U.S. patent application number 11/900757 was filed with the patent office on 2008-08-14 for endoscopic plication device and method.
Invention is credited to Dave Cole, Samuel T. Crews, Andrew Smith, Brett Swope.
Application Number | 20080190989 11/900757 |
Document ID | / |
Family ID | 39684992 |
Filed Date | 2008-08-14 |
United States Patent
Application |
20080190989 |
Kind Code |
A1 |
Crews; Samuel T. ; et
al. |
August 14, 2008 |
Endoscopic plication device and method
Abstract
In a method of stapling layers of tissue within a body cavity,
an engaging instrument is passed between a stapler cartridge and
anvil and used to engage a region of tissue. The engaging
instrument is retracted to move the engaged tissue into the
stapling position, and driving staples from the cartridge through
at least two layers of the engaged tissue. The method and
associated system may be used to form plications in body tissue,
such as stomach wall tissue. Staples simultaneously driven through
tissue may simultaneously capture a reinforcing elements positioned
adjacent the cartridge and/or anvil prior to stapling.
Inventors: |
Crews; Samuel T.; (Palo
Alto, CA) ; Swope; Brett; (Gaithersburg, MD) ;
Cole; Dave; (San Mateo, CA) ; Smith; Andrew;
(San Francisco, CA) |
Correspondence
Address: |
STALLMAN & POLLOCK LLP
353 SACRAMENTO STREET, SUITE 2200
SAN FRANCISCO
CA
94111
US
|
Family ID: |
39684992 |
Appl. No.: |
11/900757 |
Filed: |
September 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11542457 |
Oct 3, 2006 |
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11900757 |
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60825534 |
Sep 13, 2006 |
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60723160 |
Oct 3, 2005 |
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60754417 |
Dec 28, 2005 |
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60825534 |
Sep 13, 2006 |
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Current U.S.
Class: |
227/176.1 ;
128/898; 606/219 |
Current CPC
Class: |
A61B 17/072 20130101;
A61B 17/0218 20130101; A61B 2017/306 20130101; A61B 2017/00535
20130101; A61B 2017/00827 20130101; A61F 5/0086 20130101; A61B
2017/1157 20130101; A61B 17/07292 20130101; A61B 17/1285 20130101;
A61B 17/115 20130101; A61B 17/068 20130101 |
Class at
Publication: |
227/176.1 ;
606/219; 128/898 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A method of stapling layers of tissue within a body cavity,
comprising the steps of: positioning a stapler having a cartridge,
an anvil and a stapling position between the cartridge and anvil,
within the body cavity; passing an engaging instrument through the
stapling position and engaging the region of tissue using the
engaging instrument; retracting the engaging instrument to move the
engaged tissue into the stapling position; and driving staples from
the cartridge through at least two layers of the engaged
tissue.
2. The method of claim 1, wherein driving the staples from the
cartridge includes driving a staple driver into the cartridge using
fluid pressure.
3. The method of claim 1, wherein engaging the region of tissue
includes applying suction to the region of tissue.
4. The method of claim 1, wherein engaging the region of tissue
includes pinching the region of tissue.
5. The method of claim 1, wherein driving the staples forms a fold
of stapled tissue.
6. The method of claim 1, wherein driving the staples includes
driving the staples through a reinforcing element adjacent to the
engaged tissue, causing the staples to engage the reinforcing
element.
7. The method of claim 5, wherein the method includes positioning
the reinforcing element adjacent to the anvil prior to driving the
staples.
8. The method of claim 5, wherein the method includes positioning
the reinforcing element adjacent to the cartridge prior to driving
the staples.
9. The method of claim 1, further including advancing at least one
of the anvil and cartridge to compress the engaged tissue prior to
driving the staples.
10. The method of claim 1, further including forming a cut through
the engaged tissue using a cutting element other than a staple.
11. The method of claim 10, wherein forming the cut includes
forming a cutout through the tissue.
12. The method of claim 11, wherein the staples encircle the
cutout.
13. The method of claim 3, wherein the suction is applied to a
first surface of the tissue, and wherein the method further
includes expanding an engaging element adjacent a second surface of
the tissue opposite from the first, the engaging element including
a tether extending through the tissue, and wherein moving the
engaged tissue includes pulling the engaging element to move the
engaged tissue into the stapling position.
14. The method of claim 13, wherein driving the staples includes
driving the staples through the engaging element.
15. The method of claim 1, further including introducing a shaft
into the body cavity, a distal portion of the shaft including a
first branch having the cartridge and anvil thereon and a second
branch having the engaging instrument thereon, and wherein engaging
the region of tissue includes passing the second branch between the
cartridge and anvil.
16. The method of claim 15, wherein moving the region of tissue
includes withdrawing the second branch to draw the engaged tissue
into the stapling position.
17. A stapling system, including: a stapler head on a first
elongate shaft, the stapler head having a cartridge containing
staples and an anvil; and an engaging instrument on a second
elongate shaft, the engaging instrument advanceable in a first
direction from a first position on a first side of the stapler
head, between the cartridge and anvil, to a second position on a
second side of the stapler head and into engagement with tissue on
the second side, the engaging instrument retractable in a second
direction from the second position to retract engaged tissue to a
stapling position between the cartridge an anvil.
