U.S. patent application number 14/187395 was filed with the patent office on 2014-06-19 for staple cartridge including a barbed staple..
This patent application is currently assigned to ETHICON ENDO-SURGERY, INC.. The applicant listed for this patent is ETHICON ENDO-SURGERY, INC.. Invention is credited to TAYLOR W. ARONHALT, EMILY A. SCHELLIN, FREDERICK E. SHELTON, IV, MICHAEL J. VENDELY.
Application Number | 20140166725 14/187395 |
Document ID | / |
Family ID | 55307140 |
Filed Date | 2014-06-19 |
United States Patent
Application |
20140166725 |
Kind Code |
A1 |
SCHELLIN; EMILY A. ; et
al. |
June 19, 2014 |
STAPLE CARTRIDGE INCLUDING A BARBED STAPLE.
Abstract
An end effector for fastening tissue including an anvil having a
deck to support tissue. The deck has a first surface with a first
longitudinal row of staple forming pockets, and a second surface,
having a second longitudinal row of staple forming pockets wherein
the first surface is positioned vertically above the second
surface. The end effector also includes a cartridge having
plurality of staple cavities arranged in first and second
longitudinal rows. The end effector also includes a plurality of
staples removably stored within the staple cavities. The staples
include a base, a pair of legs extending from the base, wherein
each the leg comprises a tip configured to pierce tissue, and
wherein each the leg comprises at least one barb extending
therefrom. The end effector also has a firing member configured to
lift the staple drivers toward the anvil.
Inventors: |
SCHELLIN; EMILY A.;
(CINCINNATI, OH) ; ARONHALT; TAYLOR W.; (LOVELAND,
OH) ; VENDELY; MICHAEL J.; (LEBANON, OH) ;
SHELTON, IV; FREDERICK E.; (HILLSBORO, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ETHICON ENDO-SURGERY, INC. |
CINCINNATI |
OH |
US |
|
|
Assignee: |
ETHICON ENDO-SURGERY, INC.
CINCINNATI
OH
|
Family ID: |
55307140 |
Appl. No.: |
14/187395 |
Filed: |
February 24, 2014 |
Current U.S.
Class: |
227/178.1 |
Current CPC
Class: |
A61B 2017/07235
20130101; A61B 17/068 20130101; A61B 2017/00526 20130101; A61B
2017/00004 20130101; B29K 2995/0056 20130101; B29C 43/52 20130101;
A61B 17/064 20130101; A61B 17/07207 20130101; A61B 17/07292
20130101; B29C 43/00 20130101; B29L 2031/7546 20130101; A61B
2017/0688 20130101; B29C 55/00 20130101; A61B 17/0644 20130101;
A61B 2017/07285 20130101; B29C 67/20 20130101; A61B 2017/07264
20130101; A61B 2017/07271 20130101; A61B 17/105 20130101; A61B
2017/07278 20130101; A61B 2017/07242 20130101; A61B 2017/07257
20130101; A61L 31/04 20130101; B29K 2105/04 20130101; A61B 17/072
20130101; A61L 31/146 20130101 |
Class at
Publication: |
227/178.1 |
International
Class: |
A61B 17/072 20060101
A61B017/072 |
Claims
1. An end effector for fastening tissue, comprising: an anvil,
wherein said anvil comprises a deck configured to support tissue,
wherein said deck comprises: a first surface, having a first
longitudinal row of staple forming pockets; and a second surface,
having a second longitudinal row of staple forming pockets, and
wherein said first surface is positioned vertically above said
second surface; a cartridge comprising a plurality of staple
cavities, wherein said plurality of staple cavities are arranged in
a first and second longitudinal rows of staple cavities; a
plurality of staples removably stored within said staple cavities,
and a plurality of staple drivers movable within said staple
cavities, wherein said staple drivers are configured to lift said
staples toward said anvil, each said staple comprises, a base, a
pair of legs extending from said base wherein each said leg has a
tip configured to pierce tissue, and wherein each said leg
comprises at least one barb extending therefrom; and a firing
member configured to lift said staple drivers toward said anvil,
wherein said firing member comprises a first portion configured to
engage said anvil and a second portion configured to engage said
cartridge, and wherein said firing member is configured to
relatively position said anvil and said cartridge.
2. The end effector of claim 1, wherein said firing member
comprises a knife edge.
3. The end effector of claim 1, wherein said firing member
comprises at least one inclined surface configured to lift said
drivers toward said anvil.
4. An end effector for fastening tissue, comprising: an anvil
comprising a tissue compression portion configured to support
tissue, said tissue compression portion comprising: a first
compression surface, and a first longitudinal row of staple forming
pockets defined in said first compression surface; a second
compression surface, and a second longitudinal row of staple
forming pockets defined in said first compression surface; a
longitudinal slot configured to receive a cutting member, wherein
said longitudinal slot divides said tissue compression portion into
a first lateral side and a second lateral side, wherein said first
compression surface and said second compression surface are
positioned on said first lateral side of said longitudinal slot,
and wherein said first compression surface is offset from said
second compression surface; and a cartridge, comprising: a first
deck portion alignable with said first compression surface; a
second deck portion alignable with said second compression surface;
and a plurality of staple cavities, wherein said plurality of
staple cavities are arranged in a first longitudinal row of staple
cavities and a second longitudinal row of staple cavities, wherein
said first longitudinal row of staple cavities are defined in said
first deck portion, wherein said second longitudinal row of staple
cavities are defined in said second deck portion, wherein a first
gap distance is defined between said first compression surface and
said first deck portion, wherein a second gap distance is defined
between said second compression surface and said second deck
portion, and wherein said first gap distance is different than said
second gap distance; a plurality of staples removably stored within
said staple cavities, wherein each said staple comprises: a base;
and a plurality of legs extending from said base, wherein each said
leg comprises a tip configured to pierce tissue, and wherein each
said leg comprises at least one barb extending therefrom; a
plurality of staple drivers movable within said staple cavities,
wherein said staple drivers are configured to lift said staples
toward said anvil; and a firing member configured to lift said
staple drivers toward said anvil, wherein said firing member
comprises a first portion configured to engage said anvil and a
second portion configured to engage said cartridge, and wherein
said firing member is configured to relatively position said anvil
and said cartridge.
5. The end effector of claim 4, wherein said firing member
comprises a knife edge.
6. The end effector of claim 4, wherein said firing member
comprises at least one inclined surface configured to lift said
drivers toward said anvil.
Description
BACKGROUND
[0001] The present invention relates to surgical instruments and,
in various arrangements, to surgical stapling and cutting
instruments and staple cartridges therefor that are designed to
staple and cut tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0002] The 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:
[0003] FIG. 1 is a left front perspective view of a surgical
stapling and severing instrument with a handle portion;
[0004] FIG. 2 is a perspective view of a two-piece knife and firing
bar ("E-beam") of the surgical stapling and severing instrument of
FIG. 1;
[0005] FIG. 3 is a perspective view of a wedge sled of a staple
cartridge of a staple applying assembly;
[0006] FIG. 4 is a longitudinal cross-sectional view of an anvil in
a closed position and a staple cartridge comprising a rigid support
portion and a compressible tissue thickness compensator illustrated
with staples being moved from an unfired position to a fired
position during a first sequence;
[0007] FIG. 5 is another cross-sectional view of the anvil and the
staple cartridge of FIG. 4 illustrating the anvil in an open
position after the firing sequence has been completed;
[0008] FIG. 6 is an exploded perspective view of a tissue thickness
compensator and a staple cartridge assembly;
[0009] FIG. 7 is a partial cross-sectional view of the staple
cartridge assembly of FIG. 6, illustrating unfired staples
positioned in staple cavities of a staple cartridge body and
partially embedded in a tissue thickness compensator;
[0010] FIG. 8 is a partial cross-sectional view of the staple
cartridge assembly of FIG. 6, illustrating fired staples ejected
from the staple cavities of the staple cartridge body and formed
against an anvil, and further illustrating the tissue thickness
compensator and tissue captured within the staple entrapment area
of the formed staples;
[0011] FIG. 9 is a partial perspective view of an end effector of a
surgical fastening instrument illustrated with some portions
removed and other portions illustrated in cross-section; moreover,
a cutting member of the end effector is illustrated in a partially
advanced position;
[0012] FIG. 10 is a partial cross-sectional end view of the end
effector of FIG. 9 illustrated with patient tissue captured between
an anvil and a tissue thickness compensator of the end effector;
moreover, staples removably stored within a cartridge body of the
end effector are illustrated in an unfired position and the cutting
member of the end effector is illustrated in an unadvanced position
which is proximal to the tissue thickness compensator;
[0013] FIG. 11 is a partial cross-sectional end view of the end
effector of FIG. 9 illustrated with the staples in a fired position
and the cutting member in a partially advanced position in which
the patient tissue has been at least partially transected;
[0014] FIG. 12 is a partial cross-sectional end view of the end
effector of FIG. 9 illustrated with the staples in a fired position
and the cutting member in an advanced position in which at least a
portion of the tissue thickness compensator has been transected by
the cutting member;
[0015] FIG. 13 is a perspective view of a fastener cartridge
including a tissue thickness compensator;
[0016] FIG. 14 is a cross-sectional view of the tissue thickness
compensator of FIG. 13 illustrating a cutting member positioned
relative to a proximal end of the tissue thickness compensator.
[0017] FIG. 15 is an exploded view of a tissue thickness
compensator assembly;
[0018] FIG. 16 is a perspective view of layer of a tissue thickness
compensator assembly;
[0019] FIG. 17 is a cross-sectional view of the tissue thickness
compensator assembly of FIG. 15;
[0020] FIG. 18 is a cross-sectional perspective view of an
assembled tissue thickness compensator assembly and a mold for
assembling the same;
[0021] FIG. 19 is a perspective view of the assembled tissue
thickness compensator assembly of FIG. 18;
[0022] FIG. 20 is a perspective view of a tissue thickness
compensator assembly and a mold for assembling the same;
[0023] FIG. 21 is a perspective view of a tissue thickness
compensator assembly and a mold for assembling the same;
[0024] FIG. 22 is a cross-sectional perspective view of the tissue
thickness compensator assembly of FIG. 21 and the mold of FIG. 21
for assembling the same;
[0025] FIG. 23 is a perspective view of an end effector comprising
a tissue thickness compensator;
[0026] FIG. 24 is a perspective view of the end effector and the
tissue thickness compensator of FIG. 23 and a modifying member
modifying the tissue thickness compensator;
[0027] FIG. 25 is a perspective view of the end effector of FIG. 23
comprising the modified tissue thickness compensator of FIG.
24;
[0028] FIG. 26 is a cross-sectional perspective view of a tissue
thickness compensator;
[0029] FIG. 27 is a cross-sectional perspective view of a mold for
modifying the tissue thickness compensator of FIG. 26;
[0030] FIG. 28 is a cross-sectional perspective view of the tissue
thickness compensator of FIG. 26 after modification by the mold of
FIG. 27;
[0031] FIG. 29 is a cross-sectional perspective view of a tissue
thickness compensator;
[0032] FIG. 30 is a cross-sectional perspective view of a mold for
modifying the tissue thickness compensator of FIG. 29;
[0033] FIG. 31 is a cross-sectional perspective view of the tissue
thickness compensator of FIG. 29 after modification by the mold of
FIG. 30;
[0034] FIG. 32 is a cross-sectional perspective view of a tissue
thickness compensator;
[0035] FIG. 33 is a cross-sectional perspective view of a mold for
modifying the tissue thickness compensator of FIG. 32;
[0036] FIG. 34 is a cross-sectional perspective view of the tissue
thickness compensator of FIG. 32 after modification by the mold of
FIG. 33;
[0037] FIG. 35 is a cross-sectional perspective view of a tissue
thickness compensator including a first height;
[0038] FIG. 36 is a cross-sectional perspective view of the tissue
thickness compensator of FIG. 35 after modification to change the
first height to a second height;
[0039] FIG. 37 is a cross-sectional view of a mold for modifying
the tissue thickness compensator of FIG. 35;
[0040] FIG. 38 is a cross-sectional perspective view of a tissue
thickness compensator;
[0041] FIG. 39 is a cross-sectional perspective view the tissue
thickness compensator of FIG. 38 after modification;
[0042] FIG. 40 is a graph illustrating the effect of compression
forces on a spring rate of a tissue thickness compensator;
[0043] FIG. 41 is a cross-sectional perspective view of a tissue
thickness compensator;
[0044] FIG. 42 is a cross-sectional perspective view of a space
creator for modifying the tissue thickness compensator of FIG.
41;
[0045] FIG. 43 is a cross-sectional perspective view of the tissue
thickness compensator of FIG. 41 after modification by the space
creator of FIG. 42;
[0046] FIG. 44 is a partial cross-sectional elevational view of a
fastener cartridge for use with a surgical instrument including a
firing member in accordance with at least one embodiment
illustrated with portions removed;
[0047] FIG. 45 is a partial cross-sectional elevational view
depicting a tissue thickness compensator of the fastener cartridge
of FIG. 44 being removed from the fastener cartridge and the firing
member of FIG. 44 illustrated in a locked-out condition;
[0048] FIG. 46 is a partial perspective view of the tissue
thickness compensator of FIG. 45;
[0049] FIG. 47 is a partial perspective view a tissue thickness
compensator in accordance with at least one embodiment;
[0050] FIG. 48 is a partial cross-sectional elevational view of an
end effector of a surgical instrument comprising a fastener
cartridge including the tissue thickness compensator of FIG. 47, a
sled, and a firing member supported by the sled illustrated with
portions removed;
[0051] FIG. 49 is a partial cross-sectional elevational view of the
end effector of FIG. 48 illustrating the firing member in a
partially-fired position;
[0052] FIG. 50 is a partial cross-sectional elevational view of the
end effector of FIG. 48 illustrating the tissue thickness
compensator removed from the fastener cartridge and the firing
member in a locked-out condition;
[0053] FIG. 51 is a partial perspective view of a fastener
cartridge in accordance with at least one embodiment illustrated
with portions removed;
[0054] FIG. 52 is a perspective view of a sled of the fastener
cartridge of FIG. 51;
[0055] FIG. 53 is a partial perspective view of the fastener
cartridge of FIG. 51;
[0056] FIG. 54 is an elevational view of a sled in accordance with
at least one embodiment;
[0057] FIG. 55 is a perspective view of a sled in accordance with
at least one embodiment illustrated in an unlocked
configuration;
[0058] FIG. 56 is a perspective view of the sled of FIG. 55
illustrated in a locked-out configuration;
[0059] FIG. 57 is a partial cross-sectional elevational view of the
sled of FIG. 55 positioned within a fastener cartridge illustrating
the sled in its unlocked configuration, a firing member supported
by the sled, and a tissue thickness compensator of the fastener
cartridge engaged with the sled;
[0060] FIG. 58 is a partial cross-sectional elevational view of the
tissue thickness compensator of FIG. 57 being removed from the
fastener cartridge of FIG. 57 which has placed the sled of FIG. 55
in its locked-out configuration and the firing member of FIG. 57 in
a locked-out condition;
[0061] FIG. 59 is a partial cross-sectional elevational view of a
sled positioned at the proximal end of a fastener cartridge in
accordance with at least one embodiment illustrated with portions
removed;
[0062] FIG. 60 is a partial cross-sectional elevational view of the
sled of FIG. 59 illustrated at the distal end of the fastener
cartridge;
[0063] FIG. 61 is a perspective view of a sled in accordance with
at least one embodiment;
[0064] FIG. 62 is a diagram depicting a staple comprising a
plurality of barbs in accordance with at least one embodiment,
wherein the staple is illustrated in an unformed configuration and
a deformed configuration;
[0065] FIG. 63 is an elevational view of a staple comprising a
plurality of barbs in accordance with at least one embodiment,
wherein the staple is positioned within a staple cavity in an
unfired position;
[0066] FIG. 64 is an elevational view of a staple including a
plurality of barbs in accordance with at least one embodiment;
[0067] FIG. 65 is an elevational view of a staple including a
plurality of barbs in accordance with at least one embodiment;
[0068] FIG. 66 is an elevational view of a staple including a
plurality of barbs in accordance with at least one embodiment;
[0069] FIG. 67 is an elevational view of a staple including a
plurality of barbs in accordance with at least one embodiment;
[0070] FIG. 68 is an elevational view of the staple including a
plurality of barbs in accordance with at least one embodiment,
wherein the staple is positioned within a staple cavity in an
unfired position;
[0071] FIG. 69 is a plan view of the staple and the staple cavity
of FIG. 68;
[0072] FIG. 70 is a partial perspective view of a barbed staple leg
in accordance with at least one embodiment;
[0073] FIG. 71 is a partial perspective view of a barbed staple leg
of the staple of FIG. 68;
[0074] FIG. 71A is a cross-sectional plan view of the barbed staple
leg of FIG. 71;
[0075] FIG. 72 is a partial perspective view of a barbed staple leg
in accordance with at least one embodiment; and
[0076] FIG. 73 is a partial perspective view of a barbed staple leg
in accordance with at least one embodiment.
DETAILED DESCRIPTION
[0077] The Applicant of the present application also owns the U.S.
Patent Applications identified below which are each herein
incorporated by reference in their respective entirety:
[0078] U.S. patent application Ser. No. 12/894,311, entitled
SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS; now U.S.
Patent Publication No. 2012/0080496;
[0079] U.S. patent application Ser. No. 12/894,340, entitled
SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES
AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING
POCKETS; now U.S. Patent Publication No. 2012/0080482;
[0080] U.S. patent application Ser. No. 12/894,327, entitled JAW
CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS; now U.S. Patent
Publication No. 2012/0080499;
[0081] U.S. patent application Ser. No. 12/894,351, entitled
SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND
DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS; now U.S.
Patent Publication No. 2012/0080502;
[0082] U.S. patent application Ser. No. 12/894,338, entitled
IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT;
now U.S. Patent Publication No. 2012/0080481;
[0083] U.S. patent application Ser. No. 12/894,369, entitled
IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER; now
U.S. Patent Publication No. 2012/0080344;
[0084] U.S. patent application Ser. No. 12/894,312, entitled
IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS; now U.S.
Patent Publication No. 2012/0080479;
[0085] U.S. patent application Ser. No. 12/894,377, entitled
SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE; now U.S.
Pat. No. 8,393,514;
[0086] U.S. patent application Ser. No. 12/894,339, entitled
SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL
ARRANGEMENT; now U.S. Patent Publication No. 2012/0080500;
[0087] U.S. patent application Ser. No. 12/894,360, entitled
SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM;
now U.S. Patent Publication No. 2012/0080484;
[0088] U.S. patent application Ser. No. 12/894,322, entitled
SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE
ARRANGEMENTS; now U.S. Patent Publication No. 2012/0080501;
[0089] U.S. patent application Ser. No. 12/894,350, entitled
SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES; now
U.S. Patent Publication No. 2012/0080478;
[0090] U.S. patent application Ser. No. 12/894,383, entitled
IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS; now
U.S. Patent Publication No. 2012/0080345;
[0091] U.S. patent application Ser. No. 12/894,389, entitled
COMPRESSIBLE FASTENER CARTRIDGE; now U.S. Patent Publication No.
2012/0080335;
[0092] U.S. patent application Ser. No. 12/894,345, entitled
FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT; now U.S.
Patent Publication No. 2012/0080483;
[0093] U.S. patent application Ser. No. 12/894,306, entitled
COLLAPSIBLE FASTENER CARTRIDGE; now U.S. Patent Publication No.
2012/0080332;
[0094] U.S. patent application Ser. No. 12/894,318, entitled
FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION
MATRIX ELEMENTS; now U.S. Patent Publication No. 2012/0080480;
[0095] U.S. patent application Ser. No. 12/894,330, entitled
FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT
MATRIX; now U.S. Patent Publication No. 2012/0080503;
[0096] U.S. patent application Ser. No. 12/894,361, entitled
FASTENER SYSTEM COMPRISING A RETENTION MATRIX; now U.S. Pat. No.
8,529,600;
[0097] U.S. patent application Ser. No. 12/894,367, entitled
FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A
RETENTION MATRIX; now U.S. Patent Publication No. 2012/0080485;
[0098] U.S. patent application Ser. No. 12/894,388, entitled
FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER; now U.S.
Pat. No. 8,474,677;
[0099] U.S. patent application Ser. No. 12/894,376, entitled
FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES; now
U.S. Patent Publication No. 2012/0080486;
[0100] U.S. patent application Ser. No. 13/097,865, entitled
SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS;
now U.S. Patent Publication No. 2012/0080488;
[0101] U.S. patent application Ser. No. 13/097,936, entitled TISSUE
THICKNESS COMPENSATOR FOR A SURGICAL STAPLER; now U.S. Patent
Publication No. 2012/0080339;
[0102] U.S. patent application Ser. No. 13/097,954, entitled STAPLE
CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION; now
U.S. Patent Publication No. 2012/0080340;
[0103] U.S. patent application Ser. No. 13/097,856, entitled STAPLE
CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE
PORTION THEREOF; now U.S. Patent Publication No. 2012/0080336;
[0104] U.S. patent application Ser. No. 13/097,928, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS; now U.S.
Patent Publication No. 2012/0080490;
[0105] U.S. patent application Ser. No. 13/097,891, entitled TISSUE
THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN
ADJUSTABLE ANVIL; now U.S. Patent Publication No. 2012/0080489;
[0106] U.S. patent application Ser. No. 13/097,948, entitled STAPLE
CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION; now U.S. Patent
Publication No. 2012/0083836;
[0107] U.S. patent application Ser. No. 13/097,907, entitled
COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY; now U.S. Patent Publication
No. 2012/0080338;
[0108] U.S. patent application Ser. No. 13/097,861, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT
PROPERTIES; now U.S. Patent Publication No. 2012/0080337;
[0109] U.S. patent application Ser. No. 13/097,869, entitled STAPLE
CARTRIDGE LOADING ASSEMBLY; now U.S. Patent Publication No.
2012/0160721;
[0110] U.S. patent application Ser. No. 13/097,917, entitled
COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS; now
U.S. Patent Publication No. 2012/0083834;
[0111] U.S. patent application Ser. No. 13/097,873, entitled STAPLE
CARTRIDGE COMPRISING A RELEASABLE PORTION; now U.S. Patent
Publication No. 2012/0083833;
[0112] U.S. patent application Ser. No. 13/097,938, entitled STAPLE
CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS;
now U.S. Patent Publication No. 2012/0080491;
[0113] U.S. patent application Ser. No. 13/097,924, entitled STAPLE
CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR; now U.S.
Patent Publication No. 2012/0083835;
[0114] U.S. patent application Ser. No. 13/242,029, entitled
SURGICAL STAPLER WITH FLOATING ANVIL; now U.S. Patent Publication
No. 2012/0080493;
[0115] U.S. patent application Ser. No. 13/242,066, entitled CURVED
END EFFECTOR FOR A STAPLING INSTRUMENT; now U.S. Patent Publication
No. 2012/0080498;
[0116] U.S. patent application Ser. No. 13/242,086, entitled STAPLE
CARTRIDGE INCLUDING COLLAPSIBLE DECK; now U.S. Patent Publication
No. 2013/0075450;
[0117] U.S. patent application Ser. No. 13/241,912, entitled STAPLE
CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT; now U.S. Patent
Publication No. 2013/0075448;
[0118] U.S. patent application Ser. No. 13/241,922, entitled
SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS; now U.S. Patent
Publication No. 2013/0075449;
[0119] U.S. patent application Ser. No. 13/241,637, entitled
SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE
ACTUATION MOTIONS; now U.S. Patent Publication No.
2012/0074201;
[0120] U.S. patent application Ser. No. 13/241,629, entitled
SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR;
now U.S. Patent Publication No. 2012/0074200;
[0121] U.S. application Ser. No. 13/433,096, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES; now U.S.
Patent Publication No. 2012/0241496;
[0122] U.S. application Ser. No. 13/433,103, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS; now U.S.
Patent Publication No. 2012/0241498;
[0123] U.S. application Ser. No. 13/433,098, entitled EXPANDABLE
TISSUE THICKNESS COMPENSATOR; now U.S. Patent Publication No.
2012/0241491;
[0124] U.S. application Ser. No. 13/433,102, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING A RESERVOIR; now U.S. Patent
Publication No. 2012/0241497;
[0125] U.S. application Ser. No. 13/433,114, entitled RETAINER
ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR; now U.S. Patent
Publication No. 2012/0241499;
[0126] U.S. application Ser. No. 13/433,136, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT; now U.S.
Patent Publication No. 2012/0241492;
[0127] U.S. application Ser. No. 13/433,141, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION;
now U.S. Patent Publication No. 2012/0241493;
[0128] U.S. application Ser. No. 13/433,144, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT
LOAD; now U.S. Patent Publication No. 2012/0241500;
[0129] U.S. application Ser. No. 13/433,148, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT
LOAD; now U.S. Patent Publication No. 2012/0241501;
[0130] U.S. application Ser. No. 13/433,155, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS; now U.S. Patent
Publication No. 2012/0241502;
[0131] U.S. application Ser. No. 13/433,163, entitled METHODS FOR
FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL
STAPLERS; now U.S. Patent Publication No. 2012/0248169;
[0132] U.S. application Ser. No. 13/433,167, entitled TISSUE
THICKNESS COMPENSATORS; now U.S. Patent Publication No.
2012/0241503;
[0133] U.S. application Ser. No. 13/433,175, entitled LAYERED
TISSUE THICKNESS COMPENSATOR; now U.S. Patent Publication No.
2012/0253298;
[0134] U.S. application Ser. No. 13/433,179, entitled TISSUE
THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS; now U.S.
Patent Publication No. 2012/0241505;
[0135] U.S. application Ser. No. 13/763,028, entitled ADHESIVE FILM
LAMINATE; now U.S. Patent Publication No. 2013/0146643;
[0136] U.S. application Ser. No. 13/433,115, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE
ENVIRONMENT; now U.S. Patent Publication No. 2013/0256372;
[0137] U.S. application Ser. No. 13/433,118, entitled TISSUE
THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS; now
U.S. Patent Publication No. 2013/0256365;
[0138] U.S. application Ser. No. 13/433,135, entitled MOVABLE
MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR; now U.S. Patent
Publication No. 2013/0256382;
[0139] U.S. application Ser. No. 13/433,140, entitled TISSUE
THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME; now U.S.
Patent Publication No. 2013/0256368;
[0140] U.S. application Ser. No. 13/433,129, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS; now
U.S. Patent Publication No. 2013/0256367;
[0141] U.S. application Ser. No. 11/216,562, entitled STAPLE
CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE
HEIGHTS, now U.S. Pat. No. 7,669,746;
[0142] U.S. application Ser. No. 11/714,049, entitled SURGICAL
STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMING POCKETS OF VARYING
DEPTHS, now U.S. Patent Publication No. 2007/0194082;
[0143] U.S. application Ser. No. 11/711,979, entitled SURGICAL
STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT
LENGTHS, now U.S. Pat. No. 8,317,070;
[0144] U.S. application Ser. No. 11/711,975, entitled SURGICAL
STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENT HEIGHT, now U.S.
