U.S. patent application number 14/673237 was filed with the patent office on 2015-07-23 for layer arrangements for surgical staple cartridges.
The applicant listed for this patent is Ethicon Endo-Surgery, Inc.. Invention is credited to Jerome R. Morgan, Katherine J. Schmid, Frederick E. Shelton, IV, Jeffrey S. Swayze.
Application Number | 20150201937 14/673237 |
Document ID | / |
Family ID | 69468339 |
Filed Date | 2015-07-23 |
United States Patent
Application |
20150201937 |
Kind Code |
A1 |
Swayze; Jeffrey S. ; et
al. |
July 23, 2015 |
LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES
Abstract
A piece of buttress material and an end-effector of a surgical
instrument including features which can aid a surgeon in properly
and quickly attaching the piece of buttress material to the
end-effector. In various embodiments, a piece of buttress material
can include retention features which can be engaged with portions
of an end-effector to releasably retain the piece of buttress
material to at least a portion of the end-effector. Similarly, an
end-effector can include features configured to engage portions of
a piece of buttress material to releasably retain the piece of
buttress material to the end-effector. In at least one embodiment,
more than one piece of buttress material can be releasably retained
to an end-effector.
Inventors: |
Swayze; Jeffrey S.; (West
Chester, OH) ; Morgan; Jerome R.; (Cincinnati,
OH) ; Schmid; Katherine J.; (Cincinnati, OH) ;
Shelton, IV; Frederick E.; (Hillsboro, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
69468339 |
Appl. No.: |
14/673237 |
Filed: |
March 30, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13763095 |
Feb 8, 2013 |
|
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|
14673237 |
|
|
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|
12032002 |
Feb 15, 2008 |
8371491 |
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13763095 |
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Current U.S.
Class: |
227/176.1 |
Current CPC
Class: |
A61B 17/07292 20130101;
A61B 2017/2927 20130101; A61B 2018/00196 20130101; A61B 2090/037
20160201; A61B 2018/1455 20130101; A61B 17/068 20130101; A61B
2017/00473 20130101; A61B 2017/00477 20130101; A61B 2017/0725
20130101; A61B 2017/07278 20130101; A61B 2017/2923 20130101; A61B
17/072 20130101; A61B 2017/07235 20130101; A61B 2017/2933 20130101;
A61B 17/07207 20130101; A61B 2017/07228 20130101; A61B 2017/00893
20130101; A61B 2017/2946 20130101; A61B 2050/314 20160201; A61B
17/105 20130101; A61B 2017/00004 20130101; A61B 2017/07271
20130101; A61B 2017/07264 20130101; A61B 17/1155 20130101; A61B
2017/00964 20130101; A61B 2017/07242 20130101; A61B 2017/00526
20130101; A61B 2017/2919 20130101; A61B 18/1445 20130101; A61B
2017/2936 20130101; A61B 17/0643 20130101; A61B 50/30 20160201;
A61B 2017/005 20130101; A61B 2017/0053 20130101; A61B 2017/07214
20130101; A61B 2017/2908 20130101; A61B 2090/034 20160201; A61B
2017/07285 20130101; A61B 2017/00831 20130101 |
International
Class: |
A61B 17/10 20060101
A61B017/10; A61B 17/068 20060101 A61B017/068 |
Claims
1-16. (canceled)
17. A surgical instrument system, comprising: an end effector,
comprising: a first jaw; a second jaw, wherein said second jaw is
rotatable relative to said first jaw; a staple cartridge,
comprising: a deck comprising a first step and a second step; a
first longitudinal row of staple cavities defined in said first
step; a second longitudinal row of staple cavities defined in said
second step; and staples removably stored in said staple cavities;
an anvil, comprising: a tissue compression surface; and forming
pockets configured to deform said staples; an applicator assembly,
comprising: a support insertable between said deck and said tissue
compression surface, wherein said support comprises a first support
surface and a second support surface; a first implantable layer
releasably attached to said first support surface, wherein said
first implantable layer comprises a first outwardly-facing surface
configured to engage said first step and said second step of said
deck; a flowable polymer adhesive on said first outwardly-facing
surface; a second implantable layer releasably attached to said
second support surface, wherein said second implantable layer
comprises a second outwardly-facing surface configured to engage
said tissue compression surface of said anvil; a flowable polymer
adhesive on said second outwardly-facing surface, wherein each said
flowable polymer adhesive is comprised of a copolymer composed of
polycaprolactone in the range of from about 65 mole percent to
about 35 mole percent; and removable packaging which covers said
first implantable layer and said second implantable layer and
inhibits the inadvertent attachment of said flowable polymer
adhesive.
18. The surgical instrument system of claim 17, wherein said
copolymer is further composed of polyglycolic acid in the range of
from about 35 mole percent to about 65 mole percent.
19. The surgical instrument system of claim 17, further comprising
an indexing feature defined on one of said first implantable layer
and said second implantable layer configured to assist in aligning
said first implantable layer with said deck and said second
implantable layer with said compression surface.
20. The surgical instrument system of claim 17, wherein said
support is positionable between said deck and said tissue
compression surface in an alternate orientation in which said first
implantable layer is releasably attached to said anvil and said
second implantable layer is releasably attached to said deck.
21. The surgical instrument system of claim 17, further comprising
an attachment portion configured to be attached to a shaft of a
surgical stapling instrument.
22. The surgical instrument system of claim 17, wherein said staple
cartridge is configured to be removed from said end effector and
replaced with another staple cartridge.
23. A surgical instrument system, comprising: an end effector,
comprising: a first jaw; a second jaw, wherein said second jaw is
rotatable relative to said first jaw; a staple cartridge,
comprising: a deck; a first longitudinal row of staple cavities; a
second longitudinal row of staple cavities; and staples removably
stored in said staple cavities; an anvil, comprising: a tissue
compression surface; and forming pockets configured to deform said
staples; an applicator assembly, comprising: a support insertable
between said deck and said tissue compression surface, wherein said
support comprises a first support surface and a second support
surface; a first implantable layer releasably attached to said
first support surface, wherein said first implantable layer
comprises a deck; a flowable polymer adhesive on said first
outwardly-facing surface; a second implantable layer releasably
attached to said second support surface, wherein said second
implantable layer comprises a second outwardly-facing surface
configured to engage said tissue compression surface of said anvil;
a flowable polymer adhesive on said second outwardly-facing
surface, wherein each said flowable polymer adhesive is comprised
of a copolymer composed of polyglycolic acid in the range of from
about 35 mole percent to about 65 mole percent; and removable
packaging which covers said first implantable layer and said second
implantable layer and inhibits the inadvertent attachment of said
flowable polymer adhesive.
24. The surgical instrument system of claim 23, wherein said
copolymer is further composed of polycaprolactone in the range of
from about 65 mole percent to about 35 mole percent.
25. The surgical instrument system of claim 23, further comprising
an indexing feature defined on one of said first implantable layer
and said second implantable layer configured to assist in aligning
said first implantable layer with said deck and said second
implantable layer with said compression surface.
26. The surgical instrument system of claim 23, wherein said
support is positionable between said deck and said tissue
compression surface in an alternate orientation in which said first
implantable layer is releasably attached to said anvil and said
second implantable layer is releasably attached to said deck.
27. The surgical instrument system of claim 23, further comprising
an attachment portion configured to be attached to a shaft of a
surgical stapling instrument.
28. The surgical instrument system of claim 23, wherein said staple
cartridge is configured to be removed from said end effector and
replaced with another staple cartridge.
29. A surgical instrument system, comprising: an end effector,
comprising: a first jaw; a second jaw, wherein said second jaw is
rotatable relative to said first jaw; a staple cartridge,
comprising: a deck; a first longitudinal row of staple cavities; a
second longitudinal row of staple cavities; and staples removably
stored in said staple cavities; an anvil, comprising: a tissue
compression surface; and forming pockets configured to deform said
staples; an applicator assembly, comprising: a support insertable
between said deck and said tissue compression surface, wherein said
support comprises a first support surface and a second support
surface; a first implantable layer releasably attached to said
first support surface, wherein said first implantable layer
comprises a deck; a flowable polymer adhesive on said first
outwardly-facing surface; a second implantable layer releasably
attached to said second support surface, wherein said second
implantable layer comprises a second outwardly-facing surface
configured to engage said tissue compression surface of said anvil;
a flowable polymer adhesive on said second outwardly-facing
surface, wherein each said flowable polymer adhesive is comprised
of a copolymer composed of polyglycolic acid in the range of from
about 35 mole percent to about 65 mole percent and polycaprolactone
in the range of from about 65 mole percent to about 35 mole
percent; and an indexing feature defined on one of said first
implantable layer and said second implantable layer configured to
assist in aligning said first implantable layer with said deck and
said second implantable layer with said compression surface
30. The surgical instrument system of claim 29, wherein said
support is positionable between said deck and said tissue
compression surface in an alternate orientation in which said first
implantable layer is releasably attached to said anvil and said
second implantable layer is releasably attached to said deck.
31. The surgical instrument system of claim 29, further comprising
an attachment portion configured to be attached to a shaft of a
surgical stapling instrument.
32. The surgical instrument system of claim 29, wherein said staple
cartridge is configured to be removed from said end effector and
replaced with another staple cartridge.
33. The surgical instrument system of claim 29, further comprising
removable packaging which covers said first implantable layer and
said second implantable layer and inhibits the inadvertent
attachment of said flowable polymer adhesive.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application claiming
priority under 35 U.S.C. .sctn.120 to U.S. patent application Ser.
No. 13/763,095, entitled LAYER ARRANGEMENTS FOR SURGICAL STAPLE
CARTRIDGES, filed Feb. 8, 2013, now U.S. Patent Application
Publication No. 2013/0161374, which is a continuation-in-part
application claiming priority under 35 U.S.C. .sctn.120 to U.S.
patent application Ser. No. 12/032,002, entitled SURGICAL END
EFFECTOR HAVING BUTTRESS RETENTION FEATURES, filed Feb. 15, 2008,
which issued on Feb. 12, 2013 as U.S. Pat. No. 8,371,491, the
entire disclosures of which are hereby incorporated by reference
herein.
BACKGROUND
[0002] i. Field of the Invention
[0003] The present invention generally relates to buttress material
for a surgical instrument, and to buttress material configured to
be releasably attached to an end-effector assembly of a surgical
instrument.
[0004] ii. Description of the Related Art
[0005] A surgical instrument, such as a surgical stapler, for
example, can be configured to deploy staples into tissue during a
surgical procedure. In various embodiments, the surgical stapler
can include an end-effector configured to be positioned on a distal
end of the surgical stapler. The end-effector can be configured to
be positioned within, and slid at least partially through, a
cannula, or trocar, positioned in a wall of a patient's body such
that a surgeon can utilize the end-effector to perform work within
a surgical site. In various embodiments, the end-effector can
comprise a first jaw member including a staple cartridge and,
additionally, a second jaw member including an anvil. The first and
second jaw members can be configured to be moved proximally towards
each other to clamp layers of tissue therebetween and apply a
compressive force thereto. In at least one embodiment, the staple
cartridge can be configured to removably store staples therein and
the anvil can be configured to deform the staples as they are
deployed from the staple cartridge.
[0006] In some circumstances, the layers of tissue can be
relatively thin, can have a high fluid content, and/or can have a
non-uniform thickness, which can cause the staples to be improperly
formed within the tissue. To ameliorate this problem, a piece of
buttress material can be utilized to support the tissue as the
tissue is being clamped and stapled. In at least one embodiment, a
piece of buttress material can be releasably attached to at least
one of the first and second jaw members before they are inserted
into a surgical site. In various embodiments, the piece of buttress
material can be utilized to distribute the compressive force
applied by the anvil over the surface area of the buttress material
in order to create a more uniform tissue compression profile within
the tissue. In at least one embodiment, a uniform tissue
compression profile can increase the likelihood that that the
staples will be properly formed in the tissue.
