U.S. patent application number 12/836396 was filed with the patent office on 2012-01-19 for surgical fastening devices comprising rivets.
This patent application is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to John V. Hunt, Robert J. Laird, Gavin M. Monson, Suzanne E. Thompson, Richard W. Timm, Omar J. Vakharia.
Application Number | 20120016413 12/836396 |
Document ID | / |
Family ID | 45470054 |
Filed Date | 2012-01-19 |
United States Patent
Application |
20120016413 |
Kind Code |
A1 |
Timm; Richard W. ; et
al. |
January 19, 2012 |
SURGICAL FASTENING DEVICES COMPRISING RIVETS
Abstract
An end-effector assembly is configured to be attached to a
surgical instrument. The end-effector assembly comprises a first
jaw comprising an electrode, a second jaw comprising a rivet
cavity, and a rivet. At least one of the first jaw and the second
jaw is movable relative to the other jaw. At least a portion of the
rivet is removably positioned within the rivet cavity. The rivet
comprises a tissue-engaging portion, an elongate portion extending
from the tissue-engaging portion, and a meltable portion. The
end-effector assembly comprises a driver configured to move the
rivet between a first position in which the rivet is stored at
least partially within the rivet cavity and a second position in
which the rivet is at least partially deployed from the rivet
cavity. The meltable portion of the rivet is positioned against or
adjacent to the electrode when the rivet is in the second
position.
Inventors: |
Timm; Richard W.;
(Cincinnati, OH) ; Thompson; Suzanne E.; (West
Chester, OH) ; Hunt; John V.; (Cincinnati, OH)
; Monson; Gavin M.; (Oxford, OH) ; Vakharia; Omar
J.; (Cincinnati, OH) ; Laird; Robert J.;
(Morrow, OH) |
Assignee: |
Ethicon Endo-Surgery, Inc.
Cincinnati
OH
|
Family ID: |
45470054 |
Appl. No.: |
12/836396 |
Filed: |
July 14, 2010 |
Current U.S.
Class: |
606/220 |
Current CPC
Class: |
A61B 17/07207 20130101;
A61B 2018/00708 20130101; A61B 2018/1455 20130101; A61B 2018/00791
20130101; A61B 18/1445 20130101; A61B 2017/07271 20130101; A61B
2018/00678 20130101; A61B 2017/2923 20130101; A61B 2018/00875
20130101; A61B 2018/00642 20130101; A61B 2018/145 20130101; A61B
18/1442 20130101; A61B 18/1447 20130101; A61B 2018/00071 20130101;
A61B 2018/0063 20130101; A61B 2018/126 20130101; A61B 17/115
20130101; A61B 2017/07214 20130101; A61B 2017/0647 20130101; A61B
2017/07228 20130101; A61B 17/1155 20130101; A61B 17/0644 20130101;
A61B 2017/00026 20130101; A61B 17/1114 20130101; A61B 2018/00404
20130101; A61B 2017/00088 20130101; A61B 2090/061 20160201 |
Class at
Publication: |
606/220 |
International
Class: |
A61B 17/08 20060101
A61B017/08; A61B 17/10 20060101 A61B017/10 |
Claims
1. An end-effector assembly configured to be attached to a surgical
instrument, the end-effector assembly comprising: a first jaw
comprising an electrode; a second jaw comprising a rivet cavity,
wherein at least one of the first jaw and the second jaw is movable
relative to the other; a rivet, wherein at least a portion of the
rivet is removably positioned within the rivet cavity, wherein the
rivet comprises: a tissue-engaging portion; an elongate portion
extending from the tissue-engaging portion; and a meltable portion;
and a driver configured to move the rivet between a first position
in which the rivet is stored at least partially within the rivet
cavity and a second position in which the rivet is at least
partially deployed from the rivet cavity, wherein the meltable
portion of the rivet is one of positioned against and adjacent to
the electrode when the rivet is in the second position.
2. The end-effector assembly of claim 1, wherein one of the first
jaw and the second jaw comprises a positive temperature coefficient
material.
3. The end-effector assembly of claim 1, wherein the meltable
portion is meltable into a first configuration by current flowing
through a portion of the end-effector assembly when the
tissue-engaging portion is positioned within tissue having a first
thickness, and wherein the meltable portion is meltable into a
second configuration by the current flowing through the portion of
the end-effector assembly when the tissue-engaging portion is
positioned within tissue having a second thickness.
4. The end-effector assembly of claim 1, wherein the rivet
comprises a base comprising a tissue-engaging surface, wherein the
tissue-engaging portion of the rivet comprises a first end and a
second end, wherein the elongate portion extends from the first
end, and wherein the base extends from the second end.
5. The end-effector assembly of claim 1, wherein the meltable
portion is comprised of a material that is meltable when exposed to
temperatures in the range of 107.degree. F. to 121.degree. F.
6. The end-effector assembly of claim 1, wherein the meltable
portion is deformed by the first jaw when the rivet is moved
between the first position and the second position.
7. The end-effector assembly of claim 1, wherein the rivet
comprises one of an absorbable material and a dissolvable
material.
8. The end-effector assembly of claim 1, comprising a
collagen-based buttress material positioned intermediate the first
jaw and the second jaw, wherein the meltable portion comprises a
tip configured to puncture the collagen-based buttress material
when the rivet is moved between the first position and the second
position.
9. The end-effector assembly of claim 1, comprising a rivet
cartridge, wherein the rivet cartridge comprises the rivet, and
wherein the rivet cartridge is configured to be positioned at least
partially within the rivet channel of the second jaw.
10. The end-effector assembly of claim 1, wherein the elongate
portion has a first circumferential perimeter when the rivet is in
the first position, wherein the meltable portion has a second
circumferential perimeter when the rivet is in the second position,
and wherein the second circumferential perimeter is greater than
the first circumferential perimeter.
11. The end-effector assembly of claim 1, wherein the meltable
portion has a first axial length when in the first position,
wherein the meltable portion has a second axial length when in the
second position, and wherein the first axial length is greater than
the second axial length when the meltable portion is at least
partially melted.
12. A rivet cartridge configured to be engaged with an end-effector
comprising an electrode, the rivet cartridge comprising: a first
surface defining an opening therein; a second surface; a rivet
cavity defined at least partially intermediate the first surface
and the second surface, wherein the rivet cavity is in
communication with the opening in the first surface; and a rivet,
wherein at least a portion of the rivet is removably positioned
within the rivet cavity, the rivet comprising: a tissue-engaging
portion; and an elongate portion extending from the tissue-engaging
portion; the elongate portion comprising a meltable portion,
wherein the meltable portion is meltable when current flows through
a portion of the end-effector.
13. The rivet cartridge of claim 12, wherein the meltable portion
is comprised of a deformable material.
14. The rivet cartridge of claim 12, wherein the elongate portion
is a first elongate portion, wherein the meltable portion is a
first meltable portion, wherein the rivet comprises a second
elongate portion extending from the tissue-engaging portion,
wherein the second elongate portion comprises a second meltable
portion, wherein the tissue-engaging portion comprises a first end
and a second end, wherein the first elongate portion extends from
the first end, and wherein the second elongate portion extends from
the second end.
15. The rivet cartridge of claim 12, wherein the meltable portion
comprises a tissue-puncturing tip configured to puncture tissue
positioned within the end-effector.
16. A surgical instrument comprising: a shaft comprising a proximal
end and a distal end; a handle portion extending from the proximal
end of the shaft; and an end-effector assembly extending from the
distal end of the shaft, the end-effector assembly comprising: a
first jaw comprising an electrode; a second jaw comprising a rivet
cavity, wherein at least one of the first jaw and the second jaw is
movable relative to the other; a rivet, wherein at least a portion
of the rivet is removably positioned within the rivet cavity,
wherein the rivet comprises: a tissue-engaging portion; and a
meltable portion extending from the tissue-engaging portion; and a
driver configured to move the rivet between a first position in
which the rivet is stored at least partially within the rivet
cavity and a second position in which the rivet is at least
partially deployed from the rivet cavity, wherein the meltable
portion is positioned one of proximate to and in contact with the
electrode when the rivet is in the second position.
17. The surgical instrument of claim 16, wherein the end-effector
assembly comprises a rivet cartridge comprising the rivet, and
wherein the rivet cartridge is configured to be positioned at least
partially within the rivet channel of the second jaw.
18. The surgical instrument of claim 16, wherein one of the first
jaw and the second jaw comprises a positive temperature coefficient
material.
19. The surgical instrument of claim 16, wherein the meltable
portion has a first axial length when the rivet is in the first
position, wherein the meltable portion has a second axial length
when the rivet is in the second position, and wherein the first
axial length is greater than the second axial length when the
meltable portion is at least partially melted.
20. The surgical instrument of claim 16, wherein the meltable
portion comprises a tissue-puncturing tip configured to puncture
tissue positioned intermediate the first jaw and the second jaw
when the rivet is moved between the first position and the second
position.
Description
FIELD
[0001] The present disclosure is generally directed to surgical
instruments and, more particularly, is directed to surgical
fastening devices comprising rivets.
BACKGROUND
[0002] In various open, endoscopic, and/or laparoscopic surgeries,
for example, it may be desirable to coagulate, seal, and/or fuse
tissue. One method of sealing tissue relies upon the application of
energy, such as electrical energy, for example, to tissue captured
or clamped within an end effector or an end-effector assembly of a
surgical instrument in order to cause thermal effects within the
tissue. Various mono-polar and bi-polar radio frequency (Rf)
surgical instruments and surgical techniques have been developed
for such purposes. In general, the delivery of Rf energy to the
captured tissue can elevate the temperature of the tissue and, as a
result, the energy can at least partially denature proteins within
the tissue. Such proteins, like collagen, for example, can be
denatured into a proteinaceous amalgam that intermixes and fuses,
or seals, together as the proteins renature. As the treated region
heals over time, this biological seal may be reabsorbed by the
body's wound healing process.
[0003] The foregoing discussion is intended only to illustrate
various aspects of the related art and should not be taken as a
disavowal of claim scope.
SUMMARY
[0004] In one non-limiting embodiment, the present disclosure, in
part, is directed to an end-effector assembly configured to be
attached to a surgical instrument. The end-effector assembly can
comprise a first jaw comprising an electrode, a second jaw
comprising a rivet cavity, and a rivet. At least one of the first
jaw and the second jaw can be movable relative to the other jaw. At
least a portion of the rivet can be removably positioned within the
rivet cavity. The rivet can comprise a tissue-engaging portion, an
elongate portion extending from the tissue-engaging portion, and a
meltable portion. The end-effector assembly can comprise a driver
that can be configured to move the rivet between a first position
in which the rivet can be stored at least partially within the
rivet cavity and a second position in which the rivet can be at
least partially deployed from the rivet cavity. The meltable
portion of the rivet can be positioned against or adjacent to the
electrode when the rivet is in the second position.
[0005] In another non-limiting embodiment, the present disclosure,
in part, is directed to a rivet cartridge configured to be engaged
with an end-effector comprising an electrode. The rivet cartridge
can comprise a first surface defining an opening therein, a second
surface, a rivet cavity defined at least partially intermediate the
first surface and the second surface, and a rivet. The rivet cavity
can be in communication with the opening in the first surface. At
least a portion of the rivet can be removably positioned within the
rivet cavity. The rivet can comprise a tissue-engaging portion and
an elongate portion extending from the tissue-engaging portion. The
elongate portion can comprise a meltable portion that is meltable
when current flows through a portion of the end-effector.
[0006] In yet another non-limiting embodiment, the present
disclosure, in part, is directed to a surgical instrument that can
comprise a shaft comprising a proximal end and a distal end, a
handle portion extending from the proximal end of the shaft, and an
end-effector assembly extending from the distal end of the shaft.
The end-effector assembly can comprise a first jaw comprising an
electrode, a second jaw comprising a rivet cavity, and a rivet. At
least one of the first jaw and the second jaw can be movable
relative to the other. At least a portion of the rivet can be
removably positioned within the rivet cavity. The rivet can
comprise a tissue-engaging portion and a meltable portion extending
from the tissue-engaging portion. The end-effector assembly can
comprise a driver configured to move the rivet between a first
position in which the rivet can be stored at least partially within
the rivet cavity and a second position in which the rivet can be at
least partially deployed from the rivet cavity. The meltable
portion can be positioned proximate to or in contact with the
electrode when the rivet is in the second position.
[0007] The foregoing discussion should not be taken as a disavowal
of claim scope.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Various features of the embodiments described herein are set
forth with particularity in the appended claims. The various
embodiments, however, both as to organization and methods of
operation, together with the advantages thereof, may be understood
in accordance with the following description taken in conjunction
with the accompanying drawings as follows.
[0009] FIG. 1 is a perspective view a surgical instrument in
accordance with one non-limiting embodiment of the present
disclosure;
[0010] FIG. 2 is a perspective view of an end-effector of the
surgical instrument of FIG. 1 in accordance with one non-limiting
embodiment of the present disclosure;
[0011] FIG. 3 is an exploded perspective view of the end-effector
of FIG. 2 in accordance with one non-limiting embodiment of the
present disclosure;
[0012] FIG. 4 is a cut-away perspective view of the surgical
instrument of FIG. 1 in accordance with one non-limiting embodiment
of the present disclosure;
[0013] FIG. 5 is a cross-sectional view of an end-effector having
tissue compressed between a first portion and a second portion
thereof in accordance with one non-limiting embodiment of the
present disclosure;
[0014] FIG. 6 is a view of a formed anastomosis in tissue after the
end-effector of FIG. 5 has been used in accordance with one
non-limiting embodiment of the present disclosure;
[0015] FIG. 7a is a perspective view of an end-effector in
accordance with one non-limiting embodiment of the present
disclosure;
[0016] FIG. 7b is a cross-sectional view of the end-effector of
FIG. 7a, when a second portion is attached to a first portion in
accordance with one non-limiting embodiment of the present
disclosure;
[0017] FIG. 8a is a perspective view of an end-effector in
accordance with one non-limiting embodiment of the present
disclosure;
[0018] FIG. 8b is a cross-sectional view of the end-effector of
FIG. 8a, when a second portion is attached to a first portion in
accordance with one non-limiting embodiment of the present
disclosure;
[0019] FIG. 9a is a perspective view of an end-effector in
accordance with one non-limiting embodiment of the present
disclosure;
[0020] FIG. 9b is a cross-sectional view of the end-effector of
FIG. 9a, when a second portion is attached to a first portion in
accordance with one non-limiting embodiment of the present
disclosure;
[0021] FIG. 10a is a perspective view of an end-effector in
accordance with one non-limiting embodiment of the present
disclosure;
[0022] FIG. 10b is a cross-sectional view of the end-effector of
FIG. 10a, when a second portion is attached to a first portion in
accordance with one non-limiting embodiment of the present
disclosure;
[0023] FIG. 11a is a perspective view of an end-effector in
accordance with one non-limiting embodiment of the present
disclosure;
[0024] FIG. 11b is a cross-sectional view of the end-effector of
FIG. 11a, when a second portion is attached to a first portion in
accordance with one non-limiting embodiment of the present
disclosure;
[0025] FIG. 12 is a perspective view of a staple cartridge
configured to be used in a surgical stapling instrument in
accordance with one non-limiting embodiment of the present
disclosure;
[0026] FIG. 13 is a partial cut-away side view of a surgical
instrument configured to cut, staple, and/or seal tissue in
accordance with one non-limiting embodiment of the present
disclosure;
[0027] FIG. 14 is a cut-away side view of an end-effector assembly
of the surgical instrument of FIG. 13 in accordance with one
non-limiting embodiment of the present disclosure;
[0028] FIG. 15 is a side view of a cutting member of the
end-effector assembly of the surgical instrument of FIG. 14 in
accordance with one non-limiting embodiment of the present
disclosure;
[0029] FIG. 16 is a front view of the cutting member of FIG. 15 in
accordance with one non-limiting embodiment of the present
disclosure;
[0030] FIG. 17 is a cut-away side view of an end-effector assembly
with a cutting member and a driver in the fully extended position
in accordance with one non-limiting embodiment of the present
disclosure;
[0031] FIG. 18 is a cut-away side view of a handle portion of the
surgical instrument of FIG. 13 with a base portion thereof removed
and both triggers in the non-retracted position in accordance with
one non-limiting embodiment of the present disclosure;
[0032] FIG. 19 is an exploded perspective view of the handle
portion of the surgical instrument of FIG. 13 in accordance with
one non-limiting embodiment of the present disclosure;
[0033] FIG. 20 is a cut-away side view of the handle portion of the
surgical instrument of FIG. 13 with one of the triggers in the
retracted position and the one of the triggers in the non-retracted
position in accordance with one non-limiting embodiment of the
present disclosure;
[0034] FIG. 21 is a cut-away side view of the handle portion of the
surgical instrument of FIG. 13 with both of triggers in the
retracted position in accordance with one non-limiting embodiment
of the present disclosure;
[0035] FIG. 22 is a perspective view of the end-effector assembly
of the surgical instrument of FIG. 13 in an open configuration in
accordance with one non-limiting embodiment of the present
disclosure;
[0036] FIG. 23 is an exploded perspective view of a shaft and an
end-effector assembly of the surgical instrument of FIG. 13 in
accordance with one non-limiting embodiment of the present
disclosure;
[0037] FIG. 24 is a perspective view of the end-effector assembly
of the surgical instrument of FIG. 13 with a staple cartridge
partially removed in accordance with one non-limiting embodiment of
the present disclosure;
[0038] FIG. 25 is a perspective view of the end-effector assembly
of the surgical instrument of FIG. 24 with the staple cartridge
fully removed in accordance with one non-limiting embodiment of the
present disclosure;
[0039] FIG. 26 is sectional view of the end-effector assembly of
FIG. 22 taken along line 26-26 with a cutting member and a driver
in a retracted position in accordance with one non-limiting
embodiment of the present disclosure;
[0040] FIG. 27 is a sectional view of the end-effector assembly of
FIG. 22 taken along line 27-27 in accordance with one non-limiting
embodiment of the present disclosure;
[0041] FIG. 28 is a sectional view of the end-effector assembly of
FIG. 27 taken along line 28-28 in accordance with one non-limiting
embodiment of the present disclosure;
[0042] FIG. 29 is a cut-away side view of the end-effector assembly
of FIG. 13 taken along the longitudinal centerline of the
end-effector assembly in an open position in accordance with one
non-limiting embodiment of the present disclosure;
[0043] FIG. 30 is a partial cut-away side view of the surgical
instrument of FIG. 13 with the end-effector assembly in a closed
position in accordance with one non-limiting embodiment of the
present disclosure;
[0044] FIG. 31 is a sectional view of the end-effector assembly of
FIG. 30 taken along the longitudinal centerline of the end-effector
assembly when tissue positioned within the end-effector is
compressed in accordance with one non-limiting embodiment of the
present disclosure;
[0045] FIG. 32 is a partial cut-away side view of the surgical
instrument of FIG. 13 in a partially fired positioned in accordance
with one non-limiting embodiment of the present disclosure;
[0046] FIG. 33 is a sectional view of the end-effector assembly of
FIG. 32 taken along the longitudinal centerline of the end-effector
assembly in a partially fired position in accordance with one
non-limiting embodiment of the present disclosure;
[0047] FIG. 34 is a partial cut-away side view of the surgical
instrument of FIG. 13 in a fully fired positioned in accordance
with one non-limiting embodiment of the present disclosure;
[0048] FIG. 35 is a sectional view of the end-effector assembly of
FIG. 34 taken along the longitudinal centerline of the end-effector
assembly in a fully fired position in accordance with one
non-limiting embodiment of the present disclosure;
[0049] FIG. 36 is a schematic illustration of a second jaw of an
end-effector assembly in accordance with one non-limiting
embodiment of the present disclosure;
[0050] FIG. 37 is a schematic illustration of another second jaw of
an end-effector assembly in accordance with one non-limiting
embodiment of the present disclosure;
[0051] FIG. 38 is a schematic illustration of still another second
jaw of an end-effector assembly in accordance with one non-limiting
embodiment of the present disclosure;
[0052] FIG. 39 is a perspective view of a surgical instrument
configured to deploy rivets in accordance with one non-limiting
embodiment of the present disclosure;
[0053] FIG. 40 is a perspective view of an end-effector of the
surgical instrument of FIG. 39 cutting, sealing, and forming a
rivet line in tissue in accordance with one non-limiting embodiment
of the present disclosure;
[0054] FIG. 41 is an exploded perspective view of an end-effector
of the surgical instrument of FIG. 39 in accordance with one
non-limiting embodiment of the present disclosure;
[0055] FIG. 42 is a perspective view of a rivet cartridge
configured for use with an end-effector in accordance with one
non-limiting embodiment of the present disclosure;
[0056] FIG. 43 is a cross-sectional view of the rivet cartridge
taken along line 43-43 of FIG. 42 in accordance with one
non-limiting embodiment of the present disclosure;
[0057] FIG. 44 is an elevation view of a rivet that can be deployed
from an end-effector of the surgical instrument of FIG. 39 in
accordance with one non-limiting embodiment of the present
disclosure;
[0058] FIGS. 45 and 46 are cross-sectional views of an end-effector
of the surgical instrument of FIG. 39 with some rivets deployed
into the tissue in accordance with one non-limiting embodiment of
the present disclosure;
[0059] FIG. 47 is a partial view of a first face of a first portion
of an end-effector in accordance with one non-limiting embodiment
of the present disclosure;
[0060] FIG. 48 is a partial view of a second face of a second
portion of an end-effector in accordance with one non-limiting
embodiment of the present disclosure;
[0061] FIG. 49 is a partial view of a first face of a first portion
of an end-effector in accordance with one non-limiting embodiment
of the present disclosure;
[0062] FIG. 50 is a view of a piece of tissue after an end-effector
having the first portion of FIG. 49 has deployed rivets into the
tissue, created a seal in the tissue, and created a cut line in the
tissue in accordance with one non-limiting embodiment of the
present disclosure;
[0063] FIG. 51 is a partial view of a first face of a first portion
of an end-effector in accordance with one non-limiting embodiment
of the present disclosure;
[0064] FIG. 52 is a view of a piece of tissue after an end-effector
having the first portion of FIG. 51 has deployed rivets into the
tissue, created a seal in the tissue, and created a cut line in the
tissue in accordance with one non-limiting embodiment of the
present disclosure;
[0065] FIG. 53 is a partial view of a first face of a first portion
of an end-effector in accordance with one non-limiting embodiment
of the present disclosure;
[0066] FIG. 54 is a view of a piece of tissue after an end-effector
having the first portion of FIG. 53 has deployed rivets into the
tissue, created a seal in the tissue, and created a cut line in the
tissue in accordance with one non-limiting embodiment of the
present disclosure;
[0067] FIG. 55A is an elevation view of a rivet in an undeformed,
unmelted, and/or undeployed state in accordance with one
non-limiting embodiment of the present disclosure;
[0068] FIG. 55B is a perspective view of the rivet of FIG. 55A in
accordance with one non-limiting embodiment of the present
disclosure;
[0069] FIG. 55C is an elevation view of the rivet of FIGS. 55A and
55B in a melted, deformed, and/or deployed state in accordance with
one non-limiting embodiment of the present disclosure;
[0070] FIG. 56A is an elevation view of a rivet in an undeformed,
unmelted, and/or undeployed state in accordance with one
non-limiting embodiment of the present disclosure;
[0071] FIG. 56B is a perspective view of the rivet of FIG. 56A in
accordance with one non-limiting embodiment of the present
disclosure;
[0072] FIG. 56C is an elevation view of the rivet of FIGS. 56A and
56B in a melted, deformed, and/or deployed state in accordance with
one non-limiting embodiment of the present disclosure;
[0073] FIG. 57A is an elevation view of a rivet in an undeformed,
unmelted, and/or undeployed state in accordance with one
non-limiting embodiment of the present disclosure;
[0074] FIG. 57B is a perspective view of the rivet of FIG. 57A in
accordance with one non-limiting embodiment of the present
disclosure;
[0075] FIG. 57C is an elevation view of the rivet of FIGS. 57A and
57B in a melted, deformed, and/or deployed state in accordance with
one non-limiting embodiment of the present disclosure;
[0076] FIG. 58A is an elevation view of a rivet in an undeformed,
unmelted, and/or undeployed state in accordance with one
non-limiting embodiment of the present disclosure;
[0077] FIG. 58B is a perspective view of the rivet of FIG. 58A in
accordance with one non-limiting embodiment of the present
disclosure;
[0078] FIG. 58C is an elevation view of the rivet of FIGS. 58A and
58B in a melted, deformed, and/or deployed state in accordance with
one non-limiting embodiment of the present disclosure;
[0079] FIG. 59A is an elevation view of a rivet in an undeformed,
unmelted, and/or undeployed state in accordance with one
non-limiting embodiment of the present disclosure;
[0080] FIG. 59B is a perspective view of the rivet of FIG. 59A in
accordance with one non-limiting embodiment of the present
disclosure;
[0081] FIG. 59C is an elevation view of the rivet of FIGS. 59A and
59B in a melted, deformed, and/or deployed state in accordance with
one non-limiting embodiment of the present disclosure;
[0082] Corresponding reference characters indicate corresponding
parts throughout the several views. The example embodiments set out
herein illustrate various embodiments of the present disclosure, in
one form, and such example embodiments are not to be construed as
limiting the scope of the present disclosure in any manner.