18. The stapling system including: a main shaft having a distal
portion, wherein the first elongate shaft forms a first branch of
the distal portion and the second elongate shaft forms a second
branch of the distal portion.
19. The stapling system according to claim 17, wherein the engaging
instrument includes a vacuum head.
20. The stapling system according to claim 17, wherein the engaging
instrument including a grasping element.
21. The stapling system according to claim 17, further including a
reinforcing element positioned adjacent the cartridge and/or anvil
such that staples driven from the cartridge engage the reinforcing
element.
22. The stapling system according to claim 17, further including a
cutting element operatively associated with the stapler head to
form a cut through tissue during stapling using staples in the
cartridge.
23. The stapling system according to claim 21, wherein the cutting
element is a punch shaped to punch a hole through the tissue.
24. The stapling system according to claim 21, wherein the cutting
element is positioned such that the cut is formed to be surrounded
by staples.
25. The stapling system according to claim 19, wherein the vacuum
head is collapsible.
26. The stapling system according to claim 17, further including a
piston coupled to a staple driver, a chamber housing the piston,
and a fluid source fluidly coupled to the housing, the staple
driver positioned such that directing fluid from the fluid source
into the chamber advances the staple driver to the staple
cartridge.
27. The stapling system according to claim 26, further include a
cutting element carried by the staple driver into engagement with
tissue during advancement of the staple driver.
28. The stapling system according to claim 17, further including a
piston coupled to the cartridge, a chamber housing the piston, and
a fluid source fluidly coupled to the housing, the cartridge
positioned such that directing fluid from the fluid source into the
chamber advances the cartridge towards the anvil for tissue
compression.
29. A method of reinforcing an array of staples delivered to
tissue, the method comprising; providing a staple reinforcement
comprising a framework having at least one member and at least one
opening; positioning the staple reinforcement adjacent to a anvil
or cartridge of a stapler; positioning body tissue between the
cartridge and anvil; simultaneously driving a plurality of staples
from the cartridge, causing legs of the staples to fold around the
member.
30. The method of claim 29, wherein driving the staples causes legs
of the staples to pass through the at least one opening.
31. The method of claim 30, wherein the reinforcement is provided
to include a lattice having a plurality of openings, and wherein
driving the staples causes a plurality of legs to pass through a
plurality of the openings.
32. The method of claim 31, wherein the reinforcement is a lattice
having the plurality of openings.
33. The method of claim 31, further including the step of allowing
tissue ingrowth to form in a plurality of the openings.
Description
PRIORITY
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/825,534, filed Sep. 13, 2006. This application
is also a continuation-in-part of U.S. application Ser. No.
11/542,457, filed Oct. 3, 2006, which claims the benefit of U.S.
Provisional Application No. 60/723,160, filed Oct. 3, 2005; U.S.
Provisional Application No. 60/754,417, filed Dec. 28, 2005; and
U.S. Provisional Application No. 60/825,534, filed Sep. 13,
2006.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
systems and methods for performing endoscopic surgery, and
specifically to systems and methods for endoscopic plication of
tissue within body cavities.
BACKGROUND OF THE INVENTION
[0003] An anatomical view of a human stomach S and associated
features is shown in FIG. 1A. The esophagus E delivers food from
the mouth to the proximal portion of the stomach S. The z-line or
gastro-esophageal junction Z is the irregularly-shaped border
between the thin tissue of the esophagus and the thicker tissue of
the stomach wall. The gastro-esophageal junction region G is the
region encompassing the distal portion of the esophagus E, the
z-line, and the proximal portion of the stomach S.
[0004] Stomach S includes a fundus F at its proximal end and an
antrum A at its distal end. Antrum A feeds into the pylorus P which
attaches to the duodenum D, the proximal region of the small
intestine. Within the pylorus P is a sphincter that prevents
backflow of food from the duodenum D into the stomach. The middle
region of the small intestine, positioned distally of the duodenum
D, is the jejunum J.
[0005] FIG. 1B illustrates the tissue layers forming the stomach
wall. The outermost layer is the serosal layer or "serosa" S and
the innermost layer, lining the stomach interior, is the mucosal
layer or "mucosa" MUC. The submucosa SM and the multi-layer
muscularis M lie between the mucosa and the serosa.
[0006] Prior applications, including Attorney Docket No.
BARO-720PCT, WO 2005/037152 (incorporated herein by reference in
its entirety) describe methods according to which medical implants
are coupled to tissue structures formed within the stomach.
According to these applications, devices for inducing weight loss
(e.g. by restricting and/or obstructing flow of food into the
stomach, and/or by occupying a portion of the stomach volume) may
be coupled to tissue tunnels or plications P (FIG. 2) formed from
stomach tissue.
[0007] For example, U.S. application Ser. No. 11/439,461, Filed May
23, 2006, Attorney Docket BARO 910 (incorporated herein by
reference in its entirety), describes a Restrictive and/Or
Obstructive Implant System for Inducing Weight Loss. In one
embodiment, flexible loops 2 (FIG. 3) are coupled to tissue
plications P (FIG. 2) formed in the gastroesophageal junction
region of the stomach. An implant, such as a flow restrictive
and/or obstructive implant 4 (FIG. 4), is passed through the loops
2 and thus retained in the stomach as shown in FIG. 5.
