U.S. patent application number 11/229222 was filed with the patent office on 2006-02-16 for surgical stapling device with tissue tensioner.
This patent application is currently assigned to TYCO Healthcare Group, LP. Invention is credited to Russell Heinrich.
Application Number | 20060036268 11/229222 |
Document ID | / |
Family ID | 34102721 |
Filed Date | 2006-02-16 |
United States Patent
Application |
20060036268 |
Kind Code |
A1 |
Heinrich; Russell |
February 16, 2006 |
Surgical stapling device with tissue tensioner
Abstract
A circular stapling device particularly suited for surgical
treatment of internal hemorrhoids is provided. The stapling device
includes a distal head portion having an anvil and a shell
assembly. A tissue tensioner device including a tissue engagement
member is movably positioned between the anvil and the shell
assembly and is operable via a tensioner trigger to position tissue
within a bore defined within the shell assembly.
Inventors: |
Heinrich; Russell; (Madison,
CT) |
Correspondence
Address: |
UNITED STATES SURGICAL,;A DIVISION OF TYCO HEALTHCARE GROUP LP
150 GLOVER AVENUE
NORWALK
CT
06856
US
|
Assignee: |
TYCO Healthcare Group, LP
|
Family ID: |
34102721 |
Appl. No.: |
11/229222 |
Filed: |
September 16, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10892574 |
Jul 16, 2004 |
6959851 |
|
|
11229222 |
Sep 16, 2005 |
|
|
|
60487841 |
Jul 16, 2003 |
|
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|
Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 17/1114 20130101;
A61B 17/115 20130101; A61B 17/32053 20130101; A61B 17/1155
20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A transdermally operated gastric banding device comprising: an
adjustable gastric band; a drive assembly having an internal
component and an external component for moving the internal
component; and a transmission assembly for transferring movement of
the internal component to the adjustable gastric band.
Description
[0001] This application claims priority from U.S. provisional
application Ser. No. 60/487,841 filed Jul. 16, 2003, the entire
contents of which are incorporated herein by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates generally to a surgical
device for treating hollow tissue organs. More particularly, the
present disclosure relates to a surgical stapling device suitable
for the treatment of internal hemorrhoids.
[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 known circular anastomosis procedure, two ends of organ
sections are joined by means of a stapling device which drives a
circular array of staples through the end of each organ section and
simultaneously cores any tissue interior of the driven circular
array of staples to free a tubular passage. Examples of devices for
performing circular anastomsis of hollow organs are described in
U.S. Pat. Nos. 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 devices
include an elongated shaft having a handle portion at a proximal
end thereof to effect actuation of the device and a staple holding
component disposed at a distal end thereof. An anvil assembly
including an anvil rod with attached anvil head is mounted to the
distal end of the device adjacent a staple holding component.
Opposed end portions of tissue of the hollow organ(s) to be stapled
are clamped between the anvil headland the staple holding component
of the device. The clamped tissue is stapled by driving one or more
staples from the staple holding component so that the ends of the
staples pass through the tissue and are deformed by the anvil head.
An annular knife is concurrently advanced to core tissue within the
hollow organ to free a tubular passage within the organ.
[0007] Surgical stapling devices for performing circular
anastomosis have also been used to treat internal hemorrhoids in
the rectum. During the use of a circular stapling device for
hemorrhoid treatment, the anvil head and the staple holding
component of the surgical stapling device are inserted through the
anus and into the rectum with the anvil head and the staple holding
component in an open or unapproximated position. Thereafter, a
pursestring suture is used to pull the internal hemorrhoidal tissue
and/or mucosal tissue towards 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.
[0008] Although the use of circular anastomosis staplers for
hemorrhoid treatment has many benefits, some problems do exist. For
example, during approximation of the anvil head and staple holding
component of the surgical stapling device, it is sometimes
difficult to properly position tissue to be removed within the
staple holding component of the surgical stapling device. As such,
the tissue may bunch up in a tissue gap defined between the anvil
head and the staple holding component of the instrument. This may
result in malformed staples and/or ineffective removal of all the
desired tissue.
