U.S. patent application number 12/880414 was filed with the patent office on 2011-03-10 for surgical staples having compressible or crushable members for securing tissue therein and stapling instruments for deploying the same.
This patent application is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Christopher J. Hess, Jerome R. Morgan, Mark S. Ortiz, Frederick E. Shelton, IV, Carl Shurtleff, Michael J. Stokes, Jeffrey S. Swayze, James W. Voegele, William B. Weisenburgh, II.
Application Number | 20110060363 12/880414 |
Document ID | / |
Family ID | 55177659 |
Filed Date | 2011-03-10 |
United States Patent
Application |
20110060363 |
Kind Code |
A1 |
Hess; Christopher J. ; et
al. |
March 10, 2011 |
SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR
SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE
SAME
Abstract
A staple having a crown, a deformable leg extending from the
crown, and a spring extending from the crown configured to compress
tissue between the spring and the deformable member. Owing to the
flexibility of the spring, the staple can accommodate a wide range
of tissue thicknesses while still compressing the tissue captured
therein. As a result, a single staple design can be used in a wide
variety of surgical procedures thereby reducing the amount of
staple designs that must be provided to the surgeon. In at least
one embodiment, the staple includes a crushable member. This
crushable member can include a plastically deformable first portion
and an elastically deformable second portion. The present invention
can also include, in various embodiments, a crown, a first
deformable member extending from the crown, and means for
compressing the tissue against the first deformable member.
Inventors: |
Hess; Christopher J.;
(Cincinnati, OH) ; Morgan; Jerome R.; (Cincinnati,
OH) ; Weisenburgh, II; William B.; (Maineville,
OH) ; Voegele; James W.; (Cincinnati, OH) ;
Ortiz; Mark S.; (Milford, OH) ; Stokes; Michael
J.; (Cincinnati, OH) ; Shurtleff; Carl;
(Mason, OH) ; Shelton, IV; Frederick E.; (New
Vienna, OH) ; Swayze; Jeffrey S.; (Hamilton,
OH) |
Assignee: |
Ethicon Endo-Surgery, Inc.
Cincinnati
OH
|
Family ID: |
55177659 |
Appl. No.: |
12/880414 |
Filed: |
September 13, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11541123 |
Sep 29, 2006 |
7794475 |
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12880414 |
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Current U.S.
Class: |
606/219 |
Current CPC
Class: |
A61B 2017/00831
20130101; A61B 2090/036 20160201; A61B 2017/07257 20130101; A61B
2019/306 20130101; A61B 2017/07271 20130101; A61B 17/064 20130101;
A61B 17/07292 20130101; A61B 2019/302 20130101; A61B 17/1114
20130101; A61B 90/03 20160201; A61B 2017/0641 20130101; A61B
17/0644 20130101; A61B 2090/0811 20160201; A61B 2017/07242
20130101; A61B 2017/2943 20130101; A61B 2090/065 20160201; A61B
17/11 20130101; A61B 17/068 20130101; A61B 2017/07264 20130101;
A61B 2018/00666 20130101; A61B 2017/00128 20130101; A61B 17/072
20130101; A61B 2017/2932 20130101; A61B 2090/032 20160201; A61B
17/34 20130101; A61B 2017/00539 20130101; A61B 2017/0725 20130101;
A61B 17/1155 20130101; A61B 2019/4857 20130101; A61B 2017/07278
20130101; A61B 17/115 20130101; A61B 2017/00862 20130101; A61B
17/07207 20130101; A61B 2017/320052 20130101; A61B 2017/07285
20130101; A61B 2017/00004 20130101; A61B 2017/07228 20130101; A61B
17/105 20130101 |
Class at
Publication: |
606/219 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A surgical staple insertable into tissue, said staple
comprising: a wire comprising a base, wherein said wire is
comprised of a first material; a crown attached to and at least
partially surrounding said base, wherein said crown is comprised of
a second material which is different than said first material; a
first deformable member extending from said base, wherein said wire
further comprises said first deformable member; a second deformable
member extending from said base, wherein said wire further
comprises said second deformable member; and a spring extending
from said crown, said spring configured to bias said tissue against
at least one of said first deformable member and said second
deformable member, said spring extending intermediate said first
deformable member and said second deformable member; wherein said
spring comprises a cantilever extending from said crown; wherein
said cantilever comprises: a first end attached to said crown; a
second end movable relative to said crown; and a curved portion
configured to contact tissue, wherein said curved portion is
intermediate said first end and said second end.
2. The surgical fastener of claim 1, wherein said fastener further
includes a second deformable member extending from said crown, said
spring configured to bias said tissue against said second
deformable member.
3. The surgical staple of claim 1, wherein said spring includes a
first end and a second end, said first end attached to said crown,
said second end configured to move with respect to said first
end.
4. The surgical staple of claim 1, wherein said spring includes a
first end and a second end, and wherein said first and second ends
are attached to said crown.
5. The surgical staple of claim 1, wherein said spring is comprised
of foam.
6. The surgical of claim 1, wherein said spring includes a first
elastic member and a second elastic member, said second elastic
member positioned intermediate said first elastic member and said
crown.
7. The surgical staple of claim 6, wherein said spring is
integrally molded with said crown.
8. The surgical staple of claim 1, wherein at least one of said
spring and said crown are comprised of a bioabsorbable
material.
9. A surgical staple deformable between a first shape and a second
shape, said staple comprising: a crown; a first deformable member
extending from said crown; and a crushable member, said crushable
member positioned intermediate said first deformable member and
said crown after said staple has been deformed into said second
shape.
10. The surgical staple of claim 9, wherein said crushable member
is comprised of foam.
11. The surgical staple of claim 9, wherein said crown is
overmolded onto at least a portion of said first deformable member,
and wherein said crushable member is integrally molded with said
crown.
12. The surgical staple of claim 9, wherein said crushable member
includes a plastically deformable first portion and an elastically
deformable second portion.
13. The surgical staple of claim 9, wherein said crushable member
is configured to bias tissue positioned intermediate said crushable
member and said first deformable member against said first
deformable member.
14. The surgical staple of claim 13, wherein said staple further
includes a second deformable member extending from said crown, said
crushable member configured to bias said tissue against said second
deformable member.
15. The surgical staple of claim 9, wherein at least one of said
crushable member and said crown are comprised of a bioabsorbable
material.
16. A surgical staple insertable into tissue, said fastener
comprising: a wire comprising a base, wherein said wire is
comprises of a first material; a crown attached to and at least
partially encompassing said base, wherein said crown is comprised
of a second material which is different than said first material; a
first deformable member extending from said base, wherein said wire
further comprises said first deformable member; a second deformable
member extending from said base, wherein said wire further
comprises said second deformable member; and compressing means for
compressing said tissue against at least one of said first
deformable member and said second deformable member; wherein said
compressing means comprises a cantilever extending from said crown,
wherein said cantilever comprises a first end attached to said
crown; a second end movable relative to said crown; and a curved
portion configured to contact tissue, wherein said curved portion
is intermediate said first end and said second end.
17. The surgical fastener of claim 16, wherein said fastener
further includes a second deformable member extending from said
crown, said compressing means configured to bias said tissue
against said second deformable member.
18. The surgical staple of claim 16, wherein said compressing means
includes a first end and a second end, said first end attached to
said crown, said second end configured to move with respect to said
first end.
19. The surgical staple of claim 16, wherein said compressing means
includes a first end and a second end, and wherein said first and
second ends are attached to said crown.
20. The surgical staple of claim 16, wherein said compressing means
is comprised of foam.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application
claiming priority under 35 U.S.C. .sctn.120 from co-pending U.S.
patent application Ser. No. 11/541,123, entitled SURGICAL STAPLES
HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE
THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed Sep.
29, 2006, the entire disclosure of which is incorporated by
reference herein.
[0002] The subject application is related to the following
co-pending and commonly-owned applications filed on Sep. 29, 2006,
the disclosure of each is hereby incorporated by reference in their
entirety, these patent applications being respectively
entitled:
[0003] (1) U.S. application Ser. No. 11/540,735, now U.S. Pat. No.
7,467,740, entitled Surgical Stapling Instruments Having Flexible
Channel and Anvil Features For Adjustable Staple Heights to
Frederick E. Shelton, IV, Jerome R. Morgan, Michael A. Murray,
Richard W. Timm, James T. Spivey, James W. Voegele, Leslie M.
Fugikawa, and Eugene L. Timperman;
[0004] (2) U.S. application Ser. No. 11/540,734, now U.S. Pat. No.
7,472,815, entitled Surgical Stapling Instruments With Collapsible
Features For Controlling Staple Height to Frederick E. Shelton, IV,
Jeffrey S. Swayze, Leslie M. Fugikawa, and Eugene L. Timperman;
[0005] (3) U.S. application Ser. No. 11/541,050, now U.S.
Publication No. 2008/0078804, entitled Surgical Cutting and
Stapling Instrument With Self Adjusting Anvil to Frederick E.
Shelton, IV and Joshua Uth;
[0006] (4) U.S. application Ser. No. 11/541,151, now U.S. Pat. No.
7,665,647, entitled Surgical Cutting and Stapling Device With
Closure Apparatus For Limiting Maximum Tissue Compression Force to
Frederick E. Shelton, IV and Jeffrey S. Swayze;
[0007] (5) U.S. application Ser. No. 11/541,164, now U.S. Pat. No.
7,506,791, entitled Surgical Stapling Instrument With Mechanical
Mechanism For Limiting Maximum Tissue Compression to Todd Phillip
Omaits, Bennie Thompson, Frederick E. Shelton, IV and Eugene L.
Timperman;
[0008] (6) U.S. application Ser. No. 11/529,904, now U.S.
Publication No. 2008/0078800, entitled Surgical Stapling
Instruments and Staples to Christopher J. Hess, William B.
Weisenburgh, II, Jerome R. Morgan, James W. Voegele, Frederick E.
Shelton, IV and Joshua Uth;
[0009] (7) U.S. application Ser. No. 11/541,374, now U.S.
Publication No. 2008/0078808, entitled Surgical Staples Having
Dissolvable, Bioabsorbable or Biofragmentable Portions and Stapling
Instruments For Deploying The Same to Christopher J. Hess, Michael
A. Murray, Jerome R. Morgan, James W. Voegele, Robert Gill, and
Michael Clem;
[0010] (8) U.S. application Ser. No. 11/541,098, now U.S.
Publication No. 2008/0078807, entitled Connected Surgical Staples
and Stapling Instruments For Deploying The Same to Christopher J.
Hess, William B. Weisenburgh, II, Jerome R. Morgan, Frederick E.
Shelton, IV, Leslie M. Fugikawa, and Eugene L. Timperman;
[0011] (9) U.S. application Ser. No. 11/529,935, now U.S.
Publication No. 2008/0078803, entitled Surgical Staples Having
Attached Drivers and Stapling Instruments For Deploying the Same to
Christopher J. Hess, Jerome R. Morgan, Michael Clem, Frederick E.
Shelton, IV, and William B. Weisenburgh, II;
[0012] (10) U.S. application Ser. No. 11/541,182, now U.S.
Publication No. 2008/0078802, entitled Surgical Staples and
Stapling Instruments to Christopher J. Hess, William B.
Weisenburgh, II, Jerome R. Morgan, Frederick E. Shelton, IV, and
Darrel Powell; and
[0013] (11) U.S. application Ser. No. 11/529,879, now U.S.
Publication No. 2008/0078806, entitled Surgical Stapling Instrument
With Mechanical Indicator To Show Levels of Tissue Compression to
Todd. P. Omaits, Bennie Thompson, Frederick E. Shelton, IV, and
Eugene L. Timperman.
FIELD OF THE INVENTION
[0014] The present invention generally relates to endoscopic and
open surgical instrumentation and, more particularly, to surgical
staples and staplers including, but not limited to, open surgical
stapling devices, laparoscopic surgical stapling devices,
endoscopic and intralumenal surgical stapling devices.
BACKGROUND
[0015] Endoscopic and laparoscopic surgical instruments are often
preferred over traditional open surgical devices since a smaller
incision tends to reduce the post-operative recovery time and
complications. The use of laparoscopic and endoscopic surgical
procedures has been relatively popular and has provided additional
incentive to develop the procedures further. In laparoscopic
procedures, surgery is performed in the interior of the abdomen
through a small incision. Similarly, in endoscopic procedures,
surgery is performed in any hollow viscus of the body through
narrow endoscopic tubes inserted through small entrance wounds in
the skin.
[0016] Laparoscopic and endoscopic procedures generally require
that the surgical region be insufflated. Accordingly, any
instrumentation inserted into the body must be sealed to ensure
that gases do not enter or exit the body through the incision.
Moreover, laparoscopic and endoscopic procedures often require the
surgeon to act on organs, tissues and/or vessels far removed from
the incision. Thus, instruments used in such procedures are
typically long and narrow while being functionally controllable
from a proximal end of the instrument.
[0017] Significant development has gone into a range of endoscopic
surgical instruments that are suitable for precise placement of a
distal end effector at a desired surgical site through a cannula of
a trocar. These distal end effectors engage the tissue in a number
of ways to achieve a diagnostic or therapeutic effect (e.g.,
endocutter, grasper, cutter, staplers, clip applier, access device,
drug/gene therapy delivery device, and energy device using
ultrasound, RF, laser, etc.).
[0018] Known surgical staplers include an end effector that
simultaneously makes a longitudinal incision in tissue and applies
lines of staples on opposing sides of the incision. The end
effector includes a pair of cooperating jaw members that, if the
instrument is intended for endoscopic or laparoscopic applications,
are capable of passing through a cannula passageway. One of the jaw
members receives a staple cartridge having at least two laterally
spaced rows of staples. The other jaw member defines an anvil
having staple-forming pockets aligned with the rows of staples in
the cartridge. The instrument includes a plurality of reciprocating
wedges which, when driven distally, pass through openings in the
staple cartridge and engage drivers supporting the staples to
effect the firing of the staples toward the anvil.
[0019] Recently, an improved "E-beam" firing bar was described for
a surgical stapling and severing instrument that advantageously
included a top pin that slides within an internal slot formed in
the upper jaw (anvil) and has a middle pin and bottom foot that
slides on opposite sides of a lower jaw of an end effector, or more
particularly a staple applying assembly. Distal to the middle pin,
a contacting surface actuates a staple cartridge held within an
elongate staple channel that forms the lower jaw. Between the
contacting surface and the top pin, a cutting surface, or knife,
severs tissue clamped between the anvil and the staple cartridge of
the lower jaw. Since both jaws are thus engaged by the E-beam, the
E-beam maintains a desired spacing between the jaws to ensure
proper staple formation. Thus, if a lesser amount of tissue is
clamped, the E-beam holds up the anvil to ensure sufficient spacing
for the staples to properly form against an undersurface of the
anvil. In addition, if a greater amount of tissue is clamped, the
E-beam draws down the anvil to ensure that the spacing does not
exceed the length of the staple such that ends of each staple are
not sufficiently bent to achieve a desired degree of retention.
Such an E-beam firing bar is described in U.S. patent application
Ser. No. 10/443,617, entitled "Surgical Stapling Instrument
Incorporating an E-Beam Firing Mechanism", filed on May 20, 2003,
now U.S. Pat. No. 6,978,921, issued Dec. 27, 2005, the disclosure
of which is hereby incorporated by reference in its entirety.
[0020] While an E-beam firing bar has many advantages for a
surgical stapling and severing instrument, often it is desirable to
sever and staple tissue of various thicknesses. A thin layer of
tissue may result in staples that only form loosely, perhaps
requiring the need for bolstering material. A thick layer of tissue
may result in formed staples that exert a strong compressive force
on the captured tissue, perhaps resulting in necrosis, bleeding or
poor staple formation/retention. Rather than limiting the range of
tissue thicknesses that are appropriate for a given surgical
stapling and severing instrument, it would be desirable to
accommodate a wider range of tissue thickness with the same
surgical stapling and severing instrument.
[0021] Consequently, a significant need exists for an improved
surgical stapling and severing instrument that incorporates a
staple applying assembly (end effector) that adjusts to the amount
of tissue that is clamped.
[0022] In addition, the staple drivers that are commonly employed
in existing staple applying assemblies are traditionally made as
stiff as possible to assure proper "B" form staple height. Because
of this stiff construction, these drivers do not provide any
flexibility for adjusting the formed height of the staple to a
particular thickness of tissue clamped within the assembly.
[0023] Thus, another significant need exists for staple drivers
that are able to facilitate the adjustment of the formed height of
the staples in response to variations in tissue thickness.
[0024] In various types of endocutter arrangements, the anvil is
opened and closed by axially actuating a closure tube assembly that
serves to interface with closure features on the proximal end of
the anvil. The anvil is commonly formed with trunnions that are
received in somewhat elongated slots in the proximal end of the
channel. The trunnions serve to pivotally support the staple
cartridge and permit the anvil to move into axial alignment while
pivoting to a closed position. Unfortunately, however, this
arrangement lacks means for limiting or adjusting the amount of
clamping forces applied to the anvil during the clamping process.
Thus, the same amount of clamping forces generated by the closure
tube assembly are applied to the anvil regardless of the thickness
of the tissue to be clamped therein. Such arrangement can result in
thinner tissues being over clamped which could lead to excessive
bleeding and possibly damage or even destroy the tissue.
[0025] Thus, there is another need for a closure system that
includes means for limiting or adjusting the amount of closure
forces applied to the anvil based on the thickness of the tissue to
be clamped between the anvil and the staple cartridge.
[0026] In certain types of surgical procedures the use of surgical
staples has become the preferred method of joining tissue, and,
specially configured surgical staplers have been developed for
these applications. For example, intra-luminal or circular staplers
have been developed for use in a surgical procedure known as an
anastomosis. Circular staplers useful to perform an anastomosis are
disclosed, for example, in U.S. Pat. No. 5,104,025 and U.S. Pat.
No. 5,309,927 which are each herein incorporated by reference.
[0027] An anastomosis is a surgical procedure wherein sections of
intestine are joined together after a connecting section has been
excised. The procedure requires joining the ends of two tubular
sections together to form a continuous tubular pathway. Previously,
this surgical procedure was a laborious and time consuming
operation. The surgeon had to precisely cut and align the ends of
the intestine and maintain the alignment while joining the ends
with numerous suture stitches. The development of circular staplers
has greatly simplified the anastomosis procedure and also decreased
the time required to perform an anastomosis.
[0028] In general, a conventional circular stapler typically
consists of an elongated shaft having a proximal actuating
mechanism and a distal stapling mechanism mounted to the shaft. The
distal stapling mechanism typically consists of a fixed stapling
cartridge containing a plurality of staples configured in a
concentric circular array. A round cutting knife is concentrically
mounted in the cartridge interior to the staples. The knife is
moveable in an axial, distal direction. Extending axially from the
center of the cartridge is a trocar shaft. The trocar shaft is
moveable, axially, with respect to the cartridge and elongated
shaft. An anvil member is mounted to the trocar shaft. The anvil
member has a conventional staple anvil mounted to it for forming
the ends of the staples. The distance between the distal face of
the staple cartridge and the staple anvil is controlled by an
adjustment mechanism mounted to the proximal end of the stapler
shaft. Tissue contained between the staple cartridge and the staple
anvil is simultaneously stapled and cut when the actuating
mechanism is engaged by the surgeon.
[0029] When performing an anastomosis using a circular stapler,
typically, the intestine is stapled using a conventional surgical
stapler with double rows of staples being emplaced on either side
of a target section (i.e., specimen) of intestine. The target
section is typically simultaneously cut as the section is stapled.
Next, after removing the specimen, the surgeon typically inserts
the anvil into the proximal end of the lumen, proximal of the
staple line. This is done by inserting the anvil head into an entry
port cut into the proximal lumen by the surgeon. On occasion, the
anvil can be placed transanally, by placing the anvil head on the
distal end of the stapler and inserting the instrument through the
rectum. Typically the distal end of the stapler is inserted
transanally. The surgeon then ties the proximal end of the
intestine to the anvil shaft using a suture or other conventional
tying device. Next, the surgeon cuts excess tissue adjacent to the
tie and the surgeon attaches the anvil to the trocar shaft of the
stapler. The surgeon then closes the gap between the anvil and
cartridge, thereby engaging the proximal and distal ends of the
intestine in the gap. The surgeon next actuates the stapler causing
several rows of staples to be driven through both ends of the
intestine and formed, thereby joining the ends and forming a
tubular pathway. Simultaneously, as the staples are driven and
formed, a concentric circular blade is driven through the
intestinal tissue ends, cutting the ends adjacent to the inner row
of staples. The surgeon then withdraws the stapler from the
intestine and the anastomosis is complete.
[0030] During the stapling process, however, the surgeon must be
careful not to over compress the material that is being stapled to
avoid killing or detrimentally damaging that tissue. While some
prior staplers are fitted with an indicator mechanism for providing
the surgeon with some indication of the spacing between the anvil
and the staple cartridge, it is desirable for the stapler to
include a mechanism that provides a means for avoiding over
compression of the tissue.
SUMMARY
[0031] The present invention, in various embodiments, includes a
staple having a crown, a deformable leg extending from the crown,
and a spring extending from the crown configured to compress tissue
between the spring and the deformable member. In these embodiments,
owing to the flexibility of the spring, the staple can accommodate
a wide range of tissue thicknesses while still providing for
adequate compression of the tissue captured therein. As a result, a
single staple design, for example, can be used in a wide variety of
surgical procedures thereby reducing the amount of staple designs
that must be provided to the surgeon.
[0032] The present invention, in various embodiments, includes a
surgical fastener insertable into tissue wherein the fastener
comprises a crown, a deformable member extending from the crown,
and a spring extending from the crown, the spring configured to
bias the tissue against the deformable member. In at least one
embodiment, the surgical fastener includes a crushable member. This
crushable member can include a plastically deformable first portion
and an elastically deformable second portion. The present invention
can also include, in various embodiments, a crown, a first
deformable member extending from the crown, and means for
compressing the tissue against the first deformable member.
BRIEF DESCRIPTION OF THE FIGURES
[0033] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention, and, together with the general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
present invention.
[0034] FIG. 1 is a left side view in elevation of a surgical
stapling and severing instrument with an open end effector (staple
applying assembly) with a shaft partially cut away to expose a
firing member of a proximal firing rod and distal firing bar guided
by a frame ground and encompassed by a closure sleeve.
[0035] FIG. 2 is a left side view of a closed end effector (staple
applying assembly) with a retracted force adjusted height firing
bar consistent with the present invention of the surgical stapling
and severing instrument of FIG. 1 taken in longitudinal vertical
cross section along lines 2-2.
[0036] FIG. 3 is a left isometric view of the force adjusted
(compliant) height firing bar of FIG. 2.
[0037] FIG. 4 is a left side view of a distal portion ("E-beam") of
a first version of the force adjusted height firing bar of FIG. 2
having horizontal slits formed respectively between the top pin and
cutting surface and between the middle pin and the cutting surface
to enhance vertical flexure.
[0038] FIG. 5 is a lower left isometric view of a distal portion
("E-beam") of a second version of the force adjusted firing bar of
FIG. 2 having a relieved lower area of an upper pin to enhance
vertical flexure.
[0039] FIG. 6 is a front view in elevation of an upper portion of
the E-beam of FIG. 5 taken in vertical and transverse cross section
through the upper pin along lines 6-6.
[0040] FIG. 7 is a front view of an upper portion of a third
version of the E-beam of FIG. 5 taken in vertical and transverse
cross section along lines 6-6 but further including relieved upper
root attachments of the top pin for enhanced vertical flexure.
[0041] FIG. 8 is a front view of an upper portion of a fourth
version of the E-beam of FIG. 5 taken in vertical and transverse
cross section along lines 6-6 but including a resilient inner
vertical laminate layer instead of a relieved undersurface of the
top pin for enhanced vertical flexure.
[0042] FIG. 9 is a front view of an upper portion of a fifth
version of the E-beam of FIG. 5 taken in vertical and transverse
cross section along lines 6-6 but including an upper pin formed of
a resilient material instead of a relieved undersurface of the
upper pin for enhanced vertical flexure.
[0043] FIG. 10 is an upper left isometric view of a distal portion
("E-beam") of a sixth version of the force adjusted firing bar of
FIG. 2 having resilient material upon a bottom foot to enhance
vertical flexure.
[0044] FIG. 11 is a front view in elevation taken in vertical and
transverse cross section through the padded lower foot of the end
effector (staple applying assembly) of the surgical stapling and
severing instrument of FIG. 1.
[0045] FIG. 12 is a left view in elevation of a distal portion
("E-beam") of a seventh version of the force adjusted firing bar of
FIG. 2 having a proximally and upwardly extended spring arm
attached to a lower foot to enhance vertical flexure.
[0046] FIG. 13 is a left top isometric view of a distal portion
("E-beam") of an eighth version of the force adjusted firing bar of
FIG. 2 having a spring washer encompassing a lower foot to enhance
vertical flexure.
[0047] FIG. 14 is a cross-sectional end view of another staple
applying assembly or end effector of the present invention in a
clamped or closed position.