Patent Publication No. 2007/0194079;
[0145] U.S. application Ser. No. 11/711,977, entitled SURGICAL
STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS MULTIPLE WIRE
DIAMETER STAPLES, now U.S. Pat. No. 7,673,781;
[0146] U.S. application Ser. No. 11/712,315, entitled SURGICAL
STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGE CAMS FOR
DRIVING STAPLE DRIVERS, now U.S. Pat. No. 7,500,979;
[0147] U.S. application Ser. No. 12/038,939, entitled STAPLE
CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE
HEIGHTS, now U.S. Pat. No. 7,934,630;
[0148] U.S. application Ser. No. 13/020,263, entitled SURGICAL
STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVING DIFFERENT
LENGTHS, now U.S. Patent Publication No. 2011/0147434;
[0149] U.S. application Ser. No. 13/118,278, entitled
ROBOTICALLY-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCE
FORMED STAPLES HAVING DIFFERENT LENGTHS, now U.S. Patent
Publication No. 2011/0290851;
[0150] U.S. application Ser. No. 13/369,629, entitled
ROBOTICALLY-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS, now U.S.
Patent Publication No. 2012/0138660;
[0151] U.S. application Ser. No. 12/695,359, entitled SURGICAL
STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENT FORMED HEIGHTS,
now U.S. Pat. No. 8,464,923;
[0152] U.S. application Ser. No. 13/072,923, entitled STAPLE
CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE
HEIGHTS, now U.S. Pat. No. 8,567,656;
[0153] U.S. application Ser. No. 13/766,325, entitled LAYER OF
MATERIAL FOR A SURGICAL END EFFECTOR; now U.S. Patent Publication
No. 2013/0256380;
[0154] U.S. application Ser. No. 13/763,078, entitled ANVIL LAYER
ATTACHED TO A PROXIMAL END OF AN END EFFECTOR; now U.S. Patent
Publication No. 2013/0256383;
[0155] U.S. application Ser. No. 13/763,094, entitled LAYER
COMPRISING DEPLOYABLE ATTACHMENT MEMBERS; now U.S. Patent
Publication No. 2013/0256377;
[0156] U.S. application Ser. No. 13/763,106, entitled END EFFECTOR
COMPRISING A DISTAL TISSUE ABUTMENT MEMBER; now U.S. Patent
Publication No. 2013/0256378;
[0157] U.S. application Ser. No. 13/433,147, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING CHANNELS; now U.S. Patent
Publication No. 2013/0256369;
[0158] U.S. application Ser. No. 13/763,112, entitled SURGICAL
STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES; now U.S. Patent
Publication No. 2013/0256379;
[0159] U.S. application Ser. No. 13/763,035, entitled ACTUATOR FOR
RELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE;
now U.S. Patent Publication No. 2013/0214030;
[0160] U.S. application Ser. No. 13/763,042, entitled RELEASABLE
TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE
SAME; now U.S. Patent Publication No. 2013/0221063;
[0161] U.S. application Ser. No. 13/763,048, entitled FASTENER
CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESS COMPENSATOR; now
U.S. Patent Publication No. 2013/0221064;
[0162] U.S. application Ser. No. 13/763,054, entitled FASTENER
CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE
THICKNESS COMPENSATOR;
[0163] U.S. application Ser. No. 13/763,065, entitled FASTENER
CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUE THICKNESS
COMPENSATOR; now U.S. Patent Publication No. 2013/0221065;
[0164] U.S. application Ser. No. 13/763,021, entitled STAPLE
CARTRIDGE COMPRISING A RELEASABLE COVER;
[0165] U.S. application Ser. No. 13/763,078, entitled ANVIL LAYER
ATTACHED TO A PROXIMAL END OF AN END EFFECTOR; now U.S. Patent
Publication No. 2013/0256383;
[0166] U.S. application Ser. No. 13/763,095, entitled LAYER
ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES; now U.S. Patent
Publication No. 2013/0161374;
[0167] U.S. application Ser. No. 13/463,147, entitled IMPLANTABLE
ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES; now U.S. Patent
Publication No. 2013/0292398;
[0168] U.S. application Ser. No. 13/763,192, entitled MULTIPLE
THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES; now
U.S. Patent Publication No. 2013/0146642;
[0169] U.S. application Ser. No. 13/763,161, entitled RELEASABLE
LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME; now
U.S. Patent Publication No. 2013/0153641;
[0170] U.S. application Ser. No. 13/763,177, entitled ACTUATOR FOR
RELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR; now
U.S. Patent Publication No. 2013/0146641;
[0171] U.S. application Ser. No. 13/763,037, entitled STAPLE
CARTRIDGE COMPRISING A COMPRESSIBLE PORTION;
[0172] U.S. application Ser. No. 13/433,126, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES; now U.S.
Patent Publication No. 2013/0256366;
[0173] U.S. application Ser. No. 13/433,132, entitled DEVICES AND
METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO
SURGICAL STAPLING INSTRUMENTS; now U.S. Patent Publication No.
2013/0256373.
[0174] U.S. application Ser. No. 13/851,703, entitled FASTENER
CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR INCLUDING
OPENINGS THEREIN;
[0175] U.S. application Ser. No. 13/851,676, entitled TISSUE
THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH;
[0176] U.S. application Ser. No. 13/851,693, entitled FASTENER
CARTRIDGE ASSEMBLIES; and U.S. application Ser. No. 13/851,684,
entitled FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS
COMPENSATOR AND A GAP SETTING ELEMENT.
[0177] Applicant of the present application also owns the following
patent applications that were filed on even date herewith and which
are each herein incorporated by reference in their respective
entireties:
[0178] U.S. patent application Ser. No. ______, entitled STAPLE
CARTRIDGE INCLUDING A BARBED STAPLE, Attorney Docket No.
END7439USNP;
[0179] U.S. patent application Ser. No. ______, entitled STAPLE
CARTRIDGE INCLUDING A BARBED STAPLE, Attorney Docket No.
END7441USNP;
[0180] U.S. patent application Ser. No. ______, entitled
IMPLANTABLE LAYERS COMPRISING A PRESSED REGION, Attorney Docket No.
END7349USNP/130323;
[0181] U.S. patent application Ser. No. ______, entitled
IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MORE PROPERTIES
OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS, Attorney
Docket No. END7348USNP/130324;
[0182] U.S. patent application Ser. No. ______, entitled
IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THE
IMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT,
Attorney Docket No. END7347USNP/130325;
[0183] U.S. patent application Ser. No. ______, entitled
IMPLANTABLE LAYER ASSEMBLIES, Attorney Docket No.
END7346USNP/130326;
[0184] U.S. patent application Ser. No. ______, entitled
IMPLANTABLE LAYERS COMPRISING A PRESSED REGION, Attorney Docket No.
END7345USNP/130327; and
[0185] U.S. patent application Ser. No. ______, entitled FASTENING
SYSTEM COMPRISING A FIRING MEMBER LOCKOUT, Attorney Docket No.
END7350USNP/130328.
[0186] 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.
[0187] The terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "include" (and any form of include, such as
"includes" and "including") and "contain" (and any form of contain,
such as "contains" and "containing") are open-ended linking verbs.
As a result, a surgical system, device, or apparatus that
"comprises," "has," "includes" or "contains" one or more elements
possesses those one or more elements, but is not limited to
possessing only those one or more elements. Likewise, an element of
a system, device, or apparatus that "comprises," "has," "includes"
or "contains" one or more features possesses those one or more
features, but is not limited to possessing only those one or more
features.
[0188] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical", "horizontal", "up", and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0189] Various exemplary devices and methods are provided for
performing laparoscopic and minimally invasive surgical procedures.
However, the person of ordinary skill in the art will readily
appreciate that the various methods and devices disclosed herein
can be used in numerous surgical procedures and applications
including, for example, in connection with open surgical
procedures. As the present Detailed Description proceeds, those of
ordinary skill in the art will further appreciate that the various
instruments disclosed herein can be inserted into a body in any
way, such as through a natural orifice, through an incision or
puncture hole formed in tissue, etc. The working portions or end
effector portions of the instruments can be inserted directly into
a patient's body or can be inserted through an access device that
has a working channel through which the end effector and elongated
shaft of a surgical instrument can be advanced.
[0190] Turning to the Drawings wherein like numerals denote like
components throughout the several views, FIG. 1 illustrates an
exemplary surgical stapling and severing instrument 8010 suitable
for use with a tissue thickness compensator assembly as described
in greater detail below. The surgical stapling and severing
instrument 8010 can comprise an anvil 8014 which may be repeatedly
opened and closed about its pivotal attachment to an elongate
staple channel 8016. A staple applying assembly 8012 may comprise
the anvil 8014 and the channel 8016, wherein the assembly 8012 can
be proximally attached to an elongate shaft 8018 forming an
implement portion 8022. When the staple applying assembly 8012 is
closed, or at least substantially closed, the implement portion
8022 can present a sufficiently small cross-section suitable for
inserting the staple applying assembly 8012 through a trocar. In
various circumstances, the assembly 8012 can be manipulated by a
handle 8020 connected to the shaft 8018. The handle 8020 can
comprise user controls such as a rotation knob 8030 that rotates
the elongate shaft 8018 and the staple applying assembly 8012 about
a longitudinal axis of the shaft 8018. A closure trigger 8026,
which can pivot in front of a pistol grip 8036 to close the staple
applying assembly 8012. A closure release button 8038 can be
outwardly presented on the handle 8020 when the closure trigger
8026 is clamped such that the release button 8038 can be depressed
to unclamp the closure trigger 8026 and open the staple applying
assembly 8012, for example. A firing trigger 8034, which can pivot
in front of the closure trigger 8026, can cause the staple applying
assembly 8012 to simultaneously sever and staple tissue clamped
therein. In various circumstances, multiple firing strokes can be
employed using the firing trigger 8034 to reduce the amount of
force required to be applied by the surgeon's hand per stroke. In
certain embodiments, the handle 8020 can comprise one or more
rotatable indicator wheels such as, for example, rotatable
indicator wheel 8041 which can indicate the firing progress. A
manual firing release lever 8042 can allow the firing system to be
retracted before full firing travel has been completed, if desired,
and, in addition, the firing release lever 8042 can allow a
surgeon, or other clinician, to retract the firing system in the
event that the firing system binds and/or fails. Additional details
on the surgical stapling and severing instrument 8010 and other
surgical stapling and severing instruments suitable for use with
the present disclosure are described, for example, in U.S. patent
application Ser. No. 13/851,693, entitled FASTENER CARTRIDGE
ASSEMBLY, and filed on Mar. 27, 2013, the entire disclosure of
which is incorporated herein by reference. Furthermore, powered
surgical stapling and severing instruments can also be utilized
with the present disclosure. See, for example, U.S. Patent
Application Publication No. 2009/0090763 A1, entitled POWERED
SURGICAL STAPLING DEVICE, and filed on Aug. 8, 2008, the entire
disclosure of which is incorporated herein by reference.
[0191] With reference to FIGS. 2 and 3, a firing assembly such as,
for example, firing assembly 9090 can be utilized with the surgical
stapling and severing instrument 8010 to advance a wedge sled 9126
which comprises a plurality of wedges 9204 configured to deploy
staples from the staple applying assembly 8012 into tissue captured
between the anvil 8014 and the elongate staple channel 8016.
Furthermore, an E-beam 9102 at a distal portion of the firing
assembly 9090 may facilitate separate closure and firing as well as
spacing of the anvil 8014 from the elongate staple channel 8016
during firing. The E-beam 9102 may include a pair of top pins 9110,
a pair of middle pins 9112 which may follow portion 9218 of the
wedge sled 9126, and a bottom pin or foot 9114, as well as a sharp
cutting edge 9116 which can be configured to sever the captured
tissue as the firing assembly 9090 is advanced distally. In
addition, integrally formed and proximally projecting top guide
9118 and middle guide 9120 bracketing each vertical end of the
cutting edge 9116 may further define a tissue staging area 9122
assisting in guiding tissue to the sharp cutting edge 9116 prior to
being severed. The middle guide 9120 may also serve to engage and
fire the staple applying assembly 8012 by abutting a stepped
central member 9124 of the wedge sled 9126 (FIG. 2) that effects
staple formation by the staple applying assembly 8012.
[0192] In various circumstances, a staple cartridge can comprise
means for compensating for thickness of tissue captured within
staples deployed from a staple cartridge. Referring to FIG. 4, a
staple cartridge, such as staple cartridge 10000, for example, can
be utilized with the surgical stapling and severing instrument 8010
and can include a rigid first portion, such as support portion
10010, for example, and a compressible second portion, such as
tissue thickness compensator 10020, for example. The support
portion 10010 can comprise a cartridge body and a plurality of
staple cavities 10012. A staple 10030, for example, can be
removably positioned in each staple cavity 10012. Referring
primarily to FIGS. 4 and 5, each staple 10030 can comprise a base
10031 and one or more legs 10032 extending from the base 10031.
Prior to the staples 10030 being deployed, the bases 10031 of the
staples 10030 can be supported by staple drivers positioned within
the support portion 10010 and, concurrently, the legs 10032 of the
staples 10030 can be at least partially contained within the staple
cavities 10012. In various circumstances, the staples 10030 can be
deployed between an unfired position and a fired position such that
the legs 10032 move through the tissue thickness compensator 10020,
penetrate through a top surface of the tissue thickness compensator
10020, penetrate the tissue T, and contact an anvil positioned
opposite the staple cartridge 10000. As the legs 10032 are deformed
against the anvil, the legs 10032 of each staple 10030 can capture
a portion of the tissue thickness compensator 10020 and a portion
of the tissue T within each staple 10030 and apply a compressive
force to the tissue. Further to the above, the legs 10032 of each
staple 10030 can be deformed downwardly toward the base 10031 of
the staple to form a staple entrapment area in which the tissue T
and the tissue thickness compensator 10020 can be captured. In
various circumstances, the staple entrapment area can be defined
between the inner surfaces of the deformed legs 10032 and the inner
surface of the base 10031. The size of the entrapment area for a
staple can depend on several factors such as the length of the
legs, the diameter of the legs, the width of the base, and/or the
extent in which the legs are deformed, for example.
[0193] In use, further to the above and referring primarily to FIG.
4, an anvil, such as anvil 8014 of the surgical stapling and
severing instrument 8010, can be moved into a closed position
opposite the staple cartridge 10000 by depressing the closure
trigger 8026 to advance the E-beam 9102. The anvil 8014 can
position tissue against the tissue thickness compensator 10020 and,
in various circumstances, compress the tissue thickness compensator
10020 against the support portion 10010, for example. Once the
anvil 8014 has been suitably positioned, the staples 10030 can be
deployed, as also illustrated in FIG. 4. In various circumstances,
as mentioned above, a staple-firing sled 10050, which is similar in
many respects to the sled 9126 (See FIG. 3), can be moved from a
proximal end of the staple cartridge 10000 toward a distal end
10002, as illustrated in FIG. 5. As the firing assembly 9090 is
advanced, the sled 10050 can contact the staple drivers 10040 and
lift the staple drivers 10040 upwardly within the staple cavities
10012. In at least one example, the sled 10050 and the staple
drivers 10040 can each comprise one or more ramps, or inclined
surfaces, which can co-operate to move the staple drivers 10040
upwardly from their unfired positions. As the staple drivers 10040
are lifted upwardly within their respective staple cavities 10012,
the staple drivers 10040 can lift the staples 10030 upwardly such
that the staples 10030 can emerge from their staple cavities 10012.
In various circumstances, the sled 10050 can move several staples
upwardly at the same time as part of a firing sequence.
[0194] As discussed above, and referring to FIG. 5, the staple legs
10032 of the staples 10030 can extend into the compensator 10020
beyond the support portion 10010 when the staples 10030 are in
their unfired positions. In various circumstances, the tips of the
staple legs 10032, or any other portion of the staple legs 10032,
may not protrude through a top tissue-contacting surface 10021 of
the tissue thickness compensator 10020 when the staples 10030 are
in their unfired positions. In certain circumstances, the tips of
the staple legs 10032 can comprise sharp tips which can incise and
penetrate the tissue thickness compensator 10020.
[0195] In various circumstances, it may be preferable to prevent
and/or limit frictional forces between a tissue thickness
compensator and a staple. Referring now to FIGS. 6-8, a tissue
thickness compensator 20220 for use with a staple cartridge
assembly 20200 can include a plurality of clearance apertures 20224
extending at least partially through the tissue thickness
compensator 20220. In various circumstances, the staple cartridge
assembly 20200 can include a staple cartridge body 20210 and a
tissue thickness compensator 20220 releasably secured relative to
the staple cartridge body 20210. The cartridge body 20210 can
include a cartridge deck 20211 and a plurality of staple cavities
20212 defined through the cartridge deck 20211 and into the body of
the staple cartridge body 20210, for example. Staples 20230 can be
removably positioned in the staple cavities 20212, for example. The
tissue thickness compensator 20220 can include a tissue-contacting
surface 20221 (FIG. 7) and a deck-contacting surface 20222 (FIG.
6). The deck-contacting surface 20222 can be releasably positioned
against the deck 20211 of the cartridge body 20210, for example,
and the tissue-contacting surface 20221 can be positioned against
tissue T to be stapled, for example. Clearance apertures 20224 can
extend through the deck-contacting surface 20222 and into the
tissue thickness compensator 20220 and may comprise holes, slits,
gaps, bores, openings, and/or cleared pathways, for example, within
the tissue thickness compensator 20220.
[0196] Referring primarily to FIGS. 7 and 8, staples 20230 can be
positioned in the staple cavities 20212 of the cartridge body
20210. Each staple 20230 can include a base 20231 and a pair of
staple legs 20232, for example, which can extend from the base
20231. Each staple leg 20232 can extend from opposite ends of the
base 20231. Referring primarily to FIG. 7, one or more of the
clearance apertures 20224 in the tissue thickness compensator 20220
can include an opening in the deck-contacting surface 20222. The
opening of a clearance aperture 20224 can be aligned with a
corresponding staple leg 20232 that is positioned in a staple
cavity 20212. For example, a single staple leg 20232 can be aligned
with the opening of a single clearance aperture 20224 when the
tissue thickness compensator 20220 is secured relative to the
cartridge body 20210. In certain circumstances, a staple leg 20232
can extend into each clearance aperture 20224, such that at least a
portion of the staple 20230 is embedded in the tissue thickness
compensator 20220, for example. For example, referring primarily to
FIG. 7, a staple 20230 can include a first staple leg 20232a and a
second staple leg 20232b. Furthermore, the tissue thickness
compensator 20220 can include a first clearance aperture 20224a
aligned with the first staple leg 20232a, and a second clearance
aperture 20224b aligned with the second staple leg 20232b, for
example. Prior to deployment of the staple 20230, the first staple
leg 20232a can extend partially through the first clearance
aperture 20224a, and the second staple leg 20232b can extend
partially through the second clearance aperture 20224b, for
example. The tissue thickness compensator 20220 can include
additional clearance apertures 20224 that are not aligned with
staple legs 20232, for example. In certain circumstances, the
staple cartridge assembly 20200 can include additional staples
20230 and/or staple legs 20232 that are not aligned with clearance
apertures 20224, for example.
[0197] The staples 20230 can be moveable from an unfired
configuration (FIG. 7) to a fired configuration (FIG. 8). Each
staple 20230 can be moved along a staple axis when moving between
the unfired configuration and the fired configuration. When in the
unfired configuration, the staple legs 20232 can extend from the
staple cavities 20212 and into the tissue thickness compensator
20220, for example. The staple legs 20232 can be partially embedded
in the tissue thickness compensator 20220 when the staples 20230
are in the unfired configuration, for example. Furthermore, at
least a portion of the staple legs 20232 can be aligned with and/or
positioned within the clearance apertures 20224 of the tissue
thickness compensator 20220 when the staples are in the unfired
configuration, for example. In other circumstances, the staple legs
20232 can be positioned entirely within the staple cavity 20212
when in the unfired configuration, and can be aligned with the
clearance apertures 20224 positioned above the cartridge deck 20211
(FIG. 6), for example.
[0198] The staples 20230 can move from the unfired configuration
(FIG. 7) to the fired configuration (FIG. 8) during a firing
stroke, as described herein. A staple driver 20240 can be
positioned within each staple cavity 20212. The staple driver 20240
within each staple cavity 20212 can be pushed toward the cartridge
deck 20211 (FIG. 6), for example, to drive the staple 20230 into
tissue T and toward an anvil 20260 (FIG. 8) which can be similar in
many respects to other anvils described herein such as, for
example, the anvil 8014 (FIG. 1). As each staple 20230 moves from
the unfired configuration to the fired configuration, the staple
legs 20232 can move through the clearance apertures 20224 in the
tissue thickness compensator 20220. The clearance apertures 20224
can have a predefined trajectory within the tissue thickness
compensator 20220. For example, the clearance apertures 20224 can
extend along an axis that is perpendicular to and/or substantially
perpendicular to the tissue-contacting surface 20221 (FIG. 7)
and/or the deck-contacting surface 20222 (FIG. 6) of the tissue
thickness compensator 20220. In other circumstances, the clearance
apertures 20224 can extend along an axis that is oriented at an
oblique angle relative to the tissue-contacting surface 20221
and/or the deck-contacting surface 20222 of the tissue thickness
compensator 20220, for example. In certain circumstances, a group
of the clearance apertures 20224 can be parallel. In some
circumstances, all of the clearance apertures 20224 within the
tissue thickness compensator 20220 can be parallel, for example.
The clearance apertures 20224 can comprise a partially curved
trajectory and/or a partially linear trajectory. Other
characteristics and features of the clearance apertures 20224 are
described in greater detail in U.S. patent application Ser. No.
13/851,693, entitled FASTENER CARTRIDGE ASSEMBLY, and filed on Mar.
27, 2013, the entire disclosure of which is incorporated herein by
reference. Methods and techniques for modifying a tissue thickness
compensator to include clearance apertures such as, for example,
the clearance apertures 20224 are described below in greater
detail.
[0199] Referring now to FIGS. 9-12, an end effector 22090 of a
surgical instrument similar in many respects to the surgical
instrument 8010, for example, can comprise a first jaw including a
fastener cartridge assembly 22000 and a second jaw including an
anvil 10060. The first jaw can include a staple cartridge channel
10070 which can be configured to removably receive the cartridge
assembly 22000. Alternatively, the staple cartridge channel 10070
and the cartridge assembly 22000 can comprise an integral unit. In
various circumstances, the anvil 10060 can be moved between an open
position and a closed position (FIGS. 9-12). In the open position
of the anvil 10060, the anvil 10060 can be positioned on a first
side of a patient's tissue T (FIGS. 10-12) and the cartridge
assembly 22000 can be positioned on a second, or opposite, side of
the tissue T, for example. When the anvil 10060 is moved into its
closed position, the anvil 10060 can compress the tissue T against
the cartridge assembly 22000. Alternatively, the first jaw
including the cartridge assembly 22000 can be moved relative to the
anvil 10060. A firing member 10052, which is similar in many
respects to the firing assembly 9090 (FIG. 3), can be advanced
distally from a proximal end 22001 of the cartridge assembly 22000
toward a distal end 22002 of the cartridge assembly 22000 to eject
fasteners, such as staples 22030, for example, removably stored in
a cartridge body 22010 of the cartridge assembly 22000 as the
firing member 10052 is advanced from the proximal end 22001 toward
the distal end 22002 of the cartridge assembly 22000.
[0200] Further to the above, the staples 22030 can be supported by
staple drivers 10040 which are movably positioned within staple
cavities 22012 defined in the cartridge body 22010. Moreover, the
firing member 10052 can be configured to advance a staple-firing
sled 10050 distally within the cartridge body 22010 as the firing
member 10052 is moved from the proximal end 22001 toward the distal
end 22002. In such circumstances, the staple-firing sled 10050 can
be configured to lift the staple drivers 10040, and the staples
22030 supported thereon, toward the anvil 10060. In essence,
further to the above, the staple drivers 10040 can move the staples
22030 from an unfired position (FIG. 10) to a fired position (FIGS.
11 and 12) wherein the staples 22030 can contact the anvil 10060
and be deformed between an undeformed configuration (FIG. 10) and a
deformed configuration (FIGS. 11 and 12). The anvil 10060 can
comprise forming pockets 10062 which can be configured to receive
and deform the staples 22030. Staples 22030 can be the same as or
similar to staples 10030, for example and/or any other staples
disclosed herein, and, as such, staples 22030 are not described in
greater detail herein. The reader will note, however, that the
staples 22030 can comprise any suitable shape and/or suitable
dimensions, such as width and/or height, for example, in their
undeformed configuration and/or their deformed configuration. For
instance, the staples 22030 can, in certain circumstances, comprise
a height which does not extend above a deck surface 22011 of the
cartridge body 22010 when the staples 22030 are in their unfired
positions while, in other circumstances, the staples 22030 can
comprise a height in which the legs of the staples 22030 extend
upwardly from the deck surface 22011 when the staples 22030 are in
their unfired positions such that the legs of the staples 22030 are
at least partially embedded in a tissue thickness compensator 22010
of the cartridge assembly 22000.
[0201] With continued reference to the embodiment depicted in FIGS.
9-12, further to the above, the cartridge assembly 22000 can
comprise a cartridge body 22010 and a tissue thickness compensator
22020. In various circumstances, the cartridge body 22010 can be
similar to the support portion 10010, for example, in many respects
and, as a result, many of such respects are not repeated herein for
the sake of brevity. Furthermore, the tissue thickness compensator
22020 can be similar to the tissue thickness compensator 10020, for
example, in many respects. Further to the above, the firing member
10052 can include a cutting portion 10053 which can be configured
to transect the tissue positioned between the anvil 10060 and the
tissue thickness compensator 22020 as the firing member 10052 is
advanced distally. In various circumstances, as a result, the
firing member 10052 can be configured to concurrently fire the
staples 22030 to staple the tissue T and cut the tissue T. In
certain circumstances, the firing process can at least partially
lead the cutting process. Stated another way, the cutting process
can lag the firing process. In such circumstances, a portion of the
tissue T can be stapled and then incised.
[0202] As illustrated in FIGS. 9-12, the cartridge body 22010 can
include a cartridge knife slot 22015 which can be configured to
receive a portion of the firing member 10052 as the firing member
10052 is advanced distally. Further to the above, the anvil 10060
can include an anvil knife slot 10065 which can be configured to
receive a portion of the firing member 10052 as the firing member
10052 is advanced distally. In various circumstances, the tissue
thickness compensator 22020 can comprise a tissue thickness
compensator knife slot 22025 which can be aligned with the anvil
knife slot 10065 and the cartridge knife slot 22015 such that the
firing member 10052 can pass through the cartridge knife slot
22015, the anvil knife slot 10065, and the tissue thickness
compensator knife slot 22025 simultaneously. In various
circumstances, the anvil knife slot 10065 can extend over the
tissue thickness compensator knife slot 22025 such that the cutting
portion 10053 of the firing member 10052 can pass through the
cartridge knife slot 22015, the anvil knife slot 10065, and the
tissue thickness compensator knife slot 22025 simultaneously. The
tissue thickness compensator knife slot 22025 can define a tissue
thickness compensator knife path for the cutting portion 10053
wherein the tissue thickness compensator knife path can be parallel
to the anvil knife path and the cartridge knife path. In various
circumstances, the tissue thickness compensator knife path can be
longitudinal while, in certain circumstances, the tissue thickness
compensator knife path can be curved. Further to the above, curved
end effectors and curved fastener cartridges are disclosed in U.S.
