U.S. patent application number 11/458134 was filed with the patent office on 2007-02-01 for luminal anastomotic device and method.
Invention is credited to Blynn L. Shideler, Krisanne Shideler, Kevin S. Vresh, Susan E. Vresh.
Application Number | 20070027473 11/458134 |
Document ID | / |
Family ID | 26812165 |
Filed Date | 2007-02-01 |
United States Patent
Application |
20070027473 |
Kind Code |
A1 |
Vresh; Susan E. ; et
al. |
February 1, 2007 |
LUMINAL ANASTOMOTIC DEVICE AND METHOD
Abstract
An end to end anastomotic stapling device connects two lumen
sections avoiding constriction at the anastomotic ring. An
intraluminal end to end anastomotic stapler includes an expanding
head and anvil designed to fire an anastomotic ring having an inner
diameter at least equal to the nominal inner diameter of the
remaining lumen sections. An extraluminal end to end lumen stapler
is described attaching the lumen sections with an exterior flange
type connection having anastomotic rings with a diameter larger
than the inner diameter of the lumen sections whereby the
anastomotic site has a diameter at least as great as the adjacent
lumen sections
Inventors: |
Vresh; Susan E.; (Allison
Park, PA) ; Shideler; Blynn L.; (Gibsonia, PA)
; Shideler; Krisanne; (Gibsonia, PA) ; Vresh;
Kevin S.; (Allison Park, PA) |
Correspondence
Address: |
BLYNN L. SHIDELER;THE BLK LAW GROUP
3500 BROKKTREE ROAD
SUITE 200
WEXFORD
PA
15090
US
|
Family ID: |
26812165 |
Appl. No.: |
11/458134 |
Filed: |
July 18, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10910777 |
Aug 2, 2004 |
7080769 |
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11458134 |
Jul 18, 2006 |
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|
10114421 |
Apr 2, 2002 |
6769590 |
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11458134 |
Jul 18, 2006 |
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60280785 |
Apr 2, 2001 |
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Current U.S.
Class: |
606/219 ;
227/180.1; 227/19 |
Current CPC
Class: |
A61B 17/1152 20130101;
A61B 2017/00349 20130101; A61B 17/1114 20130101; A61B 17/115
20130101; A61B 2017/1132 20130101; A61B 17/1155 20130101 |
Class at
Publication: |
606/219 ;
227/180.1; 227/019 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1.-75. (canceled)
76. An external anastomotic stapler comprising two substantially
identical, separate stapling units received around the lumen
portions and coupled together with an alignment mechanism, wherein
each stapling unit includes at least two sections, connected
longitudinally by a hinge, said hinge extending longitudinally
along the length of the stapling unit.
77. The anastomotic stapler of claim 76, wherein each stapling unit
includes two semi-circular sections connected longitudinally by a
hinge, said hinge extending longitudinally along the length of the
stapling unit.
78. The anastomotic stapler of claim 77, wherein a first
semi-circular section is formed as an anvil, and a second
semi-circular section comprises a stapling mechanism and a knife
portion.
79. The anastomotic stapler of claim 78, wherein the first
semi-circular section includes a series of staple receiving slots
and a knife receiving groove, said knife receiving groove situated
at the radially outer edge of the first semi-circular section, and
wherein the second semi-circular section includes the knife portion
situated at the radially outer edge thereof.
80. The anastomotic stapler of claim 78, wherein the separate
stapling units may be engaged face-to-face such that staples fired
from the stapling mechanism of a first stapling unit may be
received in the anvil of a second stapling unit upon firing, and
staples fired from the stapling mechanism of a second stapling unit
may be received in the anvil of the first stapling unit upon firing
in the opposite direction.
81. The anastomotic stapler of claim 80, further comprising at
least pin forming the alignment and allowing for alignment of the
separate stapling units when engaged face-to-face.
82. The anastomotic stapler of claim 76, wherein said stapler may
be fired from one end of the device.
83. The anastomotic stapler of claim 76, wherein each stapling unit
further comprises a plurality of tissue retraction members spaced
around the periphery of each stapling unit.
84.-88. (canceled)
89. An extraluminal intestinal stapler for end to end anastomosis
formed of two opposed stapling units; each unit clamping around a
lumen section to be anastomized; wherein each said stapling unit
comprises two halves hinged together, and wherein one half of each
unit is a stapling unit and the other half is an anvil portion.
90. The stapler of claim 89, further including a mechanism for
pulling the lumen to be attached across the stapling face of each
stapling unit.
91. The stapler of claim 89, further including an alignment
mechanism for aligning the two adjacent stapling units prior to
firing a ring of staples.
92.-188. (canceled)
189. An extraluminal stapler for end to end anastomosis formed of
two opposed generally identical, opposed stapling units; each unit
clamping around a lumen section to be anastomized; wherein each
said stapling unit comprises two halves, and wherein one half of
each unit is a stapling unit and the other half is an anvil
portion.
190. The stapler of claim 189, further including a mechanism for
pulling the lumen to be attached across the stapling face of each
stapling unit.
191. The stapler of claim 190, further including an alignment
mechanism for aligning the two adjacent stapling units prior to
firing a ring of staples.
192. The stapler of claim 190 wherein the tissue pulling mechanism
includes a tissue grasping and positioning mechanism for
positioning a lumen portion to be anastomized across the stapling
face of the stapler in end to end anastomosis.
193. The stapler of claim 190 wherein the tissue pulling mechanism
includes a series of identical tissue grasping clips, each clip
formed of a flexible strip of material, the clips being secured
around the edge of a lumen portion to be anastomized through snap
fit connections with the clips providing for grasping and for
positioning the lumen portion across the stapling face of a
surgical sapling unit.
194.-200. (canceled)
201. The stapler of claim 190 wherein the tissue pulling mechanism
includes a tissue manipulator for attachment to tissue to be
manipulated by a surgeon, the tissue manipulator comprising: A) an
elongated band attachable to the tissue; B) a tissue attachment
mechanism on a first side of the elongated band for attaching the
tissue manipulator to the tissue; and C) at least one manipulator
on a second side of the elongated band, whereby the surgeon
manipulates the tissue through the at least one manipulator that
transfers the manipulation forces to the tissue generally evenly
along the elongated band to minimize tissue damage.
202. The stapler of claim 201, wherein the elongated band is a
flexible member adapted to be folded along an axis thereof about
the tissue.
203. The stapler of claim 202, wherein the tissue attachment
mechanism includes a plurality of snap fit connections.
204. The stapler of claim 202, wherein the tissue attachment
mechanism includes adhesive on the first side of the elongated
band.
205.-207. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of and claims the benefit
of U.S. patent application Ser. No. 10/910,777, filed on Aug. 2,
2004 and entitled "Luminal Anastomotic Device", now U.S. Pat. No.