[0007] In various embodiments, a piece of buttress material can be
difficult for a surgeon to attach to the jaw members of an
end-effector. In at least one embodiment, the piece of buttress
material can be attached to one of the jaw members using an
adhesive configured to releasably retain the piece of buttress
material thereto. In such an embodiment, a surgeon must carefully
align the piece of buttress material with the jaw member owing to
the possibility that the adhesive may immediately bond the buttress
material to the jaw member. In such circumstances, the piece of
buttress material may have to be removed from the jaw member and
replaced a new piece of buttress material. As a result, the surgeon
can spend valuable time positioning and aligning a piece of
buttress material on a jaw member of an end-effector. What is
needed is an improvement over the foregoing.
SUMMARY
[0008] In at least one form of the invention, a piece of buttress
material and/or an end-effector of a surgical instrument can
include features which can aid a surgeon, or other clinician, in
properly aligning and attaching a piece of buttress material to an
end-effector. In at least one embodiment, the piece of buttress
material can include at least one member extending therefrom,
wherein the member can be configured to be engaged with one of a
staple cavity defined in a staple cartridge and/or an anvil pocket
defined in an anvil. In at least one such embodiment, the member
can be friction-fit and/or press-fit within the staple cavity
and/or the anvil pocket to releasably retain the piece of buttress
material to one of the staple cartridge and the anvil, for example.
In various embodiments, a notch or slot can be defined in one of a
staple cartridge and/or an anvil wherein the notch can be
configured to receive a portion of a piece of buttress material and
releasably retain the piece of buttress material thereto. In at
least one embodiment, a piece of buttress material can include a
projection extending therefrom, wherein the projection can be
configured to be releasably engaged with a cutting member channel
in at least one of the staple cartridge and the anvil. In such an
embodiment, the projection can be press-fit, friction-fit, and/or
otherwise engaged with the channel, for example.
[0009] In at least one form of the invention, a piece of buttress
material and an end-effector can include co-operating features,
such as lips, for example, which can allow the piece of buttress
material to be attached to the end-effector in a snap-fit fashion.
In various embodiments, an end-effector can include resilient
members extending therefrom, wherein the resilient members can be
configured to contact portions of the piece of buttress material
and releasably retain the buttress material to the end-effector. In
at least one embodiment, one of the staple cartridge and the anvil
can include a plurality of retaining members wherein portions of a
piece of buttress material can be friction-fit against the
retaining members to releasably retain the piece of buttress
material to the staple cartridge and/or anvil.
[0010] In at least one form of the invention, a piece of buttress
material can be releasably attached to a sleeve, wherein the sleeve
can be configured to be slid over at least one of the staple
cartridge and the anvil of an end-effector. In at least one
embodiment, the piece of buttress material can include a side
portion which can be attached to the sleeve and, in addition, a
body portion configured to be engaged with staples when the staples
are deployed from the staple cartridge. In such an embodiment, the
side portion can be used to releasably retain the body portion to
the sleeve. In at least one embodiment, a recess and/or perforation
can be defined in the piece of buttress material intermediate the
side portion and the body portion, for example, such that the body
portion can be separated from the side portion. In at least one
embodiment, as a result, the perforation and/or recess can allow
the sleeve to be removed from the buttress material after the
staples have been deployed into the body portion.
[0011] In at least one form of the invention, a package for a piece
of buttress material can be utilized to quickly align and position
a piece of buttress material within an end-effector. In various
embodiments, a package can include a first portion, a second
portion, and a piece of buttress material which can be releasably
attached to the first portion. In at least one embodiment, the
second portion can be configured to be moved between a first
position in which it is adjacent to the piece of buttress material
and a second position. In various embodiments, the piece of
buttress material can be exposed when the second portion is in the
second position such that the package can be positioned
intermediate jaw members of an open end-effector to engage the
exposed piece of buttress material to one of the jaw members of the
end-effector. In various embodiments, the buttress material can
include an adhesive thereon for retaining the buttress material to
one of the maw members. After the piece of buttress material is
engaged with one of the jaw members, the second portion can be
pulled away from the end-effector to release the first portion from
the piece of the buttress material.
[0012] In at least one form of the invention, a piece of buttress
material can be fastened to at least one of an anvil and a staple
cartridge of an end-effector. In various embodiments, an anvil
and/or staple cartridge can include one or more apertures, or
openings, therein which can be configured to receive one or more
fasteners to retain a piece of buttress material to the anvil or
staple cartridge. In various embodiments, the fasteners can be
released from the apertures in the anvil and/or staple cartridge to
allow the piece of buttress material to separate from the
end-effector. The fasteners can also be configured to detach from
the piece of buttress material and can be comprised of a
bioabsorbable material such that they can be resorbed within the
patient's body. In at least one embodiment, a piece of buttress
material can be attached to an end effector by one or more
detachable clips.
[0013] In at least one form of the invention, a piece of buttress
material configured to be releasably attached to an end-effector
can include an unactivated adhesive. In various embodiments, a
surgeon can position and align the piece of buttress material on
the end-effector multiple times without the un-activated adhesive
bonding to the end-effector. Once the surgeon is satisfied with the
alignment of the piece of buttress material on the end-effector,
the surgeon can then apply a reactant to the un-activated adhesive.
In various embodiments, the reactant can activate the adhesive and
cause the adhesive to releasably bond the piece of buttress
material to a portion of the end-effector. In at least one
embodiment, the piece of buttress material can include a recess
configured to receive an applicator such that the application of
the reactant to the un-activated adhesive can be facilitated.
[0014] In at least one form of the invention, an end effector can
include a retractable retention member for retaining a piece of
buttress material on an end-effector. In various embodiments, the
retention member can be movable between a first, or distal,
position and a second, or proximal, position. In at least one
embodiment, the flexible member can be operably engaged with a
handle portion such that a surgeon can utilize the handle portion
to retract the flexible member relative to the end-effector. In
various embodiments, the flexible member can hold the piece of
buttress material in position while staples are deployed through
the buttress material. In at least one embodiment, the retention
member can be retracted relative to the end effector such that the
buttress material can be disengaged from the end effector and the
end effector can be removed from the surgical site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The above-mentioned and other features and advantages of
this invention, and the manner of attaining them, will become more
apparent and the invention itself will be better understood by
reference to the following description of embodiments of the
invention taken in conjunction with the accompanying drawings,
wherein:
[0016] FIG. 1 is a perspective view of an end-effector assembly
configured to engage, cut, staple, and apply a piece of buttress
material to tissue in accordance with one non-limiting embodiment
of the present invention;
[0017] FIG. 2 is a perspective view of the end-effector assembly of
FIG. 1 after the end-effector has been utilized to engage, cut,
staple, and apply the piece of buttress material to the tissue in
accordance with one non-limiting embodiment of the present
invention;
[0018] FIG. 3 is a perspective view of an end-effector assembly
attached to a distal end of a surgical instrument in accordance
with one non-limiting embodiment of the present invention;
[0019] FIG. 4 is a perspective view of an end-effector assembly
including at least one piece of buttress material, wherein the
end-effector assembly is in an open configuration in accordance
with one non-limiting embodiment of the present invention;
[0020] FIG. 5 is a perspective view of a staple cartridge of the
end-effector assembly of FIG. 4, wherein the buttress material is
releasably retained thereto;
[0021] FIG. 6 is an exploded perspective view of the staple
cartridge and the buttress material of FIG. 5;
[0022] FIG. 7 is a perspective view of a connection member
configured to be used with the end-effector assembly of FIG. 4;
[0023] FIG. 8 is a perspective view of an anvil of the end-effector
assembly of FIG. 4, wherein the anvil has at least one piece of
buttress material releasably retained thereto;
[0024] FIG. 9 is a side view of the connection member of FIG.
7;
[0025] FIG. 10 is an exploded perspective view of the anvil and the
buttress material of FIG. 8;
[0026] FIG. 11 is a perspective view of a staple cartridge and an
anvil of an end-effector assembly with pieces of buttress material
attached thereto in accordance with one non-limiting embodiment of
the present invention;
[0027] FIG. 12 is an exploded view of an end-effector assembly
including a staple cartridge and an anvil in accordance with one
non-limiting embodiment of the present invention;
[0028] FIG. 13 is an exploded view of the end-effector assembly of
FIG. 12 with some components removed;
[0029] FIG. 14 is a front view of the end-effector assembly of FIG.
12;
[0030] FIG. 15 is a perspective view of an end-effector assembly in
accordance with another non-limiting embodiment of the present
invention;
[0031] FIG. 16 is a partial perspective view of the end-effector
assembly of FIG. 15 with some components removed, wherein the
end-effector assembly includes a retractable member configured to
releasably retain at least one piece of buttress material;
[0032] FIG. 17 is an end view of the end-effector assembly of FIG.
15 taken along line 17-17 in FIG. 16;
[0033] FIG. 18 is an exploded partial perspective view of the
end-effector assembly of FIG. 15;
[0034] FIGS. 19-21 are side views of various cutting members
configured to be used with an end-effector assembly in accordance
with non-limiting embodiments of the present invention;
[0035] FIG. 22 is a perspective view of a staple cartridge having a
piece of buttress material releasably retained thereto in
accordance with one non-limiting embodiment of the present
invention;
[0036] FIG. 23 is an exploded perspective view of the staple
cartridge and the piece of buttress material of FIG. 22, wherein
the piece of buttress material includes a plurality of members
extending therefrom;
[0037] FIG. 24 is a cross-sectional view taken along line 24-24 in
FIG. 22 illustrating the members of FIG. 23 engaged with staple
cavities in accordance with one non-limiting embodiment of the
present invention;
[0038] FIG. 25 is a cross-sectional view of a piece of buttress
material including members engaged with staple cavities of a staple
cartridge in accordance with one non-limiting embodiment of the
present invention;
[0039] FIG. 26 is an exploded view of FIG. 25 illustrating the
members separated from the staple cavities of the staple cartridge
in accordance with one non-limiting embodiment of the present
invention;
[0040] FIG. 27 is an exploded cross-sectional view of an
end-effector assembly including retaining members extending from an
anvil and a staple cartridge of the end-effector which are
configured to releasably retain a piece of buttress material in
accordance with one non-limiting embodiment of the present
invention;
[0041] FIG. 28 is an exploded cross-sectional view of an
end-effector assembly including retaining members extending from an
anvil and a staple cartridge of the end-effector which are
configured to releasably retain a piece of buttress material in
accordance with one non-limiting embodiment of the present
invention;
[0042] FIG. 29 is a cross-sectional view of an end-effector
illustrating a piece of buttress material positioned within the
end-effector, wherein the piece of buttress material includes
recesses in accordance with one non-limiting embodiment of the
present invention;
[0043] FIG. 30 is a cross-sectional view of an end-effector
illustrating a piece of buttress material positioned within the
end-effector, wherein the piece of buttress material includes
perforations and recesses in accordance with one non-limiting
embodiment of the present invention;
[0044] FIG. 31 is a perspective view of portions of the piece of
buttress material of FIG. 30 being removed from an intermediate
portion;
[0045] FIG. 32 is a cross-sectional view of an anvil having a piece
of buttress material engaged with a cutting member slot in
accordance with one non-limiting embodiment of the present
invention;
[0046] FIG. 33 is a cross-section view of a staple cartridge
including a piece of buttress material releasably retained thereto
in accordance with one non-limiting embodiment of the present
invention;
[0047] FIG. 34 is a cross-sectional view of a piece of buttress
material releasably positioned on an anvil in accordance with one
non-limiting embodiment of the present invention;
[0048] FIG. 35 is a detail view of a piece of buttress material
releasably retained to an anvil in accordance with one non-limiting
embodiment of the present invention;
[0049] FIG. 36 is a detail view of a piece of buttress material
releasably retained to an anvil in accordance with one non-limiting
embodiment of the present invention;
[0050] FIG. 37 is a detail view of a piece of buttress material
releasably retained to an anvil in accordance with one non-limiting
embodiment of the present invention;
[0051] FIG. 38 is a perspective view of a package assembly
including a piece of buttress material, wherein the package
assembly is positioned within an open end-effector of a surgical
instrument in accordance with one non-limiting embodiment of the
present invention;
[0052] FIG. 39 is a perspective view of the package assembly of
FIG. 38 illustrating the end-effector closed onto the package and
the piece of buttress material;
[0053] FIG. 40 is a perspective view of the package of FIG. 39
illustrating the piece of buttress material engaged with an anvil
of the end-effector and the package being removed from the piece of
buttress material in accordance with one non-limiting embodiment of
the present invention;
[0054] FIG. 41 is a perspective view of a package assembly for a
piece of buttress material in a sterile outer package in accordance
with one non-limiting embodiment of the present invention;
[0055] FIG. 42 is a perspective view of an inner package of the
package assembly of FIG. 41 in an unopened position;
[0056] FIG. 43 is a perspective view of the package of FIG. 42 in a
partially opened position;
[0057] FIG. 44 is a perspective view of the package of FIG. 42 in
an opened position;
[0058] FIG. 45 is a perspective view of the package of FIG. 42
positioned within an open end-effector;
[0059] FIG. 46 is a perspective view of the package of FIG. 45
wherein the package is partially removed from the end-effector;
[0060] FIG. 47 is a perspective view of an applicator assembly for
a piece of buttress material, wherein the applicator assembly is
positioned within an end-effector of a surgical instrument in
accordance with one non-limiting embodiment of the present
invention;
[0061] FIG. 48 is a top view of the applicator assembly of FIG.