Patent Application Publication No. 2008/0169329. The entire
disclosure of U.S. patent application Ser. No. 11/652,164, entitled
CURVED END EFFECTOR FOR A SURGICAL STAPLING DEVICE, filed on Jan.
11, 2007, now U.S. Patent Application Publication No. 2008/0169329,
is hereby incorporated by reference herein. In such circumstances,
a tissue thickness compensator can be curved. In at least one such
embodiment, the tissue thickness compensator can be curved to match
the curvature of the cartridge body of the fastener cartridge.
Methods and techniques for modifying a tissue thickness compensator
to include a knife slot such as, for example, the knife slot 22025
are described below.
[0203] Further to the above, referring primarily to FIG. 9, the
tissue thickness compensator knife slot 22025 can extend between a
first stapling portion 22021a which can be stapled by a first group
of staples 22030 and a second stapling portion 22021b which can be
stapled by a second group of staples 22030. The knife slot 22025
can releasably connect the first stapling portion 22021a to the
second stapling portion 22021b. In use, as illustrated in FIG. 9,
the cutting portion 10053 can be advanced distally through the
knife slot 22025 to transect the knife slot 22025 and separate the
first stapling portion 22021a and the second stapling portion
22021b. In certain circumstances, the knife slot 22025 can comprise
a plurality of connectors, or bridges, 22026 which can connect the
first stapling portion 22021a and the second stapling portion
22021b prior to being transected by the cutting portion 10053. In
various circumstances, the connectors 22026 can have the same
thickness as the first stapling portion 22021a and/or the second
stapling portion 22021b, at least when the tissue thickness
compensator 22020 is in an uncompressed state. In at least one such
circumstance, the connectors 22026, the first stapling portion
22021a, and/or the second stapling portion 22021b can be unitarily
and integrally formed from a flat, or at least substantially flat,
piece of material, for example. In various other circumstances, the
first stapling portion 22021a can comprise a first thickness, the
second stapling portion 22021b can comprise a second thickness, and
the connectors 22026 can comprise a third thickness, wherein one or
more of the first thickness, the second thickness, and the third
thickness can be different than the other thicknesses.
[0204] The knife slot 22025 can further comprise apertures, such as
apertures 22024, for example, defined therein. For instance, the
apertures 22024 can be elongate and can extend longitudinally along
the knife slot 22025. In various other circumstances, the apertures
in the knife slot 22025 can comprise any suitable arrangement. In
certain circumstances, the apertures 22024 can comprise
perforations positioned intermediate the connectors 22026 which can
be formed utilizing a laser cutting operation, for example. In some
circumstances, the apertures 22024 can be cut from a sheet of
material to form the tissue thickness compensator 22020 such that
the apertures 22024 and the connectors 22026 are arranged in an
alternating arrangement, for example. In other instances, the
tissue thickness compensator 22020 can be molded with apertures
22024 already formed therein. In various circumstances, one or more
of the apertures 22024 can comprise through holes, for example. In
various circumstances, one or more of the apertures 22024 can
comprise clearance apertures, for example. In certain instances,
one or more of the apertures 22024 may not comprise through holes
and may instead comprise reductions in the thickness of the knife
slot 22025, for example. Methods and techniques for modifying a
tissue thickness compensator to include apertures such as, for
example, the apertures 22024 are described below.
[0205] Further to the above, referring again to FIGS. 9-11, patient
tissue can be positioned intermediate the anvil 10060 of the end
effector 22090 and the tissue thickness compensator 22020 of the
cartridge assembly 22000 when the anvil 10060 is in an open
position. When the anvil 10060 is moved into a closed position, a
bottom surface, or tissue-contacting surface, 10063 of the anvil
10060 can contact the tissue T and push the tissue T toward a deck
surface 22011 of the cartridge body 22010. The tissue T can contact
a top surface, or tissue contacting surface, 22021 of the tissue
thickness compensator 22020 wherein, when the anvil 10060 is moved
into its closed position, the anvil 10060 can press the tissue T
against the tissue thickness compensator 22020 and, further to the
above, compress the tissue thickness compensator 22020 against the
deck surface 22011 of the cartridge body 22010. In various
circumstances, the tissue thickness compensator 22020 can comprise
a bottom surface 22029 which can abut the deck surface 22011. In
some circumstances, a gap may be present between the bottom surface
22029 and the deck surface 22011 before the tissue thickness
compensator 22020 is compressed against the cartridge body 22010.
In such circumstances, the tissue thickness compensator 22020 may
first translate toward the cartridge body 22010 before being
compressed thereagainst. When the tissue thickness compensator
22020 is compressed against the cartridge body 22010, in various
circumstances, the first stapling portion 22021a and/or the second
stapling portion 22021b of the tissue thickness compensator 22020
may move laterally. For instance, the first stapling portion 22021a
and/or the second stapling portion 22021b may move laterally away
from the cartridge knife slot 22015. In various circumstances, the
connectors 22026 can be configured to inhibit such lateral movement
between the first stapling portion 22021a and the second stapling
portion 22021b. In various circumstances, referring primarily to
FIG. 11, the connectors 22026 can be configured to stretch to
permit some relative lateral movement between the first stapling
portion 22021a and the second stapling portion 22021b when the
anvil 10060 is closed. In the event that the anvil 10060 is
reopened, the connectors 22026 can be configured to elastically
return, or at least substantially return, to their unstretched
configuration and, as a result, pull the first stapling portion
22021a and the second stapling portion 22021b laterally back toward
their original positions, illustrated in FIG. 10. Moreover, the
anvil 10060 can compress the tissue T when the anvil 10060 is moved
into its closed position. In such circumstances, the tissue T may
at least partially flow into the apertures 22024.
[0206] Upon reviewing FIGS. 10-12, the reader will appreciate that
the knife slot 22025 of the tissue thickness compensator 22020
comprises less material along the longitudinal length thereof than
the first stapling portion 22021a and/or the second stapling
portion 22021b. Stated another way, a longitudinal cross-section
through the first stapling portion 22021a and/or the second
stapling portion 22021b would transect a first amount of material
while a longitudinal cross-section through the knife slot 22025
would transect a second amount of material which is less than the
first amount of material.
[0207] Once the anvil 10060 has been suitably positioned, further
to the above, the firing member 10052 can be advanced distally to
fire the staples, as illustrated in FIG. 11, and incise the tissue
T and the connectors 22026, as illustrated in FIG. 12. Furthermore,
the tissue thickness compensator incision force, the tissue
incision force, the tissue thickness compensator drag force, and/or
the tissue drag force can dull the cutting portion 10053 of the
firing member 10052. A dull knife may not be able to transect the
tissue T and/or the tissue thickness compensator 22020, for
example, according to a preferred manner. With primary reference to
FIG. 12, the cutting portion 10053 can comprise a first knife edge
zone 10053a, a second knife edge zone 10053b, and/or a third knife
edge zone 10053c, for example, wherein the first knife edge zone
10053a is positioned vertically above the second knife edge zone
10053b, and wherein the second knife edge zone 10053b is positioned
vertically above the third knife edge zone 10053c, for example. The
cutting portion 10053 can comprise any suitable number and/or
location of knife edge zones wherein the knife edge zones depicted
in FIG. 12 have been selected for the purposes of discussion.
Further to the above, the first knife edge zone 10053a can be
configured to transect the tissue T while the second knife edge
zone 10053b can be configured to transect the tissue thickness
compensator 22020. As a result, the first knife edge zone 10053a
may experience the tissue incision force and/or the tissue drag
force discussed above. Such forces may wear or dull the first knife
edge zone 10053a at a first rate. The second knife edge zone 10053b
may experience the tissue thickness compensator incision force
and/or the tissue thickness compensator drag force discussed above.
Such forces may wear or dull the second knife edge zone 10053b at a
second rate. In various circumstances, the second rate can be
different than the first rate.
[0208] Turning now to FIGS. 13 and 14, a fastener cartridge 22400
can comprise a tissue thickness compensator 22420 which can include
a first stapling portion 22421a and a second stapling portion
22421b which are connected by a knife slot 22425. The knife slot
22425 can comprise an angled longitudinal connector 22426. The
angled longitudinal connector 22426 can extend between a proximal
end 22401 of the knife slot 22425 and a distal end 22402 of the
knife slot 22425. In some circumstances, the angled longitudinal
connector 22426 can extend the entire length of the knife slot
22425 while, in other circumstances, the angled longitudinal
connector 22426 can extend less than the length of the knife slot
22425. The angled longitudinal connector 22426 can extend between a
top surface 22428 of the tissue thickness compensator 22420 and a
bottom surface 22429 of the tissue thickness compensator 22420. In
some circumstances, the angled longitudinal connector 22426 can
extend the entire distance between the top surface 22428 and the
bottom surface 22429 while, in other circumstances, the angled
longitudinal connector 22426 can extend less than the distance
between the top surface 22428 and the bottom surface 22429. In
various circumstances, the proximal end of the longitudinal
connector 22426 can extend from the top surface 22428 of the tissue
thickness compensator while the distal end of the longitudinal
connector 22426 can extend from the bottom surface 22429.
Alternatively, the distal end of the longitudinal connector 22426
can extend from the top surface 22428 of the tissue thickness
compensator while the proximal end of the longitudinal connector
22426 can extend from the bottom surface 22429. In various
circumstances, the longitudinal connector 22426 can comprise a thin
bridge (i.e. less than the full thickness of the tissue thickness
compensator 22420) or a series of thin bridges that join the first
stapling portion 22421a which can be stapled by a first group of
staples 22030 to the second stapling portion 22421b which can be
stapled by a second group of staples 22030, for example. These
thin, angled bridges, and/or the longitudinal connector 22426,
could distribute the wear across the second knife edge zone 10053b,
rather than concentrating it on one spot. In various circumstances,
as a result, the wear occurring on the second knife edge zone
10053b may be equal to, or closer to being equal to, the wear
occurring at the first knife edge zone 10053a, for example.
[0209] Referring now to FIGS. 15-17, an exemplary tissue thickness
compensator assembly 1000 may include a first layer 1002 and a
second layer 1004 attachable to the first layer 1002. The tissue
thickness compensator assembly 1000 can be utilized with a surgical
instrument such as, for example, the surgical instrument 8010 (FIG.
1). In addition, the tissue thickness compensator assembly 1000 can
be utilized in a similar manner as and can replace the tissue
thickness compensator 22020 of the cartridge assembly 22000 of the
end effector 22090 (FIG. 9). For example, the second layer 1004 of
the tissue thickness compensator assembly 1000 may include a first
portion 1006 which can be positioned on the deck surface 22011 on a
first side of the cartridge knife slot 22015 in a similar fashion
to the first stapling portion 22021a and a second portion 1008
which can be positioned on the deck surface 22011 on a second side,
opposite the first side, of the cartridge knife slot 22015 in a
similar fashion to the second stapling portion 22021b (FIGS. 9-11).
In various instances, the first portion 1006 and the second portion
1008 of the second layer 1004 can be spaced apart and may comprise
a gap 1010 therebetween which can comprise a knife path for the
cutting portion 10053 of the firing member 10052 and may extend at
least partially over the cartridge knife slot 22015 when the tissue
thickness compensator assembly 1000 is assembled with the cartridge
end effector 22090. In certain instances, the first layer 1002 can
be configured to couple the first portion 1006 and the second
portion 1008 and extend at least partially over the gap 1010, as
illustrated in FIG. 17, for example.
[0210] In use, tissue T can be captured between the anvil 10060 and
a tissue contacting surface 1012 of the first layer 1002. As the
firing member 10052 is advanced, a first group of staples 20030 can
be deployed to staple the first portion 1006 and a second group of
staples can be deployed to staple the second portion 1008. The
first and second groups of staples can be configured to penetrate
through a first deck contacting surface 1007 and a second deck
contacting surface 1009, respectively, of the second layer 1004,
then through the tissue contacting surface 1012 of the first layer,
and then through the captured tissue T to contact the pockets 10062
of the anvil 10060. Furthermore, the advancement of the firing
member 10052 can cause the cutting portion 10053 to be advanced
distally through the gap 1010 of the tissue thickness compensator
assembly 1000. The cutting portion 10053 may transect the first
layer 1002 while advancing through the gap 1010 thereby separating
the first portion 1006 and the second portion 1008 of the second
layer 1004.
[0211] Referring again to FIG. 17, the first layer 1002 of the
tissue thickness compensator assembly 1000 may comprise a first
height H1, the first portion 1006 of the second layer 1004 may
comprise a second height H2, and the second portion 1008 of the
second layer 1004 may comprise a third height H3. In certain
circumstances, as illustrated in FIG. 17, the second height H2 and
the third height H3 can be the same or substantially the same. In
other circumstances, the second height H2 can be different from the
third height H3. In certain circumstances, the first height H1 can
be less than the second height H2 and/or the third height H3, as
illustrated in FIG. 17. The first layer 1002 of the tissue
thickness compensator assembly 1000 may comprise a first density,
the first portion 1006 of the second layer 1004 may comprise a
second density, and the second portion 1008 of the second layer
1004 may comprise a third density. In certain circumstances, as
illustrated in FIG. 17, the second density and the third density
can be the same or substantially the same. In other circumstances,
the second density can be different from the third density and/or
different from the first density of the first layer 1002. The
material compositions of the first portion 1006 and the second
portion 1008 can be the same, or at least substantially the same.
In other circumstances, the material compositions of the first
portion 1006 and the second portion 1008 can be different from each
other and/or can be different from the material composition of the
first layer 1002.
[0212] As described above, repeated use of the cutting portion
10053 to cut tissue T and tissue thickness compensator material may
dull the cutting portion 10053. To slow the dulling process, it may
be desirable to reduce the tissue thickness compensator material
that is cut by the cutting portion 10053. An additional benefit can
be a reduction in the forces needed to advance the firing member
10052 distally during a firing stroke. In order to reduce the
dulling of the cutting portion 10053, the first layer 1002 can be
comprised, at least partially, of a thin film, for example. In such
circumstances, the first height H1 can be significantly less than
the second height H2 and the third height H3, as illustrated in
FIG. 17. In certain circumstances, the first layer 1002 may
comprise a uniform, or substantially uniform, height therethrough,
as illustrated in FIG. 17. In other circumstances, a gap bridging
portion 1014 of the first layer 1002 may extend at least partially
over the gap 1010 and may be thinner than the remainder of the
first layer 1002. The cutting portion 10053 may transect the gap
bridging portion 1014 of the first layer 1002 while advancing
through the gap 1010 between the first portion 1006 and the second
portion 1008 of the second layer 1004 which may reduce the
resistance experienced by the cutting portion 10053 and/or slow the
dulling of the cutting portion 10053. In any event, the first layer
1002 can be configured to maintain a coupling engagement with the
first portion 1006 and the second portion 1008 of the second layer
1004 prior to being transected, and to present the cutting portion
10053 with a reduced resistance as the cutting portion 10053 is
advanced to transect the first layer 1002.
[0213] To further reduce the dulling of the cutting portion 10053
and/or reduce he resistance experienced by the cutting portion
10053, the gap bridging portion 1014 may comprise a perforated
segment 1016 along the knife path defined by the gap 1010, as
illustrated in FIG. 16. The perforated segment 1016 can include a
plurality of perforations 1018 which can be cut into the first
layer 1002 prior to the assembly of the first layer 1002 to the
second layer 1004, for example. The perforations 1018 can reduce
the interaction between the cutting portion 10053 and the first
layer 1002 as the cutting portion 10053 is advanced through the
knife path defined by the gap 1010, which may slow the dulling of
the cutting portion 10053 and/or reduce the resistance experienced
by the cutting portion 10053.
[0214] In various circumstances, as described in greater detail
below, the tissue thickness compensator assembly 1000 can be
comprised of one or more biocompatible materials. In certain
circumstance, the first layer 1002 can be comprised of a
biocompatible buttress material and/or plastic material, such as
polydioxanone (PDS) and/or polyglycolic acid (PGA), for example,
and the second layer 1004 can be comprised of a bioabsorbable foam
material and/or a compressible haemostatic material, such as
oxidized regenerated cellulose (ORC), for example. In certain
circumstances, the first layer 1002 can be a thin film comprising a
bioabsorbable material such as polyglycolic acid (PGA) which is
marketed under the trade name Vicryl, polylactic acid (PLA or
PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name
Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA,
PDS, PHA, PGCL and/or PCL, for example. In certain circumstances,
the first portion 1006 and/or the second portion 1008 of the second
layer 1004 can be comprised of a lyophilized foam comprising
polylactic acid (PLA) and/or polyglycolic acid (PGA), for example.
In certain circumstances, the first portion 1006 and/or the second
portion 1008 of the second layer 1004 can be comprised of
biocompatible foam which may comprise a porous, open cell foam
and/or a porous, closed cell foam.
[0215] Referring again to FIGS. 15 and 17, the first layer 1002 can
be at least partially disposed over the second layer 1004 such that
the second layer 1004 may be positioned between the first layer
1002 and the deck surface 22011 (FIG. 9) when the tissue thickness
compensator assembly 1000 is assembled with the end effector 22090
(FIG. 9). In other circumstances, the first layer 1002 can be
positioned beneath the first portion 1006 and the second portion
1008 (not shown) such that the first layer 1002 may be positioned
between the second layer 1004 and the deck surface 22011 (FIG. 9)
when the tissue thickness compensator assembly 1000 is assembled
with the end effector 22090 (FIG. 9). In any event, the first layer
1002 can be attached to a first contacting surface 1020 of the
first portion 1006 and a second contacting surface 1022 of the
second portion 1008 of the second layer 1004. The first layer 1002
can be attached to the second layer 1004 via a thermal pressing
process involving the application of heat and/or pressure, as
described in greater detail below. In other circumstances, the
first layer 1002 can be attached to the second layer 1004 by a
biocompatible adhesive material such as a fibrin and/or protein
hydrogel, for example. Other means for attaching the first layer
1002 to the second layer 1004 are contemplated by the present
disclosure.
[0216] Referring now to FIGS. 21 and 22, the first layer 1002 can
be at least partially embedded into the first portion 1006 and/or
the second portion 1008 of the second layer 1004. In such
circumstances, the tissue thickness compensator assembly 1000 can
be prepared using a mold 1024, for example, as illustrated in FIG.
21. In various instances, an organic solution comprising a polymer
such as, for example, polylactic acid (PLA) and/or polyglycolic
acid (PGA) can be poured into the mold 1024. The first layer 1002
can be immersed into the organic solution. As illustrated in FIG.
22, a central shelf 1026 and a central beam 1027 of a mold cover
1028 can trap the first layer 1002 therebetween to ensure that the
first layer 1002 remains immersed in the organic solution which can
then be lyophilized using conventional lyophilization techniques
and/or any other suitable techniques, for example. Upon completion
of the lyophilization process, and/or any other suitable process,
the mold cover 1028 can be removed and the tissue thickness
compensator assembly 1000 can be recovered from the mold 1028.
[0217] As illustrated in FIG. 21, the first layer 1002 of the
tissue thickness compensator 1000 can be partially positioned
within the first portion 1006 and the second portion 1008 of the
second layer 1004. In certain circumstances, the first layer 1002
can be partially positioned within one of the first portion 1006
and the second portion 1008 and attached to a top surface or a
bottom surface of the other one of the first portion 1006 and the
second portion 1008.
[0218] In certain circumstances, the central beam 1027 and the
shelf 1026 can at least partially extend along an axis that is
parallel or substantially parallel to the first deck contacting
surface 1007 and/or the second deck contacting surface 1009 when
the cover 1028 is in a closed configuration with mold 1024, as
illustrated in FIG. 22. In such circumstances, the first layer 1002
can be embedded into the first portion 1006 and/or the second
portion 1008 such that first layer 1002 is positioned or
substantially positioned in a parallel or substantially parallel
relationship with the first deck contacting surface 1007 and/or the
second deck contacting surface 1009. In other circumstances,
although not illustrated, the central beam 1027 and the shelf 1026
can at least partially extend along an axis that is at an oblique
angle with the first deck contacting surface 1007 and/or the second
deck contacting surface 1008 when the cover 1028 is in a closed
configuration with mold 1024. In such circumstances, the first
layer 1002 can be embedded into the first portion 1006 and/or the
second portion 1008 such that first layer 1002 is positioned or
substantially positioned at an oblique angle with respect to the
first deck contacting surface 1007 and/or the second deck
contacting surface 1009. Other techniques for partially embedding
the first layer 1002 into the first portion 1006 and/or the second
portion 1008 are contemplated by the present disclosure.
[0219] Referring now to FIGS. 18 and 19, a tissue thickness
compensator assembly 1033, which is similar in many respects to the
tissue thickness compensator assembly 1000 and the tissue thickness
compensator 20020, is illustrated. The tissue thickness compensator
assembly 1033 can comprise the first portion 1006 and the second
portion 1008 which can be spaced apart and separably coupled
together by a plurality of bridging members or connectors 1030
which may extend across the gap 1010 between the first portion 1006
and the second portion 1008. In addition, some or all of the
connectors 1030 of the tissue thickness compensator assembly 1033
can be partially embedded into the first portion 1006 and the
second portion 1008, as illustrated in FIG. 19. Furthermore, some
or all of the connectors 1030 can comprise a first end positioned
within the first portion 1006, a second end positioned within the
second portion 1008, and a gap bridging portion 1032 therebetween.
The gap bridging portion 1032 may extend across the gap 1010
between the first portion 1006 and the second portion 1008, as
illustrated in FIG. 19. The connectors 1030 can be spaced apart
along the length of the gap 1010 to separably couple the first
portion 1006 to the second portion 1008.
[0220] In certain circumstances, the connectors 1030 can be evenly
distributed along an axis extending along the gap 1010, as
illustrated in FIG. 19. In other circumstances, although not
illustrated, the connectors 1030 can be unevenly distributed along
the axis extending along the gap 1010. The cutting portion 10053
can be configured to transect the gap bridging portions 1032 of the
connectors 1030 as the cutting portion 10053 is advanced between
the first portion 1006 and the second portion 1008 through the
knife path defined by the gap 1010. Where the connectors 1030 are
unevenly distributed along the axis extending along the first
portion 1006 and the second portion, in at least one instance, the
connectors 1030 can be disposed in greater frequency and/or in
closer proximity to each other at a distal segment of the gap 1010
than at a proximal segment of the gap 1010 such that the cutting
portion 10053 may experience an increasing resistance as it is
advanced along the knife path defined by the gap 1010. In other
circumstances, the connectors 1030 can be disposed in greater
frequency and/or in closer proximity to each other at a proximal
segment of the gap 1010 than at a distal segment of the gap 1010
such that the cutting portion 10053 may experience a decreasing
resistance as it is advanced along the knife path defined by the
gap 1010, for example.
[0221] In certain circumstances, the connectors 1030 can extend or
substantially extend in a single plane which can be parallel or
substantially parallel to the first deck contacting portion 1007
and/or the second deck contacting portion 1009, as illustrated in
FIG. 19. In other circumstances, although not illustrated, the
connectors 1030 can extend or substantially extend along a
plurality of planes which can be parallel or substantially parallel
to each other and/or to the first deck contacting portion 1007
and/or the second deck contacting portion 1009.
[0222] Further to the above, some or all of the gap bridging
portions 1032 of the connectors 1030 can be thinner than the
remainder of their respective connectors 1030 to present the
cutting portion 10053 with a reduced resistance as the cutting
portion 10053 is advanced to transect the connectors 1030 while
maintaining a coupling engagement with the first portion 1006 and
the second portion 1008 of the second layer 1004. For example, some
or all the connectors 1030 can comprise a dog-bone shape with
thicker ends terminating within the first portion 1006 and the
second portion 1008 of the second layer 1004 and thinner central
portions extending therebetween. In certain circumstances, the
connectors 1030 can each be comprised of a piece of suture which
may be comprised of bioabsorbable material such as polyglycolic
acid (PGA) which is marketed under the trade name Vicryl,
polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is
marketed under the trade name Monocryl, polycaprolactone (PCL),
and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for
example.
[0223] Referring again to FIG. 18, the tissue thickness compensator
assembly 1033 can be prepared using a mold 1034. An organic
solution comprising a polymer such as, for example, polylactic acid
(PLA) and/or polyglycolic acid (PGA) can be poured into the mold
1034. The connectors 1030 can be immersed into the organic
solution. As illustrated in FIG. 18, one or more of the connectors
1030 can each be trapped in one or more dedicated slots 1040 on a
central shelf 1036 by one or more beams 1039 extending from a mold
cover 1038 and configured for mating engagement with the slots 1040
when the mold cover 1038 is in a closed configuration with the mold
1034 to ensure that the connectors 1030 remain immersed in the
organic solution. The slots 1040 can be sized to receive or at
least partially receive the bridging portions 1032 which can be
secured by the beams 1039 when the mold cover 1038 is in the closed
configuration with the mold 1034. The ends of the connectors 1030
extending from the gap bridging portions 1032 may freely float in
the organic solution. Alternatively, the ends of the connectors
1030 can be secured to sides of the mold 1034, for example. In
certain circumstances, the connectors 1030 can be stretched in the
organic solution between the sides of the mold 1034. In other
circumstances, the connectors 1030 can be loosely held between the
sides of the mold 1034 to extend through the organic solution in a
non-linear fashion, for example.
[0224] Further to the above, in various instances, the organic
solution can then be lyophilized using conventional lyophilization
techniques and/or any other suitable techniques. Upon completion of
the lyophilization process, the mold cover 1036 can be removed and
the tissue thickness compensator assembly 1033 can be recovered
from the mold 1034. As illustrated in FIG. 19, the resulting tissue
thickness compensator assembly 1033 includes connectors 1030
partially positioned within the first portion 1006 and the second
portion 1008. Other techniques for partially embedding the
connectors 1030 into the first portion 1006 and/or the second
portion 1008 are contemplated by the present disclosure. The reader
will appreciate that the connectors 1030 can be positioned closer
to or further away from the deck contacting surfaces 1007 and 1009
by changing the height of the central shelf 1038 and/or depth of
the slots 1040.
[0225] Referring now to FIG. 20, a tissue thickness compensator
assembly 1042, which may be similar in many respects to the tissue
thickness compensator assembly 1033, the tissue thickness
compensator assembly 1000, and/or the tissue thickness compensator
20020, is illustrated. The tissue thickness compensator assembly
1042 may comprise the first portion 1006 and the second portion
1008 which can be spaced apart and separably coupled together by a
continuous flexible member 1044 which may form a plurality of
bridging members or connectors 1046 which may extend across the gap
1010 between the first portion 1006 and the second portion 1008.