[0009] Accordingly, a continuing need exists in the art for a
circular stapling device for the treatment of tissue which can
quickly and easily position tissue to be removed within the staple
holding component of the surgical stapling device.
SUMMARY
[0010] In accordance with the present disclosure, a circular
stapling device having a tissue tensioner is disclosed. The
stapling device includes a proximal handle portion, a central body
portion, and a distal head portion. The distal head portion has an
anvil and a shell assembly defining an internal bore or chamber.
The anvil includes an anvil head and an anvil shaft. The anvil is
movable in relation to the shell assembly from an unapproximated
position, wherein the anvil head is spaced from the shell assembly,
to an approximated position, wherein the anvil head is in lose
juxtaposed alignment with the shell assembly. A tissue tensioning
device is supported on the anvil shaft and is movable in relation
to the anvil and in relation to the shell assembly between advanced
and retracted positions. When the anvil is in its approximated
position, a tissue engagement member of the tissue tensioning
device is positioned at least partially within the bore of the
shell assembly.
[0011] In one embodiment, the tissue tensioning device includes a
hollow shaft and a trigger. The tissue engagement member extends
radially outwardly from the hollow shaft. The hollow shaft is
slidably positioned about the anvil shaft and is movable to shift
the position of the tissue engagement member in relation to the
anvil and the shell assembly. In another embodiment, the anvil
shaft defines a longitudinal bore and the tissue tensioning device
includes a tensioner shaft which is slidably positioned within the
longitudinal bore of the anvil shaft. In each embodiment, the
tissue tensioning device trigger extends through a slot formed in
the surgical stapling device and can be manually manipulated by a
surgeon to adjust the position of the tissue engagement member with
respect to the anvil and the shell assembly.
[0012] In another embodiment, one of the anvil shaft and the tissue
tensioner shaft includes a series of indentations and the other of
the anvil shaft and tissue tensioner shaft includes a projection or
nub which is releasably received in one of the indentations to
releasably retain the tissue tensioner device at a fixed position
in relation to the anvil shaft. A predetermined force can be
applied to the tissue tensioner trigger to disengage the nub from a
respective indentation to facilitate movement of the tissue
tensioner device in relation to the anvil and the shell
assembly.
[0013] In yet another embodiment, the tissue engagement member
includes a disc-shaped member which extends radially outwardly of
the tissue tensioner device shaft. The disc-shaped member can
include a proximally located concavity and/or one or more ridges or
teeth configured to engage tissue. In another embodiment, the
tissue-engagement member includes one or more fingers which extend
radially outwardly of the tissue tensioner device shaft and
proximally towards the shell assembly. In one embodiment, four
curved fingers may be provided. In another embodiment, three or
more substantially L-shaped fingers may be provided. Alternately,
other tissue engagement member configurations may be used.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Various embodiments of the presently disclosed surgical
stapling device with tissue tensioner are disclosed herein with
reference to the drawings, wherein:
[0015] FIG. 1 is a side perspective view from the top of one
embodiment of the presently disclosed surgical stapling device with
the anvil in the unapproximated position;
[0016] FIG. 2 is an enlarged view of the indicated area of detail
shown in FIG. 1;
[0017] FIG. 3 is a side perspective view from the proximal end of
the area of detail shown in FIG. 2;
[0018] FIG. 4 is a side cross-sectional view of the central body
portion and distal head portion of the surgical stapling device
shown in FIG. 1;
[0019] FIG. 5 is an enlarged view of the indicated area of detail
shown in FIG. 4 with the tissue tensioning device in its advanced
position;
[0020] FIG. 6 is a side cross-sectional view of the area of detail
shown in FIG. 5 with the tissue tensioning device in a partially
retracted position;
[0021] FIG. 7 is a side cross-sectional view of the central body
portion and distal head portion of the surgical stapling device
shown in FIG. 1 with the tissue tensioning device in a partially
retracted position;
[0022] FIG. 8 is a side perspective view from the proximal end of
the tissue tensioning device of the surgical stapling device shown
in FIG. 1;
[0023] FIG. 8a is a side perspective view of the distal end of
another embodiment of the tissue tensioning device shown in FIG.