7,080,769 and which published Mar. 31, 2005 as Publication number
2005-0067454. U.S. patent application Ser. No. 10/910,777 is a
continuation of and claims the benefit of U.S. patent application
Ser. No. 10/114,421, filed on Apr. 2, 2002 and entitled "Luminal
Anastomotic Device and Method", now U.S. Pat. No. 6,769,590 and
which published Dec. 12, 2002 as Publication number 2002-0185517
and which claimed the benefit of Provisional Patent Application
Ser. No. 60/280,785 entitled, "Luminal Anastomotic Device and
Method" filed Apr. 2, 2001. These patents and associated patent
publications are incorporated herein by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to surgical anastomotic
stapling devices. More particularly, the present invention relates
to end to end anastomotic surgical staplers avoiding minimal
constrictive area at the anastomosis site.
[0004] 2. Background Information
[0005] Surgical staplers have been developed to assist and improve
a wide variety of surgical procedures. Surgical staplers provide
precision in the placement of staples as well as decrease the time
of given surgical procedures. A wide variety of surgical staplers
have been developed for vascular, gastric, esophageal and
intestinal surgery, to name but a few. These known staplers are
often used in anastomosis procedures. In performing surgical
anastomotic stapling, generally the two pieces of lumen are
attached by a ring of staples with a closed loop stapler. The
anastomosis of the lumen may be performed in a side to side, side
to end or end to end manner which describes the relative
orientation of the lumen sections.
[0006] The surgical staplers for performing end to end anastomosis
are generally intraluminal surgical staplers that fire a pair of
staggered rings of staples. These types of surgical staplers are
often referred to as EEA's, which stands for "End to End
Anastomosis". During this procedure, a circular knife blade is used
to separate tissue which is held within the circular ring. The
separated tissue is then removed with the stapler so that a
circular opening within the lumen is completed along the surgical
stapling line.
[0007] In performing these surgical procedures with EEA's it has
become desirable to separate the anvil on which the staplers are
clinched from the stapling head portion from which the staples are
expelled. It has been typical in the past that the stapling head is
attached to the anvil and the tissue is secured through a "purse
stringed" gathering of tissue.
[0008] Generally, the tissue stapled together with an EEA leaves a
smaller opening than the original lumen into which the anvil and
stapler head were inserted. Frequently, it is desirable to provide
an anvil which can be collapsed to introduce the anvil into the
body through a relatively small incision. An example of a surgical
stapler having a variable diameter anvil is illustrated in U.S.
Pat. No. 4,505,414 disclosing an anvil, integral with a surgical
stapler, which can be collapsed and inserted through a small
incision in a patient's body and expanded outwardly after placement
inside the patients body to staple the wall of an organ to the
abdominal wall or an external tissue layer of the patient's body.
The anvil is not detachable from the stapler and thus cannot
provide a continuous stapler line, but rather applies a broken,
discontinuous line to "tack" the tissue in a circular line. This
patent also does not provide an anvil which can be placed remotely
within the body for subsequent attachment to a stapler head.
[0009] Other examples of anvils which are capable of collapsing to
a reduced diameter after stapling to facilitate removal from the
body are shown in U.S. Pat. Nos. 4,752,024; 4,893,622; 4,700,703
and 4,903,697. These anvils are introduced into the body through a
relatively large incision.
[0010] U.S. Pat. No. 5,239,639 also shows a collapsible anvil
assembly and applicator instrument for a surgical stapler
apparatus. U.S. Pat. No. 6,503,259 is relevant to the present
invention in that it discloses a surgical anastomotic fastener
array (10 in the '259 patent) comprising a plurality of fasteners
(11 of the '259 patent) each having a tissue piercing element (12
of the '259 patent), wherein the fasteners are aligned in an
annular array of a first diameter at least prior to anastomosis and
are designed to expand to form an annular array of a second larger
diameter and then contract as needed after anastomosis. The '259
patent is addressing the same broad concern of the resulting
anastomotic ring, but the earliest filing date of the '259 patent
is, however, not earlier than the conception date of the present
invention.
[0011] The retractable anvil EEA's discussed above do not address
the fundamental problem of the constrictive point formed after
luminal anastomosis. These prior art devices simply address the
problem of post operative tool removal.
[0012] It is the object of the present invention to avoid the
drawbacks of the prior art by avoiding the minimal constriction
formed at luminal anastomotic sites using anastomotic staplers
(i.e., EEA's). It is a further object of the present invention to
provide anastomotic staplers which are easy to manufacture and
utilize. A further object of the present invention is to provide
both intraluminal anastomotic end to end staplers and extraluminal
anastomotic end to end staplers.
SUMMARY OF THE INVENTION
[0013] The above objects are achieved with the anastomotic device
according to the present invention. The anastomotic device
according to the present invention is a surgical stapler that will
form an anastomosis between existing lumen sections in an end to
end alignment forming the anastomosis site with a minimal diameter
generally equal to or greater than the normal inner diameter of the
anastomized lumen sections, with the lumen sections in a normal
relaxed condition. The anastomotic device of the present invention
will preferably utilize conventional staples formed in a pair of
offset annular arrays of staples to couple the end of a first lumen
section to the end of a second lumen section.
[0014] A first embodiment of the present invention forms the
anastomotic device as an intraluminal end to end surgical stapler.
The intraluminal surgical stapler fires staples, or other fastening
devices, from a stapling head to an adjacent anvil. In accordance
with the present invention, both the head and the anvil can be
moved from a retracted position having a first relative diameter to
an expanded position of a second larger diameter. The expansion of
both the head and the anvil allows the anastomotic device to be
positioned in the lumen to be attached with minimal interference
and then expanded to an enlarged firing position, wherein when
fired the anastomotic ring formed by the array of staples is
positioned at a diameter preferably at least as large as the
minimum diameter of the adjacent lumen sections. After firing, the
head and anvil of the stapler of present invention can both be
retracted to allow for easy withdrawal of the stapler from the
anastomized lumen.
[0015] In one embodiment of the present invention, the head will be
formed of a plurality of wedge-shaped arc segments which move
radially and align in an expanded position to form the annular
head. The arc segments may be in the form of inner wedge-shaped
segments moved by an actuator and outer segments guided by the
inner wedge-shaped segments. The wedge-shaped segments may be moved
into the expanded or retracted positions by being coupled to the
actuator in the form of axially movable wedges controlled by the
user.
[0016] Another embodiment of the present invention will form the
annular head as a plurality of arc segments that slide together
with the segments formed in an overlapped position in the retracted
state and rotate into contracted and expanded positions. A further
embodiment of the present invention will hinge various arc segments
together to allow the segments to pivot between a retracted
position of a minimal diameter and an expanded position forming the
annular head ready for firing.
[0017] Each individual arc segment of the head portion will include
staples which combine to form the array of staples in the expanded
position. One key aspect of the present invention is that each arc
segment has a separate firing mechanism as well as a knife
actuating mechanism independently associated with each segment.
Each segment will have an arcuate knife portion which will combine
and overlap with the knife portions of adjacent segments to form a
continuous annular knife arrangement when the head is in the
expanded position. In this manner, the knife portions and staples
of each individual segment will combine to form the dual stapling
array and annular knife well-known to those skilled in the art
(except of a larger diameter relative to the body of the stapler).
