U.S. patent application number 13/888517 was filed with the patent office on 2013-09-19 for surgical stapler.
This patent application is currently assigned to Covidien LP. The applicant listed for this patent is COVIDIEN LP. Invention is credited to Keith L. Milliman, Nihir Patel, Ryan Williams.
Application Number | 20130240597 13/888517 |
Document ID | / |
Family ID | 43216681 |
Filed Date | 2013-09-19 |
United States Patent
Application |
20130240597 |
Kind Code |
A1 |
Milliman; Keith L. ; et
al. |
September 19, 2013 |
Surgical Stapler
Abstract
A surgical stapler includes a handle assembly, an elongated body
portion extending distally from the handle assembly, and a head
portion disposed adjacent a distal portion of the elongated body
portion and including an anvil assembly and a shell assembly. The
anvil assembly is movable in relation to the shell assembly between
spaced and approximated positions. The shell assembly includes a
pusher movable distally to advance staples from the shell assembly
into contact with the anvil assembly. First and second alignment
pins operatively associated with the pusher have distal ends
positioned distally of the pusher, the alignment pins movable
between a first non-engaged position spaced from the anvil assembly
and a second position in engagement with the anvil assembly.
Inventors: |
Milliman; Keith L.; (Bethel,
CT) ; Williams; Ryan; (Milford, CT) ; Patel;
Nihir; (Stamford, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COVIDIEN LP |
Mansfield |
MA |
US |
|
|
Assignee: |
Covidien LP
Mansfield
MA
|
Family ID: |
43216681 |
Appl. No.: |
13/888517 |
Filed: |
May 7, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13589100 |
Aug 18, 2012 |
8453911 |
|
|
13888517 |
|
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|
12819408 |
Jun 21, 2010 |
8267301 |
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13589100 |
|
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|
61235131 |
Aug 19, 2009 |
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Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 17/1114 20130101;
A61B 17/1155 20130101; A61B 2090/034 20160201; A61B 17/068
20130101; A61B 17/115 20130101 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical stapler comprising: a handle portion; an elongated
shaft extending from the handle portion; and an end effector
disposed at a distal end of the elongated shaft, the end effector
including, a shell assembly; an anvil selectively repositionable
with respect to the shell assembly between spaced and approximated
positions; and an alignment mechanism including corresponding
structures on each of the shell assembly and the anvil that engage
each other to align the shell assembly relative to the anvil.
2. The surgical stapler of claim 1, wherein the alignment mechanism
inhibits rotation of the anvil relative to the shell assembly.
3. The surgical stapler of claim 1, wherein the alignment mechanism
inhibits lateral movement of the anvil relative to the shell
assembly.
4. The surgical stapler of claim 1, wherein the alignment mechanism
comprises a projection on one of the shell assembly and the anvil
and an opening for receiving the projection in the other of the
shell assembly and the anvil.
5. The surgical stapler of claim 4, wherein the projection
frictionally engages the opening to inhibit axial movement of the
anvil relative to the shell assembly.
6. The surgical stapler of claim 1, wherein the anvil includes an
anvil head and an anvil shaft extending proximally from the anvil
head, the anvil shaft being removably mounted to an anvil retainer
of the stapler.
7. The surgical stapler of claim 1, wherein the shell assembly
includes a pusher block operatively associated with the
corresponding structure of the shell assembly and selectively
moveable to advance the corresponding structure of the shell
assembly into engagement with the corresponding structure of the
anvil assembly.
8. The surgical stapler of claim 1, further including: an annular
array of staples disposed in the shell assembly, the staples in
operative association with the pusher block; and an annular array
of pockets located on the anvil for deforming the staples.
9. The surgical stapler of claim 8, wherein the corresponding
structure of the shell assembly is positioned radially inwardly of
the annular array of staples.
10. The surgical stapler of claim 8, wherein the corresponding
structure of the anvil is positioned radially inwardly of the
annular array of pockets.