DETAILED DESCRIPTION
[0083] Various embodiments are directed to apparatuses, systems,
and methods for the treatment of tissue. Numerous specific details
are set forth to provide a thorough understanding of the overall
structure, function, manufacture, and use of the embodiments as
described in the specification and illustrated in the accompanying
drawings. It will be understood by those skilled in the art,
however, that the embodiments may be practiced without such
specific details. In other instances, well-known operations,
components, and elements have not been described in detail so as
not to obscure the embodiments described in the specification.
Those of ordinary skill in the art will understand that the
embodiments described and illustrated herein are non-limiting
examples, and thus it can be appreciated that the specific
structural and functional details disclosed herein may be
representative and illustrative. Variations and changes thereto may
be made without departing from the scope of the claims.
[0084] Reference throughout the specification to "various
embodiments," "some embodiments," "one embodiment," "certain
embodiments," or "an embodiment", or the like, means that a
particular feature, structure, or characteristic described in
connection with the embodiment is included in at least one
embodiment. Thus, appearances of the phrases "in various
embodiments," "in some embodiments," "in one embodiment," "in
certain embodiments," or "in an embodiment", or the like, in places
throughout the specification are not necessarily all referring to
the same embodiment. Furthermore, the particular features,
structures, or characteristics may be combined in any suitable
manner in one or more embodiments. Thus, the particular features,
structures, or characteristics illustrated or described in
connection with one embodiment may be combined, in whole or in
part, with the features structures, or characteristics of one or
more other embodiments without limitation.
[0085] The entire disclosures of the following non-provisional
United States patents are hereby incorporated by reference
herein:
[0086] U.S. Pat. No. 7,381,209 to Truckai et al., entitled
ELECTROSURGICAL INSTRUMENT, which issued on Jun. 3, 2008;
[0087] U.S. Pat. No. 7,354,440 to Truckai et al., entitled
ELECTROSURGICAL INSTRUMENT AND METHOD OF USE, which issued on Apr.
8, 2008;
[0088] U.S. Pat. No. 7,311,709 to Truckai et al., entitled
ELECTROSURGICAL INSTRUMENT AND METHOD OF USE, which issued on Dec.
25, 2007;
[0089] U.S. Pat. No. 7,309,849 to Truckai et al., entitled POLYMER
COMPOSITIONS EXHIBITING A PTC PROPERTY AND METHODS OF FABRICATION,
which issued on Dec. 18, 2007;
[0090] U.S. Pat. No. 7,220,951 to Truckai et al., entitled SURGICAL
SEALING SURFACES AND METHODS OF USE, which issued on May 22,
2007;
[0091] U.S. Pat. No. 7,189,233 to Truckai et al., entitled
ELECTROSURGICAL INSTRUMENT, which issued on Mar. 13, 2007;
[0092] U.S. Pat. No. 7,186,253 to Truckai et al., entitled
ELECTROSURGICAL JAW STRUCTURE FOR CONTROLLED ENERGY DELIVERY, which
issued on Mar. 6, 2007;
[0093] U.S. Pat. No. 7,169,146 to Truckai et al., entitled
ELECTROSURGICAL PROBE AND METHOD OF USE, which issued on Jan. 30,
2007;
[0094] U.S. Pat. No. 7,125,409 to Truckai et al., entitled
ELECTROSURGICAL WORKING END FOR CONTROLLED ENERGY DELIVERY, which
issued on Oct. 24, 2006; and
[0095] U.S. Pat. No. 7,112,201 to Truckai et al., entitled
ELECTROSURGICAL INSTRUMENT AND METHOD OF USE, which issued on Sep.
26, 2006.
[0096] Various embodiments of apparatuses, systems, and methods of
the present disclosure relate to creating thermal "welds," "seals,"
and/or "fusion" within native tissue volumes. These terms may be
used interchangeably herein to describe thermal treatments of a
targeted tissue volume that result in a substantially uniform
fused-together tissue mass, for example, in welding blood vessels
that exhibit substantial burst strength immediately post-treatment.
The strength of such welds is particularly useful for (i)
permanently sealing blood vessels in vessel transection procedures;
(ii) welding organ margins in resection procedures; (iii) welding
other anatomic ducts wherein permanent closure is required; and
also (iv) for performing vessel anastomosis, vessel closure or
other procedures that join together anatomic structures or portions
thereof. The sealing, welding, or fusion of tissue as disclosed
herein is to be distinguished from "coagulation", "hemostasis" and
other similar descriptive terms that generally relate to the
collapse and occlusion of blood flow within small blood vessels or
vascularized tissue. For example, any surface application of
thermal energy can cause coagulation or hemostasis--but does not
fall into the category of "sealing" as the term is used herein.
Such surface coagulation may not create a seal that provides any
substantial strength in the treated tissue.
[0097] At the molecular level, the phenomena of truly "sealing"
tissue as disclosed herein may result from the thermally-induced
denaturation of collagen and other protein molecules in a targeted
tissue volume to create a transient liquid or gel-like
proteinaceous amalgam. A selected energy density can be provided in
the targeted tissue to cause hydrothermal breakdown of intra- and
intermolecular hydrogen crosslinks in collagen and other proteins.
The denatured amalgam can be maintained at a selected level of
hydration--without desiccation--for a selected time interval which
can be very brief. The targeted tissue volume can be maintained
under a selected very high level of mechanical compression to
insure that the unwound strands of the denatured proteins are in
close proximity to allow their intertwining and entanglement. Upon
thermal relaxation, the intermixed amalgam results in protein
entanglement as re-crosslinking or renaturation occurs to thereby
cause a uniform fused-together mass.
[0098] Various embodiments disclosed herein provide electrosurgical
jaw structures or portions adapted for transecting captured tissue
between the jaws or portions and for contemporaneously sealing the
captured tissue margins with controlled application of RF energy or
other energy. The jaw structures can comprise a scoring or cutting
element which can cut or score tissue independently of the tissue
capturing and sealing functions of the jaw structures or portions.
The jaw structures or portions can comprise first and second
opposing jaws that carry fuses, such as positive temperature
coefficient materials, for example, for modulating RF energy or
other energy delivery to the engaged tissue.
[0099] The embodiments of the devices described herein may be
introduced inside a patient using minimally invasive or open
surgical techniques. In some instances, it may be advantageous to
introduce the devices inside the patient using a combination of
minimally invasive and open surgical techniques. Minimally invasive
techniques may provide more accurate and effective access to the
treatment region for diagnostic and treatment procedures. To reach
internal treatment regions within the patient, the devices
described herein may be inserted through natural openings of the
body such as the mouth, anus, and/or vagina, for example. In some
circumstances, the devices can then access various tissue treatment
regions translumenally. In other instances, the devices may not
access the various tissue treatment regions translumenally. In any
event, such procedures can be combined with laparoscopic,
percutaneous, and/or open approaches. Minimally invasive procedures
performed by the introduction of various medical devices into the
patient through a natural opening of the patient are known in the
art as NOTES.TM. procedures. Some portions of the devices may be
introduced to the tissue treatment region percutaneously or through
small--keyhole--incisions. Laparoscopic approaches can comprise
Single Site Laparoscopy (SSL), which can involve a single trocar
usually placed in the umbilicus containing multiple ports. SSL can
also include the placement of multiple trocars in a single location
to minimize scarring. In one embodiment, these SSL approaches may
be combined with most NOTES.TM. procedures, natural orifice
procedures, and/or percutaneous procedures, for example. SSL can
also be referred to as Single Incision Laparocopic Surgery
(SILS.TM.) and Single Port Access (SPA). Robotic surgical
approaches can also be used with the embodiments of the present
disclosure.
[0100] Endoscopic minimally invasive surgical and diagnostic
medical procedures can be used to evaluate and treat internal
organs by inserting a small tube into the body. The endoscope may
have a rigid or a flexible tube. A flexible endoscope may be
introduced either through a natural body opening (e.g., mouth,
anus, and/or vagina) or via a trocar through a relatively
small--keyhole--incision incisions (usually 0.5-1.5 cm). The
endoscope can be used to observe surface conditions of internal
organs, including abnormal or diseased tissue such as lesions and
other surface conditions and capture images for visual inspection
and photography. The endoscope may be adapted and configured with
working channels for introducing medical instruments to the
treatment region for taking biopsies, retrieving foreign objects,
and/or performing surgical procedures.
[0101] Certain example 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 example embodiments and that the scope of the various
embodiments of the present disclosure is defined solely by the
claims. The features illustrated or described in connection with
one example 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 disclosure.
[0102] In various embodiments, surgical instruments, such as
circular staplers, for example, have been developed for use in a
surgical procedure known as an anastomosis. Circular staplers
useful for performing an anastomosis are disclosed, for example, in
U.S. Pat. No. 5,104,025 to Main et al. entitled INTRALUMINAL
ANASTOMOTIC SURGICAL STAPLER WITH DETACHED ANVIL, which was issued
on Apr. 14, 1992, 5,205,459 to Brinkerhoff et al., entitled
SURGICAL ANASTOMOSIS STAPLING INSTRUMENT, which was issued on Apr.
27, 1993, 5,285,945 to Brinkerhoff et al., entitled SURGICAL
ANASTOMOSIS STAPLING INSTRUMENT, which was issued on Feb. 15, 1994,
and 5,309,927 to Welch, entitled CIRCULAR STAPLER TISSUE RETENTION
SPRING METHOD, which was issued on May 10, 1994, and in U.S. patent
application Ser. No. 12/408,905 to Measamer et al., entitled
CIRCULAR SURGICAL STAPLING INSTRUMENT WITH ANVIL LOCKING SYSTEM,
filed on Mar. 23, 2009, which are each herein incorporated by
reference in their respective entireties.
[0103] One form of an anastomosis comprises a surgical procedure
where two tubular sections of intestine are joined together after a
diseased portion of the intestine has been excised. The procedure
usually requires re-joining ends of the two tubular sections
together to form a continuous tubular pathway. Previously, this
surgical procedure was a laborious and time consuming operation. In
most instances, the surgeon had to precisely cut and align the ends
of the two tubular sections of intestine and maintain the alignment
while joining the ends with numerous suture stitches. The
development of surgical instruments, such as circular staplers, for
example, has greatly simplified the anastomosis procedure and has
also decreased the time required to perform an anastomosis.
[0104] In one embodiment, referring to FIGS. 1-5, a surgical
instrument 10, such a surgical stapler, a circular tissue joining
device, a circular surgical stapler, and/or a surgical stapling
assembly, for example, can comprise an elongate shaft 12 comprising
a proximal end 14 and a distal end 16. In various embodiments, the
elongate shaft 12 can be rigid, while, in other embodiments, the
elongate shaft 12 can be semi-rigid or flexible or can comprise
semi-rigid or flexible portions. In one embodiment, at least a
portion of the surgical instrument 10 can be configured to be
partially inserted through a natural orifice in a patient, such as
the anus, mouth, and/or vagina, or through an incision in a body
wall using a trocar, for example. A handle portion 18 can extend
from the proximal end 14 of the elongate shaft 12 and an
end-effector 20 can extend from the distal end 16 of the elongate
shaft 12. The terms "proximal" and "distal" are used herein with
reference to the clinician or surgeon (hereafter "surgeon") holding
the handle portion 18 of the surgical instrument 10. For example,
the end-effector 20 is located distal from the surgeon while the
handle portion 18 is located proximal to the surgeon. In various
embodiments, the handle portion 18 can comprise two portions which
are assembled together to form the handle portion 18, for example.
In one embodiment, the two portions of the handle portion 18 can be
snap-fit, press-fit, adhered, glued, and/or fastened to one
another, for example.
[0105] In one embodiment, the handle portion 18 can comprise a
trigger 22 operably engaged with an actuation mechanism 24. The
actuation mechanism 24 can extend from the handle portion 18 to or
proximate to a portion of the end-effector 20. In various
embodiments, the actuation mechanism 24, or portions thereof, can
be rigid, semi-rigid, or flexible. In an embodiment, where the
actuation mechanism 24 is flexible, or comprises flexible portions,
the material can still be rigid enough to drive a staple driver 42
and/or a cutting member 40 distally within the end-effector 20. The
trigger 22 can be moved toward the handle portion 18 in the
direction indicated generally by arrow 23 to cause the actuation
mechanism 24 to move distally and fire or drive staples positioned
within a portion of the end-effector 20 distally into tissue
compressed within the end-effector 20, as described in further
detail below. When the trigger 22 is moved toward the handle
portion 18, thereby moving the actuation mechanism 24 distally, the
cutting member 40 can also be moved distally to incise tissue
compressed within the end-effector 20, as described in further
detail below. In one embodiment, the actuation mechanism 24 or
portions of the end-effector 20 can be steerable, for example.
[0106] In one embodiment, referring again to FIGS. 1-5, the
end-effector 20 can comprise a first portion 26 and a second
portion 28. The first portion 26 can comprise an aperture 30
extending therethrough such that a portion of an actuation member
31 can extend into the aperture 30 (see e.g., FIG. 5). A portion of
the actuation member 31 can extend through the actuation mechanism
24. The second portion 28 of the end-effector 20 can comprise a
projection 32 configured to extend at least partially into the
aperture 30 and be operably engaged with the actuation member 31
via any suitable connection, such as an interlocking connection as
illustrated in FIG. 5, for example. In one embodiment, a portion of
the projection 32 can slide over a distal portion of the actuation
member 31 and engage sidewalls or detents in the sidewalls of the
actuation member 31 to operably join the portion of the projection
32 and the actuation member 31. In other various embodiments, a
distal portion of an actuation member can slide over a portion of
the projection and engage sidewalls or detents in the sidewalls of
the projection to operably join the portion of the projection and
the actuation member 31.
[0107] In one embodiment, when the projection 32 of the second
portion 28 is operably engaged with the actuation member 31, the
second portion 28 can be moved relative (e.g., distal/proximal
movement) to the first portion 26 using an adjustment knob 34
located on a proximal portion of the handle portion 18, for
example. The adjustment knob 34 can be operably engaged with the
actuation member 31 such that as the adjustment knob 34 is moved or
rotated, the actuation member 31 can move distally and/or
proximally within the surgical instrument 10 (i.e., rotational
motion of the adjustment knob 34 is converted into linear motion of
the actuation member 31). In one embodiment, referring to FIG. 5,
by turning the adjustment knob 34, the length of the adjustment
member 31 extending into the aperture 30 in the first portion 26
can be adjusted. Stated another way, rotation of the adjustment
knob 34 about its longitudinal axis can move the second portion 28
relative to the first portion 26 owing to the engagement of the
portion of the projection 32 of the second portion 28 with the
distal portion of the actuation member 31. For example, if the
adjustment knob 34 is rotated in the clockwise direction, the
length of the actuation member 31 within the aperture 30 can be
increased, while if the adjustment knob 34 is rotated in the
counter-clockwise direction, the length of the actuation member 31
within the aperture 30 can be decreased. Such adjustment of the
length of the actuation member 31 within the aperture 30 in turn
can adjust the distance that the second portion 28 is positioned
from the first portion 26 thereby allowing the end-effector 20 to
clamp and release tissue positioned intermediate the first portion
26 and the second portion 28.
[0108] In one embodiment, referring to FIG. 4, the actuation member
31 can comprise a threaded rod 36 and an adjustment tube 37. A
proximal end of the threaded rod 37 can be engaged with the
actuation knob 34, such that rotation of the actuation knob 34
rotates the threaded rod 37. A distal end of the threaded rod 36
can be operably engaged with the adjustment tube 37. The adjustment
tube 37 can comprise threads on its inner surface, for example,
such that the threaded rod 36 can be threadably engaged with the
adjustment tube 37 to move the adjustment tube 37 distally and
proximally when the threaded rod 36 is rotated. Stated another way,
the proximal end of the adjustment tube 37 can essentially ride on
the distal end or portion of threaded rod 36 in threadable
engagement. In one embodiment, the adjustment tube 37 can be
configured and situated such that it does not rotate when the
threaded rod 36 is rotated to allow distal/proximal movement of the
adjustment tube 37.
[0109] In one embodiment, the adjustment knob 34 can be fixedly
attached to the proximal end of the threaded rod 36 such that as
the adjustment knob 34 is rotated in the clockwise direction, for
example, the threaded rod 36 can also be rotated in the clockwise
direction. Likewise, as the adjustment knob 34 is rotated in the
counter-clockwise direction, the threaded rod 36 can also be
rotated in the counter-clockwise direction. In one embodiment, when
the adjustment knob 34 is rotated in the clockwise direction, the
adjustment tube 37 can be moved distally and when the adjustment
knob 34 is rotated in the counter-clockwise direction the
adjustment tube 37 can be moved proximally. Such movement can
adjust the distance between the first portion 26 and the second
portion 28 when the portion of the projection 32 is engaged with
the distal end or portion of the adjustment tube 37. In various
embodiments, the adjustment tube 37 can comprise a flexible, a
semi-rigid, and/or a rigid material, for example. In one
embodiment, although not illustrated, an adjustment tube may extend
fully through the aperture 30 in the first portion 26 such that it
can be engaged with the second portion 28. In such an embodiment,
the second portion 28 of the end-effector 20 may not comprise a
projection.