The firing mechanism of each individual segment is additionally
coupled to the controller of the stapler in a manner which
accommodates movement of the individual segments between the
retracted and expanded positions. This construction of the segments
allows for the segments to be formed in the hinged arrangements,
spirally attached arrangements or wedge arrangements discussed
above. Many other possible relatively movable combinations may be
constructed with the individual segment construction of the stapler
of the present invention.
[0018] Another aspect of the present invention is to form an
external end to end anastomotic surgical stapler. The external
stapler according to the present invention is designed to clamp
around lumen sections to be attached. The extraluminal stapler
according to the present invention is designed to form an
anastomizing ring of sutures external to the connected lumen
sections. The external stapler according to the present invention
forms a pair of annular arrays of staples around an outwardly
extending flange of the connected lumen sections.
[0019] In one embodiment according to the present invention, the
extraluminal stapler is formed of two opposed stapler units with
each stapler unit formed of two halves hinged together. The
extraluminal stapler will include a mechanism for pulling the lumen
to be attached around the stapling face of each stapling unit. The
extraluminal stapler according to the present invention will
additionally include a mechanism for aligning the stapling head and
anvil portions of the opposed stapling units with each other as
well as a firing mechanism for firing the arrays of staples in the
stapling units. One embodiment of the present invention will form
each stapling unit as an anvil and head portion hinged together
which couples with an adjacent hinged anvil and head portion of the
opposed stapling unit.
[0020] The present invention would be particularly applicable for
bowel resections as will be understood by those of ordinary skill
in the art, but is not intended to be limited thereto. It can be
used in many other applications such as, but not limited to,
vascular anastomosis, gastrointestinal anastomosis, esophageal
anastomosis and essentially any hollow lumen within the body.
Further, the specific embodiments of the invention include a
variety of unique features that can be incorporated separately or
in various combinations into other stapling and surgical devices
for improving those devices.
[0021] One advantage of the present invention is a minimally
invasive surgical stapler that will assist in stapler placement
because the diameter of the stapler (i.e. the largest diameter
portion, specifically the head and anvil of the stapler) is smaller
during insertion and retraction than at firing.
[0022] Another advantage of the present invention is having a
closed loop EEA stapler with the trimming knife formed by
individual knife segments. This feature of the present invention
may be utilized for firing the knife segments individually, or in a
given sequence, or simultaneously (as utilized in the illustrated
embodiments of the present invention.
[0023] Another feature of the present invention is the
accommodation of multiple anvil and multiple head controls in a
surgical stapler. One present illustrated embodiments provide
separate controls for expansion/retraction of the anvil and for
axial movement of the anvil. This illustrated embodiment further
provides independent control for expansion/retraction of the head
and for firing of the knife blade and staples. This system of
multiple independent control may be modified to perform a variety
of separate control features for the anvil and head portions of an
EEA stapler.
[0024] Another feature of the present invention is the provision of
an EEA stapler with a staple and knife firing mechanism that
accommodates relative motion of the head portion containing the
staples and the firing mechanism.
[0025] Another feature of the present invention is the provision of
an alignment mechanism that aligns and locks the anvil and head
portion together prior to the firing of the staples or the
knife.
[0026] Another feature of the present invention is the provision of
a closed loop surgical stapler for end to end anastomosis in which
the stapler extends around the outside of the lumen portions being
anastomised.
[0027] These and other advantages of the present invention will be
clarified in reviewing the detailed description of the preferred
embodiments taken together with the attached figures wherein like
reference numerals represent like elements throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1a is a side view, partially in section, of a pair of
lumen sections anastomized using existing intraluminal anastomotic
staplers;
[0029] FIG. 1b is a side view, partially in section, of a pair of
lumen sections anastomized with an anastomotic stapler according to
a first embodiment of the present invention;
[0030] FIG. 1c is a side view, partially in section, of a pair of
lumen sections anastomized using an anastomotic stapler according
to a second embodiment of the present invention;
[0031] FIG. 2a is a schematic plan view of an intraluminal end to
end anastomotic stapling head according to the first embodiment of
the present invention with the head in the expanded, firing
position;
[0032] FIG. 2b schematically illustrates the head illustrated in
FIG. 2a in the retracted position;
[0033] FIG. 3a schematically illustrates an expandable anvil
associated with the anastomotic stapler having the expandable head
illustrated in FIGS. 2a and 2b;
[0034] FIG. 3b schematically illustrates the anvil portion of FIG.
3a in a retracted position;
[0035] FIG. 4a schematically illustrates a spirally retracted and
expandable head for an intraluminal end to end surgical stapler
according to a second embodiment of the present invention;
[0036] FIG. 4b schematically illustrates a hinged expandable and
retractable head for an intraluminal end to end surgical stapler
according to a third embodiment of the present invention;
[0037] FIG. 5a is a plan view of an individual outer head segment
of the head illustrated in FIGS. 2a and 2b;
[0038] FIG. 5b is a radially inner side view of the head segment
illustrated in FIG. 5a;
[0039] FIG. 5c is a sectional view of the head segment illustrated
in FIG. 5a taken along line Vc-Vc;
[0040] FIG. 5d is a sectional view of the head segment illustrated
in FIG. 5a taken along line Vd-Vd;
[0041] FIG. 5e is a top plan view of an inner head segment
illustrated in FIGS. 2a and 2b;
[0042] FIG. 5f is a radially inner side view of the inner head
segment illustrated in FIG. 5e;
[0043] FIG. 5g is a sectional view of the inner head segment shown
in FIG. 5e taken along line Vg-Vg;
[0044] FIG. 6a is a perspective view of an intraluminal anastomotic
surgical stapler utilizing the expandible head illustrated in FIGS.
2a and 2b and the expandible anvil illustrated in FIGS. 3a and
3b;
[0045] FIG. 6b is a partial section of a portion of the stapler
illustrated in FIG. 6a taken along line VIb-VIb in FIG. 6a;
[0046] FIG. 6c is a cross-sectional view of the stapler illustrated
in FIG. 6b taken along line VIc-VIc;
[0047] FIG. 6d is a cross-sectional view of the stapler illustrated
in FIG. 6b taken along line VId-VId;
[0048] FIG. 6e is a side view partially in section of a distal end
of the stapler illustrated in FIG. 6a;
[0049] FIG. 7a is a perspective view partially in section of a
first half of an extraluminal end to end surgical stapler according
to the present invention;
[0050] FIG. 7b is a side view of the complete extraluminal surgical
stapler illustrated in FIG. 7a;
[0051] FIG. 8a is a perspective view of a lumen section to be
anastomized utilizing flexible clips associated with the surgical
stapler illustrated in FIGS. 7a and 7b;
[0052] FIG. 8b is an end view of the lumen and clips illustrated in
FIG. 8a;
[0053] FIG. 8c is a side view of the clips utilized in FIGS. 8a and
8b in the open position;
[0054] FIG. 8d is a plan view with the clips in the open position
of the clip illustrated in FIG. 8c;
[0055] FIG. 8e is a cross-section of the clips illustrated in FIGS.
