glycerol sebacate-co-acrylate) (PGSA), which
can promote tissue ingrowth into the scaffold, particularly when
formed as a fiber, and/or can serve as an antibacterial agent. PGSA
scaffolds can be useful as a replacement for traditional surgical
sutures and staples, and/or can serve as a waterproof sealant for
hollow organ anastomoses (e.g., ducts, intestine, etc.), 2D mesh
grafts (e.g., treatment of hernias, ulcers, burns, etc.), and/or
wound dressings (e.g., hemostatic patches, etc.). The PGSA can be
combined with glycerol, which can allow the scaffold to last longer
in situ, for example up to 20 days.
[0494] In yet another embodiment, the scaffold can be made from
poly(e-caprolactone) (PCL), which can be blended with silk fibroin
(SF) and which can be formed into a very thin film. The PCL/SF
blend can have highly biocompatible properties and/or can improve
cell attachment and/or proliferation to the scaffold. For example,
when implanted onto tissue, the scaffold can release fibroin into
the tissue to thereby promote faster healing, nearly immediate
hemostasis, and/or to attract fibroblasts in greater numbers. The
PCL component can further assist in the healing process by
providing mechanical compression of the wounded tissue. A higher
PCL content can provide better mechanical properties, while a
higher SF content can provide better degradation properties. In
general, the PCL content can be in a range of about 50 to 90%
weight/volume and the SF content can be in a range of about 10 to
50% weight/volume. More details on the properties and manufacturing
methods for scaffolds made from PCL and SF can be found in Jun Sik
Lim et al., Fabrication and Evaluation of
Poly(epsilon-caprolactone)/Silk Fibroin Blend Nanofibrous Scaffold,
Biopolymers 97: 265-275 (2012), incorporated herein by reference in
its entirety.
[0495] In still further embodiments, the scaffold can include PCL
coated with a gelatin. The scaffold can be arranged in one or more
layers, for example with the PCL serving as a substrate. The PCL
can function to increase a mechanical strength of the scaffold
and/or can support fibroblast adhesion and cell proliferation. More
details on the properties and manufacturing methods for scaffolds
made from gelatin-coated PCL can be found in Pengcheng Zhao et al.,
Biodegradable fibrous scaffolds composed of gelatin coated
poly(e-caprolactone) prepared by coaxial electrospinning, J. Biomed
Mater Res 83A: 372-382 (2007), incorporated herein by reference in
its entirety.
[0496] Table 1 below outlines exemplary molecular weight ranges,
approximate absorption times, and average dimensions of films made
from the aforementioned porous polymer scaffold materials. It will
be appreciated by a person skilled in the art that the ranges
provided in Table 1 are not intended to be limiting, and that a
molecular weight of any of the polymers described herein can be
altered to obtain the desired degradation properties.
TABLE-US-00001 TABLE 1 Average molecular Approximate weight in
absorption Average Average Average Film Daltons times thickness
length width Polyester carbonate 5,000 to 14 to 60 days 10 .mu.m to
25.4 to 10.3 to urethane 80,000 1 mil 100 mm 12.7 mm urea (PECUU)
Poly(ester 5,000 to 14 to 60 days 10 .mu.m to 25.4 to 10.3 to
urethane)urea 80,000 1 mil 100 mm 12.7 mm (PEW) Poly(carbonate
10,000 to 14 to 60 days 100 .mu.m 25.4 to 10.3 to urethane)urea
200,000 to 1 mil 100 mm 12.7 mm (PCUU) (preferably 15,000 to
50,000) Polyhydroxyalkanoate 2.107 .times. 1029 7 to 60 days 100
.mu.m 25.4 to 10.3 to (PHA) to 2.589 .times. to 1 mil 100 mm 12.7
mm 1029 Poly(polyol sebacate) 89,000 and 7 to 60 days 100 .mu.m
25.4 to 10.3 to (PPS) 124,000 to 1 mil 100 mm 12.7 mm Polyxylitol
sebacates 1.47 .times. 1027 7 to 60 days 100 .mu.m 25.4 to 10.3 to
(PXS's) to 3.73 .times. to 1 mil 100 mm 12.7 mm 1027 Poly(glycerol
5.8 .times. 1026 to 7 to 60 days 100 .mu.m 25.4 to 10.3 to
sebacate-co-acrylate) 7.5 .times. 1026 to 1 mil 100 mm 12.7 mm
(PGSA) Poly(.epsilon.-caprolactone); 25,000 to 21 to 60 days 10
.mu.m to 25.4 to 10.3 to silk fibroin; scaffold 325,000 (SF) (SF) 1
mil 100 mm 12.7 mm (PCL/SF) Blend 4.21 .times. 1028 to 2 to 3 years
PCL/SF (50/50) 4.81 .times. 1028 (PCL) (PCL) Gelatin coated PCL
3.01 .times. 1028 to 7 days 100 .mu.m 25.4 to 10.3 to (poly
(.epsilon.-caprolactone) 1.98 .times. 1029 (gelatin) to 1 mil 100
mm 12.7 mm (gelatin) 2 to 3 years 4.21 .times. 1028 to (PCL) 4.81
.times. 1028 (PCL)
[0497] Other suitable adjunct materials can include absorbable
polyurethanes, e.g., polyurethanes derived from aromatic absorbable
isocyanates that can be similar to methylene bis(phenyl isocyanate)
(MDI) and chain extender diols. The absorbable polyurethanes can be
configured to hydrolytically degrade into safe and biocompatible
products upon hydrolysis. Non-limiting examples of hydrolysable
aromatic isocyanates that can be used to form the absorbable
polyurethanes include glycolate-diisocyante,
caprolactone-diisocyanate, glycolate-ethylene glycol-glycolate,
glycolate-diethylene glycol-glycolate, lactate-diethylene
glycol-lactate, trimester of glycolic acid with trimethylpropane,
and tetraester of glycolic acid with pentaerythritol.
[0498] Another particularly advantageous adjunct material that can
be used in conjunction with the disclosures provided herein are the
materials that form the multilayered dressings disclosed in U.S.
Publication No. 2006/0257458, incorporated herein in its entirety,
which are particularly suited to absorb and retain fluids when
compressed, e.g., by the application of staples. Other exemplary,
non-limiting examples of synthetic materials that can be used in
conjunction with the disclosures provided for herein, e.g., as a
buttress, include biodegradable synthetic absorbable polymer such
as a polydioxanon film sold under the trademark PDS.RTM. or with a
Polyglycerol sebacate (PGS) film or other biodegradable films
formed from PGA (Polyglycolic acid and various forms thereof,
marketed under the trademarks Vicryl, Dexon, and/or Neoveil), PCL
(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA
(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the
trademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.),
Polyglactin 910, Poly glyconate, PGA/TMC
(polyglycolide-trimethylene carbonate sold under the trademark
Biosyn), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP),
poly(vinyl alcohol) (PVA), polydioxanone (PDO) and various forms
thereof (e.g., marketed under the trademark PDS) or a blend or
copolymerization of any of the above. Blends and/or
copolymerizations of any of the aforementioned materials can be
tailored to have a desired molecular weight and/or degradation
rate.
[0499] Some non-limiting examples of biologic derived materials
that can be used in conjunction with the disclosures provided for
herein, e.g., as a sealant material, include platelet poor plasma
(PPP), platelet rich plasma (PRP), starch, chitosan, alginate,
fibrin, thrombin, polysaccharide, cellulose, collagen, bovine
collagen, bovine pericardium, gelatin-resorcin-formalin adhesive,
oxidized regenerated cellulose, regenerated cellulose, mussel-based
adhesive, poly (amino acid), agarose, polyetheretherketones,
amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum,
starch, gelatin, silk, Progel.RTM., available from Davol Inc. of
Warwick, R.I., TachoSil.RTM., available from Baxter of Deerfield,
Ill., or other material suitable to be mixed with biological
material and introduced to a wound or defect site, including
combinations of materials, or any material apparent to those
skilled in the art in view of the disclosures provided for herein.
Biologic materials can be derived from a number of sources,
including from the patient in which the biologic material is to be
implanted, a person that is not the patient in which the biologic
material is to be implanted, or other animals.
[0500] Additional disclosures pertaining to synthetic or polymer
materials and biologic materials that can be used in conjunction
with the disclosures provided herein can be found in U.S. Pat. No.
7,772,352, PCT Publication No. WO 2014/016819, U.S. Patent
Application Publication No. 2006/0257458, U.S. Patent Application
Publication No. 2012/0080335, U.S. Patent Application Publication
No. 2012/0083835, U.S. Patent Application Publication No.
2013/0256372, U.S. Patent Application Publication No. 2013/0256365,
U.S. Patent Application Publication No. 2013/0256376, U.S. patent
application Ser. No. 13/710,931, entitled "Electrosurgical End
Effector with Tissue Tacking Features," and filed on Dec. 11, 2012,
and U.S. patent application Ser. No. 13/763,192, entitled "Multiple
Thickness Implantable Layers for Surgical Stapling Devices," and
filed on Feb. 8, 2013, each of which is incorporated by reference
herein in its entirety.
[0501] In use, the adjunct material can come pre-loaded onto the
device and/or the staple cartridge, while in other instances the
adjunct material can be packaged separately. In instances in which
the adjunct material comes pre-loaded onto the device and/or the
staple cartridge, the stapling procedure can be carried out as
known to those skilled in the art. For example, in some instances
the firing of the device can be enough to disassociate the adjunct
material from the device and/or the staple cartridge, thereby
requiring no further action by the clinician. In other instances
any remaining connection or retention member associating the
adjunct material with the device and/or the staple cartridge can be
removed prior to removing the instrument from the surgical site,
thereby leaving the adjunct material at the surgical site. In
instances in which the adjunct material is packaged separately, the
material can be releasably coupled to at least one component of the
end effector, e.g., the staple cartridge, prior to firing the
device. The adjunct material may be refrigerated, and thus removed
from the refrigerator and the related packaging, and then coupled
to the device using a connection or retention member as described
herein or otherwise known to those skilled in the art. The stapling
procedure can then be carried out as known to those skilled in the
art, and if necessary, the adjunct material can be disassociated
with the device as described above.
Adjuncts having Strain Relieving Features
[0502] A tissue adjunct can have various configurations, but can
generally be configured to contact tissue as the tissue is clamped
between a cartridge assembly and an anvil of a surgical stapler.
One advantage of tissue adjuncts is their propensity to prevent or
minimize leaks, such as fluid or gas leaks. Tissue adjuncts can
perform this function by one or more of the following mechanisms:
plugging holes or tears that occur at the staple puncture sites;
restricting movement of tissue around staple puncture sites to
prevent an increase in the size of staple holes and/or to prevent
tissue tears; and minimizing strain gradients that occur between
constrained tissues within the staple line and free tissue adjacent
to the staple line.
[0503] In certain aspects, the adjunct material can be used to
distribute the compressive clamping force over the tissue, absorb
and retain beneficial fluids at the treatment site, improve the
purchase of the staples, and/or promote hemostasis. In some
embodiments, a first piece of adjunct material can be attached to a
cartridge assembly and a second piece of adjunct material can be
attached to an anvil; however, any suitable number of adjunct
materials can be situated within the end effector.
[0504] The tissue adjunct can include various features and be
formed from various materials for assisting with sealing of tissue
at a staple line and/or for preventing the formation of leaks in
the tissue. For example, a tissue adjunct can have a central region
configured to be deployed onto tissue and attached thereto via
staples. The tissue adjunct can further include an outer region,
also referred to herein as a wing region or wing portion, which can
be positioned outside of a staple line when the adjunct is stapled
to tissue. The wing portion can help to more evenly distribute
strain and/or minimize strain gradients across a tissue as the
tissue deforms or otherwise expands and contracts during normal
bodily functions. In some embodiments, a sealant can be used in
conjunction with the adjunct to help seal the stapled tissue. The
sealant can be introduced into a patient in a first, liquid state
and can be configured to transition to a second, hardened or solid
state after a predetermined amount of time. When the sealant is in
the first, liquid state, the sealant can seep into the adjunct
and/or the staple line and then harden therein, thereby
facilitating complete sealing of the tissue. The adjunct and the
sealant can thus cooperate to provide a better, more complete seal
of the staple line than if only the tissue adjunct or the sealant
were used.
[0505] Exemplary adjuncts having central and wing regions are shown
deployed onto tissue in FIGS. 16A and 16B. As shown in FIG. 16A, an
adjunct 1000 can include a central 1002 for receiving staples
therethrough and a wing portion 1004 adjacent to the central region
1002. The central region 1002 of the adjunct 1000 can be sized and
shaped to correspond to a size and shape of a cartridge assembly 52
and/or an anvil (not shown). For example, FIG. 16A illustrates an
adjunct 1000 having a central region 1002 that corresponds in size
and shape to a tissue-contacting surface of the cartridge assembly
52. That is, the central region 1002 can be substantially equal in
size to the tissue-contacting surface. The central region 1002 of
the adjunct 1000 shown in FIG. 16A can have a substantially
elongate rectangular shape defined by proximal and distal edges
1002p, 1002d and first and second lateral edges 1002a, 1002b. The
proximal edge 1002p of the central region 1002 can terminate in a
proximal mating feature 1006 for coupling to a distal end 14d of a
shaft 14 of a stapler 10. At least two of the remaining three edges
of the central region 1002 can include a wing portion 1004
extending therearound and forming a perimeter of the adjunct 1000.
For example, as shown in FIG. 16A, the wing portion 1004 of the
adjunct 1000 can extend around the first and second lateral edges
1002a, 1002b and can extend distally beyond the distal edge 1002d
of the central region 1002. In one embodiment, adjunct 1000 is
sized and position in such a way on cartridge assembly 52 so that
in can be separated by a cutting member in the stapler during use.
In fact, a distal region of the wing portion 1004 is always cut. As
shown, the wing portion 1004 can have a modified structure that is
different from a structure of the central region 1002. In the
illustrated embodiment, the central region 1002 can be
substantially solid, e.g. a film, and the wing portion 1004 can be
a mesh. As shown in FIG. 16B, when the adjunct 1000 is stapled to
tissue T, the central region 1002 can have one or more rows/lines
of staples 1008 extending therethrough and the wing portion 1004
can extend laterally away from the staples 1008. As shown, the
adjunct 1000 stapled to the tissue T includes half of the adjunct
shown in FIG. 16A because the cutting member in the stapler severs
the tissue while the staples 1008 are deployed thereon. The meshed
wing portion 1004 can flex as the tissue expands and contracts and
more evenly distribute a strain (or minimize a strain gradient)
across a greater area of tissue than if the adjunct 1000 only
included the central region 1002. For example, the wing portion
1004 can expand and contract in a direction transverse to the
longitudinal axis LC of the central region 1002. This can help
prevent the formation of pressure points which can create leaks in
the stapled tissue after repeated expansion and contraction of the
tissue. In certain aspects, the mesh can be formed from threads of
the same film material as the central region 1002 extending in a
criss-cross pattern. The longitudinal axis of half of the threads
Ll can be disposed at an angle .theta.1 of about a 45 degrees
relative to the longitudinal axis LC of the central region 1002, as
shown, and a longitudinal axis L2 of the other half of the threads
can be disposed at an angle .theta.2 of about a 45 degree angle
relative to the longitudinal axis LC of the central region 1002, or
can be positioned at other angles relative to the central region
1002. As will be appreciated by a person skilled in the art, the
wing portion 1004 of the adjunct 1000 can be formed using various
known manufacturing techniques, such as laser cutting or punching
shapes such as squares, circles, diamonds, out of the film to
produce a mesh wing region and the solid central region 1002. Two
identical adjuncts 1000, 1000' can be stapled to tissue, as shown
in FIG. 16B, and in certain aspects, these adjuncts 1000, 1000' can
be substantially the same in size, shape, and configuration.
[0506] Another embodiment of an adjunct 1010 is shown in FIG. 17
and also includes a central region and wing region. In this
embodiment, a wing portion 1014 has a plurality of openings 1018
formed therein which can allow the wing portion 1014t o flex with
the tissue T during expansion and contraction of the tissue T. The
openings 1018 can have various sizes, shapes, and configurations,
and can be circular, oval, rectangular, etc., and can be positioned
at various locations across the wing portion 1014. In the
illustrated embodiment, the openings 1018 are slits positioned in
multiple rows, the rows being substantially parallel to the
longitudinal axis LC of a central region 1012. A longitudinal axis
of the slits 1018 can be parallel to a longitudinal axis LS of the
staples 1008. A number of longitudinal rows and a number of
openings 1018 disposed in each row can vary. In the illustrated
embodiment, a row adjacent to the central region 1012 can have a
smaller number of openings 1018 than a row adjacent to an outermost
edge 1014a of the wing portion 1014. For example, the row adjacent
to the central region 1012 can have about three openings 1018
formed therein while the row adjacent to the outermost edge 1014a
of the wing portion 1014can have about four openings 1018 formed
therein. In this way, a flexibility of the wing portion 1014can
increase from the central region 1012 to the lateral edge and can
further facilitate distribution of strain across the tissue T.
[0507] FIGS. 18A and 18B illustrate another embodiment of a tissue
adjunct having wings for distributing strain across the tissue.
FIG. 18A illustrates an adjunct 1020 having a central region 1022
and a wing region 1024, both regions being formed from a plurality
of layers. As in the previous embodiments, the central region 1022
can have a substantially rectangular shape. A top layer of material
can define the central region 1022 and both regions 1022, 1024 can
be formed from a plurality of layers. The central region 1022 can
have a substantially rectangular shape, but can be shaped in other
ways. As shown in FIG. 18A, a top layer of material 1026t can
define the central region and can be formed from a flexible
material, such as PDS.RTM., PGA, Neoveil.RTM., ORC or other
polymers and biologically derived material constructs or
combinations disclosed herein. Material geometry and structure
(material thickness, fiber orientation, polymer chain orientation,
hole patterns, etc.) may be used to create desired isotropic or
anisotropic deformation characteristics. A bottom layer of material
1026b can also be substantially flexible, and in certain aspects
can have a greater flexibility than the top layer 1026t. The bottom
layer 1026b can have a shape that corresponds to a shape of the top
layer 1026t, and is shown having a substantially rectangular shape.
The bottom layer 1026b can have a larger surface area than the top
layer 1026t such that the bottom layer 1026b extends beyond lateral
edges of the top layer 1026t. As shown, lateral edges of the bottom
layer 1026b can be scalloped, having a plurality of semicircular
protrusions 1028 along the wing portion 1024. These semicircular
protrusions can be spaced at equal distances apart along the edges,
or can be spaced in groups of two, three, four, and the groups of
protrusions can be disposed at equal distances apart along the
edge. When the adjunct 1020 is stapled to tissue, the top layer
1026t of material 1026t will be positioned away from and will not
directly contact the tissue, while the bottom layer 1026b will
directly contact tissue. Additionally, the protrusions can be
positioned away from the staple rows and can distribute a strain
across the tissue T to prevent formation of leaks. The bottom layer
1062b may be formed from a flexible material, such as PDS.RTM.,
PGA, Neoveil.RTM., ORC or other polymers and biologically derived
material constructs or combinations disclosed herein. Material
geometry and structure (material thickness, fiber orientation,
polymer chain orientation, hole patterns, etc.) may be used to
create desired isotropic or anisotropic deformation
characteristics. In an embodiment, at least one of top layer 1062t
and bottom layer 1062b is at least partially comprised of PDS.RTM.
to aid in attachment of adjacent layers. In an embodiment, both the
top layer 1062t and bottom layer 1062b are created from absorbable
materials.
[0508] The adjunct material can be constructed in various ways. For
example, the adjunct material can be formed from a continuous
material. That is, as shown in FIG. 18B, the adjunct 1020 can
include a single layer with the central region 1022 and the wing
portion 1024 having the plurality of protrusions 1024 for
distributing a strain. In other aspects, the adjunct can include
more than two layers of material. For example, one or more
intermediate layers of material (not shown) can be positioned
between the top layer and the bottom layer and can be more rigid
than the top and bottom layers. The layers can be coupled together
using known manufacturing techniques, such as lamination, adhesive,
etc. The protrusions 1028 on the wing portion 1024 of the adjunct
can also be formed using known manufacturing techniques, such as
laser cutting, stamping, punching, etc.
[0509] Another exemplary adjunct is shown in FIG. 19 and includes a
wing region having a varied geometry. As shown, an adjunct 1020'
can have a wing region 1024' extending around a perimeter of the
central region 1022' and can have a plurality of surface features
1028' formed therein and spaced evenly along the wing region 1024'.
The surface features 1028' can be generally shaped as a boomerang
and can include an elbow 1023' and first and second arms 1025',
1027' extending therefrom. As shown in FIG. 19, the elbow 1023' can
be positioned along edges 1022a', 1022b', 1022c'of the central
region 1022' while terminal ends 1025t', 1027t' of the arms 1025',
1027' can be positioned at an outer edge of the wing region 1024'.
In this way, a thickness of the wing region 1024'in a direction
transverse to a longitudinal axis of the central region 1022'can
vary and a thickness of the wing region 1024' in a direction
parallel to the longitudinal axis of the central region 1022'can
also vary. These surface features 1028' can be formed by removing a
portion of the adjunct material 1020' using known manufacturing
techniques, such as laser cutting, stamping, punching, etc.
[0510] FIGS. 20A-20C illustrate adjunct material including wing
portions with modified edges. For example, a wing portion 1034 of
an adjunct 1030 of FIG. 20A can have an outer edge in the shape of
a sine wave with peaks 1034p and valleys 1034v along its length so
that the wing portion 1034 is atraumatic and does not increase a
likelihood of forming leaks in tissue. A wing portion 1034' of FIG.
20B includes a first material 1036' forming a central region 1032'
and the wing portion 1034', the wing portion 1034' having curved
edges which loop around and extend toward the central region 1032',
and back toward the edge forming an oblong opening 1035'. In
certain aspects, a second material 1038' is disposed in the oblong,
teardrop shaped openings 1035', such as by being laminated to the
first material 1036' to form the adjunct 1030'. A thickness of this
second material 1038' can vary from a thickness of the first
material 1036'. For example, the thickness of the second material
1038' can be less than the thickness of the first material 1036',
as shown. A wing portion 1034'' of FIG. 20C can have a plurality of
openings 1035'' formed therein, such as triangular shaped openings,
that can form protrusions 1038'' similar to those protrusions 1028
shown in FIG. 18B, but the protrusions 1038'' can have corners
rather than rounded edges. The adjuncts 1030, 1030', 1030'' of
FIGS. 20A-20C can be formed from different materials, such as any
flexible or stretchable polymer material described herein. In use,
any one of the adjuncts 1030, 1030', 1030''can be stapled to tissue
and any of the respective wing portions can extend beyond the
staple line. A shown in FIG. 20D, the adjunct 1030 can be stapled
to tissue T and the wing portion 1034 can be positioned outside of
the staples 1008 which form a staple line and the central portion
1032 can be positioned inside of the staple line. In certain
aspects, as the tissue expands and contracts, the adjuncts can
stretch or flex in a direction transverse to the staple rows or can
be configured to stretch in multiple directions, such as along an
outer surface of the tissue T as shown. A person skilled in the art
will appreciate that the edges of the wing portions can be shaped
in other ways than the illustrated embodiments.
[0511] FIGS. 21A-21C illustrate another embodiment of adjunct
material including a wing portion with modified edges. As shown in
FIG. 21A, an adjunct material 1040 can be woven. A central region
1042 of the adjunct 1040 can be formed from a woven material of
higher density than a woven material at a wing portion 1044 of the
adjunct 1040. In other aspects, a less dense woven material can
encase a denser woven material on all sides, as shown in FIG. 21B.
In both embodiments, the wing portion 1044 can have soft,
atraumatic edges 1046 that have a decreased likelihood of
puncturing or otherwise damaging the tissue and causing holes to
form therein. The adjunct 1040 can be configured to wick and/or
absorb liquid therein. For example, in the embodiment of FIG. 21C,
a top layer 1048t' of material of an adjunct 1040' is shown
positioned over a bottom layer of material 1048b', liquid 1047'
being wicked through the top layer of material and into a space
between the top and bottom layers 1048b', 1048t'. These adjunct
materials can be formed from various woven materials known in the
art, such as ETHISORB.RTM. (Ethicon, Inc., Somerville, N.J.). In
one embodiment, central region 1042 may be a film comprised of
solid, but deformable absorbable material.
[0512] An adjunct material for use with a stapler that deploys
variable thickness staples is shown in FIGS. 22A-22D. As shown, a
thickness of an adjunct 1050 can vary from a central axis 1056 to
an outer edge of the adjunct 1050 in a lateral direction indicated
by arrows. That is, the adjunct 1050 can have a decreasing/tapering
thickness from the central axis 1056 of the adjunct 1050 to the
outer edge thereof in the lateral direction. As in the previous
embodiments, the adjunct material 1050 can include a central region
1052 and wing portion 1054. The adjunct 1050 can include an
elongate slot 1058 formed along the central axis 1056 of the
adjunct 1050 and having a size and shape that corresponds to a size
and shape of a cutting member (not shown). In the illustrated
embodiment, the elongate slot 1058 has a substantially rectangular
shape. FIGS. 22B and 22C provide end views of a cartridge assembly
52 and an anvil 54 having a varying thickness in a lateral
direction such that the stapler 10 can deploy staples (not shown)
of varying heights. As shown, a thickness TO of the anvil 54 near
the cutting member slot can be greater than a thickness TE of the
anvil 54 near its lateral edge. The adjunct 1050 can be coupled to
the cartridge assembly 52 and/or to the anvil 54 with at least the
central region 1052 of the adjunct 1050 directly contacting the
tissue-contacting surface 60, 58 of the cartridge assembly 52/anvil
54. The tissue-contacting surface 58 of the anvil 54 can include
one or more mating points 1057 attaching the adjunct 1050 to the
anvil 54, as shown. The wing portion 1054 of the adjunct 1050 can
be folded around the cartridge assembly 52 and/or the anvil 54 and
attached thereto, as will be described in greater detail below. In
this way, a tissue-contacting surface 1053 of the first adjunct
1050 can be substantially planar and can be disposed parallel to a
tissue contacting surface 1053' of the second adjunct 1050'
disposed on the cartridge assembly 52. When the adjuncts 1050,
1050' are stapled onto tissue, as shown in FIG. 22D, the wing
portion of the adjunct 1050 can be disposed between the staples
1008 and extend toward a cut terminal end TE of the tissue T, while
a second portion of the adjunct 1050 can extend away from the cut
terminal end TE of the tissue T and distribute strain to the tissue
T, similar to the wing portions described above. The adjunct 1050'
can have similarly positioned portions 1052', 1054', as shown.
[0513] Any of the adjunct materials can include various features
for increasing friction between the adjunct material and the tissue
to ensure that the adjunct material remains in a desired position.
For example, adjuncts 1060, 1060' in FIGS. 23A and 23B include a
plurality of teeth 1061, 1061' formed on a tissue-contacting
surface thereof and terminating in points 1063, 1063' that can
penetrate into tissue. As shown, the plurality of teeth 1061, 1061'
can be spaced at equal distances apart in the lateral direction of
the adjunct 1060, 1060'. The teeth 1061, 1061' can be formed in the
adjunct 1060, 1060' using various known manufacturing techniques,
such as via compression molding, cut/stamping, punching, etc. For
example, the adjunct 1060 of FIG. 23A can be compression molded
while the adjunct 1060' of FIG. 23B can be formed from stamping
slits 1065' into material to form the teeth 1061'. The gaps between
the teeth 1061, 1061' can push into tissue T and create a lock that
prevents sliding of the adjunct 1060, 1060', as in FIG. 23C which
illustrates multiple rows of adjuncts 1060'. In another embodiment
shown in FIG. 24A, the adjunct 1060'' can include a plurality of
micropillars 1063'' formed on a tissue-contacting surface thereof,
the micropillars 1063'' being shaped as needles configured to
penetrate into tissue T. The teeth 1063 and/or micropillars 1063''
can directly penetrate into the tissue T as shown in FIGS. 23D and
24B and can thereby prevent the adjunct 1060, 1060'' from sliding
relative to the staples 1008 as the tissue T expands and contracts.
In certain aspects, the micropillars 1063'' can have a diameter D1
in the range of about 0.01 to 0.50 mm and a height H1 in the range
of about 0.05 to 0.50 mm.
[0514] Another embodiment of an adjunct material is shown in FIGS.
25A-25C. In this embodiment, an adjunct material such as the
adjunct 1000 of FIGS. 16A and 16B is used in conjunction with a
nose extension member 1070 that can be coupled to an anvil 54
and/or a cartridge assembly 52 of a surgical stapler 10. As shown
in FIG. 25A, a distal end 1004d of the adjunct 1000, that is, the
distal end 1004d of the wing portion 1004 can terminate at or
proximal to a distal-most end 52d of the cartridge assembly 52. As
shown in FIG. 25B, a distal end 1004d of the adjunct 1000, that is,
the distal end 1004d of the wing portion 1004 can terminate at or
proximal to a distal-most end 54d of the anvil 54. The nose
extension member 1070 can be added onto the cartridge assembly 52
and/or the anvil 54 to replace or supplement a distal portion of
the adjunct material 1000. A proximal end 1070p of the nose
extension member 1070 can have a cutout 1072 formed therein and
sized so as to not obstruct or cover a slot formed in the anvil 54
for receiving a cutting member (not shown). The cutout 1072 can
define first and second extension arms 1074a, 1074b which can be
releasably coupled to the distal end 54d of the anvil 54 along a
curved portion of the anvil 54 that is distal to the anvil's 54
tissue contacting surface in various ways, such as using an
adhesive. A distal-most end 1070d of the nose extension member 1070
can be substantially rounded. A mechanism for releasing a distal
portion 1076 of the nose extension 1070 from the proximal end 1070p
of the nose extension 1070 can also be provided. In certain
aspects, this releasing mechanism can consist of a perforation 1078
extending transverse to a longitudinal axis LN of the nose
extension member 1070. In use, an adjunct 1000 can be positioned on
the anvil 54 and the nose extension member 1070 can also be coupled
to the anvil 54. The anvil 54 and cartridge assembly 52 can grasp
tissue T therebetween, and a portion of the adjunct 1000 can extend
distally beyond the nose extension member 1070, as shown in FIG.
25B. That is, the distal end 1070d of the nose extension member
1070 can be positioned distal to the distal end 1004d of the
adjunct 1000. The anvil 54 and the cartridge assembly 52 can deploy
staples 1008 through the tissue T and through the adjunct 1000,
while the wing region 1004 of the adjunct 1000 does not include
staples 1008 extending therethrough. The wing region 1004 of the
adjunct 1000 can directly contact the tissue T and the nose
extension member 1070 can be positioned above the wing region 1004.
In certain aspects, the nose extension member 1070 can be a
semi-flexible material and can be used in conjunction with the
adjunct 1000 to help relieve a strain on tissue T and/or provide
strength to the adjunct 1000. In use, the distal end of the nose
extension member 1070 can be removed from the anvil 54 and/or the
cartridge prior to, during, and/or after the tissue T is
stapled.
[0515] While features of the adjunct described above were
illustrated as separate embodiments, an adjunct can have any
combination of features described above.
Mechanisms for Attaching and Releasing Adjuncts from an End
Effector
[0516] Various mechanisms can be used to attach and then release an
adjunct having wings from an end effector, e.g. a cartridge
assembly 52 or an anvil 54. While the embodiments described below
include features formed on an anvil 54, any of these features can
be formed on a cartridge assembly 52 for mating an adjunct to the
cartridge assembly 52. FIGS. 26A-26B illustrate adjunct material
1000', 1000'' having mating features keyed to corresponding mating
features formed on an anvil 54. More specifically, FIG. 26A shows
an adjunct 1000' having a plurality of cylindrical protrusions
1003' formed on a surface 1007' that is oriented away from a tissue
contacting surface 1005' of the adjunct 1000'. While FIG. 26A
illustrates three cylindrical protrusions 1003' spaced apart along
an axis parallel to a longitudinal axis LA of the anvil 54, any
number of protrusions 1003' can be formed at various locations
along the adjunct 1000'. A lateral surface 54L of the anvil 54 can
have a plurality of depressions 53 configured to receive the
plurality of protrusions 1003' from the adjunct 1000' therein. In
one embodiment, a height (not shown) of the cylindrical protrusions
1003' can vary, and can be in the range of about 0.25 to 1.00 mm,
the height measured perpendicular to the surface 1007' of the
adjunct 1000'. The protrusions 1003' formed on the adjunct 1000'
can have other sizes and shapes. As shown in FIG. 26B, in another
embodiment, an adjunct 1000'' can have a single elongate
rectangular protrusion 1003'' extending parallel to the
longitudinal axis LA of the anvil 54. A lateral surface of the
anvil 54 can also include a corresponding elongate rectangular
depression 53' for receiving the rectangular protrusion 1003''
therein when the adjunct 1000'' is folded around the anvil 54. A
height (not shown) of the rectangular protrusion 1003'' can also
vary, but can be in substantially the same range as the height of
the cylindrical protrusions 1003' described above. While only a
first lateral surface 54L of the anvil 54 is shown in FIGS. 26A and
26B, a person skilled in the art will appreciate that identical
protrusion(s) can be formed on a second lateral surface (not shown)
of the anvil 54. Similarly, identical depression(s) can be formed
on a second lateral surface (not shown) of the adjuncts 1000',
1000''.
[0517] An adjunct can be coupled to an anvil/cartridge assembly in
other ways. As shown in FIGS. 27A and 27B, a strand of suture
1003''' can couple the adjunct to the anvil 54. The suture 1003'''
can extend from the first lateral surface 54L of the anvil 54,
across the tissue-contacting surface of the adjunct, and to the
second lateral surface 55L of the anvil 54. First and second
depressions 53''', 55'' can be formed in the first and second
lateral surfaces of the anvil 54, and a first terminal end of the
suture 1003''' can be received in the first depression 53''' and a
second terminal end can be received in the second depression 55'''.