[0110] In one embodiment, the adjustment knob 34 and the actuation
member 31 can be configured to move the second portion 28 to at
least one predetermined distance from the first portion 26 to cause
tissue positioned between the first portion 26 and the second
portion 28 to be compressed or clamped. In various embodiments, the
adjustment knob 34, during rotation, can encounter a stop (not
illustrated) when the predetermined distance or a minimum distance
between the second portion 28 and the first portion 26 is reached
so as to not allow a surgeon to over compress tissue positioned
intermediate the first portion 26 and the second portion 28. In one
embodiment, a tissue compression indicator 27 can be provided on
the surgical instrument 10. The tissue compression indicator 27 can
be operably or electronically linked to the adjustment knob 34, the
actuation member 31, or the end-effector 20 such that the tissue
compression indicator 27 can provide the surgeon with visual,
audible, or tactile feedback of the tissue compression or the
distance between the first portion 26 or the second portion 28. In
one embodiment, the tissue compression indicator 27 can indicate to
a surgeon the degree to which staple legs will be deformed, for
example, based on the distance between the first portion 26 and the
second portion 28. Various embodiments of such tissue compression
indicators are known to those of skill in the art. In one
embodiment, the projected tissue compression and projected staple
leg deformation can be measured by measuring the impedance of the
tissue across the thickness of the tissue, for example.
[0111] In one embodiment, referring to FIGS. 1 and 4, the trigger
22 extending from the handle portion 18, when moved in the
direction indicated generally by arrow 23, can cause the actuation
mechanism 24 to move distally within the elongate shaft 12 to drive
the staple driver member 42 distally and deploy staples 38 distally
into tissue compressed intermediate the first portion 26 and the
second portion 28 and/or drive the cutting member 40 distally to
incise the tissue. In one embodiment, the actuation mechanism 24,
the staples 38, the staple driver member 42, and/or the cutting
member 40 can each comprise an electrically conductive portion or
can be comprised of an electrically conductive material, such that
energy can be transmitted to the staples 38 and/or the cutting
member 40, as discussed in further detail herein. In one
embodiment, a staple driver member and a cutting member can be
formed of the same component. In various embodiments, the trigger
22 can be pivotably attached to the handle portion 18 such that as
the proximal end of the trigger 22 is moved toward the handle
portion 18, the distal end of the trigger 22 forces the actuation
mechanism 24 distally within the elongate shaft 12 owing to an
attachment between the distal portion of the trigger 22 and a
proximal portion of actuation mechanism 24.
[0112] In one embodiment, the trigger 22 can be normally-biased
away from the handle portion 18 such that after the proximal
portion of the trigger 22 is pulled toward the handle portion 18
and the force applied by the surgeon to the trigger 22 is released,
the trigger 22 can again be biased into the position shown in FIG.
1, for example. Such biasing can cause the actuation mechanism 24
to move proximally or remain proximally positioned within the
elongate shaft 12 owing to the attachment between the distal
portion of the trigger 22 and the proximal portion of actuation
mechanism 24. The biasing can be accomplished by any suitable
biasing member.
[0113] In one embodiment, referring to FIGS. 1-5, the first portion
26 can comprise a first face 44 at least partially or fully
surrounding the aperture 30. The first portion 26 can also
optionally comprise one or more staple cavities 46 defined in the
first face 44. In one embodiment, the one or more staple cavities
46 can be formed in a staple cartridge 49 and a top surface 50 of
the staple cartridge 49 can form a portion of the first face 44
and/or can be positioned flush with a plane of the first face 44.
If the staple cartridge 49 is provided, the first portion 26 can
define a receiving slot into which the staple cartridge 49 can be
removably positioned. A staple 38 can be removably positioned
within each staple cavity 46.
[0114] In various embodiments, the first portion 26 can also
comprise the cutting member 40 and the staple driver member 42. The
staple driver member 42, upon a force applied to it by the
actuation mechanism 24, can drive the cutting member 40 and the
staples 38 distally into tissue positioned intermediate the first
portion 26 and the second portion 28. In one embodiment, the staple
driver member 42 can be configured to move the one or more staples
38 between a first stored position in which the staples 38 are at
least partially positioned within the staple cavities 46 and a
second position in which the staples 38 are at least partially
deployed from the staple cavities 46 into the tissue positioned
intermediate the first face 44 of the first portion 26 and a second
face of the second portion 28.
[0115] In one embodiment, the first portion 26 can also comprise a
first electrode 54, such as an electrode comprising an arcuate or
circular shape, for example, that can at least partially surround
the aperture 30. In one embodiment, the first electrode 54 can
function as a positive electrode that provides energy to the
end-effector 20. The first electrode 54 can be positioned one of on
and proximate to the first face 44, as discussed in further detail
below. In various embodiments, the cutting member 40 and/or the
staples 38 can also act as electrodes when driven by the actuation
mechanism 24, as described herein. In one embodiment, the first
portion 26 can comprise a fuse, such as a positive temperature
coefficient material, for example, and an insulator as discussed in
further detail herein.
[0116] In one embodiment, still referring to FIGS. 1-5, the second
portion 28 can comprise a second face 56 that substantially opposes
the first face 44 when the projection 32 of the second portion 28
at least partially extends into the aperture 30 of the first
portion 26 and is engaged with the actuation member 31. The second
portion 28 can function as an anvil having one or more anvil
pockets 58 defined in the second face 56. The anvil pockets 58 can
receive portions of legs of the staples 38 after those legs extend
through tissue to deform portions of those legs and form staples in
any suitable manner. The second portion 28 can also comprise a
second electrode 60 positioned one of on and proximate to the
second face 56. In certain embodiments, the second electrode 60 can
comprise an electrically conductive portion of the second portion
28, such as a metal portion, for example. In one embodiment, the
second electrode 60 can function as the return electrode, or
negative electrode, in combination with the actuation member 31,
for example. In such an embodiment, the actuation member 31 can
comprise an electrically conductive member or portion or can be
attached to a conductive member or portion, such as a wire, for
example. In other various embodiments, the actuation member 31 can
be comprised of an electrically conductive material, for example.
In one embodiment, the second portion 28 can comprise a fuse, such
as a positive temperature coefficient material, for example, and an
insulator as discussed in more detail herein.
[0117] In one embodiment, the fuse 62 can be positioned
intermediate or at least partially intermediate the first electrode
54 of the first portion 26 and the second electrode 60 of the
second portion 28. In other embodiments, the fuse 62 can be
positioned on, attached to, or form a portion of the first portion
26 and/or the second portion 28. In still other embodiments, the
fuse can be positioned on portions of the staples 38 and/or within
the anvil pockets 58, for example. In various embodiments, the fuse
62 can function like a conventional fuse. In one embodiment, the
fuse 62 can selectively interrupt energy flowing from the first
electrode 54 to the second electrode 60 to at least inhibit over
sealing or over heating of the tissue during sealing of the tissue
positioned intermediate the first electrode 54 and the second
electrode 60. As will be recognized by those of skill in the art,
heat is generated in tissue when energy, such as electrical
current, for example, flows from one electrode, such as the first
electrode 54, through the tissue, to another electrode, such as the
second electrode 60. This heat is caused by the resistance that the
tissue provides to the energy flow between the two electrodes. In
one embodiment, the fuse 62 can be used to control the amount of
heat generated, i.e., by limiting or stopping the energy flow
between the electrodes if the temperature of the tissue exceeds a
predetermined temperature, such as a temperature of 100 degrees C.,
for example.
[0118] In one embodiment, the fuse 62 can comprise a positive
temperature coefficient material (hereafter "PTC material"), for
example. As the PTC material increases in temperature, the
electrical impedance of the PTC material can increase. Thus, the
PTC material can become power limiting when the temperature of the
PTC material rises above a desired level and, thus, the impedance
can rise above the desired level. In one embodiment, if a PTC
material is used, a constant voltage source can be used. The
electrical characteristics of the heating thus can be sensed to
indirectly sense tissue temperature. Examples of PTC materials and
their functions are described in greater detail in U.S. Pat. Nos.
5,624,452 to Yates, entitled HEMOSTATIC SURGICAL CUTTING OR
STAPLING INSTRUMENT, which was issued on Apr. 29, 1997 6,929,644 to
Truckai et al., entitled ELECTROSURGICAL JAW STRUCTURE FOR
CONTROLLED ENERGY DELIVERY, which was issued on Aug. 16, 2005,
6,770,072, to Truckai et al., entitled ELECTROSURGICAL JAW
STRUCTURE FOR CONTROLLED ENERGY DELIVERY, which was issued on Aug.
3, 2004, and 6,929,622 to Chian, entitled SAFETY SYRINGE CYLINDER,
which was issued on Aug. 16, 2005, the entire disclosures of which
are hereby fully incorporated by reference.
[0119] In one embodiment, temperature measuring devices or sensors,
such as thermocouples, RTD's (resistive thermal devices),
thermistors, and other suitable devices can be embedded at
strategic locations within the end-effector 20 or other
end-effectors or end-effector assemblies to sense the temperature
of the tissue positioned within the end-effector 20. As a result,
the delivery of energy to at least one of the electrodes can be
controlled in response to feedback from these devices, for
example.
[0120] In one embodiment, the surgical instrument 10 can be
configured to supply energy, such as electrical energy, RF energy,
ultrasonic energy, and/or thermal energy, for example, to the
tissue compressed between the first face 44 and the second face 56
using the first and second electrodes 54 and 60 to seal or
otherwise energize the tissue. As discussed above, the heat can be
generated by the resistance to energy flow between the first and
second electrodes 54 and 60 or other electrodes that the tissue
creates. In various embodiments, the surgical instrument 10 can
comprise an activation button 64 or a trigger on the handle portion
18 configured to cause the energy to flow to the first electrode
54, for example, when depressed or retracted. The activation button
64 can essentially act as a switch that is closed when the
activation button 64 is depressed. The switch can remain closed
until a predetermined time has lapsed to ensure adequate tissue
sealing. In one embodiment, the switch can be normally-open such
that energy does not flow to the end-effector at undesirable times.
In other embodiments, the trigger 22 can activate the energy flow
or can contact a switch when the proximal end of the trigger 22 is
moved toward the handle portion 18 to allow the energy to flow to
the first electrode 54 or another suitable electrode.
[0121] In various embodiments, referring to FIG. 4, the handle
portion 18 can comprise one or more energy inputs, such as input or
terminal 66, for example, which can be operably coupled with an
energy source 68, such as a voltage source, a direct current
source, an RF, and/or an ultra-sonic source, for example. Suitable
energy sources are known in the art. In various embodiments, the
energy source 68 can provide energy to the surgical instrument 10
and at least to the first electrode 54, wherein the magnitude,
duration, wave form, and/or frequency, for example, of the energy
can be sufficiently controlled or modulated, by a controller 70,
for example, to provide a desired amount of energy to the surgical
instrument 10 and/or the end-effector 20 of the surgical instrument
10. In various embodiments, the activation button 64 can be
configured to operably support a switch or a trigger, for example,
which can be configured to electrically couple the energy source 68
with a first electrical conductor 70 of the surgical instrument 10
such that the energy supplied to the input 66 can be transmitted to
the end-effector 20 and/or one of the electrodes.
[0122] In various embodiments, further to the above, the first
electrical conductor 70 of the surgical instrument 10 can comprise
a wire, such as insulated wire, for example, which can extend
between the input 66 and the activation button 64 and extend
between the activation button 64 and the first electrode 54, for
example. As discussed above, the activation button 64 can act as a
switch to allow energy to pass through the first electrical
conductor 70 from one side of the activation button 64 to the other
side of the activation button 64 when the activation button 64 is
depressed or engaged. The energy can then be in electrical
communication with the first electrode 54, for example, until the
activation button 64 is released or until a predetermined time has
lapsed, such as after 2 to 6 seconds, after 4 seconds, after 5 to
20 seconds, or after 10 to 15 seconds, for example. In one
embodiment, the first electrical conductor 70 can comprise a
conductive insert, comprised of copper or other conductive
material, for example, which can be at least partially positioned
within an insulative jacket or sheath, for example. In certain
circumstances, the insulative jacket can be molded over the first
electrical conductor 70 during an injection molding process, for
example.
[0123] In one embodiment, energy can be transmitted from the first
electrical conductor 70 to the first electrode 54, pass through the
tissue compressed intermediate the first portion 26 and the second
portion 28, and then flow to the second electrode 60. The second
electrode 60 can be in electrical communication with a second
electrical conductor 72. In one embodiment, the second electrical
conductor 72 can be formed with the activation member 31, a portion
of the activation member 31, or can be an electrical conductor
attached to, formed on, formed within, or positioned within the
activation member 31. As a result, the energy can pass from the
second electrode 60 to a contact 59 on the projection 32 or the
actuation member 31 to the second electrical conductor 72 to an
electrical output or terminal 74 and back to the energy source 68.
The contact 59 can be in electrical communication with the second
electrode 60. In other embodiments, a second electrical conductor
can extend from a contact on the distal end or portion of the
actuation member 31 to the electrical output or terminal 74. The
contact 59 can be in conductive communication with the second
electrode 60 when the projection 32 is engaged with the actuation
member 31 such that return energy can flow to the output or
terminal 74 and then back to the energy source 68 to complete the
circuit of the energy source 68.
[0124] In various embodiments, insulative materials or
non-conductive portions can be suitably positioned within the
end-effector 20 and/or the surgical instrument, such that the
energy can flow appropriately along a predetermined path through
the end-effector 20 and/or the surgical instrument 10. Those of
skill in the art will recognize the suitable placement of the
various insulative materials and non-conductive portions within the
end-effector 20 and/or the surgical instrument 10.
[0125] In one embodiment, referring to FIGS. 5 and 6, in the
performance of a surgical anastomotic operation, two tubular pieces
of lumen or tubular tissue A and B (e.g., intestinal tissue), can
be attached together by the staples 38, and/or by seals 76 created
by the energy flowing through the first and second electrodes 54
and 60 or through other electrodes. In various embodiments, it may
be desirable to use only the staples 38 or to use only the seals 76
to attach the tubular tissue A to the tubular tissue B, depending
on the wall thickness of the tubular tissue A and B compressed
between the first face 44 and the second face 56. In one
embodiment, the two pieces of tubular tissue A and B may be
attached end-to-end or one piece of the tubular tissue may be
attached laterally around an opening formed in the side of another
piece of the tubular tissue. In performing the anastomosis with the
surgical instrument 10, the two pieces of tubular tissue A and B
can first be compressed together intermediate the first face 44 and
the second face 56 by rotating the adjustment knob 34 in a
clockwise direction, for example. The activation button 64 can then
optionally be depressed to allow energy to pass to the first
electrode 54, through the fuse 62 or fuses, through the tissue, and
to the second electrode 60. The staple driver member 42 can then be
driven distally by actuation of the trigger 22 to drive the staples
38 into the tissue and form the staples 38 using the anvil pockets
58 of the second portion 28 (i.e., by deforming a portion of the
legs of the staples 38). At the same time, the cutting member 40
can be driven distally by the same actuation of the trigger 22 to
cut the excess tissue positioned intermediate the first portion 26
and the second portion 28. In other embodiments, an additional
trigger (not illustrated) can be provided such that one trigger
drives the staple driver member 42 distally and the other trigger
drives the cutting member 40 distally, for example. As a result of
the cutting member 40 being driven distally, a donut-shaped section
of tissue can be severed from each of the tubular pieces of tissue
A and B by the cutting member 40. The tubular tissue A and B joined
by the staples 38 and/or the seal 76 can be released from being
compressed intermediate the first face 44 and the second face 56 by
rotating the adjustment knob 34 in the counter-clockwise direction,
for example, to thereby move the actuation member 31 distally and
move the second portion 28 away from the first portion 26. The
surgical instrument 10 can then be removed from the surgical site
by pulling the end-effector 20 through the circular opening between
the pieces of tubular tissue A and B attached by the staples 38
and/or the seal 76.
[0126] In one embodiment, the cutting member 40 and/or the staples
38 can function as an additional or a third electrode. In other
embodiments, the cutting member 40 can function as a third
electrode and the staples 38 can function as a fourth electrode, or
vice versa, for example. In such embodiments, the cutting member 40
and/or the staples 38 can comprise a conductive material, such as a
metal, for example, such that the energy from the energy source 68
can flow therethrough. In one embodiment, the input or terminal 66
can be in electrical communication with an electrical conductor
(not illustrated) formed with, formed on, positioned on, attached
to, positioned within, or formed of the actuation mechanism 24. As
a result, when the actuation mechanism 24 is brought into contact
with the staple driver member 42, the cutting member 40 and/or the
staples 38 can be energized with the energy owing to the fact that
the staple driver member 42, the cutting member 40, and/or the
staples 38 can comprise electrically conductive portions or can be
comprised of electrically conductive materials, for example. The
energy can flow through the staples 38 and/or the cutting member
40, through the tissue compressed between the first face 44 and the
second face 56, and to the second electrode 60 and exit the
surgical instrument 10 through the second electrical conductor 72,
as discussed above. The energy can also flow through the fuse 62 or
another suitable fuse. In other embodiments, the energy can flow
through the staples, through the tissue, and be returned to the
energy source 68 using the cutting member 40 or the second
electrode 60 as a return electrode, for example. Here, again, the
energy can also flow through the fuse 62 or another suitable fuse.
In one embodiment, a separate electrical conductor (not
illustrated) can be provided in communication with the cutting
member 40 to assist the cutting member 40 in acting as the return
electrode for the energy passing through the tissue from the
staples 38. The separate electrical conductor can be used to
complete the circuit with the energy source 68. In one embodiment,
by energizing the staples 38 and/or the cutting member 40, a seal
can be created at the site of piercing and/or cutting of the tissue
(i.e., where the staple legs pierce the tissue and/or where the
cutting member 40 cuts the tissue), thereby reducing bleeding
through the creation of a seal at the piercing and/or cutting site.
In one embodiment, energy flowing through the staples 38 as they
are fired can tend to have its highest flux density at the tips of
the staples 38 owing to the tips being pointed (minimum surface
area) and the closest to the return electrode. In various
embodiments, energy flowing through the cutting member 40 can also
have its highest flux density at the tip of the cutting member 40
owing to the tip having a reduced surface area compared to the
remainder of the cutting member 40. The above can result in
enhanced mechanical sharpness and reduced force to fire of the
staples 38 and/or the cutting member.
[0127] In one embodiment, the activation button 64 can be used to
allow energy to flow to the staples 38 and/or to the cutting member
40. Although not illustrated, a separate activation button can also
be used to allow energy to pass to the staples 38 and/or to the
cutting member 40. The separate activation button can be configured
and operate similar to the activation button 64 described above. In
other embodiments, other convention types of activation buttons or
switches can be used with the surgical instrument 10, for
example.
[0128] In various embodiments, a separate energy source (not
illustrated) can be used to provide energy to the cutting member 40
and/or the staples 38 for example. In such an embodiment, a circuit
can be created through the use of electrical conductors from the
separate energy source, to the cutting member 40 and/or the staple
driver member 42, and back to the separate energy source. In one
embodiment, the separate energy source can be similar to or the
same as the energy source 68 described above and can be controlled
by a controller similar to or the same as the controller 70.
[0129] By providing energy to the cutting member 40 and/or the
staples 38, a seal can be created where the cutting member 40 cuts
the tissue and/or where legs of the staples 38 pierce the tissue.
These seals at the point of tissue cutting and/or piercing can
reduce bleeding of the tissue. In one embodiment, the seals formed
where the cutting member 40 cuts the tissue and/or where the legs
of the staples 38 pierce the tissue can be used to seal the tissue
in place of the seal 76 formed by the first and second electrodes
54 and 60. In other embodiments, the seals formed where the cutting
member 40 cuts the tissue and/or where the legs of the staples 38
pierce the tissue can be used to seal the tissue as a supplementary
seal to the seal 76 formed by the first and second electrodes 54
and 60.
[0130] In various configurations, by using more than two electrodes
of the end-effector 20, the thermal spread of heat within the
tissue compressed between the first face 44 and the second face 56
can be minimalized thereby reducing heating of the tissue adjacent
to the end-effector 20 (i.e., tissue outside of the end-effector
20). Such minimalization can occur owing to a controlled path of
the energy through the various electrodes.
[0131] In the embodiments described below, like numerals (e.g., 26,
126, 126', 226 etc.) describe similar components, as those
described above, unless otherwise indicated. A full description of
each like numbered component below has been omitted for
brevity.