47;
[0062] FIG. 49 is a top view of an applicator assembly in
accordance with one alternative non-limiting embodiment of the
present invention;
[0063] FIG. 50 is a perspective view of a buttress material
applicator assembly in accordance with one non-limiting embodiment
of the present invention;
[0064] FIG. 51 is another perspective view of the buttress material
applicator assembly of FIG. 50;
[0065] FIG. 52 is a perspective view of the buttress material
applicator assembly of FIG. 50 positioned within an end-effector of
a surgical instrument;
[0066] FIG. 53 is a perspective view of the buttress material
applicator assembly of FIG. 50 partially removed from the
end-effector;
[0067] FIG. 54 is a perspective view of a buttress material
applicator configured to apply at least one piece of buttress
material to an end-effector of a surgical instrument in accordance
with one non-limiting embodiment of the present invention;
[0068] FIG. 55 is an exploded view of the buttress material
applicator of FIG. 54;
[0069] FIG. 56 is an elevational view of the buttress material
applicator of FIG. 54 with some components removed;
[0070] FIG. 57 is a perspective view of the buttress material
applicator of FIG. 54 with some components removed;
[0071] FIG. 58 is a perspective view of an alternative buttress
material applicator configured to apply at least one piece of
buttress material to an end-effector of a surgical instrument in
accordance with another non-limiting embodiment of the present
invention;
[0072] FIG. 59 is an exploded perspective view of the buttress
material applicator of FIG. 58;
[0073] FIG. 60 is an elevational view of the buttress material
applicator of FIG. 58 with some components removed;
[0074] FIG. 61 is a perspective view of the buttress material
applicator of FIG. 58 with some components removed;
[0075] FIG. 62 is a perspective view of a piece of buttress
material in accordance with one non-limiting embodiment of the
present invention; and
[0076] FIG. 63 is a cross-sectional view of the piece of buttress
material of FIG. 62 taken along line 63-63 in FIG. 62.
DETAILED DESCRIPTION
[0077] 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 of ordinary
skill 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 the various embodiments of the present invention 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 present
invention.
[0078] In various embodiments, referring to FIGS. 1-2, an
end-effector of a surgical instrument can include at least one
piece of buttress material "B" releasably attached thereto. In at
least one embodiment, the end-effector can be configured to engage
and clamp tissue "T", deploy staples into the tissue, and cut the
tissue and the piece of buttress material. In such an embodiment,
the end-effector can then be removed from the tissue leaving the
staples and the piece of buttress material attached to the tissue
on either side of an incision "I". In various embodiments, a
surgical instrument can include a handle assembly, an end-effector
assembly, an instrument shaft, and at least one piece of buttress
material releasably attached to the end-effector assembly. In at
least one embodiment, referring to FIG. 3, handle assembly 12 can
be attached to a first, or proximal, end 13 of instrument shaft 16
and, additionally, end-effector assembly 14 can be configured to be
attached to a second, or distal, end 15 of instrument shaft 16. In
various embodiments, end-effector assembly 14 and at least a
portion of instrument shaft 16 can be configured to be positioned
within, and inserted at least partially through, a cannula, or
trocar, in a patient's body during a minimally invasive surgical
procedure. Various surgical instruments are described in further
detail in U.S. patent application Ser. No. 11/329,020, entitled
SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, which was
filed on Jan. 10, 2006, now U.S. Pat. No. 7,670,334; U.S. patent
application Ser. No. 11/343,321, entitled SURGICAL CUTTING AND
FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM, which
was filed on Jan. 31, 2006, now U.S. Patent Application Publication
No. 2007/0175955; and U.S. patent application Ser. No. 11/529,935,
entitled SURGICAL STAPLES HAVING ATTACHED DRIVERS AND STAPLING
INSTRUMENTS FOR DEPLOYING THE SAME, which was filed on Sep. 29,
2006, now U.S. Pat. No. 8,485,412, the entire disclosures of which
are hereby incorporated by reference herein.
[0079] In various embodiments, an end-effector assembly of a
surgical instrument can include a first jaw member and a second jaw
member wherein at least one of the first and second jaw members can
be configured to be moved relative to the other jaw member such
that tissue can be clamped therebetween. In various embodiments,
referring to FIGS. 4-11, first jaw member 20 can include staple
cartridge 22 and, additionally, second jaw member 24 can include
anvil 26. In at least one embodiment, staple cartridge 22 can
include deck 28 having a plurality of staple cavities 30 defined
therein. Anvil 26 can include anvil cover 27 and anvil face 32,
wherein anvil face 32 can have a plurality of anvil pockets 34
defined therein. In various embodiments, each staple cavity 30 can
be configured to removably store a staple therein and each anvil
pocket 34 can be configured to deform at least a portion of the
staple as the staple is deployed. In various embodiments, at least
one of the staple cartridge and the anvil can comprise one or more
gripping features, or ridges, 35 which can be configured to hold
the tissue within the end effector.
[0080] Further to the above, referring to FIGS. 4-11, end-effector
assembly 14 can include at least one piece of buttress material 36
and/or 36' which can be configured to be positioned intermediate
the first and second jaw members and can be releasably retained to
one of deck 28 and/or face 32, for example. In at least one
embodiment, a surface on the piece of buttress material can be
configured to contact tissue as the tissue is clamped between the
first and second jaw members. In such an embodiment, the buttress
material surface can be used to distribute the compressive clamping
force over the tissue, remove excess fluid from the tissue, and/or
improve the purchase of the staples. In various embodiments, one or
more pieces of buttress material can be positioned within the
end-effector assembly. In at least one embodiment, referring to
FIG. 11, one piece of buttress material 36a can be attached to
staple cartridge 22 and one piece of buttress material 36a' can be
attached to anvil 24. In at least one other embodiment, two pieces
of buttress material 36 can be positioned on deck 28 and one piece
of buttress material 36' can be positioned on face 32, for example.
In other various embodiments, any suitable number of pieces of
buttress material can be situated within an end-effector assembly.
In any event, in various embodiments, the piece(s) of buttress
material can be comprised of a material such as, a bioabsorbable
material, a biofragmentable material, and/or a dissolvable
material, for example, such that the buttress material can be
absorbed, fragmented, and/or dissolved during the healing process.
In at least one embodiment, the piece(s) of buttress material can
be at least partially comprised of a therapeutic drug which can be
configured to be released over time to aid the tissue in healing,
for example. In further various embodiments, the piece(s) of
buttress material can include a non-absorbable and/or
non-dissolvable material, for example.
[0081] In various embodiments, referring to FIGS. 6, 7, 9, and 10,
an end-effector assembly can include at least one connection member
or fastener which can be utilized to releasably retain a piece of
buttress material to at least one of an anvil and a staple
cartridge, for example. In at least one embodiment, each connection
member, such as connection member 38, for example, can include body
40, wherein body 40 can be cylindrically-shaped, for example. In at
least one such embodiment, connection member 38 can also include an
outwardly flared head portion 42 configured to prevent, or at least
inhibit, the connection member from sliding through an aperture or
opening 44 in the piece of buttress material. In other various
embodiments, a connection member can include any other suitably
shaped configuration to retain a piece of buttress material to an
end effector. In at least one embodiment, one ore more connection
members can comprise a clasp which can be configured to detachably
retain the buttress material to a staple cartridge and/or
anvil.
[0082] In various embodiments, referring to FIGS. 7 and 9, head
portion 42 can include recess 43, wherein recess 43 can be
configured to receive a driver, a press, or any other suitable
device. In at least one embodiment, the driver or press can be
engaged with recess 43 and utilized to insert connection members 38
through the piece of buttress material and into engagement with one
of staple cartridge deck 28 and anvil face 32, for example. In at
least one such embodiment, deck 28 and/or face 32 can include
apertures 46 which can be configured to receive at least a portion
of the connection members, such as body 40, for example. In various
embodiments, the outer perimeter of body 40 and the inner perimeter
of an aperture 46 can cooperate to retain connection members 38 to
one of the anvil and the staple cartridge in a friction-fit or
press-fit manner. Further to the above, referring to FIGS. 6 and
10, a piece of buttress material can include pre-formed apertures
44 which can be configured to allow connection members 38 to pass
therethrough into apertures 46, for example. In at least one
embodiment, piece of buttress material 36 can be positioned
adjacent to, or against, one of deck 28 and face 32 such that
buttress apertures 44 can be axially aligned with apertures 46. In
such circumstances, connection members 38 can then be positioned
through buttress apertures 44 and into apertures 46 to releasably
retain the piece of buttress material to one of deck 28 and face
32.
[0083] Further to the above, a connection member can include
threads which can be threadably engaged with an aperture in a
staple cartridge and/or anvil, for example. In various embodiments,
such threads can include self-tapping threads and/or they can be
configured to threadably engage threads within the aperture. In
embodiments which utilize self-tapping connection members, the
connection members can be used in conjunction with a piece of
buttress material, a staple cartridge, and/or anvil which do not
have pre-formed or pre-bored apertures defined therein. In either
event, the purchase between the connection members and the anvil or
staple cartridge apertures may be sufficient to hold the buttress
material in place, yet allow the buttress material to strip away
from the staple cartridge and/or deck when appropriate. In at least
one embodiment, outwardly flared head portion 42 can be configured
to be countersunk into a bevel surrounding an aperture 46 in order
to provide a smooth, or at least substantially smooth,
tissue-contacting surface on the piece of buttress material and
reduce the possibility that tissue may be caught or snagged on a
connection member.
[0084] In various embodiments, connection members can be configured
to be released from an end effector and deployed along with a piece
of buttress material. In at least one embodiment, head portions of
the connection members can be configured to be separated from body
portions of the connection members such that the head portions can
be deployed with the piece of buttress material while the body
portions remain attached to the end effector. In other various
embodiments, the entirety of the connection members can remain
engaged with the end effector when the piece of buttress material
is detached from the end-effector. In any event, in at least one
embodiment, the connection members can be at least partially
comprised of at least one of a bioabsorbable material, a
biofragmentable material, and a dissolvable material such that the
connection members can be absorbed, fragmented, and/or dissolved
within the body. In various embodiments, the connection members
comprised of a therapeutic drug which can be configured to be
released over time to aid the tissue in healing, for example. In
further various embodiments, the connection members can include a
non-absorable and/or non-dissolvable material, for example, such as
a plastic.
