U.S. patent application number 10/009138 was filed with the patent office on 2005-03-10 for flexible annular stapler for closed surgery of hollow organs.
Invention is credited to Toledano, Haviv.
Application Number | 20050051597 10/009138 |
Document ID | / |
Family ID | 22797545 |
Filed Date | 2005-03-10 |
United States Patent
Application |
20050051597 |
Kind Code |
A1 |
Toledano, Haviv |
March 10, 2005 |
Flexible annular stapler for closed surgery of hollow organs
Abstract
A improved flexible annular stapler for joining annular organs
(163, 164) is disclosed. The novel stapler features greater
accuracy of operation and better control by the operator, as well
as additional functions, such as internal illumination (76) and
viewing facility (82), and accommodation of a large number of
accessories, such as fibroscopes (90) and catheters. The novel
stapler features easy attachability of both stapling jaws (18, 25)
and easy detachability of the head (11). The novel features of the
flexible stapler, and associated methods performed thereby, are
particularly useful for closed surgery.
Inventors: |
Toledano, Haviv; (Kiryat
Bialik, IL) |
Correspondence
Address: |
Haviv Toledano
c/o David Metzman
693 Downing Street
Teaneck
NJ
07666
US
|
Family ID: |
22797545 |
Appl. No.: |
10/009138 |
Filed: |
November 26, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10009138 |
Nov 26, 2001 |
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09214039 |
Dec 28, 1998 |
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09214039 |
Dec 28, 1998 |
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PCT/IB97/00887 |
Jul 17, 1997 |
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Current U.S.
Class: |
227/176.1 |
Current CPC
Class: |
A61B 17/115 20130101;
A61B 17/1114 20130101 |
Class at
Publication: |
227/176.1 |
International
Class: |
A61B 017/10 |
Claims
What I claim is:
1. A flexible annular surgical stapler for stapling together two
parts of hollow organs, the stapler comprising (a) an elongated
flexible tubular body having two ends; (b) a handle attached to a
first end of said body; (c) a first jaw having an axial jaw hole
therethrough and two faces, a first of said faces being attached to
the second end of said body; (c) a flexible cable slidably disposed
inside said body and through said jaw hole, said cable consisting
of two portions, a first of said portions defining an end segment,
at least part of which protrudes from the second of said faces of
said first jaw; and (d) a second jaw, forming a head, being
attachable to said end segment; said jaw hole having a non-circular
cross-sectional shape and said end segment having a complementary
cross-sectional shape such as to allow easy sliding of said end
segment through said hole while keeping their mutual angular
orientation about the axis of said hole fixed; wherein one of said
first and second jaws includes a hammer and the other of said first
and second jaws includes an anvil.
2. The stapler of claim 1, wherein said head has an axial head
hole, said head hole having a cross-sectional shape such as to
accomodate said end segment, while keeping the mutual angular
orientation of said head and said end segment about the axis of
said end segment essentially fixed.
3. The stapler of claim 1, wherein said end segment is stiffer than
the second one of said two portions of said cable.
4. The stapler of claim 3, wherein said end segment is an extension
rod, which is formed separately from said second portion of said
cable and which is attached thereto.
5. The stapler of claim 1, wherein said handle includes (i) a
housing attached to the second end of said body, (ii) an elongated
externally threaded member disposed inside said housing and
attached to the second portion of said cable, (iii) a turning
assembly, which includes an internally threaded member that engages
said externally threaded member, and a knob outside said housing,
and (iv) a lever assembly, which includes a manually pressable
lever; said turning assembly being operative, upon turning of the
knob, to cause said cable to slide along said body, and said lever
assembly being operative to keep said turning assembly at a fixed
axial position relative to said housing, when said lever is not
being pressed, and to pull said turning assembly axially away from
said body, when said lever is being pressed.
6. The stapler of claim 1, wherein said head is attachable to said
end segment by a snap coupling.
7. The stapler of claim 6, wherein said head further includes means
for detaching said head from said end segment.
8. The stapler of claim 7, wherein said means for detaching can be
activated electrically.
9. The stapler of claim 7, wherein said end segment has an axial
end hole therethrough and further including a guide wire attached
to said head and insertable into said end hole.
10. A flexible annular surgical stapler for stapling together two
parts of hollow organs, the stapler comprising (a) an elongated
flexible tubular body having two ends; (b) a handle attached to a
first end of said body; (c) a flexible cable slidably disposed
inside said body having two ends, a first end being inside said
handle; and (d) a head attached to the second end of said cable and
including an end cap; said cable having, over its entire length, a
passageway therethrough for insertion of one or more additional
tools or parts thereof.
11. The stapler of claim 10, wherein each of said tools is one
of--an illuminator, a fibroscope, a video camera a catheter or an
ultrasonic probe.
12. The stapler of claim 10, further comprising an ultrasonic
transducer for ultrasonically probing tissue near said head.
13. The stapler of claim 12, wherein said ultrasonic transducer is
attachable to said head.
14. The stapler of claim 10, further comprising an illuminator for
illuminating tissue near said head.
15. The stapler of claim 14, wherein said end cap is translucent
and said illuminator includes a light source disposed inside said
end cap.
16. The stapler of claim 14, wherein said illuminator includes an
optical fiber disposed inside and along said passageway.
17. The stapler of claim 1, wherein said head further includes a
translucent end cap and a light source disposed inside said end
cap.
18. The stapler of claim 10, further comprising imaging optics for
viewing tissue near said head, said imaging optics including a
coherent fibers bundle disposed inside and along said
passageway.
19. The stapler of claim 18, wherein said fibers bundle has an open
end protruding from said first end of said cable, the stapler
further comprising a viewing assembly, attachable to said handle so
as to be optically coupled to said open end of said bundle at a
constant distance therefrom.
20. The stapler of claim 10, further comprising a video camera, for
viewing tissue near said head.
21. The stapler of claim 20, wherein said video camera is
attachable to said head.
22. The stapler of claim 10, wherein said passageway is further
operative to pass air or fluid to said end cap or to a balloon
attached thereto.
23. A method for joining two parts of hollow organs over an annular
area defined on a plane in each of the two parts, whereby each part
has an opening through the respective plane essentially inside the
respective annular area, the method sequentially comprising the
steps of (a) providing a flexible annular stapler having two round
jaws; (b) inserting said jaws into a first one of the two parts and
advancing said jaws to where one jaw is inside the first part and
the other jaw is inside the second one of the two parts, each jaw
being substantially near the respective plane; (c) for each of the
two parts, shrinking the opening so as to form an at least
partially closed butt that encloses the respective one of said
jaws; and (d) operating said annular stapler so as to pull the two
said butts together and essentially combine the two annular areas
into a combined annular area, to staple the two organs or segments
to each other over said combined annular area and to cut away
portions of said butts that are central to said combined annular
area.
24. The method of claim 23, wherein said inserting is effected
through a natural opening of the patient's body.
25. The method of claim 23, wherein said shrinking includes, with
respect to each of the two parts, pressing the tissue surrounding
the opening to form a pair of adjoining lips and stapling said lips
together by means of a linear stapler.
26. The method of claim-23, wherein any of steps (b) through (d)
are carried out under conditions of closed surgery.
27. The method of claim 23, wherein at least one additional
surgical operation is performed between steps (a) and (d).