The continuous flexible member 1044 may include a first end 1048, a
second end 1050, and a flexible portion 1052 extending between the
first end 1048 and the second end 1050. The flexible portion 1052
can be configured to extend through the first portion 1006 and the
second portion 1008 several times, for example in a zigzag pattern,
to form the connectors 1046, as illustrated in FIG. 20. The
flexible portion 1052 can be passed in a first direction through a
distal segment 1054 of the first portion 1006 and a distal segment
1056 of the second portion 1008 to form a first gap bridging
portion 1046a across the gap 1010. The flexible portion 1052 can
then be looped and passed in a second direction, opposite the first
direction, through the second portion 1008 proximal to the distal
segment 1056 and through the first portion 1006 proximal to the
distal segment 1054 thereby forming a second gap bridging portion
1046b proximal the first gap bridging portion 1046a. Additional gap
bridging portions 1046c and 1046d, for example, can be formed in
the same manner across the gap 1010, as illustrated in FIG. 20.
[0226] In certain circumstances, the continuous flexible member
1044 can comprise a suture and can be comprised of a suture
material such as polyglycolic acid (PGA) which is marketed under
the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone
(PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which
is marketed under the trade name Monocryl, polycaprolactone (PCL),
and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for
example. In certain circumstances, the tissue thickness compensator
assembly 1042 can be assembled after the first portion 1006 and the
second portion 1008 are manufactured, for example, via
lyophilization. In some circumstances, a needle (not shown) can be
attached to the first end 1048 of the continuous flexible member
1044 and can be passed through the first portion 1006 and the
second portion 1008, for example in a zigzag pattern, to couple the
first portion 1006 to the second portion 1008, as described above.
The first end 1048 and/or the second end 1050 of the continuous
flexible member 1044 can be secured to the side walls of the first
portion 1006 and/or the second portion 1008 by tying in one or more
knots at the first end 1048 and/or the second end 1050, for
example. The knots may abut against the side walls of the first
portion 1006 and/or the second portion 1008 to prevent the flexible
portion 1052 from unraveling relative to the first portion 1006
and/or the second portion 1008. In other circumstances, the first
portion 1006 and the second portion 1008 of the tissue thickness
compensator assembly 1042 can be formed around the continuous
flexible member 1044. In such circumstances, as illustrated in FIG.
20, the continuous flexible member 1044 can be disposed in a mold
1062, for example in a zigzag pattern, with slots 1064 defined side
walls 1066 and slots 1068 defined in central shelf 1070. An organic
solution comprising a polymer such as, for example, polylactic acid
(PLA) and/or polyglycolic acid (PGA) can be poured into the mold
1062 until the continuous flexible member 1044 is immersed in the
organic solution. A mold cover 1072 can be used to ensure that the
continuous flexible member 1044 remains immersed in the organic
solution which can then be lyophilized using conventional
lyophilization techniques and/or any other suitable techniques. The
first end 1048 and the second end 1050 of the continuous flexible
member 1044 can be secured at openings 1053 and 1055 of the mold
1062, respectively, by tying in one or more knots at the first end
1048 and the second end 1050 after passing the first end 1048
through the opening 1053 and the second end 1050 through the
opening 1055, for example. The knots may abut against the side
walls of the mold 1062 to prevent the continuous flexible member
1044 from unraveling relative to the mold 1066. After the tissue
thickness compensator has been removed from the mold, in various
instances, portions of the continuous flexible member 1044, such as
portions 1048, 1050, and/or 1052, for example, can then be cut and
removed from the tissue thickness compensator. Other techniques for
assembling the tissue thickness compensator assembly 1042 are
contemplated by the present disclosure.
[0227] In certain circumstances, a tissue thickness compensator
assembly such as, for example, the tissue thickness compensator
assembly 1042 can be compromised when excessive force or pressure
is applied thereto. For instance, pressure can be applied to a
tissue thickness compensator assembly such as, for example, the
tissue thickness compensator assembly 1042 when the tissue
thickness compensator assembly 1042 is loaded onto a staple
cartridge such as, for example, the staple cartridge 10000. The
tissue thickness compensator assembly 1042 can be equipped with a
pressure or force sensitive member that can provide a user with a
warning feedback if the pressure experienced by the tissue
thickness compensator assembly exceeds a threshold. For example, a
pressure or force sensitive film can be attached to the tissue
thickness compensator assembly 1042 and can be configured to change
color upon experiencing pressure that exceeds the threshold. In
certain circumstances, the pressure or force sensitive film can be
disposed over the first portion 1006 and/or the second portion 1008
and can be attached thereto via an adhesive, for example. The
pressure or force sensitive film can be biocompatible to permit
implantation of the pressure or force sensitive film with the
tissue thickness compensator assembly 1042 inside a patient.
[0228] Referring now to FIGS. 23-25, a surgical end effector 1100
is illustrated. The end effector 1100 is similar in many respects
to various end effectors disclosed elsewhere herein such as, for
example, the end effector 22090 (FIG. 9). As illustrated in FIG.
23, the end effector 1100 can include a staple cartridge assembly
1102 which is similar in many respects to the staple cartridge
assembly 20200 (FIG. 6), for example. In addition, the end effector
1100 may include a tissue thickness compensator 1104 which is
similar in many respects to other tissue thickness compensators
disclose elsewhere in this document such as the tissue thickness
compensator 22020 (FIG. 9), the tissue thickness compensator 20220
(FIG. 6), and/or the tissue thickness compensator 10020 (FIG. 4),
for example.
[0229] Further to the above, end effector 1100 can include a tissue
thickness compensator 1104 wherein the tissue thickness compensator
1104 can be prepared using conventional lyophilization techniques
and/or any other suitable techniques. In at least one example, the
tissue thickness compensator 1104 can be prepared by dissolving a
polymer such as, for example, polylactic acid (PLA) and/or
polyglycolic acid (PGA) in an organic solvent and lyophilizing the
solution. The tissue thickness compensator 1104 can be comprised of
a biocompatible foam which may comprise a porous, open cell foam
and/or a porous, closed cell foam, for example.
[0230] Further to the above, the tissue thickness compensator 1104
can be altered or modified for use in a surgical procedure. For
example, upon completion of the lyophilization process, the tissue
thickness compensator 1104 can be contacted with a modifying member
1106 to modify the tissue thickness compensator 1104 for use in a
particular surgical procedure. In certain circumstances, the
modification can occur after assembling the tissue thickness
compensator 1104 with the end effector 1100, as illustrated in
FIGS. 23-35. For example, as illustrated in FIG. 23, the tissue
thickness compensator 1104 can be releasably assembled to the
cartridge assembly 1102 and modified while assembled with the
cartridge assembly 1102. In other circumstances, the modification
can occur before assembling the tissue thickness compensator 1104
with the end effector 1100. In at least one example, the
modification can be performed as a separate step during
manufacturing. In yet another example, the modification may be
performed during a surgical procedure.
[0231] As described in greater detail below, the modification
process can involve modifying a surface or a plurality of surfaces
of the tissue thickness compensator 1104. In certain circumstances,
the modification process can involve modifying one or more portions
of the tissue thickness compensator 1104. One or more portions can
be modified in a single modification process. Alternatively, a
plurality of portions can each be modified separately in
consecutive modification processes. In certain circumstances, the
modification process can comprise a thermal pressing process which
can be used to change the shape, size, dimensions, and/or porosity
of at least a portion of the tissue thickness compensator 1104.
Furthermore, the modification process can include means for
creating space within one or more portions of the tissue thickness
compensator 1104.
[0232] Referring again to FIGS. 23-25, in certain circumstances, a
portion 1107 (FIG. 23) of the tissue thickness compensator 1104 can
be modified by a thermal pressing process which may include
transitioning the portion 1107 to a glassy state, engaging the
portion 1107 with the modifying member 1106, applying pressure onto
the portion 1107 while it is in the glassy state, and allowing the
portion 1107 to cool below the glassy state while the modifying
member 1106 is still engaged with the portion 1107. The modifying
member 1106 may be used to maintain the pressure on the portion
1107 for a time period sufficient to create the resulting modified
portion 1108 (FIG. 25). It is note worthy that a material's
transition into a glassy state can be a reversible transition from
a relatively hard state to a relatively molten or flexible state in
response to an increase in the temperature of the material to a
glass transition temperature. A glass transition temperature of the
material can be a particular temperature or, in some instances, a
range of temperatures. The tissue thickness compensator
modification process described herein takes advantage of this
phenomenon by modifying a tissue thickness compensator while the
tissue thickness compensator is in the glassy flexible state and
then allowing the tissue thickness compensator to cool below the
glass transition temperature while maintaining the
modification.
[0233] Further to the above, referring again to FIGS. 23-25, the
portion 1107 of the tissue thickness compensator 1004 can be
transitioned into the glassy state by heating at least the portion
1107 to a temperature greater than or equal to a glass transition
temperature of the material from which the portion 1107 is composed
but lower than the melting temperature of the same. For example,
the tissue thickness compensator 1104 can be comprised of
polyglycolic acid (PGA) and in such circumstances, the portion 1107
can be transitioned into the glassy state by heating the portion
1107 to a temperature that is greater than or equal to the glass
transition temperature of polyglycolic acid (PGA) but lower than
the melting temperature of the same. In various instances, the
glass transition temperature of polyglycolic acid (PGA) can be in
the range of 35-40.degree. C., for example, and its melting
temperature can be in the range of 225-230.degree. C., for example.
In at least one example, the portion 1107 of the tissue thickness
compensator 1104 can be heated to a temperature that is greater
than or equal to 35.degree. C. but lower than 225.degree. C. in
order to transition the portion 1107 to the glassy state. In
another example, the portion 1107 can be transitioned to the glassy
state by heating the portion 1107 to a temperature that is greater
than or equal to 40.degree. C. but lower than 200.degree. C., for
example.
[0234] Further to the above, the modifying member 1106 can then be
used to apply pressure onto the portion 1107 while the portion 1107
is in the glassy state. The portion 1107 can be allowed to exit the
glassy state by cooling the portion 1107 to a temperature below
35.degree. C., for example. The pressure may be maintained for a
time period sufficient to permit the tissue thickness compensator
1104 to retain, or at least partially retain, the modification
imposed by the modifying member 1106.
[0235] In certain examples, the pressure can be maintained for a
period of time from about 30 seconds to about 8 hours, for example,
during the time in the glassy state and/or for a period of time
from about 30 seconds to about 8 hours, for example, after exiting
the glassy state. In at least one example, the pressure can be
maintained for approximately 10 minutes during the time in the
glassy state and for approximately 10 minutes after exiting the
glassy state. Other time periods for maintaining the pressure are
contemplated by the present disclosure.
[0236] In certain circumstances, the modifying member 1106 can be
used to apply pressure onto the portion 1107 before the portion
1107 is transitioned to the glassy state. In certain circumstances,
the modifying member 1106 may apply pressure to the portion 1107
while the portion 1107 is heated to reach the glassy state, while
the portion 1107 is in the glassy state, and/or while the portion
1107 is transitioned or cooled to a temperature below the glassy
state. In certain circumstances, the pressure applied to the
portion 1107 can be gradually increased toward a threshold as the
temperature of the portion 1107 is gradually increased to
transition the portion 1107 toward the glassy state, for example.
In certain circumstances, the pressure applied to the portion 1107
can be removed, gradually removed, or at least partially reduced as
the portion 1107 exits the glassy state, before the portion 1107
exits the glassy state, and/or after the portion 1107 exits the
glassy state.
[0237] In certain circumstances, the modifying member 1106 can also
be a heat source for transitioning the portion 1107 of the tissue
thickness compensator 1104 to the glassy state. For example, the
modifying member 1106 can comprise a cylindrical distal portion
1110, as illustrated in FIG. 24, which may include a heating coil
(not shown). A user can may energize the heating coil and engage
the portion 1107 of the tissue thickness compensator 1104 with the
modifying member 1106 to heat the portion 1107 to a temperature
that is greater than or equal the glass transition temperature of
the material composition of the portion 1107. Upon reaching a
desired temperature, the modifying member may be pressed against
the portion 1107, as illustrated in FIG. 24. Alternatively, the
modifying member may be pressed against the portion 1107 before the
modifying member 1106 reaches the desired temperature. As described
above, the pressure may be maintained for a time period sufficient
to permit the tissue thickness compensator 1104 to retain, or at
least partially retain, the modification imposed by the modifying
member 1106. In addition, the heating coil of the modifying member
1106 can be turned off to allow the temperature of the portion 1107
to cool below the glass transition temperature. The modifying
member can then be removed. In certain circumstances, the pressure
applied by the modifying member 1106 can be initiated prior to the
portion 1107 entering the glassy state and maintained throughout
the glassy state. In some circumstances, the pressure applied by
the modifying member 1106 can be removed while the portion 1107 is
in the glassy state.
[0238] As illustrated in FIGS. 23-25, the modifying member 1106 can
be configured to change the shape, size, dimensions, density,
spring rate, and/or porosity of the portion 1107 of the tissue
thickness compensator 1104. For example, the modified portion 1108
may comprise a substantially concave top surface 1114 with a
reduced height H1, while the remainder of the tissue thickness
compensator 1104 may retain a substantially flat top surface
including an original height H which is greater than the reduced
height H1, as illustrated in FIG. 25. As described above, the
modifying member 1106 may comprise a cylindrical distal portion
1110. In such circumstances, the curvature of the resulting concave
surface 1114 can, in part, depend on the curvature of the
cylindrical distal portion 1110 of the modifying member 1106 in
contact with the portion 1107 of the tissue thickness compensator
1104 during the modification process. Furthermore, the modified
portion 1108 may possess a new lower porosity compared to the
unmodified portion 1107 which can result, at least in part, from
the compressive forces applied to the portion 1107 by the modifying
member 1106 during the modification process, as described above.
Said another way, the pressure applied to the portion 1107 during
the modification process may yield a material redistribution
wherein a cross-section through the modified portion 1108 may
comprise a greater material density than a similar cross section
through the portion 1107 prior to the modification process.
Furthermore, the modified portion 1108 may comprise a different
spring rate from the remainder of the tissue thickness compensator
1104 which can result, in part, from the changes in density and
porosity realized by the modified portion 1108 during the
modification process, as described in greater detail below. In at
least one instance, the spring rate of the modified portion 1108
may be less than or greater than the spring rate of the unmodified
portion 1107.
[0239] Referring now to FIGS. 26-34, a tissue thickness compensator
can be modified prior to assembly with an end effector such as, for
example, the end effector 22090 (FIG. 9). In certain circumstances,
as illustrated in FIGS. 27, 30, and 33, a mold can be utilized to
modify a tissue thickness compensator using a thermal pressing
process, as described above. For example, as illustrated in FIGS.
26-28, a tissue thickness compensator 1120 can be modified to
include a longitudinal slot 1122. The tissue thickness compensator
1120 may be similar in many respects to other tissue thickness
compensators described elsewhere such as, for example, the tissue
thickness compensator 22020 (FIG. 9). For example, like the
compensator 22020, the compensator 1120 can be utilized with the
end effector 22090. Furthermore, the longitudinal slot 1122 may be
similar in many respects to the knife slot 22025. For example, like
the knife slot 22025, the slot 1122 may define a tissue thickness
compensator knife path for the cutting portion 10053 between a
first stapling portion 1124a and a second stapling portion 1124b.
Furthermore, the first stapling portion 1124a and the second
stapling portion 1124b can be similar in many respects to the first
stapling portion 22021a (FIG. 9) and the second stapling portion
22021b (FIG. 9), respectively, of the tissue thickness compensator
22020. In addition, the slot 1122 can be configured to releasably
connect the first stapling portion 1124a and the second stapling
portion 1124b such that, in use with the end effector 22090, the
cutting portion 10053 can be advanced distally through the slot
1122 to transect the slot 1122 and separate the first stapling
portion 1124a and the second stapling portion 1124b.
[0240] Referring again to FIGS. 26-28, the tissue thickness
compensator 1120 can be prepared using traditional lyophilization
techniques and/or any other suitable techniques. In addition, the
tissue thickness compensator 1120 can be modified or altered to
create the slot 1122 therethrough Similar to the tissue thickness
compensator 1104, the tissue thickness compensator 1120 can be
comprised at least in part of a material comprising a glass
transition temperature and can modified by transitioning the
material into a glassy state. In one example, the tissue thickness
compensator 1120 can be heated in an oven (not shown) to a
temperature greater than or equal to the glass transition
temperature of the material composition of the tissue thickness
compensator 1120 but less than the melting temperature of the same.
A mold 1126 comprising a central beam 1128, as illustrated in FIG.
27, can be utilized to create the slot 1122 by inserting the
central beam 1128 into the tissue thickness compensator 1120 while
the tissue thickness compensator 1120 is in the glassy state. The
tissue thickness compensator 1120 can then be allowed to cool to a
temperature below the glass transition temperature while the
central beam 1128 remains inserted into the tissue thickness
compensator 1120. In some instances, the central beam 1128 can be
removed from the tissue thickness compensator 1120 while the tissue
thickness compensator 1120 is in its glassy state.
[0241] In certain circumstances, a cooling medium can be utilized
to actively cool the tissue thickness compensator 1120. In some
instances, a fan can be used to generate a flow of air over the
tissue thickness compensator 1120 while the tissue thickness
compensator 1120 is in the mold 1126 and/or after the tissue
thickness compensator 1120 has been removed from the mold. In some
instances, a refrigeration process can be utilized to cool the
tissue thickness compensator 1120 while the tissue thickness
compensator 1120 is in the mold 1126 and/or after the tissue
thickness compensator 1120 has been removed from the mold. The
central beam 1128 can be removed after transitioning the tissue
thickness compensator 1120 out of the glassy state. The central
beam 1128 can remain inserted into the tissue thickness compensator
1120 for a time period sufficient to permit the tissue thickness
compensator 1120 to retain, or at least substantially retain, the
space occupied by the central beam 1128. In certain examples, the
central beam 1128 can remain inserted for a period of time from
about 30 seconds to about 8 hours, for example, during the time in
the glassy state and/or for a period of time from about 30 seconds
to about 8 hours, for example, after exiting the glassy state. In
at least one example, the central beam 1128 can remain inserted for
approximately 10 minutes during the time in the glassy state and
for approximately 10 minutes after exiting the glassy state. Other
time periods for maintaining the central beam 1128 within the
tissue thickness compensator 1120 are contemplated by the present
disclosure.
[0242] Further to the above, as illustrated in FIG. 28, pressure
applied by the central beam 1128 during the modification process
may yield an increased material density at a portion 1130 of the
tissue thickness compensator 1120. The portion 1130 may connect the
first stapling portion 1124a and a second stapling portion 1124b
thereby providing additional stability for the slot 1122. In
certain circumstances, the mold 1126 may comprise edge modifiers
such as, for example, edge modifiers 1132a and 1132b which can
modify the tissue thickness compensator 1120 during the
modification process to produce modified edges 1134a and 1134b,
respectively, as illustrated in FIG. 28.
[0243] Referring again to FIGS. 26-28, it may be desirable to
remove a significant amount of material from the tissue thickness
compensator 1120 to create the slot 1122. In such circumstances,
the central beam 1128 can be heated to a temperature greater than
the melting temperature of the material composition of the tissue
thickness compensator 1120. Upon inserting the heated central beam
1128 into the tissue thickness compensator 1120, the central beam
1128 may melt through the tissue thickness compensator 1120 thereby
creating a space for the slot 1122 within the tissue thickness
compensator 1120, as illustrated in FIG. 28. In certain
circumstances, it may be desirable to gradually increase the
pressure applied by the central beam 1128 against the tissue
thickness compensator 1120 to gradually insert the central beam
1128 into the tissue thickness compensator 1120.
[0244] in certain circumstances, it can be desirable to increase
material density of one or more surfaces of a tissue thickness
compensator. As illustrated in FIGS. 29-31, a tissue thickness
compensator 1140 can be modified or altered such that a surface
1142 of the tissue thickness compensator 1140 may comprise a higher
material density than the remainder of the tissue thickness
compensator 1140, which can be achieved, in certain circumstances,
post lyophilization. The tissue thickness compensator 1140 may be
similar in many respects to other tissue thickness compensators
described elsewhere such as, for example, the tissue thickness
compensator 22020 (FIG. 9) and/or the tissue thickness compensator
1120 (FIG. 26). A surface modifier 1144 can be utilized to modify
the surface 1142 of the tissue thickness compensator 1140 using a
thermal pressing process which is similar in many respects to the
thermal pressing processes used to modify the tissue thickness
compensator 1104 and/or the tissue thickness compensator 1120, as
described above. For example, the tissue thickness compensator 1140
can be comprised at least in part of a material comprising a glass
transition temperature and can be modified after being transitioned
into a glassy state.
[0245] As described above, a tissue thickness compensator such as,
for example, the tissue thickness compensator 1140 can be
transitioned to the glassy state where it is heated to a
temperature greater than or equal to the glass transition
temperature of the material composition of the tissue thickness
compensator 1140 but less than the melting temperature of the same.
The surface modifier 1144 can be pressed against the surface 1142
while the tissue thickness compensator 1140 is in the glassy state.
The pressure applied by the surface modifier 1144 may compress the
surface 1142 thereby increasing the material density of the surface
1142. The increase in material density can be retained by the
surface 1142 by allowing the surface 1142 to cool to a temperature
below the glass transition temperature.
[0246] In certain instances, the pressure applied by the surface
modifier 1144 against the surface 1142 can be maintained for a
period of time from about 30 seconds to about 8 hours, for example,
during the time in the glassy state and/or for a period of time
from about 30 seconds to about 8 hours, for example, after exiting
the glassy state. In at least one example, the pressure can be
maintained for approximately 10 minutes during the time in the
glassy state and for approximately 10 minutes after exiting the
glassy state. Other time periods for maintaining the pressure
applied by the surface modifier 1144 against the surface 1142 are
contemplated by the present disclosure.
[0247] In some instances, a fan can be used to generate a flow of
air over the tissue thickness compensator 1140 while the tissue
thickness compensator 1140 is in contact with the modifier 1144
and/or after the tissue thickness compensator 1140 has been removed
from the modifier 1144. In some instances, a refrigeration process
can be utilized to cool the tissue thickness compensator 1140 while
the tissue thickness compensator 1140 is in contact with the
modifier 1144 and/or after the tissue thickness compensator 1140
has been removed from the modifier 1144. Upon transitioning the
tissue thickness compensator 1140 out of the glassy state, in
various instances, the surface modifier 1144 can be disengaged from
the tissue thickness compensator 1140. In certain circumstances,
the surface modifier 1144 can include a heating element which can
be utilized to increase the temperature of the surface 1142 to a
temperature greater than or equal to the glass transition
temperature of the material composition of the tissue thickness
compensator 1140, as described above.
[0248] Referring again to FIG. 30, the surface modifier 1144 may
comprise a flat, or at least substantially flat, contacting surface
1146 for contacting the surface 1142, for example. In other
circumstances, the contacting surface 1146 may comprise various
textures such as, for example, protrusions which can extend into
the surface 1142 of the tissue thickness compensator 1140 during
the modification process. In certain circumstances, the surface
modifier 1144 can be used to apply pressure onto the surface 1142
of the tissue thickness compensator 1140 before the tissue
thickness compensator 1140 is transitioned to the glassy state. In
certain circumstances, the surface modifier 1144 may apply pressure
to the surface 1142 while the tissue thickness compensator 1140 is
heated to reach the glassy state, while the tissue thickness
compensator 1140 is in the glassy state, and/or while the tissue
thickness compensator 1140 is transitioned or cooled to a
temperature below the glassy state. In certain circumstances, the
pressure applied by the surface modifier 1144 to the surface 1142
can be gradually increased toward a threshold as the temperature of
the tissue thickness compensator 1140 is gradually increased to
transition the tissue thickness compensator 1140 toward the glassy
state, for example. In certain circumstances, the pressure applied
to the surface 1142 can be removed, gradually removed, or at least
partially reduced as the tissue thickness compensator 1140 exits
the glassy state, before the tissue thickness compensator 1140
exits the glassy state, and/or after the tissue thickness
compensator 1140 exits the glassy state.
[0249] In certain circumstances, the tissue thickness compensator
1140 can be modified or altered to include a skin or a dense outer
layer. In certain circumstances, the resulting skin or dense outer
layer may comprise textures such as, for example, protrusions which
can extend into the surface 1142 of the tissue thickness
compensator 1140. In certain instances, the contacting surface 1146
of the surface modifier 1144 can be heated to a temperature greater
than or equal to the melting temperature of the material
composition of the tissue thickness compensator 1140. The surface
modifier 1144 and/or the tissue thickness compensator 1140 can be
moved to bring the surface 1142 of the tissue thickness compensator
1140 into contact with the heated contacting surface 1146 of the
surface modifier 1144 thereby melting, or at least substantially
melting, the surface 1142. The surface modifier 1144 and the tissue
thickness compensator 1140 can then be separated to permit the
modified surface 1142 to cool below its melting temperature which
may create a skin or a dense outer layer onto the tissue thickness
compensator 1140.
[0250] In certain instances, the contacting surface 1146 of the
surface modifier 1144 can be heated prior to coming in contact with
the surface 1142. In other instances, the contacting surface 1146
of the surface modifier 1144 can be heated after coming in contact
with the surface 1142.
[0251] In certain instances, the contacting surface 1146 of the
surface modifier 1144 can remain in contact with the surface 1142
of the tissue thickness compensator 1140 for a time period
sufficient to allow the surface 1142 to flow into a desired
geometry. Such a time period can range from about 30 seconds to
about 8 hours, for example; other time periods are contemplated by
the present disclosure. Such a time period can be sufficient to
locally affect and/or melt the material of the tissue thickness
compensator 1140 and have it flow into a new geometry. As described
herein, such a new geometry can be prescribed by the tooling used
to make the tissue thickness compensator 1140.
[0252] In certain instances, the surface 1142 of the tissue
thickness compensator 1140 can be allowed to cool, or can be
actively cooled, to a temperature below the melting temperature of
the tissue thickness compensator 1140 before separating the surface
modifier 1144 from the tissue thickness compensator 1140. In other
instances, the surface 1142 of the tissue thickness compensator
1140 can be allowed to cool, or can be actively cooled, to a
temperature below the melting temperature of the tissue thickness
compensator 1140 after separating the surface modifier 1144 from
the tissue thickness compensator 1140.
[0253] Further to the above, the modified surface 1142 can comprise
a density which is approximately 10% greater than the density of
the remainder of the tissue thickness compensator 1140,
approximately 20% greater than the density of the remainder of the
tissue thickness compensator 1140, approximately 30% greater than
the density of the remainder of the tissue thickness compensator
1140, approximately 40% greater than the density of the remainder
of the tissue thickness compensator 1140, approximately 50% greater
than the density of the remainder of the tissue thickness
compensator 1140, approximately 60% greater than the density of the
remainder of the tissue thickness compensator 1140, approximately
70% greater than the density of the remainder of the tissue
thickness compensator 1140, approximately 80% greater than the
density of the remainder of the tissue thickness compensator 1140,
approximately 90% greater than the density of the remainder of the
tissue thickness compensator 1140, and/or approximately 100%
greater than the density of the remainder of the tissue thickness
compensator 1140, for example. In various circumstances, the
modified surface 1142 can comprise a density which is more than the
density of the remainder of the tissue thickness compensator 1140
and less than twice the density of the remainder of the tissue
thickness compensator 1140, for example. In various circumstances,
the modified surface 1142 can comprise a density which is over
twice the density of the remainder of the tissue thickness
compensator 1140, for example.