11. The surgical stapler of claim 1, wherein the shell assembly
includes an annular knife and the corresponding structure of the
shell assembly is positioned radially outwardly of the annular
knife.
12. The surgical stapler of claim 1, wherein the alignment
mechanism includes two corresponding structures on each of the
anvil and the shell assembly.
13. The surgical stapler of claim 1, wherein the alignment
mechanism includes at least one more corresponding structure on one
of the anvil and the shell assembly than on the other of the anvil
and the shell assembly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/589,100 filed on Aug. 18, 2012, now U.S.
Pat. No. ______, which is a continuation of U.S. patent application
Ser. No. 12/819,408, filed on Jun. 21, 2010, now U.S. Pat. No.
8,267,301, which claims priority to, and the benefit of U.S.
Provisional Patent Application Ser. No. 61/235,131, filed Aug. 19,
2009, the entire contents of each of these prior applications are
incorporated herein by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates generally to a surgical
stapling device for applying surgical staples to body tissue. More
particularly, the present disclosure relates to a surgical stapling
device suitable for performing circular anastomosis and/or
treatment to internal walls of hollow tissue organs.
[0004] 2. Background of Related Art
[0005] Anastomosis is the surgical joining of separate hollow organ
sections. Typically, an anastomosis procedure follows surgery in
which a diseased or defective section of hollow tissue is removed
and the remaining end sections are to be joined. Depending on the
desired anastomosis procedure, the end sections may be joined by
either circular, end-to-end or side-to-side organ reconstruction
methods.
[0006] In a circular anastomosis procedure, the two ends of the
organ sections are joined by means of a stapling instrument which
drives a circular array of staples through the end section of each
organ section and simultaneously cores any tissue interior of the
driven circular array of staples to free the tubular passage.
Examples of instruments for performing circular anastomosis of
hollow organs are described in U.S. Pat. Nos. 7,303,106; 6,053,390;
5,588,579; 5,119,983; 5,005,749; 4,646,745; 4,576,167; and
4,473,077, each of which is incorporated herein in its entirety by
reference. Typically, these instruments include an elongated shaft
having a handle portion at a proximal end to actuate the instrument
and a staple holding component disposed at a distal end. An anvil
assembly including an anvil rod with attached anvil head is mounted
to the distal end of the instrument adjacent the staple holding
component. Opposed end portions of tissue of the hollow organ(s) to
be stapled are clamped between the anvil head and the staple
holding component as these components are approximated. The clamped
tissue is stapled by driving one or more staples from the staple
holding component through the staple slots so that the ends of the
staples pass through the tissue and are deformed by anvil pockets
of the anvil head. An annular knife is concurrently advanced to
core tissue with the hollow organ to free a tubular passage within
the organ.
[0007] Besides anastomosis of hollow organs, surgical stapling
devices for performing circular anastomosis have been used to treat
internal hemorrhoids in the rectum. Hemorrhoids are masses of
tissue in the anus containing enlarged blood vessels. Internal
hemorrhoids are inside the anal canal; external hemorrhoids lie
outside the anal canal. In hemorrhoidectomy, the hemorrhoids are
removed. Stapled hemorrhoidopexy is a surgical procedure in which
the stapling device is used to remove tissue just above the
hemorrhoids in order to pull the hemorrhoids back up inside the
rectum and reduce the symptoms. The staples interrupt the blood
flow of the superior hemorrhoidal arterial branches, cutting off
the blood supply to the tissue, thus causing the hemorrhoids to
shrink.
[0008] During the use of a circular stapling device for hemorrhoid
treatment, the anvil head and the staple holding component of the
device are inserted through and into the rectum with the anvil head
and the stapling holding component in an open or unapproximated
position.
[0009] Thereafter, a purse string suture is used to pull the
internal hemorrhoidal tissue and/or mucosal tissue toward the anvil
rod. Next, the anvil head and the staple holding component are
approximated to clamp the hemorrhoidal tissue and/or mucosal tissue
between the anvil head and the staple holding component. The
stapling device is fired to remove the hemorrhoidal tissue and/or
mucosal tissue and staple the cut tissue.