A length of the suture 1003''' and/or a size of the depressions
53''', 55'' can be selected so that the suture 1003''' is taught
when the terminal ends of the suture 1003''' are positioned within
the depressions 53''', 55'''. As a cutting member 59 advances
through the anvil 54 during and/or after the staples 1008 are
deployed into the tissue T, as shown in FIG. 27B, the cutting
member 59 can sever the suture 1003''', causing the terminal ends
of the suture 1003''' to slide out of the depressions 53''', 55''
and thereby releasing the adjunct from the anvil. FIGS. 28A and 28B
illustrate the strand of suture 1003''' extending around an anvil
54 and coupling a multi-layer adjunct 1020 to the anvil 54. As in
the previous embodiment, advancement of the cutting member (not
shown) relative to the anvil 54 can sever the suture 1003''' and
release the suture 1003''' from the depressions 53''', 55''' in the
anvil 54 to release the adjunct 1020. As will be appreciated by a
person skilled in the art, any number of strands of suture can be
used to couple the adjunct to one of the cartridge assembly 52 and
the anvil 54 and the depressions formed therein can vary so long as
they are configured to receive a portion of the suture therein.
[0518] FIGS. 29A-29B illustrate other mechanisms for attaching an
adjunct to an anvil/cartridge assembly. In this embodiment, the
anvil 54 of a surgical stapler 10 includes a cutting member 59 that
can advance within the slot 61, referred to as a longitudinal
track, and can move between proximal and distal ends 61p, 61d of
the track 61. A driver 1081 including first and second elongate
members (not shown) can be disposed in the longitudinal track 61,
as in FIG. 29B. Three cylindrical protrusions (not shown) extend
from the elongate members and into depressions 53'''', 55''''
formed in both lateral surfaces of the anvil 54, but there can be
any number of protrusions spaced along the driver and having
various other shapes. As shown in FIG. 29C, a first driver 1081a
can be generally elongate and can have a plurality of protrusions
1083, such as three protrusions 1083, oriented transverse to a
longitudinal axis of the driver, the protrusions 1083 being
cylindrical shaped. A wing portion 1084 of an adjunct material 1080
can be disposed around a lateral surface of the anvil 54 and can
include a plurality of protrusions 1083' oriented transverse to the
longitudinal axis LA of the anvil 54 when the adjunct material 1080
is coupled thereto. As shown in FIG. 29D, the adjunct material 1080
can have a first set of protrusions 1083' for mating with the first
lateral surface of the anvil 54 and a second set of protrusions
1083'' for mating with the second lateral surface of the anvil 54.
Prior to use, the first driver 1081a can be positioned on a first
lateral wall of the track 61 and the second driver 1081b can be
positioned on a second lateral wall of the track 61. A proximal end
of each driver 1081a, 1081b can have an angled portion 1085p, 1087p
such that when the drivers 1081a, 1081b are disposed in the track
61, a width W1 between the drivers 1081a, 1081b at a proximal end
of the track 61 is greater than a width W2 between the drivers
1081a, 1081b at and/or distal to the protrusions 1083', the width
being measured transverse to the longitudinal axis LA of the anvil
54 as shown in FIG. 29E. Additionally, the width W2 between the
drivers 1081a, 1081b distal to the proximal end 61p of the track 61
can be less than a width WC of the cutting member 59. In this way,
the cutting member 59 can be advanced toward the distal end 54d of
the anvil 54 and can increase a width between the drivers 1081a,
1081b and the protrusions 1083 can push the corresponding
protrusions 1083' on the adjunct 1080 off of and away from the
anvil as in FIG. 29F, thereby releasing the adjunct from the anvil
54. In certain aspects, the adjunct 1080 can be biased to a
flattened, substantially planar configuration such that when the
cutting member 59 advances within the track 61 and exerts a force
on the drivers 1081a, 1081b, the adjunct 1080 is more able to
release from the anvil 54.
[0519] A loading mechanism for loading an adjunct onto an
anvil/cartridge assembly is shown in FIGS. 30A-30B. A loading
mechanism 1090 can have various sizes, shapes, and configurations,
and can include a first curved arm 1092a and a second curved arm
1092b having a radius of curvature that corresponds to a radius of
curvature of the first and second lateral surfaces 54L, 55L of the
anvil 54 and the arms 1092a, 1092b can terminate in angled features
1093a, 1093b that can be grasped by a user. The loading mechanism
1090 can have a planar base 1094 from which each of the first and
second curved arms 1092a, 1092b extend. The base 1094 of the
loading mechanism 1090 can further include a track extension 1094e
extending perpendicular to the base 1094 and disposed along a
central longitudinal axis of the loading mechanism 1090 for
insertion into the cutting member slot 54s in the anvil 54, as
shown in FIG. 30B. A first inner surface 1094a of the loading
mechanism 1090 can be defined by the first curved arm 1092a and a
first portion of the base 1094 from the first arm 1092a to the
track extension, as shown in FIG. 30A Likewise, a second inner
surface 1094b of the loading mechanism 1090 can be defined by the
second curved arm 1092b and a second portion of the base 1094 from
the second arm 1092b to the track extension 1094e. In this way, the
loading mechanism 1090 can be generally E-shaped for receiving the
anvil 54. An adjunct 1000 having a central region 1002 and a wing
region 1004 can be positioned and sandwiched between inner surfaces
of the loading mechanism 1090 and the tissue-contacting surface of
the anvil 54, as in FIG. 30B, the loading mechanism 1090 clamping
onto the anvil 54 as shown. The track extension 1094e can
facilitate achieving a tight fit between the loading mechanism
1090, the adjunct 1000, and the anvil 54 with substantially no gaps
between. After the adjunct 1000 is coupled to the anvil 54, such as
using any attachment mechanisms described herein, such as
attachment mechanisms 1052, the loading mechanism 1090 can be
removed from the anvil 54. This can be accomplished, for example,
by pressing the angled features 1093a, 1093b of the curved arms
away 1092a, 1092b from one another, leaving the anvil 54 loaded
with the adjunct 1000 as in FIG. 30C.
[0520] Another exemplary loading mechanism is shown in FIGS.
31A-31C. A loading mechanism 1090' can be packaged as a kit along
with an end effector of a stapler. Alternatively, loading mechanism
1090' may be packaged separately. As in FIG. 31A, the anvil 54 and
cartridge assembly 52 of the end effector 50 can include an adjunct
material 1000 preloaded thereon or in another non-illustrated
embodiment, the adjunct material 1000 can be fixed to the anvil 54
and the cartridge assembly 52 after being removed from packaging
1100. This loading mechanism 1090' can be configured to wrap the
wing portion 1004 of the adjunct 1000 around the lateral surfaces
54L, 53L of the anvil/cartridge assembly 54, 52 such that the wing
portion is passively coupled to the anvil/cartridge assembly 54,
52. As shown in FIG. 31B, the loading mechanism 1090' can be
configured to contact the central region (not shown) of the adjunct
1000 against the tissue-contacting surface of the anvil/cartridge
assembly 54, 52 and, if needed, can be configured to shape the wing
portion (not shown) around the anvil 54. The loading mechanism
1090' can be formed of a single molded material having an upper
retaining portion 1104 and a lower retaining portion 1102, the
retaining portions having a channel (not shown) sized and shaped
for receiving the anvil/cartridge assembly 54, 52 therein. A shape
of the channel can be substantially similar to the shape of the
loading mechanism 1090 previously described and can include any of
the same features, such as the track extension. The upper and lower
retaining portions 1104, 1102 can be disposed at an angle AL
relative to one another, the angle being in the range of about 10
to 40 degrees. A support member 1106 can extend between a lower
surface of the upper retaining portion 1104 and an upper surface of
the lower retaining portion 1102 such that the angle AL between the
retaining portions 1102, 1104 is fixed. The support member 1106 can
be a substantially solid member, as shown, so as to provide
rigidity to the loading mechanism 1090'. A first end of the support
member 1106 can terminate in a grasping feature 1108, and the
grasping feature 1108 can have first and second planar surfaces
1108a, 1108b configured to be grasped by a user, such as between a
thumb and finger of a user. The grasping feature 1108 can further
include one or more surface features 1110 for increasing friction
between a user's fingers. A longitudinal axis of the grasping
feature 1108 can be oriented perpendicular to a longitudinal axis
of the stapler 10 or can be parallel to the longitudinal axis of
the stapler 10. In use, a user can grasp the grasping feature 1108
and position distal ends 1102d, 1104d of the retaining portions
adjacent to proximal ends ends 52p, 54p of the cartridge assembly
52 and the anvil 54. A user can advance the distal end of the
loading mechanism 1090' toward the proximal end of the end effector
50, as shown in FIG. 31B, and the retaining portions 1102, 1104 can
slide along the anvil/cartridge assembly 54, 52 and force the
adjunct material 1000 around the lateral surfaces thereof, as shown
in FIG. 31C. This can temporarily secure the wing region 1004 along
the lateral surfaces of the cartridge assembly 52 and the anvil 54.
With the wing region 1004 so positioned, a user can retract the
loading mechanism 1090' in the opposite direction, distally away
from the end effector 50, leaving the end effector 50 prepared for
insertion into a patient. While reference is made to a single
adjunct material 1000 loaded onto the anvil 54, adjunct material
1000' can similar be loaded onto the cartridge assembly 52. The
adjunct material 1000, such as the material shown in FIGS. 31A-31C,
can be a shape memory material such that the adjunct 1000 is biased
to a substantially straightened configuration. That is, when the
end effector 50 is positioned inside of the patient, the wing
regions can automatically move back to the substantially
straightened configuration prior to being deployed off of the end
effector 50 and onto tissue.
Delivering Adjuncts into a Patient
[0521] End effectors having one or more adjuncts coupled thereto
can be delivered into various areas of a patient, such as a chest
cavity, stomach, etc. As will be appreciated by a person skilled in
the art, an adjunct can be delivered through an access port, such
as a trocar extending into the patient. Any of the adjuncts herein
can include features that assist with delivery of the adjunct into
a patient's body. For example, FIG. 32A illustrate an adjunct 1000
having a solid central region 1002 and mesh wing region 1004
coupled to an anvil 54 of a surgical stapler 10. While a single
adjunct 1000 is shown coupled to the anvil 54, another adjunct
1000' can be coupled to the cartridge assembly 52 prior to
inserting the end effector 50 into a patient's body. A distal
portion of the adjunct 1000, such as a distal portion 1004d of the
wing region 1004, can be configured to guide proximal portions
1004p of the wing region 1004 around the lateral surfaces (not
shown) of the anvil 54 so as to minimize width of the adjunct
material, as shown in FIG. 32B. This can facilitate insertion of
the end effector 50 and the adjunct 1000 into an access port, such
as a port 1202 formed in a trocar 1200, because a width of the
anvil/cartridge assembly 54, 52 including the adjunct 1000 thereon
will be about the same as a width of the anvil/cartridge assembly
54, 52 without an adjunct. In certain aspects, this distal portion
1004d of the wing region 1004 can be formed from a more rigid
material than remaining portions of the wing region 1004 to help
guide the adjunct material 1000 into the port 1202.
Stapling Adjuncts onto Tissue
[0522] An adjunct material can include features facilitating
multiple firings of staples along tissue. FIG. 33A illustrates an
embodiment 1300 of an end effector 50 having first and second
adjunct materials 1400, 1400', the first adjunct material 1400
being coupled to the anvil 54 and the second adjunct material 1400'
being coupled to the cartridge assembly 52. As shown, each of the
adjunct materials 1400, 1400' can include multiple layers, and the
layers can have various widths in the direction transverse to a
longitudinal axis (not shown) of the anvil/cartridge assembly 54,
52. A first tissue-contacting layer 1402, 1402' of each adjunct
1400, 1400' can be positioned adjacent to tissue (not shown) when
tissue is grasped between the anvil 54 and the cartridge assembly
52. In certain aspects, the first tissue-contacting layer 1402,
1402' can be formed from a material configured to seal around a
staple line, such as an elastomeric material. The first
tissue-contacting layer 1402, 1402' can have a width W5 in a
direction transverse to the longitudinal axis LA of the anvil 54
that is substantially equal to a width WA of the anvil 54, or the
width W5 of the first layer 1402 can be less than the width WA of
the anvil 54. As shown in FIG. 33A, the first tissue-contacting
layer 1402 can include a first portion 1402a positioned on a first
side of the cutting member slot 54s and a second portion 1402b
positioned on a second side of the cutting member slot 54s rather
than being formed from a continuous piece of material. In other
aspects, the first layer 1402 can be a single continuous piece of
material. A second layer 1406, 1406' can be positioned closer to
the tissue-contacting surface of the anvil 54 and can be formed
from a substantially rigid material. As shown, a width W6 of the
second layer 1406 can be greater than the width WA of the anvil 54.
This second layer 1406, 1406' can help prevent stretching of the
tissue T near the staples 1008. A third layer 1408, 1408' can be
positioned closest to the tissue-contacting surface of the anvil 54
such that the second layer 1406, 1406' is sandwiched between the
first and third layers 1402, 1402' and 1408, 1408'. The third layer
1408, 1408'can have a width W7 that is greater than the width WA of
the anvil 54, but less than the width W6 of the second layer 1406,
as shown. This third layer 1408, 1408' can be semi-rigid to help
relieve strain on tissue T as the tissue T expands and contracts. A
longitudinal length of the layers can also vary, the length being
measured in the direction transverse to the widths. Preferably, the
third layer 1408, 1408' has a longest length measured along the
longitudinal axis of the anvil 54 compared to a longitudinal length
of each of the first and second layers 1402, 1402', 1406, 1406'. As
shown in FIG. 33B, multiple adjuncts 1400, 1400', 1400'' can be
sequentially deployed onto tissue in a row and the longitudinal
lengths of the layers can result in regions 1410a, 1410b where the
first layer 1402 of one adjunct 1400 overlaps with a first layer
1402' of another adjunct 1400'. In this way, the staples 1008 can
still penetrate through these overlapping regions than if multiple,
e.g. three or more layers 1402, 1406, 1408 were positioned there.
FIG. 33C illustrates two adjuncts 1400, 1400' stapled onto the
tissue T at about a 90 degree angle relative thereto, the first
adjunct 1400 having a first terminal end and the second adjunct
1400' having a second terminal end. The first and second terminal
ends form the overlapping region 1410a, as shown. These adjuncts
1400, 1400' can be used to allow a user to deploy adjuncts to
accommodate various geometries of tissue. These multilayer adjuncts
1400, 1400' can vary in any number of ways. While the layers 1402,
1406, 1408 can have various thicknesses, in the illustrated
embodiment the second layer 1406 has a smaller thickness than a
thickness of each of the first and third layers 1402, 1408. For
example, the first layer 1402 can be in the range of about 3 to 15
mm, the second layer 1406 can be in the range of about 5 to 20 mm,
and the third layer 1408 can be in the range of about 3 to 20 mm.
In certain aspects, these layers 1402, 1404, 1406 and 1402', 1404',
1406' can be laminated together prior to being coupled to the
anvil/cartridge assembly 54, 52. In certain aspects, layers 1406
and 1406' may be at least partially comprised of an absorbable
material such as PDS.RTM..
Reinforcing Tissue with Sealant and Adjuncts
[0523] Any of the adjuncts herein can be used in conjunction with a
sealant to help maintain a seal around staples as the tissue
expands and contracts following a surgery. A sealant can have
various formulations and differing viscosity and curing behavior.
Generally, a sealant can be made from a biocompatible and
bioabsorbable material that can be configured to transition from a
first, liquid state to a second, hardened state via a curing
process, such as a polymerization reaction. The first state can be
a softened state, e.g., a fluid, a gel, a foam, etc. and the second
state can be a hardened state, e.g., a solid, a rigid member, etc.
When the sealant is in the first, softened state, the sealant can
flow through the delivery tube and into the sealing cuff, as
described in greater detail below. The sealant can transition from
the first, softened state to the second, hardened state after a
predetermined amount of time. In certain aspects, the sealant can
be formed from biologic material. In some embodiments, the sealant
can assist in wound healing by releasing various chemical
compounds, during and/or after curing of the sealant in a patient's
body. By way of non-limiting example, the sealant can be configured
to release a therapeutic drug, such as promoters of wound healing
(e.g., transforming growth factor-beta, etc.), antibacterial agents
(e.g., triclosean, ionized silver, etc.), and other known agents
over time to aid the tissue in healing near the location of the
sealant in a body. In one embodiment, a fibrin sealant can include
two reactive components combined immediately prior to delivery into
a patient, such as Thrombin and a biologically active component
(BAC2), Fibrinogen and Factor XIII In certain aspects, the
components can be provided in a 5:1 volumetric ratio of BAC2 to
Thrombin. In an alternative embodiment, the material may be the
fibrin sealant sold under the trade name Evicel.RTM.. In another
embodiment, the sealant can be blood, such as autologous blood.
[0524] FIG. 34A illustrates the adjunct of FIG. 16B having sealant
1500 delivered thereon. As shown, the sealant 1500 can be delivered
so that it substantially covers the central 1002 and wing regions
1004 of the adjunct 1000 or in another embodiment (not shown), the
sealant 1500 can be selectively delivered onto only the central
region 1002 and not onto the wing region 1004.
[0525] The sealant 1500 can be delivered to an adjunct in other
ways, and need not be delivered to an outer surface of the adjunct
1000. For example, FIG. 34B illustrates multilayer adjuncts 1700,
1700' stapled onto tissue T. The layers 1702, 1704 can be formed
from various materials, but in the illustrated embodiment include a
first layer 1702 of fibrous scaffold positioned adjacent to the
tissue T and a second layer 1704 consisting of an elastic film. A
delivery tool 1706 having an injection needle 1708 can have a
sealant 1500 disposed therein and can penetrate into the first
layer 1702 of fibrous scaffold. The sealant 1500 can be delivered
to this first layer 1702, as in FIG. 34C and the injection needle
1708 can be removed from the patient's body. The sealant 1500 can
bind directly onto the tissue T and/or may be held in firm
apposition to the tissue by layer 1704, and as in other
embodiments, can have a wing region 1704, 1704' that distributes a
strain to tissue beyond the staples 1008 at the staple line. When
the sealant is Evicel.RTM., the material forms a fibrin clot from
fibrinogen. Without a loss in generality, other sealants form a
hardened sealing structure by different mechanisms that are useful
for sealing leak pathways. The combination of sealant 1500 and
adjunct material 1700 can prevent formation of leaks as the tissue
T expands and contracts. The adjuncts 1700' and layers 1702', 1704'
can be substantially similar to the adjunct 1700 and 1702, 1704
layers previously described.
[0526] A sealant can be used to reinforce tissue in other ways. For
example, FIGS. 35A-35C illustrate sealant 1500 being delivered to a
chest cavity 1800 of a patient. As shown in FIG. 35A, a system 1900
for delivering a sealant 1500 can include a container or canister
1902 for receiving components A, B, C of a sealant 1500 therein. In
certain aspects, the components A, B, C can include acid
solubilized collagen A, fibrinogen B, and thrombin C. A trocar 1200
can extend through an incision 1904 formed in a patient 1906 and
into the chest cavity 1800. An applicator tool 1908 can have a
shaft 1910 extending through the trocar 1200, a distal end 1910d of
the shaft 1910 terminating in the chest cavity. A handle assembly
can be formed on a proximal end 1910p of the shaft 1900 and can be
configured to be grasped be a user. The handle assembly 1912 can be
a pistol-grip type handle assembly and can include one or more
actuators, such as a lever 1914 that can be pivoted to actuate the
device1908. The canister 1902 and the applicator tool 1908 can be
coupled together in various ways, such as via a tube 1916. This
tube 1916 can be substantially flexible to facilitate movement of
the applicator tool 1908 during a procedure. The canister 1902 can
have a second tube 1918 coupled thereto and connected to a gas
source S so that gas 1920 can be delivered to the canister 1902.
The gas 1920 can include, by way of non-limiting example, CO.sub.2,
O.sub.2, etc. In certain aspects, the gas source S can be a
continuous gas source such as a continuous CO.sub.2 gas source
available in hospital operating rooms. One or more valves (not
shown) can be disposed in the tube 1916, in the handle assembly
1912, in the shaft 1910, or in any other portion of the system 1900
and can be selectively opened and closed by activating the
actuator, such as by pivoting the actuator 1914 on the handle
assembly 1912. For example, one valve can control influx of the gas
1920 into the canister 1902 and another valve can control delivery
of the sealant 1500 into the applicator tool 1908. After tissue T
is stapled, such as by deploying one or more cartridges of staples
onto lung tissue, the distal end 1910d of the shaft 1910 of the
applicator 1908 can be positioned near the staples 1008 as in FIG.
35B. Preferably, the distal end 1910d of the applicator tool 1908
is positioned about 5 to 30 mm away from a staple line depending on
the size of the region to cover. A user can grasp the handle
assembly 1912 of the applicator tool 1008 and activate the actuator
1914, such as by moving the pivotable lever 1914 proximally. This
can open a valve disposed in the system 1900 and begin delivering
the gas 1920 to the canister 1902 to nebulize the sealant 1500 so
that it forms encapsulated liquid droplets that can be sprayed
directly onto the tissue T, as shown. In this way, the sealant 1500
can be delivered onto the tissue along the staple line, as shown in
FIG. 35C. The sealant 1500 can harden thereon, forming hardened
regions 1500h facilitating formation and maintenance of a seal
along the staples 1008. The sealant 1500 can also be delivered onto
an adjunct rather than directly onto the tissue T, such as any of
the adjuncts described herein. As will be appreciated by a person
skilled in the art, sealant can be delivered to any portion of the
tissue, such as only the tissue at the staple line and/or beyond
the staple line.
[0527] A sealant can be delivered in various ways. For example, a
system 1900' for delivering a sealant 1500 is provided in FIG. 36A
and includes many of the features of FIG. 35A, including a gas
source, canister, etc. However, in this embodiment the system
delivers a nebulized sealant 1500 directly through the trocar 1200
and does not include an applicator tool. In this embodiment, the
system also need not include valves and the delivery of the gas
1920 to the canister 1902 can simply be controlled using a valve at
the gas source. The delivery of gas into the canister 1902 can also
nebulize the sealant 1500, but rather than form encapsulated liquid
droplets, the gas 1920 can be delivered at a higher pressure and
rate to create a nebulized fog of sealant 1600. As shown in FIG.
36B, this sealant fog 1500 can spread throughout the chest cavity
of the patient and can harden on all surfaces of the tissue, such
as forming hardened regions 1500h along all surfaces of the
patient's lungs.
[0528] In an embodiment in which the sealant is blood, such as
autologous blood, the blood can be harvested from the patient and
applied to the adjunct material. By way of non-limiting example,
the adjunct material can be ORC, a known hemostatic agent, and the
application of the blood to the ORC adjunct will cause the
formation of a clot, resulting in an effective sealing structure. A
person skilled in the art will appreciate that blood, such as
autologous blood can be applied to a variety of adjunct materials
to provide an enhanced sealing structure. Further, a person skilled
in the art will appreciate that the volume of blood applied to the
adjunct will vary depending upon a number of factors, including the
type and location of tissue as well, the age and condition of the
patient, and the identity of the adjunct. Generally, however, when
the adjunct is an ORC material, the blood can be applied in an
amount in the range of about 5-10 cc per line of staple used to
affix the adjunct to the tissue.
Adjuncts Having Tissue Reinforcement Features
[0529] Adjunct materials described herein may be used in any
suitable type of surgery where a surgical stapler or other
instrument is deployed to connect tissues. One advantage of tissue
adjuncts is their propensity to prevent or minimize leaks, such as
fluid or gas leaks. Tissue adjuncts can perform this function by
one or more of the following mechanisms: plugging holes or tears
that occur at the staple puncture sites; restricting movement of
tissue around staple puncture sites to prevent an increase in the
size of staple holes and/or to prevent tissue tears; and minimizing
strain gradients that occur between constrained tissues within the
staple line and free tissue adjacent to the staple line.
[0530] In some embodiments, adjunct materials described herein may
be used for sealing staple punctures created when a surgical
stapler is used in lung surgery. When surgery is performed on a
lung, the lung is typically collapsed, and a required procedure,
including application of the stapler to lung tissue, is then
performed on the collapsed lung. After the procedure is completed,
the collapsed lung is reinflated to a normal lung volume. The
reinflation of the lung stretches the lung tissue (e.g., lung
parenchyma), particularly in an area around a staple line, which
may result in increased stress at a junction between the stapled
tissue (which is restricted from stretching by the staples) and the
surrounding tissue areas. Furthermore, an airtight sealing is
required for the staple punctures of the lung. The sealing of a
good quality may be difficult to achieve--while leaks around staple
punctures typically seal within approximately five days, in some
cases, staple punctures may persist for longer periods of time,
such as, for example, six months or longer. In such circumstances,
a lengthy hospitalization of a patient may be required.
[0531] Accordingly, applicants have recognized and appreciated that
an end effector, such as a staple cartridge assembly for use with a
surgical stapler, and/or its associated anvil, can include an
adjunct material which may be used to seal punctures created by a
surgical stapler used to secure lung or other types of tissue. The
adjunct material can also reinforce the staple line, distribute
stress load on the tissue near the staple line, and minimize
tearing of the tissue--e.g., when the lung tissue is reinflated
after the surgery to transition to its normal volume.
[0532] In some embodiments, the staple cartridge assembly can
comprise a cartridge body of a surgical stapler and an adjunct
material, which is interchangeably referred to herein as a tissue
reinforcement construct. The tissue reinforcement construct can be
removably attached to the cartridge body and is configured to be
delivered to a surgical site by deployment of the staples of the
surgical stapler. When the staples are deployed, the adjunct
material can remain at the surgical site with the staples. In this
way, the adjunct material can be used to help seal holes formed by
staples and/or can be used to provide tissue reinforcement at the
treatment site.
[0533] In some embodiments, the adjunct material can comprise a
first, or outer, dissolvable and/or absorbable material
encompassing a second, or inner, material. The first material can
be selectively dissolvable and/or absorbable. In some embodiments,
the first material may be brittle. The second material can be a
swellable, hydrophilic material that is maintained within the first
material in a constrained configuration and is configured to
transition to a predetermined shape when exposed to moisture in an
unconstrained configuration. Prior to deployment of the staples,
the second material can be encompassed within the first material in
an intact form.
[0534] In some embodiments, the first material can be less
hydrophilic than the second material and can therefore serve as a
moisture barrier. The second material may be compressed within the
first material in a constrained configuration such that, when the
first material is punctured by staples deployed to connect tissue
or is otherwise penetrated (e.g., cut by a surgical knife or
compressed between a cartridge and anvil), the second material is
exposed to moisture from the surrounding environment of the
patient's body and begins to swell. In this way, the second
material gradually swells and expands to eventually transition to a
predetermined shape. As the second inner material swells, it
expands to seal the holes in the tissue created by the staples. The
second material can swell at a rate that allows it to form a seal
around a hole as the tissue, such as lung parenchyma that was
deflated prior to a surgical procedure, is inflated back to its
normal volume, while compressing the stretching tissue and
restricting its deformation or preventing its tearing around the
staple line.
[0535] In some embodiments, one or more portions of the first
material, such as, for example, portions encompassing peripheral
edges of the second material can be more dissolvable than portions
of the first material encompassing a central portion of the second
material. Additionally the portions of the first material
encompassing the peripheral edges of the second material can be
more absorbable than portions of the first material encompassing
the central portion of the second material. After the integrity of
the first material is broken and as the portions of the first
material encompassing the peripheral edges of the second material
are dissolved or absorbed by the patient's body, the second
material enclosed within those portion is allowed to expand upon
exposure to moisture to thus seal and reinforce the stapled
tissue.
[0536] The first and second materials of the adjunct material may
comprise any suitable materials. In some embodiments, it is
advantageous to select a material that is absorbable and capable of
bearing compressive and bending loads. The first material can be
formed from a variety of materials. They may be present in
continuous form so as to fully encapsulate the materials making up
the center of the device, or alternately they might be present in a
non-continuous form. These non-continuous forms include, but are
not limited to, otherwise encapsulating forms with minute openings
allowing water or bodily fluids to access the materials making up
the center of the device to facilitate rapid hydration to allow
expansion of the center material; melt blend nonwoven forms with
controlled porosity; immiscible polymer blends having a major blend
component an absorbable polymer and a minor component being a
biocompatible water soluble polymer which is capable of rapidly
dissolving creating conduits to the central material allowing for
its rapid hydration to generate an external force on the
tissue.
[0537] The absorbable polymer making up the outer layer, although
not limited to, can be selected from among polydioxanone (also
referred to as poly(1,4-dioxan-2-one), or poly(p-dioxanone));
polyglycolide (also referred to as polyglycolic acid), polylactide
(also referred to as polylactic acid) in all its forms based on the
ring-opening of the corresponding lactone monomers, L(-)-lactide,
D(+)-lactide, and meso-lactide, as well as all of its forms based
upon polycondensation of L(+)-lactic acid and D(-)-lactic acid
(e.g., poly(L(-)-lactide), poly(D(+)-lactide), poly(meso-lactide),
poly(racemic-lactide), poly(L-lactic acid), poly(D-lactic acid),
etc.); the polycaprolactones, especially
poly(epsilon-caprolactone); polyhydroxyalkanoate (PHA); the
absorbable copolymers usually formed by the ring-opening
polymerization of the lactone monomers, L(-)-lactide, (D+)-lactide,
meso-lactide, glycolide, 1,4-dioxan-2-one, trimethylene carbonate,
and the caprolactones, especially epsilon-caprolactone, in any
molar combination or in an sequential distribution. These later
copolymers include, but are not limited to
epsilon-caprolactone/glycolide copolymers such as 25/75
poly(caprolactone-co-glycolide) (also referred to as poliglecaprone
25), 10/90 poly(L(-)-lacide-co-glycolide) (also referred to as
polyglactin 910), polyglyconate, polyglycolide-trimethylene
carbonate (PGA/TMC). The absorbable polymer can be a miscible or
immiscible blend of the previously mentioned polymers (and
copolymers thereof) in any combination. In other embodiments, the
first material may be selected from biodegradable synthetic
absorbable polymers such as a polydioxanon film sold under the
trademark PDS.RTM. or with a Polyglycerol sebacate (PGS) film or
other biodegradable films formed from PGA (Polyglycolic acid and
various forms thereof, marketed under the trademarks Vicryl.RTM.
and/or Neoveil), PCL (Polycaprolactone), PLA or PLLA (Polylactic
acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold
under the trademark Monocryl.RTM.), PANACRYL.RTM. (Ethicon, Inc.,
Somerville, N.J.), polyglactin 910, poly glyconate, PGA/TMC
(polyglycolide-trimethylene carbonate sold under the trademark
Biosyn), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP),
poly(vinyl alcohol) (PVA), absorbable polyurethanes, or a blend or
copolymerization of any of the above. Blends and/or
copolymerizations of any of the aforementioned materials can be
tailored to have a desired molecular weight and/or degradation
rate. It will be clear to one skilled in the art to select a
biocompatible material.
[0538] The second material may be formed from a variety of
materials. Advantageous materials include those that are absorbable
and can undergo a controlled degree of swelling so as to create an
external force on the tissue. Swelling might be accomplished by
hydration based on an influx of water or bodily fluids. One class
of materials that is particularly advantageous is absorbable
dehydrated hydrogels. These include the materials described in U.S.
Pat. No. 5,698,213, entitled "Hydrogels of Absorbable
Polyoxaesters" and crosslinked aliphatic polyoxaesters containing
amine and/or amido groups and blends thereof with other polymers as
described in U.S. Pat. No. 5,700,583, each of which is incorporated
herein by reference in its entirety. Other materials suitable for
the second material include water soluble polymers such as
poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), and
polyethylene glycol (PEG) or the higher molecular weight
polyethylene oxide (PEO). Additionally suitable are absorbable
polyurethanes. It is to be understood that suitable materials
include copolymers that contain a hydrophilic section and an
absorbable polyester section; this would include, by way of
example, the copolymer made by reaction of a relatively low
molecular weight alpha,omega-dihydroxy polyethylene glycol and a
lactone monomer such as L(-)-lactide, (D+)-lactide, meso-lactide,
glycolide, 1,4-dioxan-2-one, trimethylene carbonate, and the
caprolactones, especially epsilon-caprolactone, in any molar
combination or in an sequential distribution. Blends of materials
and copolymers formed from a wide variety of suitable monomers,
some already mentioned above, may be suitable. In one embodiment,
the second material may also be a biologically derived material as
described above such as ORC. It will be clear to one skilled in the
art to select a biocompatible material.
[0539] The adjunct material described herein can be delivered to a
treatment site using any suitable surgical stapling device, as
embodiments are not limited to any specific methods of employing a
surgical stapling device that in used in conjunction with the
adjunct material. In some embodiments, tissue is engaged between a
cartridge assembly and an anvil of a surgical stapler at a
treatment site, wherein at least one of the cartridge assembly and
anvil has an adjunct material removably retained thereon. The
surgical stapler can then be actuated to eject staples from the
cartridge assembly through the adjunct material and into the
tissue. The adjunct material can help to reduce impact and trauma
from the stapling and distribute stress load on the tissue near the
staple line to reduce the possibility of tissue tearing.
[0540] FIG. 37A illustrates an example of a portion 2000 of an end
effector of a surgical stapler that can be used with one or more
adjunct materials as described herein. In the example illustrated,
the portion is a jaw 2000 having a distal end 2002, a proximal end
2004 and a cartridge body 2006. As shown in FIG. 37A, the surgical
stapler includes a shaft 2008 that can be configured to couple the
end effector with a handle assembly of the surgical stapler which
is not shown for ease of illustration.
[0541] The jaw 2000 of the surgical stapler can be configured to
support staples 2010 which can be arranged in any suitable
configuration. In this example, the staples 2010 are arranged in
rows and create a staple line when deployed to engage tissue.
However, it should be appreciated that the staples 2010 may be
arranged in a circular or any other configuration, as embodiments
are not limited in this respect.
[0542] As shown in FIG. 37A, the jaw 2000 serving as a cartridge
assembly can be associated with an adjunct material 2012, also
referred to interchangeably herein as a tissue reinforcement
construct. The adjunct material 2012 can be removably retained on
the cartridge body 2006 so as to be positioned over the staples
2010 in any suitable manner. In some embodiments, the cartridge
body 2006 can be preloaded with an adjunct material such as the
material 2012. In other embodiments, the adjunct material 2012 can
be positioned on the cartridge 2006 (e.g., by a surgeon or other
medical professional) prior to a surgical procedure.