8c and 8d with the clip in a partially closed position;
[0056] FIG. 9 is a sectional schematic view of an alignment
mechanism for use in a stapler of the present invention;
[0057] FIG. 10 is a sectional schematic view of a motion
accommodation mechanism for the anvil expansion mechanism of a
stapler according to the present invention; and
[0058] FIG. 11 is a schematic plan view of a lock and release
transmission for an anvil stem and an anvil expansion rod of a
stapler according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0059] The objects and advantages of the present invention can be
best clarified in reviewing the surgical results illustrated in
FIGS. 1a, 1b and 1c with the prior art surgical staplers (FIG. 1a)
and various embodiments of surgical staplers (FIGS. 1b and 1c) of
the present invention, respectively. FIG. 1a illustrates lumen
sections 10 and 12 anastomized with a conventional intraluminal
anastomotic stapler (i.e. an EEA). The first lumen section 10 and
second lumen section 12 will have a nominal diameter d.sub.1. With
existing end to end anastomotic staplers, the anastomosis site,
sometimes referred to as an anastomosis ring, formed by an array of
staples 14 will have a smaller diameter d.sub.2 than the nominal
luminal diameter d.sub.1. In addition to the constrictive point
formed by the smaller diameter d.sub.2, with the existence of (1)
the array of staples 14, (2) the additional tissue formed by the
coupled lumen sections at the anastomosis site, and (3) the scar
tissue forming around the anastomotic ring, this constricture or
constriction will have greater rigidity, i.e., less flexibility,
than the associated lumen tissue. As discussed above, the object of
the present invention is to avoid this constrictive point and the
possible detrimental effects associated therewith. Of course, the
detrimental effects associated with a more rigid constricture in an
anastomized lumen would depend on the particular lumen which is
coupled together. However, whether connecting together a bowel in
vascular anastomosis, or connecting any lumen within the body such
constrictures are universally undesirable.
[0060] FIG. 1b illustrates the anastomosis of lumen sections 10 and
12 with a surgical stapler 100 according to a first embodiment of
the present invention. The anastomotic stapler 100 of the invention
associated with the results shown in FIG. 1b is described in detail
in FIGS. 2a and 2b, 3a and 3b, 4a and 4b, 5a-5g, and 6a-6e. As
illustrated in FIG. 1b, the anastomotic ring or suture site formed
by the array of staples 14 has an inner diameter d.sub.3, which is
relatively larger than the diameter d.sub.2 associated with
conventional staplers. The diameter d.sub.3 is preferable formed at
least as great as diameter d.sub.1 of the adjacent lumen sections.
In this manner, the detrimental effects of the constricture site
can be minimized. It should be appreciated that the inner area of
the anastomized lumen is associated with the square of the diameter
such that minimal improvements in the diameter of d.sub.3 over
d.sub.2 of the prior art will result in substantial increases in
the area of the lumen. It is preferred that in the present
invention, the diameter d.sub.3 at the anastomotic ring be at least
as great, or greater than the nominal diameter d.sub.1 of the
associated lumens to avoid any problems with constricture. The
relative increase or expansion of the anastomotic ring possible
with the device according to the present invention will be
associated with the tissue flexibility of the lumen sections for
which the particular stapler is designed. For example, tissue
forming a bowel (relatively flexible) and tissue forming vascular
lumens (less flexible compared to the bowel) would accommodate
different relative dimensions for d.sub.3 compared to d.sub.1 at
the anastomotic site. However, the general operative concepts of an
intraluminal bowel stapler according to the present invention is
the same as an intraluminal vascular stapler according to the
present invention.
[0061] FIG. 1c illustrates an end to end anastomosis of two lumens
10 and 12 with an array of staples 14 utilizing an extraluminal
surgical stapler according to a second embodiment of the present
invention. The stapler according to the second embodiment of the
present invention forms an outer anastomotic ring with the array of
staples having a diameter greater than d.sub.1, the normal diameter
of the lumen, such that the anastomosis site forms no constricture.
The relative positioning of the array of staples 14 will again
depend on the particular lumen being anastomized. Examples of the
stapler forming this anastomosis are illustrated in FIGS. 7a, 7b,
and 8a-8e below.
[0062] FIGS. 2a and 2b schematically illustrate an expandable head
90 for the intraluminal anastomotic stapler 100 according a first
embodiment of the present invention. The expandable head 90 is
formed of a plurality of arc segments which interconnect in an
outer firing position to form the annular expanded head 90 as shown
in FIG. 2a. The individual segments shown in the embodiment
illustrated in FIGS. 2a and 2b comprise outer wedge-shaped segments
102 and inner wedge-shaped segments 104. The inner segments 104 are
moved radially inwardly and outwardly by individually associated
wedge elements 106. The side wedge-shaped engaging surfaces of the
inner segments 104 will force the outer segments 102 into the
expanded condition. The inner segments 104 can be pinned to the
outer segments 102 in a manner to be described later such that
retraction of the inner segments 104 to the retracted position
shown in FIG. 2b will also pull the outer segments 102 toward the
retracted position.
[0063] The structure of the individual segments 102, 104 be
discussed later in greater detail. Generally speaking, each segment
102, 104 includes a plurality of staple receiving slots 108 in a
staggered annular array consisting of both an outer ring and an
inner ring of staples receiving slots 108. As clearly evident in
the figures, it is an important aspect of the present invention
that the division between adjacent segments 102, 104 needs to be
accomplished between the staple receiving slots 108. As can be seen
in the figures, in the expanded position, the segments 102, 104
combine to form a standard annular array of staples 14 in an
offsetting overlapping arrangement. Additionally, each segment 102,
104 includes, at a radial inner side thereof, with knife portions
110 which combine in the expanded position to form an annular knife
which provides a trimmed inner edge to the anastomized lumen as is
conventional. In order to ensure a complete annular knife in the
firing position, and therefore a complete annular smooth cut to the
lumen, knife portions 110 of the inner segments 104 overlap with
the knife portions of the adjacent outer segments 102 as generally
illustrated in the figures. As can be seen in FIGS. 2a and 2b, the
wedge-shaped interacting arc segments 102, 104 of the head 90 will
allow it to be moved between retracted and expanded positions. It
should be evident that the present invention is not intended to be
limited to the specific number of segments illustrated in FIGS. 2a
and 2b. A minimization of the diameter in the retracted position
can be obtained with as little as three inner wedge-shaped segments
104 spaced about the periphery of the head 90. The number,
positioning and specific shape of the segments 102, 104 can be
changed as desired in order to allow for the desired degree of
expansion. Other factors affecting the number and shape of the
individual segments 102, 104 will be the number and length of the
specific staples 14 utilized in the inner and outer rings. All of
these factors can be considered in designing a specific expanding
head 90 which expands to the degree desired.
