U.S. patent application number 12/621667 was filed with the patent office on 2011-05-19 for circular stapler introducer with multi-lumen sheath.
This patent application is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Daniel J. Abbott, Chester O. Baxter, III, Paul T. Franer, John V. Hunt, John B. Schulte, Danius P. Silkaitis, Jeffrey P. Wiley.
Application Number | 20110114697 12/621667 |
Document ID | / |
Family ID | 65728969 |
Filed Date | 2011-05-19 |
United States Patent
Application |
20110114697 |
Kind Code |
A1 |
Baxter, III; Chester O. ; et
al. |
May 19, 2011 |
CIRCULAR STAPLER INTRODUCER WITH MULTI-LUMEN SHEATH
Abstract
Introducers for introducing a surgical circular stapler into a
patient. Various embodiments comprise a sheath that defines a first
lumen that has a closed end and an open end. The first lumen may be
sized to receive at least a distal end portion of the stapling head
of the stapler within the closed end. The sheath may have a
weakened area therein such that upon an application of a release
motion thereto, the weakened area ruptures to permit the hollow
sheath to be removed from the stapler.
Inventors: |
Baxter, III; Chester O.;
(Loveland, OH) ; Hunt; John V.; (Cincinnati,
OH) ; Silkaitis; Danius P.; (Mason, OH) ;
Wiley; Jeffrey P.; (Milford, OH) ; Franer; Paul
T.; (Cincinnati, OH) ; Schulte; John B.; (West
Chester, OH) ; Abbott; Daniel J.; (Loveland,
OH) |
Assignee: |
Ethicon Endo-Surgery, Inc.
Cincinnati
OH
|
Family ID: |
65728969 |
Appl. No.: |
12/621667 |
Filed: |
November 19, 2009 |
Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 46/13 20160201;
A61B 2090/08021 20160201; A61B 2017/3425 20130101; A61B 17/1114
20130101; A61B 2090/037 20160201; A61B 17/1155 20130101; A61B
1/00087 20130101; A61B 46/17 20160201; A61B 2017/00336 20130101;
A61B 17/115 20130101; A61B 46/10 20160201 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. An introducer for introducing a surgical circular stapler having
a handle portion, an elongated shaft protruding from the handle
portion, and stapling head coupled to the elongated shaft into a
patient, said introducer comprising a sheath defining a first lumen
having a closed end and an open end, said first lumen sized to at
least receive at least a distal end portion of the stapling head
within said closed end, said hollow sheath having a weakened area
therein such that upon an application of a release motion thereto,
said weakened area ruptures to permit said hollow sheath to be
removed from the surgical circular stapler.
2. The introducer of claim 1 wherein said weakened area comprises a
perforated seam substantially extending from said closed end to
said open end.
3. The introducer of claim 1 wherein when said sheath is installed
over the stapling head, the sheath extends over the elongate shaft
to be accessible from the handle portion of the surgical circular
stapler.
4. The introducer of claim 1 further comprising a release member
attached to said sheath and having a length such that when said
sheath is installed over the stapling head of the surgical circular
stapler, the release member is accessible from the handle portion
of the surgical circular stapler such that when an actuation motion
is applied to said release member, said release member causes said
weakened area to rupture to facilitate removal of the sheath from
the surgical circular stapler by said release member.
5. The introducer of claim 1 wherein said sheath is fabricated from
a piece of material that has two ends that are overlapped and
stitched together to form said weakened area.
6. The introducer of claim 5 wherein said two ends are stitched
together by a suture that extends beyond the open end of the first
lumen such that when the sheath is installed on the surgical
circular stapler, a free proximal end of the suture is accessible
from the handle portion of the surgical circular stapler.
7. The introducer of claim 1 wherein said sheath is fabricated from
two pieces of material that that are stitched together.
8. The introducer of claim 7 wherein said two pieces are stitched
together by at least one suture wherein said at least one suture
that extends beyond the open end of the first lumen such that when
the sheath is installed on the surgical circular stapler, a free
proximal end of the suture is accessible from the handle portion of
the surgical circular stapler.
9. The introducer of claim 8 wherein said two pieces of material
comprise two pieces of latex material.
10. An introducer for introducing a surgical circular stapler
having a handle portion, an elongated shaft protruding from the
handle portion, and stapling head coupled to the shaft into a
patient, said introducer comprising: a flexible sheath defining a
first lumen extending from an open proximal end to a releaseable
distal portion sized to receive the stapling head and at least a
portion of the elongated shaft of the circular stapler therein; a
second lumen in said flexible sheath independent from said first
lumen, said second lumen extending from said proximal open end to
said releaseable distal portion; a release member movably supported
within said second lumen and interfacing with said releaseable
distal portion, said release member protruding proximally beyond
said open proximal end of said sheath such that upon an application
of a release motion to said release member, said releaseable distal
portion exposes at least a portion of the stapling head.
11. The introducer of claim 10 wherein said release member
comprises a suture.
12. The introducer of claim 10 further comprising a weakened area
in said flexible sheath.
13. The introducer of claim 12 wherein said weakened area comprises
a perforated seam extending from said releaseable distal portion to
said open proximal end.
14. The introducer of claim 10 wherein said second lumen extends
helically around said first lumen.
15. An introducer for introducing a surgical circular stapler
having a handle portion, an elongated shaft protruding from the
handle portion, and stapling head coupled to the shaft into a
patient, said introducer comprising: means for releasably
encapsulating the stapling head and at least a portion of the
elongated shaft of the circular stapler during insertion thereof
into a patient; release means coupled to said means for releasably
encapsulating, said release means protruding from said means for
releasably encapsulating to enable a release motion to be applied
thereto when the stapling head and elongated shaft have been
inserted into the patient such that, upon application of said
release motion to said release means, said means for releasably
encapsulating exposes at least a distal face of the stapling
head.
16. The introducer of claim 15 wherein upon further application of
the release motion to said release means causes said means for
releasably encapsulating to be withdrawn from the patient.
17. The introducer of claim 16 wherein said means for releasably
encapsulating further has a weakened area such that upon
application of said release motion to said release means causes
said weakened area to rupture.
18. The introducer of claim 15 wherein said release member is
movably supported within a lumen formed in said means for
releasably encapsulating.
19. The introducer of claim 17 wherein said weakened area comprises
a perforated seam in said means for releasably encapsulating.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to surgical
staplers, and more particularly, to devices and methods for
introducing a circular stapling device into the colon of a
patient.