[0048] FIG. 15 is a partial perspective view of the staple applying
assembly of FIG. 14 with some of the elements thereof shown in
cross-section.
[0049] FIG. 16 is a cross-sectional end view of another staple
applying assembly or end effector of the present invention in a
clamped or closed position.
[0050] FIG. 17 is a partial perspective view of the staple applying
assembly of FIG. 16 with some of the elements thereof shown in
cross-section.
[0051] FIG. 18 is a partial perspective of a staple applying
assembly of the present invention clamping a piece of tissue that
has been partially cut and stapled.
[0052] FIG. 19 is a bottom view of an anvil embodiment of the
present invention;
[0053] FIG. 20 is a longitudinal cross-sectional view of a staple
applying assembly employing the anvil embodiment depicted in FIG.
19.
[0054] FIG. 21 is a cross-sectional end view of the staple applying
assembly of FIG. 20 taken along line 21-21 in FIG. 20, with some
elements shown in solid form for clarity.
[0055] FIG. 22 is another longitudinal cross-sectional view of the
staple applying assembly of FIGS. 20 and 21 clamping a piece of
tissue therein, wherein the tissue has varying cross-sectional
thicknesses.
[0056] FIG. 23 is another partial longitudinal cross-sectional view
of the staple applying assembly of FIGS. 20-22 clamping another
piece of tissue therein.
[0057] FIG. 24 is another partial longitudinal cross-sectional of
the staple applying assembly of FIGS. 20-23 clamping another piece
of tissue therein.
[0058] FIG. 25 is an end cross-sectional view of another staple
applying assembly of the present invention in a clamped
position.
[0059] FIG. 26 is longitudinal cross-sectional view of another
staple applying assembly of the present invention.
[0060] FIG. 27 is a cross-sectional view of a portion of another
staple applying assembly of the present invention with a piece of
tissue clamped and stapled therein.
[0061] FIG. 28 is a top view of a portion of a biasing plate
embodiment of the present invention.
[0062] FIG. 29 is a cross-sectional view of a portion of the
biasing plate of FIG. 28 taken along line 29-29 in FIG. 28.
[0063] FIG. 30 is an end cross-sectional view of the staple
applying assembly of FIG. 27 with some elements shown in solid form
for clarity.
[0064] FIG. 30A is an end cross-sectional view of another staple
applying assembly of the present invention with some elements shown
in solid form for clarity.
[0065] FIG. 31 is a longitudinal cross-sectional view of the staple
applying assembly of FIGS. 27 and 30 with tissue clamped and
stapled therein.
[0066] FIG. 32 is another longitudinal cross-sectional view of the
staple applying assembly of FIG. 31 with another portion of tissue
clamped and stapled therein.
[0067] FIG. 33 is another longitudinal cross-sectional view of the
staple applying assembly of FIGS. 30-32 fluidically coupled to a
fluid reservoir supported by a handle assembly of various
embodiments of the present invention.
[0068] FIG. 34 is a longitudinal cross-sectional view of a staple
applying assembly of other embodiments of the present invention
wherein tissue of varying thickness is clamped therein.
[0069] FIG. 35 is an enlarged cross-sectional view of a portion of
the staple applying assembly of FIG. 34.
[0070] FIG. 36 is an exploded perspective view of a collapsible
staple driver embodiment of the present invention in a first
(uncollapsed) position.
[0071] FIG. 37 is a cross-sectional view of the collapsible staple
driver embodiment of FIG. 36.
[0072] FIG. 38 is an exploded perspective view of another
collapsible staple driver embodiment of the present invention in a
first (uncollapsed) position.
[0073] FIG. 39 is a cross-sectional view of the collapsible staple
driver embodiment of FIG. 38.
[0074] FIG. 40 is a perspective view of another collapsible staple
driver embodiment of the present invention.
[0075] FIG. 41 is an exploded perspective view of the collapsible
staple driver embodiment of FIG. 40.
[0076] FIG. 42 is a cross-sectional view of the collapsible staple
driver embodiment of FIGS. 40 and 41 in a first (uncollapsed)
position.
[0077] FIG. 43 is another cross-sectional view of the collapsible
staple driver embodiment of FIGS. 40-42 after compression forces
have been applied thereto.
[0078] FIG. 44 is an exploded perspective view of another
collapsible staple driver embodiment of the present invention.
[0079] FIG. 45 is a cross-sectional view of the collapsible staple
driver embodiment of FIG. 44 in a first (uncollapsed) position.
[0080] FIG. 46 is an exploded perspective view of the collapsible
staple driver embodiment of FIGS. 44 and 45 with some of the
elements thereof shown in cross-section.
[0081] FIG. 47 is an exploded front view of another collapsible
staple driver embodiment of the present invention.
[0082] FIG. 48 is another front view of the collapsible staple
driver of FIG. 47 in a first (uncollapsed) position.
[0083] FIG. 49 is another front view of the staple driver of FIGS.
47 and 48 after is has been compressed to a fully collapsed
position.
[0084] FIG. 50 is an exploded assembly view of another collapsible
staple driver embodiment of the present invention.
[0085] FIG. 51 is an exploded front view of the collapsible staple
driver embodiment of FIG. 50.
[0086] FIG. 52 is another front view of the collapsible staple
driver embodiment of FIGS. 50 and 51 after being compressed into a
fully collapsed position.
[0087] FIG. 53 is a perspective view of another collapsible staple
driver embodiment of the present invention;
[0088] FIG. 54 is a side elevational view of the collapsible staple
driver of FIG. 53 in a first (uncollapsed) position.
[0089] FIG. 55 is another side elevational view of the collapsible
staple driver of FIGS. 53 and 54 after being compressed to a fully
collapsed position.
[0090] FIG. 56 is a perspective view of a surgical cutting and
staple instrument of various embodiments of the present
invention.
[0091] FIG. 57 is an exploded assembly view of an end effector and
elongate shaft assembly of various embodiments of the present
invention.
[0092] FIG. 58 is an exploded assembly view of a handle assembly
and closure shuttle arrangements of various embodiments of the
present invention, with the firing system components omitted for
clarity.
[0093] FIG. 59 is a cross-sectional side view of the handle
assembly depicted in FIG. 58 with the closure trigger thereof in a
locked position.
[0094] FIG. 60 is a left side exploded assembly view of a closure
shuttle and closure tube assembly of various embodiments of the
present invention.
[0095] FIG. 61 is a right side exploded assembly view of a closure
shuttle and closure tube assembly of various embodiments of the
present invention.
[0096] FIG. 62 is a partially enlarged view of a distal end of a
closure tube assembly interacting with a partially closed anvil
with some of the components shown in cross-section for clarity.
[0097] FIG. 63 is another partially enlarged view of the closure
tube and anvil of FIG. 62 with the anvil illustrated in a fully
closed position and some elements shown in cross-section for
clarity.
[0098] FIG. 64 is a partial perspective view of a closure tube
assembly and anvil of various embodiments of the present
invention.
[0099] FIG. 65 is a partial perspective view of another closure
tube assembly and anvil of various embodiments of the present
invention.
[0100] FIG. 66 is a partial perspective view of another closure
tube assembly and anvil of various embodiments of the present
invention with the anvil in a fully closed position.
[0101] FIG. 67 is cross-sectional end view of the closure tube and
anvil arrangement of FIG. 66 with the elongate channel omitted for
clarity.
[0102] FIG. 68 is a partially enlarged view of a closure tube and
anvil arrangement of other various embodiments of the present
invention with the anvil in a partially closed position.
[0103] FIG. 69 is another partially enlarged view of the closure
tube and anvil arrangement of FIG. 68 with the anvil in a fully
closed position.
[0104] FIG. 70 is a cross-sectional view of another endocutter
embodiment of the present invention with the anvil thereof in an
open position and some components shown in solid form for
clarity.
[0105] FIG. 71 is another cross-sectional view of the endocutter
embodiment of FIG. 70 with the anvil in a fully closed position and
some components shown in solid form for clarity.
[0106] FIG. 72 is an enlarged cross-sectional view of a portion of
the anvil and the closure tube assembly of the embodiments depicted
in FIGS. 70 and 71 with the anvil in its fully closed position.
[0107] FIG. 73 is another cross-sectional view of the endocutter
embodiment of FIG. 70 with the anvil in a maximum clamping position
with some components shown in solid form for clarity.
[0108] FIG. 74 is an enlarged cross-sectional view of a portion of
the anvil and the closure tube assembly of the embodiments depicted
in FIG. 73 with the anvil in its maximum clamping position.
[0109] FIG. 75 is an enlarged cross-sectional view of a portion of
the endocutter depicted in FIGS. 70-74 clamping a thin piece of
tissue.
[0110] FIG. 76 is another enlarged cross-sectional view of a
portion of the endocutter depicted in FIGS. 70-75 clamping a
thicker piece of tissue.
[0111] FIG. 77 is a perspective view of another stapling instrument
of various embodiments of the present invention.
[0112] FIG. 78 is an exploded perspective assembly view of an anvil
and head arrangement that may be employed with various stapler
embodiments of the type depicted in FIG. 77.
[0113] FIG. 79 is an exploded perspective assembly view of a shaft
and trigger assembly that may be employed with various embodiments
of the stapler depicted in FIG. 77.
[0114] FIG. 80 is a partial cross-sectional view of a shaft
assembly and head assembly embodiment of the present invention with
the anvil attached to the shaft assembly.
[0115] FIG. 81 is a cross-sectional view of the handle assembly and
closure knob assembly of various embodiments of the present
invention.
[0116] FIG. 82 is a perspective view of the shaft assembly, trigger
assembly, staple driver, anvil and closure knob assembly with the
handle housing, head casing and outer tubular shroud removed
therefrom.
[0117] FIG. 83 is a cross-sectional view of a knob assembly
embodiment of the present invention.
[0118] FIG. 84 is a cross-sectional view of the knob assembly of
FIG. 83 taken along line 84-84 in FIG. 83.
[0119] FIG. 85 is a partial cross-sectional view of a stapler
embodiment of the present invention inserted into separated
portions of intestine.
[0120] FIG. 86 is another cross-sectional view of the staple and
intestine arrangement of FIG. 85 with the proximal and distal ends
of the intestine being sutured around the anvil shaft.
[0121] FIG. 87 is another cross-sectional view of the stapler and
intestine arrangement of FIGS. 85 and 86 with the anvil retracted
to a fully compressed position and prior to firing the stapler.
[0122] FIG. 88 is another cross-sectional view of the stapler and
intestine arrangement of FIGS. 85-87 after the staples have been
fired and the knife has severed the portions of sutured
intestine.
[0123] FIG. 89 is a perspective view of another stapler embodiment
of the present invention.
[0124] FIG. 90 is partial cross-sectional view of a portion of the
stapler of FIG. 89.
[0125] FIG. 91 is cross-sectional view of a closure actuator that
may be employed with the stapler of FIGS. 89 and 90.
[0126] FIG. 92 is a cross-sectional view of the closure actuator of
FIG. 91 taken along line 92-92 in FIG. 91.
[0127] FIG. 93 is a cross-sectional view of a portion of the
stapler of FIGS. 89-92 inserted in a portion of an intestine with
the stapler anvil retracted to a fully compressed position and
prior to firing the stapler.
[0128] FIG. 94 is a graph illustrating the relationship between a
compression force and resistive load generated by a variable force
generator that may be used in connection with various embodiments
of the present invention.
[0129] FIG. 95 is another view of the closure actuator of FIGS. 91
and 92.
[0130] FIG. 96 is a side view of a surgical staple in an undeployed
shape in accordance with an embodiment of the present
invention;
[0131] FIG. 97 is a side view of the staple of FIG. 96 in a first
deformed shape;
[0132] FIG. 98 is a side view of the staple of FIG. 96 in a second
deformed shape;
[0133] FIG. 99 is a side view of the staple of FIG. 96 in a third
deformed shape;
[0134] FIG. 100 is a top view of the staple of FIG. 99;
[0135] FIG. 101 is a perspective view of the staple of FIG. 96;
[0136] FIG. 102 is a perspective view of the staple of FIG. 97;
[0137] FIG. 103 is a perspective view of the staple of FIG. 98;
[0138] FIG. 104 is a perspective view of the staple of FIG. 99;
[0139] FIG. 105 is a partial cross-sectional view of a surgical
stapler, and surgical staples illustrated in various deformed
shapes in accordance with an embodiment of the present
invention;
[0140] FIG. 106 is a side view of a surgical staple in accordance
with an alternative embodiment of the present invention;
[0141] FIG. 107 is a perspective view of the staple of FIG.
106;
[0142] FIG. 108 is a side view of a staple in accordance with an
alternative embodiment of the present invention;
[0143] FIG. 109 is a top view of the staple of FIG. 108;
[0144] FIG. 110 is a side view of the staple of FIG. 108 in a
deformed shape;
[0145] FIG. 111 is a side view of a staple in accordance with an
alternative embodiment of the present invention;
[0146] FIG. 112 is a side view of a staple in accordance with an
alternative embodiment of the present invention;
[0147] FIG. 113 is a side view of a surgical staple in accordance
with an embodiment of the present invention including a crushable
member;
[0148] FIG. 114 is a side view of the staple of FIG. 113 in a
deformed shape;
[0149] FIG. 115 is a side view of a surgical staple in accordance
with an embodiment of the present invention including a spring
having a first elastic member and a second elastic member;
[0150] FIG. 116 is a top view of the staple of FIG. 115;
[0151] FIG. 117 is a side view of a surgical staple in accordance
with an embodiment of the present invention including a cantilever
spring;
[0152] FIG. 118 is a top view of the staple of FIG. 117;
[0153] FIG. 119 is a side view of a surgical staple in accordance
with an embodiment of the present invention including a spring;
[0154] FIG. 120 is a side view of the staple of FIG. 119 in a
deformed shape;
[0155] FIG. 121 is a top view of the staple of FIG. 120;
[0156] FIG. 122 is a perspective view of first and second
deformable members of a staple in accordance with an embodiment of
the present invention;
[0157] FIG. 123 is a perspective view of a dissolvable, or
bioabsorbable, material overmolded onto the deformable members of
FIG. 122;
[0158] FIG. 124 is a perspective view of the staple of FIG. 123 in
a deformed shape;
[0159] FIG. 125 is a perspective view of the staple of FIG. 124
where a portion of the dissolvable material has been dissolved and
the first and second deformable members have moved relative to one
another;
[0160] FIG. 126 is a perspective view of the staple of FIG. 125
after the dissolvable material has completely dissolved;
[0161] FIG. 127 is a partial cross-sectional view of a surgical
stapler having an anvil, and a staple cartridge for removably
storing staples in accordance with an embodiment of the present
invention;
[0162] FIG. 128 is a partial cross-sectional view of the stapler of
FIG. 127 illustrating several staples in various deformed
shapes;
[0163] FIG. 129 is a partial cross-sectional view of the stapler of
FIG. 127 taken along line 129-129 in FIG. 127;
[0164] FIG. 129A is a detail view of a staple in FIG. 129;
[0165] FIG. 130 is a detail view of the staple of FIG. 129A in a
first deformed shape;
[0166] FIG. 131 is a detail view of the staple of FIG. 129A in a
second deformed shape;
[0167] FIG. 132 is a side view of a staple in accordance with an
alternative embodiment of the present invention having two
materials overmolded onto the deformable members;
[0168] FIG. 133 is a detail view of a staple in accordance with an
alternative embodiment of the present invention;
[0169] FIG. 134 is a detail view of a staple in accordance with an
alternative embodiment of the present invention;
[0170] FIG. 135 is a perspective view of staples in accordance with
an embodiment of the present invention;
[0171] FIG. 136 is a top view of a staple cartridge configured to
accommodate the staples of FIG. 135;
[0172] FIG. 137 is a detail view of the staple cartridge of FIG.
136;
[0173] FIG. 138 is a second detail view of the staple cartridge of
FIG. 136; and
[0174] FIG. 139 is a cross-sectional view of the staple cartridge
of FIG. 136 having the staples of FIG. 135 therein.
[0175] FIG. 140 is a perspective view of staples and a staple
cartridge of a stapler in accordance with an embodiment of the
present invention;
[0176] FIG. 141 is a detail view of the staple cartridge of FIG.
140;
[0177] FIG. 142 is a perspective view of a strip of the staples of
FIG. 140;
[0178] FIG. 143 is a detail view of the staples of FIG. 142;
[0179] FIG. 144 is a side cross-sectional view of the staples and
staple cartridge of FIG. 140;
[0180] FIG. 145 is a perspective view of a strip of staples in
accordance with an alternative embodiment of the present
invention;
[0181] FIG. 146 is a detail view of the staples of FIG. 145;
[0182] FIG. 147 is a side cross-sectional view of a stapler
deploying the staples of FIG. 145;
[0183] FIG. 148 is a perspective view of a strip of staples in
accordance with an alternative embodiment of the present
invention;
[0184] FIG. 149 is a detail view of the staples of FIG. 148;
[0185] FIG. 150 is a side cross-sectional view of a stapler
deploying the staples of FIG. 149;
[0186] FIG. 151 is a perspective view of a strip of staples in
accordance with an alternative embodiment of the present
invention;
[0187] FIG. 152 is a view of the staple strip of FIG. 151 stored
within a staple cartridge;
[0188] FIG. 153 is a cross-sectional view of the staple cartridge
of FIG. 152 taken along line 153-153 in FIG. 152;
[0189] FIG. 154 is a cross-sectional view of the staple cartridge
of FIG. 152 taken along line 154-154 in FIG. 153;
[0190] FIG. 155 is a cross-sectional perspective view of the staple
cartridge of FIG. 152 with staples positioned in a first
position;
[0191] FIG. 156 is a cross-sectional perspective view of the staple
cartridge of FIG. 152 with the staples positioned in a second
position;
[0192] FIG. 157 is an additional cross-sectional perspective view
of the staple cartridge of FIG. 152;
[0193] FIG. 158 is a perspective view of staples in accordance with
an embodiment of the present invention connected in a "puck"
configuration;
[0194] FIG. 159 is a bottom view of a staple cartridge in
accordance with an alternative embodiment of the present invention
configured to receive the staples of FIG. 158;
[0195] FIG. 159A is a detail view of the staple cartridge of FIG.
159;
[0196] FIG. 160 is a perspective of the staples of FIG. 158
positioned over drivers of the staple cartridge of FIG. 159;
[0197] FIG. 161 is a perspective view of the drivers of FIG.
160;
[0198] FIG. 162 is a cross-sectional view of the staple cartridge
of FIG. 159;
[0199] FIG. 163 is a second cross-sectional view of the staple
cartridge of FIG. 159;
[0200] FIG. 164 is a bottom view of a staple cartridge in
accordance with an alternative embodiment of the present
invention;
[0201] FIG. 164A is a detail view of the staple cartridge of FIG.
164;
[0202] FIG. 165 is a perspective view of staples in accordance with
an alternative embodiment of the present invention;
[0203] FIG. 166 is a second perspective view of the staples of FIG.
165;
[0204] FIG. 167 is a cross-sectional view of the staples of FIG.
165 being deployed by a stapler in accordance with an embodiment of
the present invention;
[0205] FIG. 168 is a perspective view of a staple assembly in
accordance with an embodiment of the present invention;
[0206] FIG. 169 is a top view of the staple assembly of FIG.
168;
[0207] FIG. 170 is a perspective view of a staple cartridge
configured to receive the staple assembly of FIG. 169;
[0208] FIG. 171 is a top view of the staple cartridge of FIG.
170;
[0209] FIG. 172 is a cross-sectional view of the staples of FIG.
168 and the staple cartridge of FIG. 170;
[0210] FIG. 173 is a perspective view of a staple assembly in
accordance with an alternative embodiment of the present
invention;
[0211] FIG. 174 is a perspective view of a staple assembly in
accordance with an alternative embodiment of the present invention
for forming non-parallel staple patterns;
[0212] FIG. 175 is a top view of the staple of FIG. 174 positioned
within a staple cartridge in accordance with an embodiment of the
present invention;
[0213] FIG. 176 is a top view of staples and a staple cartridge in
accordance with an embodiment of the present invention;
[0214] FIG. 177 is a detail view of the staple cartridge of FIG.
176; and
[0215] FIG. 178 is a cross-sectional view illustrating the
shearable deck of the staple cartridge of FIG. 176.
DETAILED DESCRIPTION
[0216] Turning to the Drawings, wherein like numerals denote like
components throughout the several views, in FIG. 1, a surgical
stapling and severing instrument 10 includes a handle portion 12
that is manipulated to position an implement portion 14 including a
fastening end effector, depicted as a staple applying assembly 16,
distally attached to an elongate shaft 18. The implement portion 14
is sized for insertion through a cannula of a trocar (not shown)
for an endoscopic or laparoscopic surgical procedure with an upper
jaw (anvil) 20 and a lower jaw 22 of the staple applying assembly
16 closed by depression of a closure trigger 24 toward a pistol
grip 26 of the handle portion 12, which advances an outer closure
sleeve 28 of the elongate shaft 18 to pivot shut the anvil 20.
[0217] Once inserted into an insufflated body cavity or lumen, the
surgeon may rotate the implement portion 14 about its longitudinal
axis by twisting a shaft rotation knob 30 that engages across a
distal end of the handle 12 and a proximal end of the elongate
shaft 18. Thus positioned, the closure trigger 24 may be released,
opening the anvil 20 so that tissue may be grasped and positioned.
Once satisfied with the tissue held in the staple applying assembly
16, the surgeon depresses the closure trigger 24 until locked
against the pistol grip 26, clamping tissue inside of the staple
applying assembly 16.
[0218] Then a firing trigger 32 is depressed, drawn toward the
closure trigger 24 and pistol grip 26, thereby applying a firing
force or motion thereto to distally advance a firing member from an
unfired position. The firing member is depicted as including a
proximal firing rod 34 attached to a distal firing bar 36, that is
supported within a frame ground 38 that connects the handle portion
12 to the staple applying assembly 16. During the staple firing
motion, the firing bar 36 engages an elongate staple channel 40 and
actuates a staple cartridge 42 contained therein, both forming the
lower jaw 22. The firing bar 36 also engages the closed anvil 20.
After releasing the firing trigger 32 to apply a retraction force
or motion to the firing bar 36, depression of a closure release
button 44 unclamps the closure trigger 24 so that the closure
sleeve 28 may be retracted to pivot and open the anvil 20 to
release the severed and stapled tissue from the staple applying
assembly 16.
[0219] It should be appreciated that spatial terms such as
vertical, horizontal, right, left etc., are given herein with
reference to the figures assuming that the longitudinal axis of the
surgical instrument 10 is co-axial to the central axis of the
elongate shaft 18, with the triggers 24, 32 extending downwardly at
an acute angle from the bottom of the handle assembly 12. In actual
practice, however, the surgical instrument 10 may be oriented at
various angles and, as such, these spatial terms are used relative
to the surgical instrument 10 itself. Further, "proximal" is used
to denote a perspective of a clinician who is behind the handle
assembly 12 who places the implement portion 14 distal, or away
from him or herself. However, surgical instruments are used in many
orientations and positions, and these terms are not intended to be
limiting and absolute.
[0220] In FIG. 2, the staple applying assembly 16 is closed upon
compressed tissue 46. In FIGS. 2-3, the firing bar 36 has a
proximal portion 48 that is attached to a distal E-beam 50 that
translates within the staple applying assembly 16. As depicted with
the firing bar 36 retracted, a vertical portion 52 of the E-beam 50
resides essentially aft of the staple cartridge 42, as after a new
staple cartridge 42 has been inserted into the elongate staple
channel 40. An upper pin 54 that extends laterally from an upper
portion of the vertical portion 52 of the E-beam 50 initially
resides within an anvil pocket 56 recessed near a proximal pivoting
end of the anvil 20. As the E-beam 50 is distally advanced during
the staple firing motion, the vertical portion 52 passes through a
narrow longitudinal anvil slot 58 (FIGS. 1, 11) formed in a staple
forming undersurface 60 of the anvil 20, a proximally open vertical
slot 62 formed in cartridge 42 and an underlying longitudinal
channel slot 64 formed in the elongate staple channel 40.
[0221] In FIGS. 2, 11, the narrow longitudinal anvil slot 58 (FIG.
2) communicates upwardly to a laterally widened longitudinal anvil
channel 66 sized to slidingly receive the upper pin 54. The
longitudinal channel slot 64 communicates downwardly to a laterally
widened longitudinal channel track 68 that receives a lower foot
70, which is sized to slide therein and is attached at a bottom of
the vertical portion 52 of the E-beam 50. A laterally widened
middle pin 72 extending from the vertical portion 52 of the E-beam
50 is positioned to slide along a top surface of a bottom tray 74
of the staple cartridge 42, which in turn rests upon the elongate
staple channel 40. A longitudinal firing recess 75 formed in the
staple cartridge 42 above the bottom tray 74 is sized to allow the
middle pin 72 to translate through the staple cartridge 42.
[0222] A distal driving surface 76 of the vertical portion 52 of
the E-beam 50 is positioned to translate through the proximally
open vertical slot 62 of the staple cartridge 42 and distally drive
a wedge sled 78 proximally positioned in the staple cartridge 42.