28. A method for joining two parts of hollow organs over an annular
area defined on a plane in each of said two organs or segments, the
method comprising the steps of (a) providing a flexible annular
stapler having a flexible body, two round jaws and a flexible cable
slidable through said body and through a first one of said jaws and
having an end protrudable from said first jaw, said second one of
said jaws being attachable to said end of said cable, said second
jaw being initially detached; (b) inserting said first one of said
jaws into a first one of the two parts of hollow organs, advancing
said first jaw to where it is inside the first part near the
respective plane and causing said end of said cable to protrude
from said first part; (c) introducing said second jaw and attaching
it to said end of said cable; (d) having said second jaw inside the
second one of the two parts of hollow organs and having each of the
two parts form an at least partially closed butt at or near the
respective plane, said butt enclosing the respective one of said
jaws; and (e) operating said annular stapler so as to pull said two
butts together, to staple the two organs or segments to each other
over the annular areas and to cut away portions of said butts that
are central to the annular area.
29. The method of claim 28, wherein said inserting is effected
through a natural opening of the patient's body.
30. The method of claim 28, wherein any of steps (b) through (e)
are carried out under conditions of closed surgery.
31. The method of claim 28, wherein at least one of the two parts
of hollow organs has an opening through its respective plane
essentially inside the respective annular area, the method further
comprising, for each of the two parts, the step of shrinking the
opening so as to form an at least partially closed butt.
32. The method of claim 28, wherein said shrinking includes, with
respect to each of the two parts, pressing the tissue surrounding
the opening to form a pair of adjoining lips and stapling said lips
together by means of a linear stapler.
33. The method of claim 28, further comprising, prior to step (c),
the step of causing said end of said cable to protrude into the
second one of the two parts of hollow organs.
34. The method of claim 28, wherein at least one surgical operation
is performed between steps (a) and (e).
35. A method for joining two parts of hollow organs over an annular
area defined on a plane in each of the two parts, under conditions
of closed surgery performed on a patient, the method comprising the
steps of (a) providing a flexible annular stapler having a flexible
body, two round jaws and a flexible cable slidable through said
body and through a first one of said jaws and having an end
protrudable from said first jaw, the first one of said jaws being
attachable to said body and the second one of said jaws being
attachable to said end of said cable, both of said jaws being
initially detached; (b) inserting said flexible body through the
patient's body wall; (c) introducing said first jaw through the
patient's body wall and attaching it to said flexible body; (d)
introducing said second jaw through the patient's body wall and
attaching it to said end of said cable; (e) having said first jaw
inside the first one, and said second jaw inside the second one, of
the two parts of hollow organs and having each of the two parts
form an at least partially closed butt at or near the respective
plane, said butt enclosing the respective one of said jaws; and (f)
operating said annular stapler so as to pull said two butts
together, to staple the two organs or segments to each other over
an annular area and to cut away portions of said butts that are
central to said annular area.
36. The method of claim 35, wherein at least one of the two parts
of hollow organs has an opening through its respective plane
essentially inside the respective annular area, the method further
comprising, for each part having an opening, the step of shrinking
the opening so as to form an at least partially closed butt.
37. The method of claim 33, wherein said shrinking includes
pressing the--tissue surrounding the opening to form a pair of
adjoining lips and stapling said lips together by means of a linear
stapler.
38. The method of claim 35, further comprising, prior to step (c),
the step of having said flexible body protrude into one of the two
parts.
39. The method of claim 35, further comprising, prior to step (d),
the step of having said end of said cable protrude into one of the
two parts.
40. The method of claim 35, wherein at least one surgical operation
is performed between steps (a) and (f).
Description
[0001] The present invention relates to excision of a section of a
hollow or tubular soft organ, such as the digestive tube, and
rejoining the remaining ends and, more particularly, to methods for
performing these operations under conditions of closed surgery,
using a flexible annular stapling and cutting instrument. The
invention also relates to an improved construction of such an
instrument.
[0002] Various ailments of the digestive tube, particularly of the
esophagus, the stomach, the small intestines and the colon, such as
tumors, chronic inflammation or other disorders, often require
excision of a portion of the tube, followed by rejoining of the
remaining end segments, through anastomosis to reestablish
continuity of the tube. In some cases it is necessary to thus join
one organ to another; for example, the cut end of the small
intestines may be joined to the colon, or the cut end of the
duodenum may be joined to the stomach. In some other cases, two
organs or two portions of the same organ may be joined side-to-side
(rather than end-to-end or end-to-side, as in the above cases). In
the discussion to follow and in the claims, the terms "parts of
hollow organs" or just "parts" will be used, for brevity, to
collectively denote the two parts to be joined, and the terms "part
of a hollow organ" or just "part"--to denote each of the two parts
to be joined, whether they are truly two different hollow organs or
two segments of the same hollow organ.
[0003] It has been common practice since the end of the '50s to
use, for the purpose of the anastomosis, a suitable annular
stapling and cutting instrument. An example of such an instrument,
to be referred to here below as stapler, is depicted in FIG. 1A.
The stapler basically consists of a tubular main body, at one end
of which is an annular staple gun, while the other end serves as a
handle and has a knob and activation levers thereon. A rod is
slidably disposed inside the tubular body, protruding through the
staple gun and terminating with a round head that contains an
annular anvil. The staple gun contains a set of surgical stapling
pins, arranged in one or two concentric circles and a circular
knife inside these circles. On the face of the anvil are short
grooves, one opposite each staple pin, with arc-like depth profile.
During surgery, this stapler is used, for example, to rejoin end
segments of the intestines after excision, by inserting it through
a longitudinal cut in the side of the intestines and through the
ends of both segments, then annularly folding and temporarily
sewing one end over the face of the gun and one end over the anvil;
the latter operation forms the ends into partially closed
flange-like butts. Subsequently, by turning the knob, the head with
the anvil is pulled toward the face of the gun, thus bringing the
butts into mutual contact. Finally, by activating a lever on the
handle, the staple pins are pushed through the flanges into the
grooves in the anvil until they are bent tight; at the same time,
the circular knife cuts away the inner disks of the two adjoining
flanges, leaving an annular ring as the joint.
[0004] This, conventional, type of stapler has several
shortcomings:
[0005] It always requires an extra, longitudinal, cut; for multiple
excisions, multiple extra cuts are needed.
[0006] It is not suitable for hard-to-reach or complicated portions
of the intestiness, such as those inside the pelvis, nor for the
duodenum; operation on the esophagus or the stomach is
difficult.
[0007] It is suitable almost only for end-to-end joints.
[0008] The temporary sewing of the butt ends is difficult and the
depth of the resulting flanges is small, thus risking leakage.
[0009] French patent FR 9204490 to the present applicant, which is
incorporated into the present disclosure by reference, discloses a
novel annular stapler that differs from the one described hereabove
essentially in the following (see FIG. 1B for an external view and
FIG. 1C for a longitudinal-sectional view): The main, tubular, body
consists of a flexible hose 26, which can be of any length and to
one end of which an anvil assembly 18 is attached. Through hose 26
is slidably disposed a flexible cable 21, one end of which is
pointed and to which a head 11 is attachable. The other end of
cable 21 is attached to a handle 30 by means of a long screw 52,
engaged by a nut 51, which is connected to a knob 46 so that
turning the knob causes the cable to slide along the hose and
thus--the head to move with respect to the anvil. The head contains
a cartridge with staple pins and a rigid hammer assembly 15 (to be
refrred to as hammer) that includes fingers, to push the pins, and
a circular knife. Hammer 15 is connectable to the end of cable 21
by a screw-like arrangement. Connected to the hammer through a
spring is an annular base plate, which holds the cartridge of pins
and has slots for passage of the pins. Cable 21, which may be
hollow, has a flat outer surface, which matches a flat in the shape
of a central hole in anvil 18 through which the cable slides; this
is in order to keep the head angularly aligned with respect to the
anvil prior to stapling. In handle 30 there is a window 54, through
which a millimeter scale 42, attached to cable 21 is viewable,
together with a fixed pointer. Operation of this stapler is similar
to that of a conventional one, except that the stapling and cutting
operation, after the two butts have made contact, is actuated
automatically by continued turning of the knob (rather than
activating a lever.
