U.S. patent number RE40,237 [Application Number 11/499,817] was granted by the patent office on 2008-04-15 for surgical stapling instrument.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Federico Bilotti, Antonio Longo.
United States Patent |
RE40,237 |
Bilotti , et al. |
April 15, 2008 |
Surgical stapling instrument
Abstract
A surgical stapling instrument (1) comprises a body portion (2,
3), a handle (4) and a staple fastening assembly (8). The staple
fastening assembly (8) includes a curved cartridge (10), which
comprises at least one curved open row of staples, and a curved
anvil (22), which is adapted to cooperate with the cartridge (10)
for forming the ends of the staples exiting from the cartridge
(10). The staple fastening assembly (8) is adapted to allow
unobstructed access towards the concave inner faces of the
cartridge (10) and the anvil (22). The cartridge (10) can be moved
towards the anvil (22) from a spaced position for positioning
tissue therebetween to a closed position for clamping the tissue.
Preferably, a knife is contained within the cartridge (10) and is
positioned such that there is at least one row of staples on at
least one side of the knife.
Inventors: |
Bilotti; Federico (Aprilia,
IT), Longo; Antonio (Palermo, IT) |
Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
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Family
ID: |
32175603 |
Appl.
No.: |
11/499,817 |
Filed: |
August 7, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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PCT/EP01/03615 |
Mar 29, 2001 |
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Reissue of: |
10287066 |
Nov 4, 2002 |
06805273 |
Oct 19, 2004 |
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Foreign Application Priority Data
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May 30, 2000 [DE] |
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10026683 |
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Current U.S.
Class: |
227/180.1;
227/19; 227/178.1; 227/176.1 |
Current CPC
Class: |
A61B
17/115 (20130101); A61B 17/1114 (20130101); A61B
17/072 (20130101); A61B 17/1155 (20130101); A61B
2017/07221 (20130101) |
Current International
Class: |
A61B
17/072 (20060101) |
Field of
Search: |
;227/19,175.1,176.1,178.1,180.1 ;606/219 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0213817 |
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Mar 1987 |
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EP |
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0323016 |
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Jul 1989 |
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EP |
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0373823 |
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Jun 1990 |
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EP |
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0446012 |
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Sep 1991 |
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EP |
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WO 97/47231 A61 |
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Dec 1997 |
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WO |
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WO 01/91646 A61 |
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Dec 2001 |
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WO |
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WO 02/30296 |
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Apr 2002 |
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WO |
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Primary Examiner: Rada; Rinaldl I.
Assistant Examiner: Chukwurah; Nathaniel
Attorney, Agent or Firm: Welsh & Flaxman LLC
Parent Case Text
.Iadd.CROSS REFERENCE TO RELATED APPLICATION
This application is a Continuation-In-Part of International Patent
Application Ser. No. PCT/EP01/03615, filed Mar. 29, 2001, entitled
"Surgical Stapling Instrument", which claims the benefit of German
Patent Application No. 10026683.5, filed May 30, 2000..Iaddend.
Claims
What is claimed is:
1. A surgical stapling instrument comprising: a frame having a body
portion (2, 3) and a handle (4) extending from said body portion
(2) in a proximal end region of said instrument (1), a staple
fastening assembly (8) in a distal end region of said instrument
(1), said staple fastening assembly (8) including a curved
cartridge (10), which comprises at least one curved open row (34,
35, 36) of staples (54, 55, 56), and, at the distal end of said
instrument (1), a curved anvil (22), which is adapted to cooperate
with said cartridge (10) for forming ends of the staples (54, 55,
56) exiting from said cartridge (10), a staple forming plane (26)
of said anvil (22) being arranged transversally with respect to a
longitudinal axis (L) of said body portion (3) of said instrument
(1), said staple fastening assembly (8) being adapted to allow
unobstructed access towards concave inner faces (40, 41, 42) of
said cartridge (10) and of said anvil (22), a cartridge moving
device (5, 12, 16, 18) adapted to move said cartridge (10)
essentially in parallel relationship towards said anvil (22) from a
spaced position for positioning tissue therebetween to a closed
position for clamping tissue, and a staple driving device (6, 52,
53) adapted to drive the staples (54, 55, 56) out of said cartridge
(10) towards said anvil (22).
2. Stapling instrument according to claim 1, characterized by a
knife (58), which is contained within said cartridge (10) and which
is positioned such that there is at least one row (34, 35, 36) of
staples (54, 55, 56) on at least one side of the knife (58), and a
knife actuating device (6, 52, 53) adapted to move said knife (58)
towards said anvil (22).