The vertical portion 52 of the E-beam 50 includes a cutting surface
80 along a distal edge above the distal driving surface 76 and
below the upper pin 54 that severs the clamped tissue 46
simultaneously with this stapling.
[0223] With particular reference to FIG. 11, it should be
appreciated that the wedge sled 78 drives upwardly staple drivers
82 that in turn drive upwardly staples 83 out of staple apertures
84 formed in a staple body 85 of the staple cartridge 42 to form
against the undersurface 60 of the anvil 20 which is in confronting
relationship relative to an upper surface 43 of staple cartridge 42
(FIG. 2).
[0224] In FIGS. 2, 11, advantageously, the illustrative spacing,
denoted by arrow 86 (FIG. 2), between the upper pin 54 is
compliantly biased toward a compressed state wherein 0.015 inches
of compressed tissue 46 is contained in the staple applying
assembly 16. However, a larger amount of compressed tissue 46 up to
about 0.025 inches is allowed by an inherent flexure of the E-beam
50. Excessive flexure, of perhaps up to 0.030 inches, is avoided
should the length of staples be insufficient to form with the
additional height. It should be appreciated that these dimensions
are illustrative for a staple height of 0.036 inches. The same
would be true for each category of staple, however.
[0225] In FIG. 4, a first version of a compliant E-beam 50a
includes top and bottom horizontal slits 90, 92 from a distal edge
of the vertical portion 52a, perhaps formed by electro drilling
machine (EDM). The vertical portion 52a thus contains a vertically
compliant top distally projecting arm 94 containing the upper pin
54, a knife flange 96 containing the cutting surface 80, and a
lower vertical portion 98 containing the distal driving surface 76,
middle pin 72 and lower foot 70. The horizontal slits 90, 92 allow
a compliant vertical spacing by allowing the top distally arm 94 to
pivot upwardly to adjust to increased force from compressed tissue
46 (not shown).
[0226] In FIGS. 5-6, a second version of a compliant E-beam 50b
includes left and right lower relieved areas 110, 112 formed into
an upper pin 54b to each side of the vertical portion 52, leaving
left and right lower bearing points 114, 116 respectively. The
outboard position of the bearing points 114, 116 provides a long
moment arm to exert the force to flex. It should be appreciated
given the benefit of the present disclosure that the dimensions of
the relieved areas 110, 112 and the choice of materials for the
compliant E-beam 50b may be selected for a desired degree of
flexure, given the staple size and other considerations.
[0227] In FIG. 7, a third version of a compliant E-beam 50c is as
described above in FIGS. 5-6 with further flexure provided by left
and right upper narrow relieved areas 120, 122 formed into opposite
top root surfaces of an upper pin 54c proximate to the vertical
portion 52.
[0228] In FIG. 8, a fourth version of a compliant E-beam 50d is as
described for FIGS. 2-3 with an added feature of a
composite/laminate vertical portion 52d that includes a central
resilient vertical layer 130 sandwiched between left and right
vertical layers 132, 134 that support respectively left and right
portions 136, 138 of an upper pin 54d. As the left and right
portions 136, 138 are flexed either up or down, the resulting
bowing of the left and right vertical layers 132, 134 are
accommodated by a corresponding compression or expansion of the
central resilient vertical layer 130.
[0229] In FIG. 9, a fifth version of a compliant E-beam 50e is as
described for FIGS. 2-3 with an added feature of a discrete upper
pin 54e formed of a more flexible material that is inserted through
a horizontal aperture 140 through a vertical portion 52e. Thus,
left and right outer ends 142, 144 of the discrete upper pin 54e
flex in accordance with loading forces.
[0230] Alternatively or in addition to incorporating flexure into
an upper pin 54, in FIGS. 10-11, a sixth version of a compliant
E-beam 50f as described for FIGS. 2-3 further includes resilient
pads 150 that are attached to upper surfaces 152 of the bottom foot
70. The resilient pads 150 adjust the spacing of the upper pin 54
in accordance to the compression force experienced at the bottom
foot 70.
[0231] In FIG. 12, a seventh version of a compliant E-beam 50g is
as described above for FIGS. 2-3 with the added feature of a bottom
foot (shoe) 70g having an upwardly aft extended spring finger 160
that resiliently urges the E-beam 50g downwardly to adjust vertical
spacing in accordance with loading force.
[0232] In FIG. 13, an eighth version of a compliant E-beam 50h is
as described above in FIGS. 2-3 with the added feature of an oval
spring washer 170 resting upon the bottom foot 70 encircling the
vertical portion 52 and having an upwardly bowed central portion
172 that resiliently urges the E-beam 50h downwardly to adjust
vertical spacing in accordance with loading force.
[0233] For another example, a compliant E-beam consistent with
aspects of the present invention may include engagement to an anvil
similar to the engagement in the illustrative versions of two
structures that slide against opposite sides of the elongate staple
channel. Similarly, a compliant E-beam may engage a lower jaw by
having a laterally widened portion that slides internally within a
channel formed in a lower jaw structure.
[0234] As yet an additional example, in the illustrative version,
the staple cartridge 42 is replaceable so that the other portions
of the staple applying assembly 16 may be reused. It should be
appreciated given the benefit of the present disclosure that
applications consistent with the present invention may include a
larger disposable portion, such as a distal portion of an elongate
shaft and the upper and lower jaws with a staple cartridge
permanently engaged as part of the lower jaw.
[0235] As yet another example, the illustrative E-beam
advantageously affirmatively spaces the upper and lower jaws from
each other. Thus, the E-beam has inwardly engaging surfaces that
pull the jaws together during firing in instances where a larger
amount of compressed tissue tends to spread the jaws. Thereby the
E-beam prevents malformation of staples due to exceeding their
effective length. In addition, the E-beam has outwardly engaging
surfaces that push the jaws apart during firing in stances where a
small amount of tissue or other structure attributes of the
instrument tend to pinch the jaws together that may result in
staple malformation. Either or both functions may be enhanced by
applications consistent with aspects of the invention wherein
inherent flexure in the E-beam adjusts to force to allow a degree
of closing of the jaws or of opening of the jaws.
[0236] FIG. 14 is an end cross-sectional view of a surgical
instrument 10a that has a staple applying assembly 16a of another
embodiment of the present invention wherein like reference numerals
are used to designate like elements and which employs an elongate
channel 40a for supporting a staple cartridge 42 therein. In
various embodiments, the channel 40a has resilient or flexible
features configured to enable the staple applying assembly 40a to
effectively accommodate different thicknesses of tissue. FIG. 15 is
a partial perspective view of the staple applying assembly 16a with
some components shown in cross-section for clarity. As can be seen
in FIG. 14, in this embodiment, a first longitudinally extending
relief area 180 and a second longitudinally extending relief area
184 are provided in the longitudinal channel 40a. The first
longitudinally extending relief area 180 defines a first resilient
or flexible channel ledge portion 182 and the second longitudinally
extending relief area 184 defines a second resilient or flexible
channel ledge portion 186. The elongate channel slot 64 through
which the upper end 51 of the vertical portion 52 of the firing
member in the form of E-beam 50 extends is formed between the free
ends 183, 185 of the flexible ledges 182, 186, respectively. As can
be further seen in FIG. 14, such arrangement permits the lower foot
70 of the E-beam 50 to bear upon the flexible ledge portions 182,
186 to accommodate differences in the thickness of the tissue
clamped between the anvil 20 and the lower jaw 22 as the E-beam 50
transverses therethrough. It will be understood that the thickness
188 of the ledge portions 182, 186 may be selected to provide the
desired amount of flexure to those portions of the elongate channel
40a. Also, the choice of materials for the elongate channel 40a may
be selected for a desired degree of flexure, in view of the staple
size and other considerations.
[0237] The elongate channel 40a as described above may be used in
connection with a staple applying assembly that employs a
conventional anvil 20. That is, the longitudinally extending anvil
slot 58 may essentially have a "T" shape that is sized to
accommodate the upper pins 54 and an upper end 51 of the vertical
portion 52 of the E-beam 50. The embodiment depicted in FIGS. 14
and 15 employs and anvil 20a that has resilient or flexible
features for further accommodating differences in tissue
thicknesses clamped between the anvil 20a and the lower jaw 22. In
particular, as can be seen in FIG. 14, a third longitudinally
extending relief area 190 and a fourth longitudinally extending
relief area 194 may be provided in the anvil 20a as shown. The
third longitudinally extending relief area 190 defines a first
anvil ledge portion 192 and the fourth longitudinally extending
relief area 194 defines a second anvil ledge portion 196 upon which
the upper pins 54 of the E-beam 50 may bear. Such arrangement
provides a degree of flexure to the anvil 20a to accommodate
differences in tissue thickness clamped between the anvil 20a and
the lower jaw 22. It will be understood that the thickness 198 of
the ledge portions 192, 196 may be selected to provide the desired
amount of flexure to those portions of the anvil 20a. Also, the
choice of materials for the anvil 20a may be selected for a desired
degree of flexure, in view of the staple size and other
considerations. Anvil 20a may be used in connection with the
above-described channel arrangement as shown in FIGS. 14 and 15 or
it may be employed with conventional channel arrangements without
departing from the spirit and scope of the present invention.
[0238] The person of ordinary skill in the art will also appreciate
that the anvil 20a and/or the channel 40a may be successfully
employed with a conventional E-beam arrangement or any of the
E-beam arrangements depicted herein. The E-beams disclosed herein
may be reciprocatingly driven by control arrangements housed within
the handle assembly. Examples of such control arrangements are
disclosed in U.S. Pat. No. 6,978,921, issued Dec. 27, 2005, which
has been herein incorporated by reference. Other known firing
member configurations and control arrangements for applying firing
and retraction forces or motions thereto could conceivably be
employed without departing from the spirit and scope of the present
invention.
[0239] FIGS. 16 and 17 illustrate a staple applying assembly 16b
that employs another version of a channel 40b and an anvil 20b that
each have resilient or flexible portions to accommodate differences
in tissue thicknesses clamped between the anvil 20b and the lower
jaw 22b. As can be seen in those Figures, a first pair 200 of upper
and lower longitudinally extending relieved or undercut areas 202,
204 are provided in the channel 40b to define a first
cantilever-type support ledge 206 and a second pair 210 of relieved
or undercut areas 212, 214 are provided in the channel 40b to
define a second cantilever-type support ledge 216. The first pair
relieved areas 202, 204 provide a degree of flexure to the first
support ledge 206 to enable it to flex as illustrated by arrow 205.
Likewise, the second pair 210 of relieved areas 212, 214 provide a
degree of flexure to the second support ledge 216 to enable it to
flex as illustrated by arrow 215. As with the above described
embodiments, the thickness 208 of the support ledges 206 and 216
may be selected to provide the desired amount of flexure to those
portions of the elongate channel 40b to accommodate different
thicknesses of tissue. Also, the choice of materials for the
elongate channel 40b may be selected for a desired degree of
flexure, in view of the staple size and other considerations.
[0240] FIGS. 16 and 17 further illustrate an anvil 20b that has a
T-shaped slot 58b that defines a first lateral wall portion 220 and
a second lateral wall portion 222. In various embodiments, a first
longitudinally extending undercut area 224 is provided in the first
lateral wall portion 220 to define a resilient or flexible first
ledge 226. Similarly, in various embodiments, a second
longitudinally extending undercut area 228 is provided in the
second lateral wall portion 222 to define a resilient or flexible
second ledge 230. As can be seen in FIG. 16, the ends 227, 231 of
the first and second ledges 226, 230, respectively serve to define
a portion 59b of anvil sot 58b through which an upper end portion
51 of E-beam 50b extends. Such arrangement permits the upper pins
54b of the E-beam 50b may bear upon the first resilient ledge 226
and the second resilient ledge 230 to provide a degree of flexure
to the anvil 20ab to accommodate differences in tissue thickness
clamped between the anvil 20b and the lower jaw 22b. It will be
understood that the thickness 232 of the ledges 226, 230 may be
selected to provide the anvil 20b with a desired amount of flexure
to accommodate different tissue thicknesses. Also, the choice of
materials for the anvil 20b may be selected for a desired degree of
flexure, in view of the staple size and other considerations. Anvil
20b may be used in connection with the above-described channel 40b
shown in FIGS. 16 and 17 or it may be employed with a conventional
channel arrangement. The skilled artisan will also appreciate that
the anvil 20a and/or the channel 40bg may be successfully employed
with a conventional E-beam arrangement or any of the E-beams
described herein.
[0241] FIG. 18 illustrates the cutting and stapling of tissue 240
with any one of the various surgical cutting and stapling
instrument embodiments of the present invention. A portion 242 of
the tissue 240 illustrated in FIG. 18 has already been cut and
stapled. After the clinician has cut and stapled the first portion
242, the instrument would be withdrawn to enable new staple
cartridge 42 to be installed. FIG. 18 illustrates the position of
the implement portion 14 prior to commencing the second cutting and
stapling process. As can be seen in that Figure, the portion 242 of
the tissue 240 that has been stapled has a thickness 243 that is
less than the thickness 245 of other portions 244 of the tissue
240.
[0242] FIG. 19 is a view of the underside of an anvil 20c that may
be employed with a staple applying assembly 16c of various
embodiments of the present invention. The anvil 20c includes and
anvil body 21c that supports movable staple forming pockets that
define different staple zones. In the embodiment depicted in FIG.
19, four left staple zones 252, 254, 256, 258 are provided on a
left side 250 of the anvil slot 58c and four right staple zones
262, 264, 266, 268 are provided on a right side 260 of the anvil
slot 58c within the anvil body 21c. The first left staple zone 252
is defined by a first left staple forming insert member 270 that
has a series of staple forming pockets 272 therein. In this
embodiment, three rows 274, 276, 278 of staple forming pockets 272
are provided in the insert 270. As can be seen in FIG. 19, the
central row 276 of pockets 272 are slightly longitudinally offset
from the outer two rows 274, 278 of pockets 272 and correspond to
the arrangement of the corresponding staple apertures 84 in
corresponding staple cartridges 42. Those of ordinary skill in the
art will appreciate that such arrangement serves to result in the
application of the staples 83 in a staggered manner as illustrated
in FIG. 18.
[0243] Similarly, the second left staple zone 254 may be defined by
a second left staple forming insert 280 that may have three rows
282, 284, 286 of staple forming pockets 272 therein. The third left
staple zone 256 may be defined by a third left staple forming
insert 290 that may have three rows 292, 294, 296 of staple forming
pockets 272 therein. The fourth left staple zone 258 may be defined
by a fourth left staple forming insert 300 that may have three rows
302, 304, 306 of staple forming pockets 272 therein. The first,
second, third and fourth left staple forming inserts 270, 280, 290,
300 are longitudinally aligned in a left side cavity 251 provided
in the anvil 20c on the left side 250 of the anvil slot 58.
[0244] The first right staple zone 262 may be defined by a first
right staple forming insert member 310 that has a series of staple
forming pockets 272 therein. In this embodiment, three rows 312,
314, 316 of staple forming pockets 272 are provided in the insert
310. As can be seen in FIG. 19, the central row 314 of staple
forming pockets 272 are slightly longitudinally offset from the
outer two rows 312, 316 and correspond to the arrangement of the
corresponding staple apertures 84 in corresponding staple
cartridges 42. Such arrangement serves to result in the application
of the staples 83 in a staggered manner on the right side of the
tissue cut line. The second right staple zone 264 may be defined by
a second right insert 320 that may have three rows 322, 324, 326 of
staple forming pockets 272 therein. The third right staple zone 266
may be defined by a third right staple forming insert 330 that may
have three rows 332, 334, 336 of staple forming pockets 272
therein. The fourth right staple zone 268 may be defined by a
fourth right staple forming insert 340 that may have three rows
342, 344, 346 of staple forming pockets 272 therein. The first,
second, third, and fourth right staple forming inserts 310, 320,
33, 340 are longitudinally aligned in a right side cavity 261
provided in the anvil 20c on the right side 260 of the anvil slot
58. In various embodiments, the staple forming inserts may be
fabricated from stainless steel or other suitable materials that
are harder than the material from which the staples are fabricated.
For example, the inserts may be successfully fabricated from other
materials such as cobalt chromium, aluminum, 17-4 stainless steel,
300 series stainless steel, 400 series stainless steel, other
precipitant hardened stainless steels, etc.
[0245] At least one biasing member or compliant member in the form
of a wave spring 350 or other suitable biasing or compliant medium
or member corresponding to each of the staple forming inserts 270,
280, 290, 300, 310, 320, 330, 340 is provided between the
respective left staple forming inserts 270, 280, 290, 300 and the
bottom of the left side cavity 251 as shown in FIGS. 20-23. Wave
springs 350 or other suitable biasing or compliant medium or member
is also provided between each of the right staple forming inserts
310, 320, 330, 340 and the bottom surface of the right side cavity
261. The wave springs 350 on the left side of the anvil slot 58c
may be received in a corresponding spring cavity 253 and the wave
springs 350 on the right side of the anvil cavity 58c may be
received in a corresponding spring cavity 263. To biasingly retain
each insert 270, 280, 290, 300, 310, 320, 330, 340 in the anvil
20c, each insert 270, 280, 290, 300, 310, 320, 330, 340 may be
attached to its corresponding spring 350 or biasing member by, for
example, adhesive or other fastener arrangements. In addition, each
spring 350 may be attached to the anvil 20c by, for example,
adhesive or other mechanical fastener arrangements to retain a
portion of the wave spring 350 within its respective spring cavity
253 or 263. Such spring/biasing member arrangements serve to bias
the inserts 270, 280, 290, 300, 310, 320, 330, 340 toward the
tissue 240 and staples and essentially act as resilient "shock
absorbers" to accommodate differences in tissue thicknesses. This
advantage is illustrated in FIGS. 22-24.
[0246] In particular, as can be seen in FIG. 22, the portion 242 of
the tissue 240 clamped in the proximal end 17b of the staple
applying assembly 16c has a first thickness (arrow 243) that is
thicker than the thickness (arrow 245) of the portion 244 of tissue
240 clamped in the central portion 17c of the staple applying
assembly 16c. The thickness 245 of tissue portion 244 is greater
than the thickness (arrow 247) of the portion 246 of tissue 240
that is clamped in the distal end 17a of the staple applying
assembly 16c. Thus, the staples 83 formed in the distal portion 17a
of the staple applying assembly 16c are more tightly formed that
the staples 83 formed in the central portion 17c of the staple
applying assembly 16c which are more tightly formed than those
staples 83 formed in the proximal end 17b of the staple applying
assembly 16c due to the differences in tissue thicknesses. FIG. 23
further illustrates the variations in staple formation heights
based upon the variations in the thicknesses of the tissue clamped
within the staple applying assembly 16c. FIG. 24 illustrates a
condition wherein the tissue 240 clamped in the central portion 17c
of the staple applying assembly 16c is thicker than the portions of
tissue clamped in the distal and proximal ends of the staple
applying assembly 16c. Thus, the formation heights of the staples
in the central portion 17c will be higher than the staple formation
heights of the staples associated with the proximal end 17b and
distal end 17a of the staple applying assembly 16c.
[0247] Those of ordinary skill in the art will understand that the
unique and novel features of the embodiments depicted in FIGS.
19-24 may also be employed in connection with a staple applying
assembly that is essentially identical in construction and
operation to staple applying assembly 16c described above, except
that the staple forming inserts 270, 280, 290, 300, 310, 320, 330,
340 may have just one row of staple formation pockets 272 therein
or two rows of staple formation pockets 272 therein. For example,
FIG. 25 illustrates an embodiment that only applies two rows of
staples on each side of the tissue cut line. Shown in that Figure
are staple forming inserts 270d and 310d that only have two rows of
staple forming pockets 272d each.
[0248] The skilled artisan will further understand that the number
of staple forming inserts employed on each side of the anvil slot
58 may vary. For example a single longitudinally extending insert
may be used on each side of the anvil slot 58. FIG. 26 illustrates
another staple applying assembly 16e of the present invention that
only employs one staple forming insert on each side of the anvil
slot. FIG. 26 depicts a cross-sectional view of the left side of an
anvil 20e that supports a single left staple forming insert 380
that is attached to a single wave spring 350e. Other biasing
members or multiple wave springs or biasing members may also be
employed. The biasing member or members 350e are supported in the
left side cavity 251e and attached to the anvil 20e in one of the
various manners described above. A similar rights side insert (not
shown) would be employed on the right side of the anvil slot 58.
Furthermore, although FIGS. 19-24 depict use of four staple forming
inserts on each side of the anvil slot greater numbers of staple
forming inserts may be employed.
[0249] FIGS. 27-29 illustrate another staple applying assembly 16f
of the present invention wherein a separate movable staple forming
insert is provided for each staple 83. In particular, as can be
seen in FIG. 27, a single staple forming insert 400 is provided for
each staple 83. Each staple forming insert 400 may have staple
forming pockets 404 formed on its underside 402 thereof for forming
the ends of the corresponding staple 83. As with various embodiment
described above, each insert 400 has a biasing member 412
associated therewith. In the example depicted in FIGS. 27-29, the
biasing members 412 comprise stamped portions of a biasing plate
410. The biasing plate 410 may comprise a piece of metal or other
suitable material wherein each biasing member 412 is stamped or
otherwise cut and formed to correspond with a staple forming insert
400. The biasing plate 410 may comprise a single plate that is
supported within a cavity 251f in the anvil 20f or multiple plates
410 may be employed on each side of the anvil slot. It will be
understood that a similar arrangement may be employed on the right
side of the anvil sot. Each staple forming insert 400 may be
attached to its corresponding biasing member 412 by adhesive or
other suitable fastener arrangement. Thus, it will be appreciated
that a variety of different numbers and arrangements of movable
staple forming inserts may be employed without departing from the
spirit and scope of the present invention. In particular, at least
one movable staple forming insert may be employed on each side of
the anvil slot.
[0250] FIGS. 30-32 illustrate another staple applying assembly 16g
of other embodiments of the present invention wherein the biasing
or compliant medium between the staple forming inserts and the
anvil comprises at least one fluid bladder. More specifically, as
can be seen in FIG. 30, a left bladder 420 is positioned within a
left side cavity 253g on the left side of the anvil slot 58g in the
anvil 20g. Likewise, a right side bladder 430 is positioned with a
right side cavity 263 in the anvil 20g. The series of left side
staple forming inserts 270g, 280g, 290g, 300g may be attached to
the left side bladder 430 by a suitable adhesive or other fastener
arrangement. Likewise the right side staple forming inserts (not
shown) may be attached to the right side bladder 430 by adhesive or
other suitable fastener arrangements. In one embodiment, each
bladder 420, 430 is sealed and partially filled with a liquid 432
such as, for example, glycerin oil or saline solution. Those of
ordinary skill in the art will appreciate that such arrangement
will permit the staple forming inserts to move to better
accommodate variations in the thickness of the tissue clamped
within the staple applying assembly 16g. For example, for tissues
that have a relatively constant thickness, the liquid 432 will be
relatively evenly distributed within each of the bladders 420, 430
to provide a relatively even support arrangement for the staple
forming inserts. See FIG. 31. However, when a thicker portion of
tissue is encountered, those staple forming inserts corresponding
to the thicker tissue will be compressed into their respective
anvil cavity thereby forcing the liquid in that part of the bladder
to the portions of the bladder corresponding to the thinner tissue
portions. See FIG. 32.
[0251] In some applications, it may be desirable for the clinician
to be able to control the amount of pressure within the bladders
420, 430. For example, less pressure may be desirable when cutting
and stapling more delicate tissues such as lung tissue and the
like. More pressure may be desirable when cutting and stapling
thicker tissues such as, for example, stomach tissue, intestine
tissue, kidney tissue, etc. To provide the clinician with this
additional flexibility, the bladders 420, 430 may each be
fluidically coupled by a supply line 440 or conduit to a fluid
reservoir 450 supported by the handle portion 12 of the instrument.
In the embodiment illustrated in FIG. 33, the clinician can
increase or decrease the amount of fluid within the bladders 420,
430 and resulting pressure therein by means of an adjustment
mechanism 460 mounted to the fluid reservoir 450. In various
embodiments, the adjustment mechanism 460 may comprise a piston 462
that is attached to an adjustment screw 464. By adjusting the
adjustment screw 464 inward, the piston 462 forces fluid out of the
reservoir 450 to the bladders 420, 430. Conversely, by reversing
the adjustment screw 464, the piston 462 permits more fluid 432 to
return or remain within the reservoir 450. To assist the clinician
in determining the amount of pressure within that hydraulic system,
generally designated as 405, a pressure gauge 470 may be employed
as shown. Thus, for those tissues requiring a higher amount of
pressure, the clinician can preset the pressure in the bladders
420, 430 to a pressure that is conducive to successfully clamp and
staple that particular type of tissue. While a piston/screw
arrangement has been described for controlling the pressure in the
hydraulic system, the skilled artisan will understand that other
control mechanisms could successfully be employed without departing
from the spirit and scope of the present invention.