BACKGROUND
[0002] In certain types of surgical procedures, the use of surgical
staples has become the preferred method of joining tissue and, as
such, specially configured surgical staplers have been developed
for these applications. For example, intra-luminal or circular
staplers have been developed for use in surgical procedures
involving the lower colon wherein sections of the lower colon are
joined together after a diseased portion has been excised. Circular
staplers useful for performing such procedures are disclosed, for
example, in U.S. Pat. Nos. 5,104,025; 5,205,459; 5,285,945; and
5,309,927 which are each herein incorporated by reference in their
respective entireties.
[0003] In general, a conventional circular stapler typically
consists of an elongated shaft that has a proximal actuating
mechanism and a distal stapling mechanism mounted to the elongated
shaft. The distal stapling mechanism commonly consists of a fixed
stapling cartridge that contains a plurality of staples configured
in a concentric circular array. A round cutting knife is
concentrically mounted in the cartridge interior to the staples for
axial travel therein. Extending axially from the center of the
cartridge is a movable trocar shaft that is adapted to have a
staple anvil removably coupled thereto. The anvil is configured to
form the ends of the staples as they are driven into it. The
distance between a distal face of the staple cartridge and the
staple anvil is commonly controlled by an adjustment mechanism that
is mounted to the proximal end of the stapler shaft for controlling
the axial movement of the trocar. Tissue that is clamped between
the staple cartridge and the staple anvil is simultaneously stapled
and cut when the actuating mechanism is activated by the
surgeon.
[0004] When performing a lower colon procedure using a circular
stapler, the intestine is typically stapled using a conventional
surgical stapler with double rows of staples being emplaced on
either side of the diseased portion of intestine to be removed. The
target section is simultaneously cut as the adjoining end is
stapled. After removing the diseased portion, 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. 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 clamping 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, the concentric circular knife 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 procedure is complete.
[0005] During such lower colon procedures, it may be difficult to
insert the surgical stapler thru the anus and past the transverse
folds in the rectal wall that protrude into the colon which are
commonly referred to as the "Valves of Houston" and subsequently
manipulated to the desired area. This problem is exacerbated when
the stapler must be inserted without the anvil in position. In
particular, the forward or distal end of most circular staplers
comprises a relatively abrupt circular-shaped member designed to
support a circular staple cartridge. Such blunt/abrupt shape makes
it difficult to advance the forward end of the stapler past the
Valves of Houston and other tissue.
[0006] Thus, the need exists for devices and methods for easily
inserting a surgical stapler through a patient's anus into the
lower colon or into other areas within the patient.
[0007] The foregoing discussion is intended only to illustrate some
of the shortcomings present in the field of the invention at the
time, and should not be taken as a disavowal of claim scope.
BRIEF SUMMARY
[0008] In connection with various embodiments of the present
invention, there is provided an introducer for introducing a
surgical circular stapler that has a handle portion, an elongated
shaft that protrudes from the handle portion, and a stapling head
that is coupled to the elongated shaft into a patient. In
connection with various embodiments, the introducer comprises a
sheath that defines a first lumen that has a closed end and an open
end. The first lumen may be sized to at least receive at least a
distal end portion of the stapling head within the closed end. The
hollow sheath may have a weakened area therein such that upon an
application of a release motion thereto, the weakened area ruptures
to permit the hollow sheath to be removed from the surgical
circular stapler.
[0009] In connection with yet another general aspect of the present
invention, there is provided an introducer for introducing a
surgical circular stapler that has a handle portion, an elongated
shaft that protrudes from the handle portion, and a stapling head
that is coupled to the shaft into a patient. In connection with
various embodiments, the introducer comprises a flexible sheath
that defines a first lumen that extends from an open proximal end
to a releaseable distal portion that is sized to receive the
stapling head and at least a portion of the elongated shaft of the
circular stapler therein. A second lumen may be provided in the
flexible sheath that is independent from the first lumen. The
second lumen may extend from the proximal open end to the
releaseable distal portion. A release member may be movably
supported within the second lumen and may be oriented to interface
with the releaseable distal portion. The release member may
protrude proximally beyond the open proximal end of the sheath such
that upon an application of a release motion to the release member,
the releaseable distal portion exposes at least a portion of the
stapling head.
BRIEF DESCRIPTION OF THE FIGURES
[0010] 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.
[0011] FIG. 1 is a perspective view of a surgical circular stapling
instrument;
[0012] FIG. 2 is another perspective view of the circular surgical
stapling instrument of FIG. 1 prior to the installation of an
introducer embodiment of the present invention thereon;
[0013] FIG. 3 is a side elevational view of an introducer
embodiment of the present invention;
[0014] FIG. 4 is a top view of the introducer of FIG. 2;
[0015] FIG. 5 is a top view of the introducer of FIGS. 3 and 4;
[0016] FIG. 6 is another top view of the introducer of FIGS. 2-5
with the cover panel removed from the handle assembly;
[0017] FIG. 7 is a partial perspective view of an introducer
embodiment of the present invention installed on a circular
stapling instrument;
[0018] FIG. 8 is a partial side elevation view of the introducer
and circular stapler of FIG. 7;
[0019] FIG. 9 is a partial top view of the introducer and circular
stapler of FIGS. 7 and 8;
[0020] FIG. 10 is an elevational view of a cap assembly embodiment
of the present invention;
[0021] FIG. 11 is another elevational view of the cap assembly of
FIG. 10 with the release latch removed therefrom;
[0022] FIG. 12 is a perspective view of the cap assembly of FIGS.
8-11 with the release latch removed therefrom and the cap
disengaged from the barrel assembly;
[0023] FIG. 13 is a cross-sectional view of a cap assembly
embodiment of the present invention with the cap engaged with the
barrel assembly;
[0024] FIG. 14 is a partial side elevational view of a portion of a
circular stapler and a cap of an introducer embodiment of the
present invention;
[0025] FIG. 14A is another partial side elevational view of the
circular stapler and cap with the cap sliding off the perimeter of
the stapling head portion of the circular stapler;
[0026] FIG. 15 is a top view of a cap assembly embodiment of the
present invention with the cap in an open position;
[0027] FIG. 16 is another top view of the cap assembly embodiment
of FIG. 15 with a line illustrating a low profile cap
embodiment;
[0028] FIG. 18 is a top perspective view of a cap assembly
embodiment of the present invention;
[0029] FIG. 19 is a bottom view of the cap assembly of FIG. 18;
[0030] FIG. 20 is a top perspective view of another cap assembly
embodiment of the present invention;
[0031] FIG. 21 is a bottom view of the cap assembly of FIG. 20;
[0032] FIG. 22 is a perspective view of a circular surgical
stapling instrument prior to the installation of another introducer
embodiment of the present invention thereon;
[0033] FIG. 23 is a perspective view of a circular surgical
stapling instrument prior to the installation of another introducer
embodiment of the present invention thereon;
[0034] FIG. 24 is an exploded elevational view illustrating another
introducer embodiment of the present invention prior to
installation on a portion of a stapling head of a circular
stapler;
[0035] FIG. 25 is a cross-sectional view of the introducer of FIG.