[0010] It would be advantageous to provide additional structure for
aligning the staple slots and the anvil pockets when the staple
holding component and anvil assembly are approximated.
SUMMARY
[0011] The present invention provides in one aspect a surgical
stapler comprising a handle assembly, an elongated body portion
extending distally from the handle assembly, and a head portion
disposed adjacent a distal portion of the elongated body portion
and including an anvil assembly and a shell assembly. The anvil
assembly is movable in relation to the shell assembly between
spaced and approximated positions. The shell assembly includes a
pusher movable distally to advance staples from the shell assembly
into contact with the anvil assembly. First and second alignment
pins operatively associated with the pusher have distal ends
positioned distally of the pusher. The alignment pins are movable
between a first non-engaged position spaced from the anvil assembly
and a second position in engagement with the anvil assembly.
[0012] Preferably, the anvil assembly includes an anvil head having
a first opening to receive the first alignment pin and a second
opening to receive the second alignment pin. Preferably, the first
and second alignment pins are frictionally received in the first
and second openings, respectively. The anvil assembly can include
an anvil shaft extending proximally of the anvil head and being
removably mounted to an anvil retainer of the stapler.
[0013] In a preferred embodiment, advancement of the staple pusher
advances the alignment pins to the second position as the first and
second alignment pins are advanced through openings in the staple
guide. The surgical stapler can include a plurality of staples
arranged in an annular row with the alignment pins positioned
radially inwardly of the annular row of staples. The alignment pins
can also be positioned radially outwardly of a knife of the
stapler.
[0014] In some embodiments, the anvil head has a number of openings
exceeding the number of alignment pins for selective engagement of
the alignment pins with the respective number of openings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Various embodiments of the presently disclosed device are
described herein with reference to the drawings, wherein:
[0016] FIG. 1 is a side view of the stapler of the present
disclosure incorporating the alignment pins of the present
disclosure;
[0017] FIG. 1A is a close up perspective view of the shell assembly
of the stapler of FIG. 1 with the anvil assembly in the
approximated position;
[0018] FIG. 2 is an exploded view showing the anvil head, alignment
pins and an end portion of the shell assembly of FIG. 1;
[0019] FIG. 2A is a side view of the anvil assembly of FIG. 1;
[0020] FIG. 2B is an exploded view of the shell assembly of FIG.
1;
[0021] FIG. 3 is an enlarged perspective view of the end portion of
the shell assembly with alignment pins;
[0022] FIG. 4 is a cross-sectional view taken along lines 4-4 of
FIG. 1A showing the stapler in the approximated unfired position;
and
[0023] FIG. 5 is a cross-sectional view similar to FIG. 4 showing
the end portion of the stapler in the fired position.
DETAILED DESCRIPTION OF EMBODIMENTS
[0024] The presently disclosed surgical stapler will now be
described in detail with reference to the drawings in which like
reference numerals designate identical or corresponding elements in
each of the several views. Throughout this description, the term
"proximal" will refer to the portion of the stapler closer to the
operator and the term "distal" will refer to the portion of the
instrument further from the operator. The presently disclosed
stapler is particularly suited for surgical procedures for the
treatment of colon prolapse and hemorrhoids.
[0025] FIG. 1 illustrates the presently disclosed hemorrhoid
stapler 10. Briefly, surgical stapler 10 includes a handle assembly
12, a central body portion 14, and a distal head portion 16. Head
portion 16 includes an anvil assembly 18 and a shell assembly
20.
[0026] Handle assembly 12 includes a stationary handle 22, a firing
trigger 24, an approximation knob 26, an indicator assembly 28, and
a lockout mechanism 30. Approximation knob 26 functions to retract
and advance a drive screw 32 to advance or retract anvil assembly
18 in relation to shell assembly 20. Firing trigger 24 functions to
advance a pusher link 34 to eject staples from shell assembly 20.