[0010] This novel stapler avoids the shortcomings of the
conventional one, listed hereabove. In particular, it enables
reaching any segment of the digestive tube--either through a
natural opening (mouth or anus) or through a single, conveniently
located cut. It also enables end-to-side or side-to-side
joints.
[0011] Even so, the novel stapler of French patent FR 9204490 (to
be referred to as the French patent) still has a few shortcomings
and many as yet unrealized potentialities. One shortcoming is that
in the disclosed construction there is an appreciable length of
cable between the point at which the cable emerges from the anvil
and the point at which it enters the head structure, even when
these two components are at their closest approach. This may allow
some twist in the cable and consequently some angular misalignment
between the staple pins in the head and the grooves in the face of
the anvil, which may cause malfunctioning of the stapling action.
Likewise, because of uneven back pull of an intestinal butt, the
faces of the two components may not be parallel, or may not be
axially aligned prior to the stapling action, which, again, could
cause malfunction. Another shortcoming of the instrument is in the
operation of the handle; turning the knob may not be the optimal
way to activate the stapling and cutting operation. Yet another
shortcoming is the difficulty with which the head or anvil and are
attachable or detachable, making such operations within the body,
as would be advantageous in certain procedures, close to
impossible.
[0012] The unrealized potentialities are mainly associated with a
new possible mode of its employment, a mode that was not
contemplated in the French patent but is the subject of the present
invention, namely closed surgery. The practice and techniques of
closed surgery, such as laparoscopy and thoracoscopy, have made
tremendous progress over the past five years and many surgical
procedures on internal organs are now carried out in this mode.
Whereas in conventional, open, surgery, a relatively large incision
is made in the abdominal wall or chest, closed surgery is
characterized by insertion of very thin tools through otherwise
intact walls--usually with the aid of small tubular ports, called
trocars, which also serve to seal the openings during operation.
Some of these tools serve for viewing and usually include a video
system so that the entire operation is viewed and monitored on a
video screen. The main advantages of closed surgery are (a) the
much reduced trauma, resulting in fewer complications and much
faster recuperation, which, in turn, shortens hospitalization and
costs, (b) reduced risk of infection and (c) considerable reduction
of scars.
[0013] Closed surgery of the digestive tube is also being
practiced. However, because the only practical instrument now
available for anastomosis is the rigid type described hereabove,
which has to be operated under open conditions, the surgery ends up
being, in part, of the open type (such as laparoscopically assisted
surgery) and thus foregoes some of the advantages listed above.
Basically, a flexible stapler, as described hereabove and contrary
to a conventional, rigid, stapler, lends itself to completely
closed surgery (such as laparospcopy and thoracoscopy)., since the
instrument is insertable either through the natural openings or
through a suitable opening in the intact wall and can reach almost
any location. However, such use of a flexible stapler has not yet
been attempted nor, to the best of the inventor's knowledge, even
been suggested. Moreover, there are certain aspects of this type of
surgery that render direct utilization of the instrument, as
disclosed in the French patent, difficult or impractical. For
example, the preliminary circular sewing of the butt ends over the
instrument's head or anvil, difficult even during open surgery, is
close to impossible. Under certain circumstances it is preferable
to place the active part of the instrument in the affected area
prior to excision; it is then difficult to sense its position
within the intestines. Also, there is a need for endoscopy during
the operation and it may be difficult to insert or manipulate both
the endoscope and the flexible stapler simultaneously in the same
tube. A similar difficulty holds for internal ultrasonic
examination.
[0014] Since, as stated, use of a flexible stapler in closed
surgery has not yet been attempted and since, moreover, such an
instrument is not yet available, there has been no clinical
experience with anastomosis in the digestive tube under conditions
of closed surgery and certainly no experience using such an
instrument. Thus, no suitable procedures have so far been
developed, which fact keeps the clinicians and patients from
benefiting from the tremendous potential advantages of the
technology and also hinders potential acceptance by clinicians of
the instruments when they become available.
[0015] There is thus a recognized need for, and it would be highly
advantageous to have, an improved stapler for anastomosis in the
digestive tube that will overcome the shortcomings of presently
known instruments and will, moreover, enable such operation under
conditions of closed surgery. There is, furthermore, a need for
practical methods and procedures for utilizing such an instrument
under conditions of closed surgery.
SUMMARY OF THE INVENTION
[0016] The present invention successfully addresses the
shortcomings of the presently known configurations by providing an
improved and more practical flexible annular stapler, which is
applicable to a wide variety of procedures and surgical conditions,
including closed surgery.
[0017] More specifically, the stapler of the present invention
enables accurate alignment of the head to the anvil during
stapling, more convenient activation of the stapling operation
itself, possibility of introducing into the stapler, or building
into it, various auxiliary tools, such as imagers and catheters,
and easy attachability and detachability of the head and of the
anvil, all of which are particularly advantageous for operation
under conditions of closed surgery.
[0018] The present invention discloses a novel construction of a
flexible annular stapler with a large number of optional features
and attachments. It also discloses novel methods and procedures for
using a flexible stapler, in general, and the improved stapler of
the present invention in particular, for anastomosis of hollow
organs, which methods contribute to more efficient and cleaner
operation.
[0019] According to the present invention there is provided a
flexible annular surgical stapler for stapling together two parts
of hollow organs, the stapler comprising
[0020] (a) an elongated flexible tubular body;
[0021] (b) a handle attached to a first end of the body;
[0022] (c) a first jaw having an axial hole therethrough and two
faces, a first face being attached to the second end of the
body;
[0023] (c) a flexible cable slidably disposed inside the body and
through the hole, the cable consisting of two portions, a first
portions defining an end segment, at least part of which protrudes
from the second face of the first jaw; and
[0024] (d) a second jaw, defining a head, being attachable to the
end segment;
[0025] the hole in the first jaw having a non-circular
cross-sectional shape and the end segment having a complementary
cross-sectional shape such as to allow easy sliding of the end
segment through the hole while keeping their mutual angular
orientation about the axis of the hole fixed;
[0026] wherein one of the first and second jaws includes a hammer
and the other of the first and second jaws includes an anvil.
[0027] According to further features in preferred embodiments of
the invention described below, the end segment of the cable is
stiffer than the rest of the cable and may be formed
separately.
[0028] According to still further features in the described
preferred embodiments, the handle includes
[0029] (i) a housing attached to the second end of the body,
[0030] (ii) an elongated externally threaded member disposed inside
the housing and attached to the second portion of the cable,
[0031] (iii) a turning assembly, which includes an internally
threaded member that engages the externally threaded member, and a
knob outside the housing, and
[0032] (iv) a lever assembly, which includes a manually pressable
lever;
[0033] the turning assembly being operative, upon turning of the
knob, to cause the cable to slide along the body; and the lever
assembly being operative to keep the turning assembly at a fixed
axial position relative to the housing, when the lever is not being
pressed, and to pull the turning assembly axially away from the
body, when the lever is being pressed.
[0034] According to other features of the invention, the head is
attachable to the end segment, and the anvil is attachable to the
body, by a snap coupling.
[0035] According to yet other features of the invention, the cable
has, over its entire length, a passageway therethrough for
insertion of one or more additional tools or parts thereof or to
pass air or fluid to the end cap or to a balloon attached
thereto.
[0036] According to another embodiment, the stapler further
comprises an ultrasonic transducer for ultrasonically probing
tissue near the head, or an illuminator for illuminating tissue
near the head, or imaging optics for viewing tissue near the head,
the imaging optics including a coherent fibers bundle disposed
inside and along a passageway through the cable, or a video camera,
for viewing tissue near the head.