24 installed on a stapling head of a circular stapler;
[0036] FIG. 26 is a distal end view of an introducer embodiment of
the present invention;
[0037] FIG. 27 is a distal end view of another introducer
embodiment of the present invention;
[0038] FIG. 28 is a distal end view of another introducer
embodiment of the present invention;
[0039] FIG. 29 is a cross-sectional view of another introducer
embodiment of the present invention installed on a stapling head of
a circular stapler;
[0040] FIG. 30 is a side elevational view of another introducer
embodiment of the present invention in a closed position;
[0041] FIG. 31 is another side elevational view of the introducer
of FIG. 31;
[0042] FIG. 32 is another side elevational view of the introducer
of FIGS. 30 and 31 in a closed position;
[0043] FIG. 33 is a distal end view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0044] FIG. 34 is a side elevational view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler with the trocar portion of the circular
stapler in an extended position;
[0045] FIG. 35 is a distal end view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0046] FIG. 36 is a side elevational view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler with the trocar portion of the circular
stapler in an extended position;
[0047] FIG. 37 is another side elevational view of the introducer
and stapling head of FIG. 36 with the trocar portion of the
circular stapler in a withdrawn position;
[0048] FIG. 38 is a side elevational view of another introducer
embodiment of the present invention attached to a stapling head of
a circular stapler;
[0049] FIG. 39 is a partial perspective view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0050] FIG. 40 is another partial perspective view of the
introducer embodiment of FIG. 39 being unwound from the stapling
head of the circular stapler;
[0051] FIG. 41 is a partial perspective view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0052] FIG. 42 is a partial perspective view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0053] FIG. 43 is another partial perspective view of the
introducer of FIG. 42 being withdrawn proximally from the stapling
head of the circular stapler;
[0054] FIG. 44 is a partial perspective view of another introducer
embodiment of the present invention attached to the stapling head
of a circular stapler;
[0055] FIG. 45 is another partial perspective view of the
introducer embodiment of FIG. 44 wherein a release motion has been
initially applied thereto; and
[0056] FIG. 46 is another partial perspective view of the
introducer of FIGS. 44 and 45 illustrating further application of
the release motion thereto.
DETAILED DESCRIPTION
[0057] The Applicant of the present application also owns the U.S.
patent applications identified below which were filed on even date
herewith and which are each herein incorporated by reference in
their respective entirety:
[0058] U.S. patent application Ser. No. ______, entitled "DEVICES
AND METHODS FOR INTRODUCING A SURGICAL CIRCULAR STAPLING INSTRUMENT
INTO A PATIENT", Attorney Docket No. END6320USNP/090234;
[0059] U.S. patent application Ser. No. ______, entitled "CIRCULAR
STAPLER INTRODUCER WITH RIGID CAP ASSEMBLY CONFIGURED FOR EASY
REMOVAL", Attorney Docket No. END6615USNP/090245;
[0060] U.S. patent application Ser. No. ______, entitled "CIRCULAR
STAPLER INTRODUCER WITH RADIALLY-OPENABLE DISTAL END PORTION",
Attorney Docket No. END6616USNP/090246; and
[0061] U.S. patent application Ser. No. ______, entitled "CIRCULAR
STAPLER INTRODUCER WITH RIGID DISTAL END PORTION", Attorney Docket
No. END6617USNP/090247.
[0062] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those of ordinary
skill in the art will understand that the devices and methods
specifically described herein and illustrated in the accompanying
drawings are non-limiting exemplary embodiments and that the scope
of the various embodiments of the present invention is defined
solely by the claims. The features illustrated or described in
connection with one exemplary embodiment may be combined with the
features of other embodiments. Such modifications and variations
are intended to be included within the scope of the present
invention.
[0063] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical", "horizontal", "up", and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0064] FIG. 1 illustrates a conventional circular stapler 10. The
construction and operation of such circular staplers are generally
known in the art. Thus, the specific components and features of
such circular stapler will not be discussed in detail herein beyond
what may be necessary to understand the construction and operation
of the various embodiments of the present invention. As the present
Detailed Description proceeds, those of ordinary skill in the art
will understand that the various embodiments of the present
invention may be effectively employed with a variety of different
circular stapler configurations without departing from the spirit
and scope of the present invention. Accordingly, the scope of
protection afforded to the various embodiments of the present
invention should not otherwise be limited to use with the exemplary
circular stapler depicted herein.
[0065] As can be seen in FIG. 1, a conventional circular stapler 10
generally includes a handle portion 12 that has an elongated shaft
14 protruding therefrom. A stapling head 16 is coupled to the
distal end 15 of the elongated shaft 14 and is configured to
operably support a staple cartridge 17 and movable knife assembly
(not shown) therein. The circular stapler 10 further includes an
anvil 20 that has an anvil body 22. The anvil 20 has an anvil shaft
24 that is configured to be removably attached to a trocar (not
shown) that is movably supported within the elongated shaft 14 of
the circular stapler 10. Movement of the trocar is achieved by
rotating an adjustment knob 18 that is located at the proximal end
of the handle portion 12. An indicator panel 19 may be provided on
the handle portion 12 to provide the user with an indication of the
position of the body portion 22 of the anvil 20 relative to the
staple cartridge 17. Thus, when the anvil shaft 24 is attached to
the movable trocar, the position of the anvil body 22 relative to
the staple cartridge 17 in the stapling head assembly 16 may be
adjusted by rotating the adjustment knob 18. The stapling head 16
further supports a staple driver assembly (not shown), the
operation of which is controlled by a trigger assembly 26 on the
handle portion 12. Further details concerning the operation and
assembly of the exemplary circular stapler 10, for example, may be
gleaned from reference to U.S. patent application Ser. No.