[0064] FIGS. 3a and 3b illustrate the expanding anvil 120 utilized
with the stapler 100 according to the present invention. These
figures illustrate that the anvil 120 is formed of inner segments
122 and outer segments 124 similar to the inner segments 104 and
outer segments 102 of the head 90. The anvil 120 in the expanded
position forms an annular ring with conventional staple engaging
grooves 126 which will correspond to the staple receiving slots 108
of the head 90 for cinching the fired staples 14 as known in the
art. The inner and outer segments 122, 124 can be pinned together
and the inner segments 122 can be moved by a wedge 128 similar to
the mechanism for the head 90. The anvil 120 construction is
significantly simpler than the head 90 construction for a variety
of reasons. First, the anvil 120 construction is not limited to
forming the staple engaging grooves 126 entirely on one segment 122
or 124. These expanding anvil segments 122, 124 can be formed
essentially in any position even dividing a staple receiving groove
126. This provides significantly greater flexibility in deciding
where to put the inner and outer segments 122, 124. An additional
aspect to making the anvil 120 significantly easier to design and
operate is that there is no knife or staple firing mechanisms which
needs to be incorporated into the expanding and retracting anvil
120. In fact, the prior art illustrates that expanding anvils have
been well-known in the art, and many of these constructions can
also be incorporated into the design of the present invention. For
the sake of simplicity, however, the design of the anvil 120 is
essentially the same as the design of the expanding head 90
illustrated in FIGS. 2a and 2b.
[0065] FIGS. 4a and 4b are intended to illustrate alternative
expanding head mechanisms according to the present invention. FIG.
4a illustrates an expanding head 140 according to one embodiment of
the present invention in which the head 140 is formed of individual
segments 142 which can slide past each other in an overlapping
arrangement to contract in a spiral fashion as illustrated by the
arrows. In place of an actuating wedge, the actuating mechanism may
be a rotating cam type operator, although a variety of segment 142
moving mechanisms can be envisioned.
[0066] FIG. 4b illustrates yet another embodiment for an expanding
head 150 for a stapler 100 of the present invention in which
individual segments 152 of the head 150 are hinged together by
hinges 154 to move between expanded and contracted positions. This
embodiment illustrates three hinges 154 and one open connection
which can have these segments 152 snap together to form the
continuous ring. The number of individual segments 152 may be
selected as desired. The hinges 154 may include spring-biasing to
help move the segment 152 to either the expanded or retracted
positions. A mechanical actuator linearly moving along the length
of the stapler 100 would be used to move the segments 152.
[0067] FIGS. 5a-5g illustrate the details of the individual arc
segments 102, 104 forming the expandable head 90 illustrated in
FIGS. 2a and 2b. The segments 102, 104 are discussed in detail and
illustrated associated with the specific expanding head 90
illustrated in FIGS. 2a and 2b. However, the general concepts of
these individual segments 102, 104 can be easily extrapolated for
many different embodiments, such as those illustrated in FIGS. 4a
and 4b. The key features of the arc segments 102, 104 for the
expanding head 90 according to the present invention is that the
individual segments 102, 104 have independent firing mechanisms for
the staples 14 and the knife portions 110 that are associated with
that segment 102, 104. Additionally, the firing mechanism
accommodates the relative motion of the segments 102, 104 between
the retracted and expanded positions. As will be evident in the
description of FIGS. 5a-5g, these components utilized in the
segments 102, 104 of the present invention can be utilized in the
expanding heads 140 and 150 illustrated in FIGS. 4a and 4b as well
as a wide variety of other configurations for an expanding head
having separate segments the user may contemplate.
[0068] FIG. 5a illustrates a plan view of the outer segment 102 of
the expanding head 90 illustrated in FIG. 2a. The outer segment 102
includes a plurality of slots 108 for receiving staples 14 therein
as shown in FIGS. 5c and 5d. On the radial inner side of the
segment 102 is a groove 160 extending across the entire segment
102. The arcuate knife portion 110 is positioned in the groove 160.
The knife portion 110 and staples 14 are all fired through a common
firing mechanism which can be best seen in FIGS. 5c and 5d.
Essentially, a base plate 162 is positioned in a recess 164
extending along the length of the segment 102. The base plate 162
includes a plurality of pusher bars 166 extending into the
individual staple receiving slots 108 for supporting and firing the
staples 14. As illustrated in FIG. 5c, the base plate 162 is
positioned in the recess 164 with enough room for movement
(longitudinally of the stapler 100) for allowing the firing of the
staples 14 and the knife portion 110. Additionally, the knife
portion 110 is attached to the base plate 162 through a series of
L-shaped arms 168 at spaced locations along the base plate 162. The
L-shaped arms 168 extend through slots 170 in the segment 102. The
base plate 162 is secured to an actuation rod 172 at the bottom
thereof for moving the base plate 162 in the segment 102 for firing
of the staples 14 and actuation of the individual knife portion
110.
[0069] As discussed previously, the individual knife portions of
the various segments 102, 104 will overlap to assure that a
complete annular circle is formed and cut by the combined knife
portions 110. In order to easily accommodate the overlapping of the
outer edges of the segments 102 near the groove 160 are cut out at
recess 174 to allow the overlapping portions of the knife portions
110 of the inner segments 104 discussed below to easily overlap the
knife portions 110 of the outer segments 102 when the inner
segments 104 are pushed into position. Additionally, the outer
segments 102 are provided with pin receiving grooves 176 for
pinning the outer segments 102 to the inner segments 104. The
grooves 176 will allow the inner segments 104 to follow a defined
path of movement during the expansion and contraction as well as
pull the outer segments 102 towards the retracted position when the
inner segment pin 178 reaches the radially inner extent of the
groove 176 during the retraction of the expandable head 90.
[0070] In view of the complex shape, it is expected that the
segments 102, 104 may most easily be formed of an injection molded
plastic design, however, any construction technique and material is
contemplated.
[0071] FIG. 5e illustrates a plan view of the inner segments 104
for the expandable head 90 in FIGS. 2a and 2b. The inner segment
104 additionally includes staple receiving slots 108 in two annular
arrays similar to the staple receiving slots 108 formed in the
outer segment 102. Furthermore, the inner segment 104 includes a
groove 160 on the radially inner edge thereof receiving an annular
knife portion. As illustrated in FIGS. 5e and 5f, the annular knife
portion 110 of the inner segment 104 extends beyond the edges of
the segment 104 to provide on overlapping blade section which would
be received in the recess 174 of the outer segments 102 shown in
FIG. 5a. As discussed above, this construction ensures the
overlapping of the knife portions 110 to form a complete annular
knife blade ring 178. The inner segments 102 will additionally
include the pins on the sides thereof for engaging with grooves 160
formed on the sides of the outer segment 102 thereby keying the
segments 102, 104 together.
[0072] As shown in FIG. 5g, the inner segment 104 will additionally
include a firing mechanism comprised of a base plate 162 with
staple projections extending vertically upward into the staple
receiving slots 108. The base plate 162 will also be coupled to the
knife portion 110 at spaced locations by L-shaped arms (not shown)
extending through slots (not shown) in the same manner as in the
outer segments 102 disclosed above in FIGS. 5a and 5c.