[0008] U.S. application Ser. No. 11/542,457, filed Oct. 3, 2006
(Attorney Docket No. BARO-1110) discloses other implants, including
a restrictive pouch having anchors extending from its outer
surface. During implantation, the anchors are inserted to
cutouts/holes formed in plicated tissue.
[0009] In other instances, tissue plications may themselves be
sufficient to provide the necessary treatment. For example, the
plications may be used to reduce stomach volume or form a flow
restriction within the stomach. Two or more plications may be drawn
together and retained in some way, such as to form a restriction
and/or reduce stomach volume, as also described in U.S. application
Ser. No. 11/542,457, filed Oct. 3, 2006.
[0010] Other types of implants may be coupled to such plications or
other tissue structures for a variety of purposes. These implants
include, but are not limited to gastric space occupiers, prosthetic
valves for the treatment of gastro-esophageal reflux disease,
gastric stimulators, pH monitors and drug eluting devices that
release drugs, biologics or cells into the stomach or elsewhere in
the GI tract. Such drug eluting devices might include those which
release leptin (a hormone which creates feelings of satiety),
Ghrelin (a hormone which creates feelings of hunger), octreotide
(which reduces Ghrelin levels and thus reduces hunger), Insulin,
chemotherapeutic agents, natural biologics (e.g. growth factor,
cytokines) which aid in post surgery trauma, ulcers, lacerations
etc. Still other implants might be of a type which might provide a
platform to which specific cell types can adhere, grow and provide
biologically-active gene products to the GI tract, and/or a
platform for radiation sources that can provide a local source of
radiation for therapeutic purposes, or provide a platform whereby
diagnostic ligands are immobilized and used to sample the GI tract
for evidence of specific normal or pathological conditions, or
provide an anchor point for imaging the GI tract via cameras and
other image collecting devices.
[0011] Prior applications listed above address the desirability of
forming tissue plications, pockets or tunnels in a way that regions
of serosal tissue (i.e. the tissue on the exterior surface of the
stomach) are retained in contact with one another. Over time,
adhesions formed between the opposed serosal layers create strong
bonds that can maintain the plication over extended durations,
despite the forces imparted on them by abdominal movement and
implanted devices. More durable plications can be created by
placing any of a number of materials and/or substances (e.g.
injectable sclerosing agents) between the serosal surfaces prior to
plicating the serosal surfaces together. One example of material
suitable for this purpose is polypropolyene mesh, commonly used for
hernia repair, which when inserted in the plication fold provides a
durable anchoring position within the GI tract.
[0012] Regardless of the application for which a plication is being
formed, it is highly desirable to form that plication using steps
carried out from within the stomach using instruments passed down
the esophagus, rather than using more invasive surgical or
laparoscopic methods.
[0013] The present application describes endoscopic plicators which
may be passed transorally into the stomach and used to plicate
stomach tissue by engaging tissue from inside of the stomach and
drawing it inwardly. A section of stomach wall tissue drawn
inwardly will be referred herein as a "pinch" of tissue, although
it may be drawn inwardly using suction or other means. In preferred
embodiments, a retracting component draws tissue into the path of
travel of a stapler head. Vacuum and/or mechanical retractors may
be used for retraction. By drawing a portion of the stomach wall
between the stapler head and anvil, the retracting component causes
sections of serosal tissue on the exterior of the stomach to be
positioned facing one another. The disclosed plicators deliver
staples to secure the opposed sections of tissue to one another,
but instead may deliver sutures or other means for maintaining
contact between the tissue sections at least until serosal bonds
form between them. The plicator may pass a mesh element and/or
sclerosing agent through the stomach wall into position between the
opposed regions of serosal tissue thus enhancing serosal bonding.
Each of these steps may be performed wholly from the inside of the
stomach and thus can eliminate the need for any surgical or
laparoscopic intervention. Medical devices may then be attached to
the anchor for retention within the stomach.
[0014] While this application describes plication systems and
methods with respect to the formation of plications in stomach
tissue, the embodiments described herein have equal applicability
for forming plications in parts of the body within or outside the
GI system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A is a schematic illustration of a human stomach and a
portion of the small intestine.
[0016] FIG. 1B is a cross-sectional perspective view of a portion
of a stomach wall, illustrating the layers of tissue forming the
wall.
[0017] FIG. 2 is a perspective view of a plication system.
[0018] FIG. 3 is a perspective view of the system of FIG. 2 with
the vacuum head in a tissue engaging position.
[0019] FIG. 4 is a perspective view of the system of FIG. 3,
showing tissue being engaged by the vacuum head and compressed by
the system.
[0020] FIG. 5 is a cross-section view similar to the view of FIG.
4.
[0021] FIG. 6 is similar to FIG. 5 and shows activation of the
staple driver to fire staples from the cartridge.
[0022] FIGS. 7A through 7E are a sequence of drawings illustrating
use of an engaging element to retract tissue that has been engaged
by the vacuum head.
[0023] FIG. 8 is a perspective view of a second embodiment of a
plication system.
[0024] FIG. 9 is an exploded view of the retracting component of
the embodiment of FIG. 8.