[0254] Referring now to FIGS. 32-34, a tissue thickness compensator
1150 can be modified to include a plurality of apertures 1152 which
may extend at least partially through the tissue thickness
compensator 1150. The tissue thickness compensator 1150 may be
similar in many respects to other tissue thickness compensators
described herein such as, for example, the tissue thickness
compensator 20220 (FIG. 6). Like the compensator 20220, the
compensator 1150 can be utilized with the cartridge assembly 20200
(FIG. 6) and the apertures 1152 may be similar in many respects to
the clearance apertures 20224 extending at least partially through
the tissue thickness compensator 20220. For example, like the
apertures 20224, the apertures 1152 can be aligned with
corresponding staple legs 20232 (FIG. 7) when the tissue thickness
compensator 1150 is assembled with the cartridge assembly 20200
such that the staple legs 20232 may move through the clearance
apertures 1152 in the tissue thickness compensator 1150 when the
staple legs 20232 move from the unfired configuration to the fired
configuration, as described above in greater detail.
[0255] Further to the above, referring again to FIGS. 32-34, the
tissue thickness compensator 1150 can be prepared using traditional
lyophilization techniques and/or any other suitable techniques. In
certain circumstances, a polymer having a glass transition
temperature such as, for example, polylactic acid (PLA) and/or
polyglycolic acid (PGA) can be dissolved in an organic solvent to
form a solution which can be lyophilized to produce the tissue
thickness compensator 1150. Furthermore, the tissue thickness
compensator 1150 can be modified post lyophilization using a
thermal pressing process which is similar in many respects to the
thermal pressing processes used to modify the tissue thickness
compensator 1104, the tissue thickness compensator 1120, and/or the
tissue thickness compensator 1140, for example, as described above.
For example, the tissue thickness compensator 1150 can be modified
to include the apertures 1152 once the tissue thickness compensator
1150 is transitioned to a glassy state.
[0256] As described above, a tissue thickness compensator such as,
for example, the tissue thickness compensator 1150 can be
transitioned to a glassy state by being heated in an oven (not
shown) to a temperature greater than or equal to the glass
transition temperature of the material composition of the tissue
thickness compensator 1150 but less than the melting temperature of
the same. A mold 1154 comprising a plurality of posts, dowels,
pins, and/or protrusions, for example, such as, for example,
needles 1156 can be utilized to create the apertures 1152 by
inserting the needles 1156 into the tissue thickness compensator
1150 while the tissue thickness compensator 1150 is in the glassy
state. The tissue thickness compensator 1150 can then be allowed to
cool to a temperature below the glass transition temperature while
the needles 1156 remain inserted into the tissue thickness
compensator 1150. In some instances, the needles 1156 can be
removed from the tissue thickness compensator 1150 while the tissue
thickness compensator 1150 is in the glassy state. In some
instances, a fan can be used to generate a flow of air over the
tissue thickness compensator 1150 while the tissue thickness
compensator 1150 is engaged with the needles 1156 and/or after the
tissue thickness compensator 1150 has been disengaged from the
needles 1156. In some instances, a refrigeration process can be
utilized to cool the tissue thickness compensator 1150 while the
tissue thickness compensator 1150 is engaged with the needles 1156
and/or after the tissue thickness compensator 1150 has been
disengaged from the needles 1156. In various instances, the needles
1156 can be removed after transitioning the tissue thickness
compensator 1150 out of the glassy state. The needles 1156 can
remain inserted into the tissue thickness compensator 1150 for a
time period sufficient to permit the tissue thickness compensator
1150 to retain, or at least substantially retain, the spaces
defining the apertures 1152 which are occupied by the needles
1156.
[0257] In certain examples, the needles 1156 can remain inserted
for a period of time from about 30 seconds to about 8 hours, for
example, during the time in the glassy state and/or for a period of
time from about 30 seconds to about 8 hours, for example, after
exiting the glassy state. In at least one example, the needles 1156
can remain inserted for approximately 10 minutes during the time in
the glassy state and for approximately 10 minutes after exiting the
glassy state. Other time periods for maintaining the needles 1156
inserted into the tissue thickness compensator 1150 are
contemplated by the present disclosure.
[0258] In certain circumstances, the needles 1156 can be removed
from the tissue thickness compensator 1150 prior to transitioning
the tissue thickness compensator 1150 out of the glassy state. In
other circumstances, the needles 1156 can be gradually removed over
time. For example, the needles 1156 can be partially removed from
the tissue thickness compensator 1150 prior to transitioning the
tissue thickness compensator 1150 out of the glassy state. The
needles 1156 can then be fully removed from the tissue thickness
compensator 1150 after transitioning the tissue thickness
compensator 1150 out of the glassy state. The reader will
appreciate that the greater the depth of insertion of the needles
1156 into the tissue thickness compensator 1150, the greater the
depth of the corresponding apertures 1152 that can be created in
the tissue thickness compensator 1150.
[0259] Referring again to FIGS. 32-34, in certain instances, the
needles 1156 can be heated to a temperature greater than or equal
to the melting temperature of the material composition of the
tissue thickness compensator 1150. In addition, the needles 1156
can be inserted into the tissue thickness compensator 1150 to
create the apertures 1152 by melting, or at least partially
melting, through the regions of the tissue thickness compensator
1150 that receive the needles 1156. In various instances, the
needles 1156 can be heated prior to their insertion into the tissue
thickness compensator 1150. In various instances, the needles 1156
can be heated after their insertion into the tissue thickness
compensator 1150. In various instances, the needles 1156 can be
gradually heated as the needles 1156 are inserted into the tissue
thickness compensator 1150.
[0260] In certain instances, the needles 1156 may remain positioned
within the tissue thickness compensator 1150 for a period of time
sufficient to permit the melted material of the tissue thickness
compensator 1150 to flow into a desired geometry. Such a time
period can range from about 30 seconds to about 8 hours, for
example; other time periods are contemplated by the present
disclosure. Such a time period can be sufficient to locally affect
and/or melt the material of the tissue thickness compensator 1150
and have it flow into a new geometry. As described herein, such a
new geometry can be prescribed by the tooling used to make the
tissue thickness compensator 1150.
[0261] In certain instances, the tissue thickness compensator 1150
can be allowed to cool, or can be actively cooled, to a temperature
below the melting temperature of the tissue thickness compensator
1150 before separating the needles 1156 from the tissue thickness
compensator 1150. In other instances, the tissue thickness
compensator 1150 can be allowed to cool, or can be actively cooled,
to a temperature below the melting temperature of the tissue
thickness compensator 1150 after separating the needles 1156 from
the tissue thickness compensator 1150.
[0262] Referring again to FIGS. 32-34, the needles 1156 can be
arranged in rows extending longitudinally along a length of the
mold 1154 which may correspond to staple rows in a staple cartridge
such as, for example, the staple cartridge assembly 20200 (FIG. 6).
For example, as illustrated in FIG. 33, the needles 1156 can are
arranged in six rows which can be configured to create six rows of
the apertures 1152 that can be configured to receive six rows of
the staples 20230 (FIG. 7). In certain circumstances, as
illustrated in FIG. 33, the rows of the needles 1156 can be
arranged in two groups which are spaced apart and configured to be
received in two portions 1158 and 1160 of the tissue thickness
compensator 1150 thereby creating two groups of the apertures 1152
separated by an intermediate portion 1162. The intermediate portion
1162 can be positioned, at least partially, over the cartridge
knife slot 22015 (FIG. 6), when the tissue thickness compensator
1150 is assembled with staple cartridge assembly 20200. In use, the
firing member 10052 (FIG. 10) can be advanced distally to push the
staple legs 20232 (FIG. 8) through the apertures 1152 within the
portions 1158 and 1160 and advance the cutting portion 10053 (FIG.
10) to transect the intermediate portion 1162 and separate the
portions 1158 and 1160.
[0263] Referring again to FIGS. 32-34, the apertures 1152 can be
configured to extend within the tissue thickness compensator 1150
and terminate at a certain depth within the tissue thickness
compensator 1150. The apertures 1152 may comprise uniform depths,
as illustrated in FIG. 34. In other circumstances, the apertures
1152 may comprise different depths (not shown). For example, a
first row of the apertures 1152 may comprise a first depth and a
second row of the apertures 1152 may comprise a second depth
different from the first depth and yet a third row of the apertures
1152 may comprise a third depth different from the first depth and
the second depth. The depths of the apertures 1152 can be
determined, at least in part, by the heights of the corresponding
needles 1156. For example, a first row of the needles 1156
comprising a first height and a second row of the needles 1156
comprising second height greater than first height may create a
first row of the apertures 1152 comprising a first depth and a
second row of the apertures 1152 comprising a second depth which is
greater than the first depth.
[0264] Referring again to FIGS. 32-34, the needles 1156 can be
configured to define a trajectory for the apertures 1152 within the
tissue thickness compensator 1150. In certain circumstances, the
needles 1156 can extend along an axis that is perpendicular and/or
substantially perpendicular to a mold surface 1164 of the mold
1154, as illustrated in FIG. 33. Inserting the needles 1156 into
the tissue thickness compensator 1150 while maintaining a parallel
relationship between the mold surface 1164 and a surface 1166 of
the tissue thickness compensator 1150 may result in defining a
perpendicular and/or substantially perpendicular trajectory for the
apertures 1152 relative to the surface 1166 of the tissue thickness
compensator 1150, as illustrated in FIG. 34. In other
circumstances, the needles 1156 can extend from the mold surface
1164 at an oblique angle (not shown) and/or the insertion
trajectory of the needles 1156 into the tissue thickness
compensator 1150 can be at an angle such that the needles 1156 may
define a non-perpendicular trajectory for the apertures 1152
relative to the surface 1166 of the tissue thickness compensator
1150. In certain circumstances, a group of the needles 1156 can be
parallel and/or substantially parallel to each other, as
illustrated in FIG. 33, resulting in a group of the apertures 1152
that may be parallel and/or substantially parallel to each other,
as illustrated in FIG. 24. In other circumstances, although not
illustrated, a group of non-parallel needles can extend from the
mold surface 1164 and may result in non-parallel apertures when
inserted into the tissue thickness compensator 1150. In some
circumstances, the needles 1156 can be configured to create
apertures within the tissue thickness compensator 1150 that can
comprise a partially curved trajectory and/or a partially linear
trajectory. For example, the needles 1156 can extend from the mold
surface 1164 in a partially curved trajectory and can be inserted
into the tissue thickness compensator 1150 to create apertures
within the tissue thickness compensator 1150 with a corresponding
partially curved trajectory.
[0265] Referring again to FIGS. 32-34, some or all of the needles
1156 can comprise blunt distal ends 1168, as illustrated in FIG.
33. In other circumstances, some or all of the needles 1156 can
comprise sharp distal ends (not shown). Some or all of the needles
1156 can comprise cylindrical, or at least substantially
cylindrical, shapes, for example, as illustrated in FIG. 33. Other
shapes are also contemplated by the present disclosure. [0159] In
various instances, one or more of the needles 1156 extending from
the mold surface 1164 may not be insertable through the full
thickness of the tissue thickness compensator 1150. In certain
instances, one or more of the needles 1156 extending from the mold
surface 1164 can be insertable through the full thickness of the
tissue thickness compensator 1150 to create openings an/or holes
that extend through the full thickness of the tissue thickness
compensator 1150. In certain instances, one or more of the needles
1156 extending from the mold surface 1164 can be inserted through a
first side of the tissue thickness compensator 1150 and exited
through a second side of the tissue thickness compensator 1150
which may be opposite the first side, for example. In certain
instances, one or more of the needles 1156 may comprise a length
greater than the full thickness of the tissue thickness compensator
1150 to facilitate the insertion of the one or more needles 1156
through the full thickness of the tissue thickness compensator
1150.
[0266] Referring now to FIGS. 35-37, it may be desirable to resize
a tissue thickness compensator. For example, one or more dimensions
of a tissue thickness compensator may be adjusted to correspond to
dimensions of a staple cartridge in order to provide a better fit
to the staple cartridge when the tissue thickness compensator is
assembled with the staple cartridge. In certain circumstances, a
tissue thickness compensator 1170 can be resized by changing its
height from a first height H1, as illustrated in FIG. 35, to a
second height H2, as illustrated in FIG. 36. The tissue thickness
compensator 1170 may be similar in many respects to other tissue
thickness compensators described herein such as, for example, the
tissue thickness compensator 22020 (FIG. 9), the tissue thickness
compensator 1140 (FIG. 29), and/or the tissue thickness compensator
1150 (FIG. 32). For example, like the compensator 22020, the
compensator 1170 can be utilized with the end effector 22090 (FIG.
9).
[0267] In various instances, referring again to FIGS. 35-37, the
tissue thickness compensator 1170 can be prepared using traditional
lyophilization techniques and/or any other suitable techniques. In
certain instances, the tissue thickness compensator 1170 can be
resized, as illustrated in FIG. 37, using a thermal pressing
process and a mold 1172, for example. The mold 1172 may comprise a
receiver 1174 configured to receive the tissue thickness
compensator 1170 and an adjustment member 1176 which can be
partially insertable into the receiver 1174. The tissue thickness
compensator 1170 can be resized when the tissue thickness
compensator 1170 is transitioned into a glassy state. In one
embodiment, the tissue thickness compensator 1170 can be heated in
an oven (not shown) to a temperature greater than or equal to a
glass transition temperature of the material composition of the
tissue thickness compensator 1170 but less than the melting
temperature of the same. In another embodiment, the receiver 1174
and/or the adjustment member 1176 may comprise a heating element
for transitioning the tissue thickness compensator 1170 to the
glassy state. The adjustment member 1176 can then be inserted into
the receiver 1174a distance H3, for example, as illustrated in FIG.
37, thereby compressing the tissue thickness compensator 1170 and
reducing its height from the first height H1 to the second height
H2. In some instances, the adjustment member 1176 can be inserted
into the receiver 1174 before the tissue thickness compensator 1170
enters into the glassy state or just as the tissue thickness
compensator 1170 enters into the glassy state. The adjustment
member 1176 can be held against the tissue thickness compensator
1170 to compress the tissue thickness compensator 1170 for a time
period sufficient to permit the tissue thickness compensator 1170
to retain, or at least substantially retain, the second height H2,
as illustrated in FIG. 36. The tissue thickness compensator 1170
can then be allowed to cool to a temperature below the glass
transition temperature while under compression from the adjustment
member 1176. After transitioning the tissue thickness compensator
1170 out of the glassy state, the adjustment member 1176 can be
retracted. In some instances, the adjustment member 1176 can be
retracted before the tissue thickness compensator 1170 exits the
glassy state. In certain circumstances, the above described
resizing process can be utilized to change another dimension of the
tissue thickness compensator 1170 such as a length or a width of
the tissue thickness compensator 1170, for example. In some
circumstances, these dimensions can be modified simultaneously or
modified sequentially.
[0268] In certain examples, the compression from the adjustment
member 1176 can be maintained for a period of time from about 30
seconds to about 8 hours, for example, during the time in the
glassy state and/or for a period of time from about 30 seconds to
about 8 hours, for example, after exiting the glassy state. In at
least one example, the compression from the adjustment member 1176
can be maintained for approximately 10 minutes during the time in
the glassy state and for approximately 10 minutes after exiting the
glassy state. Other time periods for maintaining the compression
imposed by the adjustment member 1176 against the tissue thickness
compensator 1170 are contemplated by the present disclosure.
[0269] In certain circumstances, the adjustment member 1176 can be
used to apply pressure onto the tissue thickness compensator 1170
before the tissue thickness compensator 1170 is transitioned to the
glassy state. In certain circumstances, the adjustment member 1176
may apply pressure to the tissue thickness compensator 1170 while
the tissue thickness compensator 1170 is heated to reach the glassy
state, while the tissue thickness compensator 1170 is in the glassy
state, and/or while the tissue thickness compensator 1170 is
transitioned or cooled to a temperature below the glassy state. In
certain circumstances, the pressure applied to the tissue thickness
compensator 1170 can be gradually increased toward a threshold as
the temperature of the tissue thickness compensator 1170 is
gradually transitioned toward the glassy state, for example. In
certain circumstances, the pressure applied to the tissue thickness
compensator 1170 can be removed, gradually removed, or at least
partially reduced as the tissue thickness compensator 1170 exits
the glassy state, before the tissue thickness compensator 1170
exits the glassy state, and/or after the tissue thickness
compensator 1170 exits the glassy state.
[0270] The reader will appreciate that the different molds utilized
in the modification processes described above such as, for example,
the molds 1144, 1154, and/or 1172 are illustrative examples. Other
mold designs and configurations can also be employed to manipulate
tissue thickness compensators in a variety of ways. Furthermore,
the forces involved in manipulating a tissue thickness compensator
need not only be compressive forces. For example, tensile forces
can also be utilized to modify, reshape, and/or resize a tissue
thickness compensator in similar manners to those described above.
For example, the tissue thickness compensator 1170 can be stretched
using tensile forces to reduce its height from the first height H1
(FIG. 35) to the second height H2 (FIG. 36), for example, using a
modification process that is similar in many respects to the
modification processes described above. In certain circumstances,
combinations of tensile and compressive forces can be used to
manipulate a tissue thickness compensator during a modification
process.
[0271] Referring again to FIGS. 35-37, it may be desirable to
modify the porosity of a tissue thickness compensator for use in a
surgical procedure. A tissue thickness compensator may comprise a
porous, open cell foam and/or a porous, closed cell foam, for
example. Traditional lyophilization techniques may provide some
control over a tissue thickness compensator's porosity but such
control may not be easily reproducible and may need additional fine
adjustments that may not be obtainable by traditional
lyophilization techniques. As illustrated in FIGS. 35-37, the
height of the tissue thickness compensator 1170 can be changed from
the first height H1 (FIG. 35) to the second height H2 (FIG. 36),
for example, using the modification process described above. In
addition, porosity of the tissue thickness compensator 1170 can
also be modified using the same and/or a similar modification
process. For example, the tissue thickness compensator 1170 may
comprise a first porosity (FIG. 35) prior to the modification
process and a second porosity (FIG. 36) after completion of the
modification process, as described above. The change in porosity
can be attributed, at least in part, to the compressive forces
and/or the energy applied to the tissue thickness compensator 1170
by the adjustment member 1176 during the modification process
described above.
[0272] Further to the above, the tissue thickness compensator 1170
may comprise a plurality of pores 1180. Some or all of the pores
1180 may be altered in position, size, and/or shape, for example,
as a result of the modification process described above. For
example, one or more of the pores 1180 may comprise a spherical, or
substantially spherical, shape prior to the modification process
which may be altered to an oval, or substantially oval, shape as a
result of the modification process. In at least one example, one or
more of the pores 1180 may comprise a first size prior to the
modification process and a second size different from the first
size as a result of the modification process. In certain
circumstances, as described below in greater detail, the porosity
changes can be localized to one or more regions or zones of the
tissue thickness compensator 1170.
[0273] Furthermore, in certain circumstances, the change in
porosity of the tissue thickness compensator 1170 may be
accompanied by a change in density of the tissue thickness
compensator 1170. In other words, as the adjustment member 1176 is
advanced against the tissue thickness compensator 1170, compressive
forces may reduce space occupied by the tissue thickness
compensator 1170 thereby causing material and/or pore
redistribution which may yield an increase in the density of the
tissue thickness compensator 1170 and/or a reduction in its
porosity. In certain circumstances, as described below in greater
detail, the density changes can be localized to one or more regions
or zones of the tissue thickness compensator 1170.
[0274] Further to the above, the change in porosity and/or density
of the tissue thickness compensator 1170 may yield a change in the
spring rate of the tissue thickness compensator 1170. A tissue
thickness compensator's spring rate can influence its ability to
compensate for tissue thickness when the tissue thickness
compensator is deployed against tissue captured by staples such as,
for example, the staples 20230 (FIG. 8), as described above in
greater detail. Furthermore, a tissue thickness compensator's
spring rate can also influence its ability to apply pressure
against tissue captured with the tissue thickness compensator by a
staple. In other words, a change in a tissue thickness
compensator's spring rate may change the pressure exerted by the
tissue thickness compensator against tissue captured by a staple.
Since different tissue types may respond more positively to certain
pressures, fine control over a tissue thickness compensator's
spring rate can be advantageous.
[0275] As illustrated in FIGS. 35-37, the tissue thickness
compensator 1170 may comprise a first spring rate (FIG. 35) which
may be altered or modified to a second spring rate (FIG. 36)
different from the first spring rate using the modification process
described above. For example, as described above, the adjustment
member 1176 can be advanced against the tissue thickness
compensator 1170 while the tissue thickness compensator 1170 is in
the glassy state. In response, the tissue thickness compensator
1170 may be compressed which may cause a change in the spring rate
of the tissue thickness compensator 1170. The adjustment member
1176 can be retained in the advanced position for a period of time
sufficient to permit the tissue thickness compensator 1170 to
retain, or at least substantially retain, the change in spring
rate. In addition, the tissue thickness compensator 1170 can be
allowed to cool below the glass transition temperature of its
material composition while maintaining the pressure applied by the
adjustment member 1176 against the tissue thickness compensator
1170.
[0276] In certain instances, the adjustment member 1176 can be
maintained in the advanced position against the tissue thickness
compensator 1170 for a period of time from about 30 seconds to
about 8 hours, for example, during the time in the glassy state
and/or for a period of time from about 30 seconds to about 8 hours,
for example, after exiting the glassy state. In at least one
example, the adjustment member 1176 can be maintained in the
advanced position against the tissue thickness compensator 1170 for
approximately 10 minutes during the time in the glassy state and
for approximately 10 minutes after exiting the glassy state. Other
time periods for maintaining the adjustment member 1176 in the
advanced position against the tissue thickness compensator 1170 are
contemplated by the present disclosure.
[0277] In certain circumstances, the adjustment member 1176 can be
used to apply pressure onto the tissue thickness compensator 1170
to change the spring rate of the tissue thickness compensator 1170
before the tissue thickness compensator 1170 is transitioned to the
glassy state. In certain circumstances, the adjustment member 1176
may apply pressure to the tissue thickness compensator 1170 while
the tissue thickness compensator 1170 is heated to reach the glassy
state, while the tissue thickness compensator 1170 is in the glassy
state, and/or while the tissue thickness compensator 1170 is
transitioned or cooled to a temperature below the glassy state. In
certain circumstances, the pressure applied to the tissue thickness
compensator 1170 can be gradually increased toward a threshold as
the temperature of the tissue thickness compensator 1170 is
gradually increased to transition the tissue thickness compensator
1170 toward the glassy state, for example. In certain
circumstances, the pressure applied to the tissue thickness
compensator 1170 can be removed, gradually removed, or at least
partially reduced as the tissue thickness compensator 1170 exits
the glassy state, before the tissue thickness compensator 1170
exits the glassy state, and/or after the tissue thickness
compensator 1170 exits the glassy state.
[0278] Referring again to FIGS. 35-40, the tissue thickness
compensator 1170 may be manufactured with a native spring rate
using traditional lyophilization techniques and/or any other
suitable techniques. As described above, the spring rate of the
tissue thickness compensator 1170 can influence its ability to
apply pressure against tissue captured with the tissue thickness
compensator 1170 by a staple. The modification process described
above may be utilized to adjust the native spring rate of the
tissue thickness compensator 1170 to adjust its ability to apply
pressure against tissue captured with the tissue thickness
compensator 1170 by the staple. In certain circumstances, the
native spring rate of the tissue thickness compensator 1170 can be
increased from a first spring rate at point A (FIG. 40) to a second
spring rate including and up to a maximum spring rate at point B
(FIG. 40). In certain circumstances, such increase of the spring
rate of the tissue thickness compensator 1170 can be achieved by
applying compression forces to the tissue thickness compensator
1170 using the adjustment member 1176 while the tissue thickness
compensator 1170 is in the glassy state, as explain in the
modification process described above. As illustrated in FIG. 40,
the point B represents a maximum elastic yield of the tissue
thickness compensator 1170. As such, any additional compression
applied by the adjustment member 1176 to the tissue thickness
compensator 1170 beyond a threshold compression at the point B may
produce a decrease in the spring rate of the modified tissue
thickness compensator 1170. For example, as illustrated in FIG. 40,
the spring rate at the point C is lower than the spring rate at the
point B even though the compression force applied by the adjustment
member 1176 to the tissue thickness compensator 1170 at point C is
greater than the compression force applied at the point B.
[0279] As discussed above, one or more processes can be used to
affect the spring rate, and/or any other property, of a material
used in conjunction with a fastener cartridge and/or a surgical
fastening instrument, for example. The spring rate, and/or any
other property, of the material may change throughout the
modification process or processes. Such a change may be gradual in
some circumstances, while in other circumstances, the change may be
sudden. In various instances, one or more of the steps of the
modification process may cause an increase in the spring rate of
the material while one or more steps may cause a decrease in the
spring rate of the material. Ultimately, the net change in the
spring rate can be measured as a comparison between an original
spring rate before the modification process begins and a subsequent
spring rate after the modification process has been completed. In
various instances, a material may comprise an altered spring rate
after the material has been heated and then cooled.
[0280] In certain circumstances, it may be desirable to apply one
or more of the above described modification processes to a tissue
thickness compensator. For example, a first modification process
can be utilized to modify porosity of the tissue thickness
compensator, as described above with respect to the tissue
thickness compensator 1170. A second modification process,
following the first modification process, can be utilized to alter
a surface of the tissue thickness compensator, as described above
with respect to the tissue thickness compensator 1140. Furthermore,
a third modification process can be utilized to modify the tissue
thickness compensator to include a longitudinal slot similar to the
longitudinal slot 1122 of the tissue thickness compensator 1120. In
yet a fourth modification process, the tissue thickness compensator
can be modified to include apertures similar to the apertures 1152
of the tissue thickness compensator 1150. The reader will
appreciate that some of above mentioned modifications can be
combined or grouped in a single modification process. For example,
a mold can be designed to include the needles 1156 of the mold 1154
and the central beam 1128 of the mold 1126. Other modification
arrangements are contemplated by the present disclosure.
[0281] Referring now to FIGS. 38 and 39, a tissue thickness
compensator such as, for example, tissue thickness compensator 1190
can be altered or modified using one or more of the modification
processes described above to include portions with different spring
rates, porosities, and/or densities. In certain circumstances, the
tissue thickness compensator 1190 can be modified using one or more
of the modification processes described above to include a gradient
pore morphology (i.e. small pores gradually increasing in size to
large pores across the thickness of the tissue thickness
compensator 1190 in one direction). Such morphology could be more
optimal for tissue in-growth or hemostatic behavior. Further, the
gradient could also be compositional with a varying bio-absorption
profile. A short term absorption profile may be preferred to
address hemostasis while a long term absorption profile may address
better tissue healing without leakages.
[0282] Referring again to FIGS. 38 and 39, the tissue thickness
compensator 1190 may include one or more zone geometries that are
different from the remainder of the tissue thickness compensator
1196. For example, as illustrated in FIG. 38, the tissue thickness
compensator 1190 may include one or more protruding portions such
as, for example, protruding portion 1196. In addition, the tissue
thickness compensator 1190 may comprise a uniform, or at least a
substantially uniform, first spring rate, first porosity, and/or
first density through the tissue thickness compensator 1190
including the one or more zone geometries, as illustrated in FIG.