[0037] Also according to the present invention there is provided a
method for joining two parts of hollow organs over an annular area
defined on a plane in each of the two parts, whereby each part has
an opening through the respective plane essentially inside the
respective annular area, the method sequentially comprising the
steps of
[0038] (a) providing a flexible annular stapler having two round
jaws;
[0039] (b) inserting the jaws into a first one of the two parts and
advancing the jaws to where one jaw is inside the first part and
the other jaw is inside the second one of the two parts, each jaw
being substantially near the respective plane;
[0040] (c) for each of the two parts, shrinking the opening so as
to form an at least partially closed butt that encloses the
respective one of the jaws; and
[0041] (d) operating the annular stapler so as to pull the two the
butts together and essentially combine the two annular areas into a
combined annular area, to staple the two organs or segments to each
other over the combined annular area and to cut away portions of
the butts that are central to the combined annular area.
[0042] According to further features of the invention, steps (b)
through (d) are carried out under conditions of closed surgery,
inserting is effected through a natural opening of the patient's
body and shrinking includes, with respect to each of the two parts,
pressing the tissue surrounding the opening to form a pair of
adjoining lips and stapling the lips together by means of a linear
stapler
[0043] An alternative method according to the invention, provides
for joining two parts of hollow organs over an annular area defined
on a plane in each of the two parts, under conditions of closed
surgery performed on a patient, the method comprising the steps
of
[0044] (a) providing a flexible annular stapler having a flexible
body, two round jaws and a flexible cable slidable through the body
and through a first one of the jaws and having an end protrudable
from the first jaw, the first one of the jaws being attachable to
the body and the second one of the jaws being attachable to the end
of the cable, both of the jaws being initially detached;
[0045] (b) inserting the flexible body through the patient's body
wall;
[0046] (c) introducing the first jaw through the patient's body
wall and attaching it to the flexible body;
[0047] (d) introducing the second jaw through the patient's body
wall and attaching it to the end of the cable;
[0048] (e) having the first jaw inside the first one, and the
second jaw inside the second one, of the two parts of hollow organs
and having each of the two parts form an at least partially closed
butt at or near the respective plane, the butt enclosing the
respective one of the jaws; and
[0049] (f) operating the annular stapler so as to pull the two
butts together, to staple the two organs or segments to each other
over an annular area and to cut away portions of the butts that are
central to the annular area.
BRIEF DESCRIPTION OF THE DRAWINGS
[0050] FIG. 1A is an isometric drawing of an annular stapler of
prior art.
[0051] FIG. 1B is an external side view of a flexible annular
stapler of prior art.
[0052] FIG. 1C is a longitudinal sectional view of the stapler of
FIG. 1B.
[0053] FIG. 2 is a longitudinal sectional view of the end portion
of a stapler according to the present invention, showing the anvil,
the head and the end segment of the flexible cable.
[0054] FIG. 3 is a longitudinal sectional view of the handle of a
stapler according to one feature of the present invention.
[0055] FIG. 4A is a longitudinal sectional view of the head and the
cable's end segment of the stapler of the present invention,
configured for illumination.
[0056] FIG. 4B is a longitudinal sectional view of the head of the
stapler of the present invention with an alternative configuration
for illumination.
[0057] FIG. 5A is a side view of the stapler of the present
invention, configured with an optical fiber viewing system.
[0058] FIG. 5B is a longitudinal sectional view of the handle of a
stapler of the present invention, showing a portion of the viewing
system of FIG. 5A.
[0059] FIG. 6 is a longitudinal sectional view of the stapler of
the present invention, configured with a commercial fibroscope.
[0060] FIG. 7 is a longitudinal sectional view of the head and the
cable's end segment of the stapler of the present invention,
configured with a video camera.
[0061] FIG. 8 is a longitudinal sectional view of the head and the
cable's end segment of the stapler of the present invention,
configured with an ultrasonic transducer.
[0062] FIGS. 9A and 9B are a longitudinal sectional view and a
cross sectional view, respectively, of the head and the cable's end
segment of the stapler of the present invention, featuring a snap
coupling.
[0063] FIGS. 10A and 10C are a longitudinal sectional view and a
cross sectional view, respectively, of the anvil and the end of the
body of the stapler of the present invention, featuring a snap
coupling.
[0064] FIG. 10B is an enlarged detail of FIG. 10A.
[0065] FIGS. 11 through 16 are sketches of a human colon,
illustrating methods according to the present invention of
employing a flexible annular stapler in surgical procedures.
[0066] FIG. 17 is a sketch illustrating a method, according to the
present invention, of closing butts of organs to be joined by a
flexible annular stapler.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0067] The present invention is of methods and apparatus for
performing anastomosis of the digestive tube under closed surgery
conditions. Specifically, the present invention includes an
improved flexible annular stapler and can be used to conveniently
and quickly perform such anastomosis at any location and in
conjunction with any of a large variety of surgical procedures,
which may include end-to-end, end-to-side and side-to-side
joints.
[0068] The principles and operation of an improved annular stapler,
as well as new surgical methods utilizing it, according to the
present invention may be better understood with reference to the
drawings and the accompanying description.
[0069] Referring now to the drawings, FIG. 2 illustrates the end
portion of a flexible stapler similar to that of the French patent,
but with an improved head-to-anvil alignment control. Flexible
cable 21 is slidingly disposed inside flexible hose-like body 26
along its entire length. A segment 83 of the cable, a few
centimeters long, at the end that is generally attachable to head
11 is designated as end segment. According to a preferred
embodiment of the invention, end segment 83, which slides through
hole 34 in anvil 18 when the head is relatively close to the anvil,
is made to be substantially stiffer than the rest of the cable.
According to an alternative preferred embodiment, the stiff end
segment 83 is a separately produced component, to be called
extension rod, which is attached to the end of cable 21.
[0070] According to the invention, there is also more freedom in
choosing a suitable cross-sectional shape (rather than a circle
with a flat, as specified in the French patent) for the end
segment, the cable and the hole, namely one that will optimize the
stiffness of the end segment (or extension rod), with respect to
both bending and twisting, as well as its rotational fixation
within the similarly shaped hole in the anvil (and thus--of the
head with respect to the anvil). The relative cross-sectional sizes
of end segment 83 and hole 34, and thus the fit between them,
should preferably be closely controlled, so as to maximally fix
their relative angular position, on the one hand, and allow easy
sliding, on the other hand. Cable 21 itself preferably has an
identical shape, though its fit within the hole need not be as
tight. Clearly, during operation, as the head is pulled toward the
anvil, the stiff end segment slides through the matching hole in
the anvil; their cooperation ensures that the opposing faces of the
head and the anvil become essentially parallel and mutually
aligned, both laterally and rotationally, while approaching each
other. Another advantage of a stiff end segment is that it lends
itself better to forming a pointed end for piercing tissue, as is
required in certain procedures. It is noted that the stiff end
segment (or extension rod) may be hollow, just as the rest of the
cable, to form a through passageway.
[0071] It is noted that the construction according to the French
patent, which serves as the preferred basis for the present
invention, calls for an anvil to be part of the mechanical assembly
that is attached to the end of the tubular body, while the
mechanical assembly that is attached, or attachable, to the end of
the cable (or the extension rod), which is referred to as the head,
contains, inter alia, a circular knife, a hammer and a cartridge of
stapling pins. In the context of the present invention it is
equally possible, and may sometimes be preferable, that the anvil
be placed in the head and the hammer and stapling pins--in the
assembly attached to the body. The knife, moreover, may be
independently placed in either one of the two assemblies.