[0073] The inner segments 104 additionally include a beveled
T-shaped slot 180 receiving a wedge rod 182 and wedge element 106
therein which operates to move the inner segments 104 and the outer
segments 102 for expanding and contracting the head 90. The
T-shaped slot 180 is intended to be just one configuration for
tying the movement of the segments 102, 104, both in the expansion
and retraction mode, to the movement of the controlling wedge rod
182 and attached wedge element 106. Other mechanical connections
and actuation mechanisms are contemplated within the scope of the
present invention. However, it is believed that the simple
mechanical coupling of the components as illustrated is generally
preferable to a spring-biasing operation which may not be
successful if the forces of the operating spring do not overcome
friction or other forces in the stapling environment. Consequently,
it is believed that the operating mechanism of the present
invention provides a mechanically simple and highly reliable method
for actuating and moving the expandable head 90.
[0074] It will be appreciated that the specific construction of the
inner and outer segments 102, 104 are not limited to the shapes
illustrated. The general construction can be expanded to any
segment shape such as those illustrated in FIGS. 4a, 4b or many
other shapes that can be contemplated for forming an expandable
head 90 for a stapler 100.
[0075] FIGS. 6a-6e illustrate the details of an intraluminal
anastomotic stapler 100 with an expanding head 90 illustrated in
FIGS. 2a and 2b as well as an expanding anvil 120 illustrated in
FIGS. 3a and 3b. The stapler 100 looks essentially like a
conventional EEA stapler having an elongated body 190 of generally
circular cross-section further including the expanding head 90 and
anvil 120 at a distal end thereof. The expanding anvil 120 will
have a length slightly longer than an anvil of a conventional EEA
to accommodate the expanding anvil mechanism. At the opposite end
of the body 190, the stapler 100 will have generally conventionally
shaped controls 192, 194 for advancing and retracting the anvil 120
relative to the head 90 and for firing of the staples 14.
Specifically, a rotatable controller 192 is utilized for expanding
and contracting the anvil 120 and clamping the lumen sections 10
and 12 together and a pair of pivoted firing grips 194 are utilized
for firing the staples 14. Additionally, the stapler 100 may
include a known safety release (not shown) which does not allow the
staples 14 to be fired unless the anvil 120 is in an acceptable
proximity of the head 90. This safety mechanism may also be tied to
the expanding mechanism, to be described, such that the firing of
the staples 14 would not be possible unless the head 90 and anvil
120 are also expanded to the appropriate expanded, firing
positions.
[0076] With regard to the expansion control, a pair of finger grip
controllers 196 extend from opposite sides of the housing or body
190 extending from a Z-shaped slot 198. When desired to expand, the
user can grip one or both expansion controllers 196, pivot them
slightly out of the retracted position (i.e., one leg of the
z-shaped slot 198) moving axially along the length of the housing
in a axial portion of the Z-shaped slot 198 and then when fully
expanded move the controllers 196 into the upper leg of the
Z-shaped slot 198 to hold the anvil 120 and head 90 in the fully
expanded position. After firing, the process can be reversed for
retracting both the anvil 120 and head 90. It will be appreciated
that within this construction, the outer diameter of the body 190
can be formed approximately equal with the diameter d.sub.1 of the
lumen sections 10 and 12 to be anastomized. It will be understood
that the expanded head 90 and anvil 120 will expand the lumen
sections to a stretched condition such that the anastomized ring
will be formed at a diameter d.sub.3, preferably at least as great
as the normal unstretched diameter d.sub.1 of the lumen sections 10
and 12 to be anastomized.
[0077] FIG. 6b is a sectional view of the controlling portion taken
along two radial sections offset 90 degrees to best illustrate the
expansion, clamping and firing controls (196, 192, 194) of the
present invention.
[0078] As shown in FIGS. 6b and 6c, for at least a portion of the
housing or body 190, the operating mechanisms are formed of a
series of concentric independently operated sleeves for controlling
the various functions of the stapler 100 of the present invention.
It should be understood that the sleeves are intended for limited
axial motion along the length of the body 190 and may be formed of
either a rigid or slightly flexible material. In other words, the
body 190 may have a certain curvature along its length, as is known
in the art, and the operating mechanism can be made of a material
to accommodate such curvature.
[0079] Beginning next to the annular housing or body 190 is a
firing ring 200 which is utilized for actuating the firing
mechanisms in the individual head segments 102, 104. At one end of
the axially movable firing ring 200, a series of the firing or
actuation rods 172 are attached which extend from the firing ring
200 to each individual base plate 162 of each individual segment
102, 104. The firing rods 172 can be pivotally attached to the
firing ring 200 and segments 102, 104 or the rods 172 can be formed
sufficiently flexible to accommodate the outward movement of the
associated segments 102, 104. The opposite end of the firing ring
200 includes a pair of L-shaped legs 202, only one of which is
shown in FIG. 6b, attached to the individual firing grips 194. As
can be easily understood by viewing FIG. 6b, when the firing grips
194 are pulled, the legs 202 in the firing ring 200 will be moved
axially along the body 190 moving the rods 172, axially along the
body thereby pushing the associated base plates 162, firing the
individual staples 14 and actuating the individual knife portions
110. It should be appreciated by those of ordinary skill in the art
that a wide variety of changes to the firing mechanism can be
envisioned. For example, a pull trigger could easily replace the
firing grips 194. The firing grips 194 are illustrated since this
represents a known acceptable operating mechanism. As discussed
above, a safety latch mechanism can be incorporated, if desired, to
avoid premature firing of the staples 14. The construction of such
safety devices is certainly known to those of ordinary skill in the
art.
[0080] Radially adjacent the firing ring 200 is an independently
movable wedge ring 210 for moving the head segments 102, 104 as
will be discussed. At a forward end of the wedge ring 210 are a
series of the longitudinally extending wedge rods 182. The wedge
rods 182 and wedge elements 206 combined have a beveled T-shape
which is engaged in the T-shaped slot 180 of the inner segments 104
for radially moving the segments 102, 104 as the associated wedge
rod 182 and wedge element 106 are moved longitudinally back and
forth along the body 190. As illustrated in FIG. 6d, there is one
wedge element 106 associated with each inner segment 104. On the
opposite end of the wedge ring 210 the wedge ring 210 is secured to
the pair of opposite extending controllers 196, only one of which
is shown in FIG. 6b, by an arm 212 or a linkage, again only one of
which is shown in FIG. 6b. As can be most apparent in FIG. 6b,
longitudinal movement of the controller 196 will move the
connecting linkage arm 212, the wedge ring 210 and the associated
wedge rod 182 and wedge element 106 for radially moving the head
segments 102, 104 between the fully extended position shown in FIG.
2a and the fully retracted position illustrated in FIG. 2b.
[0081] Radially adjacent the wedge ring 210 is an anvil stem rod
220 moving linearly in the body 190 for moving the anvil 120 into
and out of a clamping position relative to the head 90. At one end
of the anvil stem rod 220 is a generally disc-shaped actuator 222
threadedly engaging inner threads 224 on the rotatable controller
192. The rotatable controller 192 is attached to the housing in a
manner that allows for rotation such that rotation of the
controller 192 will axially move the actuator 222 and the anvil
stem rod 220 for moving the anvil 120 essentially in a conventional
fashion. As shown in FIG. 6e, a distal end of the anvil stem rod
220 has a snap fit connection 226 with an annular anvil connector
228 allowing the anvil 120 to be released from the body as known in
the art.