3. Stapling instrument according to claim 2, characterized in that
there is at least one row (34, 35, 36) of staples (54, 55, 56) on
each side of said knife (58).
4. Stapling instrument according to one of claims 1 to 3,
characterized in that said cartridge (10) and said anvil (22) have
a generally arc-like shape in a cross-sectional plane, the arc
extending over an angle in a range of 90.degree. to
270.degree..
5. Stapling instrument according to claim 1, characterized in that
said staple fastening assembly (8) includes a curved guide portion
(18), wherein said cartridge (10) is mounted for movement between a
distal end (19) of said guide portion (18) and said anvil (22).
6. Stapling instrument according to claim 5, characterized in that
said guide portion (18) and said anvil (22) are rigidly connected
by means of at least one arm (20) extending from at least one end
of said anvil (22) and generally running in parallel to the
longitudinal axis (L) of said body portion (3) of said instrument
(1).
7. Stapling instrument according to claim 1, characterized in that
a distance between said cartridge (10) and said anvil (22) in the
closed position is adjustable.
8. Stapling instrument according to claim 1, characterized in that
said staple driving device (6, 52, 53) is adapted to simultaneously
drive the staples (54, 55, 56) out of said cartridge (10) towards
said anvil (22).
9. Stapling instrument according to claim 2, characterized in that
said knife actuating device (6, 52, 53) is adapted to cause said
knife (58) to protrude from said cartridge (10) after staple points
have been driven out of said cartridge (10).
10. Stapling instrument according to claim 9, characterized in that
said staple driving device (6, 52, 53) and said knife actuating
device (6, 52, 53) are mechanically coupled for operation via a
common trigger (6).
11. Stapling instrument according to claim 2 in connection with
claim 2, characterized in that said knife (58) is removable.
12. Stapling instrument according to claim 1, characterized in that
said cartridge moving device (5, 12, 16, 18) includes a trigger
lever (5) for actuating the movement of said cartridge (10).
13. Stapling instrument according to claim 1, characterized in that
said cartridge moving device includes a threaded shaft coupled to a
rotatable knob for actuating movement of said cartridge.
14. Stapling instrument according to claim 1, characterized in that
said anvil (10) has an atraumatically shaped distal end region
(24).
15. Stapling instrument according to claim 1, characterized in that
said staple fastening assembly (8) is removably mounted in a distal
end region (9) of said body portion (2, 3).
16. Stapling instrument according to claim 1, characterized in that
said cartridge (10) is removable.
17. Stapling instrument according to one of claims 1 to 16,
characterized in that a radius of curvature is essentially
infinite.
Description
The invention relates to a surgical stapling instrument, which can
be used, e.g., in the diagnosis and therapy of all pathologies best
treated by a curved stapled resection. It provides a means to
extend the transluminal exploitation of mechanical suturing devices
introduced via the anal canal, mouth, stomas, and service accesses.
The treatment of rectal pathologies will be described as most
frequent, but not only use of the invention.
The current transanal surgical procedure of choice is Transanal
Endoscopic Microsurgery, which, however is burdened with difficulty
of execution and complications such as dehiscence and abscesses.
Current endoscopic excisions of, e.g., peduncular polyps usually do
not allow necessary histological examination. This is of particular
concern when the sample turns out to be malignant and the site is
no longer visible during follow-up surgery. In the case of sessile
polyps, the endoscopic excision presents similar drawbacks, and in
addition difficulties in retrieving the sample, a related high loss
of blood, and a risk of perforation of the intestinal wall.
Traditional surgical excisions, for example via Transanal
Endoscopic Microsurgery, are complicated and involve the
intraluminal dissemination of neoplastic cells.
WO 97/47231 discloses an endoscopic stapler including a stapling
head which is removably located on the distal end of an endoscope.
The stapling head includes a stationary part, which houses a
removable staple cartridge, and a movable part which includes an
anvil for receiving and bending the ends of staples fired from the
staple cartridge. The stationary part has a circular
cross-sectional area, but the staples are arranged in two
semi-circular rows, in which the staples are staggered relative to
each other. The cross-sectional shape of the anvil is
semi-circular, generally matching the rows of staples. After tissue
to be excised has been clamped by moving the anvil towards the
stationary part, the staples are consecutively expelled from the
staple cartridge, and a knife cuts the tissue to be excised by
moving along a staple line. Since the access for manipulating the
tissue in order to place it correctly in between the anvil and the
stationary part is somewhat obstructed by the cross-sectional shape
of the stationary part, a remote-controlled forceps device is
provided in the region of the staples and the anvil.