Therefore, for the sake of both brevity and generality, the two
assemblies will sometimes, when no differentiation is necessary, be
referred to as jaws. When differentiation is necessary, the jaw
attached to the end of the body will be referred to as anvil and
the jaw attached to the end of the cable will be refrred to as the
head. The use of the term anvil is based on the examplary
configuration for convenience only, with the other configuration
(i.e., anvil in the head and hammer and pins in the jaw attached to
the body) being understood to also come within the scope of the
present invention. Sometimes the term anvil is used to denote the
part itself (rather than the jaw), in which case the meaning will
be understood from the context.
[0072] FIG. 3 illustrates an improved handle portion of the
flexible stapler according to the present invention. As before, the
end of flexible cable 21 is connected to a long screw 52, which is
engaged by a nut 51 that is rotationally activated by a manual knob
46. However, knob 46, rather than being axially held by an annular
tongue-and-groove arrangement at the end of handle housing 47, is
now held by a similar tongue-and-groove arrangement in a separate
plate 102 that is attached to a lever 104, which is loaded by
spring 106. Spring 106 acts to normally keep plate 102 adjacent to,
and touching, end 47 of the handle housing; the axial movement of
the cable inside the body is then controlled by turning knob 46, as
before. When lever 104 is pressed, though, the knob is pushed away
from the handle, pulling the entire cable assembly with it. This
feature would normally be utilized as follows: At the beginning of
operation the knob is turned counterclockwise until the head and
anvil are the desired distance apart. After attaching the butt ends
of the tubular organ being operated on to the jaws, the knob is
turned clockwise, causing the two butts to approach each other. The
surgeon watches millimeter scale 42 (FIG. 1B) attached to the cable
and viewable, together with a fixed pointer, through window 54 in
the handle. When the position of the scale indicates that the two
butt ends have made contact, the surgeon pushes lever 104 and thus
causes the cable to be pulled further and to thus activate the
stapling and cutting mechanism. Alternatively, there may be a
stopper attached to screw 52 at the end of the cable inside the
handle, such that will impinge on the end of nut 51 when the two
butts have made contact and thus prevent any further travel due to
turning of the knob. The advantage of this feature is that it
provides the surgeon with tactile sense, and thus better control,
of the stapling operation.
[0073] Referring now to FIG. 4A, which illustrates the head portion
of a preferred embodiment of a flexible stapler with an internal
illuminator, there is shown a stapler basically similar to the one
disclosed in the French patent, the essential differences being as
follows: There is a hollow passageway along the entire flexible
cable 21 and its end segment 83. Through this passageway there is
disposed an optical fiber 62, or a bundle of fibers. The end of
this fiber that is in the handle (not shown) is optically coupled
to a fiber illuminator; the fiber illuminator and the method of
coupling it to the fiber may be any of a number known in the art.
The fiber illuminator may be attached to the handle or it may be in
a stationary console, with the fiber extending to it from the end
of the handle. The other end of fiber 62, which protrudes from end
segment 83 of the cable, is optically coupled to a diffuser 64, or
a similar optical element, inside cap 25 of the head of the
stapler. Cap 25, which forms the end of the head farthest from the
cable and will therefore be referred to as the end cap, and which
usually has a conical or hemispheric shape, is here made of an
optically translucent or transparent material, such as polymers
used for spectacle lenses. Operation of the instrument is similar
to that of its previous version, except that when the illuminator
is activated, light emanates from the cap of the head to illuminate
the surrounding tissue and is usually visible through the wall of
the digestive tube (either directly, as in open surgery, or through
the laparoscope or thoracoscope) and thus the location of the head
with respect to the digestive tube is indicated.
[0074] It is noted that an optional passageway along the instrument
is also shown in the French patent, where it, however, serves to
supply air to a dilatation balloon at the tip of the head. The
passageway according to the present invention must accommodate the
optical fiber and may optionally serve for both the fiber and the
air supply. According to an alternative embodiment, the optical
fiber is replaced by a pair of wires, which are connected inside
the head to a lamp and at the handle end--to a voltage source. In
another alternative embodiment, shown in FIG. 4B, end cap 25
contains both a lamp 66 and a small battery 68; in this case there
are no wires through the cable and thus no need for a passageway
solely for the purpose of illumination; this alternative is most
suitable for a disposable instrument. It is appreciated that the
stapler shown in FIG. 4 is by way of example and that a flexible
stapler of any construction can be modified to incorporate an
internal illuminator according to the present invention.
[0075] Another possible configuration is shown in FIG. 5A, which
depicts a preferred embodiment of a flexible stapler with internal
imaging facility. This is an augmented version of the configuration
described hereabove in conjunction with FIG. 4A, whereby there is
disposed through the passageway a coherent bundle of optical fibers
70. The end of the bundle of fibers protrudes through a hole in the
end cap of the head, where an objective lens assembly 72, of any
suitable design known in the art, serves to project an image of the
surrounding inner wall of the intestines onto the near end of fiber
bundle 70. Preferably a transparent balloon is stretched over end
cap 25 (including the objective lens assembly) and inflated by air
through the passageway; this aids in dilating the inner surface of
the intestines and protects the surface of the lens. An illuminator
76 projects light into an illumination fiber 78, which runs through
the passageway alongside fiber bundle 70 and whose other end also
protrudes through the end cap, to illuminate the viewed area; it is
appreciated, however, that other methods of illumination, as, for
example, a separately inserted illumination fiber, may be employed.
The other end of the fiber bundle, namely that which protrudes from
the cable in the handle is terminated in a viewing assembly 82,
which includes a video camera (not shown), for viewing the image on
a video screen 81, and/or in an optical eyepiece 80, for direct
viewing. The viewing assembly may be any of a number of
commercially available models. In a disposable stapler the viewing
assembly, including a lens 86 (FIG. 5B) for coupling it to the end
of the fiber bundle, is reusable, whereas the fiber bundle and the
optics in the head are disposable with the stapler. In this case
the viewing assembly must be conveniently attachable to the end of
the fiber bundle. One preferred way of doing this, depicted in the
cross-sectional view of the handle in FIG. 5B , is to mount
coupling lens 86 of viewing assembly 82 in a tube 84 that is
externally threaded (like a screw) with a pitch identical to that
of screw 52 at the end of cable 21; this tube is screwed into nut
51, which also engages screw 52 and is coaxially attached to the
turning knob 46, so that the coupling lens is focused on an end 88
of fiber bundle 70 (which protrudes from the end of screw 52, which
is hollow). Thus, when knob 46 is turned, to move cable 21 relative
to body 26, viewing assembly 82 moves at the same rate, keeping it
at a constant distance from end 88 of the fiber (which moves with
the cable).
[0076] According to an alternative embodiment of the fiber-based
imager, the fibers bundle terminates with an objective lens inside
the head--similarly to the depiction in FIG. 4A. Clearly, in this
case end cap 25 of the head should be transparent and made of
optical-quality material, such as polymers used for spectacle
lenses.