[0543] The adjunct material 2012 can have a configuration such that
at least one of peripheral edge portions 2014A and 2014B has a
cross section that is larger than a cross-section of a central
portion 2016 the adjunct material 2012. The central portion 2016 of
the adjunct material 2012 can be defined as a portion that is
closer to a longitudinal axis of the cartridge body 2006 than the
peripheral edges of the cartridge body. The central portion 2016
and the peripheral edge portions 2014A and 2014B can have any
suitable widths. Moreover, the peripheral edge portions 2014A and
2014B can have the same or different widths.
[0544] In should be appreciated that the tissue reinforcement
construct in accordance with some embodiments can be advantageously
used to reinforce a staple line created by the surgical stapler
with improved quality relative to existing approaches. For example,
in some embodiments, the tissue reinforcement construct can be used
to reinforce the staple line 270 degrees around its perimeter. In
particular, referring to FIG. 37A, the adjunct material 2012 can be
configured such that the peripheral edge portions 2014A and 2014B
and a distal portion 2015 have properties such that the staple line
created by the staples 2010 can be reinforced. For example, the
larger cross-section of the peripheral edge portions 2014A and
2014B makes the adjunct material able to reduce or prevent damage
to tissue--e.g., to sensitive tissue in thoracic cavity. Further,
in some embodiments, the peripheral edge portions 2014A and 2014B
and the distal portion 2015 can be more flexible or stretchable
than the central portion 2016 of the adjunct material 2012, which
can further help to compress tissue such as the lung parenchyma as
it is reinflated after surgery. Additionally or alternatively, in
some embodiments, some or all of the peripheral edge portions 2014A
and 2014B and the distal portion 2015 can degrade at a faster rate
than the central portion 2016, which can lead to a faster rate of
release of the inner material of the adjunct material 2012
encompassed within those portions. In this way, tissue in the area
around the staple line can be reinforced in an atraumatic way
almost immediately after the tissue is penetrated by the staples
and/or a knife.
[0545] It should be appreciated that the adjunct material 2012 can
have any other features that facilitate its use with the surgical
stapler. For example, in some cases, the adjunct material 2012 can
have cut-out tabs that can be pressed or slid into a knife slot or
cartridge of the surgical stapler. When the knife cuts down in the
middle of the adjunct material, the tabs are cut out and separated
from the stapler.
[0546] FIG. 37B illustrates an enlarged view 2100 of a cross
section 2018 of a portion of the adjunct material 2012 of FIG. 37A.
As shown in FIG. 37B, a peripheral edge, such as, for example, the
peripheral edge 2014A, may have a larger cross sectional dimension
than that of the central portion 2016. The larger cross sectional
thickness of the edge portion allows to better seal the areas
around the holes created by the staples and prevent tissue tearing.
As shown in FIG. 37A, the adjunct material 2012 can be releasably
positioned on the cartridge body 2006 so that one or both of the
peripheral edge portions 2014A and 2014B extend beyond the
cartridge body 2006. This can further improve the way in which the
adjunct material 2012, when in an unconstrained configuration upon
exposure to moisture, expands and provides effective sealing of a
staple line created by the surgical stapler against air or fluid
leakage and prevents tearing of the tissue near the staple
line.
[0547] In some embodiments, the adjunct material 2012 may comprise
an outer material that encompasses an inner material maintained
within the outer material in a constrained configuration. FIG. 38
shows by way of example that the adjunct material 2012 can comprise
a first, outer material 2022 and a second, inner material 2024. The
first material 2022 may be a suitable dissolvable and/or absorbable
material. The second material 2024 may be a suitable hydrophilic,
swellable material. The properties of the first and second material
may be uniform throughout or may vary. For example, the first
material 2022 may be selectively dissolvable and/or absorbable.
Similarly, different portions of the second material 2024 can have
different hydrophilicity. For example, in some cases, peripheral
edge portions of the second material 2024 can be more hydrophilic
than a central portion of the second material 2024.
[0548] The first material 2022 may envelop the second material 2024
and, prior to delivering staples (e.g., staples 2010 in FIG. 37A)
to the tissue, serve as a moisture barrier. The first material 2022
may be at least partially stretchable or may have any other
properties that can be selected based on a clinical application of
the adjunct material. For example, in some embodiments, the first
material 2022 may be at least partially brittle.
[0549] The first material 2022 can prevent exposure of the second
material 2024 to moisture for a certain time period--e.g., until
the adjunct material 2012 is delivered to the surgical site in the
patient's body. When the staples are deployed and the adjunct
material 2012 is thus pierced or otherwise penetrated, the second
material 2024 begins to swell upon exposure to moisture that passes
to the second material 2024 through punctures in the first material
2022. Additionally or alternatively, the first material 2022 can be
cut by a knife of the surgical stapler upon its deployment.
Furthermore, in some embodiments, the properties of the first
material 2022 may be such that the material can crack or otherwise
lose its integrity due to compression when it is pressed between
the cartridge and anvil of the surgical stapler. For example, if
the first material 2022 is brittle, it can be broken by
compression.
[0550] As discussed above, the first and second materials can be
made from a number of suitable biologic materials and/or synthetic
materials.
[0551] In some embodiments, the first and second material may be
selected such that the first material is less hydrophilic than the
second material. The same materials (e.g., polymers) may be used to
manufacture the first and second materials, but the molecular
weight of the source materials may be adjusted differently to
produce materials suitable for the first material and materials
suitable for the second material. The molecular weight of the
polymers can be altered so that to obtain materials having desired
degradation properties, as discussed above. For example, mixtures
of PGA (Polyglycolic acid and various forms thereof, marketed under
the trademarks Vicryl.RTM. and/or Neoveil), and PLA or PLLA
(Polylactic acid) can absorb at a relatively fast rate. Similarly,
polyhydroxyalkanoate (PHA) can dissolve quickly and the materials
made from PHA can begin to degrade within 20 to 30 minutes after
attachment to tissue via contact with heat and/or water.
[0552] The degradation rates of the first and second material may
be selected based on the desired clinical application--e.g., based
on a type of treated tissue and/or an amount of time that the
adjunct material is desired to remain at the surgical site. For
example, a first material for an adjunct material intended to be
used in lung surgeries may have a slower degradation rate than that
of a first material for the adjunct material to be used to staple
vessels. It should be appreciated, however, that embodiments are
not limited to materials having any specific degradation rates or
any other properties.
[0553] FIG. 39 illustrates the second material 2024 that can be
maintained within the first material 2022 in a constrained
configuration--e.g., in a compressed or otherwise constrained
configuration. In some embodiments, the second material 2024 can be
a hydrophilic foam. The second material 2024 may comprise any
suitable material(s) and, in some embodiments, may include one or
more therapeutic agents, such as, for example, drugs, promoters of
healing, antibacterial agent(s), and antimicrobial agent(s). The
therapeutic agent can be configured to be released over time to aid
the tissue in healing, for example. In embodiments where more than
one therapeutic agent is employed, different therapeutic agents can
be configured to release at different rates.
[0554] Upon exposure to moisture schematically shown in FIG. 39 as
moisture 2026, the second material 2024 can absorb moisture and
thus swell and expand. Additionally, if the second material 2024
includes one or more therapeutic substance(s), these substances can
begin to elute once the second material 2024 is exposed to
moisture. The moisture 2026 can be blood, other bodily fluid, or
any other liquid. The adjunct material 2012 can be manufactured
such that one or more portions of the second material 2024, can,
upon exposure to moisture, expand to transition to a preconfigured
shape. The shape of the second material 2024 prior to and after
exposure to moisture can be selected so as to provide a good
quality seal around the punctures in the tissue created by the
staples and provide reinforcement to the staple line against the
tissue to prevent tears in the tissue or pulling of the staples
through the tissue. For example, as illustrated in FIG. 39, the
second material 2024 can have a shape such that its peripheral
edges have a larger cross-section than its central portion.
[0555] Although FIGS. 37A-39 illustrate the adjunct material 2012
having a shape such that the peripheral edges portions have a
larger cross-section than that of the central portion of the
adjunct material, it should be appreciated that the adjunct
material 2012 can have any suitable shape, as embodiments are not
limited in this respect. For example, the adjunct material can have
a uniform thickness throughout, or the thickness of the adjunct
material can vary in any suitable manner. Regardless of the shape
and size of the adjunct material, in some embodiments, the adjunct
material can be configured such that one or more portions of the
first material are selectively dissolvable and/or selectively
absorbable by the patient's body. Furthermore, one or more portions
of the second material can be selectively swellable.
[0556] FIG. 40 is a side view of the adjunct material 2012
removably attached to the cartridge body 2006, prior to deployment
of staples supported by the cartridge body 2006. The first material
2022 of adjunct material 2012 comprises a top layer 2028 and a
bottom layer 2030, with the second material 2024 sealably enclosed
therebetween. As illustrated, a peripheral edge portion of the
adjunct material 2012 extends beyond the cartridge body 2006. Such
disposition of the adjunct material 2012 with respect to the
cartridge body 2006 enhances tissue reinforcement and offers
improved resistance to air and fluid leaks around staple holes.
[0557] In some embodiments, adjunct materials as described herein
may be used in a surgical stapling device that is employed in lung
surgery, such as in surgery to treat lung cancer, lung volume
reduction surgery, or any other type of surgery. Prior to such
surgery, the lung is deflated, and then reinflated to its normal
volume after the required procedure is completed. A common
complication after such a surgery is that air or fluid can leak
though the punctures or holes created by the staples. Moreover, as
the lung is being reinflated and the tissue stretches, holes can
increase in size (through stretching) or tears can occur in the
tissue areas around the staple holes. Accordingly, the described
adjunct material can be used to reinforce the tissue around the
staple holes and compress the tissue as the lung stretches to
assume its normal volume. It should be appreciated, however, that
the adjunct material can also be used to seal punctures created by
surgical staplers used to secure any other type of tissue, such as,
gastrointestinal tissue and vessels (e.g., intestine, stomach and
esophagus).
[0558] Additionally, in some embodiments, an adjunct material can
comprise one or more therapeutic substances, or agents, that can be
eluted when the staples are deployed to help healing the tissue at
the treatment site, or to prevent or combat infection. The
therapeutic substances can be released at different rates to
provide the desired action at the treatment site.
[0559] In some embodiments, either or both of the cartridge and
anvil of the end effector of a surgical stapler can have removably
attached thereto an adjunct material such as, for example, the
adjunct material 2012. Accordingly, FIGS. 41A and 41B show that two
adjunct materials 2100 and 2102 can be used with the surgical
stapler to reinforce tissue at a treatment site. When the staples
(e.g., staples 2010A-2010C in FIGS. 41A and 41B) are deployed to
engage tissue 2104, each of them can create a corresponding
puncture in the adjunct material. FIGS. 41A and 41B illustrate by
way of example punctures 2106 in the adjunct material 2100. It
should be appreciated, however, that the adjunct material 2102 is
similarly punctured by the staples 2010A-2010C. In addition, it
should be appreciated that only three staples 2010A-2010C are shown
for the purpose of illustration only, as embodiments are not
limited to any specific number of staples that can be seated in the
cartridge body.
[0560] The staples deployed to engage the tissue can remain with
the tissue until they are removed using an instrument, absorbed by
the patient's body or otherwise removed from the treatment site.
The adjunct material is maintained at the treatment site by the
staples for a certain period of time which can depend on a number
of factors--e.g., a period during which the staple holes are
expected to heal, a time required for one or more portions of the
adjunct materials to disintegrate, and any other suitable factors.
Furthermore, one or both of the first and second materials of the
adjunct material can be dissolvable and/or (bio)absorbable
materials that are gradually absorbed or eliminated in other ways
from the patient's body.
[0561] FIG. 41A shows the staples 2010A-2010C retaining the adjunct
materials 2100 and 2102 at the treatment site of the engaged tissue
2104 at a period of time shortly after the staples are deployed.
Because the staples 2010A-2010C penetrate the adjunct materials
2100 and 2102, the integrity of the first layer of the adjunct
materials is disturbed, and moisture can pass to activate the
second material 2024 encompassed within the first material
2022.
[0562] In some embodiments, as shown in FIG. 41B, after a certain
time period (which can be of any suitable duration), tissue 2104
begins to expand--e.g., lung parenchyma expands to eventually reach
its normal volume, after a surgery was performed on a collapsed
lung. At the same time, the second material 2024, which can be
hydrophilic, begins to swell upon contact with moisture. As the
tissue 2104 expands, the second material 2024 can swell gradually,
to transition to a large radius (denoted by way of example using
reference numeral 2108 in FIG. 41B) at peripheral edges portions
2109 and 2111 of the adjunct materials 2100 and 2102,
respectively.
[0563] The first material 2022 encompassing peripheral edge and
distal portions of the second material 2024 can stretch to
accommodate the expanding volume of the second material 2024.
Further, one or more portions of the first material 2022 can be
dissolvable and/or absorbable so that the first material 2022
gradually disintegrates as the second material 2024 swells and
expands from its constrained form to a predefined shape. In
particular, in the embodiment of FIG. 41B, the portions of the
first material 2022 at the peripheral edge portions 2109 and 2111
can be configured to dissolve at a faster rate than portions of the
first material encompassing a central portion of the second
material 2024. Additionally or alternatively, the portions of the
first material 2022 at the peripheral edge portions 2109 and 2111
can be configured to absorb at a faster rate than portions of the
first material encompassing the central portion of the second
material 2024. The described configuration of the first material,
where the staple holes in the tissue are sealed and the tissue area
surrounding a large portion of the staple line is compressed by the
swollen hydrophilic material allows reinforcing the tissue in an
effective, atraumatic manner. In this way, the sensitive lung
tissue can be sealed so as to prevent bleeding, tearing, and/or
leakage of the treated tissue. The ability to create an airtight
seal while allowing the tissue to safely stretch around the staple
line (e.g., as the lung is reinflated) is particularly useful
because the success of the patient's recovery is largely based on
how fast the tissue at the surgical site can heal.
[0564] As discussed above, in some embodiments, the first, outer
material of the adjunct material described herein can have
properties that are not uniform throughout. For example, as also
discussed above the first material may be selectively dissolvable
and/or selectively absorbable. In some embodiments, one or more
portions of the first material can be adapted to dissolve at a
faster rate than other portions of the first material. Additionally
or alternatively, one or more portions of the first material can be
adapted to absorb at a faster rate than other portions of the first
material. The portions of the first material that are adapted to
dissolve and/or absorb at a faster rate can be, for example,
peripheral edge portions of the first material, or any other
portions.
[0565] FIG. 42A illustrates an example of a first material 2201 of
an adjunct material 2200 that has portions 2202 adapted to dissolve
and/or absorb at a faster rate than portions 2204 of the first
material 2200. In this example, the adjunct material 2200 has a
uniform, or approximately uniform, thickness throughout. However,
it should be appreciated that the thickness of the adjunct material
can vary from one portion to another. It should also be appreciated
that the alternating portions 2202 and 2204 are shown by way of
example only, as the first material can be partitioned into the
portions having different dissolution rates and/or portions having
different absorption rates in any suitable manner. For example, as
mentioned above, the portions of the first material encompassing
the peripheral edge portions of the second material can be adapted
to dissolve at a faster rate than portions of the first material
encompassing the central portions of the second material.
[0566] Furthermore, the portions of the first material encompassing
the peripheral edge portions of the second material can be
configured to absorb at a faster rate than portions of the first
material encompassing the central portions of the second material.
Additionally, the portions 2202 and 2204 can have different widths,
as embodiments as not limited in this respect. By varying the
number, length, width and other properties (e.g., materials) of the
portions of the first material configured to dissolve and/or absorb
at different rates, the second material can be configured to expand
at different rates. Different materials can be selected for the
first and second materials to obtain desired degradation rates.
Depending upon the desired clinical application, different rates at
which the second material swells and expands can be controlled to
distribute load around the staple line and decrease the possibility
of tissue tearing. Additionally, a time during which the adjunct
material remains at the treatment site can be adjusted by varying
properties of the first and second materials.
[0567] FIG. 42B shows an enlarged cross-sectional view of a portion
2208 of the adjunct material 2200 of FIG. 42A. The first material
2201 of the adjunct material 2200 encloses the second material 2206
which may be a hydrophilic foam comprising any suitable material.
Similar to FIG. 42A, FIG. 42B also demonstrates that the first
material 2201 can comprise portions 2202 configured to dissolve
and/or absorb at a faster rate than portions 2204. It should be
appreciated that FIG. 42B shows that portions 2202 located on
different sides of the second materials 2206 (e.g., portions 2202A
and 2202B) are shown to be aligned with each other by way of
example only, as embodiments are not limited in this respect.
[0568] FIG. 43 illustrates an example in accordance with some
embodiments where both a cartridge and anvil side of the surgical
stapler can have an adjunct material removably retained thereon.
Accordingly, in this example, adjunct materials 2400 and 2402
(e.g., adjunct materials 2200 or any other suitable adjunct
materials) are employed to seal punctures in tissue 2404 created by
the staples 2010. As shown, when the adjunct materials 2400 and
2402 are pierced by the staples 2010, moisture 2026 from the
surrounding environment (e.g., blood, other bodily fluid, water,
medication, etc.) passes through the staple holes (e.g., a hole
2408 in FIG. 44) to the inner hydrophilic material (e.g., the
second material 2206 of FIGS. 42A and 42B) maintained within an
outer layer of the adjunct material.
[0569] FIG. 43 also shows that peripheral edge portions of the
adjunct materials which, prior to deployment of the staples, extend
beyond the cartridge body and/or anvil, can transition to a large
radius which may reinforce the tissue 2404. In particular, a
peripheral edge portion 2403 of the adjunct material 2400 can
transition to a large radius 2405. For example, the portion 2403
can transition from a radius roughly equal to half the thickness of
the adjunct (about 0.025 to 1.0 mm) to a radius up to about 5 times
the initial size of the feature. However, it should be appreciated
that the adjunct material described herein can have any suitable
dimensions and, when in an unconstrained form, can transition to a
radius of any suitable size, as embodiments are not limited in this
respect.
[0570] Additionally, a portion of a first material of the adjunct
material 2400 (e.g., the first material 2201 of FIGS. 42A and 42B)
at the peripheral edge portion 2403 can be such that it dissolves
and/or absorbs at a faster rate than other portions of the first
material. In this way, the peripheral edge portion 2403 of the
adjunct material can disintegrate faster than other areas of the
first material, thus allowing the second material encompassed
within that portion to swell and expand at a faster rate than the
central portion of the second material. As discussed above, the
adjunct materials can expand to transition to a predetermined
shape, which can be selected based on a clinical application, type
of wound to be sealed, and any other factors.
[0571] Additionally, because the outer layer of the adjunct
material, such as, for example, the first material 2201, can be at
least partially hydrophilic and/or absorbable, one or more portions
of this layer, which may or may not be pierced by a staple, can
begin to disintegrate as indicated by reference numeral 2410, as
schematically shown in FIG. 44 upon exposure to moisture 2026.
[0572] The adjunct material described herein may comprise a first
material, which is a material encompassing a second material, that
can have various properties. For example, as discussed above, the
first material can have portions that dissolve at different rates,
portions that absorb at different rates, portions of varying
widths, etc. The first and second materials can comprise different
materials.
[0573] An adjunct material 2500 shown in FIG. 45 may have a
thickness that is the same or substantially the same along a
cross-section of the adjunct material. In this example, a first
(outer) material 2502 of the adjunct material 2500 may be brittle.
It should be appreciated, however, that the adjunct material in
accordance with some embodiments having any suitable shape can be
brittle.
[0574] The first material 2502 can encompass a second material 2504
which may be a hydrophilic foam made of any suitable material.
Additionally, in some embodiments, the second material 2504 may
comprise one or more therapeutic substances. The non-limiting
examples of the therapeutic substance include fibrin, thrombin,
antibiotics, antimicrobial, and antibacterial agents. Suitable
agents can include, but are not limited to, triclosean, and silver
and copper ions and nanoparticles. It should be appreciated that
any number of any suitable therapeutic substances can be included
with the second material 2504 and can be eluted with the second
material 2504 is exposed to moisture and/or heat in the patient's
body.
[0575] In some embodiments, tissue is engaged between a cartridge
assembly and an anvil of a surgical stapler at a treatment site,
wherein at least one of the cartridge assembly and anvil has an
adjunct material removably retained thereon. The surgical stapler
can then be actuated to eject staples from the cartridge assembly
through the adjunct material and into the tissue. The adjunct
material can help to reduce impact and trauma from the stapling,
distribute stress load on the tissue near the staple line--e.g., as
the tissue such as lung parenchyma is stretched after the surgery
to its normal volume. It should be appreciated, however, that the
adjunct material described herein can be employed in any type of
surgery, and embodiments are not particularly limited to lung
surgeries.
[0576] In the example illustrated in FIG. 46, an adjunct material
2500 can be positioned on a tissue facing side 2602 of an anvil
2604 of a surgical stapler. When staples 2606 supported by a
cartridge body 2608 (which may be similar to the cartridge body
2006 in FIG. 37A) are deployed to engage tissue 2610, the first
material 2502 of the adjunct material 2500 can fracture so as to
expose the second material 2504 to moisture. Additionally or
alternatively, the adjunct material 2500 can fracture by being
compressed between the anvil 2604 and the cartridge assembly 2608.
Furthermore, in embodiments as shown in this example in which the
surgical stapler includes a knife 2612, the knife 2612 can also be
used to cut the adjunct material 2500 thus exposing the second
material 2504 to moisture. Although adjunct material 2500 is shown
in FIG. 46 as being disposed on an anvil 2604 of a surgical
stapler, adjunct material 2500 may be placed on one or both tissue
facing surfaces of opposed jaws of a surgical stapler.
[0577] Regardless of the way in which the second material 2504 of
the adjunct material 2500 is exposed to moisture, the second
material 2504 expands to seal staple holes or prevent them from
forming and the therapeutic substance is released to provide the
desired effect on the tissue 2610, as shown in FIG. 47.
Woven Adjunct Materials
[0578] Adjunct materials are provided for sealing of a staple line
against fluid leakage. One advantage of tissue adjuncts is their
propensity to prevent or minimize leaks, such as fluid or gas
leaks. Tissue adjuncts can perform this function by one or more of
the following mechanisms: plugging holes or tears that occur at the
staple puncture sites; restricting movement of tissue around staple
puncture sites to prevent an increase in the size of staple holes
and/or to prevent tissue tears; and minimizing strain gradients
that occur between constrained tissues within the staple line and
free tissue adjacent to the staple line.
[0579] A woven adjunct material can provide reinforcement to the
staple line and can prevent tears in the tissue or pulling of the
staples through the tissue by distributing stress along the tissue
near a staple line. Further, a woven adjunct material can absorb
impact from stapling and reduce trauma at and/or beyond the staple
line. In certain aspects, the woven adjunct material can act as a
medium into which staples can penetrate into when tissue at the
staple site is thin or diseased. A woven adjunct material can thus
be configured to both distribute the compressive load and to
compensate for variable tissue thickness. In certain aspects, an
adjunct material can include a plurality of layers, at least one of
which is woven, such as a core and one or more layers. A size,
shape, and a composition of the material forming each these layers
can be selected in various ways to influence mechanical properties
of the resulting adjunct material, such as a compressibility and
fluid absorption capability of the adjunct.
[0580] An adjunct material can be inserted into a patient and
deployed at a surgical site in various ways. For example, an
adjunct material can be releasably coupled to an end effector of a
surgical stapler, the end effector including a cartridge assembly
and an anvil. When the end effector is positioned adjacent to a
surgical site, tissue can be engaged between the cartridge assembly
and the anvil. Actuation of the surgical stapler can eject staples
from the cartridge assembly, through the adjunct material, and into
the tissue grasped between the jaws. The adjunct material can help
to reduce trauma from the stapling and distribute stress load
across the tissue near the staple line to reduce a likelihood that
the tissue will tear. In certain aspects, the adjunct material can
elute a therapeutic agent, serve to absorb fluid, adjust for
variations in material thickness, or perform various other
functions when the adjunct is deployed onto tissue.
[0581] A woven adjunct material can have various sizes, shapes, and
configurations. In one embodiment, a woven adjunct material
includes an inner core layer and at least one outer layer of
material. The outer layer of material can be positioned on one or
more sides of the core layer, e.g., top, bottom, and/or lateral
sides of the core layer. In one embodiment, a flexible support
layer can surround all sides of the elastic core layer so as to
envelop the elastic core. The core layer and flexible support
layers can be formed from various materials. For example, the
elastic core layer can be a layer of loosely woven material, and a
tightly woven material can surround the elastic core layer on at
least one side and can act as a flexible support layer. Each of the
flexible support layers can include fibers 3004, which can be the
same as or different than fibers 3005 in the elastic core layer
3003. FIG. 48B illustrates one exemplary embodiment of a woven
adjunct material 3000 in which flexible support layers 3001, 3002,
are positioned on the top and bottom of the elastic core layer
3003, respectively.
[0582] The woven adjunct material can be configured to releasably
couple to an end effector of a surgical instrument, such as a
cartridge assembly and/or anvil of a surgical stapler. For example,
FIG. 48A shows the woven adjunct 3000 including the two flexible
support layers 3001, 3002 on the top and bottom of the elastic core
layer 3003 and coupled to a cartridge assembly 3060 having a knife
slot 3067 and a plurality of staple cavities (not shown). The woven
adjunct can be releasably retained on any of the end effectors of
the surgical staplers provided herein e.g., staplers 10, 100, 200,
an open linear cutting stapler.
[0583] The adjunct material can deliver various benefits to the
tissue when the adjunct material is stapled to the tissue. FIG. 48C
shows the effects of an adjunct material A on a tissue T. As
illustrated in FIG. 48C, the adjunct material A can compensate for
variable thickness of the tissue at the staples S by compressing
under the load of the staples S. The adjunct material A can
distribute a strain on the tissue T from the staples S to a portion
of the tissue T positioned beyond the staple line to prevent
tearing along the tissue T at or beyond the staple line.
[0584] FIGS. 49A-C show a behavior of an adjunct material 3000 when
a compressive force is applied and then released. More
specifically, FIG. 49A shows the adjunct material 3000 before
application of a compressive force. FIG. 49B shows the adjunct
material 3000 having a compressive force applied thereto which
decreases a thickness of the adjunct. FIG. 49C shows the adjunct
material 3000 after the compressive force is released therefrom,
which increases a thickness of the adjunct. This compression and
expansion capability can result from the structure of the adjunct
material.
[0585] The support layer(s) of the woven material 3000 can be
formed in a variety of weave patterns and geometries to provide
desired mechanical properties, such as flexibility, pressure
distribution, homeostasis, and pneumostasis. The weave pattern used
to form support layer(s) can vary and can include, by way of
non-limiting example, those achieved by flat knitting processes
with various needles, circular knitting processes with various
needles, double knitting, warp knits, weft, knits, plain weaves,
pile weaves, etc. The flexible support layer 3001, 3002 and the
elastic core layer 3003 can have the same weave pattern or the
flexible support layer and the elastic core layer can have
different weave patterns to achieve a desired property for each
layer. Additional processes can be applied to a layer to adjust its
size, density, mechanical properties, surface properties,
appearance, etc. These processes include the application of heat,
the application of heat under a boundary condition such as force or
displacement, a chemical treatment (e.g., scouring, mercerizing,
singeing, raising, calendaring, sanforizing, etc.). A person of
skill in the art will appreciate that the structure of the flexible
support layer(s) of the woven adjunct can be adjusted to achieve
desired properties. For example, the flexible support layer(s) can
have a tighter weave than a weave of the core layer. In certain
aspects, the flexible support layer(s) can be densely woven.
Regarding a relative density of the support layer and the core
layer, the support layer(s) can be in the range of about 2 to 10
times more densely woven than the elastic core layer.
[0586] FIG. 50 illustrates an exemplary weave of fibers used to
form the support layers 3001, 3002 of FIGS. 48A-48C. As shown,
fibers 3004 can be woven into loops which interlock in both the X
and Y directions. A weave density of the flexible support layers
3001, 3002 can be sufficiently dense so that the support layers
3001, 3002 are not transparent to light. The weave density can be
characterized in various ways, such as by a degree of binding
between adjacent fibers. The fibers can be interlocked, as shown,
or knotted together, such that there is substantially no relative
motion between the fibers when a force is applied to the layer.
Fibers 3004 may be comprised of a braided mix of multiple smaller
fibers made of one or more materials. The selection or materials,
fiber diameter, and ratios of different fiber constituents (e.g.,
five fibers of a first material for every one fiber of a second
material) can impact the behavior of fibers 3004.
[0587] One skilled in the art will appreciate that the flexible
support layer(s) 3001, 3002 can be formed from various types of
fibers that are biocompatible and bioabsorbable. Examples of such
materials include various materials from which sutures are made,
including naturally occurring fiber materials and synthetic fibers.
Exemplary materials include polydioxanon (sold under the trademark
PDS.RTM.), Polyglycerol sebacate (PGS), PGA (Polyglycolic acid and
various forms thereof, marketed under the trademarks VICRYL.RTM.
and/or NEOVEIO, PCL (Polycaprolactone), PLA or PLLA (Polylactic
acid), PHA (Polyhydroxyalkanoate), PGCL (Poliglecaprone 25, sold
under the trademark MONOCRYL.RTM., PANACRYL.RTM. (Ethicon, Inc.,
Somerville, N.J.), polyglactin 910, polyglyconate, PGA/TMC
(polyglocolide-trimethylene carbonate sold under the trademark
BIOSYN.RTM.), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone)
(PVP), poly(vinyl alcohol) (PVA), absorbable polyurethanes,
regenerated cellulose, and oxidized regenerated cellulose fibers
(ORC). Blends and/or copolymerizations of any of the aforementioned
materials can be tailored to have a desired molecular weight,
mechanical properties, and/or degradation rate. In one embodiment,
the flexible support layers(s) 3001, 3002 can be formed as a
non-woven structure derived from the aforementioned materials.
These materials may be in the form of a foam and/or film. In one
embodiment, the flexible support layers(s) are at least partially
comprised of PDS.RTM. to facilitate adherence to elastic core layer
3003. In one embodiment, fiber 3004 is a braided filament comprised
of five Vicryl.RTM. fibers and one PDS.RTM. fiber.
[0588] In one embodiment, the flexible support layer(s) 3001, 3002
can be formed from a combination of synthetic fibers and naturally
occurring fibers. For example, a naturally occurring fiber or
fibers can be woven into the tissue contacting surface of a
flexible support layer primarily comprising synthetic fibers.
Exemplary naturally occurring materials include oxidized
regenerated cellulose fibers (ORC) and regenerated cellulose. The
naturally occurring material, particularly ORC, can be advantageous
as it can function to form a seal with the tissue as it tends to
gelatinize upon contact with a liquid.
[0589] A size of the fibers in the flexible support layer(s) can be
selected to achieve desired mechanical properties. An exemplary
composition of the flexible support layer is fibers 3004 in the
support layer(s) can be in the range of about 10-0 to 24-0 in size,
i.e., about 0.024 mm to 0.3 mm. In addition, the fibers of the
flexible support layer(s) can be of various fiber types including
monofilament and braided.
[0590] The elastic core layer 3003 can have various sizes, shapes,
and configurations, and the material of the elastic core layer can
be selected to achieve desired mechanical properties. The elastic
core layer 3003 can include a knitted or woven structure that is
loose in one direction (the direction of deformation) that readily
compress when a compressive force is applied and then can expand
when the compressive force is no longer applied. Increasing
resistance to compression (in the direction of deformation) can be
achieved by compacting the structure in the plane perpendicular to
the direction of primary deformation. This compact structure can be
achieved by post-knitting process steps such as heating, mechanical
compression, etc. Further, the fibers in the elastic core layer can
be loosely woven such that the fibers are able to move relative to
one another more readily than the interlocked or knotted fibers in
the support layer. As such, the weave density of the elastic core
layer 3003 is typically significantly less dense in at least one
direction than that of the support layers 3001, 3002. By way of
example, the relatively low weave density of the elastic core layer
3003 can be characterized in terms of the weave density being
sufficiently low so as to permit it to be transparent to light. An
alternative description would be a deformation inducing a stretch
ratio of approximately 0.5 requires a pressure of approximately 3
g/mm.sup.2.
[0591] Like the flexible support layer(s), the elastic core layer
can be formed from various types of fibers that are biocompatible
and bioabsorbable. Examples of such materials include various
materials from which sutures are made, including naturally
occurring fiberous materials and synthetic fibers. Exemplary
materials include polydioxanon (sold under the trademark PDS.RTM.),
Polyglycerol sebacate (PGS), PGA (Polyglycolic acid and various
forms thereof, marketed under the trademarks VICRYL.RTM. and/or
NEOVEIL.RTM.), PCL (Polycaprolactone), PLA or PLLA (Polylactic
acid), PHA (Polyhydroxyalkanoate), PGCL (Poliglecaprone 25, sold
under the trademark MONOCRYL.RTM., PANACRYL.RTM. (Ethicon, Inc.,
Somerville, N.J.), polyglactin 910, polyglyconate, PGA/TMC
(polyglocolide-trimethylene carbonate sold under the trademark
BIOSYN.RTM.), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone)
(PVP), poly(vinyl alcohol) (PVA), absorbable polyurethanes,
regenerated cellulose, and oxidized regenerated cellulose fibers
(ORC). Blends and/or copolymerizations of any of the aforementioned
materials can be tailored to have a desired molecular weight,
mechanical properties, and/or degredation rate. In one embodiment,
the elastic core layer 3003 can be at least partially comprised of
PDS.RTM. to facilitate adherence to flexible support layer(s) 3001,
3002. In one embodiment, fiber 3005 is a braided filament comprised
of five Vicryl.RTM. fibers and one PDS.RTM. fiber.
[0592] A size of the fibers in the elastic core layer can affect
the properties of the adjunct material, such as elasticity,
compressibility, and resiliency of the adjunct. In one embodiment,
the fibers in the elastic core layer 3005 can have a greater
diameter than the fibers in the flexible support layers 3004. The
fibers of the elastic core can be braided or can be a monofilament.