38. In certain circumstances, the tissue thickness compensator 1190
can be altered or modified using one or more of the modification
processes described above to alter or modify the one or more zone
geometries and/or to induce localized changes in the first spring
rate, the first porosity, and/or the first density, for example.
The modified tissue thickness compensator 1190 may comprise one or
more modified zones with different spring rates, porosities, and/or
densities from other modified zones and/or the first spring rate,
the first porosity, and/or the first density, respectively, of the
remainder of the tissue thickness compensator 1190. In certain
circumstances, the resulting one or more modified zones may
correspond to the one or more zone geometries. For example, as
illustrated in FIG. 39, the tissue thickness compensator 1190 may
be altered or modified to level, or at least substantially level,
the protruding portion 1196 and to form a flat, or at least a
substantially flat, surface 1198, for example. The modified tissue
thickness compensator 1190 may include a first portion 1192
comprising the first spring rate, the first porosity, and/or the
first density and a second portion 1194 comprising a second spring
rate, a second porosity, and/or a second density, which can be
different from the first spring rate, the first porosity, and/or
the first density, respectively. The second portion 1194 may
correspond to the protruding portion 1196 and can result from the
leveling, or at least substantially leveling, of the protruding
portion 1196 to form the flat, or at least substantially flat,
surface 1198, for example. In certain respects, the geometry of the
protruding portion 1196 prior to the modification of the tissue
thickness compensator 1190 mirrors, matches, or resembles the
geometry of the second portion 1194 after the tissue thickness
compensator 1190 has been modified.
[0283] Referring again to FIGS. 37-39, the tissue thickness
compensator 1190 can be altered or modified using the mold 1172, in
a similar manner to the tissue thickness compensator 1170. For
example, the tissue thickness compensator 1190 can be heated in the
receiver 1174 to a temperature greater than or equal to a glass
transition temperature of the material composition of the tissue
thickness compensator 1190 but less than the melting temperature of
the same. In certain circumstances, the adjustment member 1176 can
be advanced against the protruding portion 1196, while the tissue
thickness compensator 1190 is in the glassy state, thereby
compressing the protruding portion 1196 and rearranging its
geometry to form the second portion 1194, as illustrated in FIG.
39. Further to the above, the adjustment member 1176 can be
configured to maintain compression against the protruding portion
1196 for a time period sufficient to permit the tissue thickness
compensator 1190 to retain, or at least substantially retain, the
modification imposed by the adjustment member 1176. The tissue
thickness compensator 1190 can be allowed to cool or can be
actively cooled to a temperature below its glass transition
temperature while under compression from the adjustment member
1176. After transitioning the tissue thickness compensator 1190 out
of the glassy state, the adjustment member 1190 can be retracted.
The tissue thickness compensator 1190 may retain, or at least
substantially retain, the second portion 1194, as illustrated in
FIG. 39. In certain circumstances, the adjustment member 1176 may
apply pressure onto the protruding portion 1196 while the tissue
thickness compensator 1190 is heated to reach the glassy state,
while the tissue thickness compensator 1190 is in the glassy state,
and/or while the tissue thickness compensator 1190 is transitioned
or cooled to a temperature below the glassy state. In certain
circumstances, the pressure applied to the protruding portion 1196
of the tissue thickness compensator 1190 can be gradually increased
toward a threshold as the temperature of the tissue thickness
compensator 1190 is gradually increased to transition the tissue
thickness compensator 1190 toward the glassy state, for example. In
certain circumstances, the pressure applied to the protruding
portion 1196 of the tissue thickness compensator 1190 can be
removed, gradually removed, or at least partially reduced as the
tissue thickness compensator 1190 exits the glassy state, before
the tissue thickness compensator 1190 exits the glassy state,
and/or after the tissue thickness compensator 1190 exits the glassy
state.
[0284] Referring now to FIGS. 41-43, a tissue thickness compensator
such as, for example, tissue thickness compensator 1200 can be
prepared using traditional lyophilization techniques and/or any
other suitable techniques. In addition, the tissue thickness
compensator 1200 can be modified or altered for use in a surgical
procedure, for example. The tissue thickness compensator 1200 can
be similar in many respects to other tissue thickness compensators
such as, for example, the tissue thickness compensator 22020 (FIG.
9) and/or the tissue thickness compensator 1120 (FIG. 26). For
example, like the tissue thickness compensator 22020, the tissue
thickness compensator 1200 can be utilized with the end effector
22090. Furthermore, as illustrated in FIGS. 41-43, the tissue
thickness compensator 1200 can be modified to include a
longitudinal slot 1202 which, like the knife slot 22025, may define
a tissue thickness compensator knife path for the cutting portion
10053 between a first stapling portion 1204a and a second stapling
portion 1204b. Furthermore, the first stapling portion 1204a and
the second stapling portion 1204b can be similar in many respects
to the first stapling portion 22021a (FIG. 9) and the second
stapling portion 22021b (FIG. 9) of the tissue thickness
compensator 22020. In addition, the slot 1202 can be configured to
releasably connect the first stapling portion 1204a and the second
stapling portion 1204b such that, in use with the end effector
22090, the cutting portion 10053 can be advanced distally through
the slot 1202 to transect the slot 1202 and separate the first
stapling portion 1204a and the second stapling portion 1204b.
[0285] Referring again to FIGS. 41-43, the tissue thickness
compensator 1200 can be modified prior to assembly with an end
effector such as, for example, the end effector 22090 (FIG. 9).
Alternatively, the tissue thickness compensator 1200 can be
modified after it has been assembled with an end effector. As
described above, the tissue thickness compensator 1200 can be
prepared using traditional lyophilization techniques and/or any
other suitable techniques. A space creator 1206 can be utilized to
modify the tissue thickness compensator 1200 in a thermal pressing
process, as illustrated in FIGS. 41-43. For example, the space
creator 1206 can be heated to a temperature greater than or equal
to a melting temperature of the material composition of the tissue
thickness compensator 1200. The space creator 1206 can then be
aligned with and inserted into the tissue thickness compensator
1200 to form the longitudinal slot 1202. The space creator 1206 may
melt through the tissue thickness compensator 1200 to create space
for the longitudinal slot 1202. The space creator 1206 can be
retracted upon reaching a desired depth within the tissue thickness
compensator 1200. In certain circumstances, the thermal pressing
process can be repeated by reinserting the heated space creator
1206 through the tissue thickness compensator 1200 to widen the
space created for the longitudinal slot 1202.
[0286] Referring again to FIGS. 41-43, the space creator 1206 may
comprise a hot wire. For example, the space creator 1206 may
comprise a thin, taut metal wire, which can be made of nichrome or
stainless steel, for example, or a thicker wire preformed into a
desired shape. The hot wire can be heated via electrical resistance
to a desired temperature. As the hot wire of the space creator 1206
is passed through the material of the tissue thickness compensator
1200, the heat from the hot wire may vaporize the material just in
advance of contact. In certain circumstances, the hot wire may
comprise a cylindrical, or substantially cylindrical, shape, as
illustrated in FIG. 42. The depth of the longitudinal slot 1202 can
depend, in part, on the insertion depth of the space creator 1206
through the tissue thickness compensator 1200 and the width of the
longitudinal slot 1202 can depend, in part, on the diameter of the
hot wire of the space creator 1206.
[0287] In certain instances, the space creator 1206 can be
partially inserted through the full thickness of the tissue
thickness compensator. In certain instances, the space creator 1206
can be completely inserted through the full thickness of the tissue
thickness compensator 1200 to create openings, holes, and/or slots
extending through the full thickness of the tissue thickness
compensator 1200. In certain instances, the space creator 1206 may
be inserted through a first side of the tissue thickness
compensator 1200 and exited through a second side of the tissue
thickness compensator 1200 which may be opposite the first side,
for example.
[0288] Many processes are disclosed herein which utilize thermal
energy to modify a tissue thickness compensator. Such processes can
be referred to as felting processes. In certain instances, a
felting process may also utilize the application of compressive
and/or tensile forces to a tissue thickness compensator. In other
instances, a felting process may not utilize the application of
compressive and/or tensile forces to a tissue thickness
compensator. In either event, the felting processes disclosed
herein can also be utilized to modify and suitable implantable
layer and/or buttress material, for example.
[0289] In various circumstances, the tissue thickness compensator
assembly may comprise a polymeric composition. The polymeric
composition may comprise one or more synthetic polymer and/or one
or more non-synthetic polymer. The synthetic polymer may comprise a
synthetic absorbable polymer and/or a synthetic non-absorbable
polymer. In various circumstances, the polymeric composition may
comprise a biocompatible foam, for example. The biocompatible foam
may comprise a porous, open cell foam and/or a porous, closed cell
foam, for example. The biocompatible foam can have a uniform pore
morphology or may have a gradient pore morphology (i.e. small pores
gradually increasing in size to large pores across the thickness of
the foam in one direction). In various circumstances, the polymeric
composition may comprise one or more of a porous scaffold, a porous
matrix, a gel matrix, a hydrogel matrix, a solution matrix, a
filamentous matrix, a tubular matrix, a composite matrix, a
membranous matrix, a biostable polymer, and a biodegradable
polymer, and combinations thereof. For example, the tissue
thickness compensator assembly may comprise a foam reinforced by a
filamentous matrix or may comprise a foam having an additional
hydrogel layer that expands in the presence of bodily fluids to
further provide the compression on the tissue. In various
circumstances, a tissue thickness compensator assembly could also
be comprised of a coating on a material and/or a second or third
layer that expands in the presence of bodily fluids to further
provide the compression on the tissue. Such a layer could be a
hydrogel that could be a synthetic and/or naturally derived
material and could be either biodurable and/or biodegradable, for
example. In certain circumstances, a tissue thickness compensator
assembly could be reinforced with fibrous non-woven materials or
fibrous mesh type elements, for example, that can provide
additional flexibility, stiffness, and/or strength. In various
circumstances, a tissue thickness compensator assembly that has a
porous morphology which exhibits a gradient structure such as, for
example, small pores on one surface and larger pores on the other
surface. Such morphology could be more optimal for tissue in-growth
or hemostatic behavior. Further, the gradient could be also
compositional with a varying bio-absorption profile. A short term
absorption profile may be preferred to address hemostasis while a
long term absorption profile may address better tissue healing
without leakages.
[0290] Examples of non-synthetic polymers include, but are not
limited to, lyophilized polysaccharide, glycoprotein, elastin,
proteoglycan, gelatin, collagen, and oxidized regenerated cellulose
(ORC). Examples of synthetic absorbable polymers include, but are
not limited to, poly(lactic acid) (PLA), poly(L-lactic acid)
(PLLA), polycaprolactone (PCL), polyglycolic acid (PGA),
poly(trimethylene carbonate) (TMC), polyethylene terephthalate
(PET), polyhydroxyalkanoate (PHA), a copolymer of glycolide and
8-caprolactone (PGCL), a copolymer of glycolide and-trimethylene
carbonate, poly(glycerol sebacate) (PGS), polydioxanone,
poly(orthoesters), polyanhydrides, polysaccharides,
poly(ester-amides), tyrosine-based polyarylates, tyrosine-based
polyiminocarbonates, tyrosine-based polycarbonates,
poly(D,L-lactide-urethane), poly(B-hydroxybutyrate),
poly(E-caprolactone), polyethyleneglycol (PEG),
poly[bis(carboxylatophenoxy) phosphazene], poly(amino acids),
pseudo-poly(amino acids), absorbable polyurethanes, and
combinations thereof. In various circumstances, the polymeric
composition may comprise from approximately 50% to approximately
90% by weight of the polymeric composition of PLLA and
approximately 50% to approximately 10% by weight of the polymeric
composition of PCL, for example. In at least one embodiment, the
polymeric composition may comprise approximately 70% by weight of
PLLA and approximately 30% by weight of PCL, for example. In
various circumstances, the polymeric composition may comprise from
approximately 55% to approximately 85% by weight of the polymeric
composition of PGA and 15% to 45% by weight of the polymeric
composition of PCL, for example. In at least one embodiment, the
polymeric composition may comprise approximately 65% by weight of
PGA and approximately 35% by weight of PCL, for example. In various
circumstances, the polymeric composition may comprise from
approximately 90% to approximately 95% by weight of the polymeric
composition of PGA and approximately 5% to approximately 10% by
weight of the polymeric composition of PLA, for example.
[0291] In various circumstances, the synthetic absorbable polymer
may comprise a bioabsorbable, biocompatible elastomeric copolymer.
Suitable bioabsorbable, biocompatible elastomeric copolymers
include but are not limited to copolymers of epsilon-caprolactone
and glycolide (preferably having a mole ratio of
epsilon-caprolactone to glycolide of from about 30:70 to about
70:30, preferably 35:65 to about 65:35, and more preferably 45:55
to 35:65); elastomeric copolymers of epsilon-caprolactone and
lactide, including L-lactide, D-lactide blends thereof or lactic
acid copolymers (preferably having a mole ratio of
epsilon-caprolactone to lactide of from about 35:65 to about 65:35
and more preferably 45:55 to 30:70) elastomeric copolymers of
p-dioxanone (1,4-dioxan-2-one) and lactide including L-lactide,
D-lactide and lactic acid (preferably having a mole ratio of
p-dioxanone to lactide of from about 40:60 to about 60:40);
elastomeric copolymers of epsilon-caprolactone and p-dioxanone
(preferably having a mole ratio of epsilon-caprolactone to
p-dioxanone of from about 30:70 to about 70:30); elastomeric
copolymers of p-dioxanone and trimethylene carbonate (preferably
having a mole ratio of p-dioxanone to trimethylene carbonate of
from about 30:70 to about 70:30); elastomeric copolymers of
trimethylene carbonate and glycolide (preferably having a mole
ratio of trimethylene carbonate to glycolide of from about 30:70 to
about 70:30); elastomeric copolymer of trimethylene carbonate and
lactide including L-lactide, D-lactide, blends thereof or lactic
acid copolymers (preferably having a mole ratio of trimethylene
carbonate to lactide of from about 30:70 to about 70:30) and blends
thereof. In one embodiment, the elastomeric copolymer is a
copolymer of glycolide and epsilon-caprolactone. In another
embodiment, the elastomeric copolymer is a copolymer of lactide and
epsilon-caprolactone.
[0292] The disclosures of U.S. Pat. No. 5,468,253, entitled
ELASTOMERIC MEDICAL DEVICE, which issued on Nov. 21, 1995, and U.S.
Pat. No. 6,325,810, entitled FOAM BUTTRESS FOR STAPLING APPARATUS,
which issued on Dec. 4, 2001, are hereby incorporated by reference
in their respective entireties.
[0293] In various circumstances, the synthetic absorbable polymer
may comprise one or more of 90/10 poly(glycolide-L-lactide)
copolymer, commercially available from Ethicon, Inc. under the
trade designation VICRYL (polyglactic 910), polyglycolide,
commercially available from American Cyanamid Co. under the trade
designation DEXON, polydioxanone, commercially available from
Ethicon, Inc. under the trade designation PDS,
poly(glycolide-trimethylene carbonate) random block copolymer,
commercially available from American Cyanamid Co. under the trade
designation MAXON, 75/25
poly(glycolide-E-caprolactone-poliglecaprolactone 25) copolymer,
commercially available from Ethicon under the trade designation
MONOCRYL, for example.
[0294] Examples of synthetic non-absorbable polymers include, but
are not limited to, foamed polyurethane, polypropylene (PP),
polyethylene (PE), polycarbonate, polyamides, such as nylon,
polyvinylchloride (PVC), polymethylmetacrylate (PMMA), polystyrene
(PS), polyester, polyetheretherketone (PEEK),
polytetrafluoroethylene (PTFE), polytrifluorochloroethylene
(PTFCE), polyvinylfluoride (PVF), fluorinated ethylene propylene
(FEP), polyacetal, polysulfone, and combinations thereof. The
synthetic non-absorbable polymers may include, but are not limited
to, foamed elastomers and porous elastomers, such as, for example,
silicone, polyisoprene, and rubber. In various circumstances, the
synthetic polymers may comprise expanded polytetrafluoroethylene
(ePTFE), commercially available from W. L. Gore & Associates,
Inc. under the trade designation GORE-TEX Soft Tissue Patch and
co-polyetherester urethane foam commercially available from
Polyganics under the trade designation NASOPORE.
[0295] The polymeric composition of a tissue thickness compensator
assembly may be characterized by percent porosity, pore size,
and/or hardness, for example. In various circumstances, the
polymeric composition may have a percent porosity from
approximately 30% by volume to approximately 99% by volume, for
example. In certain circumstances, the polymeric composition may
have a percent porosity from approximately 60% by volume to
approximately 98% by volume, for example. In various circumstances,
the polymeric composition may have a percent porosity from
approximately 85% by volume to approximately 97% by volume, for
example. In at least one embodiment, the polymeric composition may
comprise approximately 70% by weight of PLLA and approximately 30%
by weight of PCL, for example, and can comprise approximately 90%
porosity by volume, for example. In at least one such embodiment,
as a result, the polymeric composition would comprise approximately
10% copolymer by volume. In at least one embodiment, the polymeric
composition may comprise approximately 65% by weight of PGA and
approximately 35% by weight of PCL, for example, and can have a
percent porosity from approximately 93% by volume to approximately
95% by volume, for example. In various circumstances, the polymeric
composition may comprise a greater than 85% porosity by volume. The
polymeric composition may have a pore size from approximately 5
micrometers to approximately 2000 micrometers, for example. In
various circumstances, the polymeric composition may have a pore
size between approximately 10 micrometers to approximately 100
micrometers, for example. In at least one such embodiment, the
polymeric composition can comprise a copolymer of PGA and PCL, for
example. In certain circumstances, the polymeric composition may
have a pore size between approximately 100 micrometers to
approximately 1000 micrometers, for example. In at least one such
embodiment, the polymeric composition can comprise a copolymer of
PLLA and PCL, for example. According to certain aspects, the
hardness of a polymeric composition may be expressed in terms of
the Shore Hardness, which can defined as the resistance to
permanent indentation of a material as determined with a durometer,
such as a Shore Durometer. In order to assess the durometer value
for a given material, a pressure is applied to the material with a
durometer indenter foot in accordance with ASTM procedure D2240-00,
entitled, "Standard Test Method for Rubber Property-Durometer
Hardness", the entirety of which is incorporated herein by
reference. The durometer indenter foot may be applied to the
material for a sufficient period of time, such as 15 seconds, for
example, wherein a reading is then taken from the appropriate
scale. Depending on the type of scale being used, a reading of 0
can be obtained when the indenter foot completely penetrates the
material, and a reading of 100 can be obtained when no penetration
into the material occurs. This reading is dimensionless. In various
circumstances, the durometer may be determined in accordance with
any suitable scale, such as Type A and/or Type OO scales, for
example, in accordance with ASTM D2240-00. In various
circumstances, the polymeric composition of a tissue thickness
compensator assembly may have a Shore A hardness value from
approximately 4 A to approximately 16 A, for example, which is
approximately 45 OO to approximately 65 OO on the Shore OO range.
In at least one such embodiment, the polymeric composition can
comprise a PLLA/PCL copolymer or a PGA/PCL copolymer, for example.
In various circumstances, the polymeric composition of a tissue
thickness compensator assembly may have a Shore A Hardness value of
less than 15 A. In various circumstances, the polymeric composition
of a tissue thickness compensator assembly may have a Shore A
Hardness value of less than 10 A. In various circumstances, the
polymeric composition of a tissue thickness compensator assembly
may have a Shore A Hardness value of less than 5 A. In certain
circumstances, the polymeric material may have a Shore OO
composition value from approximately 35 OO to approximately 75 OO,
for example.
[0296] In various circumstances, the polymeric composition may have
at least two of the above-identified properties. In various
circumstances, the polymeric composition may have at least three of
the above-identified properties. The polymeric composition may have
a porosity from 85% to 97% by volume, a pore size from 5
micrometers to 2000 micrometers, and a Shore A hardness value from
4 A to 16 A and Shore OO hardness value from 45 OO to 65 OO, for
example. In at least one embodiment, the polymeric composition may
comprise 70% by weight of the polymeric composition of PLLA and 30%
by weight of the polymeric composition of PCL having a porosity of
90% by volume, a pore size from 100 micrometers to 1000
micrometers, and a Shore A hardness value from 4 A to 16 A and
Shore OO hardness value from 45 OO to 65 OO, for example. In at
least one embodiment, the polymeric composition may comprise 65% by
weight of the polymeric composition of PGA and 35% by weight of the
polymeric composition of PCL having a porosity from 93% to 95% by
volume, a pore size from 10 micrometers to 100 micrometers, and a
Shore A hardness value from 4 A to 16 A and Shore OO hardness value
from 45 OO to 65 OO, for example.
[0297] In various circumstances, the polymeric composition may
comprise a pharmaceutically active agent. The polymeric composition
may release a therapeutically effective amount of the
pharmaceutically active agent. In various circumstances, the
pharmaceutically active agent may be released as the polymeric
composition is desorbed/absorbed. In various circumstances, the
pharmaceutically active agent may be released into fluid, such as,
for example, blood, passing over or through the polymeric
composition. Examples of pharmaceutically active agents may
include, but are not limited to, hemostatic agents and drugs, such
as, for example, fibrin, thrombin, and oxidized regenerated
cellulose (ORC); anti-inflammatory drugs, such as, for example,
diclofenac, aspirin, naproxen, sulindac, and hydrocortisone;
antibiotic and antimicrobial drug or agents, such as, for example,
triclosan, ionic silver, ampicillin, gentamicin, polymyxin B,
chloramphenicol; and anticancer agents, such as, for example,
cisplatin, mitomycin, adriamycin.
[0298] Various methods are disclosed herein for altering a tissue
thickness compensator. Such methods could be used to alter any
suitable layer for use with a fastener cartridge and/or a surgical
fastening instrument, for example. Such a layer can comprise a less
than one hundred percent dense composition which can be created
utilizing any suitable process. For instance, such processes can
include, for example, extruding, injection molding, weaving,
lyophilization, gas-foaming, and/or melt-blowing processes. Some
processes may produce a foam while other processes may not produce
a foam; however, in any event, all such embodiments are
contemplated for use with all of the embodiments disclosed
herein.
[0299] In various embodiments, referring to FIGS. 44-46, an end
effector of a surgical fastening instrument, such as end effector
100, for example, can be configured to capture, fasten, and/or
incise tissue. The end effector 100 can include a fastener
cartridge 110 and, in addition, a firing member 140 which can be
advanced through the fastener cartridge 110 to deploy staples
removably stored within the staple cartridge 110 into tissue
captured within the end effector 100. In various instances, the
firing member 140 can be advanced from a proximal position (FIG.
44) toward a distal end of the end effector 100 to simultaneously
deploy the staples and transect the tissue. There are some
circumstances, however, where it may not be desirable to advance
the firing member 140 toward the distal end of the end effector
100. For instance, the fastener cartridge 110 of the end effector
100 can be removable and/or replaceable and, in the event that a
fastener cartridge 110 is not positioned within the end effector
100, it may not be desirable for the firing member 140 to be
advanced within the end effector 100. In the event that the firing
member 140 were to be advanced through the end effector 100 without
a fastener cartridge positioned within the end effector 100, a
knife edge 142 of the firing member 140 may incise tissue captured
within the end effector 100 without simultaneously fastening the
tissue. Similarly, in the event that the fastener cartridge
positioned within the end effector 100 has been previously used, or
expended, and at least some of the fasteners have been deployed
from the fastener cartridge, it may not be desirable for the firing
member 140 to be advanced within the end effector 100. In the event
that the firing member 140 were to be advanced through the end
effector 100 with a previously expended fastener cartridge
positioned within the end effector 100, the knife edge 142 of the
firing member 140 may incise tissue captured within the end
effector without simultaneously fastening the tissue. In various
embodiments, the end effector 100 can include one or more lockout
systems which can prevent the firing member 140 from being advanced
distally when a fastener cartridge is not present within the end
effector 100 and/or when the fastener cartridge positioned within
the end effector 100 has been at least partially expended. Various
lockout systems are disclosed in U.S. Pat. No. 6,988,649, entitled
SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT, and
issued on Jan. 24, 2006. The entire disclosure of U.S. Pat. No.
6,988,649, entitled SURGICAL STAPLING INSTRUMENT HAVING A SPENT
CARTRIDGE LOCKOUT, is incorporated by reference herein.
[0300] Referring again to FIGS. 44-46, the fastener cartridge 110
can include a cartridge body and a tissue thickness compensator 120
wherein, further to the above, the tissue thickness compensator 120
can be implanted against tissue captured by the end effector 100 by
fasteners removably stored within the cartridge body. The tissue
thickness compensator 120 can be positioned above a top surface, or
deck, of the cartridge body wherein staples 180 removably stored
within staple cavities defined in the cartridge body can be ejected
from the staple cavities by a firing member, such as sled 130
and/or firing member 140, for example. In certain embodiments, the
fastener cartridge 110 can further include drivers configured to
support the staples 180 and transmit the movement of the sled 130
to the staples 180 in order to move the staples 180 between an
unfired position and a fired position. In various instances, the
staples 180 can be at least partially embedded in the tissue
thickness compensator 120 when the staples 180 are in their unfired
positions and, in certain instances, the staples 180 can hold the
tissue thickness compensator 120 in position over the cartridge
deck when the staples 180 are in their unfired position. In the
event that the tissue thickness compensator 120 were to be moved
relative to the cartridge body and/or the staples 180 prior to
deploying the staples 180 into tissue, in some instances, the
tissue thickness compensator 120 may move the staples 180 relative
to or away from their preferred positions. Moreover, in the event
that the tissue thickness compensator 120 were to be removed from
the cartridge 110 prior to the staples 180 being deployed, the
cartridge 110 may no longer be suitable for its originally intended
use. In view of the foregoing, as discussed in greater detail
below, the end effector 100 may include a lockout configured to
prevent the firing member 140 and/or the sled 130 from being
advanced distally to deploy the staples 180 in the event that the
tissue thickness compensator 120 is removed from, or becomes at
least partially dislodged from, the cartridge body prior to the
staples 180 being deployed.
[0301] Referring again to FIGS. 44-46, the tissue thickness
compensator 120 can comprise, one, a body 121 configured to be
captured by the staples 180 and, two, a lockout pin 122 extending
from the body 121. In various instances, the lockout pin 122 can
include a first end 123 embedded in the body 121 and a second end
124 positioned intermediate the firing member 140 and the sled 130
when the tissue thickness compensator 120 has not been removed from
or substantially moved from a suitable position over the cartridge
body deck. In such a position, the second end 124 of the lockout
pin 122 can be positioned intermediate a shoulder, or shelf, 134
defined on the sled 130 and a protrusion 144 extending distally
from the firing bar 140. Stated another way, when the lockout pin
122 is positioned intermediate the sled 130 and the firing bar 140,
the lockout pin 122 and the sled 130 can co-operate to support the
firing bar 140 in an unlocked position above a lockout shoulder 112
defined in the fastener cartridge 110 such that, when a distal
firing force is applied to the firing bar 140, the firing bar 140
can advance the sled 130 distally to fire the staples 180. When the
tissue thickness compensator 120 is removed from the cartridge 110
and/or sufficiently dislodged from a desirable position relative to
the cartridge body, referring primarily to FIG. 45, the lockout pin
122 may no longer be positioned intermediate the sled 130 and the
firing member 140 and/or may otherwise be unable to support the
firing member 140 in its unlocked position (FIG. 44). In such
circumstances, the firing member 140 may become positioned in a
locked position such that the distal advancement of the firing
member 140 is prevented by the lockout shoulder 112. In at least
one such circumstance, the end effector 100 can further include a
biasing member, such as a spring, for example, configured to bias
the firing member 140 into its locked condition. In certain
circumstances, the biasing member can bias the firing member 140
into contact with the sled 130, for instance, without the lockout
pin 122 positioned therebetween which can comprise the locked
position of the firing member 140.