[0077] Another alternative embodiment of a flexible stapler with an
internal fiber-based imager is shown in FIG. 6: There is provided a
passageway through the entire instrument of sufficient diameter to
allow threading through it a suitable commercially available
fibroscope 90. Such a fibroscope is available, for example, from
the Ova-Med Corporation in Sunnyvale, Calif. and usually includes
an illuminator 76, an eyepiece 80 and a video screen 81. The tip 92
of the fibroscope can either protrude through a hole in end cap 25,
as shown in the drawing, or be positioned inside a transparent cap,
as in FIG. 4A. The advantage of this embodiment, over the previous
one, is that it can easily be deployed or removed at will, thus
saving its cost when not needed, especially when the stapler is
disposable. It is appreciated that the same arrangement, that is a
clear passageway through the entire instrument, including the cable
and all its parts and possibly the end cap, can be utilized for a
variety of thinly formed or catheter-like tools. Such tools may be
specially made for the purpose or may be tools originally intended
for other applications, such as laparoscopy, hysteroscopy,
angioscopy, bronchospcopy, sinusoscopy, choledoscopy, etc.; they
may include (beside a fibroscope or microendoscope), for example,
an illuminator, a video camera, an ultrasonic probe, a suction
device, a scraper, a surgical tool;, an irrigator, a guide wire,
etc.
[0078] Another configuration of a flexible stapler with an internal
imaging facility is shown in FIG. 7. There is mounted inside cap 25
of the head a miniature video camera 94, consisting of an objective
lens assembly 96 and an array of photoelectric devices 98, which is
connected to an electronic drive circuit (not shown). The latter is
connected to an electric cable 93 that runs through a passageway
along the entire instrument and terminates at an electronic video
assembly, which displays the image on a video screen. The miniature
video camera and the external video assembly are commercially
available. Illumination for the camera is, again, preferably
provided by an illuminator as described hereabove, or by any other
method. The lens 96 can alternatively be placed inside the cap,
which is made transparent (similarly to FIG. 4A). If the stapler is
to be disposable, the assembly of end cap and camera (which is too
expensive to be disposable) is made to be easily attachable to the
head.
[0079] Yet another configuration of the flexible stapler according
to the present invention, which allows internal ultrasonic
examination, is shown in FIG. 8. An ultrasonic transducer array 91
is mounted on end cap 25, preferably protruding therefrom, and
connected by electric wiring through a passageway along the
instrument to an external drive--and control console (not shown).
An inflatable balloon 74 is stretched over the cap. Water, or
another suitable fluid, is injected into the passageway, for
example, by means of a syringe fitting into a hole in the center of
knob 46 (FIG. 1B), and is made to inflate the balloon, through a
hole in the end cap, until it makes good contact with the inner
wall of the digestive tube. Alternatively, the fluid is supplied to
the balloon through a catheter that is threaded through the
passageway and protrudes through the hole in the cap. The
ultrasonic array is then operated by means of the console in the
usual manner.
[0080] A novel configuration for attaching the head to the end of
the flexible cable (alternative to the previously disclosed set
screw arrangement) is a snap coupling, that is--an arrangement by
which the head may be simply pushed onto the end of the cable until
a flexible, or spring-loaded, member on the head engages a feature,
such as a notch, on the cable and whereby the two parts thereafter
remain interlocked until intentionally released. This feature is
useful in certain procedures in that it enables easily attaching
the head to the cable inside the patient's body, possibly inside
the affected organ, and is particularly advantageous for closed
surgery, as will be illustrated here below. There are many ways
known in the art to realize this configuration. One embodiment,
presented here by way of example, is depicted in FIG. 9A, which
shows a partial longitudinal-sectional view of the head, and FIG.
9B, which shows a cross-sectional view at the plane marked H-H in
FIG. 9A. In this example, the head includes the hammer 15, which is
connected to the shell 23 by tension spring 132. The end 22 of the
cable is attachable to the hammer as follows: The top plate of the
hammer 15 has around its center a ring-shaped protrusion 140, with
a central hole that is a continuation of the hole through the top
plate of the hammer and has therefore the identical size and shape.
In the surface of that hole is a circular notch 141, which
accomodates two arculate members 142. The arculate members 142,
more clearly seen in FIG. 9B, are disposed symmetrically within
notch 141 and each pressed inward by a compressive spring 133, the
travel being stopped by two protrusions 134 and 135 within the
notch. The end segment 22 of the cable has a notch 143 cut around
it somewhat below its pointed tip, which notch accomodates any
protruding portion of the arculate members 142. The inner surfaces
of the arculate members 142 are bevelled so that when the members
are at the stopped position, the arculate top and bottom edges of
the bevelled inner surface are part of circles that are,
respectively, somewhat smaller and just greater, than the maximal
diameter of the end segment of the cable between its tip and the
notch 143 (which, preferably is somewhat smaller than the diameter
of the rest of the end segment). Operation of this mechanism is as
follows: The cable is initially detached from the head. When the
end segment of the cable is pushed into the hole through the
hammer, its pointed tip pushes on the bevelled inner surface of the
arculate members, causing them to be pushed outward enough to allow
the cable segment to slide in. When the notch in the cable segment
reaches the arculate members, the latter snap back to their stopped
state, engaging the notch and thus locking the cable segment to the
hammer.
[0081] In order to unlock and release the cable from the head,
there is provided, in the exemplary embodiment shown and as
depicted in the cross-sectional view in FIG. 9B, a release
mechanism as follows: The ends of arculate members 142 which touch
the protrusions 134 and 135 are shaped to form funnels stradling
the protrusions. One protrusion, 134, is fixed, while the other
protrusion, 135, is movable and connected to a rod 136, which
protrudes through the end cap 25 and ends with a button 137. A
compressive spring 138 keeps the rod 136 and the protrusion 135
normally retracted. In order to unlock the snap mechanism, the
button 137 is pushed, which cause the funnel-forming ends of
arculate members 142 to be wedged by the two protrusions, thus
pushing the arculate members apart--enough for the cable segment to
be able to slide through. When the head is then pulled away from
the cable, it is released. According to an alternative version of
this embodiment, part of the rod 136 is made of soft iron and the
rod is surrounded by an electromagnetic coil (disposed internally
to the spring 138), so that when an electric current flows through
the coil, it exerts a magnetic force on the rod in an inward
direction. The coil is connected to an external switch and current
source by a pair of conductors (not shown); each conductor consists
of a pair of contact pads, one pad being on the end segment 22 of
the cable and connected to a wire running through the cable and the
other pad flexibly mounted on the hammer's protrusion 140 and
connected by wire to the coil. To unlock the mechanism, the switch
(located on an external console or on the handle) is simply closed.
It is appreciated that even in the first version, the force needed
on the button to effect unlocking action is small enough to be
practically applicable inside the body under closed surgery.
[0082] A snap coupling configuration is also possible for the
attachment of the anvil to the body. This feature as well is useful
in certain procedures, in that it enables easily attaching the
anvil to the body of the stapler inside the patient's body,
possibly inside the affected organ, and is particularly
advantageous for closed surgery, as will be illustrated here below.
Again, many ways are known in the art for realizing this
configuration. One possible embodiment, presented by way of example
and illustrated in FIGS. 10A-10C, is similar to that described
hereabove for attaching the head to the cable, though somewhat
simpler, since there is no operative need to unlock inside the
body.
[0083] The end of the body is attachable to the anvil as follows:
As illustrated in FIG. 10A, which shows a longitudinal section, and
FIG. 10B, which shows details of FIG. 10A, the bottom of the anvil
15 has around its center a ring-shaped protrusion 120, with a
central hole that accomodates the cylindrically shaped end of the
body 26. In the surface of that hole is a circular notch 121, which
contains an open ring-shaped spring disc 122. The spring disc 122
is more clearly seen in FIG. 10C, showing a detailed cross
sectional view of the protrusion area, at the line marked A-A in
FIG. 10A. The inner surface of the spring disc 122 is bevelled so
that when the disc is unflexed, its minimum inner diameter (near
the disc's left surface) is somewhat smaller, and its maximum inner
diameter (near the disc's right surface) just greater than the
diameter of the end segment of the body 26. The end segment of the
body has a notch 123 cut around it, which notch accomodates any
protruding portion of the spring disc 122. Operation of this
mechanism is as follows: The body is initially detached from the
anvil. When the end segment of the body is pushed into the hole at
the anvil's protrusion 120, it pushes on the bevelled inner surface
of the spring disk, causing it to be widened enough to allow the
body segment to slide in. When the notch in the body segment
reaches the spring disc, the latter snaps back to its unflexed
state, engaging the notch and thus locking the body to the
anvil.