12/408,905, filed Mar. 23, 2009, entitled "Circular Surgical
Stapling Instrument With Anvil Locking System" to John P. Measamer,
the disclosure of which is herein incorporated by reference in its
entirety.
[0066] FIGS. 2-6 illustrate a circular stapler introducer 100 of
the present invention that may be used in connection with a
circular stapler 10. In various embodiments, the introducer 100
comprises an elongated hollow flexible sheath 110 that may be
fabricated from, for example, a plastic material such as
polyurethane blends, polyesters, polyethylene or polypropylene
having a thickness of 0.004-0.015 inches and forms a first lumen 29
sized to be readily inserted over the elongated shaft 14 of a
circular stapler 10. The sheath 110 has a distal end 114 and an
open proximal end 112 as well as a top portion generally designated
as 111 and a bottom portion 113. See FIG. 3. A handle assembly 130
may be attached to the open proximal end 112 by, for example,
adhesive or ultrasonic welding, radio frequency (RF) welding or
heat staking. The distal end 114 of the sheath 110 may be attached
to a rigid cap assembly 130 by adhesive or by ultrasonic welding,
radio frequency (RF) welding or heat staking. In various
embodiments, a "weakened region" in the form of, for example, a
perforated seam 116 may extend along the bottom portion 113 of the
sheath 110 from the open proximal end 112 to the distal end 114. In
addition, a second lumen 120 may be formed in the wall of the
sheath 110 and extend from the open proximal end 112 to the distal
end 114. In particular, the second lumen 120 may helically extend
from the top portion 111 of the proximal end 112 to the bottom
portion 113 at the distal end 114. The second lumen 120 may
accommodate a release member 122 that extends from the handle
assembly 130 to a latch member 140 that is movably supported in a
distal end portion of the second lumen 120. In various embodiments,
the release member 122 may comprise, for example, a suture. In
other embodiments, the release member 122 may comprise a relatively
thin flexible bar or similar member for transmitting a release
motion to the latch member 140 attached thereto. The second lumen
120 may be formed in the wall of the sheath 110 by, for example,
sewing, ultrasonic welding, radio frequency (RF) welding, heat
staking, etc. The release member 122 and the latch member 140 may
collectively form a release arrangement, generally designated as
121. See FIG. 10.
[0067] FIGS. 10-19, depict a rigid cap assembly 150 that may be
used in connection with various embodiments of the present
invention. The rigid cap assembly 150 may have a barrel member 152
that is attached to the distal end 114 of the sheath 110. The
barrel member 152 comprises a partial ring-like member that has two
opposed ends 154, 156. A rigid cap member 160 is "hingeably
attached" to the barrel member 152 by a tether 162. See FIG. 17. In
various embodiments, the rigid cap assembly 150 is manufactured as
a single injection molded piece that has significantly different
physical properties. In various embodiments, for example, the rigid
cap assembly 150 may be injection molded from polyurethane blends,
polyesters, polyethylene or polypropylene.
[0068] As will be discussed in further detail below, the cap member
160 is made rigid by increasing its cross-sectional area while the
tether 162 and barrel member 152 are preferably designed to allow
significant deflection in specific directions by reducing their
respective cross-sections. The cap member 160 has a relatively
blunt distal surface 164 that is substantially smooth to minimize
the force required to insert the introducer 100 and the portions of
the circular stapler 10 housed therein through the patient's
sphincter as well as to facilitate navigation of the device through
the Valves of Houston and other anatomy. The underside 166 of the
cap member 160 may have a series of reinforcing ribs 168 formed
therein to increase its cross-sectional area and make the cap
member 160 substantially rigid. See FIGS. 13 and 19.
[0069] In various embodiments, the underside 166 of the cap member
has a shape that substantially matches the shape of a portion of
the perimeter of the stapling head 16. More specifically and as can
be seen in FIG. 13, the underside 166, which is formed by
reinforcing ribs 168, is arcuate in shape which matches a portion
of the circular parametrical shape of the stapling head 16 of the
circular stapler 10. As can be further seen in FIG. 14, the cap
member 160 has sides 170, 172 each has a cutout wall portion 174
that corresponds with the arcuate underside 166. Such arcuate
underside 166 and cutout wall portions 174 enable the cap assembly
150 to pass proximally off the stapling head 16 when being
proximally withdrawn over the circular stapler 10 to thereby reduce
the radial distention of the bowel when the cap assembly 150 passes
by the stapling head 16 of the circular stapler 10. For example,
FIG. 16 provides an illustrative comparison between a cap assembly
150 with no arcuate underside 166 (represented by dotted line 180)
and the cap assembly 150 with an arcuate underside 166. As
illustrated, for one exemplary embodiment, the cap assembly without
the arcuate underside has a 0.22'' higher profile and would
therefore further distend the bowel as it is withdrawn proximally
over the stapling head 16.
[0070] In various embodiments, the tether 162 may be designed to be
longer than the distance required to connect the cap member 160 to
the barrel member 152 in the closed position (FIG. 10). That is,
the tether 162 may coil inside the cap assembly 150 when the rigid
cap portion 160 is retained in the closed position. Such
arrangement permits the cap member 160 to follow a substantially
curved path while passing over the corner of the stapling head 16
of the stapler 10 and to move independently from the barrel member
152 during removal. See FIGS. 14 and 14A. In one embodiment, the
tether 162 is diametrically opposite from the location wherein the
latch member 140 engages the opposed ends 154, 156 of the barrel
member 152. See FIGS. 18 and 19. In an alternative embodiment, the
tether 162 is located 90 degrees from the latch 140 member. See
FIGS. 20 and 21.
[0071] Various embodiments of the cap assembly 150 employ features
which work together to ensure that the cap member 160 does not open
during the insertion process while retaining the ability to be
easily opened and removed at the appropriate time. For example, as
can be seen in FIG. 13, various embodiments of the cap assembly 150
may include an inwardly-extending retainer flange 190 that is
formed on portions of the barrel member 152. The retainer flange
190 may be positioned to retainingly engage corresponding retention
ribs 167 formed on the lower rim of the cap member 160. As can be
seen in FIG. 13, a series of gussets 194 may be formed with the
retainer flange 190 to further stabilize and rigidify the retention
flange 190. Various cap member embodiments may include at least one
retention rib on the cap member 160 to retainingly secure the cap
member 160 in a closed position wherein the cap member 160 covers
the distal face 25 of the stapling head 16 (FIG. 10). In various
embodiments, a series of three ribs 200, 202, 204 may be formed on
the two portions of the cap member 160 that are between the tether
162 and the arcuate cut out portions 174. The two outer ribs 200,
202, 204 may be provided with chamfered lead-out portions 206. See
FIG. 12. Such chamfered lead out portions 206 interface with the
retention flange 190 on the barrel member 152 and may serve to
minimize the chances of the cap member 160 binding on the retention
flange 190 during the unlatching process without significantly
jeopardizing the ability of the rib 167 and retention flange 190
arrangement to carry loads during the insertion process.