Each of the components of handle assembly 12 identified above are
as described in U.S. Pat. No. 7,303,106 ("106 patent"), the entire
contents of which are incorporated herein by reference.
Accordingly, these components and assemblies will not be described
in detail herein.
[0027] Referring to FIG. 2A, anvil assembly 18 includes an anvil
shaft 64 and an anvil head 66. (The anvil shaft has been removed
from FIGS. 2, 4 and 5 for clarity.) Anvil shaft or center rod 64
includes a tapered blunt end 64a. End portion 64b is dimensioned to
receive a central hub portion 70 of anvil head 66. End 64b of shaft
64 and hub portion 70 of anvil head 66 each define a throughbore
dimensioned to receive a pin, screw, rivet, or the like 72 for
fixedly securing anvil head 66 to anvil shaft 64. The anvil head
can be fixedly (non-rotatably) mounted to the anvil shaft or
alternatively the anvil head can be mounted for tilted movement
with respect to the anvil shaft as described for example in U.S.
Pat. Nos. 6,053,390; 6,957,758; 7,168,604; 7,431,191; and U.S.
Publication No. 2008-0230581. The entire contents of each of these
patents/applications are incorporated herein by reference.
[0028] Anvil shaft 64 includes a stepped surface or ring 74 between
end 64a and end 64b which is configured to engage retention
surfaces of flexible arms of anvil retainer 36 to releasably secure
anvil shaft 64 to anvil retainer 36. Anvil retainer 36 has a bore
to receive the anvil shaft 64. Anvil shaft 64 also includes
over-molded splines 76. Alternatively, the splines can be machined
onto the anvil shaft. The splines 76 align the anvil shaft 64 with
respect to the anvil retainer 36 of the instrument to thereby align
anvil assembly 18 with shell assembly 20 to ensure the staples are
properly aligned with the anvil pockets. A series of longitudinally
spaced suture holes 78a, 78b, 78c are formed at a distal region of
the anvil shaft 64. Each of the suture holes 78 provides for a
purse-string attachment location. As shown, three holes are
provided, although a fewer or greater number of holes are also
contemplated. The holes are configured to receive a purse-string
suture therethrough. The series of holes 78 enables the user to
decide the amount of tissue desired for purse stringing, e.g. hole
78a would enable additional tissue to be taken and presented for
stapling. That is, holes 78 are longitudinally spaced along anvil
shaft 64 such that the amount of tissue drawn into the shell
assembly 20 can be controlled by properly selecting the hole 78 to
which the purse string suture is inserted. Vent holes 69 of anvil
head 66 are illustrated in FIG. 1A. The anvil head 66 also includes
openings 67 for receipt of alignment pins discussed in detail
below.
[0029] An orientation groove or grooves 84 (FIG. 2A) is provided in
anvil shaft 64 beneath splines 76. Orientation groove(s) 84
functions to effect proper alignment of splines 76 about shaft 64
to facilitate proper alignment of anvil assembly 18 and shell
assembly 20 when anvil assembly 18 is retracted towards shell
assembly 20.
[0030] Anvil head 66 defines an outer annular recess which supports
an anvil plate 90 and an inner annular recess which supports a cut
ring 94. Anvil plate 90 has a plurality of anvil pockets 91
arranged in an annular array for deforming the staples are. Cutting
ring 94 is an annular member that is positioned within an inner
annular recess 95 formed in anvil head 66. The cutting ring 94
includes respective proximal and distal ends 98A, 98B (FIG. 5), and
defines an inner proximally facing annular shoulder 98C, as well as
an outer proximally facing annular surface 98D. The inner annular
shoulder 98C and the annular surface 98D of the cutting ring 94 are
configured and dimensioned for engagement with the anvil head 66
such that the cutting ring is retained within the recess 95. Anvil
head 66 includes an inner wall with an outwardly extending finger
71A that is configured and dimensioned for engagement with the
inner annular shoulder 98C, and an outer wall with an inwardly
extending finger (not shown) that is configured and dimensioned for
engagement with the outer annular surface 98D. During use of the
stapling device 10, upon firing, the cutting ring 94 is penetrated
by the annular knife 102. Anvil head 66 has a bulbous, smoothly
contoured member 96 defining its distal face. Bulbous member 96
facilitates insertion of anvil head 66 through a purse-string
suture.