8;
[0024] FIG. 9 is a side perspective view of the distal end of yet
another embodiment of tissue tensioning device shown in FIG. 8;
[0025] FIG. 10 is a side perspective view of the distal end of yet
another embodiment of the tissue tensioning device shown in FIG.
8;
[0026] FIG. 11 is a side perspective view of the distal end of yet
another embodiment of the tissue tensioning device shown in FIG.
8;
[0027] FIG. 12 is a side perspective view from the proximal end of
the distal head portion of the surgical stapling device shown in
FIG. 1 with the anvil in its unapproximated position and the tissue
tensioning device in its partially retracted position;
[0028] FIG. 13 is a side cross-sectional view of the central body
portion and distal head portion of the surgical stapling device
shown in FIG. 1 with the anvil in its unapproximated position and
the tissue tensioning device in its partially retracted
position;
[0029] FIG. 14 is a side perspective view of the distal end of the
surgical stapling device shown in FIG. 1 positioned adjacent an
access port to the anus with a purse-string suture applied to the
internal hemorrhoids and/or mucosal tissue, the anvil in its
unapproximated position, and the tissue tensioning device in its
advanced position;
[0030] FIG. 15 is a side perspective view of the distal end of the
surgical stapling device shown in FIG. 1 positioned through the
access port beyond the internal hemorrhoids with the purse-string
suture cinched about the tissue tensioner shaft, the anvil in its
unapproximated position and the tissue tensioning device in its
advanced position;
[0031] FIG. 16 is a side perspective view of the distal end of the
surgical stapling device shown in FIG. 1 positioned through the
access port beyond the internal hemorrhoids with the purse-string
suture cinched about the tissue tensioner shaft, the anvil in its
unapproximated position and the tissue tensioning device in a
partially retracted position; and
[0032] FIG. 17 is a side perspective view of the distal end of the
surgical stapling device shown in FIG. 1 positioned through the
access port beyond the internal hemorrhoids with the purse-string
suture cinched about the tissue tensioner shaft, the anvil in its
approximated position and the tissue tensioning device in its
retracted position.
DETAILED DESCRIPTION OF EMBODIMENTS
[0033] Embodiments of the presently disclosed surgical stapling
device 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 device closest to the operator and the term "distal" will refer
to the portion of the device furthest from the operator. U.S.
provisional application Ser. No. 60/480,074 ("'074 application"),
entitled Surgical Stapling Device, filed Jun. 20, 2003, under
Express Mail # EV328280895US is incorporated herein in its entirety
by reference.
[0034] FIGS. 1-8 illustrate one embodiment of the presently
disclosed surgical stapling device shown generally as 10. Referring
to FIG. 1, surgical stapling device 10 includes a proximal handle
assembly 12, a central body portion 14 and a distal head portion
16. Proximal handle assembly 12 is substantially identical to the
handle assembly described in the '074 application and will only be
discussed briefly herein. Proximal handle assembly 12 includes a
rotatable approximation knob 18 and a firing trigger 20.
Approximation knob 18 is operable to move anvil 22 in relation to
shell assembly 24 of head portion 16 between spaced and
approximated positions and firing trigger 20 is operable to eject
fasteners from shell assembly 24 and advance a knife blade through
shell assembly 24 to cut tissue. Operation of rotatable knob 18 and
firing trigger 20 are described in detail in the '074 application
and will not be discussed in further detail herein.