[0025] FIG. 10A is a perspective view of an embodiment of an
expandable vacuum chamber, shown in the compressed position.
[0026] FIG. 10B is a perspective view of the vacuum chamber of FIG.
10A in the expanded position.
[0027] FIGS. 11A and 11B are plan views illustrating staple
patterns.
[0028] FIGS. 12A-12C an plan views illustrating interlocking staple
patterns.
[0029] FIGS. 13A and 13B are plan views of reinforcing rings.
[0030] FIG. 14A is a perspective view showing the reinforcing ring
of FIG. 13B on a stapler anvil.
[0031] FIG. 14B is a plan view of the reinforcing ring and anvil of
FIG. 14A.
[0032] FIG. 14C is a perspective view showing the reinforcing ring
of FIG. 13A on a staple cartridge.
[0033] FIGS. 15A and 15B are plan views of a tissue plication, in
which FIG. 15A shows the side of the plication positioned on the
staple cartridge side of the plicator, and FIG. 15B shows the side
of the plication position on the anvil side of the plicator.
[0034] FIGS. 16a and 16b are plan views showing staple
reinforcements suitable for use with linear staple patterns.
[0035] FIG. 17 schematically illustrates the use of the staple
reinforcements of FIG. 16b to support fasteners for engaging tissue
plications to one another.
[0036] FIG. 18A illustrates an alternative engaging element, and
FIGS. 18B through 18E illustrate the sequence of steps for
deploying the engaging element of FIG. 18A and retaining the
engaging element within a tissue plication.
[0037] FIG. 19 illustrates an alternative engaging element and
deployment hoop.
[0038] FIGS. 20A and 20B illustrate yet another engaging element
being deployed from the hollow needle of the vacuum head.
[0039] FIGS. 21A, 21B and 21C illustrate alternative reinforcing
elements. In FIG. 21C, the reinforcing element is shown being
deployed from a hollow tube.
[0040] FIG. 22A is a perspective view of an expandable frame for
deploying a reinforcing element. FIG. 22B shows a reinforcing
element on the frame of FIG. 22A.
[0041] FIGS. 23A and 23B are cross-section views illustrating
hydraulic systems that may be used for tissue compression and
staple driving in the system of FIG. 2.
DETAILED DESCRIPTION OF THE DRAWINGS
Plication System
[0042] FIG. 2 illustrates one embodiment of a system 10 for tissue
plication that is suitable for endoscopic use, as well as surgical
or laparoscopic use if desired.
[0043] Generally speaking, system 10 includes a main shaft 11
having a distal portion extendable through the esophagus into the
stomach. The distal portion of the main shaft 11 includes a
retracting component 12 and a stapling component 13 comprised of an
anvil 40 and a staple head 42. During use of the system 10, the
retracting component 12 is used to engage stomach wall tissue and
draw the tissue into a position between the anvil 40 and staple
head 42, allowing staples to be driven through the stomach wall
tissue to form a plication. By drawing a "pinch" of the stomach
wall inwardly and then stapling the tissue, regions of serosal
tissue are stapled to one another. Over time, these serosal tissue
layers will adhere to form relatively strong bonds giving the
plications sufficient durability to support implants within the
stomach.
[0044] Retracting component 12 is provided with a vacuum head 14
and a flexible tube 16. Tube 16 preferably includes an insertion
configuration in which it extends approximately longitudinally
relative to the main shaft 11 for streamlined advancement of the
tube 16 through the esophagus. Tube 16 is equipped with pull-wires
(not shown) and/or alternative means for articulating or
retroflexing the vacuum head 14 as needed for proper positioning
within the stomach.
[0045] Vacuum head 14 defines a vacuum chamber 18 having an opening
that, during use, is positioned into contact with stomach tissue so
as to draw the tissue into the chamber 18. Vacuum chamber is
preferably formed of a flexible material such as silicone, urethane
or other suitable materials. Tube 16 is fluidly coupled to a source
of negative pressure such as a syringe or vacuum pump such that
application of suction to the tube 16 creates a vacuum in the
vacuum chamber.
[0046] A hollow needle 20 is advanceable through the tube 16 into
the vacuum chamber 18. Hollow needle 20 includes a pointed distal
tip sufficiently sharp to penetrate stomach wall tissue (FIGS.
7A-7B) when advanced against tissue drawn into the vacuum chamber.
An optional tissue engaging element (not shown in FIGS. 2-6) is
positioned within the hollow needle 20. As shown in FIGS. 7C-7E,
the tissue engaging element is deployable from the hollow needle 20
and placed in an expanded state after the needle 20 has been
advanced through tissue, and it is then withdrawn proximally using
an attached tether or catheter following deployment to maintain
engagement with the tissue.
[0047] Various types of engaging elements may be used for this
purpose. In the embodiment shown in FIG. 7D, the engaging element
22a may be a balloon 24 mounted on a small diameter catheter 26
extendable through the needle 20. After the balloon 24 is expanded
on the serosal side of the stomach wall, tension is applied to the
catheter 26 as shown in FIG. 7E to hold the retracted tissue
between the anvil 40 and staple head 42 (not shown in FIGS. 7A-7E
but discussed below) for stapling. The vacuum chamber 18 may be
withdrawn from the tissue to move it out of the area between the
staple cartridge and anvil. Staples are then driven through the
tissue in the direction of arrow A. The balloon may be removed
after stapling or it may be left in place within the body. If the
balloon is to be left in the body, it may be formed of a
biodegradable or bioerodible material, or a more permanent
biocompatible material.