[0132] In one embodiment, referring to FIG. 7a, an end-effector 120
is disclosed. The end-effector 120 can comprise a first portion 126
and a second portion 128. The first portion 126 can comprise staple
cavities 146 that can be configured to each receive a staple 138,
as explained in greater detail above. In one embodiment, the first
portion 126 can also be configured to receive a staple cartridge
149 that comprises the staple cavities 146 and the staples 138 and
fits at least partially within a receiving slot in the first
portion 126. The staples 138 can be driven distally toward the
second portion 128 by a staple driving member 142, similar to that
explained above. The first portion 126 can comprise a cutting
member 140 configured to cut tissue, a first electrode 154, and an
aperture 130. The second portion 128 can comprise a projection 132
configured to be at least partially positioned within the aperture
130, a second electrode 160, a fuse 162, such as PTC material, for
example, and anvil pockets 158. In FIG. 7a, the second portion 128
is not connected to the first portion 126 for clarity in
illustration. In one embodiment, the first electrode 154 can be
positioned radially inwardly of the staple cavities 146 and
radially outward from the cutting member 140 on the first portion
126. The anvil pockets 158 can be aligned with the staple cavities
146 when the first portion 126 is engaged with the second portion
128 such that they can deform the staple legs when the staples 138
are pushed distally. Similarly, the first electrode 154 can be
aligned with the fuse 162 when the first portion 126 is engaged
with the second portion 128. As a result, a seal can be formed in
tissue positioned intermediate the first portion 126 and the second
portion 128 between a cutting line formed by the cutting member 140
and a staple line formed by the staples 138. In various
embodiments, portions of the first face 144, the second face 156,
and/or other portions of the end-effector 120 can comprise
insulative materials "I" such that energy flows from the first
electrode 154 through the fuse 162 to the second electrode 160. If
the insulative materials "I" are not provided, the energy may flow
in undesirable directions. In one embodiment, insulative materials
(not illustrated) can be provided around the staple cavities 146
and/or around the anvil pockets 158, such that when tissue is
compressed intermediate the staple cavities 146 and the anvil
pockets 158 and the end-effector 120 is energized, energy will not
be attracted to the staples 138 owing to the insulative barrier
created by the insulative materials.
[0133] In one embodiment, FIG. 7b illustrates a cross-sectional
view of the end-effector 120 of FIG. 7a when the first portion 126
is engaged with the second portion 128. In various embodiments,
FIG. 7b illustrates the energy flow and the polarity of the first
and second electrodes 154 (+) and 160 (-) and an example of where
the insulative materials "I" are provided in the end-effector
120.
[0134] In one embodiment, although not illustrated, a first
electrode can be positioned a depth within a first face of a first
portion of an end-effector. A fuse, such as PTC material, for
example, can be positioned over the first electrode and be flush,
or substantially flush with a plane of the first face of the first
portion. In such an embodiment, a portion of a second electrode may
be positioned on a second face of the second portion. In one
embodiment, the second electrode can be positioned a depth within a
second face of the second portion of the end-effector. A fuse, such
as PTC material, for example, can be positioned over the second
electrode and be flush, or substantially flush with the plane of
the second face of the second portion. In other embodiments, the
fuse may only be provided on the first portion or the second
portion. The portions of the first face and the second face not
comprising the fuse can be comprised of an insulative material,
such that energy from the first electrode can be directed through
the fuse toward the second electrode and may be inhibited from
bypassing the fuse to get to the second electrode. As discussed
herein, the fuse can limit or stop the energy flow from the first
electrode to the second electrode, when appropriate, to maintain
the temperature of the tissue in the end-effector within a
reasonable sealing temperature, such as 100 degrees C., for
example.
[0135] In one embodiment, referring to FIG. 8a, another
end-effector 120' is illustrated. The end-effector 120' can
comprise a first portion 126' and a second portion 128'. In such an
embodiment, the first portion 126' can comprise a first electrode
154' positioned radially outward from staple cavities 146'. A
cutting member 140' can be positioned radially inward from the
staple cavities 146'. Correspondingly, a staple driver member 142'
can be positioned radially inward as compared to that illustrated
in the embodiment of FIG. 7a. Also, in such an embodiment, a fuse
162' on the second portion 128' can be positioned radially outward
from the anvil pockets 158'. Similar to the embodiment of FIG. 7a,
anvil pockets 158' can be aligned with staple cavities 146' when a
projection 132' of the second portion 128' is at least partially
positioned within an aperture 130' in the first portion 126' such
that staple legs of staples 138' positioned within the staple
cavities 146' can be deformed by the anvil pockets 158' when the
staples 138' are driven distally toward the second portion 128'. In
various embodiments, portions of the first face 144', the second
face 156', and/or other portions of the end-effector 120' can
comprise insulative materials such that energy flows from the first
electrode 154' through the fuse 162' to the second electrode 160'.
If the insulative materials are not provided, the energy may flow
in undesirable directions. In one embodiment, insulative materials
(not illustrated) can be provided around the staple cavities 146'
and/or around the anvil pockets 158', such that when tissue is
compressed intermediate the staple cavities 146' and the anvil
pockets 158' and the end-effector 120' is energized, energy will
not be attracted to the staples 138' owing to the insulative
barrier created by the insulative materials.
[0136] In one embodiment, FIG. 8b is a cross-sectional view of the
end-effector 120' of FIG. 8a when the first portion 126' is
attached to the second portion 128'. In various embodiments, FIG.
8b illustrates the energy flow and the polarity of the first and
second electrodes 154' (+) and 160' (-) and an example of where the
insulative materials "I" are provided in the end-effector 120'.
[0137] In one embodiment, referring to FIG. 9a, an end-effector 220
is disclosed which is similar to end-effector 120' above, but that
has two rows of staple cavities 246 defined in a first portion 226
and two rows of anvil pockets 258 defined in a second portion 228.
In such an embodiment, a staple driving member 242 can drive the
two rows of staples 238 into the tissue compressed between the
first portion 226 and the second portion 228. The first portion 226
can comprise a first electrode 254 and an aperture 230 configured
to at least partially receive a projection 232 of the second
portion 228. The first electrode 254 can be positioned radially
outward of the two rows of staples 254 and radially outward of a
cutting member 240. The cutting member 240 can be positioned
radially inward of the two rows of staple cavities 246. The second
portion 228 can comprise a fuse 262. The fuse 262 can be positioned
radially outward of the two rows of the anvil pockets 258. In
various embodiments, portions of the first face 244, the second
face 256, and/or other portions of the end-effector 220 can
comprise insulative materials "I" such that energy flows from the
first electrode 254, through the fuse 262, and to the second
electrode 260. If the insulative materials are not provided, the
energy may flow in undesirable directions. In one embodiment,
insulative materials (not illustrated) can be provided around the
staple cavities 249 and/or around the anvil pockets 258, such that
when tissue is compressed intermediate the staple cavities 249 and
the anvil pockets 258 and the end-effector 220 is energized, energy
will not be attracted to the staples 238 owing to the insulative
barrier created by the insulative materials.
[0138] In one embodiment, FIG. 9b is a cross-sectional view of the
end-effector 220 of FIG. 9a when the first portion 226 is attached
to the second portion 228. In various embodiments, FIG. 9b
illustrates the energy flow and the polarity of the first and
second electrodes 254 (+) and 260 (-) and an example of where the
insulative materials are provided in the end-effector 220.
[0139] In one embodiment, referring to FIG. 10a, an end-effector
220' comprising a first portion 226' and a second portion 228' is
provided. The end-effector 220' is the same as the end-effector 220
except that a first portion 226' of the end-effector 220' has a
first electrode 254' that is positioned radially inward of two rows
of staples 238' and except that the second portion 228' has a fuse
262' positioned radially inward of two rows of anvil pockets 258'.
A cutting member 240' of the first portion 226' can be positioned
radially inward of the first electrode 254'. A staple driving
member 242' on the first portion 226' can be positioned
accordingly. In various embodiments, portions of the first face
244', the second face 256', and/or other portions of the
end-effector 220' can comprise insulative materials "I" such that
energy flows from the first electrode 254' through the fuse 262' to
the second electrode 260'. If the insulative materials "I" are not
provided, the energy may flow in undesirable directions. In one
embodiment, insulative materials (not illustrated) can be provided
around the staple cavities 249' and/or around the anvil pockets
258', such that when tissue is compressed intermediate the staple
cavities 249' and the anvil pockets 258' and the end-effector 220'
is energized, energy will not be attracted to the staples 238'
owing to the insulative barrier created by the insulative
materials.
[0140] In one embodiment, FIG. 10b is a cross-sectional view of the
end-effector 220' of FIG. 10a when the first portion 226' is
attached to the second portion 228'. In one embodiment, FIG. 10b
illustrates the energy flow and the polarity of the first and
second electrodes 254' and 260' and an example of where the
insulative materials are provided in the end-effector 220'.
[0141] In one embodiment, referring to FIG. 11a, an end-effector
320 comprises a first portion 326 and a second portion 328. The
first portion 326 can comprise a first electrode 354, an aperture
330 configured to receive a projection 332 of the second portion
328, and optionally a fuse 362, such as PTC material, for example.
The first portion 326 can comprise a cutting member 340 positioned
radially inward of the first electrode 354. The second portion 328
can comprise a second electrode 360 and optionally a fuse (not
illustrated), such as PTC material, for example. In such an
embodiment, fewer or no staples may be required. Such an embodiment
may be useful for sealing relatively thin tissue, such as in tissue
in the range of 0.25 mm to 1.0 mm or less than 1.0 mm, for example.
In various embodiments, portions of the first face 344, the second
face 356, and/or other portions of the end-effector 320 can
comprise insulative materials such that energy flows from the first
electrode 354, through the fuse 362, and to the second electrode
360.
[0142] In one embodiment, FIG. 11b is a cross-sectional view of the
end-effector 320 of FIG. 11a when the first portion 326 is attached
to the second portion 328. In various embodiments, FIG. 11b
illustrates the energy flow and the polarity of the first and
second electrodes 354 (+) and 360 (-).
[0143] In one embodiment, the surgical instruments disclosed herein
can be operated in at least two ways. In a first method of
operation, the second portion of the end-effector can be engaged
with the first portion of the end-effector inside separated pieces
of tubular tissue, such as an intestine, for example, such that the
actuation mechanism is operably engaged with the second portion.
Next, the actuation knob can be rotated about its longitudinal axis
to compress the tissue positioned intermediate the first portion
and the second portion. After the tissue has been compressed to the
surgeon's liking or to a suitable predetermined thickness for
adequate staple formation in the tissue or sealing of the tissue,
possibly using a tissue compression indicator, such as tissue
compression indicator 27, for example, the proximal end of the
trigger can be moved or pulled toward the handle portion of the
surgical instrument to move the actuation mechanism distally within
the surgical instrument to fire the staples and move the cutting
member distally and optionally to energize the first electrode. In
other embodiments, the first electrode can be energized when the
activation button is depressed, for example. In various
embodiments, energy can also be supplied to the staples, such as
the staples 38, and to the cutting member, such as the cutting
member 40, as discussed above. By causing the actuation mechanism
to move distally, the staples can be fired into the tissue and
formed against the second portion of the end-effector or the anvil
pockets and the cutting member can be advanced distally to excise
the tissue. In one embodiment, the surgeon can hold, pull, or bias
the proximal end of the trigger against the handle portion of the
surgical instrument, or can hold the activation button in a
depressed position, until an indicator informs the surgeon that the
tissue has been adequately sealed. In various embodiments, the
indicator can be a visual indicator, such as a light emitting
diode, for example, or an audible indicator, such as a buzzer or an
alarm, for example. In certain embodiments, the time required to
fully seal the tissue can be in the range of 2 to 6 seconds, 4
seconds, 2 to 15 seconds, or 3 to 10 seconds, for example.
[0144] In one embodiment, further to the above, the surgical
instrument can comprise a trigger lockout (not illustrated)
configured to maintain the proximal end of the trigger proximal to
the handle portion (i.e., in the actuated position) until a
suitable sealing time has lapsed. In such an embodiment, upon
retraction of the proximal end of the trigger toward the handle
portion, a solenoid, for example, positioned proximate to the
trigger can be energized to drive a piston from the body of the
solenoid and engage an aperture or detent in the trigger to
maintain the trigger in the actuated position. The solenoid can be
de-energized and the piston can retract into the body of the
solenoid after a predetermined tissue sealing time has lapsed to
allow the trigger to be biased back into the position illustrated
in FIG. 1, thereby ceasing the energy flow to the electrodes. In
such an embodiment, energy can flow to the electrodes when the
trigger is held in the actuated position. In other various
embodiments, the solenoid can be de-energized and the piston can
retract into the body of the solenoid when the measured tissue
impedance exceeds a threshold value that indicates that the tissue
is fully treated and/or sealed. The solenoid can be activated or
energized by a switch, or other suitable activation technique, when
the trigger is initially moved toward the handle portion. Such a
trigger lockout can prevent, or at least inhibit, the surgeon from
releasing the trigger or allowing the trigger to be biased into the
positioned illustrated in FIG. 1 prior to the seal being fully
formed in the tissue compressed intermediate the first portion and
the second portion. Such a feature can prevent, or at least reduce,
the chance that a weak or unsuitable seal is formed in the tissue.
In other various embodiments, other suitable trigger lockout
devices can be used and are within the scope of the present
disclosure. Such trigger lockout devices are within the skill of
those of ordinary skill in the art.
[0145] In one embodiment, a similar solenoid can be operably
engaged with a portion of the activation button. The solenoid can
be activated or energized when the activation button is depressed.
While energized, the piston of this solenoid can be extended to
engage a portion of the activation button to hold the activation
button in the depressed position and maintain energy flow to the
electrodes for a predetermined or suitable period of time. The
solenoid can be de-energized and the piston can then be retracted
and withdrawn from contact with the portion of the activation
button after the predetermined or suitable period of time has
passed to allow energy flow to the electrodes to cease.
[0146] In the second method of operation, the second portion of the
end-effector can be engaged with the first portion of the
end-effector inside separate pieces of tubular tissue, such as an
intestine, for example, such that the actuation member is operably
engaged with the second portion. Next, the actuation knob can be
rotated about its longitudinal axis to compress the tissue
positioned intermediate the first portion and the second portion.
After the tissue has been compressed to the surgeon's liking or to
a suitable predetermined thickness for adequate staple formation in
the tissue or sealing of the tissue, possibly using a tissue
compression indicator, such as tissue compression indicator 27, for
example, the surgeon can depress the activation button 64 or other
suitable activation button to supply energy to the first electrode
or to another electrode. In various embodiments, energy can also be
supplied to the staples, such as the staples 38, and to the cutting
member, such as cutting member 40, as discussed above. While energy
is being supplied to the first electrode, the staples, and/or the
cutting member, the trigger can be locked in the biased position
illustrated in FIG. 1, such that the proximal end of the trigger
cannot be moved toward the handle portion, to thereby prevent
firing of the staples and distal movement of the cutting member,
until the first electrode, the staples, and/or the cutting member
have been energized for a period of time long enough to form a
suitable seal in the tissue. In one embodiment, the proximal end of
the trigger can be prevented from moving toward the handle portion
using a trigger lockout, similar to the trigger lockout comprising
a solenoid described above, for example. After a predetermined
sealing time has lapsed, the trigger lockout can release from the
trigger (e.g., the piston of the solenoid is retracted into a body
of the solenoid) thereby allowing the proximal end of the trigger
to be moved toward the handle portion to fire the staples and move
the cutting member distally. Other methods of operation will be
recognized as part of the present disclosure by those of skill in
the art.
[0147] In one embodiment, referring to FIG. 12, a staple cartridge
449 comprising an electrode 454 is disclosed. The staple cartridge
449 can comprise a face 444 and a tissue-contacting surface having
staple cavities 446 defined therein. The staple cavities 446 can
each comprise a staple 438 comprising one or more staple legs. The
staple cartridge 449 can be configured to be positioned within a
receiving slot in a first portion of a surgical instrument, such as
the first portion 26 of the surgical instrument 10 described above.
The staples 438 can then be driven from the staple cartridge 444
distally into tissue using a staple driver member, such as the
staple driver member 42 of the surgical instrument 10 described
above. In one embodiment, the staple driver member 42 can be
comprised of a PTC material or the staple contacting surface of the
staple driver member 42 can be comprised of a PTC material. In one
embodiment, the electrode 454 can be positioned radially inward of
the staple cavities 446, for example. The electrode 454 can be
engaged with an electrical conductor such that energy can flow to
the electrode at an appropriate time. Although one embodiment of
the staple cartridge 449 is illustrated in FIG. 12, those of skill
in the art will recognize that other configurations of staple
cartridges are within the scope of the present disclosure. For
example, a staple cartridge could have two rows of staple pockets
and/or one or more electrodes. In various embodiments, the staple
pockets can be positioned radially inward or radially outward of
the electrodes, for example.
[0148] Although multiple example embodiments of the first portion
and the second portion of the end-effector of the present
disclosure are discussed herein, those of skill in the art will
recognize that various other configurations are also within the
scope of the present disclosure. For example, a first portion of an
end-effector can have three sets of staple cavities positioned
radially inward or radially outward of an electrode, while the
second portion can have a corresponding electrode and/or fuse
positioning and anvil pocket positioning. In certain other
embodiments, one or more rows of staple cavities can be positioned
radially outward from an electrode and one or more rows of staple
cavities can be positioned radially inward from the electrode in a
first portion of an end-effector. In such an embodiment, a second
portion of the end-effector can have corresponding anvil pocket
positioning and electrode and/or fuse positioning. In such an
embodiment, a staple line can be formed in tissue compressed within
the end-effector intermediate one or more rows of staples. Other
various embodiments and configurations of the electrodes, the fuse,
the staple cavities, and the anvil pockets are envisioned and are
within the scope of the present disclosure. It will be understood
that the example embodiments presented herein are not intended to
limit the scope of the appended claims.
[0149] Although the surgical instrument 10 is illustrated and
described with a first portion 26 that functions as the staple
deploying portion and a second portion 28 that functions as an
anvil for deforming the staples, the first portion can function as
the anvil and the second portion can function as the staple
deploying portion and/or staple cartridge. In such an embodiment,
the staples can be positioned within a receiving slot, a staple
cartridge, or staple cavities in the second portion and anvil
pockets can be positioned within the first portion. A cutting
member can also be engaged with the second portion. The electrode
configuration can be similar to that discussed above. In such an
embodiment, the second portion can be pulled toward the first
portion to deploy the staples proximally against the first portion
and to move the cutting member proximally toward the first
portion.
[0150] In one embodiment, the end effector 20 can comprise a tissue
thickness indicator (not illustrated) configured to sense a
thickness of the tissue positioned intermediate the first face 44
and the second face 56. In various embodiments, the tissue
thickness indicator can be positioned on the first face 44, the
second face 56, or the first face 44 and the second face 56, for
example. In other embodiments, the tissue thickness indicator can
be positioned at other suitable locations on the end-effector 20.
Suitable tissue thickness indicators will be apparent to those of
skill in the art, such as proximity sensors, for example. In one
embodiment, the projected tissue compression and projected staple
leg deformation can be measured by measuring the impedance of the
tissue across the thickness of the tissue, for example. The tissue
thickness indicator can be in electrical communication with a
processor, such as a microprocessor, for example, which can
interpret the signal generated by the tissue thickness indicator
and instruct a suitable element accordingly. In one embodiment, the
staple driver member 42 can be activated separate from the cutting
member 40. In such an embodiment, the staple driver member 42 may
only be activated when a sensed tissue thickness is greater than a
predetermined tissue thickness threshold. Tissue thicknesses above
the predetermined tissue thickness threshold may benefit from
staples being deployed into the tissue, while tissue thicknesses
below the predetermined tissue thickness threshold may not require
staples to be deployed into the tissue. In such an embodiment, only
the cutting member 40 and the various electrodes (and not the
staple driver member 42) may be activated to create a seal in the
tissue owing to the relatively thin nature of the tissue clamped
within the end-effector 20. In various circumstances, relatively
thin tissue may not require that staples be deployed to effect a
suitable seal in the tissue.
[0151] In one embodiment, a staple sensor (not illustrated) can be
configured to sense when the staple 38 is in the first stored
position or at least partially in the first stored position. The
staple sensor 38 can also be in electrical communication with the
processor described above, or another suitable processor, to
interpret a signal received from the staple sensor. When the
processor receives an indication from the staple sensor 38 that
indicates a staple is not in the first stored position and the
tissue thickness is above a predetermined tissue thickness
threshold, the processor can activate a lockout device configured
to selectively restrict movement of the cutting member 40 and/or
the staple driver member 42 relative to the first face 44. In one
embodiment, the lockout device can be a solenoid in electrical
communication with the processor, for example. When the lockout
device is activated by the processor, it can engage the cutting
member 40 and/or the staple driver member 42 and restrict their
movement relative to the first face 44, thereby preventing, or at
least inhibiting, the cutting member 40 and/or the staple driver
member 42 from cutting and deploying staples into the tissue
clamped within the end-effector 20 at least until a staple is
sensed by the staple sensor. In other embodiments, the lockout
device can essentially function as a switch and can interrupt
energy flow to the various electrodes, for example. In other
various embodiments, the surgical instruments of the present
disclosure can comprise other suitable sensors, lockout devices,
and/or electronic controls as will be recognized by those of
ordinary skill in the art.