[0035] Referring to FIGS. 2-7, head portion 16 includes anvil 22
and shell assembly 24. Except as otherwise noted, the components of
stapling device 10 are formed from thermoplastics, e.g.,
polycarbonates, and metals, e.g., stainless steel and aluminum. The
particular material selected to form a particular component of
stapling device 10 will depend upon the strength requirements of
the component. For example, the anvil may be formed from a metal,
such as stainless steel and the housing of handle assembly 12 may
be formed from plastic, such as polycarbonate. Alternately,
materials not listed above having the requisite strength
characteristics may be used to form the components of stapling
device 10 provided the materials are suitable for surgical use.
[0036] Shell assembly 24 includes an outer housing or shell 26, a
pusher back 28, a staple guide 30 and a cylindrical knife 32. Outer
housing 26 of shell assembly 24 defines a throughbore and includes
a reduced diameter proximal portion 26a, a diverging intermediate
portion 26b and a cylindrical larger diameter distal portion 26c.
Proximal portion 26a includes a pair of resilient fingers 34 (FIG.
1) configured to releasably engage engagement structure 36 formed
on the distal end of central body portion 14. Pusher back 28 is
slidably positioned within the throughbore of outer housing 26 and
has a shape which corresponds to the shape of the throughbore.
Because of the shape of outer housing 26 and pusher back 28, pusher
back 28 will only slide distally within the outer housing 26 from
its position shown in FIG. 4. The proximal end of pusher back 28 is
operatively associated with a pusher 40 (FIG. 4) which is driven by
firing trigger 20 in a manner described in detail in the '074
application. As shown in FIG. 4, the distal end of pusher back 28
includes a multiplicity of distally extending fingers 42
dimensioned to be slidably received within slots 44 formed in
staple guide 30. Alternately, fingers 42 may be formed on a ring
which is separate from pusher back 28. Slots 44 of staple guide 30
are dimensioned to receive staples 46 (FIG. 5) such that when
pusher 40 is advanced via actuation of firing trigger 20, pusher
back 28 is moved distally to move fingers 42 through slots 44 to
eject staples 46 from staple guide 30. Staple guide 30 is secured
in distal portion 26c of outer housing 26 of shell assembly 24 in a
known manner, e.g., friction, adhesives crimping, etc.
[0037] An annular knife blade 50 is secured within a bore 52
defined within pusher back 28 and shell assembly housing 26 such as
by press-fitting. Alternately, other techniques may be used to
secure knife blade 50 within pusher back 28. Knife blade 50
includes an annular cutting edge 50a and is advanced with pusher
back 28 when firing trigger 20 is actuated to dissect tissue.
[0038] Anvil 22 includes an anvil head 60 and an anvil shaft 62.
Anvil head 60 includes an anvil plate 64 which includes a plurality
of staple deforming pockets 64a (FIGS. 2 and 3) for receiving and
deforming staples 46 ejected from staple guide 30. Anvil shaft 62
has a distal end connected to anvil head 60 and a proximal end
operatively connected (not shown) to the approximation mechanism of
stapling device 10 in a manner such as disclosed in the '074
application. When approximation knob 18 (FIG. 1) is rotated or
actuated, anvil shaft 62 is retracted into or advanced from shell
assembly 24. Although anvil head 60 and anvil shaft 62 are
illustrated as being of monolithic construction, they may be formed
separately and secured together. In one embodiment, anvil 22 is
fixedly secured to the stapling device 10. Alternately, stapling
device 10 may be adapted to receive a removable anvil and/or an
anvil having a tiltable anvil head such as disclosed in the '074
application.
[0039] Referring to FIGS. 4-8, stapling device 10 includes a tissue
tensioning device 80 supported by anvil shaft 62. In one
embodiment, tissue tensioning device 80 includes a hollow shaft 82
having a radially extending tissue engagement member 84 formed at a
distal end thereof and a tensioner trigger 86 formed at a proximal
end thereof. Tensioner trigger 86 extends through an elongated slot
88 formed in the distal end of handle assembly 12 and central body
portion 14. It is envisioned that trigger 86 may be positioned to
extend through handle assembly 12 at a location adjacent firing
trigger 20 to facilitate operation of firing trigger 20 and trigger
86 using a single hand. Elongated slot 88 should be of a length to
permit engagement member 84 to be moved proximally in relation to
anvil head 60 to adjust the depth of the internal hemorrhoids in
relation to bore 52 of shell assembly 24 and to allow for
approximation of anvil 22 and shell assembly 24. Although trigger
86 is illustrated as including a radially extending arm, other
configurations are envisioned. For example, tensioner trigger 86
may be in the form of a slidable button, an annular or semi-annular
collar, a T-bar, etc.