While a size of the fiber forming the elastic core can vary, in one
embodiment the elastic core can be formed from fibers made of
suture materials having a size in the range of about 10-0 to 2-0 in
size, i.e., about 0.02 mm to 0.3 mm.
[0593] The elastic core layer and the flexible support layer(s) can
be connected in various ways. For example, the elastic core layer
and flexible support layer(s) can be directly connected, e.g.,
woven together. As shown in FIGS. 51A and 51B, the fibers 3004 of
the flexible support layers 3001, 3002 can be woven around and
interlocked with the fibers 3005 of the elastic core layer 3003. In
another embodiment, (not shown), the elastic core and flexible
support layers can be bonded together my melting one or more
constituents (e.g., PDS.RTM., etc.) comprising fibers 3004 of the
flexible support layers 3001, 3002 and fibers 3005 of the elastic
core layer 3003. In another embodiment (not shown), the elastic
core and flexible support layers can be bonded together using any
known manufacturing technique, such as using felting or otherwise
adhering the layers together.
[0594] A thickness of an adjunct material, including the elastic
core and the flexible support layer(s), can vary depending on the
intended clinical application. In general, an adjunct material can
be at least as thick as a height of a staple in its formed state.
If a single adjunct material is coupled to one portion of an end
effector, e.g. a cartridge assembly or an anvil, the adjunct
material can be about 3.5 mm thick. Alternatively, if an adjunct
material is present on both the anvil and the cartridge, each piece
of adjunct material can be about one half of the height of the
staple in its formed state. The flexible support layers typically
have a thickness equal to about the diameter of two of the fibers
used for the flexible support layer, typically from about 0.16 to
0.6 mm thick. The elastic core typically comprises the remainder of
the thickness dimension of the adjunct material. Generally, the
thickness of the elastic core can be in the range of about 2 to 3
mm.
[0595] Woven three-dimensional structures can be formed in such a
way and using such materials that they will have desired mechanical
properties. The adjunct material generally will have a number of
desired properties that will vary depending upon the claimed
application. One of skill in the art will understand that the
material can be varied in accordance with the description above to
modify these desired properties. Typically, however, when
compressed and held at a height of 2 mm in a 37.degree. C. PBS
solution, the adjunct material construct can provide a minimum
pressure of 3.0 gf/mm.sup.2 from the time of compression (t=0)
through 72 hours. When compressed and held at a height of 2 mm in a
37.degree. C. PBS solution, the adjunct material construct can
provide pressure that does not go below the line defined by 3.0
gf/mm.sup.2 @ 72 hours and 0.0 gf/mm.sup.2 at day 28. When
compressed to 1.0 mm, held for 15 seconds, and then released, the
adjunct material can return to 2.0 mm height with at least 2.0
gf/mm.sup.2 within 30 seconds. The adjunct material can be able to
compress without excessive pressure to around 0.75 mm. The adjunct
material should be fully reabsorbed in about 120 days.
[0596] FIGS. 52A-52B show typical behavior of the adjunct material
under compressive and elongation forces, respectively. FIG. 52A
shows the adjunct material 3000 with a compressive force applied
thereto, while FIG. 52B shows the adjunct material 3000 with an
elongation force applied thereto. As shown, the adjunct material
3000 has sufficient integrity and structure such that it is not
compromised by the application of these forces. The amount of
material and degree of compression to be applied can determine the
mechanical properties of the resultant brick. Accordingly, one of
skill in the art will understand that the amount of material and
degree of compression can be varied in order to modify these
properties.
[0597] With the above teachings, one skilled in the art will
recognize that adjunct 3000 may be comprised of one or more elastic
core layers 3003 as well as one or more flexible support layers
3001, 3002. The order and number of layers as well as their
orientation result in multiple combinations that are conceived
within this disclosure. For example, the adjunct can include two
external support layers connected by a single, central flexible
layer. One skilled in the art will also appreciate that the adjunct
3000 can be formed of sandwiches of multiple flexible support
layers (e.g., three layers) with a number of (e.g., two) elastic
core layers.
Fibrous Adjunct Materials
[0598] In another embodiment, non-woven fibrous materials can form
all or portions of an adjunct material. Like a woven adjunct
material, the mechanical properties of a fibrous adjunct material
can be influenced by the shape of the adjunct, the type of fibers
used, and the density of the fibers.
[0599] The resulting material properties may also be influenced by
process steps used to create the adjunct. For example, FIG. 54A
illustrates an adjunct material 3100 with a central region that is
more dense than regions adjacent the perimeter of the structure.
FIG. 54D shows preprocessed adjunct material 3100D prior to a
compressive processing step that creates adjunct material 3100.
Pre-processed adjunct material 3100D is comprised of (woven or
non-woven) fibers of a generally homogeneous structure and
generally uniform density. By compressing the central region 3110
of 3100D to the flat height of adjunct material 3100, a central
region is created that is more dense than the perimeter region.
[0600] FIG. 54B shows a wider structure 3100B being compressed to a
more narrow structure (by force or by shrinkage through heat)
resulting in an aligned fiber pattern with anisotropic material
properties.
[0601] FIG. 54C shows a block 3100Cthat is pressed to increase the
width resulting in an anisotropic material with an aligned fiber
pattern perpendicular to that of the adjunct 3100B of FIG. 54B.
[0602] The construction of non-woven adjunct materials can be
selected in various ways, but can include a fleece (e.g., a
material that is similar to the fine web of cotton or wool removed
by the doffing knife from the cylinder of a carding machine) and/or
melt blown fibers.
[0603] A non-woven adjunct material can be formed from various
types of fibers that are biocompatible and bioabsorbable. Examples
of such materials include various materials from which sutures are
made, including naturally occurring fiber materials and synthetic
fibers. Exemplary materials include polydioxanon (sold under the
trademark PDS.RTM.), Polyglycerol sebacate (PGS), PGA (Polyglycolic
acid and various forms thereof, marketed under the trademarks
VICRYL.RTM. and/or NEOVEIL.RTM.), PCL (Polycaprolactone), PLA or
PLLA (Polylactic acid), PHA (Polyhydroxyalkanoate), PGCL
(Poliglecaprone 25, sold under the trademark MONOCRYL.RTM.,
PANACRYL.RTM. (Ethicon, Inc., Somerville, N.J.), polyglactin 910,
polyglyconate, PGA/TMC (polyglocolide-trimethylene carbonate sold
under the trademark BIOSYN.RTM.), polyhydroxybutyrate (PHB),
poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), absorbable
polyurethanes, regenerated cellulose, and oxidized regenerated
cellulose fibers (ORC). Blends and/or copolymerizations of any of
the aforementioned materials can be tailored to have a desired
molecular weight, mechanical properties, and/or degredation
rate.
[0604] One of skill in the art will understand that the fiber size
of the non-woven adjunct can be optimized in order to achieve
desired properties. In a preferred embodiment, the fibers can be
suture fibers from about 10-0 to 2-0 in size, i.e., about 0.02 mm
to 0.3 mm. In a more preferred embodiment, the fibers can be size
7-0, i.e., about 0.15 mm.
Adjuncts having Mesh and Fibrous Layers
[0605] In other embodiments, the adjunct material can have other
constructions, such as a woven or non-woven adjunct material
surrounded by a mesh. For example, FIG. 55 shows a mesh 3200 formed
from fibers 3201, can surround adjunct material 3100. The mesh 3200
can have various configurations, and can include a plurality of
fibers 3201 arranged in a repeating pattern such as a honeycomb
structure, as shown. The size of mesh, and type of mesh can be
varied, in addition to the construction of the non-woven material
described above, to modify the mechanical properties of the
non-woven material as described above. A mesh can be positioned
around a core layer similar to the core layers previously
described. For example, the mesh can surround a fleece core layer,
or one made from melt blown fibers. The mesh may be used to
constrain adjunct material 3100 in a desired state for use.
Further, the mesh may be used to facilitate attachment to a
stapling device.
[0606] In general, the mesh can be a loosely woven mesh of fibers.
The mesh can be a mesh of fibers woven in a geometry that is
transparent to light. The mesh can have a wide range of pore sizes,
such as in the range of about 0.5 to 5 mm.
[0607] In general, the mesh material can be a mesh that is suitable
for surgical implantation. The mesh can be biocompatible and may be
bioabsorbable. In one exemplary embodiment, the mesh can be
PROCEED.RTM. or PHYSIOMESH.RTM., both of which are manufactured by
Ethicon, Inc. of Somerville, N.J.
[0608] In certain aspects, the mesh surrounding the fleece material
can be coated with a therapeutic agent such that the mesh can elute
or release the therapeutic agent to a patient when the adjunct is
positioned in a patient's body. The therapeutic agent may be a drug
that promotes a beneficial outcome such as healing, or prevents
infection.
Coating an Adjunct with a Therapeutic Substance
[0609] The fibers of an adjunct material can be coated with a
therapeutic substance i.e., one that can aid in healing and/or
combat or prevent infection and that can be effective to be
released upon implantation of an adjunct material. For example,
FIG. 53A shows an adjunct material 3013, loaded on the tissue
facing surface 3058 of an anvil 3054 in which the adjunct material
includes fibers 3010 coated with a therapeutic substance 3011 as
shown in FIG. 53B. In another embodiment (not shown), the fibers in
a woven adjunct material can be coated with a therapeutic
substance. One skilled in the art will appreciate that the
number/percentage of fibers coated with a therapeutic substance can
vary. In another embodiment (not shown), only a small percentage of
the fibers of the adjunct material are coated, e.g., in the range
of about 5 to 50% of the fibers by volume can be coated.
[0610] In some embodiments, the adjunct material may include one or
more therapeutic agents, such as, for example, drugs, clotting or
sealing agents, antibacterial agent(s), and antimicrobial agent(s).
It should be appreciated that any number of any suitable
therapeutic substances can be included on an adjunct material. The
therapeutic agent can be configured to be released over time to aid
the tissue in healing, for example. In embodiments where more than
one therapeutic agent is employed, different therapeutic agents can
be configured to release at different rates.
[0611] Therapeutic substance coated onto the fibers can have
various properties. Exemplary therapeutic substances that can be
employed can include those that expedite binding as well as
antibiotics, and antimicrobials. Exemplary therapeutic substances
can include a mixture of fibrinogen and thrombin. In one
embodiment, fibrinogen and thrombin can be used as therapeutic
substances for coating the VICRYL.RTM. suture which forms the
adjunct material because lyophilized fibrinogen and thrombin (human
or animal derived) are known to adhere to VICRYL.RTM. fibers when
released from a fluid suspension VICRYL.RTM. fibers can be used in
the tissue contacting surface. In another embodiment a small number
of VICRYL fibers can be used. In another embodiment, VICRYL.RTM.
fibers can be woven (e.g., needle punch) into the structure of the
adjunct material, e.g. at the core or on the support layers, and
can be coated with a therapeutic substance. In certain aspects,
when thrombin coated onto a woven adjunct, the thrombin can
comprise about 1% or less of the woven adjunct.
[0612] As previously mentioned, various antimicrobials can be
coated onto the fibers of woven or non-woven adjunct material.
Exemplary include, by way of non-limiting example, triclosean and
ionized silver. In another embodiment, antibiotics can be deposited
only onto a woven layer of an adjunct material. Where a woven layer
of an adjunct material includes an antibiotic, antimicrobial, or
antibacterial woven therein or coated onto the fibers, the
antibiotic/antimicrobial/antibacterial can comprise about 0.5% or
less of the adjunct material.
[0613] A therapeutic substance can be coated on the fibers of the
elastic core layer of a woven adjunct material. When the
therapeutic substance is deposited on the fibers of the elastic
core, the therapeutic substance can be in liquid form and can be
absorbed into the elastic core layer. This can allow the
therapeutic substance to disperse into the tissue following
implantation of the adjunct material.
[0614] An adjunct material can include various other layers. In
another embodiment, (not shown), the elastic core layer can have a
film coupled to at least one side of the core layer. In an
exemplary embodiment the film is made of PDS.RTM.. In another
embodiment, the film can include PGA/PCL 75/250 polymeric
fibers.
Modifying Region(s) of an Adjunct Material Based on Features of a
Surgical Device
[0615] The adjunct material on the cartridge assembly can have
varied properties throughout or particular regions of the adjunct
material can be modified to correspond to a portion of the end
effector to which the adjunct will be coupled. For example, when
the adjunct material is to be used on a surgical stapler having a
knife, e.g. surgical staplers 10, 100, and 200, the properties of
the adjunct can be modified in the region in which the knife will
cut through the adjunct material. Such a modification can include
thinning out the flexible support layer, using less material, the
core layer only at this region, having a more loosely woven layer
than other layers of the adjunct, or removing excess material with
a laser. In another embodiment, felting can be applied to specified
regions of the adjunct so that the knife can more easily penetrate
and cut through the adjunct material. In another embodiment, the
properties of the adjunct can be modified by either adding or
removing fibers from the woven structure to make it stiffer or more
flexible, respectively. A zone of increased stiffness may be useful
for attachment to the stapling device. In addition, zones of
increased flexibility may be help to promote optimal tissue
interactions.
[0616] A felting process can be used to control dimensions and/or
adjust a local density of the adjunct material, such as to decrease
a density of a single layer or multiple layers of an adjunct
material. Felting can include applying heat to a specific section
of the adjunct material at a temperature between the material's
glass transition temperature and its melting temperature. By
applying heat above the glass transition temperature, and below the
melting temperature the structure of the material can be altered.
With this process it is possible to decrease the density of the
material while avoiding changes associated with complete melting of
the material.
[0617] In an alternative embodiment, the adjunct material can be
used on both the anvil and cartridge side of a surgical stapler.
For example, FIGS. 56A and 56B demonstrate the use of adjunct
material A on both the tissue facing surface 3058 of the anvil
portion 3054, and the cartridge assembly 3060, wherein the staples
3070 are covered by the adjunct material so that when deployed, the
staples can pierce the adjunct material. A thickness of the adjunct
material thickness can be varied across a lateral or longitudinal
(not shown) length of the anvil and the cartridge assembly, such as
by using methods described above. Such an asymmetric geometry on
both tissue facing surfaces of the anvil and cartridge may be
useful for tissue facing surfaces that are not flat, which may be
useful when staples 3070 are of varying unformed height, formed
heights, or both unformed and formed heights. In such an
arrangement, it is important to note that the geometry of an
adjunct material on the first opposing jaw is not necessarily
symmetric with the geometry of an adjunct material on the second
opposing jaw. In one embodiment the combined thickness of both
adjunct materials across a lateral distance is approximately the
same. In another embodiment, the combined thickness of both adjunct
materials across a lateral distance is not the same.
Stapling Adjunct Material onto Tissue
[0618] The adjunct material described herein can be deployed onto
tissue using a surgical stapling device, e.g., surgical staplers
10, 100, 200, open linear cutting stapler. In use, tissue can be
engaged between a cartridge assembly and an anvil of a surgical
stapler at a surgical site, wherein at least one of the cartridge
assembly and anvil has an adjunct material releasably retained
thereon. The surgical stapler can be actuated to eject staples from
the cartridge assembly, through the adjunct material, and into the
tissue. The adjunct material can help to reduce impact and trauma
from the stapling, evenly distribute strain along the staple line,
and can compensate for variable tissue thickness and allow staples
secure onto thin or diseased areas of tissue. Different areas of
the adjunct material can perform different functions when the
adjunct material is stapled onto tissue.
[0619] FIG. 57A shows four adjunct materials that can be releasably
coupled to an end effector of a surgical stapler. First and second
adjunct materials can couple to a tissue facing surface 3058 of the
anvil 3054 and second and third adjunct materials can coupled to
the cartridge assembly 3060. Three regions of the adjunct material
identified as B, C, and D, can each perform a different function.
For example, the B region can be used for staple sealing, the D
region can be used for stress relief and collateral damage
reduction, and the C region can be used for variable thickness
compensation. Accordingly, it can be possible to select the adjunct
material used in each region to meet desired surgical outcomes.
When the adjunct material is deployed onto the tissue T and coupled
thereto via the staples S, the adjunct material can be positioned
along an outer surface of the tissue, as shown in FIG. 57B. The
adjunct material can seal the staples, provide stress relief and
reduce collateral damage to nearby tissue, and/or can compensate
for variable tissue thickness.
Crown-Side Staple-Specific Adjuncts
[0620] As mentioned above and shown in FIG. 58, punctures formed by
staples fired from a surgical stapler may result in the leakage of
blood, air, or other fluids depending on the type of tissue being
stapled. More particularly, tissue can stretch in any of a variety
of directions 4002, 4004 after a staple 4006 is implanted therein,
thereby stretching punctures 4008, 4010 formed by the staple legs.
In some cases, bleeding or other leakage through staple punctures
can be present even though a stapled end of a vessel or other body
lumen is successfully sealed.
[0621] One advantage of tissue adjuncts is their propensity to
prevent or minimize leaks, such as fluid or gas leaks. Tissue
adjuncts can perform this function by one or more of the following
mechanisms: plugging holes or tears that occur at the staple
puncture sites; restricting movement of tissue around staple
puncture sites to prevent an increase in the size of staple holes
and/or to prevent tissue tears; and minimizing strain gradients
that occur between constrained tissues within the staple line and
free tissue adjacent to the staple line.
[0622] Embodiments of the devices and methods described herein can
address leakage from these punctures by providing one or more
adjuncts that are coupled to a staple and configured to plug or
seal the punctures 4008, 4010. As described above, the adjuncts can
be formed from viscous coatings (e.g., bio-absorbable urethane,
etc.) disposed in staple cavities of a cartridge body containing
staples. Upon ejection from the cartridge body, the adjunct
coatings can become plugs that fill punctures 4008, 4010 formed by
the staple legs. The plugs can be compressed when the staples are
formed through tissue, and as the adjunct material is compressed it
can expand and fill any defects in the tissue that could create
leak paths. The adjunct plugs can also serve to distribute pressure
applied by the staple, thereby reducing the possibility of a staple
pulling through the tissue and failing to fasten the tissue as
intended (so-called "cheese wiring"). Still further, a viscous
coating used as an adjunct material can also include other healing
properties, as described above (e.g., antimicrobial properties,
hemostats, etc.) or other features to help with the formation of
staples (e.g., lubricants, etc.).
[0623] FIG. 59A illustrates one embodiment of adjuncts 4012
disposed about legs of a surgical staple 4014. The illustrated
adjuncts 4012 are in the form of plugs disposed about each leg of
the staple, that is, they have a tapered cylindrical shape
configured to wedge into a puncture created by a staple leg as it
passes through tissue. The adjuncts 4012 can be formed at any point
along the legs of the staple 4014 and, in some embodiments, can be
configured to slide along the legs, as described in more detail
below.
[0624] In the embodiment shown in FIG. 59B, adjuncts 4016 can be
positioned at a junction between a crown 4018 of the staple 4014
and each staple leg 4020, 4022. The adjuncts 4016 can again have a
shape that tapers from the crown 4018 toward a distal end of the
staple legs 4020, 4022 such that the adjunct forms a plug
configured to be received within a puncture in tissue. The adjuncts
4016 can further be formed from a flowable material, e.g., a
hydrogel, which can retain its shape prior to implantation but can
become more flowable upon implantation in tissue to fill a puncture
or other defect in the tissue. In other embodiments, a swellable
material can be employed, i.e., a material that increases in volume
upon contact with water or other bodily fluid.
[0625] FIG. 60 illustrates an alternative embodiment of adjuncts
4024 disposed around legs of staple 4026. In this embodiment, the
staple 4026 is housed within a staple cavity of a surgical
stapler's cartridge body 4028. Adjunct plugs 4024 are disposed
around each leg of the staple 4026 at a distal end thereof. In some
embodiments, the adjuncts 4024 can be seated in small cut-outs or
shelves formed in the cartridge body 4028 (compare to FIG. 62). The
adjuncts 4024 can be configured to slide over the legs of staple
4026, as shown in FIG. 61.
[0626] In use, as shown in FIG. 62, tissue 4030 can be clamped
between the cartridge body 4028 and an anvil 4032 and the staple
4026 can be ejected out of the cartridge body through the tissue
and into the anvil. The adjuncts 4024 can abut against the tissue
4030 and begin to slide over the legs of the staple 4026 as it is
ejected from the cartridge body (see FIG. 61). Ultimately the
adjuncts 4024 can end up compressed between the tissue 4030 and a
crown of the staple 4018. Because the adjuncts 4024 can be formed
from a material that becomes flowable upon contact with water or
other bodily fluid, or under compressive forces, the
cylindrically-shaped adjuncts 4024 shown in FIG. 61 can flow into
the punctures in the tissue 4030, as shown in FIG. 62.
[0627] Viscous coatings and other flowable or swellable materials
can be suitable choices for an adjunct material because they can
adapt to varying forces experienced by tissue at different
locations within the body. FIGS. 63A and 63B illustrate that such
adjunct materials can be used to effectively seal staple leg
punctures that expand inward toward one another, as can be the case
when the tissue is under compression, as well as staple leg
punctures that expand outward away from one another, as can be the
case when the tissue is under tension. By way of example, tissue
under tension can often be found in the thoracic cavity, e.g., lung
tissue and/or cardiovascular tissue (FIG. 63B), while tissue under
compression can often be found outside of the thoracic cavity (FIG.
63A).
[0628] FIGS. 64A and 64B provide alternative views of the
configuration shown in FIG. 63B. Tissue 4034 that is under tension
can cause staple leg punctures to expand outward from the staple
4036. Accordingly, flowable adjunct plugs 4038 in the form of gel
plugs disposed around each leg of the staple 4036 can be pushed
outward by compression between the crown of the staple and the
tissue 4034 into the punctures. The gel can seal the expanded
punctures, thereby preventing any leakage therethrough.
[0629] As noted above, FIGS. 59A-64B show adjunct material disposed
around legs of a surgical staple or formed at an inner junction
between a crown of the staple and the staple legs. In an
alternative embodiment shown in FIG. 65, adjunct material 4040 can
be coupled to an outer surface of the staple 4042 at the junction
between a crown 4044 of the staple and each staple leg 4046, 4048.
The adjunct material 4040 can be a flowable or swellable material
in some embodiments, such as a hydrogel. Such a material can expand
outward upon contact with tissue and fill the punctures formed by
the staple legs 4046, 4048. The adjunct material 4040 in FIG. 65 is
in the shape of a cylindrical plug, however any of a variety of
other shapes are also possible. As mentioned above, other possible
shapes can include taper along a leg of the staple, or entirely
different shapes can be utilized, such as a cube, hexagonal
extrusion, etc.
[0630] A shape of the staple 4042 can be modified to accommodate
the adjunct material 4040, as shown in FIG. 66. In some
embodiments, for example, right-angle corners of the staple 4014
shown in FIGS. 59A and 59B can be chamfered to provide attachment
surfaces for the adjunct material 4040. The crown 4044 of the
staple 4042 also has a broader, flat shape, as opposed to the
cylindrical rod or square cross-sectional shape of the staple 4014
in FIG. 59. In addition, both the staple 4042 and the adjunct
material 4040 can have any of a variety of sizes. FIGS. 67A-67C
illustrate embodiments of staples 4050, 4052, and 4054 that have a
same width and leg length, but accommodate increasing amounts of
adjunct material 4056, 4058, 4060.
[0631] FIGS. 68A-68C illustrate the implantation of the staple 4042
shown in FIG. 65 in a patient's lung. The staple 4042 can be
initially stored within a staple cavity of a surgical stapler
cartridge body 4062. Once tissue 4064 is disposed between the
cartridge body 4062 and an anvil 4066, the staple 4042 can be
ejected from the staple cavity through the tissue and into the
anvil. Upon contact with the lung tissue 4064, the hydrogel adjunct
material 4040 can expand to fill any gaps or defects surrounding
the punctures formed by the staple legs 4046, 4048.
[0632] The flattened-crown staple of FIG. 65 is just one embodiment
of a staple that can accommodate attachment of adjunct material
thereto. FIGS. 69A and 69B illustrate still other alternative
staple geometries that can have adjunct material coupled thereto,
e.g., disposed about a leg thereof, or coupled to an outer or inner
surface of a crown. U.S. patent application Ser. No. 14/138,516,
filed on Dec. 23, 2013, the entirety of which is incorporated
herein by reference, discloses still further staple geometries that
can be combined with the adjunct materials disclosed herein.
Regardless of the particular staple geometry or attachment
mechanism for an adjunct material, the adjunct material can be
configured to fill and seal individual punctures formed by the
staple legs.
[0633] FIG. 70 illustrates an alternative embodiment of an adjunct
in the form of a pledget 4066 that is configured to seal around
both a first leg and a second leg of a surgical staple 4068. The
pledget 4066 is shown pressed against a crown (not shown) of the
staple 4068 and can be formed from a flowable and/or swellable
material, such as a hydrogel or other gel, as discussed above. The
gel can be configured to retain its shape when disposed within a
surgical stapler cartridge body, as shown in FIG. 71A, but to
become more flowable in all directions upon contact with tissue,
water, or other fluid, as shown in FIG. 71B.
[0634] FIGS. 72A and 72B show the surgical staple 4068 and adjunct
pledget 4066 from a side view before and after implantation. As
shown in FIG. 72B, the pledget 4066 has expanded outward and flowed
into tissue 4070 upon contact therewith. The gel material of the
pledget 4066 can thereby seal the punctures formed by the staple
4068, as well as distribute pressure applied to the tissue by the a
crown 4072 of the staple 4068.
[0635] In still other embodiments, adjunct material can be in the
form of a coating disposed over all or a portion of a surgical
staple, as shown in FIGS. 73 and 74. In particular, staple 4074 of
FIG. 73 includes a coating 4076 of an adjunct material disposed
over an entire outer surface thereof. The adjunct material employed
in the coating 4076 can be configured to swell upon contact with
tissue or bodily fluid, such that once the staple 4074 is implanted
in tissue the coating will expand away from the staple and fill any
gaps that may be present. FIG. 74 illustrates a side
cross-sectional view of tissue 4078 having multiple rows of staples
4074 disposed therein. The staples 4074 can seal the tissue 4078
together at the center of the figure, such that fluid cannot pass
and the tissue could be transected between the staples 4074.
[0636] Other non-flowable materials can also be employed as
adjuncts in some embodiments. For example, a compressible foam can
be used as an adjunct material in combination with a gel or other
flowable material, or on its own. FIG. 75 illustrates one
embodiment of a staple 4080 having a foam adjunct 4082 disposed
around both legs of the staple. Attempts to utilize foam in
combination with staples may sometimes encounter a problem wherein
the foam rotates about a crown of the staple during implantation.
The staple 4080 addresses this problem, and minimizes this
possibility, by incorporating an additional pledget 4084 between a
crown of the staple and the foam adjunct 4082. The pledget 4084 can
provide support to the foam adjunct 4082 during implantation to
prevent it from rotating about the crown of the staple. The pledget
4084 can be formed from a rigid biocompatible material, or can be
formed from a flowable material as described above. In the latter
embodiment, a gel or other flowable material can retain its shape
prior to implantation so as to provide the necessary support for
the foam adjunct 4082, and subsequently flow into defects in tissue
after implantation. U.S. Pat. Pub. No. 2011/0192882 to Hess et al.,
the entirety of which is incorporated herein by reference,
discloses additional techniques for coupling staples to rigid
pledgets and incorporating them into a cartridge body that can be
combined with the adjunct materials disclosed herein.
[0637] In some embodiments, it can be desirable to prevent any
adjunct material from coming into contact with the cartridge body
of the surgical stapler during implantation of a staple. If there
is contact between the cartridge body and adjuncts, it is possible
that the adjunct material can be scraped off the staple as it is
ejected from the cartridge body. In embodiments where the adjunct
material is a hydrogel or other flowable and/or swellable material,
it is further possible that the adjunct material could interfere
with ejection of a staple if it was, for example, scraped off into
a staple cavity and left to expand there or flow into neighboring
portions of the surgical stapler. Accordingly, in certain
embodiments sealing adjuncts disposed within a staple cavity of a
surgical stapler cartridge body can be configured to be ejected
therefrom along with a staple without contacting the cartridge
body.
[0638] There are a number of ways to ensure that the adjuncts do
not contact the cartridge body. In one embodiment, adjunct material
can be coupled to a staple such that the staple shields the adjunct
from contact with the cartridge body during ejection. The staple
shown in FIG. 65 is one example of a staple that shields adjunct
material from contact with the cartridge body because the adjunct
material is essentially behind the staple as it is ejected from the
cartridge body. In other embodiments, adjunct material can be
tucked into an area extending between the legs of a staple, such as
in the staple shown in FIG. 59B. This configuration can also shield
the adjunct material from contacting the cartridge body during
ejection from a staple cavity.
[0639] In other embodiments, the staple cavity openings in the
cartridge body can be shaped to accommodate passage of at least one
sealing adjunct coupled to a surgical staple. FIG. 76 illustrates
one embodiment of a cartridge body 4086 that includes a plurality
of staple cavities 4088 having openings shaped to accommodate the
staple 4080 and foam adjunct 4082 shown in FIG. 75.
[0640] FIG. 77 illustrates an alternative embodiment of a cartridge
body 4090 having a plurality of staple cavities 4092 shaped to
accommodate a staple 4094 having a plurality of adjuncts 4096
coupled to an outer portion of each staple leg. FIGS. 78A-78C
illustrate various embodiments of staple cavity openings that are
configured to allow for passage of one or more adjuncts coupled to
a surgical staple. In the top view of FIG. 78A, for example, a deck
4098 of the cartridge body is shown having an opening 4100 formed
therein. The opening 4100 can include cut-outs 4102, 4104 formed at
opposite ends thereof that are sized to accommodate sealing
adjuncts 4106, 4108 that are coupled to a flat form staple 4110
that is similar to the staple shown in FIG. 65. In the alternative
embodiments of FIGS. 78B and 78C, additional cut-outs are provided
surrounding the legs of the staple 4110 to accommodate different
configurations of adjunct material coupled thereto.
Anvil-Side Segmented Adjuncts
[0641] Certain embodiments of the methods and devices described
herein include one or more adjunct segments disposed on an
anvil-side of a surgical stapler, that is to say on an opposite
side of staple tissue from the crown-side adjuncts described above.
These anvil-side adjuncts can be used in addition to the crown-side
adjuncts. While the crown-side adjuncts serve to prevent leakage
caused by tissue deformation around the staple legs, the anvil-side
adjuncts described below can prevent tissue damage from strain
caused by the staple and the staple-line as a whole.
[0642] Adjunct segments disposed on the anvil-side of a surgical
stapler can include sheets of biocompatible or bioresorbable
material, discrete adjunct segments each designed to interact with
legs of an individual staple, discrete adjunct segments each
designed to interact with legs of multiple staples, discrete
adjunct segments attached to each other, or any suitable
combination thereof. In some embodiments, each adjunct can be of a
size that when placed adjacent the anvil-side of a surgical
stapler, each adjunct spans only a single staple-forming opening.
Further, in some embodiments, each adjunct can be of a size that
when placed adjacent the anvil-side of a surgical stapler, each
adjunct spans multiple single staple-forming openings.
[0643] In addition to preventing damage from the staple in the
stapled tissue, adjunct segments disposed on the anvil-side of a
surgical stapler can serve to hold together staples that do not
interact with tissue during a stapling procedure, that is to say
excess staples. For example, in embodiments where the anvil-side
adjuncts include sheets of material, adjunct segments that are each
designed to interact with the legs of multiple staples, or adjunct
segments that are attached to each other, a surgical stapler can be
fitted across a segment of tissue, such as a portion of intestinal
tissue or a vessel, whose diameter is shorter than the length of
the staple line created by the surgical stapler. In that case,
there will be staples that do not pass through tissue. Removal of
those excess staples that are not securing tissue from the patient
is facilitated if they remain attached to the tissue through the
adjunct segments. The surgeon or stapler operator can then sever
select adjuncts to detach the excess staples and he or she can
remove all of the excess staples while minimizing the potential for
loss of an excess staple inside the patient.
[0644] Though, as described in more detail below, some embodiments
of the segmented adjuncts described herein can be used on a
cartridge, adjunct segments can be deposited to the anvil-side of
the surgical stapler in the staple shaping depressions in the
anvil-side of the surgical stapler as a liquid that hardens over
time or after exposure to curing radiation. Adjuncts can also be
supplied as discrete adjuncts attached to a sheet. The sheet can be
a connective film, such as continuous film. The sheet can be a
woven mesh. In some embodiments, a plurality of discrete adjuncts
can be connected through a plurality of connecting branches,
through a plurality of threads, or other suitable means for
connecting the adjuncts with biocompatible or bioresorbable
material that does not impede the functioning of the staples or
irritate the tissue once the staples are applied. When the adjuncts
used are connected through a plurality of connecting branches, the
surgical stapler can include one or more features to sever the
connecting branches as the staples are deployed into tissue.
[0645] FIG. 79 shows a top view of one embodiment of a plurality of
adjunct segments coupled to one another 4112, such as might be
seated in a cartridge for use with a surgical stapler or seated
directly in a surgical stapler. The individual adjunct segments
4114 are shown to span a plurality of staple forming openings 4116,
and when applied to tissue, as seen in the top portion of the
figure on the right, there can be excess adjunct segments that do
not attach to tissue 4120. The individual adjunct segments 4114 are
joined together through branches 4118. The branches 4118 can be
made of a similar material as the adjuncts, but made thinner than
the adjuncts and of a diameter that allows for the branches 4118 to
be broken 4122 by the application of force. In this way, excess
adjunct segments 4120 can be removed.
[0646] FIG. 80 shows a perspective view of an alternative
embodiment of a plurality of adjunct segments 4124 applied on the
anvil-side of a surgical stapler. The plurality of adjunct segments
4124 shown are held together by connecting threads of filaments
4126 between individual adjunct segments 4128. Each adjunct segment
4128 is configured to span a plurality of staple forming openings
4132.
[0647] A film that may include a woven material 4130 can overlay
the individual segmented adjuncts 4128. The film, optionally
including a woven material 4130, can help to mitigate the damage to
stapled tissue by distributing forces.