[0072] As can be seen in FIGS. 11 and 12, the opposed ends 154, 156
of the barrel member 152 are spaced from each other to define a
latch region 210 for receiving the latch member 140 therein. The
latch member 140 may be formed from a plastic material and have a
body portion 141 that has a pair of distally protruding latch tabs
142, 144 formed thereon. See FIG. 11. The latch tabs 142, 144 are
sized to extend into latch cavities 157, 159 formed in the opposing
ends 154, 156 of the bar 152. See FIGS. 10 and 11. Thus, when the
latch tabs 142, 144 are received in the latch cavities 157, 159,
the barrel member 152 forms a radially-openable ring-like structure
sized to accommodate the stapling head 16 of the circular stapler
10 therein. In various embodiments, when the barrel member 152 is
latched in the closed position wherein the cap member 160 covers
the distal face 25 of the stapling head 16 of the circular stapler
10, the cap member 160 may sit directly on the distal face 25 of
the stapling head 16 of the circular stapler 10 without interfering
with any of the staple pockets in the staple cartridge 17 support
therein. Such arrangement permits the forces experienced by the cap
member 160 during the insertion process to be transmitted directly
to the stapling head 16 of the circular stapler 10 without the need
for any force balancing or intermediate components.
[0073] Also in various embodiments, the release member 140 may be
further formed with a release finger 145 that may serve to assist
with radially opening the barrel member 152 when the latch member
140 is pulled proximally out of engagement with the opposed ends
154, 156 of the barrel member 152. More specifically and with
reference to FIG. 11, the latch member 140 may be formed with a
release finger 145 that is centrally disposed between the latch
tabs 142, 144. The release finger 145 may be formed with cam
portions 147 that are designed to engage cam surfaces 161, 163
formed on the opposed ends 154, 156 of the barrel member 152 such
that, as the latch member 140 is pulled in the proximal direction
"P", the cam portions 147 engage the cam surfaces 161, 163 to urge
the opposed ends 154, 156 of the barrel member 152 radially apart
from each other (represented by arrows "R", in FIG. 12.). Thus the
latch member 140 is pulled in a direction (proximal direction "P")
that is substantially perpendicular to the direction of motion "R"
required to disengage the cap member 160 from the barrel member
152. When the latch member 140 is removed and the clinician
continues to apply an additional withdrawal motion to the
introducer 100, the opposed ends 154, 156 of the barrel member 152
are permitted to further radially separate and enable the cap
member 160 to disengage from the barrel member 152 and move to an
open position. In doing so, the cap member 160 may be permitted to
rotate to a lateral open position to facilitate proximal movement
of the cap assembly 150 over the stapling head 16 as the introducer
100 is withdrawn proximally from the patient. See FIG. 14.
[0074] As can be seen in FIGS. 7-9, the handle assembly 130 may be
designed to conform to the geometry of the handle portion 12 of the
circular stapler 10 when the stapling head 16 has been inserted
into the closed cap assembly 150 in a fully inserted position. For
example, when a lower rim portion of the rigid cap member 160 is in
contact with the distal face 25 of the stapling head 16, the
stapling head 16 may be considered to be in the "fully inserted"
position. More broadly, the circular stapler 10 may be considered
to be in a fully inserted position when the distal face 25 is in
contact with a portion of the rigid cap member 160.
[0075] In various embodiments, the handle assembly 130 may be
configured in such a way as to prevent improper installation of the
introducer 100 on the circular stapler 10. For example, the handle
assembly 130 may be "orientation-specific" such that it includes
features which mate with corresponding surfaces on the handle
portion 12 of the circular stapler 10 when the stapling head has
been inserted to the fully inserted position, while at the same
time interfering with other surfaces if the introducer 100 is
installed incorrectly. In addition, many circular staplers 10
include an indicator panel 19 that is located on the upper side of
the handle portion. See FIG. 1. Such indicator panel 19 may, for
example, provide the clinician with an indication of the position
of the anvil 20 relative to the stapling head 16. In various
embodiments, the handle portion 130 of the introducer 100 may be
designed to cover or obscure the indicator panel 19 of the circular
stapler 10. Such arrangement serves to ensure that the user is
aware that the introducer 100 is installed on the stapler 10 and
thereby prevents the user from attempting to fire the circular
stapler 10 without first removing the introducer 100. For example,
the handle assembly 130 includes a forward portion 220 that covers
or otherwise obscures the indication panel 19 of the circular
stapler 10.
[0076] In various embodiments, the proximal end 124 of the release
member 122 or suture is attached to a release slider 230. As can be
seen in FIG. 6, the suture 122 may be attached to a forward tab
portion 232 of the release slider 230 that is sized to be slidably
received within a cavity 222 formed in the forward portion of the
handle assembly 130. The forward tab portion 232 is slidably
retained within the cavity 222 by a cover 240 that may be attached
to the handle assembly 130 by a series of retainer tabs 242 that
are oriented to snappingly engage corresponding snap cavities 224
in the handle assembly 130. See FIGS. 5 and 6
[0077] Various embodiments of the present invention may also
incorporate a means for multiplying a proximal travel distance of
the suture 122 relative to a distance that the release slider 230
is moved on the handle portion 12 of the circular stapler 10. For
example, various embodiments may employ a pulley-type arrangement
250 to multiply the travel distance of the suture 122 relative the
distance that the release slider 230 is moved in the proximal
direction "P". Such arrangement may allow for greater travel to
ensure the release of the cap member 160 without the need to
lengthen the handle portion 130. For example, as shown in FIG. 6,
the proximal end portion 124 of the suture 122 extends through a
slot 252 in the handle assembly 130 and loops through a hole 234 in
the forward slider tab 232. The end 124 of the suture 122 may then
be attached to a fixed post 254 on the handle assembly 130
[0078] To facilitate easy removal of the introducer 100, the
release slider 230 may be provided with a relatively "low profile"
to enable the clinician to maintain a grip on the handle portion 12
of the stapler 10 without significantly changing their grip or
method from what they would do with the circular stapler 10 alone.