[0302] As a result of the above, the cartridge 110 may become
inoperable if the tissue thickness compensator 120 is prematurely
removed from the cartridge 110. In such circumstances, the lockout
pin 122 may comprise a fuse which deactivates the cartridge 110 in
the event that the tissue thickness compensator 120 is removed
before the firing member 140 is advanced distally. In various
circumstances, the lockout pin 122 may comprise a key which
maintains the cartridge 110 in an unlocked condition when the key
is positioned between the sled 130 and the firing member 140 and
permits the cartridge 110 to enter into a locked condition in the
event that the tissue thickness compensator 120 is removed from the
cartridge 110 before the firing member 140 is advanced distally,
i.e., before the firing member 140 begins its firing stroke. When
the firing member 140 is in its locked-out condition and cannot be
advanced distally, the knife edge 142 of the firing member 140 is
unable to incise the tissue captured within the end effector 100.
Moreover, in such circumstances, the firing member 140 cannot
advance the sled 130 distally to fire the staples 180. Thus, the
tissue thickness compensator lockout can prevent the tissue
captured within the end effector 100 from being incised and stapled
when the tissue thickness compensator 120 is not positioned on, or
properly positioned on, the cartridge 110. In the event that the
firing member 140 is advanced distally before the tissue thickness
compensator 120 is removed, or dislodged, the firing member 140 can
complete the firing stroke, or at least a portion of the firing
stroke, of the end effector 100. In such instances, the sled 130 is
advanced distally so that one or more ramps 132 defined on the sled
130 can lift the staples 180 and that a knife edge 142 of the
firing member 140 can incise the tissue thickness compensator 120
and/or the tissue captured within the end effector 100. In some
circumstances, the firing member 140 can contact the lockout pin
122 and displace it out of the way as the firing member 140 is
advanced distally. In such circumstances, the lockout pin 122 can
be flexible. In various instances, the lockout pin 122 can be
comprised of a bioabsorbable material and/or a biocompatible
material, for example. In certain circumstances, the firing member
140 can incise the lockout pin 122 as the firing member 140 is
advanced distally. In any event, the purpose of the lockout pin 122
may become obsolete once the firing member 140 has been at least
partially advanced. Stated another way, the tissue thickness
compensator lockout can serve as an initial check to verify that a
tissue thickness compensator is present within the end effector
and, once that initial check has been made, the firing stroke of
the end effector can proceed.
[0303] Referring again to FIGS. 47-50, an end effector 200 can
comprise an anvil 260 and, in addition, a fastener cartridge 210
including a cartridge body 214 and a tissue thickness compensator
220 wherein, further to the above, the tissue thickness compensator
220 can be implanted against tissue captured by the end effector
200 by fasteners removably stored within the cartridge body 214.
The tissue thickness compensator 220 can be positioned above a top
surface, or deck, 211 of the cartridge body 214 wherein staples
removably stored within staple cavities defined in the cartridge
body 214 can be ejected from the staple cavities by a firing
member, such as a sled 230 and/or a firing member 240, for example.
In certain embodiments, the fastener cartridge 210 can further
include drivers configured to support the staples and transmit the
movement of the sled 230 to the staples in order to move the
staples between an unfired position and a fired position. In
various instances, the staples can be at least partially embedded
in the tissue thickness compensator 220 when the staples are in
their unfired positions and, in certain instances, the staples can
hold the tissue thickness compensator 220 in position when the
staples are in their unfired position. In the event that the tissue
thickness compensator 220 were to be moved relative to the
cartridge body 214 and/or the staples prior to deploying the
staples into the tissue, in some instances, the tissue thickness
compensator 220 may move the staples relative to or away from their
preferred positions. Moreover, in the event that the tissue
thickness compensator 220 were to be removed from the cartridge 210
prior to the staples being deployed, the cartridge 210 may no
longer be suitable for its originally intended use. In view of the
foregoing, as discussed in greater detail below, the end effector
200 may include a lockout configured to prevent the firing member
240 and/or the sled 230 from being advanced distally to deploy the
staples in the event that the tissue thickness compensator 220 is
removed from, or becomes at least partially dislodged from, the
cartridge body 214 prior to the staples being deployed.
[0304] Referring again to FIGS. 44-46, the tissue thickness
compensator 220 can comprise, one, a body 221 configured to be
captured by the staples and, two, a loop, or tether, 222 extending
from the body 221. In various instances, referring primarily to
FIG. 47, the loop 222 can comprise ends which are at least
partially embedded in the body 221 and an intermediate portion
extending between the ends which can be releasably engaged with the
sled 230. In certain instances, the loop 222 can comprise a suture
or flexible thread, for example. In some instances, the loop 222
can be comprised of a bioabsorbable material and/or a biocompatible
material, for example. Referring primarily to FIG. 48, the sled 230
can include a longitudinal body portion 236, a hook 238 extending
from the body portion 236, and a slot 237 defined between the body
portion 236 and the hook 238. As illustrated in FIG. 48, the loop
222 is positioned within the slot 237 when the tissue thickness
compensator 220 is positioned over the cartridge deck 211 and the
sled 230 and the firing member 240 are in an unfired position. As
also illustrated in FIG. 48, a distal projection 244 extending from
the firing member 240 is positioned against and/or above a support
shoulder 234 defined on the sled 230 which holds the firing member
240 in an unlocked position, i.e., in a position in which the
distal movement of the firing member 240 will not be impeded, or at
least substantially impeded, by a lockout shoulder 212 defined in
the end effector 200 when a firing motion is applied to the firing
member 240. Thus, when the sled 230 holds the firing member 240 in
its unlocked position, referring to FIG. 49, the firing member 240
will slide past the lockout shoulder 212 to advance the sled 230
distally, fire the staples removably stored within the cartridge
body 214, and incise the tissue thickness compensator and the
tissue positioned within the end effector 200 with a knife edge
242. As illustrated in FIG. 49, the loop 222 can slide out of the
slot 237 defined in the sled 230 when the sled 230 is advanced
distally.
[0305] In the event that the tissue thickness compensator 220 is
removed from the cartridge 210 or substantially moved from a
suitable position over the deck 211 of the cartridge 210, referring
now to FIG. 50, the tissue thickness compensator 220 can pull the
sled 230 distally such that the firing member 240 is no longer
supported by the sled 230. More particularly, the loop 222 of the
tissue thickness compensator 220 positioned within the slot 237 can
pull the sled 230 distally from its unfired position such that the
support shoulder 234 is no longer positioned under the distal
projection 244 of the firing member 240. In such circumstances, the
firing member 240 may shift downwardly into a locked position
wherein the distal movement of the firing member 240 can be impeded
by the lockout shoulder 212. In certain circumstances, the end
effector 200 can further include a biasing member, such as a
spring, for example, which can bias the firing member 240 into its
locked condition. When the firing member 240 is in its locked
condition, the firing member 240 cannot be moved distally to
advance the sled 230, fire the staples from the cartridge body 210,
and/or incise the tissue captured within the end effector 200.
Although the sled 230 may be advanced distally when the tissue
thickness compensator 220 is removed from the cartridge 210, the
sled 230, in various circumstances, may not be advanced
sufficiently to deploy the staples from the cartridge 210. When the
user of the surgical instrument recognizes that the firing member
240 is in a locked-out condition, the user can remove the staple
cartridge 210 from the end effector 200 and replace it with a
staple cartridge 210, for example, in which the tissue thickness
compensator 220 is correctly positioned over the deck 211 and the
sled 230 has not been advanced distally from its unfired position.
Other embodiments are contemplated in which a staple cartridge is
not removable from the end effector; in such embodiments, the end
effector may be entirely replaced in the event that the tissue
thickness compensator is removed from the staple cartridge and/or
the firing member enters into a locked-out condition.
[0306] Turning now to FIGS. 51-53, a staple cartridge 310 can
include a cartridge body 314 and a sled 330 movably positioned
within the cartridge body 314. Similar to the above, the cartridge
body 314 can include a plurality of fastener cavities, such as
fastener cavities 316, for example, and a longitudinal slot, such
as knife slot 318, for example, defined therein. The sled 330 can
include a central body portion 336 slidably positioned within the
knife slot 318 and a hook 338 extending from the central body
portion 336. Referring primarily to FIG. 51, a tissue thickness
compensator 320 of the cartridge 310 can include a body portion 321
and a catch 322 extending from the body portion 321 wherein the
catch 322 can be releasably retained in a slot 337 defined between
the hook 338 and the central body portion 336 when the sled 330 is
in its unfired, or unadvanced, position. Similar to the above, the
catch 322 can include ends 323 mounted within the body 321 and can
extend proximally from the body 321 of the tissue thickness
compensator 320 wherein, in the event that the tissue thickness
compensator 320 is removed from the cartridge body 314, for
instance, the catch 322 can pull the sled 330 distally such that a
support shoulder 334 defined in the central body portion 336 is no
longer able to support a firing member, such as firing member 240,
for example, thereon and such that the firing member may enter a
locked out state. In various instances, a user of the surgical
instrument may attempt to reassemble or reposition the tissue
thickness compensator 320 over the deck 311 of the cartridge body
314; however, the firing member 340 will still remain in a locked
out condition as the repositioning of the tissue thickness
compensator 320 will not reset the sled 330. Thus, such an
arrangement can prevent the cartridge 310 from being used if it has
been previously tampered with.
[0307] In various instances, referring again to FIGS. 51-53, at
least a portion of the hook 338 extending from the central portion
336 of the sled 330 and/or the slot 337 defined therebetween can
extend above the deck 311. In certain instances, at least a portion
of the hook 338 extending from the central portion 336 of the sled
330 and/or the slot 337 defined therebetween can extend above the
knife slot 318. In such embodiments, the catch 322 can be easily
slid into the slot 337 when the tissue thickness compensator 320 is
assembled to the cartridge body 314. In certain instances, the
catch 322 can be positioned above or against the deck surface 311
of the cartridge body 314. In various instances, referring
primarily to FIG. 53, the cartridge body 314 can include a recess
or pocket 319 defined therein within which the hook 338 can be
positioned when the sled 330 is in its unfired, or unadvanced,
position. In such an embodiment, the top of the hook 338 may be
positioned below the deck surface 311. In various instances, the
pocket 319 can further include one or more ramped surfaces 313
which are defined in the distal end of the pocket 319 and extend
downwardly from the deck surface 311. In some instances, the catch
322 can abut the ramped surfaces 313 when the sled 330 is advanced
distally and, in such circumstances, the hook 338 can then separate
from the catch 322. In various instances, the recess 319 can be
configured to facilitate the assembly of the catch 322 to the sled
330 when the tissue thickness compensator 320 is assembled to the
cartridge body 314. In various embodiments, the slot 337 can extend
longitudinally and can include a closed distal end an open proximal
end wherein the catch 322 can be slid into the slot 337 from the
open proximal end. In the event that the tissue thickness
compensator 320 is not prematurely removed or dislodged from the
cartridge 314, the sled 330 can be advanced distally such that the
catch 322 exits the slot 337 through the distal end thereof and
such that ramps 332 defined on the sled 330 can eject the staples
from the staple cartridge 310.
[0308] In various instances, a tissue thickness compensator can be
adhered to a sled utilizing at least one adhesive. In such
instances, the adhesive attachment between the tissue thickness
compensator and the sled can be strong enough to permit the tissue
thickness compensator to pull the sled distally in the event that
the tissue thickness compensator is removed from the cartridge.
When the sled is advanced distally by the firing member as part of
the firing stroke, the adhesive attachment between the tissue
thickness compensator and the sled may fail thereby permitting the
sled to slide distally relative to the tissue thickness
compensator. In various instances, a tissue thickness compensator
can be bonded to a sled utilizing a heat steak process and/or a
thermoform process. In such instances, the bond between the tissue
thickness compensator and the sled can be strong enough to permit
the tissue thickness compensator to pull the sled distally in the
event that the tissue thickness compensator is removed from the
cartridge. When the sled is advanced distally by the firing member
as part of the firing stroke, the bond between the tissue thickness
compensator and the sled may fail thereby permitting the sled to
slide distally relative to the tissue thickness compensator.
[0309] In some instances, a loop, a catch, and/or tag, for example,
can be integrally formed with a tissue thickness compensator. In
various instances, the loop, catch, and/or tag, for example, can
comprise a unitary piece of material with the tissue thickness
compensator. In some instances, an additional layer can be attached
to the tissue thickness compensator. This layer, in various
instances, can comprise a mounting portion engaged with the
sled.
[0310] Turning now to FIG. 54, a sled 430 can include, similar to
the above, a central body portion 436 and, in addition, a plurality
of ramps 432 which are configured to eject staples removably stored
within a cartridge body, for example. Also similar to the above,
the body portion 436 can include a hook 438 extending therefrom
wherein a slot 437 can be defined between the body portion 436 and
the hook 438. In certain instances, the slot 437 can include a
closed distal end 437a and an open proximal end 437d. In various
instances, the slot 437 can further include a first portion 437b
extending in a first direction and a second portion 437c extending
in a second direction. In certain instances, the first portion 437b
can extend along a longitudinal axis and the second portion 437c
can extend along a second axis which is transverse to the
longitudinal axis. In at least one such instance, the second
portion 437c can extend at an angle relative to the first portion
437b.
[0311] Turning now to FIGS. 55-58, a sled assembly 530 can include
a first portion 535 and, in addition, a second portion 536 which is
movable relative to the first portion 535 between an unlocked
position (FIGS. 55 and 57) and a locked position (FIGS. 56 and 58).
The first portion 535 can include, one, a central portion
configured to slide within a longitudinal slot, such as a knife
slot 518 defined in a staple cartridge 510, for instance, and, two,
a plurality of ramps 532 configured to eject staples removably
stored within the cartridge 510. The central portion of the first
portion 535 can include a first slot 533a and a second slot 533b
defined therein. The first slot 533a and the second slot 533b can
be configured to receive pins 531a and 531b, respectively,
extending from the second portion 536. The first pin 531a can be
configured to slide within the first slot 533a and the second pin
531b can be configured to slide within the second slot 533b in
order to permit the second portion 536 to rotate relative to the
first portion 535. In various instances, the first pin 531a can be
closely received within the first slot 533a such that the first
slot 533a can constrain the motion of the first pin 531a along a
first path and, similarly, the second pin 531b can be closely
received within the second slot 533b such that the second slot 533b
can constrain the motion of the second pin 531b along a second
path. Referring primarily to FIG. 57, the second portion 536 of the
sled assembly 530 can comprise an arm configured to slide within
the knife slot 518 wherein the arm can include a support shoulder
534 defined on the proximal end thereof and a hook 538 defined on
the distal end thereof. Similar to the above, the support shoulder
534 can be configured to support a firing member 240, for example,
in an unlocked position when the sled assembly 530 is in a
proximal, unfired position and the tissue thickness compensator
220, for instance, is positioned over and/or against the deck
surface 511 of the cartridge 510. Also similar to the above, the
hook 538 can be configured to releasably hold the loop 222 of the
tissue thickness compensator 220 such that, in the event that the
tissue thickness compensator 220 were to be removed from and/or
substantially displaced relative to the cartridge body, the loop
222 could pull on the second portion 536 to pivot the second
portion 536 into its locked position as illustrated in FIG. 58. In
such a locked position of the second portion 536, the support
shoulder 534 may no longer support the distal projection 244 of the
firing member 240 and the firing member 240 can drop downwardly
into its locked position. As depicted in FIG. 58, the rotation of
the second portion 536 into its locked position can move the
support shoulder 534 distally and/or downwardly away from the
firing member 240. As also depicted in FIG. 58, the firing member
240 can include a lock 541 extending from opposite sides thereof
which can be configured to abut the lockout shoulder 212 when the
firing member 240 is in its locked position. When the firing member
240 is held in its unlocked position by the sled assembly 530, the
locks 541 may not contact the lockout shoulder 212 and the firing
member 240 can be advanced through the cartridge 510.
[0312] In various instances, as discussed above, a portion of a
staple-driving sled may extend above the deck surface of a
cartridge body. For instance, referring again to FIGS. 52 and 54,
the hook 338 of the sled 330 (FIG. 52) and/or the hook 438 of the
sled 430, for example, can extend above the deck surface. In such
instances, the hook 338 and/or the hook 438 can translate distally
above the deck surface and, in some instances, contact the tissue
thickness compensator positioned against or above the deck surface.
In certain instances, the hook 338 and/or the hook 438 can lift the
tissue thickness compensator upwardly away from the cartridge body
and facilitate the progressive release of the tissue thickness
compensator from the cartridge. For instance, the hook 338 and/or
the hook 438 can begin at the proximal end of the tissue thickness
compensator and move toward the distal end of the tissue thickness
compensator in order to initially lift the proximal end of the
tissue thickness compensator and then progressively lift it away
from the cartridge deck until the distal end of the tissue
thickness compensator is eventually lifted away from the cartridge
body. In other instances, as discussed in greater detail further
below. it may be preferable for the portion of the sled contacting
the tissue thickness compensator to deflect downwardly and/or
otherwise not disturb the tissue thickness compensator as the sled
is advanced distally.
[0313] Turning now to FIGS. 59 and 60, a staple cartridge 610 can
include a cartridge body 614, a tissue thickness compensator 620
releasably retained to the cartridge body 614, and a sled 630
configured to longitudinally traverse the cartridge body 614 and
eject staples removably stored therein. The sled 630 can include a
main body portion 635 having a plurality of ramp surfaces defined
thereon, a support shoulder 634, and an arm 636 extending from the
body portion 635. In various instances, the arm 636 can be
assembled to the main body portion 635. For instance, the arm 636
can include a first end embedded in the main body portion 635 and a
second end including a hook 638, for example. In various instances,
the arm 636 can comprise a cantilever beam extending from the main
body portion 635. In certain instances, the arm 636 can be
comprised of a resilient and/or flexible material, for example.
Similar to the above, a slot 637 can be defined between the hook
638 and the arm 636 which can be configured to releasably hold a
portion of the tissue thickness compensator 620 when the sled 630
is in its proximal, unfired position. In the event that the tissue
thickness compensator 620 is pulled off of the cartridge body 614,
for example, the tissue thickness compensator 620 can pull the sled
630 distally away from a firing member so that the firing member
enters into a locked out condition.
[0314] In various instances, further to the above, at least a
portion of the arm 636, such as the hook 638, for example, can
extend above the deck surface 611 of the cartridge body 614. In
certain instances, the arm 636 can be engaged with a loop, for
example, extending from the tissue thickness compensator 620 when
the sled 630 is in its proximal position (FIG. 59) and, as the sled
630 is advanced distally, the arm 636 can disengage from the loop.
As the sled 630 is advanced distally, in certain instances, the arm
636 can contact the body portion 621 of the tissue thickness
compensator 620 and flex downwardly. In various instances, the
deflected arm 636 can slide within a longitudinal knife slot 618
defined in the cartridge body 614 as the sled 630 is advanced
distally. In some instances, referring to FIG. 60, the distal end
of the longitudinal slot 618 can be defined by a nose wall, or
roof, 619 wherein, when the sled 630 reaches a distal end 617 of
the cartridge 610, the arm 636 can slide under the nose wall 619
such that the firing stroke of the end effector can be completed.
In some instances, the arm 636 may not be deflected, or
substantially deflected, downwardly by the tissue thickness
compensator 620 wherein, when the arm 636 reaches the end of the
longitudinal slot 618, the arm 636 can contact the nose wall 618
and flex downwardly in order to slide thereunder as illustrated in
FIG. 60. In various circumstances, as a result, the flexible arm
636 can permit the firing stroke to be completed and for the sled
630 to be parked at the distal end of the cartridge.
[0315] Turning now to FIG. 61, a sled, such as sled assembly 730,
for example, can include a main body portion 735 and a movable arm
736. Similar to the above, the main body portion 735 can include
one or more staple-driving ramps 732 and a support shoulder 734
configured to support a firing member in an unlocked position, as
described above. The arm 736 can include a first end pivotably
and/or rotatably mounted to the main body portion 735 and a second
end including a hook 738 configured to be releasably engaged with a
tissue thickness compensator, as described above. When the sled
assembly 730 is advanced distally, the hook 738 can detach from the
tissue thickness compensator; however, the upper surface of the
hook 738 can remain in contact with the bottom surface of the
tissue thickness compensator. In such circumstances, the arm 736
can pivot downwardly into the knife slot 318, for example, in order
to slide under the tissue thickness compensator. More particularly,
the arm 736 can pivot from a raised, or uppermost, position (FIG.
61) to a lowered, or depressed, position. In various instances, the
sled assembly 730 can further include a resilient biasing member,
such as a spring 731, for example, configured to bias the arm 736
into its raised position. When the arm 736 has been rotated
downwardly into its lowered position, the spring 731 can apply a
biasing force to the arm 736 which is transmitted into the tissue
thickness compensator. In certain instances, the spring 731 can be
positioned intermediate the arm 736 and a frame portion 733 defined
on the main body portion 735. In various instances, the spring 731
can comprise a cantilever spring or leaf spring, for example,
extending from the arm 736. When the arm 736 is pushed downwardly,
the cantilever spring can be configured to flex and/or slide along
the frame portion 731, for instance. In various embodiments, the
main body portion 735 can further include a stop shoulder 739, for
example, which can limit the upward rotation, or travel, of the arm
736. In any event, similar to the above, the arm 736 can be
configured to rotate downwardly when it contacts the roof 619 and
permit the firing stroke to be completed.
[0316] In various instances, a staple can comprise a base and one
or more legs extending from the base. In certain instances, a
staple can comprise a base including a first end and a second end,
a first leg extending from the first end, and a second leg
extending from the second end. In some instances, the staple can be
formed from a continuous wire which comprises the first leg, the
base, and the second leg. A first end of the continuous wire can
comprise a tip of the first staple leg and a second end of the
continuous wire can comprise a tip of the second staple leg. One
such staple, i.e., staple 800, is depicted in FIG. 62, for example.
The staple 800 can include a base 802, a first staple leg 804
extending from a first end of the base 802, and a second staple leg
804 extending from a second end of the base 802. The first staple
leg 804 can include a first tip 806 and, similarly, the second
staple leg 804 can include a second tip 806. In various instances,
the tips 806 can be configured to penetrate tissue, such as tissue
T depicted in FIG. 62, for example. In some instances, the tips 806
can be sharp and can be formed by a coining process, for example.
In various embodiments, the wire can be comprised of titanium
and/or stainless steel, for example.
[0317] In various embodiments, the staple 800 can be U-shaped, or
at least substantially U-shaped, for example, when it is in its
unformed configuration. In such embodiments, the legs 804 of the
staple 800 can be parallel, or at least substantially parallel, to
one another. Moreover, in such embodiments, the legs 804 can be
perpendicular, or at least substantially perpendicular, to the base
802. In certain embodiments, the staple 800 can be V-shaped, or at
least substantially V-shaped, for example, when it is in its
unformed configuration. In such embodiments, the legs 804 of the
staple 800 are not parallel to one another; rather, the legs 804
can extend in non-parallel directions. Moreover, in such
embodiments, one or both of the legs 804 are not perpendicular to
the base 802 wherein one or both of the legs 804 can extend in
directions which are oblique to the base 802. In various instances,
the legs 804 may extend, or splay, outwardly with respect to a
center or midline of the staple. In any event, the staple 800 can
be removably stored within a staple cartridge, ejected from the
staple cartridge to penetrate tissue, as illustrated in FIG. 62,
and then contact an anvil positioned on the opposite side of the
tissue. The anvil can be configured to deform the staple 800 into
any suitable shape, such as a B-form configuration, for example, as
also illustrated in FIG. 62. Various formed staple configurations,
such as the B-form configuration, for example, can define a tissue
entrapment area, such as tissue entrapment area 807, for example,
configured to entrap tissue within the staple.
[0318] As discussed above, a staple can be removably stored within
a cavity defined in a cartridge body. A cartridge body 810 is
depicted in FIG. 63 which can include one or more staple cavities
812 defined therein. Referring to FIGS. 63, 68, and 69, each staple
cavity 812 can include a first end 814 and a second end 814. In
certain embodiments, such as embodiments including a longitudinal
end effector, for example, the first end 814 can comprise a
proximal end of the staple cavity 812 and the second end 814 can
comprise a distal end of the staple cavity 812. In various
instances, a staple can be positioned within a staple cavity 812
such that a first leg 804 of the staple 800 is positioned in the
first end 814 of the staple cavity 812 and a second leg 804 is
positioned in the second end 814. In various instances, a staple
cavity width can be defined between the ends 814 of a staple cavity
812. The base 802 of a staple can be defined by a base width which
can be equal to or shorter than the staple cavity width, for
example. In certain instances, a staple can comprise a staple width
which can be defined between the tips 806 of the staple legs 804.
In some embodiments, the staple width can be equal to the staple
cavity width. In various embodiments, the staple width can be wider
than the staple cavity width. In such embodiments, the legs 804 can
be in contact with the ends 814 of a staple cavity 812 and can be
resiliently biased inwardly by the ends 814 when the staple is
positioned within the staple cavity 812. When the staple is lifted
upwardly out of the staple cavity 812, the legs 804 can resiliently
splay outwardly as they emerge from the staple cavity 812. For
example, the staple can be positioned within the staple cavity 812
such that the tips 806 of the staple legs 804 do not extend above a
top surface, or deck, of the cartridge body 810 when the staple is
in its unfired, or uplifted, position. In such a position, the tips
806 can be positioned flush with or recessed below the deck 811 of
the cartridge body 810. Alternatively, the tips 806 of the legs 804
can at least partially extend above the deck 811 of the cartridge
body 810. In any event, as the staple is lifted upwardly, the
staple tips 806 can emerge above the deck 811 and splay outwardly
as the legs 804 emerge from the cavity 812. At some point during
the lifting of the staple, the legs 804 may no longer be in contact
with the ends 814 of the staple cavity 812 and the legs 804 may no
longer be biased inwardly by the sidewalls of the staple cavity
812.
[0319] In various instances, an anvil can include one or more
pockets configured to receive the tips 806 of the staple legs 804
as the staple 800 is ejected from the staple cartridge. The anvil
pockets can be configured to turn, or bend, the staple legs 804
inwardly toward one another, for example. In other instances, the
anvil pockets can be configured to turn, or bend, the staple legs
804 outwardly away from one another, for example. In some
instances, however, one or more of the staple legs of a staple may
miss a staple pocket and may not be properly deformed. In certain
instances, one or more of the staple legs may not contact the anvil
and may not be deformed at all. In either event, the staple may not
properly capture and/or retain the tissue within its tissue
entrapment area. Moreover, the misformed or unformed staple may not
be able to apply a desired compressive pressure to the tissue. In
some instances, the misformed or unformed staple may not be
retained in the tissue and can become dislodged from the
tissue.