[0252] FIG. 30A illustrates another staple applying assembly 16hg
of other embodiments of the present invention wherein the biasing
or compliant medium between the staple forming inserts and the
anvil comprises at least one compressible polymer member. More
specifically, as can be seen in FIG. 30A, a left compressible
polymer member 420h is positioned within a left side cavity 253h on
the left side of the anvil slot 58h in the anvil 20h. Likewise, a
right side compressible polymer member 430h is positioned with a
right side cavity 263h in the anvil 20h. The series of left side
staple forming inserts 270h-300h may be attached to the left
compressible polymer member 420h by a suitable adhesive or other
fastener arrangement. Likewise the right side staple forming
inserts 310h-340h may be attached to the right side compressible
polymer member 430h by adhesive or other suitable fastener
arrangements.
[0253] FIGS. 34-37 depict a unique and novel collapsible or
compressible staple driver arrangement that enables the various
staple drivers to accommodate different tissue thicknesses by
collapsing or compressing in response to compression forces that
the driver encounters during the firing process. As used herein,
the term "firing process" refers to the process of driving the
staple drivers towards the staple forming undersurface of the
anvil. As was mentioned above, prior staple drivers were fabricated
from stiff/rigid material designed to resist deflection and
deformation when encountering compression forces during the firing
process. A variety of such driver configurations are known. For
example, some staple drivers are configured to support a single
staple and others are designed to support multiple staples. A
discussion of single and double staple drivers and how they may be
operably supported and fired within a staple cartridge is found in
U.S. patent application Ser. No. 11/216,562, filed Sep. 9, 2005,
entitled Staple Cartridges For Forming Staples Having Differing
Formed Staple Heights to Frederick E. Shelton, IV, the disclosure
of which is herein incorporated by reference.
[0254] FIG. 34 depicts a staple applying assembly 16h that includes
an elongate channel 40h that has an anvil 20h pivotally coupled
thereto in a known manner. The elongate channel 40h is configured
to operably support a staple cartridge 42h therein. The anvil 20h
has a staple forming undersurface 60h thereon that is adapted to
confront the upper surface 43h of the staple cartridge 42h when the
anvil 20h is pivoted to the closed position shown in FIG. 34. The
staples 83 are each supported on a corresponding staple driver 500,
the construction of which will be discussed in further detail
below.
[0255] Each staple driver 500 may be movably supported within a
corresponding staple channel 87h provided in the cartridge body 85h
as shown in FIGS. 34 and 35. Also operably supported within the
cartridge body 85h is a driving member or wedge sled 78 that is
oriented for engagement by the E-beam firing member 50 during the
firing process. See FIG. 34. As the E-beam firing member 50 and
wedge sled 78 are driven distally through the elongate channel 40h
and staple cartridge 42 in a known manner, the wedge sled 78 drives
the staple drivers 500 upwardly within the cartridge body 85h. As
the staple drivers 500 are driven upwardly toward the staple
forming undersurface 60h of the anvil 20h, they carry with them
their respective staple 83 or staples which are driven into forming
engagement with the corresponding staple forming pockets 61h in the
staple forming undersurface 60h of the anvil 20h. As the ends 88 of
the staple 83 contact the forming pockets 61h, they are bent over
thus providing the staple 83 with a shape that somewhat resembles a
"B". While the various embodiments of the present invention have
been described herein in connection with E-beam firing members, it
is conceivable that these various embodiments may also be
successfully employed with a variety of different firing member and
driving member arrangements without departing from the spirit and
scope of the present invention.
[0256] One collapsible staple driver embodiment of the present
invention is depicted in FIGS. 36 and 37. As can be seen in those
Figures, the collapsible or compressible staple driver 500 includes
a base portion 502 and a staple supporting portion 520 that is
movable from a first uncollapsed position relative to the base
portion 502 in response to compression forces generated during the
firing process. In various embodiments, the base portion 502 may
have a forward support column segment 504 and a rearward support
column segment 508 that is spaced from the forward support column
segment 504 and is substantially integrally formed therewith. The
base portion 502 may also have an upstanding side portion 510 that
has a rib 512 protruding from a backside therefrom. The upstanding
side portion 510 serves to define a receiving ledge 514 in the base
portion 502 for receiving the staple supporting portion 520
thereon. Those of ordinary skill in the art will understand that
when the staple supporting portion 520 is received on the ledge
514, the staple driver 500 is unable to collapse or compress any
further.
[0257] The staple supporting portion 520 of the staple driver 500
may similarly include a forward support column segment 522 and
rearward support column segment 524 that is spaced from the forward
support column segment 522. When the staple supporting portion 520
is received on the base portion 502, the forward support column
segments 504, 522 serve to form a forward column portion 530 and
the reward column segments 508, 524 form a rearward column portion
532. A forward staple receiving groove 526 is formed in the forward
support column segment 522 and a rearward staple receiving groove
528 is formed in the rearward support column segment 524. The
forward staple receiving groove 526 and the rearward staple
receiving groove 528 serve to support a staple 83 therein as
illustrated in FIG. 35. The rib 512 and the forward column 530 and
rearward column 532 may cooperate with corresponding channels (not
shown) in the staple cartridge body 85 to provide lateral support
to the staple driver 500 while permitting the driver to be driven
upward within the cartridge body 85 during the firing process.
[0258] In various embodiments, a resistive attachment structure,
generally designated as 540' is provided to support the staple
supporting portion 520 in a first uncompressed or uncollapsed
orientation relative to the base portion (FIG. 37) prior to
encountering any compressive forces during the firing operation and
to permit the staple supporting portion 520 and the base portion to
move towards each other (collapse or compress) in response to the
magnitude of the compression forces applied to the staple
supporting portion 520 and base portion 520 during the staple
firing operation. As can be seen in FIGS. 36 and 37, the resistive
attachment structure 540' in various embodiments may comprise a
pair of attachment rods 540 that protrude from the bottom 521 of
the staple supporting portion 520 and correspond to holes or
apertures 542 in the base portion 502. The rods 540 are sized and
shaped relative to the holes 542 to establish an interference fit
or "light press fit" (i.e., an interference of approximately 0.001
inches) therebetween such that when the staple supporting portion
520 and base driver portion 502 are compressed together during the
staple firing operation as will be discussed in further detail
below, the staple supporting portion 520 and the base portion 502
can compress toward each other to reduce the overall height of the
staple driver 500 in relation to the amount of compression force
encountered during the firing process. In various embodiments, for
example, the staple supporting portion 520 and base portion 520 may
be fabricated from the same material such as, for example, plastic
material such as ULTEM.RTM.. In other embodiments, the base portion
502 and the staple supporting portion 520 may be fabricated from
different materials. For example, staple supporting portion 520 may
be fabricated from ULTEM.RTM. and base portion 502 may be
fabricated from glass or mineral filled ULTEM.RTM.. However, other
materials could also be employed. For example, the base portion 502
could be fabricated from Nylon 6/6 or Nylon 6/12.
[0259] In various embodiments, a frictional or an interference fit
of approximately 0.001 inch may be established between the
attachment rods 540 and their corresponding holes 542. However,
other degrees of interference fit may be employed to attain the
desired amount and rate of driver compression in proportion to the
magnitude of compression forces encountered when stapling a
particular type/thickness of tissue. For example, in one
embodiment, the degree of interference fit between the attachment
rods 540 and their respective holes 542 may be approximately 0.002
to 0.005 inches for stapling tissues wherein it is anticipated that
compression forces on the order of 2-5 pounds may be generated
during the firing operation.
[0260] FIG. 35 illustrates various ranges of travel and compression
that the staple drivers 500 may experience when encountering
tissues of varying thicknesses. More specifically, FIG. 35
illustrates a portion of tissue 560 clamped between the upper
surface 43h of the staple cartridge 42h and the staple forming
undersurface 60h of the anvil 20h. As illustrated in FIG. 35, the
tissue 560 has three thicknesses. The thickest portion of tissue is
designated as 562 and comprises the portion of tissue that is on
the right side of the Figure. The next thickness portion of tissue
is designated as 564 and the thinnest portion of tissue 560 is
designated as 566 and is on the left side of the Figure. For the
purposes of this explanation, the staple driver associated with
tissue portion 562 is designated as staple driver 500a. The staple
driver associated with tissue portion 564 is designated as staple
driver 500b and the staple driver associated with tissue portion
566 is designated as 500c. It will be understood that staple
drivers 500a, 500b, 500c, may be identical in construction to
staple driver 500 as described above.
[0261] Turning to staple driver 500a first, as the staple driver
500a is driven upwardly towards the staple forming undersurface 60h
of the anvil 20h by the wedge sled (not shown in FIG. 35), it
encounters the thick tissue portion 562 which resists the upward
movement of the staple driver 500a. Such resistive force
(represented by arrow 570) opposes the drive force (represented by
arrow 572) generated by the wedge sled and serves to overcome the
amount of interference established between the attachment rods 540
and their respective holes 542 and forces the rods 540 deeper into
their respective holes 542 to thereby permit the staple supporting
portion 520a of the staple driver 500a and base portion 502a to
move toward each other. This movement of the staple supporting
portion 520a and base portion 502a towards each other under a
compressive force generated during the staple firing operation is
referred to herein as "collapsing" or "compressing". When in the
completely compressed position wherein the staple supporting
portion 520a is received on the ledge 514a of the base portion
502a, the staple supporting ledges 526a, 528a on the staple
supporting portion 520a may preferably support the bottom cross
member 89 of the staple 83 above the upper surface 43h of the
staple cartridge 42h to avoid catching the staple 83 on the staple
cartridge 42h when the staple applying assembly 16h is withdrawn.
The compressed height of the staple driver 500a is designated by
arrow 574 in FIG. 35.
[0262] Turning next to staple driver 500b which corresponds to
tissue portion 564, because the tissue portion 564 is not as thick
as tissue portion 562, the resistive force 570b encountered by the
staple driver 500b during the firing operation is not as great as
resistive force 570. Therefore, the attachment pins 540b of staple
driver 500b are not advanced into their respective holes 542b as
far as the pins 540 of staple driver 500a were advanced into their
respective holes 542. Thus, the compressed height 576 of staple
driver 500b is greater than the compressed height 574 of staple
driver 500a. As can also be seen in FIG. 35, the bottom portion 89
of the staple 83 supported in staple driver 500b is supported above
the upper surface 43h of the staple cartridge 42h.
[0263] Staple driver 500c is associated with the thinnest tissue
portion 566. Thus, the resistive force 570c encountered by the
staple driver 500c during the staple firing operation is less than
the resistive force 570b that was encountered by staple driver
500b. Thus, the pins 540c of staple driver 500c are not advanced
into their respective holes 542c as far as the pins 540b of staple
driver 500b were advanced into their respective holes 542b. Thus,
the compressed height 578 of staple driver 500c is greater than the
compressed height 576 of staple driver 500b.
[0264] As can be further seen in FIG. 35, because the compressed
height 578 of staple driver 500c is greater than the compressed
height 576 of staple driver 500b, the staple 83c supported by
staple driver 500c was compressed to a greater extent than the
staple 83b that was supported by staple driver 500b. Thus, the
formed height of staple 83c is less than the formed height of
staple 83b which is less than the formed height of staple 83a as
illustrated in FIG. 35.
[0265] Those of ordinary skill in the art will appreciate that the
number, shape, composition and size of the attachment rods and
their respective holes can vary from embodiment to embodiment
without departing from the spirit and scope of the present
invention. Such interrelationship between the attachment rods and
their respective holes serves to establish an amount of frictional
interference therebetween which can be overcome in relation to
various compression forces encountered when clamping/stapling
different thicknesses of tissue. In an alternative version, the
attachment to rods 540 may be formed on the base portion 502 and
the holes provided in the staple supporting portion 520.
[0266] FIGS. 38 and 39 illustrate another staple driver 500d
embodiment of the present invention that may be substantially
identical in construction and operation to the staple drivers 500
described above, except that the attachment rods 540d are somewhat
tapered or frusto-conically shaped. In various embodiments, for
example, the ends 541d of the attachment rods 540d may be sized
relative to holes 542 such that a light press fit is established
therebetween when in the first uncollapsed state depicted in FIG.
39. The degree of taper of the attachment rods 540d may be tailored
to attain the desired amount of staple driver compression in
relation to the magnitude of compression forces encountered during
the staple firing process. Thus, in these embodiments, the
magnitude of the interference fit between the attachment rods 540d
and the holes 542 increases as the staple driver 500d encounters
greater compression forces which drive the attachment rods 540d
deeper into their respective holes 542d. In alternative
embodiments, the attachment rods 540 may have a round shape and the
holes 542 may be tapered to attain the desired amount and rate of
staple driver compression in proportion to the amount of
anticipated compression forces applied thereto during the firing
operation. In an alternative version, the attachment rods 540d may
be formed on the base portion 502 and the holes 542 be formed in
the staple supporting portion 520.
[0267] FIGS. 40-43 illustrate another staple driver 500e embodiment
of the present invention that may be substantially identical in
construction and operation to the staple drivers 500 described
above, except that the attachment rods 540e are configured or
shaped to include an additional amount of material oriented to be
sheared off of the remaining portion of the rods as the staple
driver 500e encounters compression forces during the firing
operation. More specifically and with reference to FIG. 42, the
attachment rods 540e have a tip portion 541e that is received
within the corresponding hole 542e. The tip portion 541e may be
sized relative to the hole 542e such that a sliding fit is achieved
therebetween or, in other embodiments, a small interference fit may
be established between those components when in the first
uncollapsed position. The remaining portion 543e of each attachment
rod 540e may be provided or formed with an additional amount of
material 545e that is designed to be sheared therefrom as the
staple driver 500e encounters the anticipated compression forces
during the firing operation. See FIG. 43. The additional material
545e may extend completely around the circumference of the portion
543e of each attachment rod 540e or the material 543e may comprise
one or more segments oriented around the circumference of the
attachment rod 540e. For example, in the embodiment depicted in
FIGS. 40-43, two segments 547e of material 543e are diametrically
opposed on each attachment rod 540e as shown. In various
embodiments, the diametric distance between the segments may be
somewhat larger than the diameter of the holes 542e to cause the
segments 547e to be sheared or removed from at least a portion of
the rods 540e as the staple driver 500e encounters the anticipated
compression forces during the firing operation.
[0268] The portions of additional material 543e may comprise an
integral portion of the attachment rod 540e or the additional
material 543e may comprise a second material applied to the
attachment rod 540e and designed to shear off therefrom when the
staple driver 500e encounters the anticipated compression forces.
In various embodiments, the base portion 502 may be fabricated from
a material that is more rigid that the material from which
attachment rods 540e and/or the additional material 543e are
fabricated such that the base portion 502 facilitates the shearing
off of additional material 543e as the staple support portion 520e
and base portion 502e are compressed together during the staple
firing operation. In an alternative version, the attachment rods
540e may be formed on the base portion 502 and the holes 542e be
provided in the staple supporting portion 520e.
[0269] FIGS. 44-46 illustrate another staple driver 500f of the
present invention that may be substantially identical in
construction and operation to the staple drivers 500 described
above, except that the holes 542f in the base portion 502f may be
hexagonally shaped or may have one or more surfaces therein
designed to establish an interference fit with the attached rods
540 or to otherwise resist further entry of the attachment rods 540
into the holes 542f. For example, the holes 542f shown have a pair
of flat surfaces 551f formed therein that serve to establish an
interference fit or a degree of frictional resistance between the
attachment rods 540f and the holes 542f which can be overcome by
the various compression forces encountered when clamping/stapling
different thicknesses of tissue. In the embodiment depicted in
FIGS. 44-46, the attachment rods 540 have a substantially circular
cross-sectional shape and the holes 542f have flat surfaces 551
formed therein. In alternative embodiments, however, the holes 542
may be round and the flat surfaces may be formed on the attachment
rods 540. In an alternative version, the attachment rods 540 may be
provided on the base portion 502f and the holes 542f be provided in
the staple supporting portion 520.
[0270] FIGS. 47-49 illustrate another staple driver 500g of the
present invention that comprises a base portion 502g and a staple
supporting portion 520g. The staple supporting portion 520g has
staple supporting grooves (not shown) formed therein and a
downwardly protruding tang 580 protruding from its undersurface
521g. The tang 580 has two tapered surfaces 582 and is shaped to be
received in a corresponding cavity 590 formed in the base portion
502g. The cavity 590 is formed with tapered sides 592 and is sized
to receive the tang 580 therein in the following manner. As the
driver staple 500g encounters the compression forces generated
during the firing operation, the tang 580 is forced into the cavity
590. FIG. 49 illustrates the staple driver 500g in a fully
collapsed or compressed position. The staple supporting portion
520g and/or tang 580 may be fabricated from a material that is
somewhat more compliant than the material from which the base
portion 502g is formed so that the tang 580 can be forced into the
cavity 590 in the base portion 502g without substantially
distorting the base portion 502g to the extent that it would hamper
the ability of the staple driver 500g to be fully driven to a final
firing position. For example, the staple supporting portion and/or
the tang 580 may be fabricated from ULTEM.RTM. and the base portion
502g may be fabricated from glass filled Nylon to achieve the
desired amount of driver compression when encountering the
anticipated compression forces during the firing operation. In an
alternative version, the tang 580 may be provided on the base
portion 502g and the hole 590 be provided in the staple supporting
portion 520g.
[0271] FIGS. 50-52 illustrate another staple driver 500h embodiment
of the present invention that may be substantially identical in
construction and operation to the staple drivers 500 described
above, except that, instead of attachment rods, the staple
supporting portion 520h has two tapered tangs 600 protruding
therefrom designed to be compressed into a V-shaped cavity 610
formed in the base portion 502h. Prior to commencement of the
firing operation, the staple supporting portion 520h is supported
on the base portion 502h within the staple cartridge. As the staple
supporting portion 520h and the base portion 502h are compressed
together during the firing operation, the tapered tangs 600 are
forced inwardly as shown in FIG. 52. The degree to which the tangs
600 are compressed into the V-shaped cavity 610 is dependent upon
the magnitude of the compression forces encountered during the
firing operation.
[0272] The staple supporting portion 500h and/or tangs 600 may be
fabricated from a material that is somewhat more compliant than the
material from which the base portion 502h is formed so that the
tangs 560 can be forced into the V-shaped cavity 610 in the base
portion 502h without substantially distorting the base portion 502h
to the extent that it would hamper the ability of the staple driver
500h to be fully driven to a final firing position. For example,
the staple supporting portion and/or the tangs 600 may be
fabricated from Nylon with no fill and the base portion 502h may be
fabricated from ULTEM.RTM. with a glass or mineral fill to achieve
the desired amount of staple driver compression when encountering
the anticipated compression forces during the firing operation. In
an alternative version, the tangs 600 may be provided on the base
portion 502h and the cavity 610 may be provided in the staple
supporting portion 520h.
[0273] FIGS. 53-55 illustrate yet another staple driver 500i
embodiment of the present invention that includes a staple
supporting portion 520i that has V-shaped staple supporting grooves
630i, 650i therein. In this embodiment, the staple supporting
portion 520i has a first pair 620i of two tapered tangs 622i, 626i
protruding therefrom oriented to be compressed into the first
V-shaped groove or cavity 630i and a second pair 640i of two
tapered tangs 642i, 646i oriented to be compressed into the second
V-shaped groove or cavity 650i. More specifically and with
reference to FIG. 54, the first tang 622i has an end 624i that is
spaced from an end 628i of the second tang 626i prior to
commencement of the staple firing operation. When in the position
illustrated in FIG. 54, the ends 624i, 628i are biased outwardly
into frictional contact with the upper side walls of the first
V-shaped groove 630i to retain the staple supporting portion 520i
in the uncollapsed position shown in FIG. 54. Although not shown,
the second pair 640i of tangs 642i, 646i are also similarly
configured as tangs 622i, 626i and serve to engage the second
V-shaped groove 650i in the same manner.
[0274] As the staple supporting portion 520i and the base portion
502i are compressed together during the firing operation, the ends
624i, 628i of the first tangs 622i, 626i and the ends of the second
tangs 642i, 646i are biased toward each other to permit the tangs
to be driven deeper into their respective grooves 630i, 650i. FIG.
55 illustrates the first pair 620i of tangs 622i, 626i in their
fully compressed state which also corresponds to the fully
compressed state of the driver 500i. The degree to which the tangs
are compressed into their respective V-shaped grooves is dependent
upon the magnitude of the compression forces encountered during the
firing operation.
[0275] The staple supporting portion 500i and/or tangs 622i, 626i,
642i, 646i may be fabricated from a material that is somewhat more
compliant than the material from which the base portion 502i is
formed so that the tangs 622i, 626i, 642i, 646i can be forced into
their respective V-shaped grooves in the base portion 502i without
substantially distorting the base portion 502i to the extent that
it would hamper the ability of the driver 500i to be fully driven
to a final firing position. For example, the staple supporting
portion 520i and/or the tangs 622i, 626i, 642i, 646i may be
fabricated from ULTEM.RTM. and the base portion 502i may be
fabricated from Nylon with a glass or mineral fill to achieve the
desired amount of driver compression when encountering the
anticipated compression forces during the firing operation. In an
alternative version, the tangs 622i, 626i, 642i, 646i may be
provided on the base portion 502i and the V-shaped grooves 630i,
650i may be provided in the staple supporting portion 520i.
[0276] The various embodiments of the present invention described
above and their respective equivalent structures represent vast
improvements over prior staple applying assemblies and end
effectors. Various embodiments of the present invention provide
anvils and/or channels with flexible portions that permit the
overall staple height to increase as the compression within the
assembly increases due to tissue thickness. Other embodiments
employ anvil arrangements that have flexible forming pockets that
can be compressed away from the staple cartridge in response to
variations in tissue thickness. In doing so, the inherent gap
between the forming pocket and the cartridge increases which serves
to increase the formed height of the staple. Such advantages can
result in improved staple line consistency and provide better
clinical outcomes.
[0277] FIGS. 56-63 illustrate another surgical stapling and
severing instrument 1000 of the present invention. As can be seen
in FIG. 56, the instrument 1000 includes a handle assembly 1020
that is manipulated to position an implement portion 1014 including
a fastening end effector, depicted as a staple applying assembly
1016, distally attached to an elongate shaft assembly 1100. The
implement portion 1014 is sized for insertion through a cannula of
a trocar (not shown) for an endoscopic or laparoscopic surgical
procedure with an upper jaw (anvil) 1050 and a lower jaw 1018 of
the staple applying assembly 1016 closed by depression of a closure
trigger 1040 toward a pistol grip 1034 of the handle assembly 1020,
which advances an outer closure tube assembly 1130 of the elongate
shaft assembly 1100 to pivot the anvil 1050 to a closed position as
will be discussed in further detail below.
[0278] Once inserted into an insufflated body cavity or lumen, the
closure trigger 1040 may be released, opening the anvil 1050 so
that tissue may be grasped and positioned. Once satisfied with the
tissue held in the staple applying assembly 1016, the surgeon
depresses the closure trigger 1040 until locked against the pistol
grip 1034, clamping tissue inside of the staple applying assembly
1016. Then a firing trigger 1046 is drawn toward the closure
trigger 1040 and pistol grip 1034, thereby applying a firing force
or motion thereto to distally advance a firing member supported
with in the implement 1014 from an unfired position. As the firing
member advances through the implement or end effector 1014 in a
known manner, it severs the tissue clamped within the end effector
1014 and fires or drives the staples contained with the staple
cartridge 42 supported therein.
[0279] As depicted in FIG. 57, this embodiment may employ the
firing bar 36 and E-Beam 50 arrangements described above. In other
alternative embodiments, the E-Beam arrangements described in U.S.
patent application Ser. No. 11/231,456, filed Sep. 21, 2005 and
entitled "Surgical Stapling Instrument Having Force Controlled
Spacing End Effector", the disclosure of which is herein
incorporated by reference may also be employed. In addition, as the
present Detailed Description proceeds, those of ordinary skill in
the art will appreciate that the advantages provided by these
embodiments of the present invention may be effectively attained
when used in connection with other known non-E beam firing bar
configurations. Thus, these embodiments of the present invention
should not be limited solely to use in connection with E-beam type
firing and cutting arrangements.
[0280] FIG. 57 depicts the firing bar 36 as including a proximal
firing rod 34, that is supported within a "frame ground" or spine
assembly 1110 that connects the handle assembly 1020 to the staple
applying assembly 1016. During the staple firing motion, the firing
bar 36 engages an elongate staple channel 1060 and actuates a
staple cartridge 42 contained therein, both forming the lower jaw
1018 in the various manners described above.