[0082] Finally, returning to FIG. 6b, the innermost control
mechanism is an anvil expanding rod 230 axially movable in the body
90 and adapted for expanding the anvil segments 102, 104 between
the retracted and expanded positions. The control end of the anvil
rod 230 is connected to the expanding controller 196 through a
pivoting linkage 232 and a connecting arm 234. This mechanism
allows the axial movement of the controller 196 to be associated
with an opposite movement of the expanding anvil rod 230. A distal
end of the expanding anvil rod 230 includes a connector 236 having
a bayonet type connection with an anvil wedge rod 238 as shown in
FIG. 6e. The anvil wedge rod 238 is associated with four wedge rod
elements 240 which support the wedges 128 received in grooves in
the inner anvil expanding segments 122 as shown in FIG. 6e. It will
be appreciated that in the illustrated embodiment the expanding
anvil rod 230 and the anvil wedge rod 238 will only be in a secure
fitting relationship when the anvil 120 is appropriately clamped
against the head 90. With this construction, it may be helpful to
have the anvil wedge rod 238 and the associated segments 102, 104
be spring-biased to the retracted position so that there is a
retracting biasing force when the expanding anvil rod 230 is not
engaged with the anvil wedge rod 238.
[0083] It should be appreciated that other constructions are
certainly anticipated, such as having the wedge rod 238 and the
expanding anvil rod 230 always coupled when the anvil stem rod 220
and annular anvil connector 228 are connected. In this
modification, the anvil expanding rod 230 and the anvil stem rod
220 will need to be moved together. The anvil stem rod 220 is moved
relative to the body 190 by rotation of the controller 192. In this
modification, the movement of the anvil stem rod 220 can be
accommodated by moving the pivoting linkage 232 and the expanding
anvil rod 230 with the anvil stem rod 220 and having a lost motion
or motion accommodating mechanism be added to the connecting arm
234 to accommodate the change in relative position. One simple
example of such a mechanism is illustrated in FIGS. 10 and 11 and
essentially includes forming the connecting arm 234 as a
telescoping rod having first and second portions 234A and 234B,
respectively. The first and second portions 234A and 234B are
releasably pinned together with a spring-biased release pin 235
being released by a button 237 (upon which the spring 241 acts) on
the body 190 when the controller 192 is desired to be rotated. With
such a spring-biased release button 237 and pin 235, the pin 235 is
automatically reinserted to connect the first and second
telescoping portions 234A and 234B of the arm 234 such that the
connecting arm 234 would accommodate the changed length. This
embodiment additionally illustrates the use of a releasable lock or
transmission between the expanding anvil rod 230 and the anvil stem
rod 220. The releasable transmission or lock is in the form of a
mating pin 247 extending from the lower end of the controller 196.
The mating pin 247 extends into generally identically shaped slots
249 formed in both the expanding anvil rod 230 and the anvil stem
rod 220. As shown in FIG. 11 the edges of the slot 249 include
mating surfaces that will engage and mechanically lock with the
mating pin 247. The slots are designed such that the locking or
mating will occur when the controller 196 is in the far left or
right radial positions in the z-shaped slot (e.g. when the
controller 196 is in the top or bottom leg portions of the z shaped
slot) as shown in positions A and B in FIG. 11. When the controller
196 is in the center of the Z-shaped slot for longitudinal movement
the pin 247 will be disengaged from the edges of the slot 249 as
shown in position C allowing for the relative movement between the
expanding anvil rod 230 and the anvil stem rod 220. It will be
understood that this transmission will require modification of the
Z-shaped slot to accommodate movement of the controller due to
axial movement of the anvil, such as increasing the width of the
bottom leg of the z in the z shaped slot. This will additionally
provide a visual indicator of the relative axial position of the
stem prior to expansion of the anvil. This embodiment could utilize
the motion accommodating mechanism without the mechanical lock or
transmission or the mechanical lock may be used in other EEA
staplers as merely a stem position indicating mechanism. This
embodiment is described to show the possibility of such a
construction.
[0084] It should be appreciated that the intraluminal end to end
anastomotic surgical stapler 100 illustrated in FIG. 6a is utilized
in essentially the same manner as existing anastomotic devices with
the addition of an expansion and retraction step. Specifically, the
stapler 100 is inserted into one lumen section 10 or 12 to be
anastomized with the anvil 120 and head 90 either spaced apart or
separated as desired by the user. Purse strings attached to the
lumen sections 10 and 12 can secure the segments 10 and 12 around
the anvil stem rod 220 and/or the anvil connector 228. The
controller 196 is rotated to move the anvil 120 and head 90 into at
least an initial clamped position. At this point, the anvil 120 and
head 90 can be expanded to their extended positions and the staples
14 fired. Following firing, the staples 14 will form a enlarged
anastomotic ring in the connected lumen sections 10 and 12 with the
knife portions 110 trimming off the inner diameter of the lumen
sections 10 and 12 secured to the stapler 100 with the purse
strings. The head 90 and anvil 120 can be returned to the retracted
position following the loosening of the clamped sections to allow
the removal of the stapler 100.
[0085] The present invention operates essentially the same as
existing end to end anastomotic devices with a significantly
enlarged anastomosis ring. Specifically, the area at the
anastomosis site is not decreased or reduced relative to the normal
diameter of the anastomized sections.
[0086] FIGS. 7a and 7b illustrate an extraluminal end to end
surgical stapler 300 according to the present invention. The
stapler 300 is intended to form anastomized lumen sections with an
externally located anastomosis ring relative to the lumen sections
10 and 12 illustrated in FIG. 1c.
[0087] The stapler 300 according to the present invention includes
two separate stapling units 310, with each stapling unit 310
generally including two semi-circular sections 320, 322 hinged
together by a hinge 324 extending along the length of the stapling
unit. One stapling unit 310 is shown in FIG. 7a. In a preferred
embodiment of the present invention, one half of each stapling unit
310 is formed as an anvil 320 having conventionally positioned
staple receiving grooves 126 staggered thereon. The other
semi-circular section 322 includes staples 14 and knife portion
110. The section 322 includes a series of staple receiving slots
108 for the staples 14 and a knife receiving groove 160 with the
semi-circular knife portion 110 received in the groove 160. The
staples 14 and knife portions 110 can be fired with a firing
mechanism essentially the same as illustrated in the segments 102,
104 shown in FIGS. 5a-5g and therefore need not be discussed in
detail. One difference is that the groove 160 is at the radially
outer edge rather than on the radially inner edge. A firing rod 172
is attached to a base plate 162, not shown, and can be directly
connected through the housing 333 to a linkage (not shown)
associated with a firing trigger. The anvil and head sections 320
and 322 shown in FIG. 7a form one entire stapling unit 310 which
forms one-half of the stapler 300. Another identical stapling unit
310 would be attached in an opposite face to face engagement (as
shown in FIG. 7b.). Each staple and knife firing head section 322
is associated with the anvil section 320 of the opposite stapling
unit 310, and vice versa. In other words, half of the staples 14 of
the complete anastomosis ring would be fired from one direction and
the other half would be fired by the other stapling unit 310 in the
opposite direction. Each stapling unit 310 includes alignment
mechanisms for combining with the opposite stapling unit 310 to
complete the pair of the stapler 300. The alignment mechanisms can
be easily constructed as a rod 330 extending from one section 320
which is received in a locking projection 332 formed on an opposite
section 322. This construction will allow for easy alignment and
attachment of the opposed stapling units 310.