[0152] In one embodiment, FIGS. 13 and 14 illustrate a surgical
stapling, sealing, and/or severing instrument 510. The surgical
stapling and severing instrument 510 can comprise an end-effector
and/or an end-effector assembly 512 configured to be attached to or
formed with the surgical instrument 510. The end-effector assembly
512 can comprise an E-beam firing mechanism ("firing bar") 514 or
other suitable firing mechanism that can control the spacing of the
end-effector assembly 512. In particular, an elongate channel or
second jaw 516 (hereafter the terms "elongate channel" and "second
jaw" can be used interchangeably) and a pivotally translatable
anvil or first jaw 518 (hereinafter the terms "pivotally
translatable anvil," "anvil" and "first jaw" can be used
interchangeably) can be maintained at a spacing that can assure
effective stapling and severing of tissue. In various embodiments,
at least one of the first jaw 518 and the second jaw 516 can be
movable relative to the other, both of the first jaw 518 and the
second jaw 516 can be movable, and/or the second jaw 516 can be
movable relative to the first jaw 518, for example.
[0153] In various embodiments, the surgical instrument 510 can
comprise a handle portion 520 connected to an implement portion
522. The implement portion 522 can comprise a shaft 523 distally
terminating in the end-effector assembly 512 or attached to the
end-effector assembly 512. The handle portion 520 can comprise a
pistol grip 524 toward which a closure trigger 526 can be pivotally
drawn by the surgeon to cause clamping and/or closing of the first
jaw 518 toward the second jaw 516 of the end-effector assembly 512.
A firing trigger 528 can be positioned farther outboard of the
closure trigger 526 and can be pivotally drawn by the surgeon to
cause the stapling, sealing, and/or severing of tissue clamped
within the end-effector assembly 512.
[0154] In one embodiment, the closure trigger 526 can first be
actuated by the surgeon. Once the surgeon is satisfied with the
positioning of the end-effector assembly 512 about the tissue, the
surgeon can draw back the closure trigger 526 to its fully closed,
locked position proximate to the pistol grip 524. Then, the firing
trigger 528 can be actuated by the surgeon. The firing trigger 528
can springedly return to its unfired state when the surgeon removes
pressure therefrom. A release button 530, when depressed, on the
proximal end of the handle portion 520 can release the locked
closure trigger 526 and allow it to return to its unretracted
position.
[0155] In various embodiments, a closure sleeve 532 can enclose a
frame 534, which in turn can enclose a firing drive member 536 that
can be positioned by the firing trigger 528. The frame 534 can
connect the handle portion 520 to the end-effector assembly 512.
With the closure sleeve 532 withdrawn proximally by the closure
trigger 526, the first jaw 518 can springedly open, pivoting away
from the second jaw 516 and translating proximally with the closure
sleeve 532. The second jaw 516 can be configured to receive a
staple cartridge 537 comprising at least one staple.
[0156] In one embodiment, referring to FIGS. 14-16, the firing bar
514 can comprise three vertically spaced pins that can control the
spacing of the end-effector assembly 512 during firing. In
particular, an upper pin 538 can be staged to enter an anvil pocket
540 near the pivot between the first jaw 518 and the second jaw
516. When fired with the first jaw 518 closed, the upper pin 538
can advance distally within a longitudinal anvil slot 542 extending
distally through the first jaw 518. Any minor upward deflection in
the first jaw 518 can be overcome by a downward force imparted by
the upper pin 538. In various embodiments, the firing bar 514 can
comprise a lowermost pin, or firing bar cap, 544 that can upwardly
engage a channel slot 545 in the second jaw 516, thereby
cooperating with the upper pin 538 to draw the first jaw 518 and
the second jaw 516 slightly closer together in the event that
excess tissue is clamped therebetween.
[0157] In one embodiment, the firing bar 514 can comprise a middle
pin 546 that can pass through a firing drive slot 547 formed in a
lower surface of the cartridge 537 and an upward surface of the
second jaw 516, thereby driving the staples from within the
cartridge 537 as described below. The middle pin 546, by sliding
against the second jaw 516, can resist any tendency for the
end-effector assembly 512 to be pinched shut at its distal end. To
illustrate an advantage of the middle pin 546, FIG. 17 illustrates
an alternative end-effector assembly 512' that lacks a middle pin
on a firing bar 514'. In this illustration, the end-effector
assembly 512' can pinch shut at its distal end, which can tend to
impair desired staple formation.
[0158] In various embodiments, again referring to FIGS. 14-16, a
distally presented cutting member 548 between the upper and middle
pins 538 and 546 on the firing bar 514 can traverse through a
proximally presented, vertical slot 549 in the cartridge 537 to
sever tissue clamped within the end-effector assembly 512. The
affirmative positioning of the firing bar 514 with regard to the
second jaw 516 and the first jaw 518 can assure that an effective
cut of the tissue is performed.
[0159] In one embodiment, the affirmative vertical spacing provided
by the E-Beam firing bar 514 can be suitable for the limited size
available for endoscopic devices. Moreover, the E-Beam firing bar
514 can enable fabrication of the first jaw 518 with a camber
imparting a vertical deflection at its distal end, similar to the
position illustrated in FIG. 17. The cambered first jaw 518 can
assist in achieving the desired gap in the end-effector assembly
512 even with the anvil's reduced thickness, which is thus more
suited to the size limitations of an endoscopic device.
[0160] In various embodiments, the E-Beam firing bar 514 can enable
increased applications, especially in combination with a range of
configurations of staple cartridges. For instance, a surgeon may
select a gray staple cartridge yielding a 0.02 mm tissue gap, a
white staple cartridge yielding a 0.04 mm tissue gap, a blue staple
cartridge yielding a 0.06 mm tissue gap, and/or a green staple
cartridge yielding a 0.10 mm tissue gap. The vertical height of
each respective staple cartridge in combination with the length of
staples and an integral wedge sled (described in more detail below)
can predetermine this desired tissue thickness with the first jaw
518 appropriately vertically spaced by the E-Beam firing bar
514.
[0161] In various embodiments, referring to FIGS. 18-21, the handle
portion 520 can be comprised of first and second base sections 550
and 552, which can be molded from a polymeric material, such as a
glass-filled polycarbonate, for example. In one embodiment, the
first base section 550 can comprise a plurality of
cylindrical-shaped pins 554, while the second base section 552 can
comprise a plurality of extending members 556, each comprising a
hexagonal-shaped opening 558 or otherwise shaped opening. The
cylindrical-shaped pins 554 can be received within the
hexagonal-shaped openings 558 and can be frictionally held therein
or otherwise held therein for maintaining the first and second base
sections 550 and 552 in assembly.
[0162] In one embodiment, a rotating knob 560 can comprise a bore
562 extending completely therethrough for engaging and rotating the
implement portion 522 about its longitudinal axis. The rotating
knob 560 can comprise an inwardly protruding boss 564 extending
along at least a portion of the bore 562. The protruding boss 564
can be received within a longitudinal slot 566 formed at a proximal
portion of the closure sleeve 532 such that rotation of the
rotating knob 560 can effect rotation of the closure sleeve 532. It
will be appreciated that the boss 564 can extend through the frame
534 and into contact with a portion of the firing drive member 536
to effect their rotation as well. Thus, the end-effector assembly
512 (not illustrated in FIGS. 18-21) can rotate with the rotating
knob 560.
[0163] In one embodiment, a proximal end 568 of the frame 534 can
pass proximally through the rotating knob 560 and can comprise a
circumferential notch 570 that can be engaged by opposing channel
securement members 572 extending respectively from the base
sections 550 and 552. Only the channel securement member 572 of the
second base section 552 is illustrated. The channel securement
members 572 extending from the first and second base sections 550
and 552 can serve to secure the frame 534 to the handle portion 520
such that the frame 534 does not move longitudinally relative to
the handle portion 520.
[0164] In various embodiments, the closure trigger 526 can comprise
a handle section 574, a gear segment section 576, and an
intermediate section 578. A bore 580 can extend through the
intermediate section 578. A cylindrical support member 582
extending from the second base section 552 can pass through the
bore 580 for pivotably mounting the closure trigger 526 on the
handle portion 520. A second cylindrical support member 583
extending from the second base section 552 can pass through a bore
581 of the firing trigger 528 for pivotally mounting on the handle
portion 520. A hexagonal opening 584 can be provided in the
cylindrical support member 583 for receiving a securement pin (not
illustrated) extending from the first base section 550.
[0165] In one embodiment, a closure yoke 586 can be housed within
the handle portion 520 for reciprocating movement therein and can
serve to transfer motion from the closure trigger 526 to the
closure sleeve 532. Support members 588 extending from the second
base section 552 and a securement member 572, which extends through
a recess 589 in the yoke 586, can support the yoke 586 within the
handle portion 520.
[0166] In various embodiments, a proximal end 590 of the closure
sleeve 532 can comprise a flange 592 that can be snap-fitted or
otherwise fitted into a receiving recess 594 formed in a distal end
596 of the yoke 586. A proximal end 598 of the yoke 586 can
comprise a gear rack 600 that can be engaged by the gear segment
section 576 of the closure trigger 526. When the closure trigger
526 is moved toward the pistol grip 524 of the handle portion 520,
the yoke 586 and, hence, the closure sleeve 532 can move distally,
compressing a spring 602 that biases the yoke 586 proximally.
Distal movement of the closure sleeve 532 can effect pivotal
translational movement of the first jaw 518 distally and toward the
second jaw 516 of the end-effector assembly 512 and proximal
movement can effect closing, as discussed below.
[0167] In various embodiments, the closure trigger 526 can be
forward biased to an open position by a front surface 630
interacting with an engaging surface 628 of the firing trigger 628.
Clamp first hook 604 that can pivot top to rear in the handle
portion 520 about a pin 606 can restrain movement of the firing
trigger 528 toward the pistol grip 524 until the closure trigger
526 is clamped to its closed position. The first hook 604 can
restrain the firing trigger 528 motion by engaging a lockout pin
607 in the firing trigger 528. The hook 604 can also be in contact
with the closure trigger 526. In particular, a forward projection
608 of the hook 604 can engage a member 610 on the intermediate
section 578 of the closure trigger 526, the member 610 being
positioned outward of the bore 580 toward the handle section 574.
The hook 604 can be biased toward contact with the member 610 of
the closure trigger 526 and can be engaged with a lockout pin 607
in the firing trigger 528 by a release spring 612. As the closure
trigger 526 is depressed, the hook 604 can be moved top to rear,
compressing the release spring 612 that is captured between a
rearward projection 614 on the hook 604 and a forward projection
616 on the release button 530.
[0168] In one embodiment, as the yoke 586 moves distally in
response to proximal movement of the closure trigger 526, an upper
latch arm 618 of the release button 530 can move along an upper
surface 620 on the yoke 586 until dropping into an upwardly
presented recess 622 in a proximal, lower portion of the yoke 586.
The release spring 612 can urge the release button 530 outward,
which can pivot the upper latch arm 618 downwardly into engagement
with the upwardly presented recess 622, thereby locking the closure
trigger 556 in a tissue clamping position, such as illustrated in
FIG. 20, for example.
[0169] In various embodiments, the latch arm 618 can be moved out
of the recess 622 to release the first jaw 518 by pushing the
release button 530 inward. Specifically, the upper latch arm 618
can pivot upward about a pin 623 of the second base section 552.
The yoke 586 can then be permitted to move proximally in response
to return movement of the closure trigger 526.
[0170] In one embodiment, a firing trigger return spring 624 can be
located within the handle portion 520 with one end attached to the
pin 606 of the second base section 552 and the other end attached
to a pin 626 on the firing trigger 528. The firing return spring
624 can apply a return force to the pin 626 for biasing the firing
trigger 528 in a direction away from the pistol grip 524 of the
handle portion 520. The closure trigger 526 can also be biased away
from pistol grip 524 by the engaging surface 628 of the firing
trigger 528 biasing the front surface 630 of the closure trigger
526.
[0171] In various embodiments, as the closure trigger 526 is moved
toward the pistol grip 524, its front surface 630 can be engaged
with the engaging surface 628 on the firing trigger 528 causing the
firing trigger 528 to move to its "firing" position. When in its
firing position, the firing trigger 528 can be located at an angle
of approximately 45 degrees, for example, to the pistol grip 524.
After staple firing, the spring 624 can cause the firing trigger
528 to return to its initial unfired position. During the return
movement of the firing trigger 528, its engaging surface 628 can
push against the front surface 630 of the closure trigger 526
causing the closure trigger 526 to return to its initial position.
A stop member 632 can extend from the second base section 552 to
prevent the closure trigger 526 from rotating beyond its initial
position.
[0172] In various embodiments, the surgical stapling, sealing,
and/or severing instrument 510 additionally can comprise a
reciprocating section 634, a multiplier 636, and a drive member
638. The reciprocating section 634 can comprise a wedge sled in the
implement portion 522 (not illustrated in FIGS. 18-21) and a metal
drive rod 640.
[0173] In one embodiment, the drive member 638 can comprise first
and second gear racks 641 and 642. A first notch 644 can be
provided on the drive member 638 intermediate the first and second
gear racks 641 and 642. During return movement of the firing
trigger 528, a tooth 646 on the firing trigger 528 can be engaged
with the first notch 644 for returning the drive member 638 to its
initial position after staple firing. A second notch 648 can be
located at a proximal end of the metal drive rod 640 for locking
the metal drive rod 640 to the upper latch arm 618 of the release
button 530 in its unfired position.
[0174] In various embodiments, the multiplier 636 can comprise
first and second integral pinion gears 650 and 652. The first
integral pinion gear 650 can be engaged with a first gear rack 654
provided on the metal drive rod 640 and the second integral pinion
gear 652 can be engaged with the first gear rack 641 on the drive
member 638. The first integral pinion gear 650 can have a first
diameter and the second integral pinion gear 652 can have a second
diameter that is smaller than the first diameter.
[0175] In various embodiments, FIGS. 18, 20, and 21 illustrate,
respectively, the handle portion 520 in the start position (open
and unfired), a clamped position (closed and unfired), and a fired
position. The firing trigger 528 can be provided with a gear
segment section 656. The gear segment section 656 can be engaged
with the second gear rack 642 on the drive member 638 such that
motion of the firing trigger 528 can cause the drive member 638 to
move back and forth between a first drive position, illustrated in
FIG. 20, and a second drive position, illustrated in FIG. 21. In
order to prevent staple firing before tissue clamping has occurred,
the upper latch arm 618 on the release button 530 can be engaged
with the second notch 648 on the drive member 638 such that the
metal drive rod 640 can be locked in its proximal-most position, as
illustrated in FIG. 18. When the upper latch arm 618 falls into the
recess 622, the upper latch arm 618 can disengage with the second
notch 648 to permit distal movement of the metal drive rod 640, as
illustrated in FIG. 20.
[0176] Because the first gear rack 641 on the drive member 638 and
the gear rack 654 on the metal drive rod 640 are engaged with the
multiplier 636, movement of the firing trigger 528 can cause the
metal drive rod 640 to reciprocate between a first reciprocating
position, illustrated in FIG. 20, and a second reciprocating
position, illustrated in FIG. 21. Since the diameter of the first
pinion gear 650 is greater than the diameter of the second pinion
gear 652, the multiplier 636 can move the reciprocating section 634
a greater distance than the drive member 638 is moved by the firing
trigger 528. In various embodiments, the diameters of the first and
second pinion gears 650 and 652 can be changed to permit the length
of the stroke of the firing trigger 528 and the force required to
move it to be varied.
[0177] It will be appreciated that the handle portion 520 is
illustrative and that other actuation mechanisms may be employed.
For instance, the closing and firing motions may be generated by
automated means and/or can be generated by retracting a single
trigger that can accomplish both closing and firing motions, for
example.
[0178] In various embodiments, referring to FIGS. 22-28, the
end-effector assembly 512 of the surgical instrument 510 is
illustrated in further detail. As described above, the handle
portion 520 can produce separate and distinct closing and firing
motions that actuate the end-effector assembly 512. The
end-effector assembly 512 can maintain the clinical flexibility of
this separate and distinct closing and firing (i.e., stapling and
severing). In addition, the end-effector assembly 512 can introduce
the aforementioned ability to affirmatively maintain the closed
spacing during firing after the surgeon positions and clamps the
tissue within the end-effector assembly 512. Both features
procedurally and structurally enhance the ability of the surgical
instrument 510 by ensuring adequate spacing for instances where an
otherwise inadequate amount of tissue is clamped by the
end-effector assembly 512 and to enhance the clamping in instances
where an otherwise excessive amount of tissue has been clamped by
the end-effector assembly 512.
[0179] In one embodiment, FIG. 22 illustrates the end-effector
assembly 512, which is in an open position by the retracted closure
sleeve 532, with the staple cartridge 537 installed in the second
jaw 516. On a lower surface 700 of the first jaw 518, one or more
rows of stapling forming pockets 702 can be arrayed to correspond
to one or more rows of staple cavities 704 in an upper surface 706
of the staple cartridge 537. The firing bar 514 is at its proximal
position, with the upper pin 538 aligned in a noninterfering
fashion with the anvil pocket 540. The anvil pocket 540 is
illustrated as communicating with the longitudinal anvil slot 542
in the first jaw 518. The distally presented cutting member 548 of
the firing bar 514 can be aligned with and proximally from removed
from the vertical slot 549 in the staple cartridge 537, thereby
allowing removal of a spent cartridge and insertion of an unfired
cartridge, which can be snap-fit or otherwise fit into the second
jaw 516. Specifically, extension features 708 and 710 of the staple
cartridge 537 can engage recesses 712, 714 (illustrated in FIG. 24)
of the second jaw 516.
[0180] In one embodiment, FIG. 23 illustrates the implement portion
522 and the end-effector assembly 512 of the surgical instrument
510 in disassembled form. The end-effector assembly 512 can
comprises the staple cartridge 537 illustrated as being comprised
of a cartridge body 716, a wedge sled 718, drivers 720, staples
722, and a cartridge tray 724. When assembled, the cartridge tray
724 can hold the wedge sled 718, the drivers 720, and the staples
722 inside the cartridge body 716. Drivers 720 can be used when one
staple line is being deployed from a side of the staple cartridge
537 and double drivers can be used with two staple lines are being
deployed from a side of the staple cartridge 537. Of course, if
three staple lines are being deployed from each side of the staple
cartridge 537, three drivers can be provided and so forth. The
drivers 720 and the wedge sled 718 together can be referred to
herein as driver 718 and/or an electrically-conductive driver 718,
since they both function to drive staples into tissue positioned
within the end-effector assembly 512.
[0181] Having a wedge sled 718 integral to the staple cartridge 537
can enable a number of flexible design options as compared to
incorporating camming surfaces onto a firing bar itself. For
instance, a number of different staple cartridges may be selected
for use in the surgical instrument 510 with each staple cartridge
having a different configuration of one or more rows of staples,
each thus having a unique wedge sled configured to contact the
middle pin 546 of the firing bar 514 while causing the driving of
the staples 722.
[0182] In one embodiment, the second jaw 516 can have a proximally
placed attachment cavity 726 that can receive a channel anchoring
member 728 on the distal end of the frame 534 for attaching the
end-effector assembly 512 to the handle portion 520. The second jaw
516 can also have an anvil cam slot 730 that can pivotally receive
an anvil pivot 732 of the first jaw 518. The closure sleeve 532
that encompasses the frame 534 can comprise a distally presented
tab 734 that can engage an anvil feature 736 proximately on the
first jaw 518 but distal to the anvil pivot 732 to thereby effect
opening and closing of the first jaw 518. The firing drive member
536 is illustrated as being assembled to the firing bar 514
attached to a firing connector 738 by pins 740, which in turn is
rotatingly and proximally attached to the metal drive rod 640. The
firing bar 514 can be guided at a distal end of the frame by a
slotted guide 739 inserted therein, for example.
[0183] In various embodiments, with particular reference to FIG.
24, a portion of the staple cartridge 537 is removed to expose
portions of the second jaw 516, such as the recesses 712 and 714
and to expose some components of the staple cartridge 737 in their
unfired position. In particular, the cartridge body 716
(illustrated in FIG. 23) has been removed. The wedge sled 718 is
shown at its proximal, unfired position with a pusher block 742
contacting the middle pin 546 (not illustrated in FIG. 24) of the
firing bar 514. The wedge sled 718 can be in longitudinal sliding
contact upon the cartridge tray 724 and can comprise wedges 728
that force upward the drivers 720 as the wedge sled 718 moves
distally. Staples 722 (not illustrated in FIG. 24) resting upon the
drivers 720 can thus also be forced upward into contact with the
staple forming pockets 702 on the first jaw 518 to form closed
staples. Also illustrated is the channel slot 545 in the second jaw
516 that can be aligned with the vertical slot 549 in the staple
cartridge 537.