[0084] In order to unlock and release the body from the anvil,
there is provided, in the embodiment shown and as depicted in the
cross-sectional view in FIG. 10C, a wedge 124. The wedge is
disposed opposite the opening in the spring disc 122 and is held
within a hole through the ring 120, protruding therefrom. In order
to unlock the snap mechanism, the wedge 124 is pushed, which causes
it to press against the open ends of the spring disc and thus to
widen it enough for the end of the body to be able to slide
through. When the anvil is then pulled away from the body, it is
released.
[0085] FIG. 17 illustrates schematically and by way of an example
an improved method for generally preparing for, and performing,
anastomosis of the digestive tube when utilizing a flexible
stapler, such as disclosed herein or in the French patent. The
present example concerns excision of a section of the colon. At the
stage of the procedure shown, the affected part of the colon has
been excised, leaving two open butts of the colon, and the stapler
has been inserted so that its head 11 is just inside one butt and
its anvil 18 is just inside the other butt, with flexible cable 21
connecting the two. The end of each butt is now pulled over the
respective jaw and pressed together to form two lineal adjoining
lips 110. The two lips are stapled together, by means of any linear
stapler 112 used in the practice of open--or closed surgery, as the
case may be. Such staplers are available, for example, from the
U.S. Surgical Corporation. It is noted that the flexible cable,
owing to its thinness, does not materially interfere with this
stapling operation and allows the joining of the lips around
itself. Subsequently the annular stapler is activated in the usual
manner, whereby the two butt ends are pulled together, forming
adjoining flanges, which are then stapled together annularly while
their central discs are cut away. It is noted that the annular
knife in the head of the stapler is generally hard enough to cut
through staple pins left by the linear stapler. It is also noted
that this method of preparing the butt ends for anastomosis is much
easier and faster than the conventional method of hand sewing and
that it is therefore particularly suitable for closed surgery. It
is appreciated, however, that the method can also be advantageously
used in open surgery.
[0086] It is noted that the improvements in flexible staplers and
the methods utilizing them, described hereabove are applicable in
any form of surgery of the digestive tube but are particularly
advantageous in closed surgery. However, the very use of a flexible
annular stapler in performing anastomosis of the digestive tube
under closed surgery in general is considered to be part of the
present invention. The main advantage of such use is that the
flexible stapler is insertable through the mouth or the anus or
possibly also through a suitable trocar in the abdominal wall, to
reach almost any location, thus eliminating the need for a wide
incision through the wall--which is required for utilizing a
conventional stapler. The other alternative--manual suturing or
stapling--is much more difficult, particularly in closed surgery,
and takes longer. Moreover, for some hard to reach locations such
incisions are not possible and manual stitching is even more
difficult, so that a flexible stapler is the only practical
alternative. Further advantages of using a flexible stapler in
general, or an improved one according to the present invention, in
closed surgery of the digestive tube may be evident from the
description of methods disclosed here below by way of examples.
[0087] FIG. 11 illustrates schematically, by way of an example, the
usage of a flexible stapler in a typical closed surgery of the
digestive tube, which in this case aims at excision of a malignant
section of the colon. First, the colon (160) is cut across below
and above the malignancy (161) and the extirpated sement (162 dwg.
`A`) is placed in a bag, which has been introduced, and is
subsequently removed, through an abdominal incision (as shown in
`E`) or through the distal portion of the colon. At the next steps
marked in the illustration as `A`, a thread is stitched like a
purse-string around the end of each remaining segment (163 and
164). At the next step, the flexible stapler, with its head pulled
close to its anvil, is pushed through the anus until the head
protrudes from the lower segment; then the knob on the handle is
turned until the head is sufficiently distant from the anvil,
whereupon head 11 (dwg. `B`) is inserted into the upper segment
(163), while keeping anvil 18 inside the lower segment (164). At
the next step, which reaches the state illustrated in `B`, the
thread at the end of each remaining segment is pulled, thus
creating a flange of colon tissue closing on the anvil or the head.
It is noted that the latter two steps can be advantageously
replaced by the linear stapling method described hereabove. In the
last step, illustrated in `C`, the knob is activated to pull the
head and anvil together--to complete the anastomosis; subsequently
the stapler is pulled back through the anus, leaving a well joined
colon, as shown in `D`.
[0088] It is noted that the last discussed example, as well as
further examples to be discussed here below, concern end-to-end
anastomosis. It is appreciated, though, that procedures can be
similarly developed for end-to-side and side-to-side
anastomoses.
[0089] FIG. 12 illustrate schematically an improved procedure for
excising a malignant segment of a digestive tube, utilizing a
flexible stapler; again, the example of a colon is used. First, the
colon is sutured or, preferably, linearly stapled shut below the
malignancy, then a cut is made across, just below the suture and
the proximal, sutured butt (containing the malignancy) is bent
away. Next the flexible stapler, with its head pulled close to its
anvil, is pushed through the anus until the head protrudes from the
(open) end of the distal segment; then the knob on the handle is
turned until the head is sufficiently distant from the anvil. At
this point the situation is as depicted in `A`. Next, the end of
the distal segment is sutured or, preferably, linearly stapled, to
close on the anvil, and a lateral cut is made in the proximal
segment of the colon above the malignancy, as depicted in `B`. Then
the head of the stapler is inserted into the upper colon through
the lateral cut, as shown in `C`. Next, the colon is sutured or,
preferably, linearly stapled, to close on the head; it preferably
is also sutured or linearly stapled shut just below the lateral
cut; then the malignant segment is cut away from the sutured
proximal butt, as shown in `D`. Completing the lateral cut in that
segment enables removing it from the cable, as in `E`. Finally the
handle is activated to pull the two butts together, as shown in
`F`, and to then carry out stapling and cutting, as described
hereabove. After pulling the stapler back out through the anus, the
colon remains joined and clear, as shown in `G`. It is noted that
this method minimizes the time that the colon is open, thus
minimizing possibility of soilage which may be particularly
bothersome under closed surgery, e.g. because of the more limited
sponging ability. It is also noted that the method of linear
stapling, described hereabove, is particularly convenient for the
intermediate suturing--or stapling operations called for in the
present procedure.
[0090] FIG. 13 illustrate schematically a further improved
procedure for excising a malignant segment of a digestive tube,
utilizing a flexible stapler; again, the example of a colon is
used. This procedure utilizes a flexible stapler with an attachable
head as described hereabove. It provides even cleaner preparation
for anastomosis than does the previously described procedure and is
therefore even more advantageous to closed surgery. According to
this procedure, the colon is first sutured or stapled shut at two
adjacent cross planes below the malignant segment, then cut across
between the two planes, as shown in `A`, and the proximal butt is
bent away. Next, the body of the stapler, with only the anvil
attached, is inserted through the anus and pushed until the anvil
reaches the sutured lower, distal butt; the progress of the anvil
through the colon may be aided by threading a balloon, attached to
a catheter, through the passageway along the instrument, disclosed
hereabove, while the cable is kept maximally retracted, to just
protrude from the anvil, and inflating the ballon. Then the knob is
turned to extend the flexible cable out of the anvil; its pointed
end easily pierces this butt and protrudes therefrom, as
illustrated in `B`. Now the head is inserted through a suitable
small incision in the abdominal wall, as, again, shown in `B`, and
attached to the end of the cable; the snap-on feature described
hereabove is particularly advantageous for such attachment.