[0085] In various embodiments, the connection members can be
arranged in any suitable pattern or configuration. In at least one
embodiment, the connection members can be situated around the outer
perimeter of piece of buttress material 36, for example. In at
least one embodiment, the connection members can be positioned
proximate to one or more sides and/or ends of the piece of buttress
material, for example, to prevent, or at least assist in
preventing, the buttress material from peeling away from the staple
cartridge deck and/or the anvil face when the end-effector is
inserted through a trocar or engaged with tissue. In various
embodiments, the connection members can be used in conjunction with
any suitable adhesive, such as cyanoacrilate, for example, to
releasably retain the piece of buttress material, or at least a
portion of the buttress material, to the end effector. In at least
one embodiment, the adhesive can be applied to connection members
prior to the connection members being engaged with the apertures in
the piece of buttress material, staple cartridge, and/or anvil.
[0086] In various embodiments, referring to FIGS. 12-14, at least
one resilient member can be utilized to releasably retain a piece
of buttress material to a staple cartridge and/or anvil of an end
effector. In at least one embodiment, at least one resilient
member, such as resilient members 150 or 150', for example, can
include a first end, such as first ends 152 or 152', configured to
be attached to, or integrally formed with, at least one of first
and second jaw members 120 and 124. In at least one embodiment,
each resilient member 150 can include a second end, such as second
ends 154 or 154', for example, configured to contact and releasably
retain a piece of buttress material, such as piece of buttress
material 136 or 136', to at least one of the first and second jaw
members. In various embodiments, second end 154 can include tip 158
which can be configured to grip at least a portion of piece of
buttress material 136, for example. In various embodiments, tip 158
can be contoured and/or configured to include a rough or ribbed
surface, for example, in order to frictionally engage the piece of
buttress material.
[0087] In various embodiments, referring again to FIGS. 12-14, a
plurality of resilient members can be provided on at least two
sides of a jaw member to retain side portions of the piece of
buttress material to the jaw member. In at least one embodiment,
first ends 152 of each individual resilient member 150 can be
attached to one another by a connecting member, such as connecting
member, or bar, 156 or 156', for example. In various embodiments,
connecting member 156 can be attached to second jaw member 124 such
that connection member 156 can provide support to resilient members
150. In other various embodiments, a plurality of resilient members
150 can be attached to at least one of the first and second jaw
members without the use of a connecting member. In such an
embodiment, the first ends of the resilient members can be attached
directly to one of the first and second jaw members, for
example.
[0088] Further to the above, in various embodiments, at least one
resilient member can be biased towards the piece of buttress
material such that the resilient members can apply a retaining
force to the piece of buttress material and releasably retain the
piece of buttress material to one of the first and second jaw
members. In at least one embodiment, the piece of buttress material
can include tissue-contacting portion 159 or 159' and two side
portions 160 or 160' extending in a substantially perpendicular
and/or transverse direction with respect to tissue-contacting
portion 159 or 159'. In at least one such embodiment, tissue
contacting portion 159 can be configured to be positioned adjacent
to or in contact with deck 128 and, in addition, side portions 160
can be configured to abut side walls 121 of first jaw member 120.
Similarly, tissue contacting portion 159' can be positioned
adjacent to or in contact with surface 132 and, in addition, side
portions 160' can be configured to abut side walls 125 of second
jaw member 124. In various embodiments, each second end 154 of each
resilient member 150 can be configured to engage the side portions
160 of piece of buttress material 136 and apply a retaining force
thereto. In at least one embodiment, resilient members 150, for
example, can be configured to release buttress material 136 after
staples have been deployed through the buttress material and/or
when the buttress material is disengaged from the end-effector. In
at least one embodiment, the resilient members can be comprised of
an elastic material such as metal or plastic, for example.
[0089] In various embodiments, referring to FIGS. 15-18, a
retention member can be configured to be moved within an
end-effector between a first position and a second position to
releasably retain a piece of buttress material to the end-effector.
In at least one embodiment, end-effector assembly 214 can include a
first jaw including staple cartridge 222 and a second jaw including
anvil 226 wherein retention member 262 can be moved relative to
staple cartridge 222 and anvil 226. In various embodiments,
retention member 262 can be moved between a first, or extended,
position near distal end 264 to a second, or retracted, position
near proximal end 263. In its extend position, retention member 262
can hold buttress material 236 in position as end effector 214 is
inserted into a surgical site. Thereafter, end effector 214 can be
closed onto tissue, for example, and staples can be deployed
through the buttress material into the tissue. In various
embodiments, retention member 262 can be moved into its retracted
position such that retention member 262 can be operably disengaged
from buttress material 236. In at least one embodiment, retention
member 262 can be retracted prior to the staples being deployed. In
any event, as a result of the above, end effector 214 can be opened
and withdrawn from the surgical site leaving behind the stapled
buttress material and tissue.
[0090] In various embodiments, a retention member can have proximal
ends which can be operably engaged with a lever or other actuating
mechanism in a handle portion of a surgical stapling instrument
such that a surgeon can remotely retract the retention member as
outlined above. In at least one embodiment, retention member 262
can have distal ends which can be engaged with, or otherwise
releasably retained by, retention bar 264 such that a force may
need to be applied to retention members 262 to dislodge them from
retention bar 264. Thereafter, retention members 262 can be
retracted proximally a distance L in order to move them into their
second position. In at least one embodiment, retention members 262
can be retracted through channels or apertures 266 in buttress
material 236, for example, until they are sufficiently removed from
the buttress material. In at least one such embodiment, apertures
266 can encircle and guide retention members 262 as they are
retracted. In various embodiments, the retention members can be
comprised of flexible wires. In at least one embodiment, an end
effector can include two or more pieces of buttress material
retained to an end effector by retractable retention members. In at
least one such embodiment, referring to FIGS. 17 and 18, end
effector 214 can include retention members 262' for holding
buttress material 236' in position.
[0091] In various embodiments, an end-effector assembly can include
a cutting member configured to incise one or more pieces of
buttress material. In at least one embodiment, a cutting member can
be motivated relative to an end-effector by a surgical instrument
firing drive and can be guided by a cutting member slot within an
anvil and/or staple cartridge of an end-effector. In at least one
embodiment, referring to FIG. 19, top portion 267 of cutting member
268 can be configured to slide within a slot in the anvil and,
additionally, bottom portion 269 of the cutting member can be
configured to slide within a slot within the staple cartridge. In
various embodiments, cutting member 268 can include blade 270
having a positive slope, i.e., a cutting edge having a bottom end
which is positioned distally with respect to a top end. In at least
one embodiment, such a configuration can be configured to incise
the buttress material without substantially pushing the buttress
material distally and disrupting the alignment of the buttress
material within the end-effector. In at least one alternative
embodiment, referring to FIG. 20, blade 270' of cutting member 268'
can include a negative slope, i.e., a cutting edge having a bottom
end which is positioned proximally with respect to a top end. In
further alternative embodiments, referring to FIG. 21, blade 270''
of cutting member 268'' can include first portion 270a'' having a
positive slope and second portion 270b'' having a negative
slope.
[0092] As outlined above, an end-effector assembly can include a
staple cartridge, an anvil, and at least one piece of buttress
material positioned intermediate the staple cartridge and the
anvil. In at least one embodiment, referring to FIGS. 22-24, a
piece of buttress material, such as buttress material 336, can be
configured to be snap-fit to at least one of staple cartridge 322
and/or an anvil (not illustrated) to releasably retain the piece of
buttress material within the end effector. Referring to FIGS. 23
and 24, staple cartridge 322 can include first side wall 302 and
second side wall 304, wherein at least one of the first and second
side walls can include a lip 306 extending outwardly therefrom. In
various embodiments, buttress material 336 can include first edge,
or side, 308, second edge, or side, 310, and at least one lip 312
extending at least partially along the length of edges 308 and 310.
In at least one embodiment, referring to FIG. 24, lips 312 can be
configured to engage lips 306 in a snap-fit fashion in order to
releasably retain buttress material 336 to staple cartridge
322.
[0093] Further to the above, referring to FIG. 24, buttress
material 336 can include surface 316 which can be configured to be
positioned adjacent to or against deck 328 of staple cartridge 322.
In at least one embodiment, side edges 308 and 310 can comprise
sidewalls which can extend in a perpendicular or transverse
direction relative to surface 316. In such embodiments, lips 312
can extend from these sidewalls such that lips 312 can be
interlocked behind lips 306 of staple cartridge 322. In various
embodiments, lips 312 of buttress material 336 can be disengaged
from lips 306 of staple cartridge 322 when the staples are deployed
from staple cartridge 322. More particularly, when the staples are
deployed, the staples can contact buttress material 336, apply an
upward force to buttress material 336, and dislodge buttress
material 336 from staple cartridge 322. Advantageously, as a
result, buttress material 336 may be automatically disengaged from
staple cartridge 322 when the staples are deployed therefrom and/or
when the end-effector is opened as described above.
[0094] In various embodiments, referring to FIGS. 23 and 24, a
piece of buttress material can include at least one member
extending therefrom which can be configured to releasably retain
the buttress material to one of a staple cartridge and/or an anvil.
In at least one embodiment, member 318 can extend from buttress
material 336 in a direction which is perpendicular or transverse to
surface 316. In various embodiments, member 318 can be engaged with
one of staple cavity 320, and/or an anvil pocket, in a friction-fit
or press-fit manner to releasably retain the piece of buttress
material to one of the staple cartridge and the anvil. Similar to
the above, in various embodiments, staples deployed from staple
cavities 320 can apply an upward force to buttress material 336 and
disengage members 318 from staple cavities 320. In various
embodiments, the staples can pierce projections 318 and/or buttress
material 336 to secure the buttress material to the tissue as
outlined above.
[0095] As illustrated in FIG. 23, a piece of buttress material can
include more than one member, or projection, extending therefrom to
retain a piece of buttress material to one of a staple cartridge
and an anvil. In various embodiments, referring to FIGS. 25-26,
more than one member 318' can extend from piece of buttress
material 336', for example. In at least one embodiment, members
318' can be can press-fit into staple cavities 320' of staple
cartridge 322', and/or into anvil pockets of an anvil (not
illustrated), such that the members can frictionally retain the
piece of buttress material to the staple cartridge and/or the anvil
as outlined above. As described in greater detail below, a staple
cartridge and/or anvil can include slots or apertures therein in
addition to the staple cavities of the staple cartridge and the
anvil pockets of the anvil for receiving projections, or retaining
members, extending from a piece of buttress material.
[0096] In various embodiments, referring to FIG. 33, at least one
of an anvil and a staple cartridge of an end-effector assembly can
include one or more slots and/or grooves configured to releasably
retain a piece of buttress material to the end-effector assembly.
In at least one embodiment, staple cartridge 722 can include at
least one aperture 704 defined therein which can be configured to
receive projection 706 extending from buttress material 736. In at
least one such embodiment, projection 706 can be received within
aperture 704 in a press-fit and/or friction-fit fashion to
releasably retain buttress material 736 thereto. In at least one
embodiment, referring to FIG. 33, buttress material 736 can include
body 708 having surface 710, wherein surface 710 can be configured
to be positioned adjacent to and/or abut deck 728. In various
embodiments, projection 706 can extend from body 708 in a direction
which is perpendicular or transverse to a plane defined by surface
710, for example.
[0097] In various embodiments, projection 706, for example, can
include first portion, or leg, 712 and second portion, or foot,
714, wherein first portion 712 can be configured to extend through
aperture 704 and wherein second portion 714 can have a size and
shape which can be slightly larger than aperture 704, for example.