See FIGS. 7-9. Also, in various embodiments, the release slider 230
may be provided with a hole 236 and/or two lateral wing portions
238. Thus, this arrangement allows the clinician to apply force to
the release slider 230 in the proximal direction "P" using either a
single finger in the hole 236 or two fingers on the lateral wing
portions 238.
[0079] As can also be seen in FIG. 6, the forward portion 220 of
the handle assembly 130 may also be provided with stops 229 that
are arranged to engage forward tabs 239 formed on the forward tab
portion 232 of the release slider 230. Thus, in use, once the
circular stapler 10 has been inserted into the introducer 100 to
the fully inserted position and the stapler 10 and introducer 100
have been inserted to a desired position within the patient, the
clinician may then pull the release slider 230 in a proximal
direction to apply an amount of tension or release motion to the
suture 122 to draw the latch member 140 to an unlatched position.
Further pulling on the release slider 230 will result in the
forward tabs 239 contacting the stops 229. Once the forward tabs
239 contact the stops 229, further pulling of the release slider
230 in the proximal direction causes the entire introducer 100 to
move in the proximal direction. Such arrangement enables the entire
introducer 100 to be decoupled from the stapler 10 and withdrawn
from the patient by moving the release slider 230 in the proximal
direction on the handle portion 12 of the circular stapler 10. The
removal of the introducer 100 from the stapler 10 may be
accomplished without removing the stapler 10 from the patient.
[0080] To use the introducer 100, the clinician simply inserts the
circular stapler 10 into the sheath 110 to the fully inserted
position and aligns the introducer 100 relative to the handle
portion 12 such that the forward portion 220 of the handle portion
130 covers the indication panel 19 of the circular stapler 10. To
aid in the insertion process, the stapling head 16 and shaft
portion 14 of the circular stapler 10, as well as the cap assembly
150 and sheath 110 of the introducer 100, may be lubricated prior
to commencing the insertion process. When the circular stapler 10
has been properly inserted into the introducer 100, the rim of the
cap 160 which is engaged with the flange 190 of the barrel assembly
152 and thereby retained in the closed position as illustrated in
FIGS. 3-6, 10 and 13, will rest on the stapling head 16 of the
stapler 10. The user then inserts the stapler 10 and introducer 100
into a desired position in the colon. Once the stapler 10 is in a
desired position, the clinician may pull on the release slider 230
in the proximal direction "P" which causes the suture 122 to pull
the retainer latch 140 out of engagement with the ends 154, 156 of
the barrel assembly 152. As the retainer latch 140 is drawn
proximally, the cam surfaces 147 on the release finger 145
cooperate with the cam surfaces 161, 163 formed on the opposed ends
154, 156 of the barrel assembly 152 such that, as the release
member 140 is pulled in the proximal direction "P", the ends 154,
156 are urged radially apart. Further pulling of the release slider
230 results in the forward tabs 232 contacting the stops 229 such
that further pulling of the slider 230 results in the entire
introducer 100 being pulled proximally over the circular stapler
10. Such pulling of the introducer 100 may cause the sheath 110 to
separate along the line of perforations 116 and the cap 160 to move
to an open position (FIGS. 14 and 15) to thereby enable the
introducer 100 to be withdrawn from the patient prior to firing the
stapler 10.
[0081] FIG. 22 illustrates another introducer 300 of the present
invention. In this embodiment, the introducer 300 comprises a
hollow sheath 302 that has a closed end 304 and an open end 306 for
insertion onto the circular stapler 10. The sheath 302 may be
fabricated from a flexible material such as from those materials
commonly employed to fabricate condoms. In one embodiment, the
sheath 302 is fabricated from a single piece of material that has
an elongate seam 310 that extends the length of the sheath 302. In
particular, the sheath material is folded over such that the end
312 of the material overlaps end 314 of the material represented by
distance "O" in FIG. 22. The ends 312, 314 are then stitched
together by a suture 316 forming the seam 310. Thus, the sheath 302
is inserted over the stapling head 16 of the stapler 10 prior to
insertion into the patient. After the stapler 10 and sheath 302
have been inserted into position, the sheath 302 may be removed by
pulling the suture 316 to thereby release the seam 310 to permit
the sheath 302 to be removed. In other embodiments, the sheath 302
is fabricated from two pieces of flexible material that are
stitched together with two sutures 316 in the manner described
above. To remove the sheath 302, the clinician simply pulls on one
or both of the sutures 316.
[0082] FIG. 23 illustrates another introducer 320 of the present
invention. In this embodiment, the introducer 320 comprises a
hollow sheath 322 that has a closed end 324 and an open end 326 for
insertion onto the circular stapler 10. The sheath 322 may be
fabricated from a flexible material such as that material commonly
employed to fabricate condoms. In one embodiment, the sheath 320
has a closed end 342 and an open end 326 and is provided with at
least one weakened area 328 which may comprise a perforated line or
seam that extends the length of the sheath 322. Thus, the sheath
322 is inserted over the stapling head 16 of the stapler 10 prior
to insertion into the patient. After the stapler 10 has been
inserted into position, the sheath 322 may be removed by pulling on
the weakened area 328 to permit the sheath 322 to be separated from
the stapler 12.
[0083] FIGS. 24-28 illustrate another introducer 330 of the present
invention. In this embodiment, the introducer 330 comprises a
sheath 332 that has a closed distal end 334 and an open proximal
end 336 that is sized to be stretched over at least a distal
portion of the stapling head 16 of the circular stapler 10. The
sheath 332 may be fabricated from, for example, silicone, latex or
other relatively low durometer material (i.e., a durometer of 90
A). In various embodiments, a circumferentially-extending raised
bumper area 338 may be formed around the circumference of the
closed distal end 334 as shown in FIGS. 24 and 25. In some
embodiments, a central portion 335 extends inwardly from the
circumferentially-extending bumper area 338 to enclose an open
central area 27 in the stapling head 16. See FIG. 25.