[0040] Referring also to FIG. 8, hollow shaft 82 of tissue
tensioning device 80 defines a longitudinal bore 90 dimensioned to
sidably receive anvil shaft 62. An indexing mechanism can be
provided for controlling movement of hollow shaft 82 about anvil
shaft 62. In one embodiment (FIGS. 5 and 6), the indexing mechanism
includes a nub or projection 92 formed on anvil shaft 62 and a
series of indentations 94 formed on an inner wall of hollow shaft
82. Engagement between nub 92 and one of indentations 94 releasably
retains hollow shaft 82 at a fixed position in relation to anvil
shaft 62. See FIG. 5. By applying a predetermined force to trigger
86, nub 92 can be disengaged from the indentation 94 and moved in
relation to anvil shaft 62 into engagement with another indentation
94. See FIGS. 6 and 7. Relative movement between anvil shaft 62 and
hollow shaft 82 is limited by engagement of trigger 86 with the
proximal and distal ends of slot 88. It is envisioned that other
means may be provided to limit movement of hollow shaft 82 about
anvil shaft 62 (until a predetermined force is applied to trigger
86), e.g., frictional engagement between shaft 82 and shaft 62, a
ratcheting mechanism, frictional engagement of tensioner trigger 86
within slot 88, etc.
[0041] Radially extending engagement member 84 of tissue tensioning
device 80 is configured to engage tissue positioned between anvil
head 60 and shell assembly 24 when tensioner trigger 86 is moved
from an advanced position (FIG. 4) to a retracted position (FIG. 7)
to move engagement member 84 from an advanced position (FIG. 4) to
a retracted position (FIG. 7). Although engagement member 84 is
illustrated as being disc-shaped in FIGS. 1-8, other configurations
are envisioned. For example,. the engagement member may include 1)
a disc-shaped member 100 having a proximal concavity 102 (FIG. 8a);
2) a disc-shaped member 104 having a series of ridges or teeth 106
formed about an annular proximal edge thereof (FIG. 9); or 3) a
series of curved fingers 108 and 108a (FIGS. 10 and 11). Fingers
108 curve radially outwardly from shaft 82 and extend proximally
toward shell assembly 24. Fingers 108a are substantially L-shaped
and have a distal end 108c which extend in a direction towards
shell assembly 24. Although three fingers 108a and four fingers 108
are shown, it is envisioned that one or more fingers may be
provided. Alternately, other configurations not shown here and
capable of engaging tissue and/or a-purse string suture may also be
used.
[0042] FIGS. 12 and 13 illustrate another embodiment of the
presently disclosed surgical stapling device shown generally as
200. Stapling device 200 includes a tissue tensioning device 210
having a tensioner shaft 282 which is sidably positioned within a
longitudinal bore defined in anvil shaft 262. Elongated slots 212
are provided in a distal portion of anvil shaft 262 to facilitate
passage of fingers 214 of the engagement member 216. It is
envisioned that tissue engagement member 216 may be configured as
shown in any of FIGS. 8-11 or assume other configurations capable
of achieving the desired result. An indexing mechanism including a
nub 218 formed on tensioner shaft 282 and a series of indentations
294 formed on an inner wall of anvil shaft 262 is also provided to
limit movement of tensioning device 210 in relation to anvil shaft
262 until a predetermined force has been applied to trigger 286 of
tensioning device 200. An elongated slot 222 is provided in a
proximal portion of anvil shaft 262 and another elongated slot 288
is provided in central body portion 14 and handle assembly 12 to
facilitate passage of trigger 286 from within anvil shaft 262 to a
position to be engaged by an operator or surgeon. Tissue tensioning
device 200 functions identically to tensioning device 80.