[0648] FIG. 81A shows a view of one embodiment of surgical end
effector 4134 having a plurality of adjunct segments 4124. The
surgical end effector 4134 is shown accepting a vessel 4136. In
FIG. 81B, the surgical end effector 4134 is shown transecting the
vessel 4136, causing staples to engage with the adjunct segments
4124 of FIG. 81A. FIG. 81C shows the vessel 4136 and adjuncts 4124
after transection of the vessel 4136. Filaments or threads 4126 can
connect the adjuncts 4124, and the filaments or threads 4126 can
aid in the application of the plurality of adjuncts 4124 to the
surgical end effector 4134. Yet the filaments or threads 4126 can
be torn when separating the ends of the transected vessel 4136. The
filaments or threads 4126 can hold excess adjunct segments 4138 in
place until removed by a surgeon.
[0649] FIG. 82 shows another embodiment of segmented adjuncts 4140
disposed on the anvil-side of a surgical stapler 4142. Each
individual adjunct segment 4144, 4146 spans multiple staple forming
openings. As shown, each adjunct segment 4144, 4146 can have a
distinct configuration from that of the adjunct segments adjacent
to it. However, each adjunct segment 4144, 4146 interlocks with its
neighbors. In this way, it may be possible to have some degree of
adhesion between adjacent adjunct segments 4144, 4146 so that no
filaments or branches are needed, and so that no filaments or
partial branches will be exposed after the excess adjunct segments
are removed from stapled tissue. Additionally, the adjuncts are
shown as including a woven material.
[0650] FIG. 83 shows a portion of a surgical staple anvil 4148 with
a plurality of staple forming openings filled with a viscous
sealant material 4150. Some of the ways in which the material
arrives in the staple forming openings of the staple anvil 4148 are
shown in FIGS. 84-86D. FIG. 84 shows a surgical stapler anvil 4152
with staple forming openings in which pre-formed sealing gel 4154
is placed, as described in greater detail below. FIG. 85 is a cross
sectional view of an anvil 4156 with staple forming openings filled
with a sealing liquid or gel 4158. The sealing liquid or gel 4158
has a film or layer 4160, above the bulk of the sealing material,
that is flush with the surface of the anvil 4156. FIG. 86A shows
the addition of the sealing material 4158 in a liquid or gel state
to staple forming openings on an anvil 4156. FIG. 86B shows the
staple forming openings filled with sealing liquid or gel, and FIG.
86C shows the creation of the film or layer 4160. A light source,
such as a UV light source, provides lights at an energy level
sufficient to cause partial curing of the sealing material 4158 to
form the film or layer 4160.
[0651] In some embodiments, the staple forming openings of an anvil
can contain completely cured sealing material 4162, as shown in
FIG. 86D. Fully cured sealing material 4162 can have different
materials properties than the partially cured material shown in
FIG. 85A. FIG. 87 shows a staple 4164 that was shaped using a
surgical stapler with partially cured sealing material in the
staple forming openings of the stapler anvil. The staple 4164 has
legs that pass through the cured layer 4160, into the uncured
sealing material 4158, and back through the cured layer 4160, and
in some embodiments, the end of each leg of the staple 4164 can end
in tissue. The sealing material helps to prevent any passage of
fluids through tissue, adjacent to the staple, as well as
preventing undesirable deformation or damage to the tissue.
[0652] FIG. 88 shows an alternate way of delivering adjuncts for
the anvil-side of surgical staples 4166 that includes multiple
adjuncts 4168 that fit into staple forming openings on the anvil of
a surgical stapler and a thin connecting film 4170. The thin
connecting film 4170 can be a continuous film that allows for easy
transport and placement of multiple adjuncts 4168 at once.
[0653] FIG. 89 is a perspective view of showing adjuncts 4172 with
4174 mesh material. FIG. 90 shows an exploded view of the view of
FIG. 89. FIGS. 91A and 91B show adjuncts 4184 that are cured with a
film above the adjuncts 4186, in which the film connects the
adjuncts 4186, as well as discrete adjuncts which are not connected
4190 to each other. In the system of discrete adjuncts 4188, each
adjunct 4190 has un-cured seal material that fits the within the
staple forming openings of the anvil of a surgical stapler. Each
adjunct also has a layer of cured material 4194 above the uncured
sealing material 4192.
[0654] FIG. 92 shows a cross-sectional view of a surgical staple
4198 in a cartridge 4196 that is opposite the anvil 4202 of a
surgical stapler. In the figure, tissue 4200 is between the
cartridge 4196 and the anvil 4202. The anvil 4202 is shown to have
multiple staple forming openings 4190, each opening filled with
uncured sealing material 4192 and having a layer of cured sealing
material 4194 over each staple forming opening 4190.
[0655] FIG. 93 is a cross-section view of a surgical staple 4198
inserted in tissue 4200 with an adjunct that includes both cured
and uncured sealing material present on the free-ends of the legs
of the staple. The legs of the staple have passed through the
tissue, through a cured portion of the adjunct material 4204,
through a portion of un-cured adjunct material 4206 and then back
into the tissue 4200. FIG. 94 shows curing of the un-cured adjunct
material 4206 in FIG. 93 so that it becomes a cured, conforming
material 4210. A light source 4208 provides the appropriate
radiation to cure the liquid or gel setting material 4206 after the
material has spread to conform to the surface of the tissue
4200.
[0656] FIG. 95 shows a grouping 4212 of discrete adjunct segments
4214 that are joined by a plurality of connecting branches of
adjunct material 4216. The adjunct segments 4214 in the grouping
4212 can be partially or fully cured, such that the grouping 4212
can be stored for long periods of time. FIG. 96 shows the adjunct
grouping 4212 of FIG. 95 fitting over staple forming openings, or
anvil pockets, 4220 on a surgical stapler anvil 4218.
[0657] FIG. 97 shows an anvil 4222 with adjunct-separating features
4226 between the staple forming openings 4224. FIG. 98 shows a side
view of an embodiment of a surgical stapler that includes a staple
4228 in a staple cartridge 4230 and a plurality of adjunct segments
4214 coupled to the anvil 4222. The plurality of adjunct segments
4214 are joined by branches 4216. The branches 4216 are severed by
the sharp features 4216 when the staple 4228 is inserted into the
tissue (4232 in FIG. 99). FIG. 99 shows the staple 4228 as it is
formed by actuation of the surgical staple, ad FIG. 100 show the
staple 4228 after it is fully implanted in the tissue 4232, with
the branches 4216 severed, making breaks 4234 in the branches, and
with the adjunct segments 4214 between a portion of the ends of the
legs of the staple 4228 and the tissue 4232.
[0658] FIG. 101 is a cross-sectional view of an embodiment of a
retainer 4238 to hold adjunct material 4240 in place against a
surgical stapler anvil 4236. FIG. 102A is a cross-sectional view of
the retainer 4238 and anvil 4236 shown in FIG. 101, with adjunct
material 4240 between the anvil and the retainer. FIG. 102B is a
variation of the embodiment shown in FIG. 102A in which the adjunct
material is present only as discrete adjuncts 4240, without any
connecting material.
[0659] FIG. 103 is a cross-sectional view of an embodiment of a
staple forming opening 4246 with bulge tabs 4244. The tabs 4244 are
shaped during manufacturing into retainer features. FIG. 104 shows
the staple forming opening 4246 of FIG. 103 filled with a plug
element 4250, or adjunct material, and the bulge tabs 4244 shaped
into trapping features 4248. FIG. 105 is a top view of the staple
forming opening 4246 shown in FIG. 103. The line A-A is that along
which the cross-sectional views are taken.
[0660] FIG. 106 shows a perspective view of one embodiment of a
surgical stapler with adjunct segments 4256, 4258 associated with
both the anvil 4254 and staple cartridge 4252. In this embodiment,
the adjunct segments 4258 on the anvil 4254 have branches of
adjunct material or filaments 4260 between the adjunct segments
4258. The adjunct segments 4256 on the staple cartridge 4252
interlock with each other, such that a notch 4262 in one adjunct
segment receives a protrusion 4264 from its neighboring adjunct
segment. In this way, additional means of holding together the
adjuncts 4256 on the staple cartridge 4252, which is on the
crown-side of the staples, are needed. Further, the adjuncts 4256
on the staple cartridge 4252 span more than one staple, so that two
or more staples will be connected by each adjunct.
[0661] FIGS. 107 and 108 show an embodiment of a surgical stapler
with an anvil 4266 that includes attachment 4272 and alignment
features 4274 for adjunct material 4270. FIG. 107 is an exploded
view of the anvil 4266 with staple forming openings 4268 and
features 4274 on the side of the anvil for anchoring or interfacing
with loops 4272 on a sheet of adjunct material 4270. FIG. 108 shows
the adjunct material 4270 flush against the anvil 4266 with the
loops 4272 attached to the features 4274 which are shown to be tabs
or pegs that attach to the loops. Such features 4274 can be present
on a staple cartridge and used with a similar type of adjunct
material instead of or in addition to being used on the anvil 4266
of a surgical stapler.
[0662] FIGS. 109-111 show an embodiment of a surgical stapler 4276
with adjunct assemblies 4284, 4278 coupled to both the anvil 4282
and the staple cartridge 4280 of the stapler. The adjunct
assemblies 4284, 4278 are shown to include adjunct segments 4286,
4288 that are joined by a sheet of adjunct material. On the anvil
4282, there are a plurality of staple forming openings 4290 which
can accept adjunct segments 4286. FIG. 111 shows the relative
thickness of an adjunct segment 4286 to that of the sheet of
adjunct material. The adjunct segments 4286 on the stapler anvil
4282 can include partially cured or fully cured sealing material,
as described above. The adjunct material 4278 for use with the
staple cartridge 4280 has adjunct segments 4288 which can fit over
the ends of the staples in the cartridge 4280, either in contact
with or above the staple legs. In practice, using such a surgical
stapler 4276 would insert staples into tissue in with adjunct
material both at the crown of each staple and at the anvil-side of
each staple, thus potentially reducing leaking and tissue damage
caused by the staple.
[0663] FIG. 112 shows a cross-sectional view of one embodiment of a
plurality of adjunct segments 4288 (e.g., micro-fingers) connected
to one another by a film 4278. These adjunct segments 4288 may not
correspond to individual features on a stapler anvil or a staple
cartridge, but instead may serve to act as a cushion or a
light-weight, highly conformable and compressible material. FIGS.
113A and 113B show cross-sectional views of a surgical stapler,
similar to that shown in FIG. 109, with a staple 4294 in a
cartridge 4292 with an adjunct material 4296 that includes a
plurality of adjunct segments 4292 that can act as a light-weight,
conformable and compressible material 4296. The anvil 4300 shown in
FIG. 113A has staple forming openings 4302 in which include adjunct
segments 4304 that are attached to a sheet of adjunct material
4306. FIG. 113B shows the staple 4294 after the stapler has been
actuated on tissue 4308. The tissue 4308 contacts adjunct material
with micro-fingers 4298 near the crown of the staple and thicker,
continuous adjunct material 4304 at the anvil-side of the
staple.
[0664] FIGS. 114A and 114B show an embodiment of a surgical stapler
component 4310 that includes adjunct segments of varying thickness
4312. Each adjunct segment is discrete and spans only one staple.
FIG. 114B shows that adjunct segments of greater thickness 4318 are
located nearest the centerline of the stapler component 4310, and
that the thinner adjunct segments 4316 correspond to staples
further away from the centerline, where a cut in stapled tissue
would be made.
[0665] FIG. 115 shows another embodiment of adjunct segments 4322,
4326 on one part of a surgical stapler. The adjunct segments 4322,
4324 are not of uniform thickness. Each adjunct segment has a thick
side, 4328, 4330, and a thin side 4332, 4334. Each adjunct segment
4322, 4324 spans more than one staple 4326 location shown in the
exemplary staple cartridge 4320. The adjunct segments are shown
with their thick sides 4328, 4330 towards the center of the staple
cartridge 4320. When the surgical stapler cuts through tissue after
stapling the tissue, it will cut the tissue through the center of
the cartridge, between the thick sides 4328, 4330 of the adjunct
segments. In this way, the adjunct segments 4322, 4324 provide more
support to the staples nearest the free ends of the tissue.
[0666] FIG. 116 shows a cross-sectional view of the stapler of FIG.
115. The staple cartridge 4320 holds staples 4336. Over the staples
4336 are adjunct segments 4334 and 4324 which have their thick
sides 4330, 4328 near the center of the cartridge and their thin
sides 4324, 4322 toward the outer edges of the cartridge 4320, over
the outermost staples. The stapler anvil 4338 has staple forming
openings 4340, over which are adjunct segments 4342, 4344. The
anvil-side adjunct segments 4342, 4344, are shown to have their
thick sides 4346, 4348 near the venter of the anvil, corresponding
to the innermost staples. The thin sides 4350, 4352 of the
anvil-side adjuncts 4342, 4344 are located toward the edges of the
anvil such that the thin sides are associated with the outermost
staples once the stapler is actuated.
[0667] FIG. 117 shows an embodiment of a surgical stapler component
4310 that includes adjunct segments of varying thickness 4312. Each
adjunct segment is discrete and spans only one staple. Adjunct
segments of greater thickness 4318 are located nearest the
centerline of the stapler component 4310, and that the thinner
adjunct segments 4316 correspond to staples further away from the
centerline, where a cut in stapled tissue would be made. These
adjunct segments are discrete, not interlocking as those shown in
FIG. 115.
[0668] FIGS. 6118A and 118B show a multi-material adjunct 4354 that
includes a film 4356 with openings 4360 and a base layer 4358 with
connecting features 4362. The base layer 4358 can be a layer of
elastomeric material. The connecting features 4362 can be shaped to
fit through the openings 4360, for example the connecting features
4362 shown are columns and the openings 4360 are circular holes.
The connecting features 4362 and openings 4360 can be any suitable
shape, symmetrical or asymmetrical, as in when a particular
orientation between the base layer 4358 and the film 4356 is
desired. FIGS. 119A and 119B show the adjunct of FIGS. 118A and
118B in context, with a staple 4364 shown. FIG. 119A shows the
staple prior to insertion into the adjunct 4354. The staple 4364 is
shown as aligned with the connecting features 4362 so that each leg
of the staple moves through a connecting feature 4362 when stapling
tissue. FIG. 119B shows the staple 4364 after being moved toward an
anvil of a surgical stapler.
[0669] FIGS. 120-122 show different embodiments of a surgical
staple and adjunct in tissue, with the legs of the surgical staple
shaped to retain the tissue in a particular configuration. FIG. 120
shows a staple 4368 in tissue 4370 with adjunct material 4372 near
the anvil-side of the staple, such that the adjunct material 4372
acts as a seal to avoid leaking from the tissue 4368. FIG. 121
shows a staple 4374 in tissue 4376 with an adjunct on the
anvil-side of the staple 4374. The adjunct includes a film 4378, a
depression in the film 4382, and a thicker area in the adjunct 4380
into which the ends of the legs of the staple 4374 move when the
staple forms. In FIG. 122, the staple 4374 is used with an adjunct
with a film 4378, multiple depressions in the film per staple 4386,
and a pair of thicker areas in the adjunct 4380 into which the ends
of the legs of the staple 4374 move when the staple forms, one pair
of thicker areas per staple.
[0670] FIGS. 123A-123E show different embodiments for a plurality
of adjuncts coupled to a surgical stapler anvil. The adjunct array
4388 shown in FIG. 123A includes portions near the anvil edge 4392,
portions near the anvil centerline 4390, and multiple adjunct
segments 4394. The adjunct segments shown include openings 4400 for
staple legs to pass through as they move toward the anvil and
openings 4402 for staple legs to pass through as they move away
from the anvil during staple forming. The adjunct segments 4394
connect to each other and to the portions of the adjunct array near
the anvil edge 4392 and anvil centerline 4390 through branches of
adjunct material 4398. The edge 4392 and centerline 4390 portions
also have branches 4396 to connect to the adjunct segments 4394.
FIG. 123B shows an adjunct assembly 4404 that is similar to that
shown in FIG. 123A. The adjunct array 4404 shown in FIG. 123B
includes portions near the anvil edge 4392, portions near the anvil
centerline 4390, and multiple adjunct segments 4408. The adjunct
segments shown include openings 4412 for staple legs to pass
through as they move toward the anvil and openings 4414 for staple
legs to pass through as they move away from the anvil during staple
forming. The adjunct segments 4408 connect to each other and to the
portions of the adjunct array near the anvil edge 4392 and anvil
centerline 4390 through branches of adjunct material 4406. Unlike
the adjunct array 4388 in FIG. 123A, the adjunct array 4404 has no
connectors between rows of adjunct segments. The adjunct array 4416
of FIG. 123C is similar to that of FIG. 123B, in that there are no
connectors between the rows of adjunct segments, only connectors
4420 between each adjunct segment 4418 and its neighboring segment.
Each segment has openings 4422 for staple legs to pass through as
they move toward the anvil and openings 4424 for staple legs to
pass through as they move away from the anvil during staple
forming. The adjunct array 4426 shown in FIG. 123D includes
portions near the anvil edge 4428, portions near the anvil
centerline 4430, and multiple adjunct segments 4432. The adjunct
segments shown include openings 4438 for staple legs to pass
through as they move toward the anvil and openings 4440 for staple
legs to pass through as they move away from the anvil during staple
forming. The adjunct segments 4432 connect to each other and to the
portions of the adjunct array near the anvil edge 4428 and anvil
centerline 4430 through branches of adjunct material 4434, 4436.
The adjunct array 4442 shown in FIG. 123E is different from that
shown in FIG. 123D and includes portions near the anvil edge 4444,
portions near the anvil centerline 4446, and multiple adjunct
segments 4452. The adjunct segments shown include openings 4458 for
staple legs to pass through as they move toward the anvil and
openings 4456 for staple legs to pass through as they move away
from the anvil during staple forming. The adjunct segments 4452
connect to each other and to the portions of the adjunct array near
the anvil edge 4444 and anvil centerline 4446 through branches of
adjunct material 4448, 4454, 4450.
[0671] FIG. 124 shows a first side 4460 and a second side 4470 of a
plurality of adjuncts 4464 that are connected in a row. The first
side view 4460 show the adjunct segments 4464, their connectors
4462, the openings 4466 in the adjunct segments for when the legs
move towards the stapler anvil during staple forming, and the
openings 4468 in the adjunct segments for when the legs move away
from the stapler anvil during staple forming. The second side view
4470 shows elements of the first side view 4460, but there is
additional material on this side of the adjuncts 4464. Through this
additional material, there are openings 4474 in the adjunct
segments for when the legs move towards the stapler anvil during
staple forming, and the openings 4472 in the adjunct segments for
when the legs move away from the stapler anvil during staple
forming.
[0672] FIGS. 125-129 show embodiments of adjuncts segments that
overlap and interlock to some degree when in use with surgical
staples. The configurations shown can be used to accommodate for
movement in the tissue, such as expansion on contraction after
stapling. In FIG. 125, there are two configurations of adjunct
segments, 4512, 4514. The adjunct segments shown 4512, 4514 are
minor images of each other. Each adjunct segment spans two staples.
For example, as in FIG. 127, each adjunct segment is shown with two
staple crowns in contact with each segment. However, it should be
noted that in the configuration shown in FIGS. 126 and 127 each
staple, aside from the staples at the end of the row, contacts two
overlapping adjunct segments. In FIG. 126, the two adjunct segments
4512 and 4514 are seen in an extended configuration 4526 and in a
compact configuration 4528. Openings are shown in the adjunct
segments through which staple legs pass as staples are formed by
moving from the staple cartridge toward the anvil in a surgical
stapler. As can be seen, when the adjunct 4512, 4514 are overlaid,
some of the openings overlap and align to allow a staple leg to
pass through. Opening 4516 aligns with opening 4522, and opening
4520 aligns with opening 4518 at the bottoms of the adjunct
segments. Opening 4518 is shown as not aligning with any other
opening, but opening 4518 may align with opening 4525 of another
adjunct segment that is similar to 4512. Similarly, opening 4524 is
not shown aligning with any other opening, but it may align with
opening 4516 of another adjunct segment that is similar to 4512.
FIG. 126 shows that in an extended configuration 4526, adjacent
openings on the top portions of the adjunct segments, 4525 and
4524, are further apart than in a compact configuration 4528. FIG.
128 shows the relative position of two adjacent adjunct segments
that are similarly oriented 4514. In an extended configuration 4526
there is a gap or space between the adjunct segments 4514. In a
compact configuration 4528 the adjacent adjunct segments 4514 are
very close, in some instance touching, and in some instances
slightly overlapping. FIG. 129 shows a compact configuration 4528
in which only half of the adjunct segments are visible, such as
when the adjunct segments are opaque and only the topmost adjunct
segments are visible.
[0673] FIGS. 130A-130C show embodiments of adjunct segments that
connect adjacent surgical staples. FIG. 130A shows rows 4530 of
surgical staples 4532 that are connected the next staple in the row
via an adjunct segment 4534. The adjunct segments 4534 are shown as
being in or on a supporting layer or film 4536. Such
configurations, adjunct segments with supporting layers or films,
are described in greater detail herein elsewhere. The adjunct
segments 4534 shown in FIG. 130A are located near the anvil-side of
the staples once the staples are deployed in tissue. FIG. 130B
shows row 4540 of surgical staples 4542 in use with adjunct
segments 4544 and a supporting film 4546. As in FIG. 130A, the
adjunct segments 4544 are located near anvil-side of the staples
4542. However the adjunct segments 4544 of FIG. 130B are shaped
differently from those in FIG. 130A, in that the openings for
accepting staple legs are larger in FIG. 130B. This increased size
can allow for slight contraction or expansion of the tissue and the
corresponding motion of the staples. FIG. 130C shows another
embodiment in which rows 4550 of surgical staples 4552 with adjunct
segments 4554 and a support film 4556 are used together. The
adjunct segments 4554 in FIG. 130C are different from those in
FIGS. 130A and 130B because the adjunct segments 4554 are rings,
allowing the maximum amounts of motion of the staple legs within
the center 4558 of the adjunct segments 4554. This allows even
greater motion of the each surgical staple with regards to its
neighbor, and thus the stapled tissue can accommodate greater
expansion and contraction.
[0674] FIGS. 131 and 132 show the adjunct segments 4534 and
surgical staples 4532 of FIG. 80A. In FIG. 131, an artery 4560 has
staples 4532 and adjunct segments 4543 seal a portion of the artery
4562. FIG. 132 shows the artery 4560, staples 4532, and adjuncts
4534. In both FIGS. 131 and 132, each staple 4532 is shown
connected to its neighbor through opposite ends of an adjunct
segment.
[0675] FIGS. 133-135 are similar to FIG. 131, except that each
shows a different type or use of an adjunct segment. In FIG. 133,
an artery or other type of tissue 4560 is sealed by two rows 4570
of staples 4572. The row of surgical staples 4572 at the free edge
of the tissue 4562 has thick adjunct segments 4574. The row of
surgical staples 4572 further away from the free edge of the tissue
4562 has thinner adjunct segments 4576. The adjunct segments 4574,
4576 connect each surgical staple 4572 to at least one neighboring
staple. Also, the adjunct segments 4574, 4576 are near the crowns
of the staples 4579 when the staples are deployed, as shown. Using
different thickness adjunct segments 4574, 4576 can help to prevent
tissue damage and can help to promote healing of the tissue 4560
after the stapling procedure. The embodiment of rows of staples
4580 shown in FIG. 134 is similar to that shown in FIG. 133, except
that the adjunct segments 4584, 4586 are positioned near the
anvil-side portions 4588 of the surgical staples 4582. The
thickness of the adjunct segments 4584, 4586 are different, in that
those adjunct segments nearest the free edge 4562 of the tissue are
thicker adjunct segments 4584 and those away from are thinner 4586.
FIG. 135 shows an embodiment of rows 4590 of surgical staples 4592
where thicker adjuncts 4594, 4595 are used closer to the free edge
4562 of the tissue 4560 and thinner adjuncts are used away from the
free edge 4562 of the tissue 4560 to attach each staple 4592 to a
neighboring staple along the length of the rows 4590. In the
embodiment shown in FIG. 135, adjuncts 4594, 4595, 4596, 4597 are
located near the crowns 4599 of the staples 4592, as well as near
the anvil-side portions 4598 of the staples 4592.
[0676] Staple lines that include a plurality of surgical staples
and adjunct segments that connect two surgical staples together can
exhibit a myriad of configurations that correspond to a range of
contraction or expansion of the underlying tissue. FIGS. 136-139
show exemplary configurations adjunct segments and surgical staples
in which each staple connects two adjunct segments. FIG. 136 shows
a staple cartridge 4600 with adjunct segments 4604 that contact two
staples 4602 when forming a staple line. The staple line includes
two rows of staples that are applied parallel to the surgical cut,
with the first row adjacent to a surgical cut and the second row
further away from the surgical cut. The staples in the first row
are offset from the second row. Each adjunct segment 4604 connects
a staple from the first row with a staple from the second row.
Because of the offset, the adjunct segments 4606 are applied in a
position that is tilted when compared to a line perpendicular to
the surgical cut, and in a relaxed state, as shown, the adjunct
segments 4616 are as close together as they can be, touching or
nearly touching. FIG. 139 shows the progression of the
configuration changes from a tensioned state 4620 to a fully
relaxed state 4630. In an extremely tensioned state 4620, the
adjunct segments 4616 are at an angle in the range of about
0.degree. to 90.degree. in a position that so that the adjunct
segments 4616 are further away from each other than in the relaxed
state 4630. In the intermediate state 4625 shown in FIG. 139, the
adjunct segments 4616 are perpendicular to the surgical cut. The
relaxed state 4630 is similar to that shown in FIG. 136.
[0677] FIG. 137 shows another configuration of adjunct segments
4608 and surgical staples 4606 in which the staples are applied
along a surgical cut at an angle. In a relaxed state 4610, such as
when first applied to tissue, the staples 4606 are between about
0.degree. and 90.degree. to the cut, such as at about 45.degree. to
the cut, and the adjunct segments 4608 are perpendicular to the
cut. When the tissue stretches, the staples 4606 are at a different
angle, such as about 30.degree. from the cut. The adjunct segments
4608 move from a position substantially perpendicular to the
surgical cut to one that is no longer perpendicular. FIG. 138A
shows a side view of the relaxed configuration 4610, and FIG. 138B
shows a side view of the tensioned configuration 4612 of staples
4606 and adjunct segments 4608.
[0678] FIGS. 140A-140B show an embodiment 4640 of surgical staples
and adjunct segments 4652 connected by a serpentine connector 4646
on an optional support layer 4642. The support layer 4642 can also
include adjunct segments 4644 that are not connected. The
serpentine connector 4646 is connected to the adjunct segments 4652
at connection points 4648. The support and adjunct segments 4652
shown include openings for staple legs.
[0679] As shown in other figures described above, adjunct segments
can have many configurations. FIGS. 141A-145D show four different
configurations. FIGS. 141A-141D show an adjunct segment 4690 that
is symmetric, such that the top view and the bottom view are
similar. The adjunct segment 4690 includes openings 4692 for staple
legs. FIG. 141A is a cross-sectional view of the adjunct segment
4690, FIG. 141B is an end view of the adjunct segment, FIG. 141C is
a bottom view of the adjunct segment 4690, and FIG. 141D is a top
perspective view of the adjunct segment 4690. FIGS. 142A-142D show
an adjunct segment 4700 which includes a thicker portion 4704 in
the center of the adjunct segment, between the openings 4702 for
staple legs.
[0680] FIG. 143 shows an embodiment of a delivery configuration
assembly 4710 for adjunct segments 4712. The adjunct segments 4712
can be made as individual components, not connected by branches or
filaments, adhered to a compliant or removable backing 4714. The
arrangement of the adjunct segments 4712 on the backing 4714 can be
such that mating the delivery configuration assembly 4710 with a
surgical stapler anvil or staple cartridge allows for perfect or
near perfect alignment of the adjunct segments 4712 with the
stapler features.
[0681] FIGS. 144A-144D show an embodiment for an adjunct segment
4715 that has a base portion 4717 and thicker portions 4716 with
openings 4718. The openings 4718 go through the thicker portions
4716 as well as the base portion 4717. The thicker portions 4716
may be a different material than the base portion 4717 or the
thicker and base portions may be of the same or similar materials.
The thicker portions 4716 may prevent tissue damage from staple
legs when the tissue expands or contracts. FIGS. 145A-145D show an
adjunct segment 4720 that has a base portion 4722 with openings
4726 for staple legs and portions around the openings 4724. The
openings portions around the openings 4724 may be of a different
material than the base portion 4722, or they base 4722 and the
portions surrounding the openings 4726 may be of the same material,
but, because of their configuration, have different materials
properties, such as they may act as cushions between the adjunct
segment 4720 and a surgical staple or tissue.
Application of Adjunct Materials
[0682] Sealant materials can be applied to tissue that is treated
with surgical staples directly, prior to or after being treated
with a surgical stapler and endocutter as a film or a liquid as an
alternative to being applied as an adjunct segment.
[0683] FIGS. 146-149C show an applicator for applying liquid or gel
adjunct material 4899 directly to an anvil or a staple cartridge of
a surgical stapler 4891. FIG. 146 shows an embodiment 4890 in which
an adjunct material 4899 is applied from a tube 4896, through an
applicator 4897 attached to the tube 4896. The adjunct material
4899 is shown on the anvil 4892. FIG. 147 shows a cross-sectional
view of an applicator 4897 with gel adjunct material 4894 in
contact with the anvil 4892 to fill staple forming openings 4893.
FIG. 148 shows a view of an applicator 4897 with a squeegee feature
4898 to apply adjunct material 4894 to an anvil 4892 to fill staple
forming openings 4893 with adjunct material. FIG. 149A shows an
applicator 4909 for applying adjunct material 4906 from a reservoir
4908 to an anvil 4904 of a surgical stapler 4900. FIG. 149B shows
an alternate type of applicator 4920 for applying adjunct material
4922 to an anvil 4914 of a surgical stapler 4910. The applied
adjunct material 4922 is smoothed by the applicator 4920 into the
staple forming openings 4916 to form adjuncts 4918. FIG. 149C shows
the adjuncts 4918 in the staple forming openings 4916 in the anvil
4914.
[0684] FIGS. 150-154 show an applicator for applying an adjunct
material directly to an anvil of a surgical stapler, in which the
material is composed of two precursors or two materials which mix
prior to application to the anvil or staple cartridge. FIG. 150
shows an embodiment 4930 of an applicator 4942 for an adjunct
material from two materials 4936, 4940. The applicator 4942
includes a dual syringe set 4932 and a mixing nozzle 4944. The dual
syringe set 4932 includes individual syringes 4934, 4938 that
interface with the applicator nozzle 4946 through fittings, such as
Luer fittings or threaded fittings. The individual syringes are
shown as syringe A 4934, that can contain a first material 4936,
such as fibrin; and syringe B 4938, that can contain a second
material 4940, such as thrombin. A single plunger expels the first
and second materials into the mixing nozzle 4994 before the adjunct
material exits through the applicator nozzle 4946. FIG. 151 is a
similar embodiment, but the diameters of the syringes 4952, 4954 in
the syringe set 4950 are different, so that upon application of the
plunger, a ratio of materials other than 1:1 exits the syringes and
mixes in a common lumen, the mixing nozzle 4958, before exiting
through the applicator nozzle 4959.
[0685] FIGS. 152A and 152B show the interface between a syringe or
other container 4960 filled with an adjunct material 4962 and a
portion of a mixing or applicator nozzle 4963. The interface
includes a fitting between a threaded portion 4966 of the container
4960 of adjunct material 4962 and a threaded portion 4965 of the
nozzle 4963. The container 4960 of adjunct material 4962 can
include a seal 4961 that keeps the adjunct material 4962 within the
container 4960 during shipping and storage. The nozzle 4963
includes a piercing feature 4964 to break the seal 4961 when the
threaded portions 4965 and 4966 are fully engaged. When the
threaded portions 4965 and 4966 are fully engaged the adjunct
material 4962 flows from the container 4960 into the nozzle 4963.
FIGS. 153 and 154 show a dual syringe set 4932 attached to a mixing
nozzle 4944 and applicator nozzle 4946, as in FIG. 150, in use
applying adjunct material 4969 to an anvil 4968 of a surgical
stapler 4967.
[0686] FIGS. 155-160 show fittings and which can apply liquid or
gel to a portion of a surgical stapler, either to the anvil or the
staple cartridge and the resulting adjunct layer. In FIG. 155 and
FIG. 156, the applicator nozzle 4977 is shown fitted over an anvil
4976. In FIG. 155, the adjunct material 4978 is a single adjunct
material, that is to say that it is not a material that needed to
be mixed immediately prior to application. The adjunct material
4979 shown in FIG. 156 includes two precursors or components that
are mixed immediately prior to application of the adjunct material
to the anvil. FIG. 157 shows an anvil 4980 with staple forming
openings 4981 filled with adjunct material 4982 that was applied
with a nozzle applicator, such as shown in FIG. 155 and FIG.
156.
[0687] Adjunct material can be applied to staple cartridges used
with surgical staplers. FIG. 158 shows an applicator nozzle 4984
coupled to a staple cartridge 4983 to apply adjunct 4985 to staples
4986 loaded in the cartridge. FIG. 159 also shows an applicator
nozzle 4988 fitted to a staple cartridge 4983. In FIG. 159, the
adjunct material 4987 flowing over the staple 4986 is made of two
constituents or components which are mixed immediately prior to
application of the adjunct material to the cartridge. FIG. 160
provides a view of applied adjunct material 4989 on staples 4986
loaded in a stapler cartridge 4983.
[0688] FIG. 161 shows a surgical staple 4992 improperly situated
inside of tissue 4991. Such a configuration 4990 can occur when no
adjunct material is present to distribute forces from the staple on
the tissue and prevent the staple from cutting through tissue or
inappropriately compressing the tissue. FIG. 163 shows how the
presence of adjunct material 4998 on the anvil-side of a staple
4997 can allow proper placement of the staple 4997 in tissue
4996.