[0084] As can also be seen in FIG. 25, the bumper area 338 extends
distally beyond (or in other words is "raised above") a plane D-D
defined by a distal face 25 of the stapling head 16. In some
embodiments, the bumper area 338 is formed from solid material. See
FIG. 26. In other embodiments, a circumferentially-extending hollow
area 340 is formed therein. In other embodiments, hollow area 340
comprises a plurality of pockets 341. See FIG. 28. The area 340 and
pockets 341 may be filled with air or a liquid such as saline
solution for example. In use, the sheath 332 is rolled over the
stapling head 16 of the stapler 10. The sheath 332 may be left in
place while closing and firing the stapler 10 in which case the
area 340 or pockets 341 would be broken leaving only the sheath
material behind under the staple crown inside the rectal lumen.
[0085] FIG. 29 illustrates another introducer 350 of the present
invention. In this embodiment, the introducer 350 comprises a
sheath 352 that has a distal end 354 and an open proximal end 356
that is sized to be stretched over the stapling head 16 of the
circular stapler 10. The sheath 352 may be fabricated from, for
example, silicone, latex or other relatively low durometer material
(i.e., a durometer of 90 A). In various embodiments, a
circumferentially-extending raised bumper area 357 may be formed
around the circumference of the sheath 352 such that it covers the
distal face 25 of the stapling head 16 and a portion 359 extends
into the central open area 27 and below the plane D-D defined by
the distal face 25. See FIG. 29. In some embodiments, the bumper
area 357 is formed from solid material. In other embodiments, a
circumferentially-extending hollow area 358 is formed therein. The
hollow area 358 may be filled with air or a liquid such as saline
solution. In other embodiments, the circumferentially extending
hollow area 358 is segmented (e.g., comprises a series of discrete
pockets that extend around the circumference of the sheath 352).
The discrete pockets may be filled with air or liquid such as
saline solution for example. In use, the sheath 352 is rolled over
the distal end portion of the stapling head 16. The sheath 352 may
be left in place while closing and firing the stapler 10 in which
case the hollow area 358 or pockets would be broken leaving only
the sheath material behind under the staple crown inside the rectal
lumen.
[0086] FIGS. 30-32 illustrate another introducer 360 of the present
invention. In this embodiment, the introducer 350 comprises a cover
362 that is sized to be installed on at least a distal portion of
the stapling head 16. In one embodiment, the cover 362 comprises a
"C"-shaped body portion 363 that may be fabricated from, for
example, polyurethane blends, polyesters, polyethylene,
polycarbonate or polypropylene and be sized to be snapped onto the
stapling head 16 and portion of the elongated shaft 14 of the
circular stapler 10. See FIG. 31. In various embodiments, the
distal end 364 of the body portion 363 has at least three normally
closed fingers 366 that, when moved distally on the stapling head
16, close together forming, for example, a "tulip-like" shape for
insertion into the anus. See FIG. 30. The body portion 363 may have
a retraction member 370 formed thereon for facilitating the
application of a retraction motion thereto. When the stapler 10 has
reached its targeted insertion point, the cover 362 may be pulled
toward the handle portion 12 of the stapler 10, thus pulling the
fingers 366 to the vertical sides of the stapling head 16 exposing
the distal face 25 of the staple cartridge 17. See FIG. 32.
[0087] FIGS. 33 and 34 illustrate another introducer 380 of the
present invention. In this embodiment, the introducer 380 comprises
a cover 382 that includes four fingers 384 that extend from a
centrally disposed hub 386 that has a trocar access hole 388
therethrough. The proximal end 390 of each of the fingers 384 has a
retention flange 392 formed thereon that extend into the central
opening 27 and engage the central wall portion 21 of the stapling
head 16. To install the cover 382, the cover 382 is positioned over
the stapling head 16 as shown in FIGS. 33 and 34 and the trocar 23
of the circular stapler 10 is advanced such that the distal end
portion 35 of the trocar 23 protrudes through the hole 388 in the
central hub 386. Once in position, the trocar 23 is retracted
proximally into central opening 27 to thereby force the fingers 384
into a generally bulbous, "mushroom-like" cross-sectional shape.
Once the stapler 10 is positioned in the rectum, the trocar 23 can
then be deployed and pushed thru the rectal wall allowing access to
the accessory fingers 384 which can be removed from the trocar
23.
[0088] FIGS. 35-37 illustrate another introducer 400 of the present
invention. In this embodiment, the introducer 400 comprises a cover
402 that include four fingers 404 that are attached together by a
sheath 410. See FIG. 35. The sheath may be made from, for example,
silicone material. The apex area 412 of the sheath 410 may have a
trocar access hole 414 therethrough. The proximal end 406 of each
of the fingers 404 has a retention flange 408 formed thereon that
extend into the central opening 21 in the stapling head 16. To
install the cover 400, the cover 402 is positioned over the
stapling head 16 as shown in FIGS. 35 and 36 and the trocar 23 of
the circular stapler 10 is advanced distally such that the distal
end portion 35 of the trocar 23 protrudes through the hole 414 in
the sheath 410. Once in position, the trocar 23 is retracted to
thereby force the fingers 404 into a generally mushroom
cross-sectional shape. See FIG. 37. Once the stapler 10 is
positioned in the rectum, the trocar 23 can then be deployed and
pushed thru the rectal wall allowing access to the accessory
fingers 404 which can be removed from the trocar 23.
[0089] FIG. 38 illustrates another introducer 420 that may be
fabricated from, for example, polyurethane blends, polyesters,
polyethylene, polycarbonate or poly propylene that has at least
four fingers 422 that are interconnected at a hub or apex area 424.
The proximal ends 426 of the fingers 422 snap onto the stapling
head 16. In this embodiment, the introducer 420 is designed to go
up the colon and then be removed. This is unlike the introducer 400
described above wherein the trocar is in the extended position to
hold it in place until the device is in position and then the
trocar is brought proximally.