[0281] A variety of different firing arrangements for applying an
actuation force to the firing bar 36 to cause the firing bar to
linearly advance and retract through the staple applying assembly
1016 are known. Such firing motions may be manually generated such
as through use of the various firing system arrangements disclosed
in U.S. patent application Ser. No. 11/475,412, filed Jun. 27,
2006, entitled "Manually Driven Surgical Cutting and Fastening
Instrument" to Frederick E. Shelton, IV, et al., the disclosure of
which is herein incorporated by reference. Still other actuation
systems, such as the pneumatically powered actuation systems
disclosed in U.S. patent application Ser. No. 11/497,868, filed
Aug. 2, 2006, entitled "Pneumatically Powered Surgical Cutting and
Fastening Instrument With a Variable Control of the Actuating Rate
of Firing With Mechanical Power Assist" to Frederick E. Shelton, IV
et al., the disclosure of which is herein incorporated by reference
may be successfully employed. Other embodiments may include, for
example, the electrical motor driven actuation systems disclosed in
U.S. patent application Ser. No. 11/343,562, filed Jan. 31, 2006,
entitled "Motor-Driven Surgical Cutting and Fastening Instrument
With Articulatable End Effector" to Frederick E. Shelton, IV et
al., the disclosure of which is also herein incorporated by
reference. Still other embodiments may include other known
mechanically, electrically, hydraulically and/or pneumatically
powered firing systems without departing from the spirit and scope
of the present invention.
[0282] In various embodiments, the elongate shaft assembly 1100
consists of a closure tube assembly 1130 that is received on the
spine assembly 1110. See FIG. 57. The spine assembly 1110 may
comprise a single member or it may comprise multiple segments with
an articulation joint (not shown) mounted therein. Such
articulation joints are known in the art and may, for example, be
mechanically, electrically, hydraulically or pneumatically
controlled. In the embodiment depicted in FIGS. 57 and 58, the
spine assembly 1110 includes a proximal portion 1112 (FIG. 58) and
a distal portion 1116 (FIG. 57). As will be discussed below, the
proximal portion 1112 is attached to the handle assembly 1020 such
that the closure tube assembly 1130 may be axially moved thereon to
cause the anvil 1050 to pivot between open and closed positions. As
can be seen in FIG. 57, the elongate channel 1060 has proximally
placed attachment cavities 1062 that each receive a corresponding
channel anchoring member 1118 formed on the distal end of the
distal spine portion 1116. The elongate channel 1060 also has
elongated anvil cam slots 1064 that movably receive a corresponding
anvil trunnion 1052 on the anvil 1050 as will be discussed in
further detail below.
[0283] The closure tube assembly 1130 may comprise a distal closure
tube portion 1140 and a proximal closure tube portion 1150. The
distal closure tube portion 1140 and the proximal closure tube
portion 1150 may be fabricated from a polymer or other suitable
material. The distal closure tube portion 1140 and the proximal
closure tube portion 1150 are each hollow for receiving a
corresponding portion of the spine assembly 1110 therein. The
closure tube assembly 1130 is depicted as comprising two separate
portions 1140 and 1150 for ease of assembly of the entire elongate
shaft assembly 1100. Those portions 1140 and 1150 may be attached
together after assembly by adhesive or other suitable fastening
means. It is conceivable, however, that the closure tube assembly
1130 may be fabricated as one piece. In addition, as was mentioned
above, the spine assembly of various embodiments of the present
invention may have an articulation joint mounted therein. For those
embodiments, a double pivot closure joint (not shown) may be
employed in the closure tube assembly 1130. Examples of such double
pivot closure arrangements are disclosed in U.S. patent application
Ser. No. 11/497,868, which has been herein incorporated by
reference.
[0284] In use, the closure tube assembly 1130 is translated
distally to close the anvil 1050, for example, in response to the
actuation of the closure trigger 1040. The anvil 1050 is closed by
distally translating the closure tube assembly 1130 on the spine
assembly 1110, causing the back of a horseshoe aperture 1142 in the
distal closure tube portion 1140 to strike a closure feature 1053
in the form of an open/closing tab 1052 on the anvil 1050 and cause
it to pivot to the closed position. See FIG. 57. To open the anvil
1050, the closure tube assembly 1130 is axially moved in the
proximal direction on the spine assembly 1110 causing a tab 1144 on
the distal closure tube portion 1140 to contact and push against
the open/closing tab 1054 on the anvil 1050 to pivot the anvil 1050
to the opened position.
[0285] FIG. 58 illustrates an exploded assembly view of a
non-limiting handle assembly 1020 of various embodiments of the
present invention wherein the various firing system components have
been omitted for clarity. In the embodiment depicted in FIG. 58,
the handle assembly 1020 has a "pistol grip" configuration and is
formed from a right hand case member 1022 and a left handed case
member 1028 that are molded or otherwise fabricated from a polymer
or other suitable material and are designed to mate together. Such
case members 1022 and 1028 may be attached together by snap
features, pegs and sockets molded or otherwise formed therein
and/or by adhesive, screws, bolts, clips, etc. The upper portion
1024 of the right hand case member 1022 mates with a corresponding
upper portion 1030 of the left hand case member 1028 to form a
primary housing portion designated as 1031. Similarly, the lower
grip portion 1025 of the right hand case member 1022 mates with the
lower grip portion 1032 of the left hand case member 1028 to form a
grip portion generally designated as 1034. See FIG. 56. Those of
ordinary skill in the art will readily appreciate, however, that
the handle assembly 1020 may be provided in a variety of different
shapes and sizes.
[0286] For the purposes of clarity, FIG. 58 only illustrates the
components employed to control the axial movement of the closure
tube assembly 1130 which ultimately controls the opening and
closing of the anvil 1050. As can be seen in that Figure, a closure
shuttle 1160 that is coupled to the closure trigger 1040 by a
linkage assembly 1180 is supported within the primary housing
portion 1031. Closure shuttle 1160 may also be fabricated in two
pieces 1162, 1164 that are molded or otherwise fabricated from a
polymer or other suitable material and are designed to mate
together. For example, in the embodiment illustrated in FIGS. 58,
60, and 61, the right hand portion 1162 may be provided with
fastener posts 1163 that are designed to be received within
corresponding sockets 1167 (FIG. 61) in the left hand portion 1164.
The right and left hand portions 1162, 1164 may be otherwise
retained together by snap members and/or adhesive and/or bolts,
screws, clips, etc. As can be seen in those Figures, a retention
groove 1152 is provided in the proximal end 1151 of the proximal
closure tube portion 1150. The right hand portion 1162 of the
closure shuttle 1160 has a right retention flange 1165 (FIG. 60)
that is adapted to cooperate with a left hand portion 1164 of the
closure shuttle 1160 such that the retention flange 1165 extends
into the retention groove 1151 in the proximal closure tube portion
1150. The retention flange 1165 serves to affix the closure tube
assembly 1130 to the closure shuttle 1160 while facilitating its
limited axial movement relative thereto as will be discussed in
further detail below.
[0287] As can also be seen in FIG. 58, a right spine assembly
retention peg 1027 protrudes inward from the right hand case member
1024. Such peg 1027 protrudes into an elongated slot or window 1166
in the right hand portion 1162 of the closure shuttle 1160. A
similar closure shuttle retention peg (not shown) protrudes inward
from the left hand case member 1164 to be received in another
window or slot 1168 provided in the left hand side portion 1164 of
the closure shuttle 1160. The retention pegs are configured to
extend into a hole 1115 in the proximal end 1114 of the proximal
spine portion 1110 to non-movably affix the spine portion 1110 to
the handle assembly 1020 while permitting the closure shuttle 1160
to move axially relative thereto. See FIG. 58. The retention pegs
may be mechanically attached to the proximal end 1114 of the
proximal spine portion 1112 by, for example, bolts, screws,
adhesive, snap features, etc. In addition, the closure shuttle 1160
is provided with laterally extending guide rails 1170, 1172. Rail
1170 is configured to be slidably received within rail guide 1026
in the right hand case member 1024 and rail 1172 is configured to
be slidably received within a rail guide (not shown) in left hand
case member 1028. See FIG. 58.
[0288] Axial movement of the closure shuttle 1160 and closure tube
assembly 1130 in the distal direction (arrow "A") is created by
moving the closure trigger 1040 toward the grip portion 1034 of the
handle assembly 1020 and axial movement of the closure shuttle 1160
in the proximal direction (arrow "B") is created by moving the
closure trigger 1040 away from the grip portion 1034. In various
embodiments, the closure shuttle 1160 is provided with a connector
tab 1174 that facilitates the attachment of the closure linkage
assembly 1180 thereto. See FIGS. 58 and 59. The closure linkage
assembly 1180 includes a yoke portion 1182 that is pivotally pinned
to the connector tab 1174 by a pin 1184. The closure linkage
assembly 1180 further has a closure arm 1186 that is pivotally
pinned to a yoke assembly 1043 formed on the closure trigger 1042
by a closure pin 1188 as illustrated in FIG. 58. The closure
trigger 1140 is pivotally mounted within the handle assembly 1020
by a pivot pin 11890 that extends between the right hand case
member 1024 and the left hand case member 1028.
[0289] When the clinician desires to close the anvil 1050 to clamp
tissue within the end effector 1014, the clinician draws the
closure trigger 1040 toward the pistol grip portion 1034. As the
clinician draws the closure trigger 1040 toward the pistol grip
portion 1034, the closure linkage assembly 1180 moves the closure
shuttle 1160 in the distal "A" direction until the closure linkage
assembly 1180 moves into the locked position illustrated in FIG.
59. When in that position, the closure linkage assembly 1180 will
tend to retain the closure shuttle 1160 in that locked
position.
[0290] In various embodiments, to further retain the closure
shuttle 1160 in the closed position, the closure trigger 1040 may
be provided with a releasable locking mechanism 1190 that is
adapted to engage the pistol grip portion 1034 and releasably
retain the closure trigger 1040 in the locked position. Other
locking devices may also be used to releasably retain the closure
shuttle 1160 in the locked position.
[0291] In the embodiment depicted in FIG. 59, the closure trigger
1040 includes a flexible longitudinal arm 1192 that includes a
lateral pin 1194 extending therefrom. The arm 1192 and pin 1194 may
be made from molded plastic, for example. The pistol grip portion
1034 of the handle assembly 1020 includes an opening 1036 with a
laterally extending wedge 1037 disposed therein. When the closure
trigger 1040 is retracted, the pin 1194 engages the wedge 1037, and
the pin 1194 is forced downward (i.e., the arm 1192 is rotated
clockwise) by the lower surface of the wedge 1037. When the pin
1194 fully passes the lower surface, the clockwise force on the arm
1192 is removed, and the pin 1194 is rotated counterclockwise such
that the pin 1194 comes to rest in a notch 1038 behind the wedge
1037 thereby locking the closure trigger 1040. The pin 1194 is
further held in place in the locked position by a flexible stop
1039 extending from the wedge 1037.
[0292] To unlock the closure trigger 1040, the operator may further
squeeze the closure trigger 1040, causing the pin 1194 to engage a
sloped back wall 1041 of the opening 1036, forcing the pin 1194
upward past the flexible stop 1039. The pin 1194 is then free to
travel out of the opening 1036 such that the closure trigger 1040
is no longer locked to the pistol grip portion 1034. Further
details of such arrangement may be found in U.S. patent application
Ser. No. 11/344,020, filed Jan. 31, 2006 and entitled "Surgical
Instrument Having A Removable Battery to Shelton, IV et al.," the
relevant portions of which are herein incorporated by reference.
Other releasable locking arrangements could also be employed.
[0293] As the closure shuttle 1160 is moved to the locked position,
the closure tube assembly 1130 is moved distally on the spine
assembly 1110 causing the closure/opening tab 1054 on the anvil
1050 to be contacted by the proximal end of the horseshoe aperture
1142 in the distal closure tube portion 1140 to thereby pivot the
anvil 1050 to the closed (clamped) position. Thus, the clamping
forces attained by the anvil 1050 during the clamping process are
ultimately dependant upon the closure forces generated by the
closure tube assembly (represented by arrow 1196 in FIGS. 62 and
63) as it contacts the tab 1054 on the anvil 1050. As was discussed
above, prior closure tube arrangements lack means for limiting the
amount of actuation force applied to the closure/opening tab 1054
of the anvil 1050.
[0294] Various embodiments of the present invention address such
shortcomings of prior closure tube arrangements by including a
force limiting member generally designated as 1200 for limiting the
amount of closure force or load applied by the closure tube
assembly to the closure/opening tab 1054 of the anvil. For example,
in one embodiment, the force limiting member 1200 may comprise a
cushioning member 1210 oriented adjacent to the proximal end 1151
of the proximal closure tube portion 1150. More specifically and
with reference to FIGS. 60 and 61, the cushioning member 1210
comprises a wave spring assembly 1212 that may be supported in a
cavity 1169 formed in the closure shuttle 1160. The wave spring
assembly 1212 may be supported between an attachment post 1163 and
the proximal end 1151 of the proximal closure tube portion 1150. In
various embodiments, the wave spring assembly 1212 may be
fabricated from spring steel in the form depicted in the Figures.
However, other cushioning arrangements or compliant member
arrangements such as, for example, members fabricated from rubber,
elastomer, polymer, foam rubber, etc. could be successfully
employed to provided the closure tube assembly 1130 with some
freedom to axially move in the proximal direction to reduce the
clamping force ultimately applied to the anvil 1050 during the
anvil closing process which will be discussed in further detail
below.
[0295] As can also be seen in FIGS. 60 and 61, the retention groove
1152 in the proximal closure tube portion 1150 comprises an area
1154 that has a diameter that is less than the outer diameter of
the proximal closure tube portion 1150. The area 1154 is axially
elongated to provide the closure tube assembly 1130 to move axially
and distally relative to the closure shuttle 1160 a distance that
is defined by the axial length (arrow 1155 in FIG. 60) of the
retention groove 1152.
[0296] In this embodiment, as the closure trigger 1040 is moved
toward the pistol grip portion 1032, the closure shuttle 1160 is
advanced in the distal direction (arrow A). As the closure shuttle
1160 moves distally, the closure tube assembly 1130 is also forced
distally. As can be seen in FIGS. 62 and 63, distal end 1141 of the
distal closure tube portion 1140 is oriented to move axially up a
ramp portion 1070 of the anvil 1050. As the distal end 1141
contacts the anvil ramp 1070 and continues to move distally up the
ramp, it imparts a closure force to the anvil 1050. The anvil
trunnions 1052 are received in corresponding "kidney-shaped" slots
1064 in the proximal end of the elongate staple channel 1060 and
serve to guide the anvil 1050 in a desired closure path which
results in the clamping of the tissue between the staple forming
undersurface of the anvil 1051 and the upper surface of the staple
cartridge 42. As the anvil 1050 contacts the tissue, a resulting
resistive force is transferred to the anvil 1050 and ultimately to
the distal end 1141 of the distal closure tube portion 1140. The
magnitude of such resistive force is effected by the thickness of
the tissue being clamped. Thinner tissues will exert less resistive
forces than thicker tissues. However, as the resistive forces are
encountered, the cushioning member 1210 enables the closure tube
assembly 1130 to move proximally to ultimately limit the amount of
closure force applied to the anvil 1050 by the closure tube
assembly 1130.
[0297] The magnitudes of the resistive forces for various
thicknesses and types of tissues may be determined and the wave
spring 1212 sized accordingly such that the desired amount of
clamping force is applied to the tissue between the anvil 1050 and
the staple cartridge 42. The wave spring 1212 may be sized and
oriented such that when the anvil 1050 is at a fully compressed
position, the wave spring 1212 is not fully compressed or "bottomed
out".
[0298] FIGS. 64 and 65 illustrate other versions of closure tube
assemblies that may be employed to limit closure forces applied to
the anvil 1050. As can be seen in those Figures, the force limiting
members 1200a, 1200b comprise spring sections 1212a, 1212b actually
formed into the distal closure tube portion 1140a, 1140b,
respectively. While the spring sections 1140a, 1140b are depicted
as being somewhat helical in nature and formed in the distal
closure tube portions 1140a, 1140b, those of ordinary skill in the
art will understand that the spring sections 1212a, 1212b may be
provided in any portion of the closure tube assemblies 1130a, 1130b
and could conceivable be provided in different configurations.
Those of ordinary skill in the art will understand that in these
embodiments, the retention groove 1152 in the proximal closure tube
portion may not be elongated such that the closure tube assembly
1130a, 1130b is essentially not axially movable relative to the
closure shuttle 1160. In addition, while only one spring section is
shown as being provided in the closure tube assembly, it is
conceivable that more than one spring section may be formed in a
single closure tube assembly. As with the above-described versions,
as the resistive forces are encountered during clamping, the spring
members 1212a, 1212b enable their respective closure tube assembly
1130a, 1130b to move proximally to ultimately limit the amount of
closure force applied to the anvil 1050.
[0299] FIGS. 66 and 67 illustrate another closure tube assembly of
various embodiments of the present invention that may be employed
to limit closure forces applied to the anvil 1050. As can be seen
in those Figures, the force limiting member 1200c comprises a leaf
spring 1212c formed in the distal end 1141 of the distal closure
tube portion 1140c. When the closure tube assembly 1130c is
actuated to move distally to close the anvil 1050, the leaf spring
1212c rides up the anvil ramp 1070 and is free to move radially
(arrows 1214 in FIG. 66) and axially (arrow 1216 in FIG.). As with
the above-described versions, as the resistive forces are
encountered during clamping, the leaf spring 1212c enables the
closure tube assembly 1130c to move proximally (arrow B) to
ultimately limit the amount of closure force applied to the anvil
1050.
[0300] FIGS. 68 and 69 illustrate another embodiment of the present
invention that may be employed to limit closure forces applied to
the anvil 1050 by the closure tube assembly 1130. As can be seen in
those Figures, this embodiment employs an anvil 1050d that has a
stepped ramp 1070 that is configured to be engaged by the distal
end 1141 of the distal closure tube portion 1140. In particular,
the anvil 1050d depicted in those Figures has a series of steps
1074d, 1076d, 1078d, 1080d formed therein. As the closure tube
assembly 1130 is moved distally, the distal end 1141 starts to ride
up the smooth portion 1072d of the ramp 1070 until it contacts the
first step 1074d. The closure tube assembly 1130 will not advance
further up the ramp 1070d to apply a higher amount of closure force
to the anvil until the actuation force applied to the closure tube
assembly 1130 attains a sufficient magnitude to cause the distal
end 1141 to bump up over the first step 1074d and proceed to engage
the next step 1076d. The closure tube assembly 1130 will not
advance further up the ramp 1070d until the actuation force attains
a sufficient magnitude to cause the distal end 1141 to bump up over
the second step 1076d at which time it will engage the next step
1078d and so on. Thus, the stepped anvil 1050d cooperates with the
closure tube assembly 1130 to provide a means for relating the
amount of clamping forces ultimately applied to the tissue between
the anvil 1050d and the staple cartridge 42 based on the amount of
resistive forces generated thereby and encountered by the closure
tube assembly 1130 during clamping. While four such steps have been
disclosed, other numbers of steps may be employed. For example,
only one such step may be used or 2, 3, or more than 4 steps could
conceivably be employed.
[0301] FIGS. 70-76 illustrate another unique and novel endocutter
implement portion 1014e of various embodiments of the present
invention that includes an elongate channel 1060e and an anvil
arrangement 1050e that are "self adjusting" with respect to tissue
thickness. In various embodiments, the proximal end of the anvil
1050e is pivotally attached to the proximal end of the elongate
channel 1060e by mounting members which may comprise trunnions
1052e movably received in corresponding elongate slots 1064e formed
in the proximal end 1061e of the elongate channel 1060e. As can be
seen in FIGS. 70-74, at least one of the slots 1064e on each side
of the elongate channel 1060e (only one slot 1064e is illustrated
in FIGS. 70-74) and preferably both of the slots 1064e each have an
end wall 1065e that has a discrete number of predetermined
locations in the form of detents or pivot nests 1066e, 1067e,
1068e, 1069e formed therein. As can be seen in these Figures, the
detents 1066e, 1067e, 1068e, 1069e may each comprise a V-shaped
notch that is adapted to seatingly receive the pointed end of a
pawl 1080e formed on the corresponding trunnion 1052e. It is
conceivable that other detent and pawl configurations may be
successfully employed. As can also be seen in FIGS. 70-74, this
embodiment may further include a leaf spring 1090 or other suitable
biasing member for applying a downward biasing force to the
proximal end 1055e of the anvil 1050e. In various embodiments, the
leaf spring 1090 may be attached to the distal portion 1116 of the
spine assembly 1110 and oriented to bear upon the proximal end
1055e of the anvil 1050e.
[0302] As can be seen in FIG. 74, the slot 1064e is sized relative
to the trunnion 1052e to permit the trunnion 1052e to find
different clamped heights in response to the thickness of the
tissue clamped between the anvil 1050e and the cartridge 42 and the
application of the closing motion to the anvil 1050e. The leaf
spring 1090 serves to bias the pawl 1080e into a slightly upward
position wherein it can be received in any one of the notches
1066e, 1067e, 1068e, 1069e. As the anvil 1050e is closed onto the
tissue by means of distally advancing the closure tube assembly
1130 in the above-described manner, the tissue thickness itself may
dictate which of the notches 1066e, 1067e, 1068e, 1069e that the
pawl 1080 ultimately seatingly engages. Because the leaf spring
1090 biases the pointed pawl upwardly, the pawl 1080 would find the
uppermost notch 1069e when no tissue is between the anvil 1050e and
the cartridge 42 which would clamp the end effector 1014e to is
most closed position. See FIGS. 71 and 74. However, if during the
clamping process, the anvil 1050e and channel 1060e encounter
resistance, the leaf spring 1090 would be compressed and the anvil
trunnions 1052e would find a lower pivot notch which would
ultimately result in a larger gap between the anvil 1050e and the
cartridge 42.
[0303] FIG. 70 illustrates the anvil 1050e in an open position.
FIG. 71 illustrates the anvil 1050e in its most closed position.
The tissue clamping space or distance between the underside 1051e
of the anvil 1050e and the cartridge 42 is designated as "t". FIG.
75 also illustrates the position of the anvil 1050e relative to the
staple cartridge 42 and tissue 1092 that has a thickness "t".
Similarly, FIG. 73 illustrates the anvil 1050e in its uppermost
clamped position wherein the distance between the underside 1051e
of the anvil 1050e and the cartridge 42 is designated as "T". FIG.
76 also illustrates the anvil 1050e relative to the staple
cartridge 42 and tissue 1094 that has a thickness "T". As can be
seen in FIGS. 75 and 76, the staples 83 in the thinner tissue 1092
are more tightly formed than the staples 83 extending through the
thicker tissue 1094.
[0304] FIGS. 77-88 illustrate another embodiment of the present
invention that may be employed in connection with a circular
stapler 1600 that includes a unique and novel apparatus for
limiting the amount of compression force that can be generated
between the anvil and the staple cartridge to avoid over
compressing and possibly destroying the tissue to be stapled. A
variety of different circular staplers are known in the art. FIGS.
77-88 illustrate an exemplary circular stapler arrangement that may
employ the benefits of various aspects of the subject invention. It
is conceivable, however, that the various embodiments of the
present invention may be successfully employed with other stapler
constructions without departing from the spirit and scope of the
present invention.
[0305] As seen in FIG. 77, there is disclosed the circular stapler
1600 includes a head 1610, an anvil 1700, an adjustment knob
assembly 1800, and trigger 1664. The head 1610 is coupled to a
handle assembly 1660 by an arcuate shaft assembly 1630. The trigger
1664 is pivotally supported by the handle assembly 1660 and acts to
operate the stapler 1600 when a safety mechanism 1670 is released.
As will be discussed in further detail below, when the trigger 1664
is activated, a firing mechanism (not shown in FIG. 77) operates
within the shaft assembly 1630 so that staples 1618 are expelled
from the head 1610 into forming contact with the anvil 1700.
Simultaneously, a knife 1620 operably supported within the head
1610 acts to cut tissue held within the circumference of the
stapled tissue. The stapler 1600 is then pulled through the tissue
leaving stapled tissue in its place.
[0306] FIG. 78 illustrates one form of anvil 1700 and head 1610
that may be employed in connection with various embodiments of the
subject invention. As can be seen in that Figure, the anvil 1700
may have a circular body portion 1702 that has an anvil shaft for
attaching a trocar thereto. The anvil body 1702 has a staple
forming undersurface 1706 thereon and may also have a shroud 1708
attached to the distal end thereof. The anvil 1700 may be further
provided with a pair of trocar retaining clips or leaf-type springs
1710 that serve to releasably retain a trocar 1644 in retaining
engagement with the anvil shaft 1704 as will be discussed in
further detail below. In the embodiment depicted in FIG. 78, a
plastic knife board 1714 may be fitted into a cavity 1712 in the
anvil body 1702.
[0307] As can also be seen in FIG. 78, the head 1610 may comprise a
casing member 1612 that supports a cartridge supporting assembly in
the form of a circular staple driver assembly 1614 therein that is
adapted to interface with a circular staple cartridge 1616 and
drive staples 1618 supported therein into forming contact with the
staple forming undersurface 1706 of anvil 1700. A circular knife
member 1620 is also centrally disposed within the staple driver
assembly 1614. The proximal end of the casing member 1612 may be
coupled to an outer tubular shroud 1631 of the arcuate shaft
assembly 1630 by a distal ferrule member 1632.