[0048] As mentioned previously, stapling component 13 includes an
anvil 40 and a stapler head 42. Although FIGS. 2-6 show the head 42
positioned distally of the anvil 40, in other embodiments the
positions of these features might be reversed. Likewise, while in
the illustrated embodiments the staple head is advanced to compress
the tissue, in other embodiments the anvil might instead be
advanced.
[0049] The stapling component 13 is pivotable relative to the main
shaft 11 so that once the stapling component 13 is positioned
within the stomach, it may be moved laterally towards the stomach
wall. In the FIG. 2 embodiment, anvil 40 is mounted to an
articulated base 52 coupled to the main shaft 11 at pivot point 54
(FIG. 5), allowing for rotation of the base (and thus the stapling
component 13) relative to the main shaft 11. The base 52 is
moveable to a longitudinal position (not shown) relative to the
shaft to facilitate streamlined movement of the system 10 through
the esophagus. As shown in FIG. 5, a motor driven worm screw 56 is
activated to articulate the base 52.
[0050] As best shown in FIG. 5, staple head 42 includes a staple
cartridge 44 containing staples (not visible in the drawing), and a
staple driver 46 positioned to drive staples from the cartridge 44
when it is advanced proximally into contact with the staples. Fluid
lines 58a, 58b extend from the cartridge 44 and staple driver 46
respectively and are coupled to air, gas other fluid (any of which
will be referred to as "fluid") sources positioned external to the
body. During use, fluid or gas pressure is directed through fluid
line 58a and used to advance the staple cartridge 44 into contact
with tissue positioned between the anvil 40 and cartridge 44 as
shown in FIG. 4, thereby compressing the tissue. In an alternative
embodiment, the fluid line 58a may be replaced with a cable
configured to drive a lead screw that, when activated, advances the
staple cartridge 44 to compress tissue disposed within the gap
between the anvil 40 and the staple cartridge 44.
[0051] Once tissue is compressed between the cartridge 44 and anvil
40, fluid/gas is then directed through fluid line 58b to pressurize
cylinder 48 sufficiently to drive the staple driver 46 into contact
with staples positioned in the staple cartridge 44. A tissue
cutting element 50, which in the illustrated embodiment is a
tubular element having a sharpened end, is coupled to the staple
driver 46 such that it will core through the tissue during stapling
to form a hole in the plication.
[0052] FIGS. 23A and 23B show collapsible hydraulic systems that
may be used to advance the cartridge 44 and staple driver 46.
[0053] System 110 of FIG. 23A allows for sequential movement of the
cartridge and the driver allowing for compression and then
stapling. System 110 includes nested cylinders 112a, 112b and 112c,
fluid inlets 114a, 114b and 114c, and o-ring seals 116a-d. When
fluid pressure is introduced into the system via inlet 114a,
cylinder 112b advances to the left. Once seal 116b of cylinder 112b
crosses over inlet 114b, fluid pressure is applied to cylinder 112a
through inlet 114c, causing cylinder 112a to begin moving towards
the left of the drawing. This arrangement can be used to first
compress (e.g. using staple cartridge coupled to cylinder 112b),
and to then staple (e.g. using a staple driver coupled to cylinder
112a) the tissue using a single source of fluid or gas
pressure.
[0054] System 111 of FIG. 23B is a telescoping fluid power actuator
that may be used when the length of the path of travel needed for a
feature (e.g. the stapler driver, cartridge, and/or anvil) would
require a cylinder that is longer than can be accommodated by the
environment (e.g the stomach). System 111 includes cylinders 118a,
118b and 118c, inlets 120a and 120b, and seals 122. Pressure
applied at inlet 120a will cause cylinder 118a (which may be
coupled to the cartridge) to advance to the left. Once cylinder
118a has moved a distance "1", it will engage with a shoulder 124
on cylinder 118b, causing cylinder 118b to travel with cylinder
118a as cylinder 118a continues to move. In this arrangement, a
long stroke for cylinder 118a is gained from a short fluid power
system.
[0055] FIG. 8 shows an alternative embodiment of a modified
plication system 10a which utilizes rigidizable cables 80 to
deflect the stapling component 13 relative to the main shaft 11
Cables 80 are preferably formed of a plurality of spine elements 82
strung onto a pull wire (not shown). Fluid lines 58a, 58b may
extend through holes in the spine elements, or they may be separate
from the cables 80. When tension is applied to the cables using
actuators positioned outside the body, the spine elements 82 engage
one other to stiffen the cable. The spine elements 82 may be shaped
such that the cable will assume a predetermined bend when tension
is applied to them.
[0056] In the FIG. 8 embodiment, a rigidizable cable 86 also
carries the vacuum chamber 18a. Cable 86 includes a pull wire (not
shown) extending through spine elements 88. The spine elements 88
are shaped to orient the chamber 18a for advancement between the
anvil 40 and cartridge 44. Cable 86 may extend from a sheath 89
that is longitudinally extendable from a lumen in the main shaft
11.