[0689] FIG. 162 shows a stick of gel adjunct material 4994 that is
applied to the anvil 4995 or staple cartridge of a surgical stapler
4993. This is an alternate embodiment for a method for applying,
and an applicator of, adjunct material. In this way, a surgical
stapler can be reloaded and prepared quickly, such as when a
surgeon needs to use a single surgical stapler multiple times in a
single procedure.
[0690] FIGS. 164A-164C show surgical staples 41010 used with
adjuncts 41012 used with a surgical stapler 41000 to transect
tissue 41002. In the surgical stapler 41000, the anvil 41004 can be
loaded with adjunct segments 41012 which interact with the staples
41010 loaded in the staple cartridge 41006. The adjuncts 41012 in
the anvil 41004 can hold staples 41010 that are not applied to
tissue 41002, as shown in FIG. 164C.
Adjuncts for Anastomosis
[0691] Anastomosis is a process which requires creating a circular
cut through a staple line in each end of the tissues to be
connected. Cutting through a staple line can cause torn or
partially cut staples. Dog ears of tissue at the corners of the
staple line can have leaks or allow debris to collect, however, if
it is not possible to eliminate dog ears altogether, then it
sealing them to minimize leakage is desirable. Described below are
adjunct assemblies for use with specific staple cartridge
configurations that include seals for dog ears, as well as provide
a minimal amount of staples through the area that is eventually cut
by a circular cutting implement.
[0692] FIG. 165 shows an embodiment of a non-continuous adjunct
41020 for use in forming an anastomosis. The non-continuous adjunct
41020 includes a ring 41022, or washer, in the center of the
adjunct. Attached on either side, 180.degree. apart, are suture
filaments 41026. The suture filaments connect to sealing material
41024. Each portion of sealing material 41024 is configured to seal
a dog ear portion of the staple line by. The sealing material 41024
is configured to span multiple staples and once inserted into
tissue, the staple can have the sealing material 41024 adjacent to
the crown of the staple or adjacent to the anvil-side of the
staple. In some embodiments, the sealing material 41024 is
configured to be adjacent to the crown of staples deployed in
tissue. Such sealing material can be complemented with sealing
material, such as adjunct segments, on the anvil-side of the
staple.
[0693] FIGS. 166 and 167 show a surgical staple cartridge 41028 and
a staple pattern for use with the adjunct of FIG. 165. The staple
pattern on the cartridge 41028 is shown to have areas of two or
more rows of staples 41030 and areas with a single row of staples
41031. The single row of staples 41031 is intended to, or
configured to, correspond to the portion of the tissue that will be
cut through in forming a circular cut. The suture filament 41026 of
the non-continuous adjunct 41020 is delivered parallel to this
single row of staples 41030. The areas of two or more rows of
staples 41030 correspond to where the dog ears in the tissue will
be. The sealing material 41024 of the non-continuous adjunct 41020
is configured to be used with the two or more rows of staples
41030, as shown in FIG. 166.
[0694] In the staple cartridge 41028 shown in FIG. 166 and the
staple pattern shown in FIG. 167, it can be seen that the single
row of staples 41031 is centered with respect to the multiple rows
of staples 41030 in the dog ear area. The suture filament 41026 of
the non-continuous adjunct 41020 will not only be substantially
parallel to the single row of staples 41031, but the suture
filament 41026 will almost overlay the single row of staple 41031
once the adjunct 41020 is deployed with surgical staples into
tissue. More than one non-continuous adjunct 41020 can be deployed
at a time, and is shown in FIG. 166, in such situations, the
non-continuous adjuncts 41020 can be substantially similar.
[0695] FIG. 168 is an illustration of an alternative embodiment of
a non-continuous adjunct for use in forming an anastomosis. Shown
are two non-continuous adjuncts 41040, 41050 that are minor images
of each other. The non-continuous adjuncts 41040, 41050 each have a
washer 41046, 41056, attached to suture filaments 41044, 41054. The
suture filaments 41044, 41054 are attached to sealing material
41042, 41052 that is configured to span multiple surgical staples
in the dog ear area of the stapled tissue.
[0696] FIGS. 169-173 show a surgical stapler cartridge 41060 for
use with the adjuncts of FIG. 168, as well as further views of the
non-continuous adjuncts 41040, 41050 of FIG. 168. The stapler
cartridge 41060 is symmetric about a centerline, where a cut
through stapled tissue can be made. The cartridge 41060 has areas
for a single row of staples 41064 and for multiple rows of staples
41062 on each half of the cartridge. The multiple rows of staples
41062 are at the ends of the staple line and are where the dog ear
portion of the tissue will be. The single rows of staples 41064 are
off-center with respect to the multiple rows of staples 41062, such
that the single rows of staples 41064 are located towards the edges
of the cartridge 41060. When the non-continuous adjuncts 41040,
41050 are overlaid onto the cartridge, the sealing material 41042,
41052 corresponds to the areas on the cartridge 41060 with multiple
rows of staples 41062, the washers 41046, 41056 are each in the
center of a single row of staples 41064, each on one half of the
cartridge 41060. The suture filaments 41046, 41056 are
substantially parallel to the single rows of staples 41064, but do
not overlay them. FIG. 171 shows the relative positioning of the
non-continuous adjuncts 41040, 41050 and staples, showing the
unsealed staples 41066 of the single rows of staples. These
unsealed staples 41066 can be cut through or removed when an
anastomosis is formed. FIG. 172 shows the view of FIG. 171 overlaid
on the view of FIG. 170. FIG. 173 includes depressions in the
staple cartridge 41060 underneath the washers 41046, 41056.
[0697] FIG. 174 shows an embodiment of an adjunct washer 41066
before and during actuation of a surgical stapler. The washer 41066
can be one similar to any of the previously discussed washers,
41022, 41046, 41056. The washer 41066 is shown in a recess in a
stapler cartridge 41064. Suture filaments 41068 connect to the
washer 41066. When the adjunct is placed in the surgical stapler,
before staple deployment, the washer 41066 is substantially
circular in cross-section. During staple deployment, the washer
41066 compresses under pressure 41070 from the surgical stapler.
The washer 41066 then has a substantially elliptical cross-section.
Under pressure, the washer 41066 becomes flush, or nearly flush,
with an upper portion of the staple cartridge while filling, or
nearly filling, the recess.
[0698] FIG. 175 shows an embodiment of a surgical staple cartridge
for use in forming an anastomosis. This side view allows a
comparison for the tips of a standard staple cartridge 41072 and
that of a LAR 41074. A person skilled in the art will appreciate
that it could be useful in LAR procedures to reduce the length of
the end effector distal to an articulation joint in the stapler. It
is believed that reducing the distance from a distal most staple in
the cartridge to the distal most location on the staple cartridge
will enable this effort as shown in FIG. 175. A person skilled in
the art will be able to ascertain the appropriate relative
distances.
[0699] FIG. 176 shows a body lumen transected by a surgical stapler
with an adjunct, such as the one shown in 118. The tissue 41076 is
shown with non-continuous adjuncts 41040, 41050 in place. The
washers 41046, 41056 align, and alongside each washer 41046, 41056
and the suture filaments 41044, 41054 connected to each washer is a
single row of staples 41066 that is not sealed by adjunct material.
Sealing material 41042, 41052 prevents leaks in the dog ear
portions of tissue with multiple rows of staples.
[0700] FIGS. 177A-177C shows a cross-sectional view of the use of
an adjunct 41050, such as the one shown in FIG. 168 and a circular
stapler trocar 41078. FIG. 177A shows the non-continuous adjunct in
tissue 41076 with the washer 41056 above a staple line that
includes the unsealed, single row of staples 41066. FIG. 177B shows
the trocar 41076 approaching the staple line 41066 and washer 41056
as it moves through a lumen in the tissue 41076. FIG. 177C shows
the engagement of the trocar 41078 with the washer 41066. FIG. 178
shows the relative positioning of all of the components of the
adjunct 41505 when the trocar 41078 is engaged with the washer
41056.
[0701] FIGS. 178-186 shows a circular stapler trocar 41078 passing
through a washer portion of a non-continuous adjunct 41050. FIG.
179 shows the non-continuous adjunct 41050 with a washer 41056,
suture filaments 41054, and sealing material 41052 at the dog ears
of the tissue 41076. A circular staple and cutting implement 41080
is inside the tissue 41076. A trocar 41078 is at the center of the
staple and cutting implement 41080. The trocar 41078 extends
through the washer 41056 toward a shaft 41084 that is connected to
an anvil 41082 in another portion of the tissue 41076 that has been
cut and sealed along a staple line 41088. The anvil 41082 is shown
above a buttonhole that is adjacent the shaft 41084.
[0702] FIG. 180 shows an embodiment similar to that shown in FIG.
179. In FIG. 180 the non-continuous adjuncts 41040, 41050 are shown
each with a washer 41046, 41056, suture filaments 41044, 41054, and
sealing material 41042, 41052 at the dog ears of the tissue 41076.
A single row of staples 41066 surrounds each of the washers 41046,
41056 near the suture filaments. A circular staple and cutting
implement is inside the tissue 41076, and the trocar 41078 extends
through one washer 41056 towards a mating shaft that extends
through the other washer 41046.
[0703] FIGS. 181-183 show cross-sectional views of the movement of
the sections of tissue 41076 toward each other, so that the tissue
can be stapled (FIG. 185) and cut FIG. 186 to create an
anastomosis. FIG. 181 is a cross-sectional view of FIG. 179, but
with the shaft 41084 attached to the anvil 41082 fitted over the
trocar 41078 and in contact with the washer 41056. FIG. 182 is a
closer view of the shaft 41084 connected to the anvil and the
center portion of the adjunct 41050, particularly the washer 41056
and suture filaments 41054. As the shaft 41084 moves down, so that
the two portions of the tissue 41076 move together, the shaft 41084
moves the suture filaments 41054 downward so that the sealing
material 41052 on the dog ears move closer together, as shown in
FIG. 183. FIG. 184 shows the movement of the sealing material 41052
on the dog ears toward the trocar 41078 as the shaft moves the
washer 41056 downward. FIG. 185 shows the tissue sections attached
with staples 41100. The adjunct 41050, with the washer 41056 pushed
down by the shaft and the sealing material 41052 at the dog ear
portion, are shown in the center of the stapling and cutting
implement 41080. FIG. 186 shows the tissue 41076 after the circular
cut has been made. The tissue is joined with three rows of staples
41100 in a circular configuration with the previously stapled
tissue, including the non-continuous adjunct 41050, removed. The
adjuncts 41033, 41040, 41040 described above can be used
interchangeably or in combination in the methods for creating an
anastomosis shown in FIG. 176-186.
[0704] Various exemplary bronchus sealants and methods of sealing
bronchial tubes are provided. In general, the bronchus sealants and
methods of sealing bronchial tubes can facilitate sealing of
stapled bronchial tubes. In some embodiments, a reinforcement
material, e.g., a mesh (e.g., a knitted mesh, a non-woven mesh, or
a woven mesh), a non-woven matrix, a film, a melt-blown non-woven
material, a felt material, a closed-cell foam, an open-cell foam, a
braided suture, or a sponge, can be introduced into a bronchial
tube, and then the bronchial tube and the reinforcement material
can be stapled using a surgical stapler. A sealant can be
introduced into the bronchial tube and can harden therein, thereby
helping to seal the bronchial tube where the bronchial tube was
stapled. Prior to hardening, the sealant can seep or wick in a
first state into the staple line, thereby facilitating complete
sealing of the bronchial tube. The reinforcement material and the
sealant can cooperate to provide a better, more complete seal of
the staple line than if either of the reinforcement material and
the sealant were used without the other. The reinforcement material
at the staple line can cause inflammation of the bronchial tube,
thereby causing the bronchial tube to encapsulate the reinforcement
material as an irritant. Such encapsulation can facilitate long
term sealing of the bronchial tube. The reinforcement material can
thus take advantage of the bronchial tube's natural inflammatory
response, and natural slow healing of the bronchial tube, to help
seal the stapled bronchial tube. The sealant can facilitate short
term sealing of the bronchial tube during the time the bronchial
tube reacts to and encapsulates the reinforcement material, e.g.,
for a time period of up to about two weeks. The reinforcement
material that has been stapled can extend from the staple line into
the bronchial tubes passageway, thereby providing the sealant with
a structure within the bronchial tube to help hold the sealant in
position adjacent the applied staples while the sealant hardens
within the bronchial tube and to help hold the sealant in position
adjacent the applied staples after the sealant has hardened. By
being held adjacent to the staple line by the reinforcement
material, the sealant can be more likely to harden at and
completely seal the staple line. The bronchial tube can thus be
more likely to remain sealed during expansion and contraction of
the lung during breathing.
[0705] The sealant can be introduced into the bronchial tube before
the stapling of the bronchial tube and the reinforcement material,
such as by the reinforcement material being imbibed with the
sealant in a first state, e.g., as a softened state such as fluid,
a gel, etc., or as a dry state, e.g., as a powder, etc. The
reinforcement material being coupled to the sealant before stapling
can facilitate delivery of the reinforcement material and the
sealant into the bronchial tube by allowing the reinforcement
material and the sealant to be simultaneously delivered thereto.
Alternatively or in addition, the sealant can be introduced into
the bronchial tube after the stapling of the bronchial tube and the
reinforcement material, such as by injection of the sealant in a
first state into the bronchial tube adjacent a staple line formed
by the stapling. The sealant being delivered into the bronchial
tube subsequent to the stapling can help prevent the sealant from
hardening within the bronchial tube before the bronchial tube is
stapled. If the sealant is delivered into the bronchial tube
subsequent to the stapling, the same surgical instrument that
delivered the reinforcement material into the bronchial tube can
deliver the sealant, thereby making the surgical procedure easier
to perform since only one delivery device need be introduced into
the bronchial tube.
[0706] FIG. 187 illustrates one embodiment of a surgical instrument
5000 configured to deliver a reinforcement material (not shown) and
a sealant (not shown) into a bronchial tube 5002 of lungs 5004 of a
patient 5006. The instrument 5000 can include a proximal handle
portion (not shown) configured to be held, e.g., handheld by a
medical practitioner, held by a robotic surgical arm, etc., outside
the patient 5006, as will be appreciated by a person skilled in the
art. The instrument 5000 can be configured to be transorally
advanced into the bronchial tube 5002, as shown in FIG. 187, by
being advanced into a mouth 5008 of the patient 5006. The
instrument 5000 can be advanced into the patient 5006 in other
ways, as will be appreciated by a person skilled in the art. For
example, the instrument 500 can be configured to be advanced into a
patient through an introducer device, such as a trocar, inserted
into the patient through an incision formed through skin of the
patient.
[0707] As shown in FIG. 188, the instrument 5000 can include a
scoping device 5010, e.g., an endoscope, a laparoscope, etc., and
an end cap 5012 configured to be coupled to a distal end 5014 of
the scoping device 5010. The scoping device 5010 in this
illustrated embodiment has one working channel 5016 extending
longitudinally therethrough, includes one visualization element
5058, e.g., a lens, etc., and includes two lights 5018, e.g., light
emitting diodes (LEDs), etc. The lights 5018 and the viewing
element 5058 can be distal-facing, as in the illustrated
embodiment, which can facilitate visualization of a target surgical
site distal to the instrument 5000. In other embodiments, a scoping
device can have a plurality of working channels extending
longitudinally therethrough and/or can have a different number of
lights.
[0708] The end cap 5012 can be configured to be selectively
attachable to the scoping device's distal end 5014, such as by
being snap fit thereon, by being fit thereto via interference fit
(as in the illustrated embodiment), by being threaded thereto, etc.
In other words, the end cap 5012 can be configured to be removably
and replaceably attachable to the scoping device 5010. The end cap
5012 being configured to be selectively attachable to the scoping
device 5010 can allow the end cap to be disposable, can facilitate
cleaning of the scoping device 5010 and/or the end cap 5012 before
reuse with another patient, and/or can help prevent the scoping
device 5010 from being damaged by sealant delivered using the
instrument 5000. Exemplary embodiments of attachment techniques for
attaching an end cap to a scoping device are described in further
detailed in U.S. Pat. No. 8,551,058 entitled "Endoscopic
Translumenal Surgical Systems" filed on Jul. 10, 2007, which is
hereby incorporated by reference in its entirety.
[0709] The end cap 5012 can include a working port 5020, a window
5022, and a balloon 5024 around a perimeter thereof. The working
port 5020 can be configured to be aligned with the scoping device's
working channel 5016 when the end cap 5012 is attached to the
scoping device 5010, which can allow a surgical device (not shown)
to be advanced distally through the scoping device's working
channel 5016 and through the end cap's working port 5020. The
window 5022 can be configured to be aligned with the scoping
device's lights 5018 when the end cap 5012 is attached to the
scoping device 5010, thereby allowing the lights 5018 to shine
through the window 5022 so as to illuminate a target surgical site
distal to the instrument 5000.
[0710] The balloon 5024 can be configured to be selectively
inflatable when the end cap 5012 is attached to the scoping device
5010. The balloon 5024 can be configured to move between an
uninflated configuration, shown in FIG. 188 with the balloon 5024
in solid line 5026, and an inflated configuration, shown in FIG.
188 with the balloon 5024 in broken line 5028. When the balloon
5024 is in the uninflated configuration, the end cap 5012 can have
a first diameter that is less than a second diameter of the end cap
5012 when the balloon 5024 is in the inflated configuration. The
balloon 5024 can be configured to be selectively inflated and
deflated in a variety of ways. As in this illustrated embodiment,
the end cap 5012 can include an inflation line 5030 extending
distally therefrom. The balloon 5024 can be in fluid communication
with the inflation line 5030. The inflation line 5030 can be
configured to extend through the working channel 5016 of the
scoping device 5010 and couple to an inflation source (not shown)
at a proximal end of the scoping device 5010, as will be
appreciated by a person skilled in the art. In some embodiments,
the inflation line 5030 can extend through the working channel 5016
of the scoping device 5010 and be configured to be attached to the
end cap 5012 when the end cap 5012 is attached to the distal end
5014 of the scoping device 5010.
[0711] The end cap 5012 can include a cleaning mechanism (not
shown) configured to clean a distal end of the instrument 5000,
e.g., a distal end of the scoping device 5010 and/or a distal end
of the end cap 5012, when the end cap 5012 is attached to the
scoping device's distal end. The cleaning mechanism can allow for
the instrument 5000 to be cleaned within a patient's body such that
the instrument 5000 need not be removed for cleaning should the
viewing element 5058, the lights 5018, and/or other feature become
obscured, clogged, etc. during use due to fluid and/or other
matter. Exemplary embodiments of cleaning mechanisms are described
in further detailed in U.S. Pat. Pub. No. 2009/0270686 entitled
"Methods And Devices For Maintaining Visibility During Surgical
Procedures" filed on Apr. 29, 2008, and U.S. Pat. Pub. No.
2009/0234193 entitled "Apparatus For Keeping Clean A Distal Scope
End Of A Medical Viewing Scope" filed on Mar. 13, 2008, which are
hereby incorporated by reference in their entireties.
[0712] FIGS. 189-192 illustrate an exemplary embodiment of a
surgical procedure for stapling and sealing the bronchial tube 5002
using the instrument 5000. Although the procedure is illustrated
with respect to the surgical instrument 5000 of FIGS. 187 and 188,
any of the surgical instruments discussed herein can be similarly
used. Similarly, although the procedure is illustrated with respect
to the bronchial tube 5002 of FIG. 187, another tubular anatomical
structure, e.g., a blood vessel, etc., can be similarly treated.
Also, although the procedure is illustrated with respect to
stapling, a bronchial tube (or other anatomical structure) can be
sealed as discussed herein in conjunction with a type of fastener
other than staples, e.g., clips, sutures, energy, etc.
[0713] As shown in FIG. 189, the bronchial tube 5002 can include a
tumor 5032. As will be appreciated by a person skilled in the art,
treatment of the tumor 5032 can include removing a portion of the
bronchial tube 5002 that includes the tumor 5032 and leaving
another portion of the bronchial tube 5002 within the patient
5006.
[0714] As also shown in FIG. 189, a reinforcement material 5034 can
be introduced into the bronchial tube 5002. The reinforcement
material 5034 can include a flexible material configured to be
stapled or otherwise fastened, e.g., using clips, etc., within the
bronchial tube 5002. Examples of the reinforcement material 5034
include a mesh (e.g., a knitted mesh, a non-woven mesh, or a woven
mesh), a non-woven matrix, a composite matrix including a non-woven
polymer (e.g., polyglactin 910) and a knitted or woven backing
material (e.g., oxidized cellulose), a film, a melt-blown non-woven
material, a felt material, a closed-cell foam, an open-cell foam, a
sponge, a braided suture, and oxidized cellulose (e.g., oxidized
regenerated cellulose (ORC)). Various embodiments of multilayered
dressings that can be used as the reinforcement material 5034 are
described in U.S. Pat. Pub. No. 2006/0257458 entitled "Reinforced
Absorbable Multilayered Hemostatis Wound Dressing" filed on Apr.
10, 2006, which is hereby incorporated by reference in its
entirety. The reinforcement material 5034 can be absorbable or
non-absorbable. The reinforcement material 5034 in this illustrated
embodiment includes a mesh. The mesh can be formed from any one or
more materials. In general, material suitable for implantation,
such as material for a surgical suture, can be suitable for the
mesh. Examples of absorbable materials that can be used, alone or
in any combination thereof, to form the mesh include poliglecaprone
(e.g., Monocryl.RTM. available from Ethicon, Inc. of Somerville,
N.J.), polyglactin (e.g., polyglactin 910, such as Vicryl.RTM.
available from Ethicon, Inc. of Somerville, N.J.), polydioxanone,
collagen, oxidized cellulose, glycerol, glycolide, lactide,
dioxanone, trimethylene carbonate, and gut suture. Examples of
non-absorbable materials that can be used, alone or in any
combination thereof, to form the mesh include polypropylene,
polyethylene, polybutester fiber, stainless steel, nylon,
polyester, silk, and polyvinylidene difluoride (PVDF). The
reinforcement material 5034 in this illustrated embodiment has a
rectangular shape, but the reinforcement material 5034 can have any
shape, e.g., ovular, triangular, etc.
[0715] The reinforcement material 5034 can be introduced into the
bronchial tube 5002 by being advanced through the working channel
5016 of the scoping device 5010, as also shown in FIG. 189. The end
cap 5012 is not attached to the scoping device 5010 in FIG. 189. A
grasper 5036 grasping the reinforcement material 5034 can be
advanced through the scoping device's working channel 5016 so as to
hold and pass the reinforcement material 5034 through the working
channel 5016 and out a distal end thereof so as to position the
reinforcement material 5034 within the bronchial tube 5002, as
shown in FIG. 189. The reinforcement material 5034 can be
introduced into the bronchial tube 5002 in another way, as will be
appreciated by a person skilled in the art, such as by being
advanced through a different scoping device, advancing the
reinforcement material 5034 into the bronchial tube 5002 using the
grasper 5036 without a scoping device, etc.
[0716] The reinforcement material 5034 can be positioned at a
target site within the bronchial tube 5002 located on one side of
the tumor 5032. The target site can be an area intended to be
stapled with a surgical stapler 5038. The stapler 5038 can be any
surgical stapler configured to staple a bronchial tube, such as a
linear stapler, as shown in the illustrated embodiment. Exemplary
embodiments of staplers are described in further detail in U.S.
Patent Application entitled "Adjunct Materials and Methods of Using
Same in Surgical Methods for Tissue Sealing" filed on even date
herewith Atty. Dkt. No. 47059-253F01US (END7380USNP)), which is
hereby incorporated by reference in its entirety.
[0717] The stapler 5038 can be located outside the bronchial tube
5002, as shown in FIG. 189. The stapler 5038 and the grasper 5036
can include a location mechanism configured to help position the
stapler 5038 relative to the target site within the bronchial tube
5002 where the reinforcement material 5034 is positioned. The
bronchial tube 5002 is a relatively hard member that can make it
difficult, if not impossible, to locate the grasper 5036 and/or the
reinforcement material 5034 therein by touch. In another, softer
body lumen, such as the intestinal tract, the grasper 5036 and/or
the reinforcement material 5034 could be located by external touch
of the lumen, e.g., by touching the lumen with a finger, by gently
pressing the stapler 5038 against the lumen, etc.
[0718] The location mechanism can have a variety of configurations.
Exemplary embodiments of location mechanisms that can be used to
facilitate positioning of a stapler are described in U.S. Pat. Pub.
No. 2012/0024934 entitled "Transwall Visualization Arrangements And
Methods For Surgical Circular Staplers" filed on Jul. 30, 2010,
which is hereby incorporated by reference in its entirety.
[0719] For example, the location mechanism can include a light
illuminated within the bronchial tube 5002 that can be detectable
from outside the bronchial tube 5002. For example, the lights 5018
of the scoping device 5010 can be configured to be bright enough to
be visually detectable from outside the bronchial tube 5002. For
another example, the location mechanism can include a light (not
shown) illuminated from outside the bronchial tube 5002 that can
allow location of the grasper 5036 and/or the reinforcement
material 5034 within the bronchial tube 5002 to be visually
identified, such as by the stapler 5038 including a light (not
shown) and/or a second scoping device (not shown) located outside
the bronchial tube 5002 including one or more lights similar to the
lights 5018 of the scoping device 5010. For yet another example,
the location mechanism can include one or more magnets, such as
rare earth magnets, located within the bronchial tube 5002, e.g.,
by being attached to the grasper 5036, by being attached to
detection members (e.g., lights, extendable bumpers, etc.) coupled
to the scoping device 5010, etc. A probe (e.g., a Hall effect
sensor, etc.) positioned near the tumor 5032 side of the bronchial
tube 5002 can be configured to measure a distance between the
magnet(s) and the tumor 5032, thereby indicating a location for
stapling of the bronchial tube 5002. The probe can be attached to
the stapler, e.g., to a distal tip of an anvil of the stapler. The
magnet(s) can be configured to alternate in polarity and/or vary in
intensity, which can facilitate the probe's measurement of the
distance by allowing the probe to detect distance and
orientation.
[0720] In this illustrated embodiment, the location mechanism
includes a magnet 5040 coupled to the grasper 5036 and a sensor
(not shown), e.g., a proximity sensor, a Hall effect sensor, etc.,
coupled to the stapler 5038 and configured to sense the magnet 5040
coupled to the grasper 5036 when the sensor is within a certain
predetermined distance of the magnet 5040. In this way, the sensor
being positioned near the magnet 5040 disposed within the bronchial
tube 5002, so as to sense the magnet 5040, can indicate that the
stapler 5038 is adjacent the reinforcement material 5034 within the
bronchial tube 5002. In other words, the detection of the magnet
5040 by the sensor can indicate that the stapler 5038 is at a
position relative to the bronchial tube 5002 at which the stapler
5038 can staple the bronchial tube 5002. The sensor sensing the
magnet 5040 can be configured to trigger a notification at a
proximal end (not shown) of the stapler 5038 when the stapler's
magnet is magnetically attracted to the magnet 5040, which can help
indicate to a user of the stapler 5038 that the stapler 5038 is
positioned adjacent the target site. The notification can include,
e.g., a light, a sound, a vibration, etc. The grasper 5036 includes
one magnet 5040 in this illustrated embodiment, but the grasper
5036 can each include any number of magnets. Although the grasper
5036 includes the magnet 5040 in this illustrated embodiment,
another element, such as the scoping device 5010 (e.g., the distal
end 5014 thereof), the reinforcement material 5034, etc., can
include the magnet 5040 and/or can include one or more additional
magnets. In an exemplary embodiment, the magnet 5040 can be coupled
to an element that is not implanted within the bronchial tube 5002,
e.g., on a surgical device used to deliver the reinforcement
material 5034 and/or a sealant to the bronchial tube 5002, which
can help prevent the location mechanism from interfering with any
subsequent surgical procedures.
[0721] When the stapler 5038 is positioned at a desired location
relative to the bronchial tube 5002, e.g., adjacent the target site
where the reinforcement material 5034 is within the bronchial tube
5002, the stapler 5038 can staple the bronchial tube 5002 and the
reinforcement material 5034 by ejecting one or more staples 5042
therefrom, as shown in FIG. 190. The stapler 5038 in this
illustrated embodiment ejects six staples 5034, but the stapler
5038 can eject any number of staples, simultaneously or
sequentially. The stapler 5038 can also, as will be appreciated by
a person skilled in the art, cut the stapled bronchial tube 5002
using a knife or other cutting element. The cutting of the
bronchial tube 5002 can result in a specimen portion 5044 of the
bronchial tube 5002, which includes the tumor 5032 and which can be
removed from the patient 5006, and a remainder portion 5046 of the
bronchial tube 5002, which can remain within the patient 5006. As
shown in FIG. 191, the stapling and cutting can form first and
second staple lines 5052a, 5052b in the bronchial tube, with the
first staple line 5052a being formed in the specimen portion 5044
and the second staple line 5052b being formed in the remainder
portion 5052b.
[0722] As mentioned above, the stapler 5038 can staple the
reinforcement material 5034 when the stapler 5038 staples the
bronchial tube 5002. The stapler 5038 can thus cut the
reinforcement material 5034 when the stapler 5038 cuts the
bronchial tube 5002. A first portion 5048 of the reinforcement
material 5034 can be in the specimen portion 5044 after being
stapled and cut and can be removed from the patient 5006 with the
specimen portion 5044. A second portion 5050 of the reinforcement
material 5034 can be in the remainder portion 5046 and can remain
in the bronchial tube 5002 after being stapled and cut, as shown in
FIG. 191. The second portion 5050 of the reinforcement material
5034 within the bronchial tube 5002 can extend from the staple line
5052b into the bronchial tube 5002.
[0723] As shown in FIG. 191, a sealant 5054 can be introduced into
the bronchial tube 5002. The sealant 5054 can include a material
configured to transition from a first state to a second state in
which the material is harder than in the first state. The first
state can thus be a softened state or a dry state, and the second
state can be a second, harder state, e.g., hardened as a solid, a
rigid member. The sealant 5054 can be configured to transition from
the first state to the second, harder state in a predetermined
amount of time. As will be appreciated by a person skilled in the
art, the predetermined amount of time can vary based on the
substance(s) forming the sealant 5054. Examples of the sealant 5054
include one or a combination of one or more of an adhesive, fibrin
thrombin, a hydrogel, fibronectin, gelatin, collagen, Factor XIII,
transglutaminase, polyethylene glycol (e.g., Progel.RTM. Pleural
Air Leak Sealant available from Davol Inc. of Providence, R.I.),
alginate, carboxymethylcellulose, methylcellulose,
hydroxypropylmethyl cellulose, pectin, polyvinyl alcohol,
polyvinylpyrrolidone, benzocaine (e.g., Projel-20.TM. available
from Septodont of Lancaster, Pa.), cyanoacrylate, polyglycolic
acid, hyaluronic acid, magnesium peroxide, 2 octyl cyanoacrylate
(e.g., Dermabond.RTM. available from Ethicon, Inc. of Somerville,
N.J.), and hydrogen peroxide. In another embodiment, the sealant
can be blood, such as autologous blood. Exemplary embodiments of
sealants are described in further detail in U.S. Patent Application
entitled "Methods And Devices For Sealing A Body Lumen" filed on
even date herewith (Atty. Dkt. No. 47059-254F01US (END7381USNP)),
which is hereby incorporated by reference in its entirety.
[0724] The sealant 5054 can be introduced into the bronchial tube
5002 by being advanced through the working channel 5016 of the
scoping device 5010, as also shown in FIG. 191. The sealant 5054
can be advanced into the bronchial tube 5002 in the first state, as
also shown in FIG. 191.
[0725] The end cap 5012 can be attached to the scoping device 5010
when the sealant 5054 is delivered into the bronchial tube 5002, as
also shown in FIG. 191. If the end cap 5012 is not already attached
to the scoping device 5010, e.g., when the reinforcement material
5034 is introduced into the bronchial tube 5002, the scoping device
5010 can be removed from the bronchial tube 5002 after delivering
the reinforcement material 5034, and the end cap 5012 can be
attached to the distal end 5014 of the scoping device 5010. The end
cap 5012 being attached to the scoping device 5010 when the sealant
5054 is delivered into the bronchial tube 5002 can help protect the
scoping device 5010 from damage by helping to keep the sealant 5054
from contacting the scoping device 5010 and hardening thereon.
Hardened sealant 5054 on the scoping device 5010 can cause damage
to the scoping device 5010 by, e.g., clogging the working channel
5016 and/or obscuring the lights 5018. If the sealant 5054 contacts
the end cap 5012 and hardens thereon, the end cap 5012 can be
disposed of at typically much lower monetary cost than disposing
the scoping device 5010 and/or the end cap 5012 can be more easily
cleaned than the scoping device 5010 since, e.g., the end cap 5012
is smaller than the endo scope 5010.
[0726] An applicator 5056 can be slidably advanced through the
scoping device's working channel 5016 and deliver the sealant 5054
therethrough. The applicator 5056 can have a variety of
configurations. In this illustrated embodiment, the applicator 5056
includes an elongate tube through which the sealant 5054 can
pass.
[0727] The sealant 5054 can be directed toward the staple line
5052b. The sealant 5054 can thus be directed toward the second
portion 5050 of the reinforcement material 5034 extending from the
staple line 5052b. The applicator 5056 can be advanced through the
scoping device's working channel 5016 and out the end cap's working
port 5020, as shown in FIG. 191, to facilitate directing the
sealant 5054 toward the reinforcement material 5034. The lights
5018 of the scoping device 5010 can be on and can shine through the
end cap's window 5022, as shown in FIG. 191, which can facilitate
visualization of the applicator 5056, the reinforcement material
5034, and/or the sealant 5054 using the viewing element 5058, which
can help the sealant 5054 be directed toward the staple line
5052b.
[0728] The sealant 5054 can be introduced into the bronchial tube
5002 so as to be applied to the reinforcement material 5034 and/or
an interior tissue surface of the bronchial tube 5002. The
reinforcement material 5034 can provide an object within the
bronchial tube 5002 for the sealant 5054 to attach to, thereby
helping to ensure that the sealant 5054 hardens adjacent the staple
line 5052b, thereby helping to seal the staple line 5052b. In an
exemplary embodiment, the sealant 5054 is applied to both the
reinforcement material 5034 and the interior tissue surface of the
bronchial tube 5002, as shown in FIGS. 191 and 192.