[0308] FIGS. 79-82 illustrate one form of arcuate shaft assembly
1630 that may be employed with various embodiments of the present
invention. As can be seen in FIGS. 79 and 80, the arcuate shaft
assembly 1630 may include a compression shaft 1634, a distal
compression shaft portion 1635, a top tension band 1636, a bottom
tension band 1638 and a spacer band 1640 that are assembled within
the outer tubular shroud 1631 (FIG. 80). A trocar tip 1644 may be
attached to the top tension band 1636 and bottom tension band 1638
by fasteners 1646. The proximal ends of the top tension band 1636
and bottom tension band 1638 may be attached to a distal end of an
adjustment shaft 1650. As can be seen in FIG. 80, the trocar tip
1644 may be inserted into the anvil shaft 1704 of the anvil 1700
and retained in engagement by trocar retaining clips 1710.
[0309] As can be seen in FIG. 80, the distal compression shaft
portion 1635 is coupled to the staple driver assembly 1614. Thus,
axial movement of the compression shaft 1634 within the outer
tubular shroud 1631 causes the staple driver assembly 1614 to move
axially within the casing member 1612. As will be discussed below,
actuation of the firing trigger 1664 will cause the compression
shaft 1634 to move in the distal direction (arrow "DD") thereby
driving the staple driver assembly 1614 distally to fire the
staples 1618 into forming contact with the staple forming
undersurface 1706 of the anvil 1700. As the staple driver assembly
1614 is driven distally, it also drives the distal end 1622 of the
knife 1620 through the tissue held within the circumference of the
stapled tissue into the knife board 1714 mounted in the anvil 1700.
The knife board 1714 may be fabricated from plastic or other
suitable material that will permit the sharp distal end 1622 of the
knife 1620 to penetrate and achieve a desirable cutting action
through the clamped tissue.
[0310] In various embodiments, the adjusting shaft 1650 is axially
movably supported within a handle assembly 1660 that may comprise
two handle casing segments 1661, 1662 that are interconnected
together by suitable fastener arrangements for ease of assembly.
The trigger 1664 is pivotally attached to the handle assembly 1660
by a pivot pin 1666. A spring 1668 is supported on pivot pin 1666
and serves to bias the trigger 1664 away from the handle assembly
1660 to an unactuated position. A safety yoke 1670 is pivotally
coupled to the trigger assembly 1664 by pin 1672 such that it can
be pivoted between a safe position wherein the trigger 1664 cannot
be depressed towards the handle 1660 and an off position wherein
the safety yoke 1670 does not inhibit pivotal travel of the trigger
assembly 1664 toward the handle assembly 1660. As can be seen in
FIG. 79, the trigger 1664 may have a pair of fins 1665 that are
sized to be received in slots 1676 in a firing clip 1674 that is
attached to the proximal end 1637 of compression shaft 1634 by a
protrusion 1639 or other suitable fastener arrangements. Such
arrangement permits the distal axial movement (arrow "DD") and the
proximal axial movement (arrow "PD") of the compression shaft 1634
by pivoting the trigger 1664 as will be further discussed below.
The trigger 1664, the compression shaft portions 1634, 1635 and the
firing cap 1674 and other related components may comprise a firing
assembly generally designated as 1675.
[0311] As can be seen in FIGS. 79 and 81, the adjustment shaft 1650
has a distal portion 1651 that is attached to the top and bottom
tension bands 1636, 1638 and a proximal portion 1652 that is
adjoined to the distal portion 1651 by a reduced diameter segment
1653. The proximal portion 1652 is axially received within an axial
passage 1722 in the distal closure nut 1720 that is keyed onto or
otherwise attached to a proximal closure nut 1740 to form a closure
nut assembly generally designated as 1721 such that the distal
closure nut 1720 and the proximal closure nut 1740 may rotate
together. The distal closure nut 1720 may further have a distally
extending hub portion 1724 that abuts an inwardly extending
retainer flange 1667 formed inside the handle assembly 1660. See
FIG. 81. Such arrangement permits the distal closure nut 1720 to
freely rotate within the handle assembly 1660, but is unable to
move axially therewithin. Likewise, the proximal end portion 1652
of the adjustment shaft 1650 is axially received within an axial
passage 1742 within the proximal closure nut 1740. A
circumferentially extending groove 1744 may be provided in the
outer surface of the proximal closure nut 1740 for receiving an
inwardly protruding proximal retainer flange 1669 formed on the
proximal end of the handle assembly 1660. Such arrangement serves
to permit the proximal closure nut 1740 to freely rotate relative
to the handle assembly 1660.
[0312] Also in various embodiments, the closure knob assembly 1800
is attached to the proximal end 1741 of the proximal closure nut
1740. In one embodiment for example, the proximal end 1741 of the
proximal closure nut 1740 may be formed with a proximally extending
tapered hub portion 1746 that is adapted to be nonrotatably
received in an axial passage 1832 in a clutch hub portion 1830. See
FIG. 81. The tapered hub portion 1746 can also be formed with a key
or spline arrangement to non-rotatably affix the hub portion 1746
with the clutch hub portion 1830. Other fastener arrangements and
methods may be employed to non-movably attach the hub portion 1746
of the proximal closure nut 1740 to the clutch hub portion 1830.
Thus, rotation of the clutch hub portion 1830 will cause the
proximal closure nut 1740 and distal closure nut 1720 to also
rotate.
[0313] As can also be seen in FIGS. 81, 83, and 84, the knob
assembly 1800 may further include a proximal cap portion 1810 and a
distal cap portion 1820. The proximal end 1831 of the clutch hub
portion may be received in a circular slot 1814 formed in a distal
end of the proximal cap portion 1810. The slot 1814 may be sized to
permit the proximal cap portion 1810 to rotate about the proximal
end 1831 of the clutch hub portion 1830. In addition, the proximal
cap portion 1810 may have a protrusion 1812 that rotatably extends
into the axial passage 1832 in the clutch hub portion 1830. Also in
various embodiments, the closure knob assembly 1800 may comprise a
distal cap portion 1820 that is rigidly and non-rotatably coupled
to the proximal cap portion 1810. Those of ordinary skill in the
art will understand that the closure knob assembly 1800 may be
fabricated in multiple parts for ease of assembly of various
components of the instrument. In various embodiments, the mating
ends of the proximal cap portion 1810 and distal cap portion 1820
may be configured with complementary flanged portions 1813, 1823,
respectively as shown in FIGS. 81 and 83, that are interconnected
by adhesive, welding, etc. or other fastener arrangements may be
employed. Thus, when fastened together, the proximal cap portion
1810 and the distal cap portion 1820 rotate together as a unit.
[0314] As can further be seen in FIGS. 81 and 83, various
embodiments may comprise a slip clutch assembly generally
designated as 1821. The slip clutch assembly 1821 may take various
forms that are supported by or are integrally formed in the
adjustment knob assembly 1800. In one embodiment, for example, the
distal cap portion 1820 may be provided with an inwardly extending
cap flange 1824 that is in confronting orientation with an
outwardly extending clutch flange 1834 formed on the clutch hub
portion 1830. A first friction pad 1840 is non-rotatably affixed to
the inwardly extending cap flange 1824. A pad cavity 1836 may be
formed within the clutch flange 1834 for movably receiving a second
friction pad 1850 and a wave spring 1852 therein. The second
friction pad 1850 may be provided with splines or keys (not shown)
to prevent rotation thereof in the cavity 1836, but facilitate some
axial travel thereof within the cavity 1836. In various
embodiments, the first and second friction pads 1840, 1850 may be
fabricated from, for example, liquid crystal polymer, Nylon,
ULTEM.RTM., polycarbonate, aluminum, etc.
[0315] In various embodiments, the proximal portion 1652 of the
adjustment shaft 1650 has a low pitch thread segment 1654 formed
therein that communicates with a higher pitched threaded segment
1657. See FIG. 79. As can be seen in FIG. 81, a drive pin 1726
protrudes inwardly into the axial passage 1722 for "driving"
engagement with the threaded segments 1654, 1657 in the adjustment
shaft 1650. In addition, the proximal end 1652 of the adjustment
shaft 1650 has a threaded section 1658 adapted for threaded
engagement with a threaded cavity 1748 in the tapered hub portion
1746 of the proximal closure nut 1740. In various embodiments, the
drive pin 1726 is oriented in the distal closure nut 1720 such that
when the drive pin 1726 is still engaged with the low pitched
distal thread segment 1654 of the adjustment shaft 1650, the
threaded end 1658 of the adjustment shaft 1650 has sufficiently
threadedly engaged the threaded cavity 1748 in the tapered hub
portion 1746 of the proximal closure nut 1740 for threaded travel
therein as the closure knob assembly 1800 is rotated. In
particular, as the closure knob assembly 1800 is rotated in the
counterclockwise ("CC") direction, the adjustment shaft 1650 is
moved in the distal direction "DD" by virtue of the engagement of
the drive pin 1726 with the threaded segments 1654 and 1657 formed
in the attachment rod 1650. Those of ordinary skill in the art will
appreciate that rotation of the distal closure nut 1720 when the
drive pin 1726 is engaged with the distal threaded segment 1654
will result in fastener axial movement of the adjustment shaft 1650
than when the drive rod 1726 is engaged with the threaded segment
1567 which has a larger pitch than the threaded segment 1564. Axial
movement of the adjustment shaft 1650 moves the top and bottom
tension bands 1636, 1638, the trocar tip 1644 and the anvil 1700
(when attached to the trocar tip 1644) in the distal "DD" direction
away from the head 1610.
[0316] To close the anvil 1700 or move it toward the head 1610 and
staple cartridge 1616 supported therein in the "PD direction, the
surgeon begins to turn the closure knob assembly 1800 in the
clockwise ("CW") direction. The frictional forces generated between
the first and second friction pads 1840, 1850 serves to retain the
closure knob assembly 1800 in frictional engagement with the clutch
hub 1830 which is non-rotatably attached to the proximal closure
nut 1740. Because the proximal closure nut 1740 is non-rotatably
affixed to the distal closure nut 1720, the distal closure nut 1720
is also rotated in the clockwise direction. Rotation of the distal
closure nut 1720 results in the driving engagement of the drive pin
1726 with either of the thread segments 1654, 1657 (depending upon
the position of the adjustment shaft 1650 relative thereto) and
causes the adjustment shaft 1650 to be drawn in the proximal
direction ("PD"). As the adjustment shaft 1650 is drawn in the
proximal direction, the threaded end 1658 of the adjustment shaft
1650 threadably engages the threaded cavity 1748 of the tapered
threaded hub portion 1746 of the proximal closure nut 1740 and
reduced diameter segment 1653 moves adjacent to the drive pin such
that the drive pin is no longer in driving engagement with the
adjustment shaft 1650. Now, the threaded end 1652 is in full
threaded engagement with the threaded hole 1748 in the proximal
closure nut 1740. Further rotation of the closure knob assembly
1800 in the clockwise direction continues to draw the adjustment
shaft 1650 in the proximal direction "PD". As the adjustment shaft
1650 is drawn in the proximal direction, the anvil 1700 is moved
towards the cartridge 1616 supported in the staple driver assembly
1614 to clamp an amount of tissue therebetween. As the anvil 1700
continues to move toward the staple cartridge 1616, the tissue is
compressed therebetween and resists further travel of the anvil
1700 in the proximal direction.
[0317] In various embodiments, to prevent the tissue from being
over compressed which could result in damaging or killing the
tissue to be stapled, the composition of the first and second
friction pads 1840, 1850 and the size of the spring 1852 are
selected such that when a predetermined amount of tissue
compression is attained, the friction pads 1840, 1850 begin to slip
to prevent further rotation of the closure knob assembly 1800 from
being transferred to the clutch hub 1830. Thus, even if the surgeon
continues to rotate the closure knob assembly 1800 after the tissue
has been adequately compressed, such further rotation will not
result in continued movement of the adjustment shaft 1650 (and
anvil 1700) in the proximal direction to avoid over compressing the
tissue. For example, in various embodiments, the instrument may be
constructed such that the maximum amount of compression forces that
may be applied to the tissue between the anvil 1700 and the
cartridge 1616 may be approximately 150 pounds per square inch. For
such applications, the first and second friction pads 1840, 1850
and the wave spring 1852 may be so configured to permit slippage
between the first and second friction pads 1840, 1850 if the
closure knob assembly 1800 continues to be rotated after that
maximum amount of compression force has been attained. In such
example, the rotation of the closure knob assembly 1800 may
generate an approximate amount of torque of, for example, 15 inch
pounds which overcomes the frictional forces that are established
when the maximum amount of desirable compression has been attained
(which serves to retain the first and second friction pads 1840,
1850 in frictional engagement with each other) and permit the
desired slippage between the first and second friction pads. In
various embodiments, to ensure that the adjustment shaft 1650 is
moved distally when the closure knob assembly 1800 is rotated in a
counterclockwise direction, a series of circumferentially extending
ratchet teeth 1816 may be formed in the interior of the closure
knob assembly 1800 for engagement with circumferentially extending
engagement teeth 1835 formed on the circumference of the clutch
flange 1834. See FIGS. 83 and 84. The teeth 1816, 1835 may be
configured such that when the closure knob assembly 1800 is rotated
in the clockwise direction to move the anvil 1700 toward the
cartridge 1616, the teeth 1816 on the closure knob assembly 1800
slip over the teeth 1835 formed on the clutch flange 1834. However,
when the closure knob assembly 1800 is rotated in the
counterclockwise direction, the teeth 1816 engage teeth 1845 on the
clutch flange 1834 to cause the clutch hub 1830 and the proximal
and distal closure nuts 1720, 1740 to rotate therewith to move the
anvil 1700 away from the cartridge 1616.
[0318] As indicated above, various embodiments may be provided with
a safety yoke 1670 that prevents actuation of the trigger assembly
1664 when the safety yoke 1670 is in a "safe" or engaged position.
In various embodiments, a safety spring 1686 may be journaled on
the adjustment shaft 1650 and be received on the hub portion 1724
of the distal closure nut 1720. The spring 1686 may be oriented
between the distal closure nut 1720 and an upstanding end wall
portion 1688 of the safety release 1684. See FIG. 81. The safety
spring 1686 serves to bias the safety release 1684 in the distal
direction and into contact with the safety yoke 1670 to prevent the
safety yoke from being pivoted to an off position wherein the
trigger 1664 may be actuated. Also in these variations, a rod clip
1690 may be attached to the adjustment shaft 1650 by and adjusting
screw 1692 that extends through a slot (not shown) in the rod clip
1690. The rod clip 1690 may be so located on the adjustment shaft
1650 such that when the adjustment shaft 1650 has been axially
positioned in its most proximal position which results in the
maximum amount of desirable compression being applied to the tissue
or in a position wherein the anvil 1700 has begun to clamp the
tissue, but has not yet attained the predetermined maximum amount
of compression force, the rod clip 1690 has contacted the
upstanding end wall 1688 and moved it proximally a sufficient
distance to move the distal end 1685 of the safety release 1684 out
of retaining engagement with the safety yoke 1670. The surgeon may
then pivot the safety yoke 1670 to the off position thereby
enabling the trigger 1664 to be depressed.
[0319] Various embodiments of the invention may also be fitted with
a staple form indicator 1676 that may be pivotally mounted within
the handle assembly 1660 by a pivot pin 1678. The staple form
indicator 1676 may have a pointer end portion 1679 that is viewable
through a viewing window 1663 (FIG. 77) formed in the handle
assembly 1660. The end portion 1679 may be biased in the distal
direction by an indicator spring 1680. As can be seen in FIG. 79,
the staple form indicator 1676 may be formed with a tab 1682 that
is oriented for engagement by a hooked end 1685 of a safety release
1684. As the safety release 1684 is moved proximally in connection
with the proximal movement of the adjustment shaft 1650, the hooked
end 1685 causes the staple form indicator 1676 to pivot in the
proximal direction. An indicator plate (not shown) may be
positioned within the window 1663 and so calibrated such the
indicator 1676 cooperates with the indicator plate to indicate the
amount of distance between the anvil 1700 and the cartridge
1616.
[0320] One exemplary method of using the circular stapler 1600 will
now be described with reference to FIGS. 85-88. When performing an
anastomosis using a circular stapler, the intestine 1900 may be
stapled using a conventional surgical stapler with multiple rows of
staples being emplaced on either side of a target section (i.e.,
specimen) of intestine 1900. FIG. 85 illustrates the liner staple
lines 1910, 1920. The target section is typically simultaneously
cut as the section is stapled. The target section has already been
removed in FIG. 85. Next, after removing the target specimen, the
surgeon inserts the anvil 1700 into the proximal portion 1902 of
the intestine 1900, proximal of the staple line 1910. This is done
by inserting the anvil head 1700 into an entry port cut into the
proximal intestine portion 1902 or the anvil 1700 can be placed
transanally, by placing the anvil 1700 on the distal end of the
stapler 1600 and inserting the instrument through the rectum. Next,
the surgeon attaches the anvil 1700 to the trocar tip 1644 of the
stapler 1600 and inserts the anvil 1700 into the distal portion
1906 of the intestine 1900. The surgeon may then tie the distal end
1904 of the proximal section 1902 of the intestine 1900 to the
anvil shaft 1704 using a suture 1912 or other conventional tying
device and also tie the proximal end 1908 of the distal intestine
portion 1906 around the anvil shaft using another suture 1914. See
FIG. 86. The surgeon then begins to rotate the closure knob
assembly 1800 in the clockwise direction to draw the anvil 1700
toward the cartridge 1616 supported in the staple driver 1614 to
close the gap between the anvil 1700 and cartridge 1616 and thereby
engage the proximal end 1908 of the distal intestine portion 1906
with the distal end 1904 of the proximal intestine portion 1902 in
the gap "G" therebetween. See FIG. 87. The surgeon continues to
rotate the closure knob assembly 1800 until the first and second
friction pads 1840, 1850 slip and the desired amount of compression
(the desired gap G) is attained. When in that position, the surgeon
may then pivot the safety yoke 1670 to the off position and fire
the stapler 1600 by depressing the firing trigger 1664. Depressing
the trigger 16614 causes the compression shaft 1634 to drive the
staple driver 1614 distally to drive the staples 1618 to be driven
through both ends 1904, 1908 of the intestine 1900, thereby joining
the portions 1902 and 1906 and forming a tubular pathway.
Simultaneously, as the staples 1618 are driven and formed, the
knife 1620 is driven through the intestinal tissue ends 1904 and
1908, cutting the ends adjacent to the inner row of staples 1618.
The surgeon then withdraws the stapler 1600 from the intestine and
the anastomosis is complete.
[0321] FIGS. 89-95 illustrate another stapler embodiment 1600a of
the present invention. Stapler 1600a may essentially employ the
same components described above with respect to stapler 1600 except
for the changes that will be discussed in detail below. For
example, in this embodiment, a slip clutch assembly may not be
employed. However, this embodiment may employ a closure actuator
assembly 2000 that includes a proximal cap portion 2010 and a
distal cap portion 2040 that are rotatably retained together.
[0322] More specifically, as shown in FIGS. 90 and 91, in various
embodiments, the proximal cap portion 2010 may have a sleeve
portion 2012 that is sized to extend over the outer wall portion
2044 of the distal cap portion 2040 and be retained thereon by
virtue of an inwardly extending flange 2014 formed on the sleeve
portion 2012. Flange 2014 may be snapped over an outwardly
protruding rim 2046 formed on the circumference of the wall portion
2044 of the distal cap portion 2020. Such arrangement serves to
attach the proximal cap portion 2010 to the distal cap portion 2040
while facilitating its rotation relative thereto. To facilitate
ease of attachment, a beveled edge 2048 may be provide on the end
2041 of the wall portion 2044.
[0323] As can also be seen in FIGS. 90 and 91, the distal cap
portion 2040 may further have a cap hub portion 2050 that has a
proximal end 2052 that may be rotatably received in a circular slot
2016 formed in the proximal cap portion 2010. The slot 2016 may be
sized relative to the cap hub portion 2050 such that the proximal
cap portion 2010 can freely rotate around the cap hub portion 2050.
In addition, the proximal cap portion 2010 may have a protrusion
2018 that rotatably extends into an axial passage 2054 in the cap
hub portion 2050 to provide additional rotational support to the
closure knob assembly 2000. As can be seen in FIG. 90, the proximal
end 1741 of the proximal closure nut 1740 may be formed with a
proximally extending tapered hub portion 1746 that is adapted to be
nonrotatably received in the axial passage 2054 in the cap hub
portion 2050. The tapered hub portion 1746 may also be formed with
a key or spline arrangement to non-rotatably affix the hub portion
1746 with the cap hub portion 2050. Other fastener arrangements and
methods may be employed to non-movably attach the hub portion 1746
of the proximal closure nut 1740 to the cap hub portion 2050. Thus,
rotation of the cap hub portion 2050 will cause the proximal
closure nut 1740 and distal closure nut 1720 to also rotate in the
manners described above and axially advance the adjustment shaft
1650 distally or proximally depending upon the direction in which
the proximal and distal closure nuts are rotated.
[0324] Rotation of the proximal and distal closure nuts 1740, 1720
is attained by rotating the proximal cap portion 2010 relative to
the distal cap portion 2040. The interaction between the proximal
cap portion 2010 and the distal cap portion 2040 may be controlled
by a variable force generating member 2060 that interconnects those
components and serves to apply a resistive force to the proximal
cap portion 2010 in relation to the amount of compression
experienced by the tissue compressed between the anvil 1700 and the
staple cartridge 1616. In various embodiments, for example, the
variable force generating member may comprise a spiral spring 2060.
In some embodiments, the innermost end 2062 of the spiral spring
2060 may be configured as shown in FIG. 92 and inserted into a
retaining slot 2020 in the proximal cap portion 2010. End 2062 of
spring 2060 may also be attached to the proximal cap portion 2010
by other fastener arrangements. Likewise, the outer end 2064 of the
spring 2060 may be configured as shown in FIG. 92 and received in a
retention slot 2045 formed in the distal cap portion 2040. However,
the outer end 2064 of spring 2060 may be attached to the distal cap
portion 2040 by other suitable fastener arrangements.
[0325] In various embodiments, a reference indicator mark 2070 may
be provided on the proximal cap portion 2010 such that it aligns
with a corresponding initial mark 2072 on the outer wall 2044 of
the distal cap portion 2040 when the stapler 1600a is in the
unadvanced or neutral position. See FIGS. 89 and 95. When in that
aligned position, the spiral spring 2060 may essentially be
unloaded or it may be under a relatively small amount of load
necessary to retain the proximal cap portion 2010 in that starting
position. Rotation of the proximal cap portion 2010 in the
clockwise "CW" direction will be transferred to the distal cap
portion 2040 through the spring 2060 and to the proximal closure
nut 1740 attached to the distal cap portion 2040. Rotation of the
proximal closure nut 1740 also causes the distal closure nut 1720
to rotate and axially draw the adjustment shaft in the proximal
"PD" direction. When the adjustment shaft 1650 is drawn proximally,
is also causes the anvil 1700 to move towards the cartridge because
it is attached to the trocar tip 1644 which is attached to the
adjustment shaft 1650 by means of the top and bottom tension bands
1636, 1638 as was discussed above. As the anvil 1700 moves closer
to the staple cartridge 1616 supported in the head 1610, the tissue
1904, 1908 clamped therebetween begins to compress and resist
further travel of the anvil 1700 to the cartridge. See FIG. 93.
Such resistive compressive force also must be overcome by the
spring load to enable the anvil 1700 to further compress the tissue
1904, 1908 between the anvil 1700 and the cartridge 1616.
[0326] In various embodiments, the amount of spring load ("L1")
necessary to attain a minimum amount of tissue compression ("Min")
may be determined as well as the amount of spring load "(L2")
required to attain a maximum amount of tissue compression ("Max")
may also be determined. In addition, the distance "D1" that the
proximal cap portion 2010 must be rotated from the neutral position
to generate spring load L1 and the distance "D2" that the proximal
cap portion 2010 must be rotated to generate spring load "L2" may
be determined. The graph depicted in FIG. 94 illustrates an example
of a relationship between these parameters. Those of ordinary skill
in the art will appreciate that such relationships may change
depending upon the spring used and various other factors such as,
for example, frictional forces encountered by the moving components
of the device.
[0327] As can be seen in FIG. 95, a second indicator mark or
indicia 2080 corresponding to the position of the proximal cap
portion 2010 when it has been rotated to generate the minimum
amount of compression force "Min" is provided on the outer wall
2044 of the distal cap portion 2040 such that the second indicia
2080 coincides with the reference indicator 2070 on the proximal
cap portion 2010. Likewise a third indicator mark or indicia 2082
may be provided on the outer wall 2044 of the distal cap portion
2040 such that the third indicia 2082 coincides with the reference
indicator 2070 on the proximal cap portion 2010 when the proximal
cap portion 2010 has been rotated to that position which generates
the maximum amount of compression force "Max". See FIG. 95. Those
of ordinary skill in the art will recognize that a variety of
different indicia arrangements may be employed without departing
from the spirit and scope of the present invention. For example,
the area 2084 on the outer wall 2044 of the distal cap portion 2040
between the second indicia member 2080 and the third indicia member
2082 may be painted or other wise colored green to indicate to the
surgeon that if the reference indicator 2070 is located in that
region and acceptable amount of compression force may be
attained.