[0031] Referring to FIGS. 1, 2B and 4, shell assembly 20 is secured
to the distal end of central body portion 14 in a manner
substantially similar to that described in the '106 patent
incorporated herein by reference. Shell assembly 20 includes a
shell or housing 198, a pusher back 100 positioned within housing
198, a cylindrical knife 102, and a staple guide 104. Staple guide
104 houses one or more annular rows of staples 150.
[0032] Shell 198 includes an outer housing portion 196 and an inner
guide portion 108 having grooves for mating with splines 76 on the
anvil shaft 64. Outer housing portion 196 defines a throughbore 192
having a distal cylindrical section 114, a central conical section
116, and a proximal smaller diameter cylindrical section 118. A
plurality of openings 120 are formed in conical section 116,
dimensioned to permit fluid and tissue passage during operation of
stapler 10. A pair of diametrically opposed flexible engagement
members 117 are formed on proximal cylindrical section 118 of shell
198 for reception in openings formed on a distal end body portion
14 to secure shell 198 to body portion 14.
[0033] Pusher back 100 includes a central throughbore 120 which is
slidably positioned about inner guide portion 108 of shell 98.
Pusher back 100 includes a distal cylindrical section 127 which is
slidably positioned within distal cylindrical section 114 of shell
198, a central conical section 125, and a proximal smaller diameter
cylindrical section 129. The proximal end of pusher back 100
includes members 132 which are configured to lockingly engage with
pusher link 34 of stapler 10 as described in the '106 patent
incorporated by reference herein. Pusher back 100 also defines a
receptacle for receiving excised tissue.
[0034] Referring to FIG. 1, a rigid bushing 140 is supported in the
proximal end of inner guide portion 108 of shell 198. Bushing 140
defines a throughbore dimensioned to slidably receive anvil
retainer 36 and anvil shaft 64 of anvil assembly 18.
[0035] The distal end of pusher back 100 includes a pusher 126
(FIG. 2B). Pusher 126 includes a multiplicity of distally extending
fingers 128 dimensioned to be slidably received within slots 105
formed in staple guide 104 to eject staples 150 therefrom.
Cylindrical knife 102 is retained within the central throughbore
120 of pusher back 100 to fixedly secure knife 102 in relation to
pusher 126. Knife 102 may be retained within pusher back 100 using
adhesives, crimping, pins, friction, etc. The distal end of knife
102 includes a circular cutting edge.
[0036] The rigid bushing 140 is supported in the proximal end of
inner guide portion 108 of shell 198. Bushing 140 defines a
throughbore dimensioned to slidably receive anvil retainer 36 and
anvil shaft 64 of anvil assembly 18. Anvil retainer 36 is connected
to drive screw 32 by connector 38 as a proximal end of connector 38
is connected to a distal end of drive screw 32 via pin 60. Bushing
140 provides lateral support for flexible arms 48 of anvil retainer
36 when the anvil assembly 18 has been approximated to prevent
disengagement of anvil assembly 18 from anvil retainer 36. In the
unapproximated position, flexible arms 48 of anvil shaft 64 are
positioned externally of bushing 140 to permit removal of anvil
assembly 18 from anvil retainer 36.
[0037] As discussed above, stapler 10 is particularly suitable for
use in surgical procedures for treating hemorrhoids. During such a
procedure, an access port can be inserted into the anus to
facilitate access to the hemorrhoids. Next, a purse string suture
(not shown) is placed into, above or in the vicinity of the
hemorrhoids and the anvil assembly 18 is inserted through the
access port into the anus and rectum. Bulbous member 96 of anvil
head 66 functions to allow smooth passage of anvil assembly 18 past
the purse string suture. Anvil assembly 18 and shell assembly 20
are approximated via knob 26 to draw the hemorrhoids into shell
assembly 20.