[0090] FIGS. 39 and 40 illustrate another introducer 500 that may
be used in connection with a circular stapler 10. As can be seen in
those Figures, the introducer 500 may comprise a molded arrangement
with perforations and may be fabricated from, for example,
polyurethane blends, polyesters, polyethylene or polypropylene or
alternatively could comprise wound strip that is sewn together or
held in place without covering. The strip 504 may have a width of,
for example, 0.250 inches and a thickness of, for example, 0.020
inches. The strip 504 may form a base portion 506 sized to extend
around the circumference of the stapling head 16. The base portion
506 may be sized relative to the stapling head 16 such that, when
held together in close spiral relationship, the spiral strip 504
forms a relatively tight (interference) fit with the stapling head
16 to retain the introducer thereon. The spirally wound strip 504
forms a plurality of successive passes 508 that tapers to a blunt
distal end 510. As can be seen in FIG. 36, one embodiment resembles
a blunt-ended "beehive-shape" that substantially encloses or covers
the distal face of the stapling head 16. The spiral passes 508 may
be held in substantial abutting relationship (i.e., spirally wound
closed ended relationship) by a retainer member 510. In various
embodiments, the retainer member 510 may comprise a thin (e.g., 1
to 4 Mils) layer of shrink wrap that extends over the introducer
500. The introducer 500 also includes a release member 520 that is
attached to the strip material 504 such that upon application of a
release motion thereto, the spiral wound strip member 504 is
unwound from engagement with the distal portion of the stapling
head 16. In one embodiment, for example, the release member
comprises a release suture 520 that is attached to the distal end
512 of the strip 504. The release suture 520 may pass through a
hole 522 in a portion of the strip 504 forming the base portion 506
and extend proximally out to the handle portion of the stapler 10
to enable the release suture 520 to be grasped by the
clinician.
[0091] The introducer 500 may be installed by the supplier of the
stapler 10 by shrink wrapping the introducer 500 to the stapling
head 16. In use, the clinician inserts the stapler and introducer
assembly 530 into the patient's anus and past the Valves of Houston
to the desired area. Once the clinician has determined that the
stapler 10 is in the desired position, the clinician can then pull
the release suture 520 in the proximal direction "P" which causes
the shrink wrap 510 to rupture thereby permitting the introducer
500 to unwind as illustrated in FIG. 40. Continued pulling on the
release suture 520 will enable the introducer 500 to be withdrawn
from the patient.
[0092] FIGS. 41-43 illustrate another introducer 600 that may be
used in connection with a circular stapler 10. As can be seen in
those Figures, the introducer 600 may have a base portion 602 sized
to be retained on the stapling head 16. The introducer 600 is
formed with a plurality of tapered "petal" portions 504 that taper
to a substantially rounded point 606. In some embodiments, for
example, there are four diametrically opposed petal portions 604
that, when closed (FIG. 41), converge to form a relatively blunted
pointed end 610. The petal portions 604 have an open area 612
therebetween. In various embodiments, the petal portions 604 are
retained in the closed position by a releaseable retainer member
620. In some embodiments for example, the retainer member comprises
shrink-wrap material 620 that is applied around the introducer 600.
In some embodiments, a plurality of retention ledges 630 may be
formed around the inner perimeter of the base 602 to engage the
distal face 25 of the stapling head 16 when the shrink wrap 620 has
been applied. Release sutures 640 may be sewed through those
portions 622 of the shrink-wrap 620 that cover the open area 612.
The release sutures 640 terminate in or are each attached to a
release suture 650 that passes through a hole 652 in the base
portion 602 and extends proximally out to the handle portion of the
stapler 10 to enable the release suture 650 to be grasped by the
clinician.
[0093] The introducer 600 may be installed by the supplier of the
stapler 10 by shrink wrapping the introducer 600 to the stapling
head 16. In use, the clinician inserts the stapler and introducer
assembly 660 into the patient's anus and past the Valves of Houston
to the desired area. Once the clinician has determined that the
stapling head of the stapler 10 is in the desired position, the
clinician can then pull the release suture 650 in the proximal
direction "P" which causes the shrink-wrap 620 to rupture thereby
permitting the introducer 600 to be pulled distally over the
stapling head 16 as illustrated in FIG. 43.
[0094] FIGS. 44-46 illustrate another introducer 700 that may be
used in connection with a circular stapler 10. As can be seen in
those Figures, the introducer 700 may be fabricated from, for
example, polyurethane blends, polyesters, polyethylene or
polypropylene and have a base portion 702 sized to be retained on
the stapling head 16. The introducer 700 is formed with a plurality
of tapered "segment" portions 704 that taper to a substantially
rounded point 706. In some embodiments, for example, there are four
diametrically opposed segment portions 604 that, when closed (FIG.
44), converge to form a relatively blunted pointed end 710. In the
embodiment depicted in FIGS. 44-46, the introducer 700 includes
four segment portions 704. The segment portions 704 are
interconnected at their base portions except for two adjacent
segment portions 704 wherein the bases of the two segment portions
704 are not attached together. More particularly, segment portion
704A has a base edge 705A and segment portion 704B has a base edge
705B. Edges 705A and 705B are not attached to each other. Thus,
segment portion 704A and segment portion 704B comprise free ends of
the base portion 702. The free ends 704A and 704B are retained in
abutting relationship by a retainer member in the form of a radial
release tab 720 that is attached to 704A and 704B. In various
embodiments, the release tab 720 is fixed or molded to segment
portion 704A and may not necessarily be removed therefrom. The
release tab 720 is releasably attached to segment portion 704B. The
release tab 720 may be attached to the segment portion 704 by a
releasable retainer 722 such as, for example, a releasable adhesive
or piece of rupturable material. When the release tab 720 is
attached as shown in FIG. 41, the segment portions 704 form an
annular base portion 702 that may be retainingly snapped onto or
other wise retainingly engage the stapling head 16 of the circular
stapler 10. A release suture 730 is attached to the release tab 720
and extends proximally out to the handle portion 12 of the stapler
10 to enable the release suture 730 to be grasped by the
clinician.
[0095] The introducer 700 may be snapped onto or pressed onto the
stapling head 16 by the clinician. In use, the clinician inserts
the stapler and introducer assembly 740 into the patient's anus and
past the Valves of Houston to the desired area. Once the clinician
has determined that the stapling head 16 of the stapler 10 is in
the desired position, the clinician can then pull the release
suture 730 in the proximal direction "P" which causes the release
tab 720 to release from the segment portion 704B to enable the
introducer 700 to release from the stapling head 16. Continued
pulling on the release suture 730 will enable the introducer 700 to
be withdrawn from the patient.
[0096] Thus, the various embodiments of the circular stapler
introducer of the present invention may facilitate the transanal
and transabdominal insertion and navigation to access the staple
line of the distal stump in lower anterior resections. The various
introducers may be provided as a part of a kit that also includes a
circular stapler 10. Various embodiments of the introducer will
have no impact on the current functions of the circular
stapler.
[0097] The various embodiments of the present invention represent a
vast improvement over prior circular staple arrangements that fail
to provide any means for locking the anvil in a firing position.
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.
[0098] 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.
[0099] 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.
* * * * *