[0328] Thus, in these embodiments, the spring 2060 provides a means
for interrelating the amount of compression experienced by the
tissue located between the anvil 1700 and the staple cartridge 1616
and the distance that the proximal cap portion 2010 must be rotated
to attain that amount of compression. Such arrangement permits the
use of reference indicators and indicia on the proximal and distal
cap portions 2010, 2040 to enable the surgeon to accurately
determine when the anvil has been located in a position that will
result in acceptable staple formation. These reference indicators
and indicia can be so oriented to inform the surgeon when the anvil
has been moved to a position that will result in a minimum amount
of compression being applied to the tissue while still facilitating
the formation of sealing staples. Likewise, such reference
indicators and indicia may be so oriented to inform the surgeon
that the anvil has been moved to a position that will result in a
maximum amount of compression being applied to the tissue while
still facilitating the formation of sealing staples.
[0329] While the present invention has been illustrated by
description of several embodiments and while the illustrative
embodiments have been described in considerable detail, it is not
the intention of the applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may readily appear to those skilled in the art.
For example, while various manually operated surgical instruments
have been depicted for clarity, it should be appreciated that such
devices may also be robotically manipulated. In addition, those
skilled in the art will appreciate that the embodiments, features
and improvements disclosed herein may be readily employed in
connection with a variety of other known surgical cutter/staplers,
staplers, etc. that may have application in open, laparoscopic,
endoscopic and/or intralumenal surgical procedures. In particular,
such unique and novel features may be practiced in connection with
linear staplers, cutters, contour cutters, etc. Thus, the scope and
protection afforded to the various embodiments disclosed herein
should not be limited solely to endocutter-type surgical
staplers.
[0330] While several embodiments of the invention have been
described, it should be apparent, however, that various
modifications, alterations and adaptations to those embodiments may
occur to persons skilled in the art with the attainment of some or
all of the advantages of the invention. For example, 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. This
application is therefore intended to cover all such modifications,
alterations and adaptations without departing from the scope and
spirit of the disclosed invention as defined by the appended
claims.
[0331] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include an
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those of ordinary skill in the art will appreciate that the
reconditioning of a device can utilize a variety of different
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0332] Preferably, the invention described herein will be processed
before surgery. First a new or used instrument is obtained and, if
necessary, cleaned. The instrument can then be sterilized. In one
sterilization technique, the instrument is placed in a closed and
sealed container, such as a plastic or TYVEK.RTM. bag. The
container and instrument are then placed in a field of radiation
that can penetrate the container, such as gamma radiation, x-rays,
or higher energy electrons. The radiation kills bacteria on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0333] As used herein, the term "fluidically coupled" means that
the elements are coupled together with an appropriate line or other
means to permit the passage of pressurized gas therebetween. As
used herein, the term "line" as used in "supply line" or "return
line" refers to an appropriate passage formed from rigid or
flexible conduit, pipe, tubing, etc. for transporting fluid from
one component to another.
[0334] 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.
[0335] The invention which is intended to be protected is not to be
construed as limited to the particular embodiments disclosed. The
embodiments are therefore to be regarded as illustrative rather
than restrictive. Variations and changes may be made by others
without departing from the spirit of the present invention.
Accordingly, it is expressly intended that all such equivalents,
variations and changes which fall within the spirit and scope of
the present invention as defined in the claims be embraced
thereby.
[0336] As known in the art, surgical staples can be used to hold
several layers of tissue together after the tissue has been
resected, for example. Often, as described above, a surgical
stapler is used to deform the staples from an undeployed shape into
a deployed, i.e., deformed, shape. Referring to FIG. 27, the
staples, such as staples 83, for example, include a base, or crown,
and deformable legs extending therefrom. In use, the deformable
legs are typically deformed toward the crown by an anvil in the
surgical stapler. Referring to FIG. 27, the amount of this
deformation is usually dependent upon the thickness of the tissue
being stapled. More particularly, if the tissue is thinner, the
anvil is brought closer to the staple cartridge before the anvil
contacts the tissue and, as a result, the staples will have less
distance to be deployed before they are deformed against the anvil.
For example, the legs of the staple on the left in FIG. 27 are
inserted through thinner tissue while the legs of the staple on the
right are inserted through thicker tissue and, as a result, the
legs of the staple on the left are deformed more than the legs of
the staple on the right. As a result of the foregoing, a common
staple design can be readily adapted to various tissues having
different thicknesses.
[0337] As described above, referring to FIG. 27, the legs of
staples 83 are bent toward the base, or crown, of the staple. More
particularly, the ends of the legs are curled by the anvil of the
stapler until the desired deformation is achieved. Stated another
way, when the ends of the legs contact the anvil of the stapler,
the ends are guided by the anvil such that the legs are
continuously bent into an arcuate configuration until the staple is
deformed into a "B" shape, for example. In embodiments where the
staple has long legs, and/or embodiments where the staples are used
in very thin tissue, the legs may be curled significantly such that
their ends project outwardly from the staple. In these embodiments,
the ends may be sharp and may impinge on surrounding tissue causing
discomfort to the patient. To ameliorate this problem, the present
invention includes staple 1300 which can be bent in segments, as
opposed to a continuous arcuate shape as described above.
[0338] Similar to the above, referring to FIG. 96, staple 1300
includes crown 1302 and deformable legs 1304 and 1306 extending
therefrom. Legs 1304 and 1306 include first notches 1310, second
notches 1312, and third notches 1313 therein. In use, referring to
FIG. 105, when ends 1308 of legs 1304 and 1306 contact pockets 1314
of anvil 1316, ends 1308 can be guided toward each other, for
example. As the staple is further driven toward anvil 1316 by sled
driver 78, referring to staple 1300b, legs 1304 and 1306 may bend
significantly at first notches 1310. Referring to FIG. 97, owing to
the reduced cross-section of legs 1304 and 1306 at first notches
1310, legs 1304 and 1306 are more susceptible to deformation at
this location. For example, when legs 1304 and 1306 are bent at
notches 1310, first segments 1318 may bend at an approximately 90
degree angle, for example, with respect to second segments 1320 of
legs 1304 and 1306. In other embodiments, first segments 1318 may
be bent at any suitable angle with respect to second segments
1320.
[0339] Further to the above, referring to FIG. 98, second notches
1312 in legs 1304 and 1306 permit second segments 1320 to bend with
respect to third segments 1322 at an approximately 90 degree angle,
for example. In other embodiments, second segments 1320 may be bent
at any other suitable angle with respect to third segments 1322.
Similar to the above, notches 1313 permit third segments 1322 to
bend with respect to fourth segments 1325. As a result of notches
1310, 1312, and 1313, legs 1304 and 1306 may not be bent into a
continuous curl as described above; rather, they can be bent into a
segmented, rectangular configuration. As a result of the above,
staples having long legs 1304 and 1306 may be deformed in a manner
such that the ends of the deformable members do not extend
outwardly from the staple, rather, they can be positioned
intermediate legs 1304 and 1306 as illustrated in FIG. 99. While
the legs of the illustrated staples in FIGS. 96-105 have three
notches and four segments, various embodiments are envisioned which
have additional, or less, notches and segments. Furthermore, while
the segments of the staple legs described above are substantially
straight, various embodiments are envisioned in which the segments
are curved, curvilinear, or other otherwise suitably configured to
achieve a desired shape.
[0340] To facilitate the bending of third segments 1322 with
respect to fourth segments 1325, for example, crown 1302 may
include a forming surface, or anvil, for guiding and/or deforming
legs 1304 and 1306 when they contact crown 1302. More particularly,
referring to FIGS. 99 and 101-104, as legs 1304 and 1306 are being
deformed from the shape illustrated in FIG. 98 to the shape
illustrated in FIG. 99, ends 1308 of deformable members 1304 and
1306 may contact crown 1302. To guide ends 1308, anvil 1323 of
crown 1302 includes recesses 1324 which can direct ends 1308 to
move outwardly as illustrated in FIG. 99 or in any other suitable
direction. In various embodiments, recesses 1324 may not deform
legs 1304 and 1306 significantly, however, in the illustrated
embodiment, recesses 1324 are configured to deform legs 1304 and
1306 at an approximately 90 degree angle. In various embodiments,
anvil 1316 of the stapler and anvil 1323 in crown 1302 can
co-operate to deform staple 1300 into the shape illustrated in FIG.
99, for example, or any other suitable shape.
[0341] In various embodiments, although not illustrated, a forming
surface, or anvil, can be included in staple cartridge 1326 in
addition to, or in lieu of, anvil 1323 in crown 1302. In these
embodiments, anvil 1316 deforms legs 1304 and 1306 such that ends
1308 contact the recesses in stapler cartridge 1326. Similar to the
above, the staple cartridge recesses can be configured to guide
and/or deform legs 1304 and 1306 when they contact stapler
cartridge 1326. In various embodiments, anvils on both crown 1302
and stapler cartridge 1326 can be utilized to deform and/or guide
the staple. In the illustrated embodiment, crown 1302 includes
material 1303 overmolded onto base 1301. As discussed in greater
detail below, material 1303 can be comprised of a plastic material,
for example, a bioabsorbable material, and/or a non-bioabsorbable
material. In at least one of these embodiments, the material 1303
is formed around a single continuous wire comprising base 1301 and
deformable members 1304 and 1306. In other embodiments, deformable
members 1304 and 1306 can include separate deformable members
embedded in plastic material 1303. Further, in various embodiments,
the wire comprising base 1301 can be deformed to provide the
recesses and anvils described above.
[0342] Referring to FIGS. 106 and 107, similar to the above, the
staple, in various embodiments, can include several necked down
sections in the staple legs which can be configured to cause the
staple legs to deform and/or buckle at the necked down sections.
More specifically, staple 1340 can include several necked-down or
tapered sections 1342 which allow staple legs 1344 to deform in
segments as described above. Tapered sections 1342, similar to
notches 1310, 1312, and 1313, provide a stress concentration area.
Stress concentration areas are typically locations in which a
loaded member, for example, will fail. Stated another way, stress
concentration areas may magnify the stress in a particular area of
a loaded member causing the loaded member to yield, or plastically
strain, at the stress concentration area before the remainder of
the loaded member plastically strains. As used herein, the term
"yield" generally refers to the point of maximum stress and/or
strain above which a material will no longer behave in a completely
elastic manner. However, various embodiments are envisioned in
which the materials used herein do not have a traditional yield
point, for example. These materials can include materials which
strain plastically as soon as they are stressed and/or
super-elastic materials which do not have a discernable yield
point. These materials can include shape memory alloys, such as
Nitinol, for example, that allow for large strain deformations
during the above-described forming processes. Typically, engineers
are charged with eliminating stress concentration areas to achieve
a desired goal; however, according to the teachings of the present
invention, stress concentration areas can be utilized to achieve
the above-described goals.
[0343] In various embodiments, referring to FIGS. 108-110, staple
1329 includes base portion 1331 and two deformable legs 1333
extending therefrom. Legs 1333 can each include a first portion
1335 having a substantially round cross-section and a second
portion 1337 having a substantially flat cross-section. In at least
one embodiment, legs 1333 and base 1331 are comprised of a metal
wire that is coined, or formed, on its ends to create substantially
flat portions 1337. As known in the art, coining, or forming, a
metal wire may be performed with a stamping press before and/or
after, the wire is bent into the "U" shape illustrated in FIG. 108.
Referring to FIG. 110, legs 1333 are configured such that flat
portions 1337 can be bent to secure tissue within the staple while
round portions 1335 can remain substantially unbent. In use, as a
result, staple 1329 can be used to secure thicker tissues. More
specifically, owing to substantially unbent portions 1335, thicker
tissues can be accommodated between portions 1335 while flat
portions 1337 can be bent to retain the tissue therebetween. The
amount in which flat portions 1337 are deformed is typically
dependent upon the thickness of the tissue captured in the
staple.
[0344] In various embodiments, referring to FIG. 111, staple 1441
can include deformable legs 1443 which have a tapered
configuration. More particularly, staple legs 1443 can include a
base portion 1444 that has a larger cross-section than the
cross-section of tip portion 1445. In use, similar to the above,
staple 1441 can accommodate thicker tissues as, owing to the
thicker cross-section of base portions 1444, base portions 1444 may
remain substantially unbent while tip portions 1445 are bent to
retain the tissue in the staple. In other various embodiments,
referring to FIG. 112, staple 1446 can include several stepped
portions 1447 and 1448 which allow some portions of legs 1449 to be
bent, some portions to be only partially bent, and other portions
to remain substantially unbent. The suitable amount and
configurations of the stepped portions may be selected to
accommodate the type and/or thickness of the tissue being
secured.
[0345] Referring to FIGS. 113 and 114, staple 1350, similar to
staple 1340, includes crown 1302 and deformable legs 1344. Staple
1340, as described above, in at least one embodiment, is configured
to compress tissue between deformable legs 1344 and crown 1302.
However, in applications in which the tissue is very thin, for
example, sufficient compression of the tissue between deformable
legs 1344 and crown 1302 may be difficult to achieve and a gap
between the tissue and legs 1344, for example, may exist. For these
applications, it may be desirable to include an additional member
intermediate the tissue and the deformable members and/or crown
which not only fills the gap, but compresses the tissue against at
least one of the crown and/or deformable members.
[0346] Staple 1350, referring to FIGS. 113 and 114, can include, in
various embodiments, deformable, or compressible, member 1352. As
described above, referring to FIG. 114, compressible member 1352
can bias tissue 1353 against deformable legs 1344. As a result of
this compression, the lumens, or vessels, in tissue 1353 can be
compressed and thereby slow the flow of blood therethrough. In at
least one embodiment, compressible member 1352 is entirely elastic
after it has been compressed, i.e., the addition of, or the removal
of, any stress onto compressible member 1352 will result in a
linearly corresponding increase, or decrease, in strain thereof.
Stated in another way, in these elastic embodiments, compressible
member 1352 can substantially act like a spring. However, in at
least one embodiment, compressible member 1352 can be crushable,
i.e., after it has been compressed, at least a portion, if not all,
of compressible member 1352 is permanently deformed and the
addition of, or removal of, any stress onto compressible member
1352 does not necessarily result in a linearly corresponding
strain. In various embodiments, compressible member 1352 can be
comprised of foam. The foam can be absorbable or non-absorbable.
The foam can be comprised of synthetic materials and/or
mammalian-derived materials including, but not limited to,
polyglycolide trimethylene carbonate copolymer, polyglycolic acid,
caprolactone/glycolide, EPTFE, and bovine pericardium. Further, in
at least one embodiment, compressible member 1352 may include a
first portion which is elastically deformable and a second portion
which is plastically deformable.
[0347] Referring to FIGS. 115 and 116, staple 1360 can include
collapsible spring member 1362. Collapsible spring member 1362 can
include a plurality of first elastic members 1363 and second
elastic members 1364. Each first elastic member 1363 can include an
arcuate profile which includes projections 1365 extending therefrom
which are sized and configured to contact corresponding projections
1366 extending from each second elastic member 1364. More
specifically, first elastic members 1363 and second elastic members
1364 are configured such that they can be stacked upon each other
and, when a compressive load is applied to such a stack, the first
and elastic members can flatten and thereby "collapse" the stack of
elastic members. In the illustrated embodiment, collapsible spring
member 1362 further includes fasteners 1367 and 1368. Referring to
FIG. 115, fasteners 1367 can connect the central portions of
adjacent first elastic members 1363 and second elastic members 1364
to prevent the elastic members from becoming dislodged or
misaligned with respect to each other. Similarly, fastener 1368 can
prevent collapsible spring member 1362 from becoming dislodged with
respect to crown 1302. In use, collapsible spring member 1362 can
provide a compressive load to tissue in between said deformable
members and said crown.
[0348] Referring to FIGS. 117 and 118, staple 1370 can include
cantilever spring 1372. Cantilever spring 1372 includes first end
1373 attached to crown 1302 and second end 1374 which is free to
move with respect to first end 1373. In use, when tissue is
compressed between spring 1372 and deformable legs 1344, spring
1372 can apply an upwardly-directed biasing, or compressive, force
against the tissue. More particularly, as deformable legs 1344 are
deformed and pushed against the tissue, second end 1374 of spring
1372 can move downwardly with respect to first end 1373. As a
result of this deflection, spring member 1372 stores potential
energy and acts to release this potential energy by applying an
upward force against the tissue, thereby compressing the tissue
between spring member 1372 and deformable legs 1344. In an
alternative embodiment, referring to FIGS. 119-121, spring member
1382 of staple 1380 can have first and second ends, 1382 and 1384,
respectively, attached to crown 1302. In at least one embodiment,
springs 1372 and 1382, for example, can be integrally molded with
crown 1302. In these embodiments, springs 1372 and 1382 can be
comprised of a dissolvable, bioabsorbable, or biofragmentable
material such that, as the material dissolves, the biasing force of
springs 1372 and 1382 can decrease throughout the healing process.
As a result, a larger compressive force can be applied during the
initial healing stages when the restriction of blood loss is
important and a smaller compressive force can be applied during the
later healing stages when tissue regeneration is important wherein
the smaller force permits expansion and growth of the tissue within
the staple.
[0349] In other various embodiments, although not illustrated, the
tissue can be positioned, and compressed between, the compressible
member and the crown of the staple. In these embodiments, the
deformable members are deformed against the compressible member
which, as a result, is compressed between the deformable legs and
the tissue.
[0350] Referring to FIGS. 122 and 123, staple 1400 includes crown
1402, first deformable member 1404, and second deformable member
1406. Deformable members 1404 and 1406 each include a base 1408, a
deformable leg 1410, and a second leg 1412 which, in the
illustrated embodiment, are comprised of a single continuous wire.
In other various embodiments, staples 1400 may be configured in any
other suitable manner to achieve the goals of the invention
described herein. In the illustrated embodiment, members 1404 and
1406 are connected together by a material that is overmolded onto
the bases 1408 of members 1404 and 1406. In various embodiments,
the material can include a dissolvable, bioabsorbable, or
biofragmentable material such as Vicryl and PDS from Ethicon, Inc.,
for example. As used herein, the terms dissolvable, bioabsorbable,
and biofragmentable all generally refer to materials that can be at
least partially assimilated by the body after being implanted into
a patient, for example.
[0351] In use, staple 1400 can be inserted into the soft tissue of
a person, for example, via a stapler and can be deformed into the
configuration illustrated in FIG. 124. More particularly, in the
illustrated embodiment, deformable members 1404 and 1406 can be
deformed by the anvil of the stapler such that ends 1411 of legs
1410 are brought into close proximity to crown 1402. Once staple
1400 is implanted into the tissue, crown 1402 may begin to break
down, dissolve and weaken. More particularly, referring to FIG.
125, the bioabsorbable material of crown 1402 may deteriorate to
the point where first member 1404 and second deformable member 1406
become disconnected from each other as illustrated in FIG. 126.
Once first member 1404 and second member 1406 have become
disconnected, they can move relative to one another. The time
required for crown 1402 to sufficiently dissolve may depend on the
material used and/or the size of crown 1402. Polyglatin 910
material, sold under the tradename Vicryl, for example, may
dissolve in 7-14 days.
[0352] In various embodiments, dissolvable crown 1402 may provide
several therapeutic advantages. For example, when staple 1400 is
initially deployed, deformable members 1404 and 1406 may
significantly compress the tissue within the staple against crown
1402. In some applications, this compression may be desirable to
limit bleeding from the tissue. As crown 1402 deteriorates, the gap
between the deformed members 1404 and 1406 and crown 1402 may
increase thereby relaxing the compressive forces acting on the
tissue. In some applications, relaxing the compression forces
during the healing process may allow the tissue to slowly expand
and return to its normal thickness over a period of time. In some
embodiments, crown 1402 can be coated with a hydrophilic material
that initially expands to compress the tissue captured within the
staple before dissolving away thereafter. In these embodiments, the
hydrophilic material expands by absorbing water from the
surrounding tissue and fluids. In addition to the above, staple
1400, when it is inserted into the tissue, may be very stiff and,
if several staples are inserted into the tissue, the tissue may not
be permitted to move and expand during the healing process.
However, after crowns 1402 of staples 1400 have dissolved, the
deformable members 1404 and 1406 of the staples may be able to move
relative to each other while still holding the underlying tissue
together.
[0353] In various embodiments, deformable members 1404 and 1406 may
be comprised of a substantially non-dissolvable or
non-bioabsorbable material. In other embodiments, at least one of
deformable members 1404 and 1406 may be comprised of a dissolvable,
bioabsorbable, or biofragmentable material such as magnesium or
iron, for example. In at least one embodiment, the iron is pure
iron. In either event, the dissolvable material of members 1404 and
1406 can be selected such that they dissolve at the same rate as,
slower than, or faster than the dissolvable material of crown 1402.
For example, the material of crown 1402 can be selected such that
it completely dissolves away while deformable members 1404 and 1406
are still holding tissue together. Further, in various embodiments,
the material of first deformable member 1404 can be selected such
that it dissolves faster than the material of second deformable
member 1406. Accordingly, the deformable members of these
embodiments may allow for a staggered release of the tissue.
Further, in various embodiments, at least two adjacent staples
1400, as described in greater detail below, can be connected by a
bridge before and/or after the staples have been deployed into the
tissue. In these embodiments, a first staple can be comprised of
bioabsorbable materials that dissolve away at a faster rate than
the materials of a second staple attached thereto. Similarly, the
bridge connecting the staples can be comprised of materials that
dissolve away at the same rate, and/or a different rate, than the
first and second staples. In these embodiments, the first staples
can dissolve away before the second staples allowing for a
staggered release of the tissue.
[0354] The staples described above can be used to approximate
tissue, i.e., the staples can secure resected or damaged tissue
such that the strength of the resected or damaged tissue
approximates that of healthy tissue. To this end, a method of
approximating tissue can include suturing tissue with a surgical
staple comprised of a dissolvable material and a non-dissolvable
material to approximate tissue in a first state, and dissolving the
dissolvable material to cause the remaining non-dissolvable
material to approximate the tissue in a second state. In at least
one embodiment, the tissue approximation in the second state is
more flexible than in the first state.
[0355] In addition to the above, referring to FIG. 132, crown 1402
may be comprised of at least two overmolded or co-molded materials.
More particularly, crown 1402 may be comprised of a first material
1435 overmolded onto deformable members 1404 and 1406 and a second
material 1436 overmolded onto second material 1436, for example. In
this embodiment, second material 1436 can be configured to dissolve
away quickly thereby allowing deformable members 1404 and 1406 to
separate from each other early on in the healing process. However,
first material 1435 can be selected to dissolve at a slower rate
than second material 1436 in order for crown 1302 to continue to
provide a compressive force on the tissue even after second
material 1436 has completely dissolved away. In at least one
embodiment, first material 1435 can be injection molded onto
deformable members 1404 and 1406 and then permitted to cure, and/or
substantially solidify, before second material 1436 is injection
molded onto first material 1435. In other various embodiments,
first material 1435 and second material 1436 can be injection
molded onto deformable members 1404 and 1406 at substantially the
same time or in rapid succession. In these embodiments, the first
and second materials can chemically bond together to provide
sufficient strength therebetween so that the staple may be handled
without the first and second materials separating from one another.
In other embodiments, the first and second materials can form
mechanically interlocking features to accomplish the same
result.
[0356] In the embodiment illustrated in FIG. 123, crown 1402 may
include reduced cross-section 1414 intermediate portions 1416 and
1418. In use, intermediate section 1414, as it has a smaller
cross-section than portions 1416 and 1418, may completely dissolve
away before sections 1416 and 1418 thereby allowing first member
1404 to become unconnected from second member 1406 before the
entirety of crown 1402 has dissolved (FIG. 125). In at least one
embodiment, the cross-sections of sections 1414, 1416, and 1418 can
be selected such that deformable members 1404 and 1406 become
unconnected at a desired stage in the healing process. In at least
one embodiment, referring to FIG. 133, crown 1402 can include score
marks 1437 which reduce the thickness of crown 1402 in the scored
areas. In these embodiments, the score marks may be formed when
crowns 1402 are overmolded onto deformable members 1404 and 1406 or
formed by a cutting tool thereafter. As a result of score marks
1437, crown 1402, as it dissolves, can break up into several small
pieces which are, in some circumstances, more easily absorbable by
the body. In at least one embodiment, referring to FIG. 134, crown
1402 may include a plurality of pockets 1438 intermediate raised
portions 1439. In use, the material intermediate raised portions
1439 may dissolve away leaving behind a lattice, or grid, of raised
portions 1439 intermediate deformable members 1404 and 1406.
[0357] In at least one embodiment, crown 1402 is also comprised of
at least one therapeutic drug. In these embodiments, as the
dissolvable material deteriorates, the therapeutic drug can be
absorbed by the surrounding tissue. In some embodiments, the drug
is dispersed throughout the dissolvable material such that the drug
is steadily released during the healing process, however, in other
embodiments, the therapeutic drug may be unevenly dispersed
throughout the dissolvable material, or layered within and/or on
the material to provide an increased dosage of the drug at a
particular stage in the healing process.