[0038] When surgical stapler 10 is fully approximated (FIGS. 1A and
4), firing trigger 24 can be actuated or fired in a manner
described in the '106 patent 10 to staple, sever and allow removal
of a portion of the hemorrhoids. Thereafter, stapler 10 is removed
from the body with the excised tissue contained within the
receptacle of pusher back 100 within shell assembly 20.
[0039] Shell assembly 20 has a plurality of projections shown in
the form of alignment pins 171 engagable with alignment openings 67
in the anvil assembly (see e.g. FIGS. 2 and 4). More specifically,
the pins 171 extend distally from pusher back 100 and extend
through openings 109 in the staple guide 104, functioning as
described below to help align the anvil head 66 and shell assembly
20 and to limit axial movement of the anvil head 66, especially in
the instance where a relatively long anvil shaft is provided such
as in certain hemorrhoid staplers. The alignment pins 171 can be
attached to the pusher back 100 via interference ribs press fit
into holes into pusher back 100 or by other methods such as screw
threads. It should be appreciated that the alignment pins
(projections) can also be utilized on other circular staplers in
addition to stapler 10. The pins 171 can have tapered ends 173 as
shown. Alternately, they can have planar ends or other
configurations.
[0040] The pins function to limit movement of the anvil head 166
with respect to the shell assembly 120. In one embodiment, the pins
171 have an outer dimension substantially equal to the inner
diameter of the alignment openings 67 of the anvil assembly to
frictionally fit within the alignment openings 67 with sufficient
force for retention, while not inhibiting re-approximation of the
anvil assembly. In other embodiments, the pins can have a smaller
outer dimension in relation to the inner diameter of the alignment
openings to thereby more loosely be seated in the alignment
openings, while still functioning to limit axial movement and
rotational movement of the anvil head. The pins 171 are preferably
outboard (radially outward) of the circular knife 102 of the
stapler 10 and inboard (radially inward) of the staples 150. Pins
171 are shown spaced approximately 180 degrees apart. Two or more
pins substantially equally radially spaced or spaced at varying
intervals can be provided. Although the pins 171 are shown for use
with an anvil shaft having through holes 175 for a purse string
suture, the pins can be used with staplers having other anvil
shafts. Also, the alignment pins 171 can be used with non-pivoting
anvils as well as pivotally mounted anvils which move from
non-tilted to tilted operative positions, such as those disclosed
in the U.S. patents/publication listed above.
[0041] The anvil head 66 is shown with a plurality of openings 67
to receive alignment pins 171. The openings are positioned radially
inward of the annular array of staple forming (anvil) pockets. At
minimum, the number of anvil openings 67 is equal to the number of
alignment pins 171. However, it is also contemplated, as shown in
the illustrated embodiment, that there are more anvil openings 67
than alignment pins. For example, in the illustrated embodiment,
two alignment pins 171 are provided while eight anvil openings 67
are provided. In this manner, the alignment pins 171 can align with
two of the respective anvil openings 67 at various orientations of
the anvil head 66 with respect to the shell assembly 20.
[0042] In use, upon firing of the stapler 10, the pusher back 100
is advanced distally to advance the staple pusher 126 with fingers
128 into contact with the staples 150 positioned within slots 105
in the staple guide 104. As the pusher 126 is advanced distally,
alignment pins 171, operatively associated with the pusher 126 via
their attachment thereto, are likewise moved distally. The
alignment pins 171 move distally from a retracted, non-engaged
position shown in FIG. 4 where they are retracted within the shell
assembly to an advanced position protruding beyond the shall
assembly and into engagement with the anvil openings 67 of the
anvil head 66.
[0043] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplifications of preferred embodiments. Those skilled in the art
will envision other modifications within the scope and spirit of
the claims appended hereto.
* * * * *