[0184] In one embodiment, FIG. 25 illustrates the end-effector
assembly 512 of FIG. 24 with all of the staple cartridge 537
removed to show the middle pin 546 of the firing bar 514 as well as
portion of the second jaw 516 removed adjacent to the channel slot
545 to expose the firing bar cap 544. In addition, the shaft 523 is
removed to expose a proximal portion of the firing bar 514.
Projecting downward from the first jaw 518 near the pivot, a pair
of opposing tissue stops 744 can prevent, or at least inhibit,
tissue from being positioned too far up into the end-effector
assembly 512 during clamping.
[0185] In various embodiments, FIG. 26 illustrates the end-effector
assembly 512 closed in a tissue clamping position with the firing
bar 514 unfired. The upper pin 538 can be in the anvil pocket 540,
vertically aligned with the anvil slot 542 for distal longitudinal
movement of the firing bar 514 during firing. The middle pin 546
can be positioned to push the wedge sled 718 distally so that wedge
728 can sequentially contact and lift drivers 720 and the
respective staples 722 into forming contact with staple forming
pockets 702 in the lower surface 700 of the first jaw 518.
[0186] In various embodiments, FIG. 27 illustrates the upper
surface 706 of the staple cartridge 537 with the firing bar 514 in
its unfired, proximal position. The one or more staple cavities 704
can be arrayed on each side of the vertical slot 549 in the staple
cartridge 537.
[0187] In one embodiment, FIG. 28 illustrates the end-effector
assembly 512 near the pivot showing that the second jaw 516 has
opposing ramp portions 746 to thereby cooperate with the tissue
stops 744 of the first jaw 518 (not illustrated in FIG. 28) to
prevent tissue from jamming the end-effector assembly 512. Also
illustrated in greater detail are the drivers 720 and their
relation to the staples 722.
[0188] The features of the surgical instrument 510 which enable
sealing of tissue disposed and/or clamped within the end-effector
assembly 512 will now be described. It will be understood by those
of skill in the art that surgical instruments, other than the
surgical instrument 510, can be configured or produced to comprise
such sealing features. The present disclosure is not limited to the
use of such features with the surgical instrument 510 and can be
used with other surgical instruments.
[0189] In one embodiment, referring generally to FIGS. 13-15, 17,
18, 20-22, and 24-35, the surgical instrument 510, can be
electrically coupled to an energy source 768 in communication with
a controller 770. In various embodiments, the energy source 768 can
provide energy to the surgical instrument 510 and at least to one
electrode of the end-effector assembly 512, wherein the magnitude,
duration, wave form, and/or frequency, for example, of the energy
can be sufficiently controlled or modulated, by the controller 770,
for example, to provide a desired amount or type of energy to the
surgical instrument 510. The energy source 768 and the energy
provided to the surgical instrument 510 can be the same as or
similar to that described herein. Further, the controller 770 can
be the same as or similar to that described herein. The energy
source 768 can be in electrical communication with the surgical
instrument 510 through first and second conductors 571 and 573 or
through other suitable methods. The first and second conductors 571
and 573 can extend from the energy source 768 to or proximate to
the end-effector assembly 512 or to other portions of the surgical
instrument 510.
[0190] In one embodiment, the first conductor 571 can extend
proximate to a portion of the firing bar 514 when the firing bar
514 is in the retracted position (see e.g., FIG. 14). In various
embodiments, the first conductor 571, which can act as the supply
or positive conductor, can be engaged with a contact 575 positioned
adjacent to the firing bar 514. The contact 575 or other conductive
element in communication with the contact 575 can be biased or
spring-biased towards the firing bar 514 such that energy can be
provided to a conductive track 525 in the firing bar 514, to the
firing bar 514 itself, and/or to a conductive portion of the firing
bar 514, for example. By providing such a contact 575 and
conductive track 525 or conductive portion of the firing bar 514,
energy can be supplied by the first conductor 571 to a distal
portion of the firing bar 514 even when the firing bar 514 is moved
distally within the end-effector assembly 512 into its extended
position (see e.g., FIG. 17). In one embodiment, the energized
portion of the firing bar 514, such as the conductive track 525,
for example, can be surrounded by an insulative material or a
non-conductive material (indicated as "I" in the figures) such that
only the conductive track 525 is energized, instead of the entire
firing bar 514. In other various embodiments, the entire firing bar
514 can be energized and can be surrounded by an insulative
material or a non-conductive material in the appropriate places,
such that energy can be directed within the end-effector assembly
512 as necessary.
[0191] Various conductors 577, 577', 577'', and/or other conductors
can extend from the contact 575 or from portions of the conductive
track 525 to energize various portions of the end-effector assembly
512 or the staple cartridge 537. The conductor 577, if provided,
can extend from the contact 575 or the conductive track 525 to the
cutting member 548 to supply energy to the cutting member 548. The
conductor 577', if provided, can extend from the contact 575 or the
conductive track 525 to the driver 718, such as an
electrically-conductive staple driver, for example, to supply
energy to the staples 722 when contacted by the driver 718. The
conductor 577'', if provided, can extend from the contact 575 or
the conductive track 525 to an electrode on or in one of the first
jaw 518 and the second jaw 516 (or on or in a staple cartridge of
the second jaw 516) to supply energy to the electrode. In other
various embodiments, the contact 575 or the first conductor 571 can
be in electrical communication with an electrode on the first jaw
518 and/or the second jaw 516, for example, and may not be in
contact with the firing bar 514. In any event, energy can be
supplied to the end-effector assembly 512 such that tissue can be
sealed by the end-effector assembly 512.
[0192] In various embodiments, the second conductor 573, which can
act as the return or negative conductor, can extend from the energy
source 768 to a portion of the end-effector assembly 512, such as
the first jaw 518, for example. In one embodiment, the second
conductor 573 can be in electrical communication with a contact on
the first jaw 518 or can be directly attached to the first jaw 518
at a conductive section of the first jaw 518. The second conductor
573 can channel energy from the end-effector assembly 512 back to
the energy source 768 and/or the controller 770, for example.
Although the first conductor 571 is described as being the supply
or positive conductor and the second conductor 573 is described as
being the return or negative conductor, in various embodiments, the
first conductor 571 can be the return or negative conductor and the
second conductor 573 can be the supply or positive conductor, for
example.
[0193] In one embodiment, at least one of the first and second
conductors 571 and 573, such as the first conductor 571, can
comprise a switch 579, optionally engaged with an activation button
764 on the surgical instrument 510. The switch 579 can act as a
typical switch and can disrupt the flow of energy through the
surgical instrument 510 and/or through the end-effector assembly
512 of the surgical instrument 510 when in an open position. In one
embodiment, the switch 579 can be in a normally-open position and
the activation button 764, when depressed, can be used to close the
switch 579 to complete the circuit between the energy source 768
and the surgical instrument 510. In other embodiments, full
retraction of the closure trigger 526 or the firing trigger 528 can
close the switch 579 or another suitable switch and allow energy to
flow to the surgical instrument 510. In any event, the switch 579
can be configured to remain closed until a predetermined time has
lapsed such that energy can flow through portions of the
end-effector assembly 512 and through the tissue to cause a
suitable seal to be formed in the tissue. In one embodiment, the
switch 579 can remain closed for a predetermined period of time
although the activation button 764 is released or although the
firing trigger 528 is released and allowed to retract into its
unfired state.
[0194] In various embodiments, portions of the end-effector
assembly 512 and/or portions of the surgical instrument 510 can
comprise insulative materials or non-conductive materials, such as
plastic or rubber, for example. Such insulative materials or
non-conductive materials can aid in confining the energy within the
end-effector assembly 512 within the conductive portions. For
instance, an insulative material can be provided on the proximal
portion of the first jaw 518 such that energy can be returned from
the first jaw 518 though the second conductor 573 without coming
into electrical contact with the firing bar 514, for example.
[0195] In one embodiment, the staples 722 positioned with the
staple cavity 704 of the second jaw 516 can comprise the first
electrode. Although referred to as the "first electrode", those of
ordinary skill in the art will recognize that each staple 722 or
less than all of the staples 722 can comprise a first electrode
(i.e., only some staples make comprise conductive portions). In
various embodiments, the staples 722 can comprise conductive
portions or can be comprised of conductive materials, such as
metals, for example. To allow energy to flow to the staples 722,
the first conductor 571 can supply energy to the contact 575. The
contact 575 can then supply energy to the firing bar 514, the
conductive track 525, and/or to the electrically conductive driver
718 optionally using the conductor 577'. In one embodiment, the
staples 722 can supply energy to the tissue when they are in
contact with the electrically-conductive driver 718. In one
embodiment, the staples 722 can be removably positioned within
staple cavities 704 in the second jaw 518 or the staple cartridge
537. In various embodiments, the electrically-conductive driver 718
can be configured to move each of the staples 722 between a first
stored position in which the staple 722 is at least partially
positioned within the staple cavity 704 and a second position in
which the staples 722 are at least partially deployed from the
staple cavity 704 into tissue positioned intermediate the first jaw
518 and the second jaw 516. In one embodiment, more than one staple
722 can be in electrical communication with the
electrically-conductive driver 718 at one time or more than one
electrically-conductive driver can be in communication with the
staples 722 at one time. By supplying energy to the staples 722,
the tissue can be sealed in the area in which staple legs of the
staples 722 puncture the tissue. Such sealing about a perimeter of
the staple legs can decrease bleeding caused by the puncturing of
the tissue by the staple legs. In various embodiments, the staples
722 and/or the electrically-conductive driver 718 can comprise a
fuse, such as the PTC material described above, for example, to
regulate the energy flow of the energy from the staples 722 to
another electrode within the end-effector 512.
[0196] In one embodiment, the end-effector assembly 512 and/or the
staple cartridge 537 can comprise a second electrode on one of the
first jaw 518 or the second jaw 516. The second electrode can have
the same polarity or a different polarity than the first electrode.
In various embodiments, a second electrode 754 can be positioned on
or form a portion of the first jaw 518 and can be in electrical
communication with the second conductor 573. In such an embodiment,
the second electrode 754 can receive the energy supplied by the
first electrode after such energy passes through and seals the
tissue. In this configuration, portions of a tissue-contacting
surface of the second jaw 516 and/or the staple cartridge 537 can
be comprised of an insulative material such that energy flows from
the first electrode (e.g., portions of the staples 722) toward the
second electrode 754 on the first jaw 518. The first jaw 518 can
comprise a fuse 762, such as the PTC material described above, to
regulate or inhibit the energy flow between the first electrode and
the second electrode 754. The fuse 762 can be positioned around or
in the pockets of the first jaw 518 and the second electrode 754
can be positioned underneath the fuse 762, for example. In such an
embodiment, a tissue-contacting surface of the first jaw 518 can
comprise an insulative material such that energy can pass from the
first electrode, through the fuse 762, to the second electrode 754,
and then to the second conductor 573.
[0197] In one embodiment, the end-effector assembly 512 can
comprise a third electrode. In various embodiments, a third
electrode 756 can be positioned on or form the cutting member 548.
In other various embodiments, the third electrode 756' can be
positioned on or form a portion of the second jaw 516. In various
embodiments, the third electrode 756 or 756' can have the same
polarity or a different polarity than the first electrode and/or
the second electrode 754, for example. In one embodiment, the third
electrodes 756 and 756' can both be provided on an end-effector
assembly of a surgical instrument. In various configurations,
energy can flow from the third electrode 756 or 756', through the
tissue, toward the first electrode and/or the second electrode 754,
for example. By providing the third electrode 756 on the cutting
member 548, tissue can be sealed as it is cut by the cutting member
548 thereby reducing bleeding at the cutting site. In one example
embodiment, energy can travel from the first electrode (i.e.,
staples 722) and the cutting member (i.e., third electrode 756),
through the tissue, and possibly through a fuse, to the second
electrode 754 on the first jaw 518. The fuse 762 can be positioned
adjacent to the second electrode 754 on the first jaw 518. In such
an embodiment, the first electrode and the third electrode 756 can
have the same polarity (e.g., positive) while the second electrode
754 can have a different polarity (e.g., negative). Other polarity
configurations of the various electrodes are also within the scope
of the present disclosure. In various embodiments, the various
electrodes can be positioned within the end-effector assembly 512
in a fashion such that the flow of energy through the tissue and
the end-effector assembly 512 can be controlled to control the
thermal spread caused by the energy flow. As discussed herein, heat
can be generated in the tissue by the resistance to energy flow
that the tissue creates between the various electrodes.
[0198] In an embodiment, where the third electrode 756' is
positioned on the second jaw 516, the third electrode 756' can act
as a supply or a return electrode. In one embodiment, the third
electrode 756' can be positioned on or in the staple cartridge 537
positioned within the second jaw 516, for example. In other various
embodiments, the third electrode 756' can be positioned adjacent to
a fuse, such as fuse 762, for example. The fuse 762 can be similar
to the fuse 62 discussed herein and can be positioned more proximal
to a tissue-contacting surface of the second jaw 516 than the third
electrode 756', such that energy can passes through the fuse 762
before reaching the third electrode 756' or can pass through the
fuse 762 after leaving the third electrode 756'. As discussed
herein with respect to the fuse 62, the fuse 762 can be used to
limit, restrict, and/or stop the energy flow from one electrode to
another.
[0199] In one embodiment, temperature measuring devices or sensors,
such as thermocouples, RTD's (resistive thermal devices),
thermistors, and other suitable devices can be embedded at
strategic locations within the end-effector assembly 512 to sense
the temperature of the tissue positioned within the end-effector
assembly 512. As a result, the delivery of energy to at least one
of the electrodes can be controlled in response to feedback from
these devices, for example.
[0200] In various embodiments, by using more than two electrodes
(e.g., three or four), the thermal spread of heat within the tissue
compressed between the first jaw 518 and the second jaw 516 can be
minimalized thereby reducing heating of the tissue adjacent to the
end-effector assembly 512. Such minimalization can occur owing to a
controlled path of the energy through the various electrodes.
[0201] In various embodiments, in order to direct the energy flow
through the end-effector assembly 512 through the various
electrodes and the tissue properly, certain portions of the
end-effector assembly 512 can comprise insulative materials or
non-conductive portions. In one embodiment, portions of the
tissue-contacting surfaces of the first jaw 518 and the second jaw
516 can comprise insulative materials or non-conductive portions to
cause energy to flow from at least one electrode, through the fuse
762 or another fuse, to at least one other electrode. In other
embodiments, portions of the first jaw 518 and the second jaw 516
adjacent to the electrodes can comprise insulative materials or
non-conductive portions to maintain the energy flow between the
various electrodes and at least inhibit energy from flowing to
other portions of the end-effector assembly 512. Those of skill in
the art will understand how and where, in various embodiments, the
various insulative materials or non-conductive portions can be
placed within the end-effector assembly 512.
[0202] In one embodiment, referring to FIGS. 36-38, a staple
cartridge 737 is illustrated. The staple cartridge can be
configured to be positioned on or within the second jaw 518 and can
comprise a plurality of staple cavities 704, a plurality of staples
722, and a tissue-contacting surface 703 comprising an outer
perimeter 705. The tissue-contacting surface 703 can comprise an
electrode 707, such as a third electrode, for example. The staple
cartridge 737 can also comprise a first side 709, a second side
711, and a cutting member slot 749 defined at least partially
intermediate the first side 709 and the second side 711. A first
plurality of staples 722 can be at least partially positioned
within a first plurality of staple cavities 704 in the first side
709. The first plurality of staples 722 can form at least one row
of staples 722. A second plurality of staples 722 can be at least
partially positioned within a second plurality of staple cavities
704 in the second side 711. The second plurality of staples 722 can
form at least a second row of staples 722. In various embodiments,
FIGS. 37 and 38 illustrate the staple cartridge 737' and the staple
cartridge 737'', respectively. Like numbers between FIG. 36 and
FIGS. 37 and 38 designate like components.
[0203] In one embodiment, referring to FIG. 36, the electrode 707
can be positioned proximate to the outer perimeter 705 of the
staple cartridge 737, while the one or more rows of staples 722 can
be positioned distal from the outer perimeter 705 or closer to the
cutting member slot 749 than the one or more rows of staples 722.
In another embodiment, referring to FIG. 37, the one or more rows
of staples 722' can be positioned proximate to the outer perimeter
705' of the staple cartridge 737', while the electrode 707' can be
positioned distal from the outer perimeter 705' or closer to the
cutting member slot 749' than the electrode 707'. In one
embodiment, referring to FIG. 38, the electrode 707'' can be
positioned intermediate a first row of staples 722'' and a second
row of staples 722''. In various embodiments, more than one first
row of staples 722'' can be provided on the first side 709'' of the
electrode 707'' and more than one second row of staples 722'' can
be provided the second side 711'' of the electrode 707'', for
example. As a result of the various embodiments described above,
the staples can be applied more proximal to a cut line in tissue
than the seal created by the electrode (in conjunction with another
electrode) or can be applied more distal from the cut line while
the seal is positioned more proximal to the cut line in the tissue.
In one embodiment, it may be desirable to have the staples
positioned in the tissue more distal from the cut line in the
tissue than the seal, such that the tissue can be sealed proximate
to the cut line to reduce bleeding at the cut line while the
staples provide support to the seal and maintain it in place. In
other various embodiments, the staples can be deployed directly
adjacent to or within a seal created in the tissue.
[0204] In one embodiment, referring to FIG. 13, the end effector
assembly 512 can comprise one or more tissue thickness sensors,
such as tissue thickness sensors 780 and 781, for example,
positioned on the end-effector assembly 512. The tissue thickness
sensors 780 and 781 can sense the distance between a
tissue-contacting surface of the first jaw 518 and a
tissue-contacting surface of the second jaw 516 to determine the
thickness of the tissue clamped between the first jaw 518 and the
second jaw 516. In various embodiments, the sensors 780 and 781 can
be any suitable sensors known in the art, such as Hall effect
sensors, capacitive sensors, optical sensors, RF sensors, and/or
strain gauges, for example. In one embodiment, a signal generated
by the sensors 780 and 781 can be outputted to a processor, such as
a microprocessor, for example. The processor can interpret the
signal to determine the thickness of the tissue clamped between the
first jaw 518 and the second jaw 516. Upon determining the
thickness of the tissue, the processor can be used to control a
solenoid that can extend a piston to engage a recess (not
illustrated) in the driver 718. Such a feature can essentially
lock-out the driver 718 and prevent it from moving from the
proximal position (see e.g., FIG. 14) into the extended position
(see e.g., FIG. 17) if the tissue thickness is below (i.e., less
than) a predetermined tissue thickness threshold. Such a feature
can also prevent staples 722 from being deployed into tissue that
can be sufficiently sealed with energy delivered by the various
electrodes. In such an embodiment, a cutting member can be moved
within the end-effector assembly 512 independently from the staple
driver. If the measured tissue thickness is at or above (i.e.,
thicker) the predetermined tissue thickness threshold, the staples
722 can be deployed into the tissue using the driver 718. In
various embodiments, the tissue thickness can also be used to
determine how long (e.g., in seconds) or how much energy flows
(e.g., watts) between the various electrodes when activated. For
thinner tissue, the duration or strength of energy flow can be less
than when sealing thicker tissue, for example.
[0205] In one embodiment, referring to FIG. 17, one or more staple
sensors 782 can sense when at least one staple 722 is positioned
within at least one staple cavity 704 (i.e., when the staple is in
or at least partially in the first, undeployed position). The one
or more staple sensors 782 can also be in communication with the
processor described above such that when at least one staple 722 is
not sensed within at least one staple cavity 704 and the tissue
thickness measured by the sensors 780 and 781 is at or above the
predetermined tissue thickness threshold, a solenoid can extend a
piston to engage a recess in the firing bar 514, a staple driver,
and/or cutting member and restrict or prevent movement of the
firing bar 514, the staple driver, and/or the cutting member
between the proximal position (see e.g., FIG. 14) and the extended
position (see e.g., FIG. 17). This solenoid mechanism is one
example of a lockout device, although other lockout devices known
to those of skill in the art are envisioned and are within the
scope of the present disclosure. The movement of the firing bar
514, the staple driver, and/or the cutting member can be restricted
in that the tissue clamped within the end-effector assembly 512 may
be too thick to be sealed merely by the electrodes without the use
of the staples 722. Once the sensor 782 senses that at least one
staple 722 is present in at least one staple cavity 704, the
solenoid can retract the piston from engagement with the firing bar
514, the staple driver, and/or the cutting member and the firing
bar 514, the staple driver, and/or the cutting member can advance
distally within the end-effector assembly 512 and staples 722 can
be deployed into the tissue using the firing bar 514 or the staple
driver 718. If the tissue thickness is below the predetermined
tissue thickness threshold and the sensor 782 indicates that at
least one staple 722 is not present in at least one staple cavity
704, the solenoid may not extend the piston to engage the recess in
the firing bar 514, the staple driver, and/or the cutting member
and a seal and a cut may be made in the tissue, (i.e., no staples
are required). Such a feature can at least inhibit a surgeon from
merely sealing tissue using the various electrodes when staples
should also be deployed into the tissue to aid the tissue seal
owing to the thickness of the tissue. In various embodiments, the
predetermined tissue thickness threshold can be in the range of 0
mm to 4 mm, alternatively in the range of 0.0 mm to 1.0 mm,
alternatively in the range of 1 mm to 2 mm, and alternative in the
range of 2 mm to 3 mm, for example. In other embodiments, the
predetermined tissue thickness threshold can be set at other tissue
thicknesses for various suitable applications. In various
embodiments, more than one staple sensor 782 can be provided to
sense staples in more than one staple cavity 704. In other various
embodiments, a staple cartridge sensor (not illustrated) can be
provided to sense the presence of a staple cartridge within the
end-effector assembly 512.