[0358] In at least one embodiment, having an absorbable staple with
an absorbable insulator reduces the possibility of arcing along a
row of staples when an electrocautery device is used in situ, for
example. The absorbable insulators, or crowns, on the staples
substantially prevent an electrical current from jumping betweens
staples as the top of each staple is not electrically conductive
under normal operating conditions. As a result, the possibility of
damaging tissue is reduced.
[0359] In use, as described above, and referring to FIGS. 127 and
128, deformable members 1404 and 1406 of staple 1400 are deformed
by anvil 1420 of stapler 1422. More particularly, ends 1411 of
members 1404 and 1406 are received within recesses 1424 in anvil
1420 and are guided toward crown 1402 as members 1404 and 1406 are
deformed by anvil 1420. Referring to FIGS. 129 and 129A, recesses
1424 can include a configuration which causes the ends of members
1404 and 1406 to bend out of plane with members 1412 and bases
1408. More particularly, referring to FIGS. 130 and 131, each
recess 1424 includes several planar surfaces oriented to initially
deflect end 1411 laterally, and then downwardly, to curl the top
portion of deformable leg 1410 alongside the bottom portion of
deformable leg 1410 as illustrated in FIG. 131. Referring to FIGS.
130 and 131, recess 1424 includes surfaces 1426 and 1428 which form
vertex 1430 therebetween. Surfaces 1426 and 1428, and vertex 1430,
are configured to receive end 1411 of deformable member 1406, for
example. After sufficient pressure is applied by anvil 1420, leg
1410 of deformable member 1406 is curled within vertex 1430.
Thereafter, as leg 1410 is further deformed, leg 1410 also contacts
vertex 1432 which is intermediate surfaces 1428 and 1434 of recess
1424. As illustrated in FIG. 131, vertex 1432 assists in deforming
member 1406 into a desired shape. While the above anvils are
described in connection with staples 1400, these anvils can be used
to deform other differently-configured staples including the
suitable staples disclosed in this application.
[0360] Referring to FIGS. 96 and 97, staple 1300 includes an
integral staple crown and driver. More particularly, referring to
FIG. 105, crown 1302 is configured to be directly driven by cam
sled 78. In use, as described in detail above, cam sled 78 is
progressed through staple cartridge 1326 from the position
illustrated in FIG. 105 toward distal end 1327 of staple cartridge
1326. As cam sled 78 is moved in this direction, staples 1300 are
successively lifted by cam sled 78 toward anvil 1316. In previous
surgical staplers, a separate driver was positioned intermediate
the cam sled and the staple. However, the present invention
simplifies these previous systems by including features in crown
1302 which allow staples 1300 to be directly lifted by cam sled 78.
More particularly, referring to FIGS. 96 and 97, crown 1302
includes beveled surfaces 1328 which are configured to co-operate
with angled surface 1330 of cam sled 78 such that crowns 1302 slide
up cam surface 1330. In the illustrated embodiment, both beveled
surfaces 1328 and cam surface 1330 are oriented at an approximately
30 degree angle with respect to the horizontal. As a result, in the
present embodiment, beveled surface 1328 may sit flushly on cam
surface 1330, however, embodiments are envisioned in which beveled
surfaces 1328 and cam surface 1330 are not oriented at the same
angle. Furthermore, the present invention is not limited to
embodiments having 30 degree angles. On the contrary, any suitable
angle, or angles, can be used.
[0361] Referring to FIGS. 96 and 97, base 1301 of staple 1300, in
the illustrated embodiment, is embedded in crown 1302. More
particularly, crown 1302 can be overmolded onto base 1301 such that
crown 1302 tightly surrounds base 1301 and wherein, in the present
embodiment, base 1301 is enveloped or enclosed by crown 1302. In
other various embodiments, crown 1302 may be separately
manufactured and then assembled to base 1301. In either event, base
1301 and/or deformable members 1304 and 1306 can be at least
partially embedded into crown-driver 1302. As a result, staple 1300
can include larger deformable members 1304 and 1306 than in
previous designs. In these embodiments, as a result of the above,
staple 1300 may accommodate larger tissues intermediate the
deformable members and tissue-contacting surface 1336 of crown
1302. In one embodiment, crown-driver 1302 may be comprised of a
dissolvable or bioabsorbable material, as described above, that, as
it dissolves, allows the tissue compressed within staple 1300 to
expand and grow. In various embodiments, as described above,
crown-driver 1302 may be comprised of, or coated by, a hydrophilic
material that expands when exposed to water in the body to further
compress the tissue in the staple. Further, similar to the above,
crown-driver 1302 may be configured to increase the contact area
between crown 1302 and the tissue. In some embodiments, increasing
this contact area reduces the localized stress on the tissue
surface which may reduce the possibility of tissue necrosis, for
example.
[0362] As indicated above, an integral staple crown and driver may
reduce the quantity of components needed to deploy the staples. As
a result, embodiments in accordance with the present invention may
reduce the cost and/or manufacturing time to produce the stapling
systems. Further, eliminating the separate driver components may
reduce the possibility of misalignment between the staples and the
cam sled.
[0363] In an alternative embodiment of the present invention,
referring to FIG. 135, staples 1450 can each include a crown 1451
and two deformable legs 1452 extending therefrom. Referring to FIG.
135, the crowns of staples 1450 can be connected together by bridge
1455. Similar to the above, crowns 1451 and bridge 1455 can be
integrally molded onto staple legs 1452. Also similar to the above,
crowns 1451 can include beveled surfaces 1453 which, referring to
FIG. 139, can be configured to cooperate with angled surface 1454
of cam driver 1462. As above, cam driver 1462 is configured to
successively raise staples 1450 toward an anvil positioned opposite
deck 1456 of staple cartridge 1457. As discussed in greater detail
below, bridges 1455 can be configured to connect staples 1450 even
after they have been deployed or, alternatively, staple cartridge
1457 can include shears which break bridges 1455 and separate
staples 1450 when they are deployed.
[0364] Staple cartridge 1457, referring to FIGS. 136-138, further
includes cavities 1458 configured to receive staples 1450. In at
least one embodiment, cavities 1458 include keys 1459 which are
sized and configured to fit within slots 1460 in crowns 1451. More
particularly, slots 1460 and keys 1459, in the present embodiment,
are configured to substantially limit the motion of staples 1450
with respect to staple cartridge 1457 to a substantially linear
motion, i.e., in the present embodiment, an upwardly and/or
downwardly motion. As a result of these features, the possibility
of staples 1450 becoming bound within or misaligned with respect to
cavities 1458 can be reduced. In alternative embodiments, cavities
1458 can include slots and staples 1450 can have keys.
[0365] Although surfaces 1453 have been described herein as being
beveled, surfaces 1453 are not limited to flat surfaces. On the
contrary, various embodiments are envisioned in which surfaces 1453
are curved, radiused, curvilinear, and/or include several sections
having various configurations. In either event, surfaces 1453 are
configured to co-operate with cam sled 1462 such that staples 1450
are deployed as described above. Similarly, surface 1454 of cam
sled 1462 is not limited to a flat surface. On the contrary,
surface 1454 can be curved, radiused, curvilinear, and/or have any
other suitable configuration.
[0366] Staple cartridge 1500, referring to FIG. 140, includes
recesses 1502 for receiving staple strips 1504. Referring to FIGS.
140 and 141, staple strips 1504 include several staples 1506
connected together by bridges 1508. Recesses 1502 include several
pockets 1510 which are sized and configured for receiving staples
1506 therein. In at least one embodiment, staples 1506 include
deformable members 1512 which are sized and configured to be biased
against the sidewalls of notches 1514 in recesses 1502. More
particularly, deformable members 1512 can be configured to create a
press-fit between staples 1506 and pockets 1510 such that staple
strips 1504 remain seated within recesses 1502 under normal usage
conditions. However, in the present embodiment, staple strips 1504
can be removed from recesses 1502 with a moderate application of
force.
[0367] As illustrated in FIG. 140, recesses 1502 open to top
surface 1516 of staple cartridge 1500 such that staple strips 1504
can be inserted into staple cartridge 1500 by aligning strips 1504
with recesses 1502 in top surface 1516 and pressing them into the
position illustrated in FIG. 141. Referring to FIG. 141, recesses
1502 further include recess portions 1518 intermediate adjacent
pockets 1510 which are sized and configured for receiving bridges
1508. In the embodiment illustrated in FIGS. 140-143, bridges 1508
are configured such that adjacent staples 1506 can move with
respect to each other when being inserted into pockets 1510.
Accordingly, bridges 1508 can accommodate dimensional differences,
and/or manufacturing tolerances, in the alignment of strips 1504
with recesses 1502. More particularly, each bridge 1508 can include
a curved portion 1520 configured to allow portions 1522 of bridge
1508 to move with respect to each other.
[0368] In the illustrated embodiments, the deformable members of
each staple 1506 comprise a single continuous wire that can be bent
into a "U" and/or "V" shape. Crowns 1513, in the present
embodiment, can be overmolded onto a portion of these wires such
that the wires are embedded into and supported by crown 1513. In
addition, as illustrated in FIG. 143, bridges 1508 can be
integrally molded with crowns 1513 when crowns 1513 are overmolded
onto the wire. As a result, bridges 1508 and crowns 1513, in the
present embodiment, can comprise an integral, continuous body of
plastic, for example. Although not illustrated, bridges 1508 and
crowns 1513, in various embodiments, may be molded as a separate
component, or components, that are attached to the staples. In
these embodiments, the wires of the staples can be press-fit and/or
glued into recesses in the separately molded components, for
example.
[0369] In use, referring to FIG. 144, as sled 78 is moved forward,
sled 78 lifts staples 1506 upwardly toward an anvil positioned
opposite top surface 1516. Owing to the angled orientation of
surface 1523 of sled 78, staples 1506a-1506e, for example, are
incrementally lifted in successive order. More particularly,
staples 1506a and 1506b, while they are being lifted by sled 78,
may be lifted to different relative heights with respect to surface
1516 at any given moment. To accommodate this difference in
relative position, bridge 1508a can be flexible such that it does
not break as staple 1506a is being deployed. Bridge 1508a, in the
embodiment illustrated in FIG. 144, can be configured such that it
remains attached to staples 1506a and 1506b during the deployment
thereof and, in addition, during the initial healing process of the
patient.
[0370] In other various embodiments, referring to FIGS. 145-147,
staples 1506 can be connected together by bridges 1526 to form
staple strips 1528. Similar to bridges 1508, bridges 1526 can be
integrally formed with crowns 1513 when crowns 1513 are overmolded
onto deformable members 1512 as described above. However, bridges
1526, unlike bridges 1508, can be configured such that they break
away from at least one of the two adjacent staples 1506 that they
connect. More particularly, referring to FIGS. 146 and 147, bridges
1526 can include notches 1530 therein which are configured to
reduce the cross-sectional thickness, and strength, of bridges
1526. In use, referring to FIG. 147, as staple 1506a is lifted
upwardly with respect to staple 1506b, bridge 1526a can break away
from staple 1506a. Stated another way, when staple is 1506a is
lifted upwardly, the stress created within bridge 1526a by pulling
staple 1506a away from staple 1506b may cause bridge 1526a to
break, especially in the portion of bridge 1526a having notch 1530
therein.
[0371] In the illustrated embodiment, bridge 1526a may remain
attached to staple 1506b after it has been deployed. In other
embodiments, bridge 1526a may remain attached to staple 1506a. In
either event, notches 1530 can be designed such that bridges 1526
remain attached to a desired staple. In other embodiments, bridges
1526 may separate from both adjacent staples 1506 and fall into a
cavity (not illustrated) within staple cartridge 1500, and/or sled
78. In these embodiments, the separated bridges 1526 may be removed
from the stapler by removing the staple cartridge and/or removing
them through an access panel in either the staple cartridge and/or
the sled. In various embodiments, notches 1530 are not included in
every bridge 1526. In these embodiments, several staples may remain
attached to each other after being deployed while other staples may
be detached. In these embodiments, the stiffness of the row of
staples, when inserted into the tissue, can be controlled by
selectively alternating whether the staples are attached or
detached.
[0372] Referring to FIG. 146, bridges 1526 may include a
substantially flat top surface 1532 which is substantially flush
with top surfaces of crowns 1513. Bridges 1526 may further include
a substantially arcuate surface, or lobe, 1534 in the bottom of
bridges 1526 such that the thickest portions of bridges 1526 are
adjacent to staples 1506. As a result of this configuration, the
overall deflection of staple strip 1528 may be reduced making
staple strip 1528 easier to insert into the staple cartridge. In
other embodiments, referring to FIGS. 148-150, bridges 1536 may
have lobes 1534 which face upward, i.e., in the opposite direction
that they face on bridges 1526. In lieu of the configurations of
bridges 1526 and 1536 which have a flat surface 1532, the bridges
may comprise an arcuate configuration on both sides of the bridge.
In these embodiments, similar to the embodiment in FIGS. 142 and
143, the bridges may deflect to permit some relative movement
between adjacent staples 1506.
[0373] In various other embodiments, referring to FIGS. 151-157,
the staple strips may be loaded into the staple cartridge from the
bottom of the staple cartridge. For example, referring to FIGS.
155-157, staple cartridge 1550 includes cavities 1552 and 1554
which are sized and configured for receiving staple strips 1540 and
1542, respectively. In use, staple strips 1540 and 1542 are aligned
with openings 1555 and 1557 in bottom surface 1551 and are inserted
into cavities 1552 and 1554, respectively. In various embodiments,
staple strips 1540 and 1542 may be configured such that they are
press fit into cavities 1552 and 1554. In these embodiments,
similar to the above, deformable members 1512 could engage the
sidewalls of the cavities to retain staple strips 1540 and 1542 in
staple cartridge 1550. In various embodiments, crowns 1513 and/or
bridges 1538 of staple strips 1540 and 1542 can be dimensioned such
that they engage the sidewalls of cavities 1552 and 1554 in a
friction-fit manner. In other embodiments, staple cartridge 1550
and staple strips 1540 and 1542 may include co-operating detent
features which retain the staple strips in the staple cartridge.
Once inserted into the cavities, staples 1541 of staple strips 1540
and 1542 can be positioned such that a portion of their deformable
members 1512 extend through openings 1559 and 1561 in top surface
1553. Deformable members 1512 of staples 1541, as illustrated in
FIG. 151, can extend substantially perpendicularly from crowns
1513.
[0374] Similar to the above, referring to FIGS. 155 and 156, staple
strips 1540 and 1542 can be advanced upward through cavities 1552
and 1554 toward an anvil positioned opposite top surface 1553 from
a first position illustrated in FIG. 155 to a second position
illustrated in FIG. 156. When staple strips 1540 and 1542 are
advanced into the position illustrated in FIG. 153, bridges 1538
may be pressed against shears 1560 of staple cartridge 1550.
Thereafter, the staple strips may be pushed further upward causing
shears 1560 to break bridges 1538 away from one or more of staples
1541, as described above. Referring to FIG. 154, shears 1560 in
cavity 1552 include projections 1562 which extend therefrom and are
configured to break bridges 1538 away from crowns 1531 at locations
1564 (FIG. 151).
[0375] In any of the embodiments described herein, the material
overmolded onto the staples to form crowns 1513 and bridges 1526,
and/or bridges 1508, may be comprised of a dissolvable,
bioabsorbable or biofragmentable material. Further, similar to the
above, in various embodiments, the bioabsorbable material may
include at least one therapeutic drug mixed therein or coated
thereon, for example. Similar to the above, in various embodiments,
drivers may be connected to, and/or integrally molded with, the
crowns of the staples.
[0376] In alternative embodiments, the staples may be connected in
"puck" configurations in lieu of strips, for example. In various
embodiments, referring to FIG. 158, staple pucks 1571 and 1572
include staples 1506 which are interconnected by bridges 1574 and
1575. Staple pucks 1571 have five staples 1506 which are
interconnected by two bridges 1574 and two bridges 1575. As
illustrated in FIG. 158, bridges 1575 connect adjacent staples 1506
such that the tops of their crowns 1513 are substantially flush
with each other, however, bridges 1574 connect adjacent staples
1506 such that the top of their crowns 1513 are vertically offset
from each other. Similarly, staple pucks 1572 include four staples
1506 which are interconnected by two bridges 1574 and two bridges
1575.
[0377] Referring to FIGS. 159 and 159A, staple cartridge 1576
includes cavities 1577 which are sized and configured for receiving
staple pucks 1571, and cavities 1578 which are sized and configured
for receiving staple pucks 1572. Referring to FIG. 160, staple
cartridge 1576 further includes drivers 1579 and 1580 which are
sized and configured for supporting staple pucks 1571 and 1572,
respectively, thereon. More specifically, referring to FIGS.
161-163, drivers 1579 and 1580 can include shears 1581 upon which
staples pucks 1571 and 1572 are supported. After being inserted
into cavities 1577 and 1578, referring to FIG. 163, bridges 1574
and 1575 are positioned over shears 1581. In use, as described
above, drivers 1579 and 1580 are lifted toward deck 1582 of staple
cartridge 1576 by a cam sled. However, referring to FIG. 163, once
drivers 1579 and 1580 contact bridges 1574 and 1575, and the upward
movement of staple pucks 1571 and 1572 is prohibited by staple
cartridge 1576, further upward movement of drivers 1579 and 1580
causes shears 1581 to break bridges 1574 and 1575, thereby
separating staples 1306. Once bridges 1574 and 1575 have been
broken, support surfaces 1582 of drivers 1579 and 1580 are
configured to push staples 1306 upwardly toward an anvil, as
described above. Referring to FIGS. 164 and 164A, an alternative
staple cartridge 1583 is illustrated having recesses sized and
configured for receiving alternate configurations of the staple
pucks.
[0378] In at least one alternative embodiment of the present
invention, referring to FIGS. 165 and 166, staple pucks 1584 and
1585 can be configured such that bridges 1586 interconnecting
staples 1587, for example, include shears 1588 extending therefrom.
In the present embodiment, referring to FIG. 167, shears 1588 can
be configured to dissect deck 1589 of staple cartridge 1590. More
particularly, as staple pucks 1585 are raised by cam sled 1591, for
example, shears 1588 can break through deck 1589 such that pucks
1585 can be raised above deck 1589 when deployed. As a result,
staples 1587 can be completely deployed from staple cartridge 1590
before staple cartridge 1590 is removed from the surgical site. In
alternative embodiments, although not illustrated, the staple
cartridge can also include shears which detach staples 1587 from
bridges 1586, and/or shears 1588, after shears 1588 have dissected
staple cartridge deck 1589. Similar to the above, bridges 1589 can
include beveled surfaces 1592 which are configured to co-operate
with cam sled 1591.
[0379] Referring to FIG. 168, staples 1465 can each include a first
deformable leg 1466, a second deformable leg 1467, and a base 1468
connecting deformable legs 1466 and 1467. Unlike previous staples
which have a base that is substantially co-planar with its legs,
base 1468 can extend in at least one direction that is transverse
to a plane defined by legs 1466 and 1467. More particularly, base
1468 can include first portion 1469 and second portion 1470 which
extend laterally from legs 1466 and 1467 and form an angle
therebetween. In the present embodiment, referring to FIG. 169,
first portion 1469 forms an approximately 90 degree angle with
respect to second portion 1470. However, the present invention is
not limited to 90 degree angles; rather, any suitable angle may be
used. More particularly, the angle between first portion 1469 and
second portion 1470 may, in some embodiments, be greater than 90
degrees and may, in other embodiments, be less than 90 degrees.
Furthermore, in other embodiments, base 1468 may include several
substantially linear segments and/or curved sections.
[0380] Staple 1465 can further include crown 1471 overmolded onto
base 1468. More particularly, owing to the configuration of base
1468 as described above, crown 1471 can also extend transversely
with respect to the plane defined between legs 1466 and 1467.
Referring to FIGS. 168 and 169, crown 1471 can include
tissue-contacting surface 1472 which is sized and configured for
supporting tissue thereon. Tissue-contacting surface 1472, owing to
the configuration of crown 1471, can be larger than the tissue
contacting surfaces of previous staples. Accordingly, the larger
contact surface can reduce the localized pressure acting on the
tissue captured within the staple. As known in the art, reducing
this localized pressure can reduce the possibility of tissue
necrosis without reducing the compressive force acting on the
tissue. Stated another way, the pressure acting on the tissue is a
function of the force acting on the tissue divided by the area in
which it acts. Increasing the area can reduce the localized
pressure while not reducing the clamping force applied by the
staple.
[0381] Further, owing to the configurations of base 1468 and crown
1471, the larger surface area of crown 1471 can improve the
stability of crown 1471, and the surrounding tissue, after the
staple has been deployed into the tissue. More particularly, after
previous staples are deployed, the relatively-narrow crowns of
these previous staples may not prevent the staples from rocking
with respect to the tissue or straining the tissue surrounding the
staple. Staples 1465, owing to the configuration of crown 1471, can
reduce, and possibly eliminate, these previous problems. More
specifically, owing to larger contact surface 1472, crown 1471 is
more stable, i.e., it is less likely to rotate with respect to the
tissue. Furthermore, the crowns of previous staples, owing to their
narrower configurations, may cut through the underlying tissue.
Staple 1465, owing to the larger configuration of crown 1471, may
reduce, or even eliminate, this possibility. In an alternative
embodiment, referring to FIG. 173, staple assembly 1479 can include
several of the "J" deformable members of staple 1400 (FIGS. 122 and
123).
[0382] To further improve the stability of staples 1465, two
adjacent staples 1465, for example, may be connected together by
bridge 1473. More specifically, referring to FIGS. 168 and 169, the
base 1468, and crown 1471, of the first staple may be laterally
disposed in one direction and the base 1468, and crown 1471, of the
second staple may be laterally disposed in the opposite direction.
These oppositely disposed features may improve the stability of the
staples by providing stabilizing surfaces on opposite sides of the
assembly. The two staples, referring to FIG. 172, may be deployed
from staple cartridge 1475 by cam sled 1474 at the same time. To
facilitate the deployment of the staples, staple cartridge 1475 may
include, similar to the above, slots 1476 sized and configured for
receiving keys 1477 extending from crowns 1471 of staples 1465.
More particularly, keys 1477 and slots 1476 can be configured to
limit the movement of staples 1465 with respect to staple cartridge
1475 to a substantially linear upward motion. In addition, similar
to the above, each bridge 1473 can include an integral driver 1478
which is configured to co-operate with cam sled 1474. In at least
one embodiment, crowns 1471, bridge 1473 and driver 1478 can be
comprised of a dissolvable or bioabsorbable material.
[0383] As known in the art, staples can be deployed into tissue
such that staples are aligned in a row. However, in the past,
staples configured in diagonal patterns have been disincentivized
owing to potential leak paths between the staples. The staples of
the present invention can overcome these previous problems.
Referring to FIGS. 174 and 175, staples 1480 each include two
deformable members 1481 extending from a crown 1482 and bridge 1483
connecting crowns 1482. When staples 1480 are inserted into tissue,
as described above, the tissue is compressed between crowns 1482
and deformable members 1481. However, in the embodiments in which
bridges 1483 are inserted into the body along with staples 1480,
bridges 1483 can also compress the tissue and close off any leak
paths therebetween. Referring to FIG. 175, staple cartridge 1484
includes recesses 1485 therein which are configured to receive
staples 1480 in a diagonal pattern such that staples 1480 can be
deployed into the tissue as described above.
[0384] In an alternative embodiment, a portion of the staple
cartridge can be broken away therefrom during the deployment of the
staple. This portion can be configured to be positioned
intermediate the base of the staple and the tissue captured within
the staple. More particularly, referring to FIGS. 176-178, a
surgical stapling system can include staple cartridge 1486 having
staple pads 1487 integrally molded into deck 1488 of staple
cartridge 1486. Staple cartridge 1486 can include score marks 1489
and slots 1490 surrounding staple pads 1487 such that staple pads
1487 can be easily separated from deck 1488. More particularly,
referring to FIG. 178, the stapling system can include drivers 1491
having shears 1492 which are configured to press against staple
pads 1487 when base 1493 is brought in close proximity to staple
saddle 1494 and "punch-out" staple pads 1487. In at least one
embodiment, after they have been punched out, the staple pads can
be positioned intermediate base 1493 and the tissue captured within
the staple. As a result, staple pads 1487 can be configured to act
as the crown of the staple or, in alternative embodiments, act as a
buttressing member intermediate the staple and the tissue. In at
least one embodiment, similar to the above, staple pads 1487 can be
comprised of a bioabsorbable material.
[0385] The staples described above can be used in various surgical
techniques. For example, one surgical technique can include a
method of transecting tissue or a hollow organ by positioning a
surgical stapling system adjacent tissues to be transected, the
surgical stapling system including at least one of the staples
described above, actuating the surgical stapling system to compress
the tissues together, actuating the surgical stapling system to
fasten and divide the tissue with said staple, and removing the
surgical stapling system from the operative site. In at least one
embodiment, the surgical technique can include the anastomosis of
two hollow organs and/or the fixation of at least two tissues.
* * * * *