Subsequently, a lateral cut is made above the malignant segment and
the situation is then as depicted in `C`, which is identical to
that of FIG. 12B, so that the procedure continues as in the
previously described procedure. It is again noted that the method
of linear stapling, described hereabove, is particularly convenient
for the intermediate suturing--or stapling operations.
[0091] Another procedure utilizing a flexible stapler, which
features even greater cleanliness and maximum simplicity, is
illustrated schematically in FIG. 14--again, by way of an example
of excision in the colon. This procedure is suitable for cases
where the affected segment is relatively clear, such as benign
small tumors or inflammation. According to this procedure, the
flexible stapler, with the head drawn close to the anvil, is first
pushed through the anus until the head just reaches the affected
segment; the knob is then turned to extend the head until it clears
the affected segment; it is noted that the internal illumination
attachment, disclosed in the present invention, is advantageous in
locating the head with respect to the segment. Next, the colon is
sutured or stapled just below the head and just above the anvil, to
enclose them, and a cut is made across each end of the affected
segment, next to the sutures, as depicted in `A`; it is noted that
here again the method of linear stapling is particularly
convenient. Then, according to the preferred procedure, the
affected segment, which is now loose but still enclosing the cable,
is pushed to touch the cable, as shown in `B`. Next, the segment is
sutured or stapled across its ends as well as lengthwise, close to
the cable, as depicted in `C`; then it is cut lengthwise so as to
free it from the cable, as shown in `D`. An alternative procedure,
which is shorter but somewhat less clean, is illustrated in `Ca`;
here the extirpated segment is simply cut lengthwise and folded
away. In any case, the segment can be removed intact (e.g. in a
bag) or after shredding. Subsequent operation is as described for
previous procedures.
[0092] Yet another procedure utilizing a flexible stapler and
suitable for cases where the affected segment is relatively clear
is illustrated schematically in FIG. 15--again, by way of an
example of excision in the colon. The stapler utilized in this
procedure uses two features of the configurations described
hereabove, namely (a) detachability and attachability of the head
from, and to, the cable and (b) a clear passageway through the
cable. In addition, head 11 is equipped with a short piece of guide
wire 150, whose end is attached to the inside of end cap 25 and
which is normally disposed within the passageway in end segment 22
of cable 21. According to this procedure, which features ultimate
cleanliness, the jaws are first inserted and positioned to straddle
the segment to be excised in a manner similar to that described
hereabove with respect to FIG. 14. Now, however, a pair of closely
spaced sutures is made across the colon at each end of the affected
segment, as shown in `A`; it is again noted that the method of
linear stapling is particularly convenient for carrying out these
sutures. Then the colon is cut across between each pair of the
sutures just made, as depicted in `B`; it is noted that the three
segments thus separated remain totally closed, thus preventing any
soilage. Next, the cable is detached from the head and partially
withdrawn, as shown in `C`; then the bottom and middle segments are
pulled away from the upper segment, to reach the situation depicted
in `D`. Now the middle, excised segment is removed, as shown in
`E`. Next, cable 21 is extended toward the head while end segment
22 is guided to slide around protruding guide wire 150, as
illustrated in `F`; it is then pushed through the suture at the end
of the upper segment and into head 11, where it is again locked on
to it, as shown in `G`. Subsequent operation is then as described
for previous procedures.
[0093] It is appreciated that the procedures described above are by
way of examples only and that many variations and extensions are
possible and that they can be applied also to organs other than the
colon. These may be any of a number of hollow organs, including any
part of the digestive tube (or alimentary tract) and organs
external thereto, such as the gall bladder and the biliary tree,
the urinary bladder and tree or the bronchial tree. The procedures
may also be applied to joining two different ones of such organs,
as well as to joining two different segments of the same organ.
Furthermore, neither of the parts to be joined need to be naturally
tubular near the joint (like the cut end of the intestines), but
may, for example, be a wall of the respective organ. What is common
to all cases is that there is conceptually defined, for each of the
two parts, a plane and an annular area thereon, the two annular
areas being essentially congruent; during the joining operation,
the two annular areas are brought together and conceptually
combined into one annular area, over which the stapling and
eventually the anastomosis take place. In the case that one of the
parts is tubular at the joint, as in an end-to-end or end-to-side
anastomosis, (in which case that part is always cut across) the
defined plane is transverse and a short distance away from the
plane of cutting: in the case that one of the parts presents an
outer face of a wall at the joint, as in a side-to-end or
side-to-side anastomosis, the plane is essentially at that face.
Furthermore, in the case of a tubular part, there is an inherent
opening through it at the defined plane and interior to the annular
area (which opening is, in some procedures, not always initially
accessible to the stapler, or, in some other procedures, may be
intentionally closed off before the stapler reaches it); on the
other hand, in the case of a part being joined at its wall, there
is no such initial opening and, if required by a particular
procedure (e.g. for insertion of part of the stapler thereto), a
suitable opening has to be cut through the wall, interior to the
annular area. Of course and as the raison d'etre, after the end of
the procedure there remains in all cases a clear opening through
both parts.
[0094] It is further appreciated that the stapler can also be
inserted through openings other than the anus, including, in
particular, the mouth and artificial openings through the body
wall, such as practiced in closed surgery, and obviously also the
wide opening of open surgery; clearly, insertion through such an
artificial opening also requires a suitable lateral cut in the
affected organ, for insertion of the stapler, or of a jaw,
therein.
[0095] It is further appreciated that the pointed end of the cable
can pierce the wall of an organ, or an artificially closed butt
thereof, so as to protrude into, or out of, the organ.
[0096] Insertion of the stapler through the body wall may be called
for during closed surgery in cases where the affected area is too
far from a natural opening, such as proximal portions of the small
intestines, or where there are intervening obstructions or where
none of the organs to be joined has a clear passageway to a natural
opening. In such cases it may be possible to insert the stapler,
including the head and/or the anvil, through a sufficiently wide
trocar. Such a wide trocar would, however, be generally considered
inappropriate or disadvantageous. Fortunately, configurations with
detachable head and anvil, particularly the snap-coupling
configurations for attachment of the head and the anvil, described
hereabove, enable alternative procedures, exemplified by the
following, as illustrated in FIG. 16: Initially, the head is
detached from the cable and the anvil is detached from the body. A
small incision is made in the abdominal wall, through which the
anvil and the head are pushed in (dwg. A). The body of the stapler,
with the cable maximally retracted, is inserted through a trocar
provided and installed for the purpose (dwg. B); a trocar having a
nominal diameter of about 10 mm may be suitable. The anvil is then
attached to the end of the stapler's body and the head is attached
to the end of the cable (dwg. C); it is noted that the
snap-coupling feature described hereabove is particularly
advantageous for these operations. The affected segment of the
colon is excised or otherwise prepared, using laparoscopic
techniques. A lateral cut is then made in the colon (dwg D), and
the two jaws at the end of the stapler are inserted therethrough
and pushed until they reach their respective butt segments (dwg.
E). The butt ends are then sutured over the two jaws (dwg F) and
are pulled together and stapled, as described heretofore. Finally
the stapler is pulled back (dwg. G) and out through the abdominal
wall, together with the trocar (dwg H). In some procedures it may
be preferable to first insert the end of the body into the colon,
through a small lateral cut, so that the body protrudes into the
colon, then insert the anvil, through an open end of the segment or
through another lateral cut, and attach it to the body, finally
attaching also the head. It is appreciated that many variations of
the procedures are possible--either analogous to procedures
previously described or others.
* * * * *