[0057] Vacuum chamber 18a may be foldable or compressible for
positioning within the sheath 89. FIG. 10A shows a folded vacuum
chamber 18b beginning to expand as it exits the distal end of
sheath 89, and FIG. 10B shows the vacuum chamber 18b fully expanded
after exiting the sheath 89. FIG. 10A illustrates that in
alternative embodiments, endoscopes 98 and/or other instruments may
be passed through the vacuum chamber 18b to give access and/or
visualization to the stomach wall or other organs or tissues. In
the FIG. 8 embodiment, a collar 96 is positioned on the main shaft
11 for receiving endoscope 98.
[0058] FIG. 9 is an exploded view of the vacuum chamber 18a of the
FIG. 8 embodiment, and illustrates that a pair of gripping jaws 90
is positioned within the vacuum chamber 18a. The jaws 90 are
constructed using a linkage arrangement and are controlled using a
pull wire extending through a back plate 92 of the vacuum chamber
18a, through spine elements 88 (FIG. 8), and to the proximal end of
the plicating system outside the body. Before vacuum is applied,
the jaws are moved to an open position. When vacuum pressure draws
tissue into the vacuum chamber 18a, the jaws 90 are closed to
engage the tissue.
[0059] The FIG. 8/9 vacuum chamber 18a additionally includes
stabilizing arms 94 extending into the vacuum chamber 18a. The
stabilizing arms are retained in contact with the interior walls of
the chamber 18a to prevent the chamber from collapsing when vacuum
is applied. The arms may be moveable between closed and opened
positions to allow the vacuum chamber to collapse for passage
through the esophagus, or they may remain fixed in the opened
position.
Plication Reinforcements
[0060] Reinforcements of various types may be implanted in or on
plications formed using the plication system. Such reinforcements
may function to reinforce the staple array, help to more evenly
distribute the forces applied to the tissue by the staples, and/or
facilitate bonding between the opposed serosal layers. Suitable
reinforcements include ones positionable on or between the serosal
tissue layers ("serosal side reinforcements"), as well as those
delivered on the side of the mucosal tissue ("mucosal side
reinforcements").
[0061] For serosal side reinforcements, a reinforcement similar to
engaging element 22a described in connection with FIG. 7D may serve
as a permanent or semi-permanent implant that will reinforce the
staple array applied to the tissue and/or facilitate serosal tissue
bonding between the layers of stomach wall tissue that are to be
stapled together. For this purpose, the material may be a synthetic
or non-synthetic mesh (formed of nitinol, polyester, or other
natural or synthetic material), porous or non-porous material,
slotted material, or any other material through which adhesions
will form or onto which tissue will grow. Examples include, but are
not limited to, polypropylene, materials sold under the trade names
Goretex or Dacron, or tissue graft material such as the Surgisis
material sold by Wilson Cook Medical, Inc. The material may be
treated with tissue-ingrowth promoting substances such as
biologics. In an embodiment shown in FIG. 18A, the reinforcement
22b is a mesh/braid embedded in or coated with a dissolvable or
bioabsorbable coating. The reinforcement 22b is preferably
positioned in a manner similar to that described in connection with
the balloon of FIG. 7D. Specifically, vacuum chamber 18 is used to
engage a region of tissue where a plication is to be formed. Hollow
needle 20 is advanced from within the chamber 18 through the
stomach wall, and the reinforcement 22b is advanced from the hollow
needle and inflated to a toroidal shape between the opposed regions
104 of serosal tissue. The reinforcement 22b may optionally be used
for retraction of the stomach wall via application of tension on
the tether 33 as shown in FIG. 18D. Staples driven through the
tissue pierce and deflate the inflated reinforcement as shown in
FIGS. 18D and 18E, and capture the deflated reinforcement between
the opposed serosal tissue layers. The reinforcement is left in
place between the two layers of stomach wall tissue after stapling.
The coating on the deflated balloon dissolves, exposing the
interstices of the underlying mesh or porous material to serosal
growth.
[0062] As shown in FIG. 19, the reinforcement 22c may instead be a
mesh disk 30 detachably carried (e.g. using sutures 32) on a wire
hoop 34 extendable through needle 20 in a compressed shape and then
self-expandable to the illustrated position to expand the mesh on
the outside of the stomach. The sutures 32 are severed during
stapling, leaving the mesh in place between the plicated tissue
layers. The hoop 34 is withdrawn into the needle 20 and removed
from the body.
[0063] In another embodiment shown in FIGS. 20A and 20B, the
reinforcement 22d may be an elongate nitinol mesh or braid backbone
35 that may be positioned longitudinally within the hollow needle
20, but that is shape set to assume a circular or other suitable
configuration once released from the hollow needed between the
serosal tissue layers. In modifications to this concept shown in
FIGS. 21A-21C, the reinforcement 22e may be a wire 37 or ribbon
shape set to assume one of a variety of expanded configurations
when it is pushed out of the hollow needle 20. In the expanded
configuration, the wire may assume a pattern shaped such that when
it is positioned between serosal tissue layers, it will be captured
by staples advanced through the tissue. As with the other
reinforcements disclosed above, the pattern may be annular as in
FIG. 21A or 21C, or it may be disk-like as in FIG. 21B. Moreover,
while the patterns are shown to have an approximately circular
silhouette, other shapes may instead be used.