In at least one such embodiment, projection 706 can be inserted
into and pushed through aperture 704 until second portion 714 at
least partially extends therethrough. In various embodiments,
projection 706 can deflect inwardly as it is inserted into aperture
704 and then snap outwardly after it has been inserted
therethrough. In addition to or in lieu of the above, second
portion 714 can be compressed as it is inserted into aperture 704
and then expand once it has been inserted therethrough. In any
event, second portion 714 can engage a backside surface of deck 728
near aperture 704 in order to releasably retain buttress material
736 to staple cartridge 702 in a snap-fit fashion. In at least one
embodiment, projection 706 can be releasably retained within
aperture 704 until a force is applied thereto by staples deployed
from the staple cartridge and/or when the end-effector is opened as
described above.
[0098] In various embodiments, referring to FIG. 27, staple
cartridge 322'' and/or anvil 326'', for example, can include
notches 334'' which can be configured to receive buttress material
336''. In at least one embodiment, notches 334'' can be configured
to releasably retain buttress material 336'' to staple cartridge
322''. In at least one such embodiment, buttress material 336'' can
be press-fit between retaining members 302'' and 304'' such that a
force must be applied thereto to overcome friction between buttress
material 336'' and retaining members 302'' and 304''. In various
embodiments, retaining members 302'' and 304'' can include lips or
overhangs which can prevent, or at least inhibit, buttress material
336'' from lifting upwardly. In various embodiments, referring to
FIG. 28, an end-effector assembly can include staple cartridge 422
and anvil 426, wherein at least one of the staple cartridge and the
anvil can include first retaining member 402 and/or second
retaining member 404 extending therefrom. In at least one
embodiment, the first and second retaining members 402 and 404 can
extend substantially perpendicular to and/or transverse with
respect to one of deck 428 and/or face 432 to retain a piece of
buttress material 436 to the end effector. In various embodiments,
first and second retaining members 402 and 404 can be configured to
releasably retain buttress material 436 therebetween in a
friction-fit fashion. In at least one embodiment, the coefficient
of friction between the side walls and the retaining members can be
sufficient such that the buttress material may not be dislodged as
the end effector is inserted into and manipulated within a surgical
site. After the staples have been deployed into the soft tissue,
the end-effector can be re-opened and, in various embodiments, the
friction force between buttress material 436 and retention members
402 and 404 can be overcome.
[0099] In various embodiments, referring to FIG. 32, an
end-effector of a surgical stapling instrument can include an anvil
and a staple cartridge (not illustrated), wherein, as outlined
above, the anvil can be operatively engaged with the staple
cartridge such that the end-effector can be configured to clamp
tissue therebetween. In at least one embodiment, anvil 626 can
include face 632 and, in addition, slot 602 which can be configured
to slidably receive a cutting member, such as cutting member 668,
for example, therein. In various embodiments, although not
illustrated, the staple cartridge can also include a slot
configured to slidably receive cutting member 668 therein. In any
event, cutting member 668 can include a blade, such as blade 670,
for example, where blade 670 can be configured to incise soft
tissue and/or buttress material 636 positioned within the end
effector.
[0100] In at least one embodiment, referring again to FIG. 32,
buttress material 636 can include a body portion having a surface,
such as surface 604, for example, wherein the surface can be
configured to be positioned adjacent to anvil face 632, for
example. In various embodiments, buttress material 636 can further
comprise projection 606 extending from the body portion in a
perpendicular and/or transverse direction with respect to surface
604. In at least one embodiment, projection 606 can be configured
to be inserted into and engaged with cutting member slot 602 to
releasably retain buttress material 636 to anvil 626. Although not
illustrated, a piece of buttress material can include similar
features which can retain the buttress material to a staple
cartridge.
[0101] In various embodiments, cutting member slot 602 can include
first side wall 608 and second side wall 610 wherein projection 606
can be configured to be frictionally engaged with, and/or press-fit
between, the first and second side walls and releasably retain
projection 606 within slot 602. In at least one embodiment, slot
602 can include transverse portion 612 which can be configured to
receive cam members 631 extending from cutting member 668, wherein
cam members 631 can be configured to hold anvil 626 in a closed
position. In at least one embodiment, projection 606 can include at
least one tab 614 extending therefrom which can be configured to at
least partially extend into transverse portion 612 and assist in
retaining projection 606 within slot 602. In various embodiments, a
projection can include resilient features which can apply a biasing
force to the side walls of slot 602 when they are compressibly
received within slot 602.
[0102] In various embodiments, further to the above, cutting member
668 can be configured to incise projection 606 as it is advanced
within anvil 626 and separate first portion 618 from second portion
620. In at least one embodiment, grooves 616 can reduce the
cross-sectional thickness of buttress material 636 in order to
reduce the force needed to transect the buttress material. In
various embodiments, one or more of grooves 616 can be sized and
dimensioned such that at least a portion of projection 606 is
thinner than first portion 618 and/or second portion 620. As
described above, at least one of grooves 616 can be V-shaped, for
example, such that cutting edge 670 can contact projection 606 at
or near the point of the V-shaped profile. In various embodiments,
although not illustrated, projection 606, for example, can include
at least one perforation defined therein which can lower the force
needed to incise the projection.
[0103] In various embodiments, either in addition to or in lieu of
the buttress material attachment devices discussed above, a piece
of buttress material can be attached to an end-effector of a
surgical instrument using an adhesive. In at least one embodiment,
referring to FIGS. 29 and 30, end-effector assembly 514 can include
anvil 526 having face 532 and, in addition, staple cartridge
channel 522 having deck surface 528. In at least one embodiment, a
piece of buttress material, such as buttress material 536, for
example, can be positioned adjacent to one of face 532 and deck
surface 528, wherein buttress material 536 can include body portion
502 and at least one handle portion 506. In at least one such
embodiment, handle portion 506 can extend from body 502 such that a
surgeon can use handle portion 506 to position and align buttress
material 536 within the end-effector assembly. In at least one
embodiment, handle portion 506 can extend in a direction which is
parallel to, and/or transverse to, a plane of surface 504.
[0104] In various embodiments, referring to FIGS. 29 and 30, a
piece of buttress material can include an un-activated or inert
adhesive, such as adhesive 512, for example, on the surface of the
buttress material which can be applied to the surface prior to the
surface being positioned against one of the staple cartridge deck
and the anvil face. In at least one embodiment, adhesive 512 can be
configured to releasably bond surface 504, for example, to face 532
and/or deck 528 when the adhesive is activated by a reactant.
Similar to the above, such an activated adhesive can be used to
releasably retain surface 504 in contact with face 532 and/or deck
528. In various embodiments, the activated adhesive can be
configured to release the buttress material from the deck and/or
face in response to a force applied thereto such as when the
staples are deployed from the staple cartridge and/or when the
end-effector is opened, for example. In various embodiments, the
un-activated adhesive can be applied to the buttress material along
the outer perimeter of body portion 502 such that a reactant, for
example, can be easily applied to the un-activated adhesive.
[0105] In various embodiments, the un-activated adhesive on the
buttress material can comprise one component of a binary adhesive
and the reactant can comprise the other component of the binary
adhesive such that, when the two components are combined, the
adhesive is activated. Stated another way, the un-activated
adhesive can include a material which is inert until it is
introduced to a reactant as described below. In at least one
embodiment, the un-activated adhesive and the reactant can comprise
a surgically suitable epoxy, for example. In various embodiments,
the un-activated adhesive can include a hydro-stable material, for
example, such that the adhesive can be substantially non-soluble
and/or substantially non-reactive when introduced to water. In at
least one embodiment, the adhesive can include a material such as a
hot melt adhesive, silicone, urethane, cyanoacrylate, hydrogel,
and/or isocyanolate, for example, or any suitable monomer and/or
polymer. In various embodiments, suitable adhesives and attachment
devices can include those disclosed in U.S. Pat. No. 5,263,629,
entitled METHOD AND APPARATUS FOR ACHIEVING HEMOSTASIS ALONG A
STAPLE LINE, which issued on Nov. 23, 1993; U.S. Pat. No.
6,656,193, entitled DEVICE FOR ATTACHMENT OF BUTTRESS MATERIAL TO A
SURGICAL FASTENING DEVICE, which issued on Dec. 2, 2003; U.S. Pat.
No. 6,592,597, entitled ADHESIVE FOR ATTACHING BUTTRESS MATERIAL TO
A SURGICAL FASTENING DEVICE, which issued on Jul. 15, 2003; U.S.
Pat. No. 6,273,897, entitled SURGICAL BETTRESS AND SURGICAL
STAPLING APPARATUS, which issued on Aug. 14, 2001; and U.S. patent
application Ser. No. 10/674,303, entitled APPARATUS AND METHOD FOR
ATTACHING A SURGICAL BUTTRESS TO A STAPLING APPARATUS, which was
filed on Sep. 30, 2003, now U.S. Patent Application Publication No.
2005/0070929, the entire disclosures of which are hereby
incorporated by reference herein. In various embodiments, the
reactant can include a material comprising at least one aerobic
initiator, anaerobic initiator, quaternary ammonium salt or
compound, and/or any other suitable radical mechanism initiator
such as anionic initiators, for example, including the materials
disclosed in U.S. patent application Ser. No. 11/479,424, entitled
ABSORBABLE CYANOACRYLATE COMPOSITIONS, which was filed on Jun. 30,
2006, now U.S. Patent Application Publication No. 2008/0003196, the
entire disclosure of which is hereby incorporated by reference
herein. In various embodiments, adhesives and/or reactants which
are commercially available from Closure Medical Corporation, for
example, can be used. In at least one embodiment, an adhesive can
be configured to be activated by ultra-violet light or any suitable
photochemical process. Several such adhesives are commercially
available from Henkel Loctite Corporation, for example.
[0106] Further to the above, in various embodiments, the use of the
un-activated or inert adhesive on the piece of buttress material
can enable a surgeon to position and re-position the piece of
buttress material on the anvil face and/or the staple cartridge
deck without the adhesive immediately bonding thereto. In at least
one embodiment, the un-activated adhesive may not bond to the face
and/or deck until the reactant is applied to the un-activated
adhesive. This feature provides a significant advantage in that the
surgeon does not have to properly position the piece of buttress
material on a first attempt, but instead can position and
re-position the piece of buttress material on the deck and/or face
to ensure a proper fit and alignment with the face and/or the deck.
In various embodiments, at least one retention or alignment member,
such as retention member 318 (FIG. 23), for example, can be used in
conjunction with the adhesive/reactant to retain the piece of
buttress material to the face and/or deck of the end-effector prior
to application of the reactant, for example.
[0107] In various embodiments, a piece of buttress material can
include at least one groove or channel which can be configured to
receive the reactant. In at least one embodiment, referring to FIG.
29, buttress material 536 can include recesses 508 which can be
located intermediate body portion 502 and handle portions 506. More
particularly, a first recess 508 can be provided intermediate a
first side of body 502 and a first handle portion 506 and,
additionally, a second recess 508 can be provided intermediate a
second side of body 502 and a second handle portion 506. In various
embodiments, at least a portion of un-activated adhesive 512 on
buttress material 536 can extend along recesses 508 such that an
applicator, such as applicator 514, for example, can be inserted
into recesses 508 to apply the reactant to adhesive 512 and
activate the adhesive. In at least one embodiment, as a result,
recesses 508 can facilitate the application of the reactant. In
various embodiments, reactant applicator 514 can include absorbent
tip 516 which can be configured to releasably store and apply a
quantity of reactant.