[0320] Referring again to FIG. 62, the staple 800, and/or various
other staples disclosed herein, can include one or more barbs
extending therefrom. In various instances, the barbs can be
configured to engage tissue captured within and/or surrounding the
staple. In certain instances, the barbs can assist in retaining the
staple within the tissue, especially when the staple has been
misformed or unformed. The staple 800 can include barbs extending
from one or both of the legs 804. For instance, each leg 804 can
include one or more barbs 808 which face outwardly from the center
of the staple 800 and/or one or more barbs 809 which face inwardly
toward the center of the staple 800, for example. In certain
instances, the barbs 808 can extend away from the tissue entrapment
area 807 and/or the barbs 809 can extend toward or into the tissue
entrapment area 807. As depicted in FIG. 62, both of the staple
legs 804 of staple 800 can include barbs 808 and barbs 809. In some
instances, the staple legs 804 can include barbs 808, but not barbs
809. A staple 820 is depicted in FIG. 63 which includes barbs 808,
but not barbs 809. In some instances, the staple legs 804 can
include barbs 809, but not barbs 808. Staples 830, 840, 850, 860,
and 870 are depicted in FIGS. 64, 65, 66, 67, and 68, respectively,
which include barbs 809, but not barbs 808. In some embodiments, a
first leg 804 of a staple can include barbs 808 while a second leg
804 of the staple can include barbs 809, for example.
[0321] In various instances, the legs 804 and the base 802 of a
staple can define a staple plane when the staple is in an unformed
configuration. The barbs 808 can extend outwardly from the legs 804
within such a staple plane. Similarly, the barbs 809 can extend
inwardly from the legs 804 within such a plane. In some instances,
a staple can include barbs which extend laterally with respect to
such a staple plane. Other embodiments are envisioned in which the
legs 804 and the base 802 do not lie within, or entirely lie
within, a single plane. In such embodiments, the barbs can extend
in any suitable direction. In various embodiments, referring now to
FIG. 67, a staple, such as staple 860, for example, can include
barbs 803 extending from the base 802. In various instances, the
barbs 803 can extend inwardly toward the tissue entrapment area 807
of the staple 860. In certain instances, the barbs 803 can extend
outwardly away from the tissue entrapment area 807. As illustrated
in FIG. 67, the barbs 803 can extend within a staple plane defined
by the legs 804 and the base 802. In certain instances, the barbs
803 can extend laterally with respect to such a staple plane.
Various exemplary barb configurations are discussed in greater
detail further below.
[0322] In various instances, a staple leg 804 can comprise an array
of barbs 808 which extends along the entire length thereof. In some
instances, a staple leg 804 can comprise an array of barbs 808
which extends along less than the entire length thereof. By way of
example, referring to FIG. 62, the legs 804 of the staple 800 each
comprise an array of barbs 808 which extends along less than the
entire length of the legs 804. Similarly, referring to FIG. 63, the
legs 804 of the staple 820 each comprise an array of barbs 808
which extends along less than the entire length of the legs 804.
With regard to the staple 800, for example, an array of barbs 808
can extend along each of the legs 804 from the base 802 of the
staple 800 toward the tips 806 of the legs 804. As illustrated in
FIG. 62, the arrays of barbs 808 may not extend to the tips 806 of
the legs 804. In various instances, the arrays of barbs 808 can
extend along half, or approximately half, the lengths of the legs
804, for example; however, any suitable length of the barb arrays
could be utilized. For instance, the arrays of barbs 808 can extend
along less than half or more than half of the lengths of the legs
804. In some embodiments, an array of barbs 808 can extend along
each of the legs 804 from the tips 806 of the legs 804 toward the
base 802. In such embodiments, the array of barbs 808 may not
extend to the base 802. In some embodiments, a leg 804 can comprise
an array of barbs 808 which does not extend to the tip 806 of the
leg 804 or the base 802. In certain embodiments, a leg 804 can
comprise more than one array of barbs 808.
[0323] In various instances, further to the above, a staple leg 804
can comprise an array of barbs 809 which extends along the entire
length thereof. By way of example, referring to FIG. 64, the legs
804 of the staple 830 each comprise an array of barbs 809 which
extends along the entire length of the legs 804. In some instances,
a staple leg 804 can comprise an array of barbs 809 which extends
along less than the entire length thereof. By way of example,
referring to FIG. 65, the legs 804 of the staple 840 each comprise
an array of barbs 809 which extends along less than the entire
length of the legs 804. Similarly, referring to FIG. 68, the legs
804 of the staple 870 each comprise an array of barbs 809 which
extends along less than the entire length of the legs 804. With
regard to the staple 840, for example, an array of barbs 809 can
extend along each of the legs 804 from the base 802 of the staple
840 toward the tips 806 of the legs 804. As illustrated in FIG. 65,
the arrays of barbs 809 may not extend to the tips 806 of the legs
804. In various instances, the arrays of barbs 809 can extend along
half, or approximately half, the lengths of the legs 804, for
example; however, any suitable length of the barb arrays could be
utilized. For instance, the arrays of barbs 809 can extend along
less than half or more than half of the lengths of the legs 804. In
some embodiments, an array of barbs 809 can extend along each of
the legs 804 from the tips 806 of the legs 804 toward the base 802.
In such embodiments, the array of barbs 809 may not extend to the
base 802. In some embodiments, as illustrated in FIG. 66, a leg 804
can comprise an array of barbs 809 which does not extend to the tip
806 of the leg 804 or the base 802. In certain embodiments, a leg
804 can comprise more than one array of barbs 809.
[0324] Various barb configurations are depicted in FIGS. 70-73,
although any suitable barb configuration could be utilized.
Referring to FIG. 70, a staple leg 804 can include at least one
barb 809, for example. In various instances, the barb 809 can
comprise a prong. The prong can include a first surface 809a and a
second surface 809b which can extend from the perimeter 805 of the
staple leg 804. The first surface 809a can comprise an inclined
surface, a convex surface, and/or a concave surface, for example.
The second surface 809b can comprise a flat, or an at least
substantially flat, surface, for example. In various instances, the
first surface 809a and the second surface 809b can converge at an
edge 809c, for example. The barb 809 can be formed utilizing any
suitable process. For instance, the barb 809 can be formed
utilizing a stamping process. In at least one embodiment, a forming
die, for example, can be utilized to strike the perimeter 805 of
the wire comprising the leg 804 in order to upset, or disturb,
enough material to create the barb 809. In various instances, a
barb can comprise any suitable nib or spur, for example. In various
embodiments, the barb 809 can be tapered. In various instances, the
barb 809 can include a base adjacent to the perimeter 805 which is
thicker than a tip of the barb 809.
[0325] Referring now to FIGS. 68, 69, 71, and 71A, a staple leg 804
can include at least one barb 879, for example. In at least one
embodiment, the barb 879 can extend around a portion of the
perimeter 805 of the staple leg 804. In various instances, the barb
879 can include a first surface 879a and a second surface 879b
which can extend from the perimeter 805 of the staple leg 804. The
first surface 879a can comprise an inclined surface, a convex
surface, and/or a concave surface, for example. The second surface
879b can comprise a flat, or an at least substantially flat,
surface, for example. In various instances, the first surface 879a
and the second surface 879b can converge at an edge 879c, for
example. In various instances, the edge 879c can be arcuate, for
example. The barb 879 can be formed utilizing any suitable process.
For instance, the barb 879 can be formed utilizing a stamping
process. In at least one embodiment, a forming die, for example,
can be utilized to strike the perimeter 805 of the wire comprising
the leg 804 in order to upset, or disturb, enough material to
create the barb 879. Referring primarily to FIG. 71A, the wire
comprising the leg 804 can be defined by a diameter 801 and the
barb 879 can be defined by a diameter which is larger than the
diameter 801. Correspondingly, the wire comprising the leg 804 can
be defined by a radius and the barb 879 can be defined by a radius
which is larger than the wire radius. In various embodiments, the
barb 879 can be tapered. In various instances, the barb 879 can
include a base adjacent to the perimeter 805 which is thicker than
a tip of the barb 879.
[0326] Referring now to FIG. 72, a staple leg 804 can include at
least one barb 889, for example. In at least one embodiment, the
barb 889 can extend around the entirety of the perimeter 805 of the
staple leg 804. In various instances, the barb 889 can include a
first surface 889a and a second surface 889b which can extend from
the perimeter 805 of the staple leg 804. The first surface 889a can
comprise an inclined surface, a convex surface, and/or a concave
surface, for example. The second surface 889b can comprise a flat,
or an at least substantially flat, surface, for example. In various
instances, the first surface 889a and the second surface 889b can
converge at an edge 889c, for example. In various instances, the
edge 889c can be arcuate, for example. The barb 889 can be formed
utilizing any suitable process. For instance, the barb 889 can be
formed utilizing a stamping process. In at least one embodiment, a
forming die, for example, can be utilized to strike the perimeter
805 of the wire comprising the leg 804 in order to upset, or
disturb, enough material to create the barb 889. The wire
comprising the leg 804 can be defined by a wire diameter and the
barb 889 can be defined by a diameter which is larger than the wire
diameter. Correspondingly, the wire comprising the leg 804 can be
defined by a radius and the barb 889 can be defined by a radius
which is larger than the wire radius. In various embodiments, the
barb 889 can be tapered. In various instances, the barb 889 can
include a base adjacent to the perimeter 805 which is thicker than
a tip of the barb 889.
[0327] Referring now to FIG. 73, a staple leg 804 can include at
least one barb 899, for example. In various instances, the barb 899
can comprise a prong. The prong can include a first surface 899a
and a second surface 899b which can extend from the perimeter of
the staple leg 804. The first surface 899a can comprise an inclined
surface, a convex surface, and/or a concave surface, for example.
The second surface 899b can comprise a flat, or an at least
substantially flat, surface, for example. In various instances, the
first surface 899a and the second surface 899b can converge at an
edge 899c, for example. The barb 899 can be formed utilizing any
suitable process. For instance, the barb 899 can be formed
utilizing a stamping process. In at least one embodiment, a forming
die, for example, can be utilized to strike the perimeter of the
wire comprising the leg 804 in order to upset, or disturb, enough
material to create the barb 899. In various embodiments, the wire
comprising the staple can include one or more flat sides. In at
least one embodiment, the wire can include opposing flat sides 895,
for example. In at least one such embodiment, the flat sides 895
can be formed into a cylindrical wire. In some instances, the wire
can retain one or more cylindrical surfaces in addition to the flat
sides 895. In various instances, a barb can comprise any suitable
nib or spur, for example. In various embodiments, the barb 899 can
be tapered. In various instances, the barb 899 can include a base
adjacent to the perimeter of the leg 804 which is thicker than a
tip of the barb 899.
[0328] In various instances, the legs of a staple can define a
staple plane. The base of the staple may or may not be positioned
within the staple plane. In either event, one or more barbs
extending from the legs and/or the base may extend within and/or
extend parallel with respect to the staple plane. In some
instances, one or more barbs extending from the legs and/or the
base can extend outwardly from the staple plane. One or more barbs
extending from the legs and/or the base can extend transversely
with respect to the staple plane. In various instances, a barb can
extend circumferentially around a staple leg. Such a barb can
extend within and outwardly from the staple plane. In some
instances, a barb can extend around the entire circumference of a
staple leg. In certain instances, the barb can extend less than 360
degrees around a staple leg. A barb extending within a staple plane
can readily control tissue within the staple plane. A barb
extending outwardly from a staple plane can readily control tissue
outside of the staple plane. A staple, and/or a staple leg, can
include one or more barbs extending within the staple plane and one
or more barbs extending outwardly from the staple plane.
[0329] Referring again to FIG. 62, the barbs extending from a
staple leg 804 can be configured to retain the staple leg 804
within tissue. As outline above, the staple legs 804 may be
malformed and/or unformed by an anvil in certain instances and,
owing to the barb, or barbs, extending therefrom, the staple leg
804 may still be retained in the tissue. In various instances, the
barbs can be configured to trap tissue within the tissue entrapment
area of the staple. In certain instances, the barbs can be
configured to hold the tissue against the base 802. In such
instances, the barbs can apply a compressive force or pressure to
the tissue. As discussed above in connection with the embodiments
depicted in FIGS. 70-73, a barb can comprise an inclined, convex,
and/or concave top surface, such as surfaces 809a, 879a, 889a,
and/or 899a, for example. The top surfaces of the barbs can be
configured to facilitate the insertion of the barbs and the staple
legs 804 into and/or through the tissue. As also discussed above in
connection with the embodiments depicted in FIGS. 70-73, a barb can
comprise a flat, or at least substantially flat, bottom surface,
such as surfaces 809b, 879b, 889b, and/or 899b, for example. The
bottom surfaces of the barbs can be configured to inhibit the
removal of the barbs and the staple legs 804 from the tissue. As a
result of the above, in certain circumstances, the top surfaces of
the barbs can be configured to pierce the tissue while the bottom
surfaces of the barbs can be configured to abut the tissue. In
various circumstances, the tips 806 of the staple legs 804 can be
configured to puncture a hole in the tissue while the staple legs
804 and the barbs extending therefrom can be configured to
resiliently expand the hole such that such that the tissue can flow
around the barbs as the staple legs 804 are being pushed through
the tissue and flow back underneath the bottom surfaces of the
barbs.
[0330] In certain embodiments, a first barb can extend from a first
leg 804 of the staple and a second barb can extend from a second
leg 804 of the staple. In various instances, the first barb and the
second barb can be located the same, or at least substantially the
same, distance between from the base 802. In certain instances, the
first barb and the second barb can be located the same, or at least
substantially the same, vertical distance from the base 802. As
discussed above, a staple leg 804 can include an array of barbs
extending along the length of the staple leg 804. In various
embodiments, referring primarily to FIG. 62, a staple can include a
first leg 804 including a first array of barbs and a second leg 804
including a second array of barbs wherein the first array of barbs
and the second array of barbs can be configured to co-operatively
hold the staple within the tissue. In various embodiments, a barb
from the first array and a barb from the second array can comprise
a pair of barbs configured to engage tissue at the same vertical
distance from the base 802, for example. In various instances, a
staple can comprise more than one pair of barbs. In certain
instances, each of the barb pairs can be configured to engage the
tissue at a different vertical distance from the base 802. In such
circumstances, a staple can be suitable for use with different
tissue thicknesses. For instance, when a staple is used to staple
thin tissue, one pair of barbs, or less than all of the barb pairs,
may engage the thin tissue. If that staple were used to staple
thick tissue, however, additional barb pairs, or all of the barb
pairs, may engage the tissue. In certain embodiments, the barbs
extending from the legs 804 can be arranged in a manner in
accordance with the tissue thickness, or range of tissue
thicknesses, that can be stapled by the staple. For instance,
referring again to FIG. 62, the barbs 808 and 809 can be
selectively positioned along the legs 804 such that they are
positioned within and/or adjacent to the tissue captured within the
staple. In certain instances, the portions of the staple legs 804
that are deformed by, or come into contact with, an anvil may not
include barbs extending therefrom. In at least some instances, an
array of barbs extending from the inwardly-facing side of the
staple legs 804 may be longer than an array of barbs extending from
the outwardly-facing side of the staple legs 804. In other
instances, an array of barbs extending from the inwardly-facing
side of the staple legs 804 may be shorter than an array of barbs
extending from the outwardly-facing side of the staple legs 804. In
yet other instances, an array of barbs extending from the
inwardly-facing side of the staple legs 804 may be the same length
as an array of barbs extending from the outwardly-facing side of
the staple legs 804.
[0331] As discussed above, the barbs extending from the staple legs
804 can assist in retaining the staple within the tissue if the
staple legs 804 are malformed and/or unintentionally unformed.
Certain circumstances are contemplated, however, where a staple
including one or more of the barbs disclosed herein is inserted
into tissue and remains intentionally unformed. In any event,
staples including one or more of the barbs disclosed herein can be
useful in stapling thick tissue. More particularly, in some
instances, the presence of thick and/or dense tissue between a
staple cartridge and an anvil and/or the presence of thick and/or
dense tissue within a staple may prevent the staple from becoming
fully formed or closed. For instance, the staple may not be fully
closed into a B-form configuration or the staple may not be closed
at all. In such instances, the barbs of the unclosed staples may
inhibit or prevent the tissue from being pulled out of the staple,
for example. An array of barbs extending along the length of a
staple leg may permit the leg to remain retained in the tissue
regardless of the thickness of the tissue.
[0332] Various embodiments are contemplated in which at least one
barbed staple, such as barbed staple 800, for example, are
removably stored within a staple cartridge, such as the staple
cartridge 22000 illustrated in FIGS. 10-12, for example. Certain
embodiments are envisioned in which a staple cartridge includes
only barbed staples while other embodiments are envisioned which
utilize barbed staples and non-barbed staples. For instance, a
first row of staples can comprise barbed staples while a second row
of staples can comprise non-barbed staples. In some instances, the
staples stored within a staple cartridge can have the same, or
essentially the same, unformed height. At least with regard to
U-shaped and/or V-shaped staples, for example, the unformed height
of a staple can be defined as the vertical distance between the
bottom of the base of the staple and the tips of the staple legs.
Such a measurement can be taken before the staples are inserted
into the staple cartridge, when the staples are removably stored
within the staple cartridge, and/or before the staples are deformed
against the anvil. In some instances, barbed staples arranged in a
first row in a staple cartridge can comprise a first unformed
height and barbed staples arranged in a second row in the staple
cartridge can comprise a second unformed height. Barbed staples in
a third row in the staple cartridge can comprise the first unformed
height, the second unformed height, or a third unformed height. The
first row, the second row, and/or the third row of barbed staples
can be positioned on the same side of a knife slot defined in the
staple cartridge or on opposite sides of the knife slot. In use,
the barbed staples removably stored in a staple cartridge can be
formed to the same formed height or different formed heights. The
formed height of a staple can be defined as the overall vertical
distance of the staple after it has been deformed against an anvil.
At least with regard to a staple that has been deformed into a
B-form, for example, the formed height of the staple can be
measured between the bottom of the base of the staple and the
top-most portion of the staple legs. In some instances, barbed
staples arranged in a first row in a staple cartridge can be
deformed to a first formed height and barbed staples arranged in a
second row in the staple cartridge can be deformed to a second
formed height. Barbed staples in a third row in the staple
cartridge can comprise the first formed height, the second formed
height, or a third formed height. The first row, the second row,
and/or the third row of barbed staples can be positioned on the
same side of a knife slot defined in the staple cartridge or on
opposite sides of the staple cartridge. As the reader will
appreciate, the staples depicted in FIGS. 10-12 have been deformed
to different formed heights. Barbed staples 800, for example, could
be utilized in staple cartridges and/or stapling instruments which
create staple rows having different formed heights. A first row of
barbed staples 800 could be deformed to a first formed height and a
second row of barbed staples 800 could be deformed to a second
formed height. In various instances, a third row of barbed staples
800 could be deformed to a third formed height. In some instances,
the barbed staples 800 deformed to different heights can begin with
the same, or essentially the same, unformed height. In certain
instances, the barbed staples 800 deformed to different formed
heights can begin with different unformed heights. Various
structures can be utilized to form staples to different formed
heights. For instance, movable drivers supporting the staples can
support the staples at different distances relative to the anvil.
In some instances, the anvil can include staple forming pockets
having different depths. In various instances, a staple driver can
include a cradle configured to support the base of a staple and
push the staple upwardly toward a forming pocket defined in the
anvil. The formed height of a staple can be determined by the
distance between the bottom surface of the cradle and the top
surface of the forming pocket. U.S. Pat. No. 8,317,070, entitled
SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING
DIFFERENT LENGTHS, issued on Nov. 27, 2012, is incorporated by
reference in its entirety. In certain instances, the deck of a
staple cartridge can include stepped surfaces, as illustrated in
FIG. 1. A first row of staple cavities can be defined in a first
step and a second row of staple cavities can be defined in a second
step wherein the first step and the second step can be vertically
offset from one another. For instance, the first step can be
positioned vertically above, or closer to, the anvil than the
second step. In certain instances, a wall can be defined between
the first step and the second step. In some instances, the deck of
a staple cartridge can comprise a first step, a second step
positioned vertically above the first step, and a third step
positioned vertically above the second step. Various embodiments
are envisioned in which the deck of a staple cartridge includes any
suitable number of steps and any suitable number of walls between
the steps. A first row of staple cavities can be defined in the
first step, a second row of staple cavities can be defined in the
second step, and/or a third row of staple cavities can be defined
in the third step, for example. The first row of staple cavities
can include staples having a first unformed height, the second row
of staple cavities can include staples having a second unformed
height, and/or the third row of staple cavities can include staples
having a third unformed height, for example. Various embodiments
are envisioned in which a staple cartridge includes any suitable
number of staple rows having different unformed heights. The
staples in the first row of staple cavities can be deformed to a
first formed height, the staples in the second row of staple
cavities can be deformed to a second formed height, and/or the
third row of staple cavities can be deformed to a third formed
height, for example. Various embodiments are envisioned in which a
staple cartridge includes any suitable number of staple rows which
are deformed to different formed heights. In addition to or in lieu
of having different formed staple heights, an end effector of a
stapling instrument can have different tissue gaps. For instance,
referring generally to FIGS. 10 and 11, a gap can be defined
between the cartridge deck surface 22011 of a staple cartridge and
the anvil tissue compression surface 10063 of an anvil. This gap
can be configured to receive tissue T. This gap can also be
configured to receive a tissue thickness compensator; however, a
barbed staple may or may not be used with a tissue thickness
compensator and the discussion provided with respect to barbed
staples can be applicable in either circumstance. In any event, the
reader will appreciate that the anvil tissue compression surface
10063 is stepped. The anvil tissue compression surface 10063
comprises a first portion positioned vertically above a second
portion. When the anvil and the staple cartridge of an end effector
are in a closed condition, as illustrated in FIG. 11, a first gap
distance is defined between an outer portion of the anvil tissue
compression surface 10063 and the cartridge deck surface 22011 and
a second, different, gap distance is defined between an inner
portion of the anvil tissue compression surface 10063 and the
cartridge deck surface 22011. The first gap distance is illustrated
as being larger than the second gap distance, but it is possible
for the first gap distance to be shorter than the second gap
distance. Tissue compressed between the anvil and the staple
cartridge in the shorter gap distance can be compressed more than
tissue in the larger gap distance. The barbs of a barbed staple
800, for example, may engage the tissue differently depending on
whether the tissue is positioned within a shorter tissue gap or a
larger tissue gap. More particularly, tissue compressed within a
shorter tissue gap may seek to re-expand more after it is released
from an end effector than tissue compressed within a larger tissue
gap and the barbs of a barbed staple may inhibit or resist this
re-expansion, depending on their configuration and/or position on
the barbs. In other instances, the barbs may be configured and/or
positioned so as to not inhibit or resist the re-expansion of the
tissue. As the reader will appreciate, anvil tissue compression
surface 10063 is stepped and the cartridge deck surface is flat, or
at least substantially flat, and, thus, the difference in tissue
gaps defined within the end effector is a function of the height of
the stepped anvil surfaces. Other embodiments are envisioned. For
instance, the anvil tissue compression surface can be flat, or at
least substantially flat, and the cartridge deck surface can be
stepped. In other instances, the anvil tissue compression surface
and the cartridge deck surface can both be stepped. In any event,
different gap distances can be defined between the anvil tissue
compression surface and the cartridge deck surface. While two gap
distances have been illustrated in FIGS. 10 and 11, more than two
gap distances may be possible, such as three gap distances, for
example. With further reference to FIGS. 10 and 11, a first
longitudinal row of forming pockets can be arranged within a first
portion of an end effector having first tissue gap distance and a
second longitudinal row of forming pockets can be arranged within a
second portion of the end effector having a second tissue gap
distance which is different than the first tissue gap distance. In
some instances, the end effector can include a third longitudinal
row of forming pockets arranged within a third portion of the end
effector having a third tissue gap distance which is different than
the first tissue gap distance and the second tissue gap distance.
In certain instances, the end effector can include a third
longitudinal row of forming pockets arranged within a third portion
of the end effector having a tissue gap distance which is the same
as the first tissue gap distance or the second tissue gap distance.
The reader will appreciate that an end effector can have different
tissue gap distances and/or different formed staple heights. An end
effector can have one, the other, or both. In certain instances,
shorter formed staple heights can be associated within shorter
tissue gap distances while larger formed staple heights can be
associated with larger tissue gap distances. In other instances,
shorter formed staple heights can be associated with larger tissue
gap distances while larger formed staple heights can be associated
with shorter tissue gap distances. Further to the above, a staple
can include a U-shape configuration in its unformed state. A
U-shape staple can comprise a base and two staple legs extending
from the base wherein the staple legs extend in parallel directions
to each other. Also further to the above, a staple can include a
V-shape configuration in its unformed state. A V-shape
configuration can comprise a base and two staple legs extending
from the base wherein the staple legs extend in directions which
are not parallel.
[0333] Various embodiments described herein are described in the
context of linear end effectors and/or linear fastener cartridges.
Such embodiments, and the teachings thereof, can be applied to
non-linear end effectors and/or non-linear fastener cartridges,
such as, for example, circular and/or contoured end effectors. For
example, various end effectors, including non-linear end effectors,
are disclosed in U.S. patent application Ser. No. 13/036,647, filed
Feb. 28, 2011, entitled SURGICAL STAPLING INSTRUMENT, now U.S.
Patent Application Publication No. 2011/0226837, which is hereby
incorporated by reference in its entirety. Additionally, U.S.
patent application Ser. No. 12/893,461, filed Sep. 29, 2012,
entitled STAPLE CARTRIDGE, now U.S. Patent Application Publication
No. 2012/0074198, is hereby incorporated by reference in its
entirety. U.S. patent application Ser. No. 12/031,873, filed Feb.
15, 2008, entitled END EFFECTORS FOR A SURGICAL CUTTING AND
STAPLING INSTRUMENT, now U.S. Pat. No. 7,980,443, is also hereby
incorporated by reference in its entirety. The entire disclosure of
U.S. Pat. No. 7,845,537, entitled SURGICAL INSTRUMENT HAVING
RECORDING CAPABILITIES, which issued on Dec. 7, 2010, is
incorporated by reference herein. The entire disclosure of U.S.
application Ser. No. 13/118,241, entitled SURGICAL STAPLING
INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S.
Patent Application Publication No. 2012/0298719, which was filed on
May 27, 2011, is incorporated by reference herein.
[0334] 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.
[0335] 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.
[0336] Any patent, publication, or other disclosure material, in
whole or in part, that is said to be incorporated by reference
herein is incorporated herein only to the extent that the
incorporated materials does not conflict with existing definitions,
statements, or other disclosure material set forth in this
disclosure. As such, and to the extent necessary, the disclosure as
explicitly set forth herein supersedes any conflicting material
incorporated herein by reference. Any material, or portion thereof,
that is said to be incorporated by reference herein, but which
conflicts with existing definitions, statements, or other
disclosure material set forth herein will only be incorporated to
the extent that no conflict arises between that incorporated
material and the existing disclosure material.
[0337] 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.
* * * * *