[0064] In another embodiment shown in FIGS. 22A and 22C, a
reinforcement 22f (which may be formed of a polyester fabric or
other material including those listed elsewhere in this
application) is carried by a frame 106 having a plurality of
outwardly extending arms 108 that spring to an expanded position
when released from hollow tube 20. The reinforcement 22e is
deployed using hollow needle 20 in a manner similar to those
described above. Specifically, the hollow needle 20 is pierced
through engaged stomach wall tissue, and the frame is advanced out
the distal end of the needle 20 to allow arms 108 to spread to the
expanded position shown in FIGS. 22A and 22C, thereby expanding the
reinforcement 22e between the opposed serosal layers. The element
is fixed between the layers by the staples driven through the
opposed regions of stomach wall, and the frame is withdrawn from
the needle and out of the body.
[0065] Mucosal side reinforcements may take the form of
reinforcements that are positioned on or adjacent to one or both of
the mucosal surfaces lining the "pinch" of tissue that will form
the plication. These reinforcements may be features of the staples
or staple arrays, or they may be separate components engaged by
staples as the staples are advanced through the tissue.
[0066] Referring to FIG. 21A, conventional stapling procedures will
often include two parallel rows of staples, in which the staples in
one row are laterally offset from the staples of the other row.
According to the disclosed method, it is useful to employ this
technique to the circular staple pattern delivered using the
plicator 10, to produce two concentric rings of offset staples, as
shown in FIG. 11B. It has been found to be additionally beneficial
to form mucosal side reinforcements by linking or interlocking the
staples to provide greater structural reinforcement to the stapled
tissue and/or to more evenly distribute forces applied to the
tissue by the staples. Linked staple arrays may be formed by
arranging the staples 70 in the cartridge of the plicator 10 in a
single circular pattern to interlock as shown in FIG. 12A, or in a
double circular pattern with two concentric rings of interlocked
staples. The staples 70a may be curvilinear so as to form a locking
pattern shown in perspective view of FIG. 12B. A linear arrangement
of staples 70 may also be linked as shown in FIG. 12C.
[0067] In alternative embodiments, staples are linked together by
reinforcing members formed of metallic or polymeric materials, such
as nitinol, titanium, stainless steel PEEK, or other biocompatible
materials. According to these embodiments, the reinforcing members
are positioned on one or both of the mucosal sides of the "pinch"
of tissue engaged by the plication system such that they are
captured by staples being driven through the tissue. In a preferred
embodiment, the staples capture a cartridge side reinforcing ring
72 (FIG. 13A) as they leave the cartridge and/or capture an anvil
side reinforcing ring 74 (FIG. 13B) as the anvil shapes and bends
them. Upon completion of the placation, the staples are linked to
one another so that they cannot separate or expand radially. The
use of the reinforcing rings is advantageous compared with prior
art staple buttressing materials such as sheets formed of bovine
pericardium or hydrogel, both of which are penetrated (and thus
potentially compromised) by staples as they are driven through the
tissue. The open structure or lattice pattern of the reinforcing
rings provides openings for the staples to pass through as well as
supportive members for the staples to wrap around--so that the
staples capture but do not penetrate the ring material. Over time,
tissue may grow into the lattice structure and/or around the
supportive members. The proportions of the ring, such as the sizes
of the openings in the lattice structure, may be adjusted to
increase or decrease the amount of ingrowth that might occur.
[0068] The reinforcing rings are preferably provided separate from
the staples although they instead may be integral with the staples.
In this embodiment, ring 74 is positioned against the staple anvil
40 as shown in FIGS. 14A and 14B. The anvil may include retaining
elements to maintaining the ring's position on the anvil. Ring 72
is seated within the cartridge 44, with the staples 70 aligned with
their prongs 76 extending through openings 73 in the ring 72.
Alternatively, the cartridge may have retaining elements to hold
the ring in place prior to stapling.
[0069] When staples 70 are driven from the cartridge, they advance
further through openings 73, capturing ring 72 against the adjacent
mucosal tissue as shown in FIG. 15A. The staple legs/prongs 76 pass
through the stomach wall tissue into contact with the indentations
78 of the anvil 40. When they contact the anvil 40, the prongs 76
fold around the staple ring 74 to capture the ring and interlock
the staples on the anvil side of the plication as shown in FIG.
15B. Rings or other interlocking elements of this type may be used
with single- or double-staple row configurations.
[0070] Rings 72, 74 are shown as generally circular, although
alternative reinforcements of different shapes and patterns may
also be used, including those shaped to accommodate linear, oval
and other staple patterns.
[0071] FIGS. 16a and 16b show two examples of reinforcements 75a,
75b useful for linear staple patterns. As shown, reinforcements are
similar to the ring 72 in their use of a plurality of
interconnecting members that define openings 73a for receiving
staple legs. The legs of any given staple may pass through two
laterally positioned openings 73a, longitudinally positioned
openings 73a, just a single opening, or any other combination.