[0729] The sealant 5054 can be configured to transition from the
first state in which it is delivered into the bronchial tube 5002,
as shown in FIG. 191, to the second, harder state, as shown in FIG.
192. The sealant 5054 being introduced into the bronchial tube 5002
in the first state can allow the sealant 5054 to seep or wick into
the staple line 5052b and into the reinforcement material 5034,
which can facilitate sealing of the staple line 5052b so as to help
prevent a leak. The sealant 5054 in the hardened state being
coupled to the reinforcement material 5034, as shown in FIG. 192,
can help keep the sealant 5054 in position within the bronchial
tube 5002 where the sealant 5054 is helping to seal the staple line
5052b.
[0730] The balloon 5024 can be in the inflated within the bronchial
tube 5002 when the sealant 5054 is being advanced out of the
applicator 5056, as shown in FIG. 191. In other words, the balloon
5024 can be in the inflated configuration during delivery of the
sealant 5054 into the bronchial tube 5002. The balloon 5024 being
inflated during delivery of the sealant 5054 can help prevent the
sealant 5054 from blowing back proximally after being advanced
distally from the applicator 5056 by filling any excess space
between the end cap 5012 and the interior surface of the bronchial
tube 5002, can help prevent the sealant 5054 from hardening within
the bronchial tube 5002 at a location that could potentially
interfere with the bronchial tube's ordinary function during
breathing, can help hold the end cap 5012 in a fixed position
relative to the bronchial tube 5002 during delivery of the sealant
5054 so as to facilitate introduction of the sealant 5054 into the
bronchial tube 5002 at a desired location, and/or can help direct
all of the sealant 5054 toward the staple line 5052b.
[0731] The balloon 5024 can be in the uninflated configuration when
the end cap 5012 is advanced into bronchial tube 5002 and can be
moved from the uninflated configuration to the inflated
configuration after the end cap 5012 has been positioned within the
bronchial tube 5002 adjacent the staple line 5052b. The balloon
5024 can be expanded within the bronchial tube 5002 using the
inflation line 5030, e.g., by passing a fluid (e.g., air, water,
etc.) through the inflation line 5030 and into the balloon 5024.
The balloon 5024 being in the uninflated configuration during
advancement of the end cap 5012 through the patient's mouth 5008
and through advancement of the end cap 5012 to the target site
within the bronchial tube 5002 can allow the end cap 5012 to have a
smaller outer diameter, which can facilitate passage of the end cap
5012 through the patient's body.
[0732] If the end cap 5012 is attached to the scoping device 5010
when the reinforcement material 5034 is advanced into the bronchial
tube 5002, the balloon 5024 can be in the inflated configuration
when the reinforcement material 5034 is being advanced into the
bronchial tube 5002. The balloon 5024 being inflated during
delivery of the reinforcement material 5034 can help prevent the
reinforcement material 5034 from blowing back proximally after
being advanced distally from the scoping device 5010 by filling any
excess space between the end cap 5012 and the interior surface of
the bronchial tube 5002 and/or can help hold the end cap 5012 in a
fixed position relative to the bronchial tube 5002 during delivery
of the reinforcement material 5034 so as to facilitate positioning
the reinforcement material 5034 at a desired location.
[0733] After the sealant 5054 has been delivered into the bronchial
tube 5002, the scoping device 5010, the end cap 5012 (if attached
to the scoping device 5010 during sealant 5054 delivery), and any
devices within the scoping device's working channel 5016, e.g., the
applicator 5056, can be removed from the bronchial tube 5002. FIG.
192 shows the removal of the scoping device 5010, the end cap 5012,
and the applicator 5056 from the bronchial tube 5002 in a direction
shown by a retraction arrow 5060. The applicator 5056 is removed
from the bronchial tube 5002 simultaneously with the scoping device
5010 and the end cap 5012 in this illustrated embodiment, but the
applicator 5056 can be removed from the bronchial tube 5002 before
the scoping device 5010 and the end cap 5012, e.g., by being
withdrawn from the working channel 5016. Although FIG. 192 shows
the scoping device 5010, the end cap 5012, and the applicator 5056
being removed from the bronchial tube 5002 after the sealant 5054
has transitioned from the first state to the second, harder state,
any of the scoping device 5010, the end cap 5012, and the
applicator 5056 can be removed prior to the sealant 5054 completing
the transition to the hardened state. Keeping at least the scoping
device 5010 within the bronchial tube 5002 until the sealant 5054
has transitioned to the hardened state can help ensure that the
sealant 5054 hardens in the proper location adjacent the staple
line 5052b, e.g., by allowing visualization of the sealant 5054
within the bronchial tube 5002 using the viewing element 5058.
[0734] In some embodiments, the reinforcement material 5034 can
include sealant coupled thereto prior to the reinforcement material
5034 being stapled. For example, the reinforcement material 5034
can have a sealant coupled thereto, e.g., imbibed therein, soaked
therein, coated thereon, etc., when the reinforcement material 5034
is advanced into the bronchial tube 5002. For another example, the
reinforcement material 5034 can include a composite matrix (e.g.,
the composite matrix mentioned above including a non-woven polymer
and a knitted or woven backing material) coated or impregnated with
a sealant such as lyophilized fibrinogen and thrombin, a non-woven
support. By the reinforcement material 5034 including sealant prior
to the stapling thereof, the surgical procedure can include fewer
steps since sealant need not be separately delivered after the
stapling. However, even if the reinforcement material 5034 includes
sealant prior to the stapling thereof, sealant can be delivered
after the stapling, which can help ensure complete sealing of the
staple line 5052b. For example, sealant coupled to the
reinforcement material 5034 can include a first component, and
sealant delivered subsequent to delivery of the reinforcement
material 5034 can include a second component configured to activate
the first component when in contact therewith. The second component
activating the first component can trigger the transitioning from
the first state to the hardened state so as to create a third
material that acts as the sealant. In this way, timing of hardening
of the sealant can be user-controlled by preventing hardening of
the sealant until the second component is introduced to the first
component, which can help prevent premature hardening of the
sealant before the reinforcement material 5034 is desirably
positioned and/or before stapling occurs. Delivering the sealant as
multiple components can ease delivery of the sealant through the
relatively small diameter bronchial tube 5002 by allowing the
sealant to be introduced therein in multiple parts. In other words,
less sealant material can be passed through the tube 5002 at any
given time. Delivering the sealant as multiple components can be
less expensive monetarily than introducing a singular sealant
material into the bronchial tube 5002 since amounts of the sealant
introduced can be better controlled and/or less of a more expensive
component can be introduced than a less expensive component.
Exemplary embodiments of multi-component sealants configured to be
activated are described in further detail in previously mentioned
U.S. Patent Application entitled "Methods And Devices For Sealing A
Body Lumen" filed on even date herewith (Atty. Dkt. No.
47059-254F01US (END7381USNP)), which is hereby incorporated by
reference in its entirety.
[0735] FIGS. 193 and 194 illustrate another embodiment of a
reinforcement material 5062 and a sealant 5064. In this illustrated
embodiment, as shown in FIG. 193, the reinforcement material 5062
is coupled to the sealant 5064 prior to stapling of the
reinforcement material 5062 and a bronchial tube 5066 within which
the reinforcement material 5062 can be positioned. The
reinforcement material 5062 in this illustrated embodiment includes
a sponge. The sealant in 5064 in this illustrated embodiment
includes a therapeutic agent, e.g., a biologic, soaked into the
sponge. The sealant 5064 being coupled to the reinforcement
material 5062 prior to stapling thereof can help the sealant 5064
seal a staple line in the bronchial tube 5066 since the sealant
5064 can be positioned within the bronchial tube 5066 at a location
of the staple line prior to formation of the staple line. The
sealant 5064 including a therapeutic agent can help facilitate
healing, as will be appreciated by a person skilled in the art.
[0736] The reinforcement material 5062 can be advanced into the
bronchial tube 5066 similar to that discussed above regarding the
reinforcement material 5034 of FIGS. 189-192. The scoping device
5010 of FIGS. 188-192 and the grasper 5036 of FIGS. 189 and 190 are
shown advancing the reinforcement material 5062 into the bronchial
tube 6066, but these and/or other devices can be used to introduce
the reinforcement material 5062 into the bronchial tube 5066, as
discussed above. Similarly, the stapler 5038 of FIGS. 189 and 190
is shown stapling the bronchial tube 5066, the reinforcement
material 5062, and the sealant 5064 in FIG. 194, but a different
stapler or a device applying a different type of fastener can be
used to cut and secure a portion of the bronchial tube 5066. The
bronchial tube 5066 in this illustrated embodiment has a tumor 5068
therein that is being excised, thereby prompting introduction of
the reinforcement material 5062 and the sealant 5064 therein, but a
bronchial tube can be treated for this and/or another reason using
any reinforcement material and any sealant described herein.
[0737] The sealant 5064 can be sufficient sealant to seal the
staple line formed by the stapler 5038. However, as mentioned
above, additional sealant (not shown), such as an activator of the
sealant 5064 previously delivered, can be introduced into the
bronchial tube 5066 and delivered adjacent to the staple line so as
to facilitate sealing thereof. The additional sealant can be
advanced into the bronchial tube 5066 in a variety of ways, such as
by the using the applicator 5056 of FIGS. 191 and 192 discussed
above.
[0738] In some embodiments, a bronchial tube can be stapled, or
otherwise cut and fastened, before a reinforcement material or a
sealant are introduced into the bronchial tube. Stapling or
otherwise fastening the bronchial tube before introducing the
reinforcement material or the sealant are introduced therein can
allow the bronchial tube to be stapled without a chance of the
bronchial tube being stapled at a location where the reinforcement
material is not positioned.
[0739] FIG. 195 illustrates another embodiment of a surgical
instrument 5070 configured to deliver a reinforcement material (not
shown) and a sealant (not shown). The instrument 5070 can include a
proximal handle portion 5074 configured to be held outside the
patient 5072. The instrument 5070 can be configured to be
transorally advanced into the patient 5072, as shown in FIG. 195,
by being advanced into a mouth 5076 of the patient 5072, although
the instrument 5070 can be advanced into the patient 5072 in other
ways that will be appreciated by a person skilled in the art.
[0740] The instrument 5070 can be configured to deliver the
reinforcement material and the sealant into a bronchial tube after
the bronchial tube has been stapled or otherwise cut and fastened.
FIG. 196 shows an embodiment of a stapler 5078 including a pair of
jaws 5080a, 5080b positioned on opposite sides of a bronchial tube
5082 of the patient 5072. As mentioned above, the stapler 5078 can
have a variety of configurations. FIG. 197 shows the bronchial tube
5082 after being stapled by the stapler 5078. The stapler 5078 can
cut the bronchial tube 5082 when stapling and accordingly create
first and second staples lines 5084a, 5084b at facing ends of the
cut bronchial tube 5082. The cutting of the bronchial tube 5082 by
the stapler 5078 can result in a specimen portion 5082a of the
bronchial tube 5082, which includes the first staple line 5084a and
can be removed from the patient 5072, and a remainder portion 5082b
of the bronchial tube 5082, which can include the second staple
line 5084b and can remain within the patient 5072.
[0741] As shown in FIG. 198, the instrument 5070 can be configured
to be advanced into the remainder portion 5082b of the bronchial
tube 5082. A distal end 5070d of the instrument 5070, also shown in
FIG. 199, can be positioned adjacent the second staple line 5084b.
The instrument 5070 can include a first chamber 5090 configured to
have a sealant 5086 disposed therein when the distal end 5070d is
advanced into the bronchial tube 5082, and can include a second
chamber 5092 configured have a reinforcement material 5088 disposed
therein when the distal end 5070d is advanced into the bronchial
tube 5082. In this illustrated embodiment, the sealant 5086
includes a fibrin and the reinforcement material 5088 includes ORC,
but as mentioned above, the sealant 5086 and the reinforcement
material 5088 can have other configurations. When the reinforcement
material 5088 is acidic, such as when it includes ORC, the
reinforcement material 5088 can provide an anti-microbial benefit
during healing of the bronchial tube 5082, which can help reduce
infection and/or other complications from the stapling. The first
chamber 5090 in this illustrated embodiment includes a passageway
of a tubular shaft 5094 extending longitudinally through the
instrument 5070. The second chamber 5092 in this illustrated
embodiment includes a cavity formed in a distal-most portion of the
instrument 5070. The instrument 5070 can also include a piston 5096
configured to release the reinforcement material 5088 from the
second chamber 5092, as discussed further below. In general, the
piston 5096 can be slidably movable relative to the tubular shaft
5094 so as to move the reinforcement material 5088 out of the
second chamber 5092 and out of the instrument 5070.
[0742] The instrument 5070 can be configured to advance the sealant
5086 and the reinforcement material 5088 into the bronchial tube
5082 adjacent the staple line 5082b. As shown in FIG. 200, when the
instrument's distal end 5070d is positioned adjacent the staple
line 5084b, the sealant 5086 can be released from the first chamber
5090 so as to be delivered into the bronchial tube 5082 at the
staple line 5086. The sealant 5086 can seep or wick into the staple
line 5082b, as discussed above. The sealant 5086 can be released
from the first chamber 5090 in a variety of ways, as will be
appreciated by a person skilled in the art. For example, a force
can be applied to the first chamber 5090 in a distal direction,
e.g., air pushed into the first chamber 5090 through an open
proximal end (not shown) of the tubular shaft 5094 so as to push
the sealant 5086 out a distal end of the tubular shaft 5094. All of
the sealant 5086 can be released from the first chamber 5090 or, as
shown in FIG. 200, only a portion of the sealant 5086 can be
released from the first chamber 5090 so as to be disposed within
the bronchial tube 5082.
[0743] As shown in FIGS. 200 and 201, when the instrument's distal
end 5070d is positioned adjacent the staple line 5084b, the
reinforcement material 5088 can be released from the second chamber
5092 so as to be delivered into the bronchial tube 5082 at the
staple line 5086. The reinforcement material 5088 can be released
from the second chamber 5092 in a variety of ways, as will be
appreciated by a person skilled in the art. For example, the piston
5096 can be advanced distally, as shown by directional arrows 5098
in FIG. 200, so as to push the reinforcement material 5088 out an
open distal end of the instrument 5070. The piston 5096 can be
slidably disposed around the tubular shaft 5094, as mentioned
above, and slid relative thereto to release the reinforcement
material 5088 without also causing release of the sealant 5086. All
of the reinforcement material 5088 can be released from the second
chamber 5092, as in this illustrated embodiment, or only a portion
of the reinforcement material 5088 can be released from the second
chamber 5092 so as to be disposed within the bronchial tube
5082.
[0744] The sealant 5086 can be applied only before the
reinforcement material 5088, the sealant 5086 can be applied only
after the reinforcement material 5088, or the sealant 5086 can be
applied both before and after the reinforcement material 5088.
Application of the sealant 5086 after the application of the
reinforcement material 5088 can allow the sealant 5086 to seep or
wick into any space between the reinforcement material 5088 and an
internal surface of the bronchial tube 5082, thereby further
facilitating sealing. In this illustrated embodiment, the sealant
5086 is applied both before and after the reinforcement material
5088. FIG. 200 shows a first application of the sealant 5086 before
application of the reinforcement material 5088, and FIG. 201 shows
a second application of the sealant 5086 after the application of
the reinforcement material 5088.
[0745] In an embodiment in which the sealant is blood, such as
autologous blood, the blood can be harvested from the patient and
applied to the adjunct material. By way of non-limiting example,
the adjunct material can be ORC, a known hemostatic agent, and the
application of the blood to the ORC adjunct will cause the
formation of a clot, resulting in an effective sealing structure. A
person skilled in the art will appreciate that blood, such as
autologous blood can be applied to a variety of adjunct materials
to provide an enhanced sealing structure. Further, a person skilled
in the art will appreciate that the volume of blood applied to the
adjunct will vary depending upon a number of factors, including the
type and location of tissue as well, the age and condition of the
patient, and the identity of the adjunct. Generally, however, when
the adjunct is an ORC material, the blood can be applied in an
amount in the range of about 5-10 cc per line of staple used to
affix the adjunct to the tissue.
[0746] A person skilled in the art will appreciate that the
methods, devices, systems, and apparatus described herein
application in conventional minimally-invasive and open surgical
instrumentation as well application in robotic-assisted
surgery.
[0747] As will be appreciated by persons skilled in the art,
various surgical staplers known in the art can be used to form an
anastomosis. In general, referring back to FIG. 7, a surgical
stapler 200 includes a handle assembly 212 with a shaft 214
extending distally therefrom, an end effector 250 being disposed on
a distal end thereof for treating tissue. The end effector 250 can
include a cartridge assembly 252 and an anvil 254, each having a
tissue-contacting surface 260p, 260d that is substantially circular
in shape. The cartridge assembly 252 and anvil 254 can be coupled
together via a shaft 262 extending from the anvil 254 to the handle
assembly 212 of the stapler 200, and manipulating an actuator 222
on the handle assembly 220 can retract and advance the shaft 262 to
move the anvil 254 relative to the cartridge assembly 252. In one
embodiment, the shaft 262 can be formed of first and second
portions (not shown) configured to releasably couple together to
allow the anvil 254 to be detached from the cartridge assembly 252,
allowing greater flexibility in positioning the anvil 254 and the
cartridge assembly 252 in a body. For example, the first portion of
the shaft can be disposed within the cartridge assembly 252 and
extend distally outside of the cartridge assembly 252, terminating
in a distal mating feature. The second portion of the shaft 214 can
be disposed within the anvil 254 and extend proximally outside of
the cartridge assembly 252, terminating in a proximal mating
feature. In use, the proximal and distal mating features can be
coupled together to allow the anvil 254 and cartridge assembly 252
to move relative to one another. The anvil 254 and cartridge
assembly 252 can perform various functions and can be configured to
capture tissue therebetween, staple the tissue by firing of staples
from a cartridge assembly 252 and/or can create an incision in the
tissue. In general, the cartridge assembly 252 can house a
cartridge containing the staples and can deploy staples against the
anvil 254 to form a circular pattern of staples around a
circumference of a tubular body organ.
[0748] The handle assembly 212 of the stapler 200 can have various
actuators disposed thereon that can control movement of the
stapler. For example, the handle assembly 212 can have a rotation
knob 226 disposed thereon to facilitate positioning of the end
effector 250 via rotation, and/or a trigger 222 for actuation of
the end effector 250. Movement of the trigger 222 through a first
range of motion can actuate components of a clamping system to
approximate the jaws, i.e. move the anvil 254 toward the cartridge
assembly 252. Movement of the trigger 222 through a second range of
motion can actuate components of a firing system to cause the
staples to deploy from the staple cartridge assembly 252 and/or
cause advancement of a knife to sever tissue captured between the
cartridge assembly 252 and the anvil 254.
[0749] The surgical stapler 200 is only one example of many
different staplers that can be used in conjunction with the sealant
and sealing cuffs disclosed herein. Further detail on the
illustrated embodiment, as well as additional exemplary embodiments
of surgical staplers, components thereof, and their related methods
of use, that can be used in accordance with the present disclosure
include those devices, components, and methods provided for in U.S.
Publication No. 2013/0256377, U.S. Pat. Nos. 8,393,514, 8,317,070,
7,143,925, each of which is incorporated by reference herein in its
entirety.
Sealing Cuff
[0750] A sealing cuff is provided herein that can be positioned
around a tubular body organ and can act as a mold for a sealant
when the sealant is in the first, liquid state. The sealing cuff
can have various sizes, shapes, but is generally configured to be
positioned around an anastomosis of a tubular organ. In general,
the sealing cuff can be formed from a spherical-shaped member with
truncated proximal and distal ends. The sealing cuff can include a
central portion and first and second flared portions. The central
portion of the cuff can correspond to a shape of a tubular body
organ, while the first and second flared portions can facilitate
movement of the cuff along the tubular organ before sealant is
delivered thereto. In one embodiment shown in FIGS. 202A-202C, a
sealing cuff 6000 can have a substantially circular cross-sectional
shape taken along a central longitudinal axis LC of the cuff 6000.
The central portion 6002 of the sealing cuff 6000 can have an inner
surface 6004 configured to directly contact or be positioned
adjacent to an outer surface of a tubular body organ (not shown).
The inner surface 6004 can define an interior chamber 6006 for
receiving a sealant therein. For example, the inner surface 6004 of
the sealing cuff 6000 can have a substantially concave shape that
defines the interior chamber 6006. As a result, sidewall edges of
the sealing cuff can contact tissue to hold a sealant within the
interior chamber of the cuff. The sealing cuff 6000 can have
various features for facilitating even distribution of sealant
within the interior chamber 6006. For example, the sealing cuff
6000 can include any number of protrusions 6008 formed on the inner
surface 6004 of the sealing cuff 6000. In general, the protrusions
6008 can be configured to directly contact an outer surface of a
tubular body organ when the sealing cuff 6000 is positioned around
the organ and can prevent gravity from pulling sealant toward a low
portion of the sealing cuff 6000. The protrusions 6008 can be
shaped in various ways, such as cylindrical, spherical, conical,
etc., and can have a radial height selected so that a terminal end
6008t of the protrusion 6008 directly contacts the outer surface of
the tubular body organ. The protrusions 6008 can also be spaced
apart in various ways, such as around a circumference of the
sealing cuff 6000 in a single row or in multiple rows, e.g. two
rows, three rows, four rows, etc. The protrusions 6008 can be
spaced evenly around the circumference in a single plane or can be
spaced in any other pattern configured to facilitate an even
distribution of sealant within the interior chamber 6006 of the
sealing cuff 6000. The protrusions can have a radial height
substantially equal to or larger than a radial thickness between
the inner surface of the sealing cuff and the outer surface of the
body lumen to help achieve a uniform thickness of sealant around
the circumference of the cuff. As shown in FIG. 202C, the sealing
cuff 6000 can further include first and second flared portions
positioned 6010a, 6010b on either side of the central portion 6002
of the cuff 6000 and having an inner diameter DF that is greater
than the inner diameter DI of the central portion 6002 of the cuff
6000. These flared portions 6010a, 6010b can facilitate sliding the
cuff around a tubular body organ, as will be discussed in greater
detail. By way of non-limiting example, the inner diameter DF of
the flared portions can be about 95% of the inner diameter DI of
the central portion of the cuff. The sealing cuff 6000 can have a
relatively thin wall, for example, with a thickness in the range of
about 1 to 5 mm. An inner diameter DI of the cuff can correspond
to, e.g. be greater than or equal to, an outer diameter of a
tubular body organ. For example, the inner diameter DI of the
sealing cuff 6000 can be in the range of about 19 to 35 mm.
[0751] The sealing cuff can have variety of features that allow it
to be positioned around a tubular organ and then removed from the
organ. For example, the sealing cuff 6000 in FIGS. 202A-202C can be
substantially ring-shaped when the cuff 6000 inserted in a patient.
One or more reinforcement ribs 6012, 6014 can extend between and
substantially perpendicular to the first and second flared portions
6010a, 6010b. In order to facilitate removal of the cuff 6000 from
an organ, the sealing cuff 6000 can have a breakaway portion (not
shown) configured to fracture or tear when a pulling force is
applied to the cuff 6000. This breakaway portion can be positioned
in the narrow space between the first and second reinforcement ribs
6012, 6014, as shown in FIG. 202B. As will be appreciated by
persons skilled in the art, the breakaway portion can be formed
from a different, weaker material than the remaining portion of the
sealing cuff 6000, e.g. different from the material forming central
portion 6002 of the sealing cuff 6000 and/or the reinforcement ribs
6012, 6014. The sealing cuff 6000 can further include a plurality
of tabs that can be grasped by a tool to help position the sealing
cuff 6000 and/or remove the sealing cuff 6000 from an organ. For
example, as shown in FIG. 202A, a first tab 6012a can be formed on
a first terminal end of the first reinforcement rib 6012 and a
second tab 6012b can be formed on a second terminal end of the
first reinforcement rib 6012. Similarly, a third tab 6014a can be
formed on a first terminal end of the second reinforcement rib 6014
and a fourth tab 6014b can be formed on a second terminal end 6014b
of the second reinforcement rib 6014. Each of the tabs 6012a,
6012b, 6014a, 6014b can have a substantially rectangular
cross-sectional shape with a relatively thin thickness so that the
tabs 6012a, 6012b, 6014a, 6014b can be grasped by one or more
tools.
[0752] The sealing cuff can be configured to move in other ways and
need not include a breakaway portion. For example, the sealing cuff
can pivot between an open position in which first and second ends
of sealing cuff are separated and a closed position in which first
and second ends of sealing cuff are joined together. In this way,
when the sealing cuff is in the closed position, the sealing cuff
is ring-shaped and defines the interior chamber for receiving
sealant. The sealing cuff can include any number of features to
facilitate pivotable movement of the sealing cuff, such as a
pivot-type hinge and one or more locking mechanisms configured to
lock the sealing cuff in the closed position.
[0753] A sealing cuff can include one or more ports for receiving
sealant therein and for directing the sealant to the interior
chamber of the cuff. For example, the sealing cuff 6000 of FIG.
202A includes a port 6024 having a delivery tube 6026 coupled
thereto for delivering sealant to the cuff 6000. The port 6024 can
be positioned so that it extends substantially parallel to the
central longitudinal axis LC of the sealing cuff 6000 so as to
minimize a diameter DP of the sealing cuff 6000 at the port 624. As
shown in FIG. 202C, the port 6024 can include a passageway 6028
extending into the inner surface 6004 of the cuff 6000, the
passageway 6028 having a mating feature 6030 configured to mate
with the delivery tube 6026. The delivery tube 6026 can be
configured to couple to the mating feature 6030 in various ways,
such as via a press-fit or a snap-fit, so that the delivery tube
6026 can be removed and cleaned or replaced after a single use. The
passageway 6028 can be shaped in various ways, but in the
illustrated embodiment includes a first portion 6028a that is
perpendicular to a second portion 6028b for receiving fluid from
the port, the second portion 6028b directing the fluid
substantially toward a central inner diameter of the sealing cuff
and thus, toward a staple line of an anastomosis. As will be
appreciated by persons skilled in the art, while the sealing cuff
is shown with only one port, the cuff can include any number of
ports for delivering sealant to the cuff.
[0754] The sealing cuff can have other features that facilitate
positioning of the sealing cuff around a tubular body organ. As
shown in FIG. 203, a sealing cuff 6100 can have one or more
extension ports 6114, 6116 formed in an outer surface 6112. One or
more of the extension ports 6114, 6116 can have an inner diameter
DP sized and shaped to receive a grasping tool therein. The
extension ports can have various features. As shown, the extension
port 6114 can have an inner lumen 6118 that determinates on the
outer surface 6112 of the sealing cuff 6100 so as to not interfere
with the interior chamber 6106 of the cuff 6100. In another
embodiment, the inner lumen 6118 of the extension port 6114 can be
in communication with the interior chamber 6106 of the cuff such
that fluid can be delivered into the interior chamber 6106
therethrough, such as through a tube (not shown) extending between
the inner lumen 6118 and an outer. Any number of the extension
ports can have an inner lumen configured to deliver fluid to the
interior chamber 6106. The inner lumen 6118 can be substantially
perpendicular to the outer surface 6112 of the sealing cuff 6000 or
can be disposed at other angles relative to the outer surface 6112
of the cuff 6000. For example, as shown in FIG. 203, the sealing
cuff 6100 can include the first and second extension ports 6114,
6116, the first extension port 6114 being positioned about 90
degrees relative to the second extension port 6116. In another
embodiment (not shown), any number of extension ports can include
features for angularly positioning the extension port relative to
the outer surface of the cuff, such as a ball and socket joint. The
extension ports can include locking mechanisms configured to lock
the port at a desired position. As will be appreciated by a person
skilled in the art, the sealing cuff 6100 can include any number of
extension ports positioned at any number of locations around the
sealing cuff selected so as to not substantially interfere with
delivery of the cuff 6100 into a patient's body. The inner lumen
6118 can be cylindrical in shape and the inner diameter DP can be
in the range of about 19 to 35 mm. The second extension port 6116
can include an inner lumen 6120 being sized and shaped
substantially the same as the inner lumen 6118, or the inner lumen
6120 can have a different size and shape. A sealing cuff can
include features that facilitate a user locating a position of the
cuff when the cuff is in a patient. For example, the cuff and/or
the graspers can be configured to emit light.
[0755] A sealing cuff can include other features that help hold the
sealant in a desired position between the tubular body organ and
the inner surface of the sealing cuff. For example, FIG. 204A
illustrates a perspective, partial cross-sectional view of a
sealing cuff 6200 having suture 6232 woven across an inner surface
6204 of the sealing cuff 6200. The strand of suture 6232 can be
provided in a criss-crossed pattern forming intersecting triangles
across the inner surface 6204 of the cuff In another embodiment
(not shown), the strand of suture 6232 can include multiple strands
of suture that can be woven in various patterns across the inner
surface 6204 of the cuff 6200. In general, this suture 6232 can be
used to hold the sealant away from the inner surface 6204 of the
sealing cuff 6200 to prevent sealant from solidifying thereon and
can therefore facilitate removal of the cuff 6200 from a patient's
body. The suture 6232 can be attached to the sealing cuff 6200 in
various ways. For example, a plurality of attachment points 6234
can be formed on a proximal end 6200p of the cuff 6200 and spaced
equally about the circumference of the proximal end 6200p of the
cuff 6200. As shown in FIG. 204B, a passageway 6236 can be formed
around the circumference of the proximal end 6200p of the cuff 6200
and can have an elongate member 6238, e.g. a second strand of
suture, extending therethrough. The passageway 6236 can further
include a plurality of radial openings formed therein, each radial
opening 6240 being substantially perpendicular to the passageway
6236, as shown in FIG. 204B. Each radial opening 6240 can allow the
first strand of suture 6232 to pass therethrough from the inner
surface 6204 of the cuff 6200, around the second strand of suture
6236, and back through the radial opening 6249 toward the inner
surface 6204 of the cuff 6200, as shown in FIG. 204B. In use, the
second strand of suture 6236 can be cut to release the first strand
of suture 6232 from the inner surface 6204 of the cuff.
[0756] A sealing cuff according to any of the exemplary embodiments
can be formed from various materials. Preferably, the sealing cuff
is formed from a substantially rigid material so that it is
configured to withstand the forces applied to the cuff sealant is
injected through the delivery tube and into an anastomosis. A
sealing cuff can be formed into a single, unitary structure, such
as via injection molding, or into multiple pieces joined together
using any known fixation techniques.
Sealants
[0757] A sealant can have various formulations and differing
viscosity and curing behavior. Generally, a sealant can be made
from a biocompatible and bioabsorbable material that can be
configured to transition from a first, liquid state to a second,
solidified state via a curing process, such as a polymerization
reaction. The first state can be a softened state, e.g., a fluid, a
gel, a foam, etc. and the second state can be a hardened state,
e.g., a solid, a rigid member, etc. When the sealant is in the
first, softened state, the sealant can flow through the delivery
tube and into the sealing cuff, as described in greater detail
below. The sealant can transition from the first, softened state to
the second, solidified state after a predetermined amount of time.
In certain aspects, the sealant can be formed from biologic
material. In some embodiments, the sealant can assist in wound
healing by releasing various chemical compounds, during and/or
after curing of the sealant in a patient's body. By way of
non-limiting example, the sealant can be configured to release a
therapeutic drug, such as fibrin, thrombin, etc. over time to aid
the tissue in healing near the location of the sealant in a body.
In one embodiment, a fibrin sealant can include two reactive
components combined immediately prior to delivery into a patient,
such as Thrombin and a biologically active component (BAC2),
Fibrinogen and Factor XIII In certain aspects, the components can
be provided in a 5:1 volumetric ratio of BAC2 to Thrombin. While
the resulting sealant can have different viscosity and curing
behavior depending on its formulation, this exemplary formulation
of sealant can have a viscosity in the range of about 1 cp to 90 cp
after the components have been mixed and the polymerization
reaction has started, and the sealant can cure to a solidified
state in about 3 minutes.
[0758] FIG. 205A illustrates a first component 6340 of a sealant
6300 positioned in an injection syringe 6342. As shown, the syringe
can include a plunger 6341 for drawing the component 6340 therein.
The syringe 6342 can be configured to introduce gas, e.g. air, into
the component 6340 through various techniques. For example, an
opening 6344 can be formed in a needle 6346 of the injection
syringe 6342 so that air can be introduced into the component 6340
as it is drawn into the syringe 6342. This first component 6340 can
be mixed with one or more additional components (not shown)
immediately prior to or during injection into a patient, and these
additional components can also have gas introduced therein. The
presence of gas in one or more of the components of the sealant
6300 can form air pockets/closed cells 6348 as the sealant 6300 has
solidified into a staple line 6350, as shown in FIG. 205B,
resulting in a sealant 6300 that has increased flexibility in its
solidified form than if the sealant 6300 lacked these air
pockets/closed-cells 6348. This can allow the sealant 6300 to move
radially and longitudinally, in coordination with a movement of a
tubular body organ, as the organ radially expands, contracts,
and/or twists during normal bodily function. Further, this
preparation technique can decrease an amount of sealant 6300 that
is applied to a sealing cuff because the gas can form the
closed-cells 6348 in the sealant 6300 that increase the overall
volume for a given mass of sealant 6300. The presence of these
closed-cells 6348 can act as a visual indicator to a user regarding
the location and/or thickness of the sealant 6300.
Expandable Devices
[0759] An expandable device can be used in conjunction with a
sealing cuff to hold the sealant in a desired position as the
sealant cures from the liquid state to the solidified state. In
general, the expandable devices provided herein can be positioned
inside of a tubular body organ in a compressed position and can
move to an expanded position in which the devices expand against an
inner surface of the tubular body organ. This can force an outer
surface of the tubular organ toward the inner surface of sealing
cuff and can help hold the sealant in this position to achieve a
complete seal around the anastomosis. An expandable device can have
various sizes, shapes, and configurations. In some embodiments, an
expandable device can include first and second expandable members
so that the first expandable member can be positioned on a first
side of anastomosis and the second expandable member can be
positioned on second side of the anastomosis. In certain aspects,
the expandable device can be expanded/inflated by delivering liquid
or gas to the expandable members. In one embodiment shown in FIG.