Accordingly, the method of use of the tensioning device will be
discussed only with reference to tensioning device 80.
[0043] Referring to FIGS. 14-17, the surgical stapling devices 10
and 200 are particularly suitable for use in surgical procedures
for treating internal hemorrhoids from a patient. Such treatment
may include partial removal of internal hemorrhoid(s) and/or
mucosal tissue. During such a procedure, an access port 300 can be
inserted into the anus to facilitate access to the internal
hemorrhoids. Next, a purse string suture 302 is placed into, above
or in the vicinity of each of the internal hemorrhoids 304 above
the dentate line and the distal end of the surgical stapling device
10 is inserted through access port 300 into the anus and rectum.
The tissue tensioner device 80 should be in the advanced position
(FIG. 4) when the stapling device is inserted into the anus and
rectum. In one embodiment, the purse string suture is placed about
the entire circumference of the anus/rectum even though the
hemorrhoids may not extend about the entire circumference of the
anus/rectum. The anvil 22 and tissue tensioner device 80 are
inserted past internal hemorrhoids 304 and through purse string
suture 302. Thereafter, purse string suture 302 is cinched about
tissue tensioner shaft 82 to draw internal hemorrhoids and/or
mucosal tissue 304 towards and about anvil shaft 62 (FIG. 15).
Next, tensioner trigger 86 (FIG. 1) is retracted to retract tissue
engagement member 84 in relation to anvil shaft 62 and shell
assembly 24. Tissue engagement member 84 is positioned and
configured to engage internal hemorrhoids and/or mucosal tissue 304
and/or purse string suture 302 to adjust the depth of the internal
hemorrhoids and/or mucosal tissue within bore 52 of shell assembly
24. When internal hemorrhoids 304 are positioned at the desired
depth within shell assembly 24, the anvil 22 and shell assembly 24
are approximated by rotating approximation knob 18 in a manner
described in the '074 application (FIG. 1). As anvil shaft 62 is
drawn into shell assembly 24, tissue tensioning device 80 including
engagement member 84 is drawn into shell assembly 24 to pull
internal hemorrhoids and/or mucosal tissue 304 into the bore 52
defined by pusher back 28 and shell assembly 24 (FIG. 17). It is
noted that tensioner device 80 may be repositioned during
approximation of anvil 22 and shell assembly 24 by retracting or
advancing tensioner trigger 86 to readjust the depth of internal
hemorrhoids 304 within bore 52 of shell assembly 24.
[0044] When surgical stapling device 10 is fully approximated,
firing trigger 20 can be actuated in a manner described in the '074
application to staple, sever and allow removal of internal
hemorroids and/or mucosal tissue 304. Thereafter, stapling device
10 is removed from the anus with the excised internal hemorrhoids
contained within bore 52 of pusher back 28 within shell assembly
24.
[0045] It is envisioned that instrument accessories may be used to
assist in performing particular steps of the above described
procedures. For example, a speculum may be inserted into the anus
to simplify placement of the purse string suture by providing
easier access to the surgical site. An obturator may also be used
to assist in placement of the dialator. Further, an expandable
introducer may be provided to reduce the trauma that results from
insertion of the stapling device into the anus.
[0046] It will be understood that various modifications may be made
to the embodiments disclosed herein. For example, the particular
configuration of the tissue tensioning device may be changed to
provide a more ergonomic or accessible trigger. Further, the tissue
tensioning device shaft need not be rigid but may be formed of a
resilient or bendable wire or rod having a tissue engaging segment.
Moreover, the position of the tensioner trigger on the device may
be changed, i.e., moved to the handle assembly, to simplify
operation of the tensioning device or to facilitate operation of
the firing trigger and tensioner trigger using a single hand.
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.
* * * * *