[0088] Another key aspect of the present invention is a tissue
holding mechanism for pulling the tissue of the lumen sections 10
or 12 to be attached over the operating face of the stapling units
310. As will be appreciated by those of ordinary skill in the art,
with such an extraluminal stapler 300 as disclosed, purse strings
would not be very efficient for positioning of the lumen sections
10 and 12 to be attached on the stapler 300. To accomplish the
positioning of the tissue, each stapling unit 310 includes a
plurality of tissue retraction members 340 spaced around the
periphery of each stapling unit 310. The tissue retraction members
340 are in the form of hooks 342 formed at the end of cables 344 at
circumferentially spaced locations. The cables 344 extend along
grooves formed in the body 190 back to a central controlling
structure 350 in the form of an axially movable stud 352 controlled
by a rotatable controller 354 journaled to the body 190. It should
be evident that rotation of the controller 354 will axially move
the stud 352 allowing the cables 344 to be pulled out of the body
190 or retracted back into the body 190. With this construction,
the hooks 342 can be pulled out and clipped onto the tissues at
circumferentially spaced locations around the lumen section 10 or
12 and the controller 354 can be rotated to pull the hooks 342 and
the associated tissue back until tissue is surrounding the
operating face of the one stapling unit 310.
[0089] It is anticipated that certain tissue may not be efficiently
stretched by a hook 342 attached at a single location (i.e., it may
tear). To eliminate this, the present invention contemplates
flexible clips 360 attached to the edge of the lumen sections 10 or
12 such as shown in FIGS. 8a-8e. The clips 360 are formed of a
flexible hinged strip of material that can be secured around the
edge of the resected lumen section. As shown in FIGS. 8c-8e, one
simple construction for forming the clips 360 is to provide a
series of piercing projections 362 on one side of the clip 360
which engage in snap fit receiving holes 364 on the opposite side
of the clips 360 such that the clips 360 can be easily press fit in
position in a fast and secure manner. The clips 360 include a pair
of eyelets 366 at spaced locations thereon with the eyelets 366
forming a connection point for the associated hooks 342 of each
stapling unit 310. The purpose of the clips 360 is to provide
rigidity to the end of the lumen sections 10 or 12 being pulled and
to distribute the stresses of pulling on the lumen section 10 or 12
across a greater area to avoid damaging the lumen section 10 or 12
and to easily pull the lumen section 10 or 12 into the extended
position around the face of a stapling unit 310.
[0090] In operation, the extraluminal stapler 300 illustrated in
FIGS. 7a and 7b operates as follows. After the resected portion of
the lumen is removed and the two remaining lumen sections 10 and 12
are to be attached, two separate stapling units 310 forming a
combined stapler 300 are attached with one unit 310 around each
lumen section 10 or 12. Clips 360 are positioned around the edge of
each lumen section 10 or 12 as illustrated in FIG. 8a and the
controller 354 is rotated to release the cables 344 to allow enough
slack to attach the hooks 342 to the eyelets 366 of the clips 360.
Once the eyelets 366 are attached to the associated clips 360, the
controller 354 can be rotated retract the cables 344, the hooks 342
and the associate clips 360 properly positioning the lumen section
10 or 12 over the operating face of the associated stapling unit
310. Following this, the stapler 300 of the present invention
allows for visual inspection to assure that the lumen is properly
positioned prior to snapping the two stapling units 310 together
using the alignment mechanisms formed by rod 330 and locking
projection 332. The alignment mechanisms will preferably snap or
hold the two stapling units 310 together at a position sufficient
for firing. It will be understood that an appropriate safety
mechanism can be associated so that the staples 14 could not be
fired until the opposing stapling unit 310 is secured thereto. Once
the opposing stapling unit 310 is secured, the staplers 14 on both
halves (i.e., in both stapling units 310) can be fired performing
the anastomosis. Following this, the two stapling units 310 can be
removed from each other and each independently opened and the
external stapler is removed from the anastomized lumen.
[0091] The use of an alignment mechanism for aligning the head and
anvil portions of EEA staplers such as shown in staplers units 310
would also be beneficial for internal EEA staplers such as shown in
FIGS. 6a-e. The present invention contemplates an alignment
mechanism 400 associated with such an EEA stapler as schematically
shown in FIG. 9. The alignment mechanism 400 essentially includes a
plurality of locking pins 402 associated with each head segment 102
and 104. The locking pins 402 are received in mating holes 404 on
the associated anvil segments 122 or 124. The holes 404 preferably
have a beveled outer surface to receive and guide the locking pins
402 into the holes 404. With the locking pins 402 received in the
holes 404 the head and anvil portion of the stapler will be
properly aligned. The pins 402 may be moved by the same firing
mechanism as the staples and the blade as shown in FIG. 9. A
separate pin movement mechanism may also be provided. It is
important that the pins 402 be engaged with the holes 404 prior to
the engagement of the staples or the knife blade with the lumen
tissue, since it is the pins 402 which are assuring the alignment
of the head and anvil portions. Consequently where a single firing
mechanism is utilized the pins 402 should be axially ahead of the
staple and knife blade portions as shown in an exagerated fashion
in FIG. 9. Another feature of the present invention is to offset
the anvil segments and the head segments such that the pins 402 of
each head segment will lock the head segment to two corresponding
overlapping anvil segments. This will effectively interlock all of
the head and anvil segments during firing to provide a conventional
solid hoop structure for these components during the staple firing
and knife trimming operation. It should be apparent that this
alignment mechanism 400 will be applicable to EEA devices that do
not have separate head and anvil segments.
[0092] Various modifications to this invention are contemplated
within the scope of the present invention. For example, additional
clamping between the stapling units 310 may be accomplished by
having the alignment mechanism on each stapling unit 310 (i.e., the
rod 330 and locking projection 332) be independently axially
movable such that when the two stapling units 310 are clamped
together, axial movement of the associated alignment mechanism will
move the two stapling units 310 closer together (or farther apart)
to accommodate the desired clamping. Another modification of the
present invention would be to connect the firing of one stapling
unit 310 to the firing of the other stapling unit 310, such as
through the associated alignment mechanism, so that the user need
only pull one trigger 334 to fire the two halves of staples 14.
Another modification to the present invention would be to form the
separate units as having an entire array of staples on one stapling
unit 310 and two anvil portions on the other stapling unit 310.
However, the present invention simplifies the manufacturing of the
stapler 300 by forming an entire stapler 300 of two identical
stapling units 310. Regardless, these and other modifications make
it clear that various changes to the present invention can be
accomplished without departing from the spirit and scope thereof.
For example, the staples 14 could be replaced with another type of
fastener. The described embodiments are merely intended to be
illustrative of the present invention and not restrictive thereof.
The scope of the present invention is intended to be defined by the
appended claims and equivalents thereof.
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