206A, an expandable device 6400 can include first and second
expandable members 6410, 6412, i.e. inflatable balloons, coupled to
an elongate member 6416, such as a cylindrical rod, via a coupling
mechanism 6417. The elongate member 6416 can be configured to mate
with a distal end 6418d of a scoping device 6418, as shown, to
allow a user to visualize the expandable members 6410, 6412 when
the expandable device 6400 is positioned inside of a tubular body
organ (not shown). The first and second expandable members 6410,
6412 can be fixedly coupled to the elongate member 6416 and spaced
apart along an axial length of the elongate member 6416. The first
and second expandable members 6410, 6412 can be sealed around the
elongate member 6416 using any attachment mechanism known in the
art, such as an adhesive. As a result, the elongate member 6416 can
extend through a central longitudinal axis of each of the first and
second expandable members 6410, 6412 without interfering with the
expansion and compression of the expandable members 6410, 6412. As
will be appreciated by a person skilled in the art, the elongate
member 6416 can be made from various materials and can be flexible
or semi-flexible so as to allow the elongate member to navigate a
tortuous tubular body organ.
[0760] The device can include various features for delivering
fluid, e.g. liquid or gas, to the expandable members. As shown in
FIG. 206A, the elongate member 6416 can have proximal and distal
terminal ends 6416p, 6416d, and an inner lumen extending 6420
therethrough from the proximal terminal end 6416p of the elongate
member 6416 and terminating proximal to the distal terminal end
6416d. The inner lumen 6420 of the elongate member 6416 can have
one or more inflation lumens disposed therein for delivering fluid,
e.g. liquid or gas such as saline, oxygen, carbon dioxide, etc., to
one or both of the expandable members. For example, the device of
FIG. 206A includes first and second inflation lumens 6422, 6424.
The first inflation lumen 6422 can be configured to deliver fluid
therethrough and into a first exit port (not shown) formed in the
elongate member 6416, the first expandable member 6410 being
disposed around the first exit port. Similarly, the second
inflation lumen 6424 can be configured to deliver fluid
therethrough and into a second exit port (not shown) formed in the
elongate member 6416, the second expandable member 6412 being
disposed around the second exit port. Each of the first and second
inflation lumens 6422, 6424 can be coupled to first and second
fluid sources (not shown) that can allow for selective inflation of
the expandable members 6410, 6412, e.g. simultaneous inflation of
the first and second expandable members 6410, 6412 or sequential
inflation of the expandable members 6410, 6412 in any order. As
will be appreciated by a person skilled in the art, the expandable
device can have any number of inflation lumens, such as one
inflation lumen in fluid communication with first and second
expandable members. The expandable devices can include other
features for facilitating moving the expandable members from a
compressed position to an expanded position by inflating and
deflating the expandable members. For example, the expandable
members can include one or more valves (not shown) positioned in
any of their respective inflation lumens. In certain aspects, the
valves can be configured to close when the expandable member
achieves a certain inflation volume to prevent liquid or gas from
flowing out of the expandable members. After a procedure is
performed, the valves can be opened to allow the expandable members
to deflate to the compressed position to facilitate removal of the
device from the patient's body.
[0761] The expandable members can have various sizes and shapes in
the expanded and compressed positions. When the expandable members
of FIG. 206A are in an expanded position, the expandable members
6410, 6412 can be substantially disc-shaped. The expandable members
can have any size and shape configured to expand a tubular body
organ, such as spherical, tubular, etc. In general, each of the
expandable members can have a maximum diameter in the expanded
position that is greater than an inner diameter of the tubular body
organ in its resting state, such as in the range of about 110 to
115% greater than the inner diameter of the tubular body organ. As
explained in further detail below, this can facilitate positioning
of the sealant between an outer surface of the tubular body organ
and an inner surface of the sealing cuff. The expandable members
can be formed from various materials that can be inflated, such as
rubber, silicone, PET, and Teflon.
[0762] FIG. 206B illustrates another embodiment of an expandable
device having a first expandable member 6410', e.g. a first
inflatable balloon, fixedly coupled to a flexible tether 6416'. A
second expandable member 6412', e.g. a second inflatable balloon,
can be positioned over a proximal terminal end 6416p' of a tether
6416' and can slide along an axial length of the tether 6416' in a
compressed position so as to allow a user to selectively position
the second expandable member 6412' relative to the first expandable
member 6410'. The second expandable member 6412' can include an
inflation lumen 6422' that can be integrally formed thereon or the
inflation lumen 6422' can consist of a tube removably attachable to
the second expandable member 6412'. As in the previous embodiment,
an inflation source (not shown) can be coupled to the inflation
lumen 6422'. The proximal terminal end 6416p' of the tether 6416'
can also be coupled to an inflation source (not shown) while a
distal terminal end 6416d' of the tether 6416' can be inserted into
the tubular body organ with the first expandable member 6410'
fixedly coupled thereto. In certain aspects, the distal terminal
end 6416d' of the tether 6416'can be attached to an anvil of a
circular stapler to allow the expandable device 6400' to be
positioned inside of the tubular body organ as the anastomosis is
being formed, as will be described in greater detail below. The
tether 6416' can have anti-tangle features, such as being biased to
a coiled position, and can be formed from a flexible material
configured to navigate a tortuous tubular body organ. The tether
6416' can include a location device (not shown) such as a magnet,
disposed thereon and positioned proximal to the second expandable
member 6412', the location device allowing a surgeon to determine a
location of the tether 6416' relative to an anastomosis.
[0763] An expandable device can vary in any number of ways and can
include a single expandable member rather than a plurality of
expandable members, as shown in FIG. 206C and 206D. In the
illustrated embodiments, expandable devices 6500, 6500' can perform
many of the functions of the previous expandable devices 6400,
6400' using different features. For example, expandable members
6510, 6510' are a single balloon fixedly coupled to an elongate
member, such as the scope 6418 at proximal fixation points 6526p,
6526p' and distal fixation points 6528p, 6528p'. Each expandable
member 6510, 6510' includes a single inflation lumen 6522, 6522'
that can extend along an outer surface 6418, 6418' of the scope
6418. Alternatively, the expandable member can have an inflation
lumen extending through the scope 6418 rather than along an outer
surface of the elongate member. The expandable members 6510, 6510'
can be shaped in various ways. For example, FIG. 206C illustrates
the expandable member 6510 having proximal and distal expandable
portions 6510p, 6510d that form a substantially dumbbell-shape when
the expandable member 6510 is in the expanded position and having a
nonexpandable central portion 6510c. FIG. 206D illustrates an
expandable member 6510' having a substantially cylindrical shape
when it is in the expanded position. As in the previous
embodiments, a maximum diameter of each of the expandable members
6510, 6510' can be selected so that the maximum diameter is greater
than an inner diameter of the tubular body organ in its resting
state, that is, before the expandable members 6510, 6510' are
positioned therein in the expanded position. In another embodiment
shown in FIG. 207, the expandable device 6600 can include the first
and second expandable members 6410, 6412, and can include first and
second inflation lumens 6622, 6624 terminating in distal ends
6622d, 6624d delivered to direct fluid to the first expandable
member 6410 and the second expandable member 6412, respectively.
The expandable device 660 can further include a third inflation
lumen 6626 having a distal end 6626d configured to deliver liquid
or gas to a central portion of the device, i.e. to the space in
between the first and second expandable members 6410, 6412. As will
be described in greater detail below, this lumen 6626 can deliver
liquid or gas to the inner wall of the anastomosis to allow a user
to test leakage therefrom.
[0764] As will be appreciated by persons skilled in the art,
various inflation fluids (liquid and/or gas) can be delivered to
the expandable member(s), such as air, carbon dioxide, saline,
water. Additionally, the inflation fluid can be colored, such as by
adding methylene blue to the inflation fluid prior to injection,
and can be any biocompatible contrast material known in the art to
facilitate visualization of the surgical procedure.
[0765] In other embodiments, the expandable devices can be
configured to move to an expanded position without the use of
liquid and inflation lumens. For example, FIGS. 208A-208C,
illustrate various embodiments of stents in their expanded
positions. In general, the stents can be configured to move between
a compressed position and an expanded position, but can generally
be biased to the expanded position. To facilitate delivery of the
stent into a tubular body organ, the expandable stents can be
positioned within an elongate sheath (not shown) that holds the
stent in the compressed condition and can be removed once the stent
is in a desired position relative to an anastomosis. As in the
previous devices, the expandable stents can have various sizes,
shapes, and configurations in the expanded position. For example, a
stent 6700 of FIG. 208A has first and second expandable members
6710, 6712, each having a frustoconical shaped terminal portion
6732, 6734 and a central cylindrical portion 6736, 6738 configured
to contact an inner wall of a tubular body organ adjacent to the
anastomosis when the stent 6700 is in the expanded position. The
stent 6700 can be coupled to an elongate member 6716 or rod having
an actuator 6740 extending through the elongate member 6716. The
actuator 6740 can be configured to be pulled proximally relative to
the elongate member 6716 to deploy the expandable members 6710,
6712 to the expanded position of FIG. 208A. A stent 6700' of FIG.
208B can include first and second expandable portions 6710', 6712'
being substantially funnel shaped and having a smaller diameter at
a central portion 6736' thereof than at terminal ends 6732', 6734',
the terminal ends 6732', 6734' being configured to contact an inner
wall of the tubular body organ at a distance from the anastomosis.
The expandable portions 6710', 6712' can be coupled to a flexible
body, such as a tether 6716 that can have one or more location
features (not shown) disposed thereon. A stent 6700'' of FIG. 208C
can include elongate bundles of wire 6742 extending along a
longitudinal axis of the body organ and coupled to an elongate
member 6716'', the bundles of wire 6742 defining a first expandable
portion 6710 and second expandable portion 6712. The proximal and
distal ends 6'742p, 6742d of the loops can be configured to expand
against an inner wall of the tubular body organ while central
portions of the loops have a same diameter in the expanded and
compressed positions, i.e. have a smaller diameter than the tubular
body organ at the anastomosis. As will be appreciated by persons
skilled in the art, the expandable stents can be formed from
various materials, such as Nitinol, metal wire, plastics, etc.
While the expandable stents shown in FIGS. 208A-208C all include
central portions having a maximum diameter less than a diameter of
the organ at the anastomosis, the stents can include expandable
central portions. The stents can vary in any number of ways and can
have any combination of features, such as being coupled to a scope
rather than an elongate member.
[0766] An expandable device can include features that facilitate a
user locating a position of the device when it is positioned in a
patient. For example, the expandable device can be configured to
emit light, such as by being formed from a material that can emit
light.
Delivery of Cuff to an Organ
[0767] A surgical procedure can be performed on a patient and can
include removing a section of a tubular body organ that has an
obstruction or tumor therein. This procedure can include, by way of
non-limiting example, a lower anterior resection (LAR) of a rectum.
Similarly, although the procedure is illustrated with respect to a
tubular body organ, i.e. a rectum, another tubular anatomical
structure, can be similarly treated such as entero-entero
anastomosis of an intestine, uretero-uretero anastomosis of a
kidney duct, esophagogastric anastomosis in the thorax or neck,
aorto-iliac anastomosis, etc. After the section of the tubular body
organ is removed, the procedure can include reattaching two
sections of the tubular, e.g. performing a lumen-to-lumen
anastomosis, such as using a circular surgical stapler. As will be
appreciated by persons skilled in the art, the procedure can be an
open surgical procedure, but is preferably a minimally invasive,
laparoscopic and endoscopic surgical procedure in which multiple
incisions are formed in a patient, the stomach cavity is
insufflated with gas, and one or more trocars extend into the
incisions and define a working channel for instruments to be
inserted therethrough. A scope can be inserted through one of the
incisions to allow a surgeon to visualize the surgical site.
Alternatively or additionally, a scope can be inserted through a
patient's body, i.e. through an anus to facilitate visualization of
the surgical site. As described in greater detail below, various
devices can be delivered endoscopically to the surgical site,
including the expandable devices and the circular surgical
stapler.
[0768] FIGS. 209A-209E illustrate an exemplary embodiment of a
surgical procedure for stapling and sealing a tubular body organ
using the sealing cuff Although the procedure is illustrated with
respect to the sealing cuff 6000 of FIGS. 202A-202C and the
surgical stapler 200 of FIG. 207, the sealing cuff 6000 can include
any combination of features described herein. Although the
procedure is illustrated with respect to stapling, a tubular body
organ can be sealed as discussed herein in conjunction with a type
of fastener other than staples, e.g., clips, sutures, etc. While
the surgical procedure is shown without an expandable device
positioned inside of the tubular body organ, any of the devices
herein can be used to expand the organ and force the outer surface
of the organ toward the inner surface of the cuff to hold the
sealant therebetween.
[0769] FIG. 209A illustrates first and second sections 6800a, 6800b
of a tubular body organ 6800 after a portion of the organ 6800 has
been removed and prior to the first and second sections 6800a,
6800b being joined in an anastomosis. The first section 6800a of
the tubular body organ 6800 includes the cartridge assembly (not
shown) of the surgical stapler 200 positioned therein and having a
first shaft portion 262a extending therefrom. As shown in FIG.
209B, the cartridge assembly can be held within the first section
6800a of the organ 6800a via one or more strands of suture 6802a.
The second section 6800b of the tubular body organ 6800 includes
the anvil (not shown) of the surgical stapler 200 positioned
therein and having the second shaft portion 262b extending
therefrom. The anvil can also be held within the second section
6800b of the organ via one or more strands of suture 6802b. Prior
to joining the two sections 6800a, 6800b, the sealing cuff 6000 can
be introduced onto the tubular body organ 6800 by sliding the cuff
6000 over the second shaft portion 262b and the second section
6800b of the tubular body organ.
[0770] With the sealing cuff 6000 positioned on the second section
6800b of the tubular body organ 6800, the sealing cuff 6000 can
optionally be held in position by inserting a first grasper tool
6818 directly through a first incision in a patient (without a
trocar) or through a trocar 6804 and into a first extension port
6114 formed on the sealing cuff 6000, as shown in FIG. 209B.
Optionally, a second grasper tool (not shown) can be inserted
directly through a second incision in a patient (without a trocar)
through a second trocar (not shown) and into the second extension
port 6116. The grasper tools can be manipulated to move the sealing
cuff 6000 axially along the tubular body organ 6800 and/or can
rotate the sealing cuff 6000 relative to the organ 6800. In certain
aspects, when the extension ports include a joint that allows
angle(s) of the extension ports to be adjusted relative to an outer
surface of the cuff, the grasper tools can be used to change an
angle of one or more of the ports relative to the outer surface of
the cuff, and each of the ports can be locked in an angulated
position when a desired angle is achieved. With the sealing cuff
6000 positioned away from terminal ends 6806a, 6806b of the first
and second sections 6800a, 6800b of the tubular organ 6800, the
anvil 254 and the cartridge assembly 252 can be joined together,
capturing tissue therebetween to begin forming an anastomosis. As
shown in FIG. 209C, the first and second sections 6800a, 6800b of
the tubular organ 6800 can be moved toward one another and the
first and section portions 262a, 262b of the shaft 262 can then be
coupled together to prepare the surgical stapler 200 to form an
anastomosis. As shown, the anvil 254 and the cartridge assembly 252
of the stapler 200 can then be separated at a distance. The
actuator (not shown) on the stapler 200 can be manipulated by a
user, and this can retract the anvil 254 toward the cartridge
assembly 252 until the anvil 254 and cartridge assembly 252 capture
a portion of the tubular body organ 6800 therebetween, as shown in
FIG. 209D. With the anvil 254 and cartridge assembly 252 positioned
adjacent to one another, the device 200 can fire staples from the
cartridge assembly 252 in a circular pattern around a circumference
of the tubular body organ 6800, forming an anastomosis 6808. After
the anastomosis 6808 is formed, the surgical stapler 200 can be
removed from the patient, such as by retracting the stapler 200
proximally and out of the rectum of the patient.
[0771] The sealing cuff 6000 can be positioned over the anastomosis
6808 in various ways and can be moved toward the anastomosis 6808,
such as by sliding the cuff 6000 relative thereto, as shown in FIG.
209E. The interior chamber 6006 of the sealing cuff 6000 can be
positioned over the anastomosis 6808 so that the sealing cuff 6000
can direct the sealant 6300 toward the anastomosis 6808. For
example, the sealing cuff 6000 can be substantially centered over
the anastomosis 6808, that is, the second portion 6028b of the
passageway 6028 can be aligned with a central longitudinal axis LA
of the anastomosis 6808 to facilitate delivery of the sealant 6300
thereto. If the sealing cuff is configured to emit light, as
previously mentioned, a user can visually monitor a position of the
cuff based in part on a location of the emitted light. As shown in
FIG. 209F, with the sealing cuff 6000 in the desired position, the
sealant 6300 can be introduced into the delivery tube 6026 when the
sealant 6300 is in a liquid state and can pass through the port
6024 and into the interior chamber 6306 of the cuff 6000. The
sealant 6300 can seep into the staple line of the anastomosis 6808
and can solidify therein so as to prevent leaks. As will be
appreciated by persons skilled in the art, a sufficient volume of
the sealant 6300 can be delivered into the interior chamber 6306 so
that the sealant 6300 is positioned 360 degrees around the
anastomosis 6808. The protrusions 6008 formed on the inner surface
6004 of the sealing cuff 6000 can help distribute the sealant 6300
evenly across the anastomosis 6808 and can ensure that gravity does
not pull the sealant 6300 toward a portion of the sealing cuff 6000
closest to the ground. The sealing cuff 6000 can remain positioned
around the anastomosis 6808 until the sealant 6300 transitions from
the liquid state to the solidified state for a predetermined amount
of time, at least as long as the curing time of the sealant 6300.
In certain aspects, the sealing cuff 6000 can be rotated around the
body lumen as the sealant 6300 is curing from the liquid to the
solidified state to facilitate uniform coverage of the sealant 6300
around the anastomosis. After the sealant 6300 has cured and is in
its solidified state, one or more grasping tools (not shown) can
contact and grasp the sealing cuff 6000 at various locations, such
as along the tabs 61012a, 6012b, 6014a, 6014b or in the extension
ports 6114, 6116. The grasping tools can be used to pull apart the
sealing cuff 6000 and remove the breakaway sections so that the
first reinforcement rib 6012 is detached from the second
reinforcement rib 6014, the sealing cuff 6000 having a C-shaped
profile, as in FIG. 209G. If the cuff includes suture woven on an
inner surface thereof, as in the cuff 6200 previously described,
the second strand of suture 6236 can be cut to release the first
strand of suture 6232 from the inner surface 6204 of the cuff 6000,
thereby releasing the solidified sealant 6300 from the cuff 6000.
The sealing cuff 6000 can be removed from the tubular body organ
6800 and withdrawn from the patient's body, leaving a substantially
ring-shaped structure of solidified sealant 6300b around the
anastomosis 6808. The sealant 6300b can be absorbed into the body
after a predetermined amount of time, such as after two weeks.
Preferably, this time is selected so that the tubular body organ
6800 is substantially healed at the anastomosis 6808.
Delivery of Expandable Devices to an Organ
[0772] While the surgical procedure of FIGS. 209A-209G includes
formation of the anastomosis and positioning of the sealing cuff
around an anastomosis, the expandable devices disclosed herein can
be used in conjunction with the sealing cuff to hold the sealant
between the outer surface of the organ and the inner surface of the
cuff. An expandable device can be delivered to the anastomosis in
various ways, such as via the circular surgical stapler or a scope.
For example, as shown in FIG. 210A, the anvil 254 of a surgical
stapler 200 can be used to facilitate positioning of the expandable
members 6410, 6412 inside of the tubular body organ 6800 prior to
an anastomosis being formed. A tether 6416' and two expandable
members 6410, 6412 can be coupled to a distal terminal end 254d of
the anvil 254, as shown in FIG. 210B. The tether 6416' can be in a
coiled position to prevent the tether 6416' from tangling around
structures in the tubular body organ 6800. The tether 6416' can
optionally include a location device 6430, such as a magnet,
configured to allow a surgeon to visually monitor a position of the
tether 6416' relative to the anastomosis. After the surgical
stapler 200 fires the staples and forms the anastomosis 6808, the
proximal end 6416p' of the tether 6416' can be detached from the
anvil 254 and pulled proximally through the tubular body organ 6800
until the proximal end 6416p' is positioned outside of a patient's
body. Alternatively, as shown in FIG. 210C, the tether 6416' and
the expandable members 6410, 6412 can be coupled to the distal
terminal end 6418d of the scoping device 6417 via the elongate
member 6416 or rod. The scope 6418, elongate member 6416, and the
expandable members 6410, 6412 can be inserted trans-anally through
the tubular body 6800 and after a user confirms a positioning of
the expandable members 6410, 6412 near the anastomosis 6800, the
tether 6416' can be detached from the scoping device 6418. Any of
the expandable devices/expandable members can be configured to emit
light, and a user can include locate a position of the expandable
device/expandable members relative to the anastomosis based in part
on a location of the emitted light. The tether 6416' can be pulled
proximally until the proximal end 6416p' of the tether 6416' is
positioned outside of a patient's body. In both of these
embodiments, a surgeon can position the first expandable member
6410 on a first side of the anastomosis 6808, i.e. distal to the
anastomosis 6808, while the surgeon can position a second
expandable member 6412 on a second side of the anastomosis 6808,
i.e. proximal to the anastomosis 6808. With the expandable members
6410, 6412 so positioned, the proximal end 6416p' of the tether
6416' can be coupled to one or more inflation sources (not shown)
and can deliver gas or liquid to the expandable members 6410, 6412.
For example, a first inflation source (not shown) can be fluidly
coupled to a first inflation lumen 6422 and can inflate the first
expandable member 6410 to the expanded position, as shown in FIG.
210D. After the first expandable member 6410 is in the expanded
position, a second inflation source (not shown) can be coupled to a
second inflation lumen 6424 to inflate the second expandable member
6412 to the expanded position, as shown in FIG. 210E. The order of
the steps can vary in any number of ways, for example, the first
expandable member 6410 can be inflated at the same time as the
second expandable member 6412 is inflated or the expandable members
6410, 6412 can be inflated sequentially, and this can be repeated
any number of times until a desired amount of force is exerted on
the tubular body organ 6800. In another embodiment shown in FIGS.
211A-211B, a scope such as a sigmoidoscope can be inserted
trans-anally into the tubular body organ and can have the single
expandable member 6500 positioned thereon. When the scope is
inserted in the anus, as shown in FIG. 211A, the expandable member
6500 can be in the compressed position. More specifically, a
surgeon can insert the expandable member 6500 into the anus of a
patient so that the first coupling member 6526d is positioned on a
first side of the anastomosis 6808, i.e. distal to the anastomosis
6808, and so that the second coupling member 6526p is positioned on
a second side of the anastomosis 6808, i.e. proximal to the
anastomosis 6808. The central portion 6510c of the expandable
member 6500 can be axially aligned with a central portion of the
sealing cuff 6000, as shown in FIG. 211B. Further, the sealing cuff
6000 can be substantially centered over the anastomosis 6808, that
is, the second portion of the passageway of the cuff 6000 can be
aligned with a central longitudinal axis LA of the anastomosis 6808
to facilitate delivery of the sealant 6300 to the interior chamber
6006 of the cuff 6000 and to the anastomosis 6808. A surgeon can
confirm a positioning of these devices using visualization
techniques known in the art. The central portion 6510c of the
expandable member 6500 can be positioned adjacent to the
anastomosis 6800. As in the other devices, the expandable member
6500 and sealing cuff 6000 can be positioned so that the cuff 6000
is substantially centered over the anastomosis 6808. As shown in
FIG. 211C, as gas or fluid is delivered to the expandable member
6500 through the inflation lumen 6522, the first and second
expandable portions 6510p, 6510d exert a force against an inner
surface of the tubular body organ 6800 and increase an outer
diameter of the tubular body organ 6800. This forces the outer
surface of the tubular body organ 6800 toward the inner surface
6004 of the sealing cuff 6000. As will be appreciated by a person
skilled in the art, the fluid can be delivered to the expandable
member 6500 until a desired volume or pressure is achieved. After
the sealant has substantially cured to its solidified state, the
expandable member 6500 can be moved to the compressed position by
releasing the fluid therefrom, and then retracted proximally and
removed from the patient's body.
[0773] Any of the expandable devices disclosed herein can be
positioned proximate to the anastomosis and can move from a
compressed position to an expanded position to increase an outer
diameter of portions of the tubular body organ adjacent to or
surrounding the anastomosis. This includes the expandable devices
and the expandable stents previously described. For another
example, the expandable device 6400' of FIG. 206B can be used to
increase an outer diameter of the tubular body organ 6800 adjacent
to or surrounding the anastomosis 6808. In this embodiment, a
surgeon can selectively position the second expandable member 6412'
relative to the first expandable member 6410'. More specifically, a
surgeon can position the first expandable member 6410' on the first
side, i.e. distal to the anastomosis 6808 and the location of the
expandable member 6410' can be monitored using the scope 6418, as
shown in FIG. 212A. Alternatively or additionally, a surgeon can
monitor the location of the expandable member 6410' using known
imaging techniques to identify the location device 6430, e.g.
magnet, coupled to the proximal end 6416p' of the tether 6416'and
to the distal end 6416d of the elongate member 6416. A surgeon can
detach the tether 6416' from the elongate member 6416 using various
techniques, such as by inserting a grasper tool (not shown) into
the tubular body organ 6808 and severing the tether 6416', and the
scope 6418 can be retracted proximally until it is positioned
outside of the patient, as in FIG. 212B. An inflation source (not
shown) can be coupled to the proximal end 6416p'of the tether
6416'and can deliver liquid or gas to expand the expandable member
6410'. As shown in FIG. 212C, the scope 6418 can be inserted into
the tubular body organ 6800 and can monitor a degree of inflation
and positioning of the first expandable member 6410' relative to
the anastomosis 6808. The second expandable member 6412', e.g. a
second inflatable balloon, can be positioned over the proximal
terminal end 6416p' of the tether 6416' when the proximal terminal
end 6416p' is positioned outside of the patient's body, and the
second expandable member 6412' can slide along an axial length of
the tether 6416' in a compressed position. In this way, a user can
selectively position the second expandable member 6412' relative to
the first expandable member 6410' and relative to the anastomosis
6800, and the user can monitor this positioning using the scope
6418. After the second expandable member 6412' is in a desired
position, the proximal terminal end 6416p' of the tether 6416' can
be coupled to an inflation source (not shown) and can be activated
to expand the second expandable member 6412', as shown in FIGS.
212D and 212E. The scope 6418 can be retracted proximally and
removed from the patient's body. As a procedure is performed on the
tubular body organ 6800, such as delivering sealant 6300 into the
sealing cuff 6000 positioned around the anastomosis 6808, a volume
of the expandable members 6010', 6012' can be adjusted as desired
to ensure that the outer surface of the tubular body organ 6800 and
the sealing cuff 6000 hold the sealant 6300 during the curing
process. After the sealant 6300 has substantially cured to its
solidified state, the first and second expandable members 6010',
6012' can be deflated to the compressed position and then retracted
proximally and removed from the patient's body.
Methods for Testing a Seal of an Organ
[0774] Methods for testing a seal of an anastomosis can improve a
surgical outcome by providing feedback to a surgeon as to the
effectiveness of a seal along an anastomosis. More specifically,
this can allow a surgeon to intervene and correct any leaks prior
to completing the procedure. A leak test can be performed before a
sealant is applied to an anastomosis and if liquid or gas fails to
leak out of the staple line of the anastomosis, a surgeon may
determine that it is not necessary to apply a reinforcing sealant
to the anastomosis. As another example, the leak test can be
performed after the sealant is applied to allow a surgeon to
confirm that the sealant has penetrated the staple line and cured
to its solidified state. While any of the expandable members
provided herein can be modified to include an additional lumen for
delivering liquid or gas to the portion of the tubular body organ
adjacent to the anastomosis, specific reference is made to the
expandable device of FIG. 207 for performing a leak test. After
fluid has been delivered to the device so that the expandable
members 6410, 6412 are in their expanded position, as shown in FIG.
213, fluid or gas can be delivered to the third inflation lumen
6626. This fluid can be trapped between first and second expandable
members 6410, 6412, thereby exerting pressure on the anastomosis
6808. With the expandable members 6410, 6412 so positioned, leaks
are more likely to occur at the staple line due to stretching of
the tissue. As the surgeon continues to deliver the liquid or gas
to this portion of the anastomosis 6808 until a desired volume and
pressure is achieved in the expandable members 6410, 6412, any
leaks can be observed using known imaging techniques. For example,
a surgeon can confirm the presence of leaks by visually identifying
gas bubbles or liquid moving out of the tubular body organ 6800
through the staple line. As previously mentioned, the use of dyes
or contrast material can assist a surgeon with visually identify
these leaks. The method can further include delivering therapeutic
agents through the tubular body organ 6800 and into the anastomosis
6808 using the inflation lumen 6626. Such therapeutic agents can
include, by way of non-limiting example, additional sealant
material, adhesives, coagulants, promoters of healing, oncologic
medicines, and colonic stents. The method can be performed in other
ways. For example, a fourth lumen (not shown) can also be provided
in the expandable device 6600 and a surgeon can use this fourth
lumen to drain gas or liquid from the space between the expandable
members 6410, 6412, such as to allow the leak test to be performed
multiple times and/or to deliver various therapeutic agents, gas,
liquid, etc. to the anastomosis 6808.
[0775] Other methods for performing a leak test are also shown in
FIGS. 214A and 214B, which illustrate pressure being applied to the
anastomosis 6808 at various locations. For example, FIG. 214A
illustrates an expandable device 6900 having first and second
mandrels 6910, 6912 having a thickness that increases from a
central portion of the mandrels 6910, 6912 to an outer
circumference thereof for facilitating a seal between the
expandable device 6900 and the tubular body organ 6800. As shown, a
side portion 6910s, 6912s of the mandrels 6910, 6912 can have an
increased thickness near the inner wall of the tubular body organ
6800 so that a greater surface area of the expandable member 6910,
6912 contacts the inner surface of the organ 6800. In this way, the
expandable device 6900 can withstand increased pressures and
maintain in a substantially fixed position relative to the
anastomosis 6808 as the fluid is delivered into a sealed space 6914
in between the first and second expandable mandrels 6910, 6912. As
in the previous embodiment, the first expandable member 6910 can be
inflated by delivering fluid thereto via a first inflation lumen
6922 and the second expandable member can be inflated by delivering
fluid thereto via a second inflation lumen 6924 simultaneously or
successively in any order. As shown in FIG. 214A, once the
expandable mandrels 6910, 6912 are in the expanded positions, fluid
such as gas can be delivered into the space 6914 between the
mandrels 6910, 6912 via a third inflation lumen 6926. This can
ensure that fluid does not leak out proximal or distal to the
anastomosis 6808, as such leaking could decrease a pressure being
applied to the anastomosis 6808 and thus, decrease an effectiveness
of the leak test.
[0776] FIG. 214B illustrates a method for performing a leak test
that includes a single expandable mandrel 6900' having proximal and
distal portions 6912', 6910', sized and shaped similar to the
expandable mandrels 6910, 6912 of FIG. 214A. Fluid can be delivered
to the expandable mandrel 6900' via the first inflation lumen 6922'
to expand the mandrel 6900'. In the expanded position, the
expandable mandrel 6900' has an enlarged central portion 6900c'
positioned adjacent to and in direct contact with the anastomosis
6800. The central portion 6900c' of the expandable mandrel 6900'
can exert a force perpendicular to the anastomosis 6808 and forming
a staple line support zone, as shown. In this way, the expandable
mandrel 6900' can prevent the anastomosis 6808 from compressing
radially inward as the sealant 6300 is curing therearound and held
in position in the cuff 600. Radial compression of the staple line
is undesirable because it could decrease a diameter of the tubular
body organ 6800 and prevent liquids and solids from passing
therethrough. When the expandable mandrel 6900' is so positioned,
fluid can be delivered to a first chamber 6902' positioned distal
to the anastomosis 6808 via a second inflation lumen 6924', the
first chamber 6902' being positioned between the distal portion
6910' and the anastomosis 6808. Simultaneously or sequentially,
fluid can be delivered to a second chamber 6904' positioned
proximal to the anastomosis 6808 via a third inflation lumen 6926',
the second chamber 6904' being positioned between the proximal
portion 6912' and the anastomosis 6808. As in the previous
embodiments, a surgeon can visually identify any leaks from the
anastomosis 6808. If leaks are observed, a surgeon can apply
sealant 6300 to the anastomosis using a sealing cuff 6000, etc. and
perform the leak test any number of times until the surgeon
determines that the leaks are repaired.
[0777] After the leak test is performed and/or where a sealant has
been cured to reinforce the anastomosis, the liquid or gas can be
removed from the expandable member so that the expandable member is
in the compressed position and the expandable device can be
retracted proximally and out of the patient's body.
Reprocessing
[0778] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device can utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
[0779] In some embodiments, devices described herein can be
processed before surgery. First, a new or used instrument, which
can include an adjunct material, is obtained and if necessary
cleaned. The instrument can then be sterilized. In some
embodiments, the instrument can be dried, e.g., in an oven,
together with a desiccant item, which can have a greater affinity
for moisture than the adjunct material. In one sterilization
technique, the instrument is placed in a closed and sealed
container, such as a plastic or TYVEK bag or a foil bag. The
container and instrument are then placed in a field of radiation
that can penetrate the container, such as gamma radiation, x-rays,
or high-energy electrons. The radiation kills bacteria on the
instrument and in the container. In another sterilization
technique, the instrument is placed in a first container, such as a
plastic or TYVEK bag, having a vapor permeable backing. The first
container can then be packaged in a second container, e.g., a foil
bag, which can be left open. The first and second containers,
together with the instrument, can undergo ethylene oxide
sterilization. The second container can then be sealed to prevent
moisture exposure. Prior to sealing, a desiccant item may be
included in at least one of the first and second containers to
further prevent changes to one or more device components. In both
techniques, the sterilized materials can then be stored in the
sterile container(s) to keep the materials sterile until the
container(s) is/are opened in the medical facility.
[0780] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
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