[0108] In various embodiments, referring to FIGS. 30 and 31, at
least one perforation can be defined within a piece of buttress
material 536 to allow at least one of handle portions 506 to be
detached from body portion 502, for example. In at least one
embodiment, perforations 510 can be located intermediate body
portion 502 and handle portions 506 such that, when a sufficient
force is applied to a handle portion 506, the piece of buttress
material can tear along a line, or path, defined by perforations
510. In various embodiments, perforations 510 can be positioned
adjacent to and/or within recesses 508 such that handle portion 506
can easily be separated from body 502 owing to the reduced material
thickness of the buttress material within and/or adjacent to
recesses 508. In at least one embodiment, as a result of the above,
a piece of buttress material can be positioned within an
end-effector, a reactant can be applied to un-activated adhesive on
the buttress material, and at least one of the handle portions can
be removed from a central body portion of the buttress
material.
[0109] In various embodiments, a piece of buttress material, an
un-activated adhesive, and a reactant can be included in a surgical
accessory kit, for example. In at least one embodiment, the
un-activated adhesive can be pre-applied to the buttress material.
In other embodiments, a surgeon can use the kit to apply the
un-activated adhesive to a surface of the buttress material and
allow the adhesive to "set", i.e., cure or dry such that it can be
positioned on a surface without substantially adhering to the
surface. In at least one embodiment, the piece of buttress material
can then be positioned against one of the staple cartridge or anvil
of an end-effector. In at least one such embodiment, as outlined
above, the buttress material can include at least one handle
extending therefrom in which the surgeon can grasp to manipulate
the buttress material relative to the end-effector. Thereafter, the
anvil of the end-effector can be closed onto the buttress material
to hold it in position until the reactant is applied thereto. At
such point, referring to FIG. 31, the handle portion can be removed
while the anvil is closed. Alternatively, the surgeon can wait for
the activated adhesive to at least partially cure before removing
the handle. In either event, the end-effector can then inserted
into a surgical site and the buttress material can be attached to
tissue with staples as described above. In other various
embodiments, the handle portion(s) can be torn away from the body
portion of the buttress material after staples are engaged with the
tissue.
[0110] In various embodiments, a package assembly for at least one
piece of buttress material can include means for activating an
un-activated adhesive on the buttress material. In at least one
embodiment, a package assembly can include a quantity of reactant
stored therein wherein the reactant can be released such that it
can come into contact with the un-activated adhesive and activate
the adhesive. In other various embodiments, a package assembly can
include an initiator which can be configured to cause a reaction
between an un-activated adhesive and another chemical within the
package assembly. In further various embodiments, an un-activated
adhesive can be configured to activate when sufficient pressure is
applied thereto. Such pressure can be generated when the anvil of
the end effector is closed onto the buttress material and clamped
against the staple cartridge. Such materials can comprise one or
more pressure-sensitive adhesives such as silicone adhesives and
acrylic adhesives, for example. In various embodiments, a package
can include a piece of buttress material having a biocompatible
hot-melt adhesive positioned thereon, wherein the adhesive can be
configured to melt when heat, generated by an exothermic chemical
reaction, is applied thereto. In at least one embodiment, an
initiator can be mixed with a chemical to create the exothermic
reaction and thereby generate heat in the localized region of the
adhesive, for example. In various embodiments, the initiator can be
separated from the chemical by a removable sheet or other suitable
separation device such that, when the sheet is removed, the
initiator and the chemical can be exposed to each other. In at
least one such embodiment, the initiator can include an oxidizer,
or any suitable chemical compound that readily transfers oxygen
atoms, for example, and the chemical can include can include iron
or an iron compound, for example, which can be oxidized by the
oxidizer to create an exothermic reaction.
[0111] In various embodiments, a package can include a piece of
buttress material having a biocompatible hot-melt adhesive thereon,
wherein the adhesive can be configured to be melted when heat
generated by an electrical power source, such as a battery, for
example, is applied thereto. In at least one embodiment, the
package can include the electrical power source. In further various
embodiments, the energy source can be provided on a portion of an
end-effector, a piece of buttress material, a sleeve for an
end-effector, and/or a buttress material applicator, for example.
In various embodiments, the package assembly can include first and
second contacts, and/or any other suitable conductors and
resistors, which can be configured to operably complete an
electrical circuit with the battery. In at least one embodiment,
the electrical power source can be activated by a switch on the
package, for example, and the electrical energy can be applied to
the contacts.
[0112] In various embodiments, the anvil of an end-effector
assembly can include a detachable portion or sleeve which can be
configured to be slid over a second portion of the anvil and
attached to the end-effector assembly. In at least one embodiment,
as described in greater detail below, a piece of buttress material
can be attached to the sleeve before the sleeve is assembled to the
end-effector assembly. In at least one embodiment, referring to
FIG. 34, sleeve 802 can be configured to be slid over anvil portion
826 such that sleeve 802 is held in place by at least one of a
snap-fit and press-fit configuration. In at least one such
embodiment, sleeve 802 can be configured to at least partially
surround an outer perimeter 804 of anvil portion 826 wherein sleeve
802 can be configured to engage outer perimeter 804. In various
embodiments, sleeve 802 can include anvil pockets 806 defined in
working surface 808 wherein pockets 806 can be configured to deform
staples deployed from a staple cartridge as described above. In
various embodiments, sleeve 802 can be cast or machined from a
piece of metal into any suitable configuration and can be comprised
of any suitable material such as aluminum, for example.
[0113] As indicated above and referring to FIG. 34, sleeve 802 can
include buttress material 836 thereon, wherein at least a portion
buttress material 836 can be releasably attached to sleeve 802
using an adhesive, for example. In at least one embodiment,
referring to FIG. 35, buttress material 836' can include body
portion 812' and at least one side portion 814', wherein side
portions 814' can be releasably attached to sleeve 802' with an
adhesive 810'. In various embodiments, side portions 814' can be
detached from sleeve 802' when a force is applied thereto. In at
least one embodiment, similar to the above, such a force can be
created when staples are deployed from the staple cartridge and
engaged with the buttress material. In various embodiments,
referring to FIG. 36, a piece of buttress material can further
include at least one perforation and/or recess which can allow a
tissue-contacting portion of the buttress material to be separated
from a portion of the buttress material which is adhered to the
end-effector. In at least one embodiment, buttress material 836''
can include body portion 812'' which can be configured to contact
tissue positioned within the end-effector and, in addition, side
portions 814'' which can be adhered to anvil sleeve 802'', for
example, by adhesive 810''. In various embodiments, buttress
material 836'' can further include one ore more perforations 816''
defined therein which can be located intermediate body portion
812'' and side portions 814''. In addition to or in lieu of side
portions 814'' separating from sleeve 802'' as outlined above, body
portion 812'' can be configured to detach from side portions 814''
along a path defined by perforations 816'' when a force is applied
thereto. In at least one such embodiment, side portions 814'' can
remain attached to sleeve 802'' after body portion 812'' has been
separated therefrom. In other various embodiments, referring to
FIG. 37, sleeve 802''' can include a piece of buttress material,
such as buttress material 836''', for example, can include one or
more recesses 818''' positioned intermediate body portion 812'''
and side portions 814''' which can, similar to the above, allow
body portion 812''' to separate from side portions 814'''.
[0114] Further to the above, in various embodiments, once the body
portion has been released from the side portions, the end-effector
can be moved away from the tissue and the buttress material stapled
to the tissue. In at least one embodiment, the spent sleeve 802,
for example, can then be slid off of anvil portion 826, discarded,
and replaced with another sleeve. In at least one such embodiment,
the replacement sleeve can include a piece of buttress material,
such as buttress material 836, for example, positioned thereon such
that the end-effector can be re-used. In various embodiments, the
discarded sleeve can be sterilized, as described below, and another
piece of buttress material can be attached to the sleeve such that
it can be used once again.
[0115] In various embodiments, a package including a piece of
buttress material can be configured to apply the piece of buttress
material to one of an anvil and a staple cartridge of an
end-effector. In at least one embodiment, referring to FIGS. 38-40,
package 902 can include first portion 904 having surface 905 which
can be configured to releasably retain piece of buttress material
936 thereto. In various embodiments, surface 908 of buttress
material 936 can include adhesive 910, wherein adhesive 910 can be
configured to releasably attach buttress material 936 to anvil 926.
In addition to first portion 904, package 902 can include second
portion 906 attached to first portion 904 where second portion 906
can have a second piece of buttress material, such as buttress
material 937, for example, attached thereto. In various
embodiments, similar to buttress material 936, buttress material
937 can include adhesive thereon which can be utilized to
releasably attach buttress material 937 to staple cartridge 922. In
order to remove portions 904 and 906 from the pieces of buttress
material, at least one of portions 904 and 906 can be grasped by
the surgeon and pulled away from the pieces of buttress material as
illustrated in FIG. 40. In effect, package 902 can be moved between
a first, attached position and a second, detached position.
[0116] In various embodiments, referring to FIGS. 41-46, a package
assembly for at least one piece of buttress material can include an
outer package 901' which can be configured to enclose an inner
package 902' in a sterile environment. In use, a surgeon can open
outer package 901', remove inner package 902', and manipulate inner
package 902' to expose buttress material 936'. In at least one
embodiment, inner package 902' can include a cover sheet comprising
first portion 904' and second portion 906', wherein the first and
second portions can be configured to at least partially enclose
buttress material 936' when they are in a first position as
illustrated in FIG. 42. In various embodiments, a surgeon can
rotate second portion 906' relative to first portion 904' by
grasping and pulling tab 938' positioned on second end 940' of
second portion 906', as illustrated in FIG. 42, and moving second
portion 906' into a second position as sequentially illustrated in
FIGS. 43 and 44. In at least one such embodiment, the surgeon can
rotate second portion 906' relative to first portion 904' until
second portion 906' is at least partially positioned adjacent to
first portion 904'.
[0117] Thereafter, in various embodiments, buttress material 936'
can then be aligned with one of an anvil and/or staple cartridge of
an end-effector as described above. In at least one embodiment,
referring to FIGS. 45 and 46, inner package 902' can be inserted
within end-effector 914' intermediate anvil 926' and staple
cartridge 922' such that buttress material 936' can be aligned with
staple cartridge 922', for example. In various embodiments, similar
to the above, anvil 926' can be rotated toward staple cartridge
922' and clamped onto package 902' and buttress material 936' such
that buttress material 936' can be pressed against staple cartridge
922' and adhesive 910 can secure buttress material 936' thereto.
Thereafter, anvil 926' can be reopened and sheet 918' can be
peeled, or otherwise removed, from buttress material 936'.
[0118] In various alternative embodiments, a package assembly can
include one or more draw strings configured to detach a cover sheet
from a buttress material contained within the package assembly. In
at least one such embodiment, the cover sheet can be manipulated to
expose the buttress material, the buttress material can be secured
to an end effector, and the draw strings can be pulled proximally,
or distally, to detach the cover sheet from the buttress material.
In various other embodiments, referring to FIGS. 47 and 48, draw
strings can be attached to a portion of the buttress material such
that a handle portion, for example, of the buttress material can be
removed from a tissue-contacting portion of the buttress material.
In at least one such embodiment, buttress material 1002 can be
clamped between an anvil and a staple cartridge of an end effector,
and a force can be applied to draw strings 1006 which are attached
to handle portion 1004 of buttress material 1002. In various
embodiments, as a result, distal end 1003 of buttress material 1002
can be pulled toward proximal end 1005 by draw strings 1006 such
that handle portion 1004 can detach from tissue-contacting portion
1036 along perforations 1008. In at least one embodiment, buttress
material 1002 can further include aperture 1010 which can be
located at the distal end of tissue-contacting portion 1036,
wherein aperture 1010 can define a pre-detached point between
handle portion 1004 and tissue-contacting portion 1036 in order to
reduce the force required to detach handle portion 1004. In at
least one embodiment, referring to FIG. 49, at least one draw
string 1006' can be attached to handle portion 1004' of buttress
material 1002' such that proximal end 1005 can be pulled toward
distal end 1003 to remove handle portion 1004.