These reinforcements may be used with linear staplers in a manner
described above with respect to the circular staplers. The
reinforcements may include members 77 positioned to receive
implants that might be used within the body (e.g. pH monitors or
other sensors, stimulation/pacing leads, etc.). FIG. 17 illustrates
use of the loops 77 to support fasteners 79a, 79b in a system for
engaging one tissue plication to another tissue plication. Staples
70 driven through the openings 73a engage the reinforcements and
form the plications. The fasteners 79a, 79b are then brought into
engagement with one another to draw and couple the plications
together. This may be used to form a restriction and/or reduce
stomach volume, or for other purposes.
[0072] The disclosed reinforcements may be sold as individual
components that may be used together with commercially available
staplers to reinforce the lines/rings of staples to be delivered by
those staplers.
Exemplary Method of Use
[0073] One method of using the illustrated system will next be
described with reference primarily to FIGS. 8 and 9.
[0074] In preparation for use, the orientation of the staple head
42 and the vacuum chamber 18a are adjusted using the appropriate
pullwires to place them in their longitudinal positions.
[0075] Next, the assembled plicator 10a is passed into the stomach
S via the esophagus, preferably through a protective sheath passed
through the esophagus. Endoscope 98 is also passed into the stomach
to provide visualization of the procedure. The endoscope is
preferably mounted to plicator 10a, or it may be a separate
component.
[0076] The plicator 10a is advanced towards a target location at
which a plication is to be formed. The rigidizable cable 86 is
manipulated using pull wires to extend vacuum chamber 18a between
the fluid lines 58a, 58b and against adjacent stomach tissue.
Suction is applied to the vacuum chamber 18 to draw stomach tissue
into the vacuum chamber. The gripper arms 90 are closed to pinch
the tissue within the chamber, and the vacuum chamber 18a is
withdrawn from between the fluid lines 58a, 58b, carrying the
engaged tissue with it (see FIG. 4). Consequently, a pocket 100
forms in the tissue such that if the stomach were to be viewed from
the outside a depression in the stomach wall would be visible.
Serosal tissue surfaces 104 line the outside surfaces of the pocket
100. If gripper arms are not used, suction maintained to stabilize
the tissue within the vacuum chamber.
[0077] If additional stabilization of the tissue is desired, such
as during use of the FIG. 2 embodiment, hollow needle 20 may be
advanced through the engaged tissue as shown in FIGS. 7A and 7B,
and balloon 24 is inflated within the pocket 100 as shown in FIGS.
7C and 7D. As shown in FIG. 7E, the inflated balloon 24 is
withdrawn using catheter 26, thus retracting the tissue surrounding
the pocket 100. Alternatively, the engaging element 22b of FIG. 8A,
or element 22d of FIGS. 10A and 10B may be deployed and used in
similar fashion. If element 22c of FIG. 9 is to be used, the hoop
34 is advanced through the hollow needle 20 into the pocket 100
where it springs to its opened configuration to expand the mesh
element 22c.
[0078] Referring again to FIG. 8, once the tissue has been drawn
between the fluid lines 58a, 58b, fluid is driven through fluid
line 58a to bring the staple cartridge 44 into contact with the
tissue and to compress the tissue between the cartridge 44 and the
anvil 40 (see FIG. 4). Once the tissue is fully compressed, fluid
pressure is via line 58b, causing the staple driver 46 to advance
into contact with staples in the cartridge 44, thus driving the
staples through the tissue and simultaneously forming a hole or
incision through the layers of stomach wall tissue. The sharp ends
of the staples fold against the anvil 40 after passing through the
two layers of stomach wall tissue, thus maintaining the plication.
If the mucosal reinforcements 72, 74 of FIGS. 13A, 13B are used,
the staples engage one or both mucosal reinforcing rings as during
stapling.
[0079] The procedure may be repeated to form multiple plications if
needed. Following formation of the plication(s), a medical implant
may be coupled to the hole/incision formed by the hollow needle 20.
Coupling may be carried during the course of the same procedure or
during a later procedure scheduled to permit sufficient formation
of adhesions between the serosal tissue layers 102 to support the
implant.
[0080] The system or other components described herein may be
packaged with instructions for use instructing a user to utilize
the system according to methods disclosed herein.
[0081] As is evident from above, the disclosed endoscopic systems
function to draw a tissue into the stomach to form a depression on
the exterior surface of the stomach, and staple (or suture, or
fasten or adhere etc) the opposed stomach wall sections lining the
depression together another to form a plication. The system may
additionally place material of a type that will promote strong
tissue adhesion within the depression (on the exterior of the
stomach) and retain the material between the serosal surfaces to
enhance. Additionally or alternatively, mucosal reinforcements such
as structures that interconnect the staples may be implanted. While
these systems provide convenient embodiments for carrying out this
function, there are many other widely varying instruments or
systems may alternatively be used within the scope of the present
invention. Moreover, the disclosed embodiments may be combined with
one another in varying ways to produce additional embodiments.
Thus, the embodiments described herein should be treated as
representative examples of systems useful for forming endoscopic
tissue plications, and should not be used to limit the scope of the
claimed invention.
[0082] Any and all patents, patent applications and printed
publications referred to above, including those relied upon for
purposes of priority, are incorporated herein by reference.
* * * * *