[0206] In one embodiment, another lockout device can be configured
to deactivate the electrode system when the sensed thickness of the
tissue is greater than the predetermined tissue thickness threshold
and when the sensor 782 does not sense a staple 722 in or at least
partially in the first, undeployed position. To accomplish the
same, the lockout device can be in electrical communication with
the processor and can essentially function as a switch. When the
lockout device receives a signal from the processor that the tissue
thickness is greater than the predetermined tissue thickness
threshold and/or no staples 722 are sensed in or at least partially
in the first position by the sensor 782, the lockout device can
interrupt the energy flow to the various electrodes of the
end-effector assembly 512 by opening a switch positioned in series
with the conductor supplying energy to the electrode. The lockout
device can then allow energy flow to the various electrodes when
the staples 722 are sensed in or at least partially in the first
position by the sensor 782. Such a feature can prevent, or at least
inhibit, sealing of tissue that is too thick to be sealed without
the use of fasteners, such as staples, for example.
[0207] In one embodiment, a predetermined tissue sealing time can
be associated with each tissue thickness or each range of tissue
thickness. For example, if the tissue thickness is in the range of
3 mm to 8 mm, the tissue sealing time (or time energy is flowing
through the end-effector assembly 512) can be 5 to 10 seconds, for
example. In one embodiment, for a 45 mm staple cartridge, the
tissue sealing time can be 4 to 15 seconds or longer, for example.
Longer tissue sealing times may be helpful or required for staple
cartridges longer than 45 mm. In various embodiments, when the
energy flow to the end-effector assembly 512 is activated by
retraction of the firing trigger 528, the cutting member 548 can be
restricted in its movement along the cutting member slot 549 in the
staple cartridge 537 or the second jaw 516. Such restriction can be
to cause adequate energy flow to the various electrodes and create
a suitable seal in the tissue for a predetermined period of time
prior to advancing the cutting member 548. In one embodiment, the
speed of the cutting member 548 can be modulated by allowing the
cutting member 548 to be energized so that energy at the cutting
edge enhances the sharpness of the cutting edge. If the cutting
member 548 moves too quickly along the cutting member slot 549, a
seal may not be fully formed in the tissue depending on the
thickness of the tissue. The restriction of the movement of the
cutting member 548 can be effected by a resistive member acting on
or against the firing bar 514 or another cutting member, for
example. In one embodiment, the resistive member can comprise a
biasing or biased member that pushes against a side surface or
other portion of the firing bar 514 or another cutting member to
create a frictional resistance to proximal to distal movement of
the firing bar 514 or another cutting member. In other embodiments,
magnets can be used as the resistive member to restrict proximal to
distal movement of the firing bar 514 or another cutting
member.
[0208] In use, in one embodiment, the surgical stapling and
severing instrument 510 can be used as illustrated in FIGS. 13, 14,
and 29-35. In FIGS. 13 and 14, the surgical instrument 510 is in
its initial position, having had an unfired, fully loaded staple
cartridge 537 snap-fitted or otherwise fitted into the distal end
of the second jaw 516. Both of the triggers 526, 528 are forward
and the end-effector assembly 512 is open, such as would be typical
after inserting the end-effector assembly 512 through a trocar or
other opening into a body cavity of a patient. The surgical
instrument 510 can then be manipulated by the surgeon such that
tissue 748 to be stapled, sealed, and/or severed is positioned
between the staple cartridge 537 and the first jaw 518, as
illustrated in FIG. 29.
[0209] In various embodiments, referring to FIGS. 30 and 31, next,
the surgeon can move the closure trigger 526 proximally until it is
positioned adjacent or directly adjacent to the pistol grip 524,
thereby locking the handle portion 520 into the closed and clamped
position. The retracted firing bar 514 in the end-effector assembly
512 may not impede the selective opening and closing of the
end-effector assembly 512, but rather resides within the anvil
pocket 540. With the first jaw 518 closed and clamped, the firing
bar 514 can be aligned for firing through the end-effector assembly
512. In particular, the upper pin 538 can be aligned with the anvil
slot 542 and the second jaw 516 can be affirmatively engaged about
the channel slot 545 by the middle pin 546 and the firing bar cap
544.
[0210] In one embodiment, referring to FIGS. 32 and 33, after
tissue clamping has occurred, the surgeon can move the firing
trigger 528 proximally to cause the firing bar 514 to move distally
into the end-effector assembly 512. In particular, the middle pin
546 can enter the staple cartridge 537 through the firing drive
slot 547 to effect the firing of the staples 722 (not illustrated
in FIGS. 32 and 33) via wedge sled 718 toward the first jaw 518.
The lower most pin, or firing bar cap 544, can cooperate with the
middle pin 546 to slidingly position cutting member 548 of the
firing bar 514 to sever the tissue 748. The firing bar cap 544 and
middle pin 546 can also position the upper pin 538 of the firing
bar 514 within the longitudinal anvil slot 542 of the first jaw
518, affirmatively maintaining the spacing between the first jaw
518 and the second jaw 516 throughout its distal firing
movement.
[0211] In one embodiment, referring to FIGS. 34 and 35, the surgeon
can continue moving the firing trigger 528 until brought proximal
to the closure trigger 526 and the pistol grip 524. As a result,
all of the ends of the staples 722 can be deformed owing to their
engagement with the first jaw 518. The firing bar cap 544 can be
arrested against a firing bar stop 750 projecting toward the distal
end of the channel slot 545. In such a position, the cutting member
548 has traversed completely through the tissue 748. The process
can be completed by releasing the firing trigger 528 and by then
depressing the release button 530 while simultaneously squeezing
the closure trigger 526 to open the end-effector assembly 512.
[0212] In one embodiment, the retraction of the firing trigger 528
can activate the electrode system of the surgical instrument 510 by
closing a switch in the first conductor 571, for example, thereby
allowing energy from the energy source 768 to flow to and through
the end-effector assembly 512 and back to the energy source 768.
The energy can flow from one electrode, such as the first
electrode, in electrical communication with the first conductor
571, flow through the tissue clamped within the end-effector
assembly 512 to create a seal in the tissue, and flow to the second
electrode 754, for example. In other embodiments, the energy can
flow to a third or a fourth electrode depending on the electrode
configuration within the end-effector assembly 512. The energy can
then flow back to the energy source 768, thereby completing the
circuit between the surgical instrument 510 and the energy source
768.
[0213] In other various embodiments, referring to FIG. 13, the
energy can flow to the end-effector assembly 512 and at least one
electrode thereof when the activation button 764 is depressed.
Depression of the activation button 764 can close the switch 579 in
the first conductor 571 to allow energy to flow the end-effector
assembly for a predetermined amount of time or as long as the
activation button 764 is depressed by the surgeon.
[0214] The present disclosure has been illustrated by describing
several embodiments and while the example embodiments have been
described in detail, it is not the intention of the applicants to
restrict or in any way limit the scope of the appended claims to
such detail. Additional advantages and modifications will be
readily apparent to those of skill in the art.
[0215] For example, the affirmative spacing of the first jaw 518
and the second jaw 516 can be achieved in part with two pins 544
and 546 on the firing bar 514 engaging opposite sides of a channel
slot and a single upper pin 538 entrained within an first jaw slot
542. It would be consistent with aspects of the present disclosure
for a first jaw to be captured by opposing pins on either side of a
longitudinal slot and/or for a second jaw to have an internal slot
that entrains a lower pin.
[0216] As another example, although the firing bar 514 has various
advantages for an endoscopically employed surgical instrument 510,
a similar firing bar may be used in other clinical procedures. It
is generally accepted that endoscopic procedures are more common
than laparoscopic procedures. Accordingly, the present disclosure
has been discussed in terms of endoscopic procedures and
apparatuses. However, use herein of terms such as "endoscopic,"
should not be construed to limit the present disclosure to a
surgical instrument for use only in conjunction with an endoscopic
tube (i.e., trocar). On the contrary, it is believed that the
present disclosure may find use in any procedure where access is
limited to a small incision, including but not limited to
laparoscopic procedures, as well as open procedures.
[0217] As still another example, although an illustrative handle
portion 520 described herein is manually operated by a surgeon, it
is consistent with aspects of the present disclosure for some or
all of the functions of a handle portion to be powered (e.g.,
pneumatic, hydraulic, electromechanical, ultrasonic, robotic etc.).
Furthermore, controls of each of these functions can be manually
presented on a handle portion or be remotely controlled (e.g.,
wireless remote, automated remote console, etc.), for example.
[0218] In one embodiment, referring to FIGS. 39-41, 47, and 48, a
surgical instrument, such as surgical instrument 910, can comprise
an elongate shaft 912 comprising a first proximal end 914 and a
second distal end 916. A handle portion 918 can extend from the
first end 914 and an end-effector 920 or an end-effector assembly
can extend from the second end 916. In various embodiments, the
surgical instrument 910 can be used to sever and/or join tissue or
layers of tissue. In various embodiments, the surgical instrument
910 can be used to create a seal in tissue. In one embodiment, the
surgical instrument 910 can be operably connected to an energy
source 968 such that energy can flow to the end-effector 920 to
seal tissue and then flow back to the energy source 968. Such
energy flow and the energy source 968 can be the same as or similar
to that described herein with respect to surgical instrument 510
and the energy source 768, for example. The energy source 968 can
be operatively connected with a controller 970, which can be the
same as or similar to the controllers 70 and/or 770 described
above.
[0219] In one embodiment, the handle portion 918 can comprise an
articulation knob 919 configured to rotate the end-effector 920
about a longitudinal axis of the elongate shaft 912. Such
articulation can be useful in positioning the end-effector 920
during a surgical procedure. The handle portion 918 can also
comprise a trigger 922 and a trigger 923. The trigger 922 can be
used to close the end-effector 920 and clamp or compress tissue
therein, while the trigger 923 can be used to distally advance a
cutting member to cut tissue positioned within the end-effector 920
and/or distally advance a rivet driver to deploy or fire rivets
from the end-effector 920 and into the tissue. In various
embodiments, the cutting member can be part of the rivet driver,
for example. In one embodiment, the trigger 923 can be geared such
that more than one stroke of the trigger 923 can be used to
distally advance the cutting member and/or the rivet driver. In
other embodiments, only one trigger may be provided and that
trigger can close the end-effector 920 and also distally advance
the cutting member and/or the rivet driver. In various embodiments,
the handle portion 918 or one of the triggers can comprise an
activation button 964, as described herein.
[0220] In one embodiment, still referring to FIGS. 39-41, 47 and
48, the end-effector 920 can comprise a first jaw 926 and a second
jaw 928. At least one of the first jaw 926 and the second jaw 928
can be moved toward each other by retraction of the trigger 922,
for example, to thereby compress or clamp tissue positioned
therebetween. In one embodiment, the first jaw 926 can be moved or
pivoted toward the second jaw 928 to compress tissue therebetween.
Such tissue compression can aid in sealing the tissue using rivets
or electrodes in that the compression can reduce the amount of
water in the tissue and can reduce the thickness of the tissue at
locations in the tissue where a rivet line or a seal is to be
formed. In one embodiment, the first portion 926 can comprise an
anvil comprising anvil pockets 958. The anvil pockets 958 can be
formed in the first portion 926 and can be configured to deform
portions of rivets or staples. In other embodiments, the anvil
pockets 958 may not be provided and a face of the anvil can deform
and/or melt portions of the rivets. In one embodiment, formation of
rivet heads can be dependent on the shape of the anvil pockets 958.
Cubical-shaped anvil pockets can create cubical-shaped rivet heads
and half sphere-shaped anvil pockets can create half sphere-shaped
rivet heads, for example. Other shapes of the rivet heads are also
envisioned within the scope of the present disclosure. In various
embodiments, the first portion 926 can comprise a first electrode
954 and an optional fuse 962, such as the PTC material, for
example, as discussed in further detail herein. In various
embodiments, one or more insulative materials can also be provided
on the face or other portions of the first jaw 926 to properly
direct the energy flow within the end-effector 920. In other
embodiments, the first electrode 954 can be at least a portion of
the first portion 926, for example.
[0221] In one embodiment, the second jaw 928 can comprise a rivet
cartridge receiving portion 929 configured to receive or at least
partially receive a rivet cartridge 949 in a snap-fit or a
press-fit fashion, for example. In various embodiments, the rivet
cartridge 949 and/or the rivet cartridge receiving portion 929 can
comprise a second electrode 960 and an optional fuse 962, such as
the PTC material, for example, as discussed in further detail
herein. In certain embodiments, the fuse 962 can be provided on
both of the first portion 926 and the second portion 928 or on one
of the first portion 926 and the second portion 928. The rivet
cartridge 949 and/or the second jaw 928 can also comprise one or
more insulative materials to help direct the energy between the
electrodes 954 and 960 or between other various electrodes.
Although the present disclosure discusses the rivet cartridge 949
comprising rivets, it will be understood that the rivet cartridge
949 can also comprise staples or other fasteners in addition to the
rivets. Such a cartridge may be suitable for various surgical
procedures. Also, although the rivet cartridge 949 is illustrated
and described herein, it will be understood that rivet cavities can
be formed in the second jaw 928 and that a separate rivet cartridge
may not be required. Further, those of skill in the art will
understand that the rivet cartridge 949, if provided, can be formed
with or formed on the second jaw 928. As such, an end-effector or a
surgical instrument used to deploy rivets can be provided with or
without the rivets and/or with or without the rivet cartridge 949.
In various embodiments, the rivet cartridge 949 can be disposable
or can be reusable after being reloaded with rivets.
[0222] In one embodiment, referring to FIGS. 39-41, the trigger 922
can be retracted proximally to close the end-effector 920 and
compress tissue "T" between the first jaw 926 and the second jaw
928. Once suitable tissue compression in the end-effector 920 is
achieved, using a tissue compression indicator and/or a rivet
formation indicator 927, for example, the trigger 923 can be
retracted proximally one or more times (i.e., more than one stroke)
to drive a cutting member 940 and a driver 942 distally within the
end-effector 920. A stroke of the trigger 923 could advance the
driver 942 1/3 of the length of the rivet cartridge 949, for
example. Such actuation can cause the driver 942 to move rivets 938
within the rivet cartridge 949 between a first position in which
the rivets 938 can be at least partially positioned within a rivet
cavity 946 and a second position in which the rivets 938 can be at
least partially deployed from the rivet cavity 946. This can cause
the rivets 938 to form a rivet line 941 in the tissue "T" by
formation of the rivet heads 969, as illustrated in one example
embodiment in FIG. 40, and as discussed in further detail herein.
The rivet heads 969 can be formed by deforming and/or melting
portions of the rivets 938. In one embodiment, the rivet heads 969
and/or other portions of the rivets 938 can be melted and/or
deformed at temperatures in the range of about 107.degree. F. to
about 121.degree. F., for example. In other embodiments, the rivet
heads 969 and/or other portions of the rivets 938 can be melted
and/or deformed at temperatures in the range of about 100.degree.
C. to about 220.degree. C., greater than about 50.degree. C., or
less than about 100.degree. C. In the latter embodiment, the tissue
being anchored by the rivets 938 may need to be insulated from this
higher heat such that overheating or burning of the tissue does not
occur. In still other embodiments, other suitable melting and/or
deforming temperatures of the rivets 938 can be used depending on
the material(s) of the rivets 938 as will be recognized by those of
skill in the art. The actuation of the trigger 923 can also cause
the cutting member 940 to advance distally within the end-effector
920 and sever or incise the tissue "T", again as illustrated in one
example embodiment in FIG. 40. In one embodiment, the driver 942
and the cutting member 940 can be formed of a single component or
can be formed of more than one component. In any event, both the
cutting member 940 and the driver 942 can be configured to be
driven distally within the end-effector 920 upon retraction of the
trigger 923 or other suitable trigger.
[0223] The general operation of a surgical instrument, such as
surgical instrument 910 is described in further detail herein and
in U.S. Pat. No. 7,000,818 to Shelton et al., entitled SURGICAL
STAPLING INSTRUMENT HAVING SEPARATE CLOSING AND FIRING SYSTEMS,
which issued on Feb. 21, 2006, the entire disclosure of which is
incorporated herein by reference in its entirety. The surgical
instrument 910 can also operate in other fashions and still be
within the scope of the present disclosure. Surgical instruments
operably engaged with energy sources are described in greater
detail above.
[0224] In one embodiment, referring to FIGS. 42 and 43, the rivet
cartridge 949 is illustrated. The rivet cartridge 949 can be
configured to be engaged with, attached to, or formed with an
end-effector of a surgical instrument, such as the end-effector 920
of the surgical instrument 910, for example. In one embodiment, the
rivet cartridge 949 can be configured to be positioned within the
receiving portion 929 of the second portion 928. In one embodiment,
although not illustrated, the rivet cartridge 949 can be engaged
with, attached to, or formed with the first portion 926 and the
second portion 928 can act as the anvil, for example. In various
embodiments, the rivet cartridge 949 can comprise a first surface
950 defining one or more openings 952 therein and a second surface
953. One or more of the rivet cavities 946 can be defined at least
partially intermediate the first surface 950 and the second surface
953. In one embodiment, the one or more rivet cavities 946 can
extend from the first surface 950 to the second surface 953. The
one or more rivet cavities 946 can be in communication with the
openings 952 in the first surface 950. The rivet 938 can be
removably positioned within each of the rivet cavities 946 and/or
the openings 952 or less than each of the rivet cavities 946 and/or
the openings 952. FIG. 43 illustrates a cross-sectional view of the
rivet cartridge 949 taken along line 43-43 of FIG. 42. In FIG. 43,
none of the rivets 938 have been fully deployed from the rivet
cartridge 949. As such, the rivets 938 are illustrated in the
stored position, or substantially in the stored position. In other
embodiments, the rivet cartridge 949 can comprise other suitable
configurations.
[0225] In various embodiments, referring to FIG. 44 as an example,
the rivet 938 can comprise a tissue-engaging portion 955, an
elongate portion 957 extending from the tissue-engaging portion
955, and a meltable and/or deformable portion 959. In one
embodiment, the elongate portion 957 can comprise or form the
meltable and/or deformable portion 959. The meltable and/or
deformable portion 959 can be deformed by the first portion 926 or
the anvil pockets 958 of the first portion 926 and/or melted by
heat generated within the end-effector 920. In various embodiments,
the rivet 938 can comprise a base 961 comprising a tissue-engaging
surface 975. In such an embodiment, the tissue-engaging portion 955
of the rivet 938 can comprise a first end 963 and a second end 965,
such that the elongate portion 957 extends from the first end 963
and the base 961 extends from the second end 965. In one
embodiment, a base of the rivets can comprise a camming surface
configured to be engaged with the driver 942 or a camming surface
on the driver 942 to drive the rivets into tissue and against the
first portion 926.
[0226] In one embodiment, the rivets 938 can comprise a meltable
and/or a deformable material. Example materials can comprise
collagen, keratin, synthetic absorbable and non-absorbable
polymers, amorphous (as opposed to crystalline) thermoplastics,
such as Noryl (blend of polyphenylene oxide and polystyrene), ABS
(acrylonitrile butadiene styrene), polycarbonate, Ultem
(polyetherimide), and/or polystyrene, for example, although other
suitable materials can also be used. In one embodiment, the
materials of the rivets 938 can comprise polylactic acid (PLA),
high density polyethylene (HDPE), poly(lactic-co-glycolic acid)
(PLGA), polyether ether ketone (PEEK), ethylene-vinyl acetate
(EVA), and/or polyethylene oxide (PEO), for example. In various
embodiments, the rivets 938 can comprise meltable and/or deformable
portions, such as the meltable and/or deformable portion 959 and
the elongate portion 957, for example. In one embodiment, the
rivets 938 comprising the meltable and/or deformable material can
have portions thereof melted through heat generated in the
end-effector 920 by the resistance to energy flow through the
tissue. In other embodiments, the rivets 938 comprising the
meltable and/or deformable material can have portions thereof
deformed by the first portion 926. In one embodiment, the rivets
938 can comprise absorbable and/or dissolvable materials, such as
collagen, keratin, and/or synthetic absorbable materials, for
example. These various materials can comprise biologically active
components, for example. As a result of the usage of such
materials, after the rivets 938 are deployed into the tissue and
the end-effector 920 is removed from the surgical site, the rivets
938, over time, can be absorbed and/or dissolved into tissue and/or
the body. In other various embodiments, the rivets 938 can comprise
or can be coated with a medication, a therapeutic agent, and/or a
collagen-based material to aid the tissue surrounding the rivets
938 in the healing process.