[0119] In various embodiments, an applicator can be used to apply a
piece of buttress material to at least one of an anvil and a staple
cartridge of an end-effector. In at least one embodiment, referring
to FIGS. 50-53, applicator assembly 1102 can comprise applicator
1104 and at least one piece of buttress material 1136, wherein
applicator 1104 can include at least one surface for supporting
buttress material 1136 thereon. In at least one such embodiment,
applicator 1104 can include top surface 1106 and bottom surface
1108 wherein each of the top and bottom surfaces can be configured
to releasably receive at least one piece of buttress material 1136.
In various embodiments, each piece of buttress material 1136 can be
releasably attached to the top and bottom surfaces of applicator
1104 through the use of an adhesive and/or mechanical attachment
member, for example. Referring to FIGS. 50 and 51, each piece of
buttress material 1136 can include a face 1110 which can be at
least partially coated with an adhesive to retain face 1110 to the
end-effector. In at least one such embodiment, the adhesive can be
applied to buttress material 1136 at a plurality of locations
1112.
[0120] In order to apply a piece of buttress material to a staple
cartridge and/or anvil of an end-effector assembly using an
applicator such as applicator 1104, for example, the applicator can
be at least partially positioned intermediate the staple cartridge
and the anvil such that the anvil can be closed onto the buttress
material. In various embodiments, referring to FIGS. 52 and 53,
applicator assembly 1102 can be at least partially positioned
intermediate anvil 1126 and staple cartridge 1122 of end-effector
1114 such that anvil 1126 can be aligned with and closed onto
buttress material 1136. In at least one embodiment, applicator 1104
can further include alignment slot 1116 at a first end and tongue
portion 1117 at a second end, wherein a surgeon can use alignment
slot 1116 to align and position applicator assembly 1102 within
end-effector 1114. In at least one such embodiment, alignment slot
1116 can be configured such that end-effector 1114 is closely
received between the sidewalls of alignment slot 1116. Owing to
adhesive 1112, the pieces of buttress material 1136 can be adhered
to anvil 1126 and staple cartridge 1122 such that when anvil 1126
is reopened, applicator 1104 can be removed from end-effector
assembly 1114, leaving behind the pieces of buttress material
within the end-effector.
[0121] In various embodiments, at least one protective sheet (not
illustrated), similar to sheet 918, for example, can be positioned
over face 1110 such that applicator 1104 can be positioned and
repositioned on one of the anvil and the staple cartridge of
end-effector 1114 without adhesive 1112, for example, bonding to
the anvil and/or the staple cartridge. In at least one such
embodiment, the sheets can be removed by the surgeon once the
applicator is properly positioned and aligned within the
end-effector to allow the adhesive to contact the staple cartridge
and/or anvil of the end-effector. In various embodiments, in
addition to or in lieu of tongue 1117, an applicator can include at
least one grip, such as grips 1134, for example, which can be
configured to allow a surgeon to more easily manipulate the
applicator within an end-effector. In at least one embodiment, a
first grip 1134 can be provided on a first side of applicator 1104,
and, in addition, a second grip 1134 can be provided on a second
side of the applicator. In various embodiments, a grip can include
ridges 1138 which can be configured to allow the surgeon to more
easily handle applicator 1104. To this end, at least a portion of
grips 1134 can be comprised of a soft or elastic material such as
rubber, for example.
[0122] In other various embodiments, although not illustrated, the
packaging for at least one piece of buttress material can comprise
a tubular sleeve which can be configured to be positioned around at
least one of an anvil and a staple cartridge. In at least one
embodiment, the buttress material can include an adhesive thereon
which can be configured to releasably attach the piece of buttress
material to at least one of the anvil and the staple cartridge. In
at least one such embodiment, the tubular sleeve can be configured
to receive at least one of the anvil and the staple cartridge
therein such that the anvil and/or staple cartridge are aligned
with a piece of buttress material within the tubular sleeve. In
various embodiments, a tubular sleeve can include a middle wall
extending between a first side and a second side of an inner
perimeter of the sleeve. In various embodiments, the middle wall
can include a top surface and a bottom surface, wherein the top and
bottom surfaces can each be configured to releasably retain a piece
of buttress material thereto. In at least one such embodiment, the
end-effector can be aligned relative to the middle wall and can be
closed onto the middle wall to attach the buttress material to the
anvil and/or staple cartridge.
[0123] In various embodiments, a buttress material dispenser can be
utilized to dispense buttress material. In at least one embodiment,
referring to FIGS. 54 and 55, dispenser 1200 can be configured to
dispense buttress material 1236 from a housing assembly comprised
of housing portions 1210 and 1212. As described in greater detail
below, dispenser 1200 can include a roll, or spool, 1224 of
buttress material wherein the buttress material can be dispensed
from spool 1224 onto an end effector of a surgical instrument as
illustrated in FIG. 57. In various embodiments, buttress material
1236 can be adhered to, or otherwise supported by, carrier strip
1202 such that, as buttress material 1236 is dispensed, buttress
material 1236 can be separated from carrier strip 1202. In various
embodiments, referring to FIGS. 54-57, carrier strip 1202 can
include surface 1204 which can be configured to receive buttress
material 1236 thereon. In various embodiments, buttress material
1236 can be divided into pieces before and/or after it is placed
onto surface 1204. In at least one embodiment, the pieces of
buttress material 1236 can each have a width which is the same as
or less than the width of surface 1204 and, in various embodiments,
the pieces of buttress material can be releasably attached to
surface 1204 of carrier 1202 using a low-strength adhesive, for
example.
[0124] In various embodiments, referring to FIGS. 54-57, internal
wall 1214 of first housing portion 1210 can include a plurality of
connectors 1216 extending therefrom. In at least one embodiment,
connectors 1216 can be engaged with other connectors extending
from, or apertures within, an internal wall of second portion 1212
in order to secure the first and second housing portions together.
In various embodiments, referring to FIG. 56, dispenser 1200 can
further include spool pin 1242 which can be configured to rotatably
support spool 1224. In at least one such embodiment, spool pin 1242
can be engaged with aperture 1241 in housing portion 1210 and an
aperture (not illustrated) in second portion 1212. In various
embodiments, spool pin 1242 can be mounted to spool 1242 such that
they can be rotated together. As outlined above, buttress material
1236 and carrier strip 1202 can be unspooled from spool 1224 as
buttress material 1236 is dispensed. In at least one embodiment, a
force can be applied to buttress material 1236 such that it can be
manually pulled out of dispenser 1200. In other various
embodiments, as described in greater detail below, buttress
dispenser 1200 can further include thumb roller 1234 which can be
sufficiently engaged with buttress material 1236 such that a
surgeon, or other clinician, can rotate thumb roller 1234 and push
buttress material 1236 out of dispenser 1200. In at least one
embodiment, referring to FIG. 55, dispenser 1200 can further
include thumb roller pin 1235 which can be configured to rotatably
support thumb roller 1234 within the dispenser housing. In at least
one embodiment, thumb roller 1234 can be mounted to pin 1235 such
that they can be rotated together about an axis defined by aperture
1249 in first housing portion 1210 and an aperture (not
illustrated) in second housing portion 1212
[0125] In various embodiments, referring to FIG. 55, thumb roller
1234 can be configured to extend at least partially through
aperture 1239 in the dispenser housing such that thumb roller 1234
can be rotated by the surgeon. In at least one embodiment, thumb
roller 1234 can be configured to operatively contact, or
frictionally engage, buttress material 1236 and/or carrier 1202
such that the rotation of thumb roller 1234 can drive or motivate
buttress material 1236 distally toward drive roller 1232. In
addition to or in lieu of the above, drive roller 1232 can be
configured to operatively contact, or frictionally engage, buttress
material 1236 and/or carrier 1202. In at least one embodiment,
drive roller 1232 can be operably engaged with thumb roller 1234
via drive belt 1243, for example, such that the rotation of thumb
roller 1234 can be transmitted to drive roller 1232. Although a
drive belt is illustrated, any other suitable device, such as a
drive chain or band, for example, can be used. In various
embodiments, at least one of housing portions 1210 and 1212 can
include guides 1262 which can be configured to align drive belt
1243 with thumb roller 1234 and drive roller 1232.
[0126] As described above, carrier strip 1202 can be separated from
buttress material 1236 as buttress material 1236 is dispensed from
dispenser 1200. In various embodiments, dispenser 1200 can further
include carrier strip collector 1228 which can be configured to
wind up carrier strip 1202 after it has been detached from buttress
material 1236. In at least one embodiment, carrier strip collector
1238 can be mounted to at least one of spool 1224 and spool pin
1242 such that spool 1224 and strip collector 1228 can be rotated
in unison. In at least one such embodiment, carrier strip 1202 can
be collected around strip collector 1228 in a direction which is
opposite to the direction in which buttress material 1234 is
dispensed from spool 1224. As a result, buttress material 1234 can
be dispensed and carrier strip 1202 can be collected
simultaneously. In various embodiments, dispenser 1200 can further
include separating plate 1230 which can be utilized to peel, or
separate, buttress material 1234 from carrier 1202. In at least one
embodiment, separating plate 1230 can include edge 1258 about which
carrier 1202 can be redirected such that carrier 1202 can be pulled
proximally by strip collector 1228 as described above.
[0127] In various circumstances, slack may be developed within
carrier strip 1202 after it has been separated from buttress
material 1236. In at least one embodiment, dispenser 1200 can
include one ore more tensioning devices to reduce such slack within
carrier strip 1202. In various embodiments, similar to the above,
dispenser 1200 can further include pin 1218 which can be rotatably
supported within aperture 1251 in first housing portion 1210 and an
aperture (not illustrated) in second housing portion 1212 wherein
pin 1218 can be configured to rotatably support pressure roller
1222. In various embodiments, referring particularly to FIGS. 56
and 57, dispenser 1200 can further include second drive roller 1253
which can be configured to cooperate with pressure roller 1222. In
at least one embodiment, second drive roller 1253 can be operably
engaged with thumb roller 1236 such that the rotation of thumb
roller 1234 can be transmitted to drive roller 1253. In various
embodiments, dispenser 1200 can further include a gear train
comprising spur gear 1244 mounted to at least one of thumb roller
1234 and pin 1235, intermediate gear 1246 rotatably supported by
pin 1247, and driven gear 1252 which can be operably engaged with
drive roller 1253. In at least one such embodiment, carrier strip
1202 can be positioned intermediate drive roller 1253 and pressure
roller 1222 such that, when driver roller 1253 is rotated by thumb
roller 1234, driver roller 1253 can drive carrier strip 1202
proximally. In at least one embodiment, pressure roller 1222 and/or
driver roller 1253 can be comprised of an at least partially
compressible material such that pressure roller 1222 can hold
carrier strip 1202 against driver roller 1253.
[0128] As described above, referring to FIGS. 54-57, applicator
1200 can include housing 1201 comprising first portion 1210 and
second portion 1212, wherein the first and second portions can be
configured to be attached to one another. In at least one
embodiment, the first and second portions of housing 1201 can be
screwed, snapped, and/or otherwise engaged with each other. In
various embodiments, the first and second housing portions can be
releasably engaged with each other such that the first and second
housing portions can be separated in order to remove and replace an
expended spool of buttress material. In at least one embodiment,
the housing can include ergonomic features such that the housing
can be easily gripped by a surgeon.
[0129] In other various embodiments, referring to FIGS. 58-61,
dispenser, or applicator, 1266 can include spool 1267 from which
buttress material 1236 can be dispensed and, in addition,
collection spool 1270 which can be configured to collect carrier
strip 1202 after it has been separated from buttress material 1236.
Similar to the above, buttress material 1236 can be dispensed from
applicator 1266 via the engagement between buttress material 1236,
thumb roller 1234, and/or drive roller 1232. In at least one
embodiment, collection spool 1270 can also be operatively engaged
with thumb roller 1234 such that the rotation of thumb roller 1234
can rotate spool 1270 and collect carrier strip 1202 therearound.
In various embodiments, applicator 1266 can include a gear train
comprising spur gear 1244 mounted to at least one of thumb roller
1234 and pin 1235, intermediate gear 1246 rotatably supported by
pin 1247, and driven gear 1272 which can be mounted to at least one
of spool 1270 and pin 1271. In at least one such embodiment, as a
result, the rotation of thumb roller 1234 can drive collection
spool 1270, directly apply a force to carrier strip 1202, and
collect carrier strip 1202 around spool 1270.
[0130] In various embodiments, referring to FIGS. 57 and 61,
buttress material applicators 1200 and/or 1266 can be used to apply
a piece of buttress material to a deck "D" of a staple cartridge
"SC" and/or a face "F" of an anvil "A". In at least one embodiment,
as illustrated in FIG. 61, a surgeon can first place applicator
1266, for example, against first end 1276 of deck D. Thereafter,
the surgeon can pull the applicator towards second end 1278 of deck
D while rotating thumb roller 1234 to dispense buttress material
1236. As discussed above, buttress material 1236 can be separated
into pieces and, in at least one embodiment, the length of the
pieces can such that the pieces of buttress material properly fit
on the staple cartridge deck and/or the anvil face. In other
various embodiments, the piece of buttress material can be
comprised of one continuous strip and the applicator can include a
cutting member (not illustrated) which can be configured to cut the
buttress material to any suitable length. In various embodiments,
the pieces of buttress material can include an adhesive thereon, or
which can be applied thereto, which can be configured to releasably
retain the buttress material to one of the deck and/or the
face.
[0131] In various embodiments, a piece of buttress material can be
manufactured utilizing an injection molding process. In at least
one embodiment, an injection mold (not illustrated) can include one
or more mold cavities defined therein which can be configured to
receive a molten material, for example. In various embodiments, the
molten material can include a plastic and/or any other suitable
buttress material. In various embodiments, the mold can further
include at least one sprue cavity and/or runner which can place the
mold cavities in fluid communication with an injection molding
machine. In at least one embodiment, the mold can include first and
second portions which can be separated after the molten material
has sufficiently solidified or hardened within the mold
cavities.
[0132] In various embodiments, referring to FIGS. 62 and 63, piece
of buttress material 1336 can include first surface 1302 and second
surface 1304, wherein the first and second surfaces can each
include plurality of apertures, or recesses, 1306 formed therein.
In at least one embodiment, recesses 1306 can be formed by molten
material within a mold during an injection molding process. More
particularly, the mold can include one or more cavities having a
plurality of projections which can be configured such that the
molten material will flow around the projections and, when the
piece of buttress material 1336 has solidified and is removed from
the mold, recesses 1306 may be present within buttress material
1336 where the projections were previously situated.
[0133] In various embodiments, buttress material 1336 can further
include a plurality of walls, such as walls 1305, for example,
formed intermediate first and second surfaces 1302 and 1304 wherein
walls 1305 can define recesses 1306. In at least one embodiment,
walls 1305 can be perpendicular and/or transverse to the first and
second surfaces such that walls 1305 can be structured and arranged
to form a pattern or grid of recesses 1306 within buttress material
1336. In various embodiments, buttress material 1336 can be
resilient such that first surface 1302 and/or second surface 1304
can be compressed towards one another. In at least one such
embodiment, buttress material 1336 can be configured such that it
can be compressed or press-fit between two or more retention
members of an end-effector as described above. In various
embodiments, a piece of buttress material can be compressed when
applied to an end-effector of a surgical instrument and can then
expand when it is released from the end-effector. In at least one
embodiment, buttress material 1336 can be configured to be
compressed such that first surface 1310 can be moved toward surface
1312. In any event, walls 1305 can be configured such that they can
deflect or collapse and allow portions of buttress material 1336 to
resiliently move toward one another.
[0134] Suitable bioabsorbable releasable adhesives that may be used
according to the present invention include cellulosic and aliphatic
ester homopolymers and copolymers made from polymers of the
formula: [--O--r.sup.11--C(O)--].sub.y, wherein R.sup.11 is
selected from the group consisting of --CR.sup.12H--,
--(CH.sub.2).sub.3--O--, --CH.sub.2--CH.sub.2--O--Ch.sub.2--,
CR.sup.12H--CH.sub.2, --(CH.sub.2).sub.4--, --(CH.sub.2).sub.z--O--
and --(CH.sub.2).sub.z--C(O)--CH.sub.2--; R.sup.12hydrogen or
methyl; z is an integer in the range of from 1 to 7; and y is an
integer in the range of from about 10 to about 20,000; blends of a
viscous PEG liquid and a low melting solid PEG (solid at room
temperature that melts at less than about 60.degree. C.);
biocompatible monosaccharides, disaccharides and polysaccharides
(such as pectin) that may be mixed with a plasticizer (such as
glycerine) to form a tacky adhesive and biocompatible proteins
(such as gelatin) that may mixed with a plasticizer (such as
glycerine) to form a tacky adhesive.
[0135] Many nontoxic bioabsorbable aliphatic ester polymers that
are semi-crystalline solids or tacky liquids at room temperature
may be used as a releasable adhesive. The releasable adhesive of
this invention are generally characterized as being flowable at
body temperature (37.degree. C.) and preferably will flow at room
temperatures (25.degree. C.). Most preferably these liquids will
have a low yield point to avoid migration of the polymer. Examples
of suitable tacky liquid copolymers are contained in U.S. patent
application Ser. No. 08/746,180, filed Nov. 6, 1996, now U.S. Pat.
No. 5,824,333. Additionally, tacky microdispersions may also be
used such as those described in U.S. Pat. No. 5,599,852.
[0136] In particular liquid copolymers composed of in the range of
from about 65 mole percent to about 35 mole percent of
epsilon-caprolactone, trimethylene carbonate, ether lactone (which
for the purpose of this invention is defined to be
1,4-dioxepan-2-one and 1,5-dioxepan-2-one) repeating units or
combinations thereof with the remainder of the polymer being a
plurality of second lactone repeating units are preferred. The
second lactone repeating units will be selected from the group
consisting of glycolic acid repeating units, lactic acid repeating
units, 1,4-dioxanone repeating units,
6,6-dialkyl-1,4-dioxepan-2-one, combinations thereof and blends
thereof. Additionally, epsilon-caprolactone, trimethylene
carbonate, or an ether lactone may be copolymerized to provide a
liquid copolymer. Preferred polymers for use as particulate solids
are bioabsorbable polymers including homopolymers of
poly(epsilon-caprolactone), poly(p-dioxanone), or poly(trimethylene
carbonate), copolymers of epsilon-caprolactone and trimethylene
carbonate, copolymers of epsilon-caprolactone and a plurality of
second lactone repeating units. The second lactone repeating units
may be selected from the group consisting of glycolic acid
repeating units, lactic acid repeating units, 1,4-dioxanone
repeating units, 1,4-dioxepan-2-one repeating units,
1,5-dioxepan-2-one repeating units and combinations thereof. The
copolymers of epsilon-caprolactone will preferably be composed of
from 99 mole percent to 70 mole percent epsilon-caprolactone with
the remainder of the polymer being a plurality of second lactone
repeating units.
[0137] The polymers may be linear, branched, or star branched;
block copolymers or terpolymers; segmented block copolymers or
terpolymers. These polymers will also be purified to substantially
remove unreacted monomers that may cause an inflammatory reaction
in tissue.
[0138] Preferred liquid copolymers for use as the releasable
adhesive are composed of in the range of from about 65 mole percent
to about 35 mole percent epsilon-caprolactone or an ether lactone
repeating unit with the remainder of the copolymer being
trimethylene carbonate repeating units. Examples of suitable
terpolymers are terpolymers selected from the group consisting of
poly(glycolide-co-epsilon-caprolactone-co-p-dioxanone) and
poly(lactide-co-epsilon-caprolactone-co-p-dioxanone) wherein the
mole percent of epsilon-caprolactone repeating units is from about
35 to about 65 mole percent.
[0139] Preferred are terpolymers having in the range of from 40 to
60 mole percent of epsilon-caprolactone repeating units. Examples
of liquid copolymer for use as the releasable adhesive may be
selected from the group consisting of
poly(epsilon-caprolactone-co-trimethylene carbonate),
poly(lactide-co-trimethylene carbonate),
poly(epsilon-caprolactone-co-p-dioxanone), poly(trimethylene
carbonate-co-p-dioxanone), poly(epsilon-caprolactone-co-lactide),
poly(lactide-co-1,5-dioxepan-2-one), and
poly(1,5-dioxepan-2-one-co-p-dioxanone),
poly(lactide-co-1,4-dioxepan-2-one), and
poly(1,4-dioxepan-2-one-co-p-dioxanone). The mole percent of
epsilon-caprolactone, trimethylene carbonate or ether lactone
repeating units in these polymers should be in the range of from
about 35 to about 65 mole percent and preferably in the range of
from 40 to 60 mole percent. Most preferably these liquid polymers
will be statistically random copolymers. These polymers will also
be purified to substantially remove unreacted monomers that may
cause an inflammatory reaction in tissue.
[0140] The polymers used as the releasable adhesive should have an
inherent viscosity as determined in a 0.1 g/dL solution of
hexafluoroisopropanol (HFIP) at 25.degree. C. ranging from about
0.1 dL/g to about 0.8 dL/g, preferably from about 0.1 dL/g to about
0.6 dL/g, and most preferably from 0.15 dL/g to 0.25 dL/g for
liquid polymers. Additionally, blends of liquid and solid
polyethylene glycols (PEG) may be used as releasable adhesives. The
liquid PEG may have a molecular weight from about 200 to about 600.
The solid PEG may have a molecular weight from about 3400 to about
10,000. Generally it is theorized, but in no way limits the scope
of this invention, that the low molecular weight liquid PEG
plasticizes the solid PEG to render the solid PEG tacky.
Consequently the majority of the composition should be the solid
PEG and preferably between about 50 and about 80 percent by weight
of the composition will be solid PEG. For example, a liquid
polyethylene glycol with molecular weight of 400 (PEG 400) may be
blended with a solid polyethylene glycol with a molecular weight of
about 2,000 (PEG 2000). The ratio of PEG 400 to PEG 2000 may vary
from about 40:60 to about 30:70. These blends may be formed by
mixing the liquid PEG and the solid PEG with constant stirring in a
heated water bath until the solid melts and a clear liquid solution
is formed. After these solutions are allowed to cool and the
resulting mixture may be tested for tackiness and used if the
desired tackiness is obtained used in the present invention.
[0141] Alternatively biocomptaible monosaccharides, disaccharides,
polysaccharides or proteins can be used with a biocompatible
plasticizer such as glycerine to form tacky films in the presence
of water. These materials may be applied to the surface of the
buttress material and activated by applying water before contacting
with the staple applier.
[0142] The amount of releasable adhesive that will be applied
depends on a variety of factors such as the releasable adhesive
used the desired degree of resistance desired for the foam to
release and the geometry of its application. Those skilled in the
art will readily be able to determine the appropriate amount of
releasable adhesive to apply to achieve the desired release
profile.
[0143] 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.
[0144] Preferably, the invention described herein will be processed
before surgery. First, a new or used instrument is obtained and if
necessary cleaned. The instrument can then be sterilized. In one
sterilization technique, the instrument is placed in a closed and
sealed container, such as a plastic or TYVEK 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. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0145] While this invention has been described as having exemplary
designs, the present invention may be further modified within the
spirit and scope of the disclosure. This application is therefore
intended to cover any variations, uses, or adaptations of the
invention using its general principles. Further, this application
is intended to cover such departures from the present disclosure as
come within known or customary practice in the art to which this
invention pertains.
* * * * *