[0227] In one embodiment, the rivets 938 can comprise a
tissue-puncturing tip 967 or tissue-piercing tip on the meltable
and/or deformable portion 959 or on the elongate portion 957. The
tissue-puncturing tip 967 can be configured to pierce tissue and/or
buttress material, such as a collagen-based buttress material, for
example, when forced into the tissue by the driver 942. In various
embodiments, the tissue-puncturing tip 967 can be comprised of the
same material as the meltable and/or deformable portion 959 and/or
the elongate portion 957 or can be comprised of a different
material, such as titanium or other biocompatible alloy, for
example. In an embodiment where the tissue-puncturing tip 967
comprises the same materials as the meltable and/or deformable
portion 959 or other meltable and/or deformable materials, it may
be advantageous to first cut the tissue and then energize the
end-effector and deploy the rivets 938 to prevent, or at least
inhibit, the tissue-puncturing tip 967 from melting prior to being
deployed into the tissue, for example.
[0228] In one embodiment, FIGS. 45 and 46 illustrate the rivets 938
in the process of being deployed or fired into tissue compressed
intermediate the first jaw 926 and the second jaw 928. In various
embodiments, the rivets 938 can be moved from the first stored
position into a second deployed positioned using the driver 942. As
illustrated in FIG. 46, the extent to which the rivets heads 969 of
the rivets 938 are formed can be based on the tissue thickness
where a particular rivet 938 is deployed into the tissue "T."
Stated another way, in various embodiments, the rivets heads 969
can be melted and/or deformed more in thinner areas of the tissue
and melted and/or deformed less in thicker areas of the tissue.
Such adjustability of rivet head formation can allow a suitable
bond to be formed in the tissue regardless of the thickness of the
tissue where a particular rivet 938 is deployed. In one embodiment,
the elongate portion 957 of the rivets 938 can have a first
circumferential perimeter when the rivets 938 are in the first,
stored position (i.e., the undeployed position) and can have a
meltable and/or deformable portion 959 that has a second
circumferential perimeter when the rivets 938 are moved into the
second position (i.e., the deployed position). In such an
embodiment, the second circumferential perimeter of the meltable
and/or deformable portion 959 can be greater than the first
circumferential perimeter of the elongate portion 957 after the
rivet head 969 is formed. In one embodiment, the meltable and/or
deformable portion 959 of the rivet 938 can have a first axial
length when the rivet 938 is in the first stored position and can
have a second axial length when the rivet 938 is in the second
deployed position after the rivet head 969 is formed. The first
axial length of the meltable portion 959 can be greater than the
second axial length of the meltable and/or deformable portion 959
when the meltable and/or deformable portion 959 is at least
partially melted or deformed. In various embodiments, the base 961
can form the other rivet head on the side of the tissue proximate
to the second portion 928. In other embodiments, a rivet head can
be formed on the rivet on the side of the tissue proximate to the
second portion 928 by the driver 942 applying pressure to the rivet
while deploying the rivet and/or by heat created within the
end-effector 920. In any event, either a base or a rivet head is
generally present on both ends of the various rivets when the
rivets are deployed into tissue, such that the rivets remain within
the tissue.
[0229] In one embodiment, the rivets 938 and the driver 942 can be
comprised of or can comprise a conductive or electrically
conductive portion such that energy can pass to the driver 942 and
to the rivets 938 when the driver 942 is in contact with the rivets
938. In such an embodiment, the rivets 938 can be deformable, for
example. Such a feature allows the rivets 938 to seal tissue as the
rivets 938 are forced through the tissue by the driver 942, similar
to that described above with respect to the staples 72.
[0230] In one embodiment, referring to FIGS. 47 and 48, an example
configuration of a first face 944 of the first jaw 926 (FIG. 47)
and a second face 956 of the second jaw 928 (FIG. 48) is
illustrated. In various embodiments, the first jaw 926 can comprise
the first electrode 954 and optionally can comprise the fuse 962,
such as the PTC material, for example, positioned at least
partially over the first electrode 954. The cutting member 940 can
be moved through a cutting member channel 980 when forced distally
within the end-effector 920 by the driver 940. In one embodiment,
the anvil pockets 958 can be formed in the first face 944. These
anvil pockets 958 can be configured to receive the meltable and/or
deformable portion 959 and/or the elongate portion 957 of the rivet
938 and deform and/or melt the same. Although, the anvil pockets
958 of FIG. 47 are illustrated as being dome-shaped, those of skill
in the art will recognized that anvil pockets can be any other
suitable shape configured to deform and/or melt portions of the
rivet 938 and form the rivet head 969 in tissue. In one embodiment,
the shape of the rivet heads 969 can be dependent on the shape of
the anvil pockets 958. In other embodiments, the shape of the rivet
heads 969 can be dependent on the shape of the meltable and/or
deformable portion 959 and/or the elongate portion 957. The first
face 944 can comprise an insulator material thereon to aid in
directing energy from the first electrode 954 to the second
electrode 960 with minimal thermal spread of the heat generated
between the electrodes 954 and 960.
[0231] In one embodiment, referring to FIG. 48, the second face 956
of the second portion 928 can comprise the rivet cavities 946 which
can each comprise the rivet 938 removably positioned therein. As
discussed above, the rivet cavities 946 can be defined in the
second portion 928 or defined in a rivet cartridge that can be
attached to or engaged with the second portion 928. The second
portion 928 can comprise the fuse 962, such as PTC material, for
example, and can also comprise or can be comprised of the second
electrode 960. In general, the fuse 962 is usually provided on only
one of the first portion 926 and the second portion 928, although,
in some embodiments, the fuse 962 can be provided on both of the
first portion 926 and the second portion 928. For example, the
second portion 928 can comprise conductive portions underneath the
fuse 962. Similar to the first face 944, the second face 956 can
comprise an insulator material thereon to aid in directing energy
from the first electrode 954 to the second electrode 960 with
minimal thermal spread of the heat generated between the electrodes
954 and 960.
[0232] In various embodiments, the rivets 938 in the rivet cavities
946 can be deployed by the driver 942 from the second portion 928
toward the first portion 926 or toward the anvil pockets 958 such
that portions thereof can be deformed by the anvil pockets 958. In
other embodiments, the rivets 938 can be deformed by the first face
944 of the first portion 926. At the same time, before, or after
the rivets 938 are deployed into the tissue, the first electrode
954 or the second electrode 960 can be energized to supply energy
to the tissue and to the first electrode 954 or the second
electrode 954. The energy can be supplied to the first electrode
954 and returned from the second electrode 960 or can be supplied
to the second electrode 960 and returned from the first electrode
954 similar to or the same as that described above. An activation
button 964 (FIG. 39) can also be used to allow the energy to pass
through the end-effector 920, similar to or the same as that
described above. In one embodiment, various lockouts or lockout
devices can also be provided in the rivet firing trigger 923 or in
the activation button 964 similar to or the same as that described
above.
[0233] In the example embodiments of FIGS. 47 and 48, the rivets
938 and the anvil pockets 958 are illustrated in a linear fashion
and positioned outwardly from the first electrode 954, the second
electrode 960, and the fuse 962. Such example embodiments are not
intended to limit the scope of the present disclosure. In fact, the
rivets 938 and the anvil pockets 958 can be positioned in a linear
or non-linear fashion outwardly or inwardly from the first
electrode 954, the second electrode 960, and the fuse 962, for
example. In certain other embodiments, two or more lines of the
rivets 938 can be provided. If two or more lines of the rivets 938
are provided, a first line of the rivets 938 can be staggered or
off-set from the second line of the rivets 938 such that a better
seal can be created in the tissue by reducing the spacing of gaps
between the rivets 938. In one embodiment, one or more lines of the
rivets 938 can be positioned on each side of the seal, for example.
Furthermore, spacing between one rivet 938 and another rivet 938
may vary according to a particular surgical purpose of the rivets
938. As discussed above, in certain embodiments, staples or other
suitable fasteners may also be used to compliment the rivets
938.
[0234] In one embodiment, referring to FIGS. 49 and 50, another
example of a first portion 926' that can be used with the second
portion 928 of FIG. 48 is provided. In such an embodiment, anvil
pockets 958' can be defined in a first face 944'. The anvil pockets
958' can have a rectangular or substantially rectangular opening at
or proximate to the first face 944' to produce a rivet line 941'
having rivet heads 969' in the tissue "T" as illustrated in FIG.
50. The tissue can also comprise a seal 976' produced by the
electrodes and a cut line 973' produced by the cutting member 940
when the cutting member 940 is moved along the cutting member
channel 980'.
[0235] In one embodiment, referring to FIGS. 51 and 52, another
example of a first portion 926'' that can be used with the second
portion 928 of FIG. 48 is provided. In such an embodiment, anvil
pockets 958'' can be defined in a first face 944''. Channels 971''
can be defined in the first face 944'' intermediate a first anvil
pocket 958'' and a second anvil pocket 958''. The anvil pockets
958'' can have a circular or substantially circular opening at or
proximate to the first face 944'' to produce a rivet line 941''
having rivet heads 969'' in the tissue "T" connected by elongate
members 981'' as illustrated in FIG. 52. The elongate members 981''
can be formed by portions of the rivets 938'' being melted and/or
being deformed within the channels 971''. As can be seen in FIG.
52, the rivets 938'' of the rivet line 941'' can be connected to
each other from the rivet material melted within the channels
971''. As a result, the rivet line 941'' can be robust and can
create an appropriate seal in the tissue or layers of tissue. Such
a rivet line 941'' can also protect, by providing structural
support to the tissue "T", the seal 976'' formed in the tissue "T"
around the cut line 973'' by the various electrodes. The cut line
973'' can be formed by the cutting member 940 moving along the
cutting member channel 980''.
[0236] In one embodiment, referring to FIGS. 53 and 54, another
example of a first portion 926''' that can be used with the second
portion 928 of FIG. 48 is provided. In such an embodiment, anvil
pockets 958''' can be defined in a first face 944''. One anvil
pocket 958''' can touch or be positioned very proximal to another
anvil pocket 958''' to form a rivet line 941''' in the tissue "T"
as illustrated in FIG. 54. The anvil pockets 958''' can have an
elongate opening at or proximate to the first face 944''' to
produce the rivet line 941''' having rivet heads 969''. As can be
seen from FIG. 54, the rivet heads 969''' of the rivets 938''' can
be connected to each other from the rivet material melted within
the anvil pockets 958'''. As a result, the rivet line 941''' can be
robust and can create an appropriate seal in the tissue or layers
of tissue. Such a rivet line 941''' can also protect, by providing
structural support to the tissue, a seal 976''' formed in the
tissue by the various electrodes around the cut line 973''. The cut
line 973''' can be formed by the cutting member 940 moving along a
cutting member channel 980'''. Those of skill in the art will
recognize that other suitable patterns of rivets and/or rivet lines
are within the scope of the present disclosure.
[0237] In one embodiment, referring to FIGS. 55A-55C, a rivet 938
is illustrated. The rivet 938 is illustrated in the undeployed,
undeformed, and/or unmelted state in FIGS. 55A and 55B and is
illustrated, in one example embodiment, in a deployed, deformed,
and/or melted state in FIG. 55C. In one embodiment, the rivet 938
can comprise a tissue-puncturing tip 967, a meltable and/or
deformable portion 959, an elongate portion 957, a tissue-engaging
portion 955, and a base 961. The tissue engaging-portion 955 can
comprise a first end 963 and a second end 965. The elongate portion
957 can extend from the first end 963 and the base 961 can extend
from the second end 965. The base 961 can comprise a
tissue-engaging surface 975. The meltable and/or deformable portion
959 and possibly a portion of the elongate portion 957 can be
deformed by the first face of the first portion and the driver and
can be at least partially melted by heat within the end-effector
generated by the resistance to the energy flow that the tissue
provides intermediate the first electrode and the second electrode.
In such an embodiment, the elongate portion 957 and/or the meltable
and/or deformable portion 959 can form a rivet head 969 while the
base 961 can form the other rivet head.
[0238] In one embodiment, referring to FIG. 46, a buttress material
"B", such as a collagen-based buttress material, for example, can
be positioned intermediate the first jaw 926 and the second jaw 928
and/or can be attached to one of the first jaw 926 and the second
jaw 928. The tissue-puncturing tip 967 or other various
tissue-puncturing tips can be configured to puncture not only the
tissue, but also the buttress material when the rivet 938 is
deployed towards the first portion 926. Such use of the
collagen-based buttress material can aid the healing process in the
area near the cut line 973 or where the rivets 938 have punctured
the tissue. Such a buttress material can be used with any of the
other rivets or end-effectors of the present disclosure in the same
or a similar fashion.
[0239] In one embodiment, referring to FIGS. 56A-56C, a rivet 1038
is illustrated. The rivet 1038 is illustrated in the undeployed,
undeformed, and/or unmelted state in FIGS. 56A and 56B and is
illustrated, in one example embodiment, in a deployed, deformed,
and/or melted state in FIG. 56C. In one embodiment, the rivet 1038
can comprise a tissue-puncturing tip 1067, a meltable and/or
deformable portion 1059, an elongate portion 1057, a
tissue-engaging portion 1055, a second elongate portion 1057', and
a second meltable and/or deformable portion 1059'. The tissue
engaging-portion 1055 can comprise a first end 1063 and a second
end 1065. The elongate portion 1057 can extend from the first end
1063 and the second elongate portion 1057' can extend from the
second end 1065. The meltable and/or deformable portions 1059 and
1059' and possibly a part of the elongate portions 1057 and 1057'
can be deformed and/or melted by the first face of the first
portion and the driver and can be melted by heat within the
end-effector generated by the resistance to the energy flow that
the tissue provides intermediate the first electrode and the second
electrode. In such an embodiment, the elongate portions 1057 and
1057' and/or the meltable and/or deformable portions 1059 and 959'
can form rivet heads 1069 and 1069'.
[0240] In one embodiment, referring to FIGS. 57A-57C, a rivet 1138
is illustrated. The rivet 1138 is illustrated in the undeployed,
undeformed, and/or unmelted state in FIGS. 57A and 57B and is
illustrated, in one example embodiment, in a deployed, deformed,
and/or melted state in FIG. 57C. In one embodiment, the rivet 1138
can be similar to the rivet 938, but can comprise a base 1161
comprising a camming surface 1166 configured to be engaged with the
driver or a camming surface on the driver to drive the rivets 1138
into tissue. In one embodiment, such a camming surface 1166 can be
provided on all of the rivets of the present disclosure.
[0241] In one embodiment, referring to FIGS. 58A-58C, a rivet 1238
is provided. The rivet 1238 is illustrated in the undeployed,
undeformed, and/or unmelted state in FIGS. 58A and 58B and is
illustrated, in one example embodiment, in a deployed, deformed,
and/or melted state in FIG. 58C. In one embodiment, the rivet 1238
can be similar to the rivet 1038, but can comprise a different
tissue-puncturing tip 1267 and a meltable and/or deformable portion
1259 configured to be formed into a rivet head 1269.
[0242] In one embodiment, referring to FIGS. 59A-59C, a rivet 1338
is provided. The rivet 1338 is illustrated in the undeployed,
undeformed, and/or unmelted state in FIGS. 59A and 59B and is
illustrated, in one example embodiment, in a deployed, deformed,
and/or melted state in FIG. 59C. In one embodiment, the rivet 1338
can be similar to the rivet 1238, but can comprise two
tissue-puncturing tips 1367 and 1367' and a differently shaped
meltable and/or deformable portion 1359 configured to be formed
into a rivet head 1369.
[0243] Although the rivets and rivet cartridges have been discussed
herein with respect to the surgical instrument 910, it will be
understood that the rivets and rivet cartridges disclosed herein
can be used with other linear cutting instruments, other linear
cutting and sealing instruments, or other circular stapling
instruments, such as the circular stapling instrument 10, for
example. In a circular stapling instrument, the rivet cartridge can
be circular or substantially circular such that it can be
positioned within a receiving slot defined in the first portion 26
or the second portion 28 of the surgical instrument 10, for
example. In one embodiment, the rivet cartridges discussed herein
can be disposable or reloadable after use.
[0244] While the present disclosure has been illustrated by
description of several example embodiments and while the example
embodiments have been described in considerable detail, it is not
the intention of the applicants to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may be readily apparent to those of skill in the
art. Furthermore, although the example embodiments disclosed herein
have been described in connection with various surgical instrument,
other embodiments are envisioned in connection with other suitable
medical devices and/or surgical instruments, such as a linear
cutter for open surgery techniques, as disclosed in U.S. Patent
Application Publication No. 2010/0072251 to Baxter et al., entitled
LOCKOUT ARRANGEMENT FOR A SURGICAL STAPLER, filed on Sep. 19, 2008,
the entire disclosure of which is hereby incorporated by reference.
Furthermore, adjustable staple formation height technology can be
used with the present disclosure. Example embodiments of the
adjustable staple formation height technology are disclosed in U.S.
Patent Application Publication No. 2010/0032470 to Hess et al.,
entitled SURGICAL STAPLING SYSTEMS AND STAPLE CARTRIDGES FOR
DEPLOYING SURGICAL STAPLES WITH TISSUE COMPRESSION FEATURES, filed
on Oct. 16, 2009, the entire disclosure of which is hereby
incorporated by reference. While this disclosure has been described
as having exemplary designs, the disclosure 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 disclosure using its general principles. Further, this
disclosure is intended to cover such departures from the present
disclosure as come within known or customary practice in the art to
which this disclosure pertains.
[0245] The various embodiments of the present disclosure have been
described above in connection with cutting-type surgical
instruments. It should be noted, however, that in other
embodiments, the surgical instruments disclosed herein need not be
a cutting-type surgical instrument. For example, it could be a
non-cutting endoscopic instrument, a grasper, a stapler, a clip
applier, an access device, a drug/gene therapy delivery device, an
energy device using ultrasound, RF, laser, etc. In certain
embodiments, an ultrasonic instrument can be utilized in accordance
with the embodiments disclosed herein. In one such embodiment, an
ultrasonic instrument can comprise a first portion comprising a
handle portion and/or end effector, for example, and a second
portion comprising radiation-sensitive electronics. Various
ultrasonic instruments are disclosed in U.S. Pat. No. 6,063,098 to
Houser et al., entitled ARTICULATABLE ULTRASONIC SURGICAL
APPARATUS, which issued on May 16, 2000, the entire disclosure of
which is hereby incorporated by reference in its entirety.
Adjustable height staples and/or adjustable height staple formation
technology may also be used with the embodiments of the present
disclosure. An examples of such technology is disclosed in U.S.
patent application Ser. No. 12/622,113 to Bedi et al., entitled
SURGICAL STAPLER COMPRISING A STAPLE POCKET, filed on Nov. 19,
2009, the entire disclosure of which is incorporated herein by
reference in its entirety. Although the present disclosure has been
described herein in connection with certain disclosed embodiments,
many modifications and variations to those embodiments may be
implemented. For example, different types of end effectors may be
employed. Also, where materials are disclosed for certain
components, other materials may be used. The foregoing description
and following claims are intended to cover all such modification
and variations.
[0246] Further to the above, the various staple cartridges and/or
rivet cartridges disclosed herein can be disposable. In one
embodiment, an expended staple cartridge or rivet cartridge, or an
at least partially expended staple cartridge or rivet cartridge,
can be removed from a surgical stapler and replaced with another
staple cartridge or rivet cartridge. In other various embodiments,
the staple cartridge or rivet cartridge may not be removable and/or
replaceable during the ordinary use of the surgical instrument but,
in some circumstances, may be replaceable while and/or after the
surgical stapler is reconditioned as described in greater detail
below. In various embodiments, the staple cartridge or rivet
cartridge can be part of a disposable loading unit or end-effector
which can comprise a staple cartridge carrier or rivet cartridge
carrier, an anvil, a cutting member, and/or a staple or rivet
driver. In one embodiment, the entire, or at least a portion of,
the disposable loading unit or end-effector can be detachably
connected to a surgical instrument and can be configured to be
replaced.
[0247] The surgical instruments 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 surgical
instruments can be reconditioned for reuse after at least one use.
Reconditioning can comprise any combination of the steps of
disassembly of the surgical instruments, followed by cleaning or
replacement of particular pieces, and subsequent reassembly. In
particular, the surgical instruments can be disassembled, and any
number of the particular pieces or parts of the surgical
instruments can be selectively replaced or removed in any
combination. Upon cleaning and/or replacement of particular parts,
the surgical instruments 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 surgical instrument can
utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned surgical instrument, are all within the
scope of the present disclosure.
[0248] Although the various embodiments of the devices have been
described herein in connection with certain disclosed embodiments,
many modifications and variations to those embodiments may be
implemented. For example, different types of end effectors may be
employed. Also, where materials are disclosed for certain
components, other materials may be used. Furthermore, according to
various embodiments, a single component may be replaced by multiple
components, and multiple components may be replaced by a single
component, to perform a given function or functions. The foregoing
description and following claims are intended to cover all such
modification and variations.
[0249] 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.
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