In U.S. Pat. No. 5,355,897, a surgical stapler is shown which
derives from the well-known circular staplers for performing an
anastomosis. In order to enable the local excision of tissue by
means of this instrument, instead of a circular anastomosis, a
shield extending around part of the periphery of the stapling
region prevents unwanted tissue from entering the head of the
device. A similar instrument is known from U.S. Pat. No. 5,360,154.
In both cases, the region between the anvil and the staple
cartridge is not easily accessible.
Surgical staplers comprising a staple cartridge having one or more
straight rows of staples and a cutting blade running in parallel to
the staples are disclosed in U.S. Pat. Nos. 4,665,916 and
4,881,545. In these instruments, tissue to be stapled and excised
can be clamped between the staple cartridge and an anvil which is
pivotally connected to the staple cartridge at one of its ends.
Staplers having straight rows of staples, in which the staple
cartridge can be moved in parallel relationship with respect to a
stationary anvil in order to clamp the tissue to be stapled and
excised, are known from U.S. Pat. Nos. 4,527,724, 5,137,198, and
5,605,272; these staplers are not provided with an automated
cutting device. Generally, in many applications, straight staplers
are not anatomically correct, i.e. straight staple lines do not fit
a circular lumen contour.
U.S. Pat. No. 4,617,928 discloses a surgical instrument for
Practising mechanical sutures and biopsies. This instrument
comprises a fixed anvil and a staple cartridge (including a knife),
which can be moved towards the anvil in order to clamp tissue
between the anvil and the staple cartridge. In one embodiment,
there are two staple rows arranged in a V-shaped configuration
around a V-shaped knife. In another embodiment, an approximately
semi-circular double row of staples surrounds an approximately
semi-circular knife. In this embodiment, which is designed for
practising pulmonary biopsies, free access to the inner faces of
the cartridge and the anvil is hindered by an arm supporting the
cartridge.
The object of the present invention is to provide an economical
surgical stapling instrument for stapling (and optionally
resecting) tissue, in particular inside the digestive track, which
can be operated and used in a safe, effective, and fast manner.
This problem is solved by a surgical stapling instrument having the
features of claim 1. Advantageous versions of the invention follow
from the dependent claims.
The surgical stapling instrument according to the invention
comprises a frame having a body portion and a handle extending from
the body portion in the proximal end region of the instrument. A
staple fastening assembly is mounted in the distal end region of
the instrument. Here and in the following, the terms "proximal" and
"distal" relate to the user as reference, which means that the
parts of the instrument close to the user under normal operating
conditions are designated as "proximal".
The staple fastening assembly includes a curved cartridge, which
comprises at least one curved open row of staples, and, at the
distal end of the instrument, a curved anvil, which is adapted to
cooperate with the cartridge for forming the ends of the staples
exiting from the cartridge. The staple forming plane of the anvil
is arranged transversally with respect to the longitudinal axis of
the body portion of the instrument. The staple fastening assembly
is adapted to allow unobstructed access towards the concave inner
faces of the cartridge and the anvil and thus to the tissue to be
resected.
A cartridge moving device is adapted to move the cartridge
essentially in parallel relationship towards the anvil from a
spaced position for positioning tissue therebetween to a closed
position for clamping the tissue. The staples can be driven out of
the cartridge towards the anvil by means of a staple driving
device.
Herein, the term "staple" is used in a very general sense. It
includes metal staples or clips, but also surgical fasteners made
of synthetic material and similar fasteners. Synthetic fasteners
usually have a counterpart (retainer member) held at the anvil. In
this sense, the terms "anvil" and "staple forming plane" also have
a broad meaning which includes, in the case of two-part synthetic
fasteners, the anvil-like tool and its plane where the retainer
members are held, and similar devices.
Preferably, a knife is contained within the cartridge and is
positioned such that there is at least one row of staples on at
least one side of the knife. The knife is moved towards the anvil
by means of a knife actuating device. If the stapling instrument
does not include a knife, tissue to be resected after stapling can
be cut by means of a separat surgical instrument.
The main advantage of the surgical stapling instrument according to
the invention is its ability to allow endoluminal tissue resections
and stapling through direct vision. Additionally, separate optics
(e.g., an endoscope) can be used as an option. When the instrument
is introduced into, e.g., the anal canal, free view onto and access
to the site of the tissue to be resected is not obstructed by any
parts of the instrument. The tissue to be excised can be pulled
into the area in between the anvil and the cartridge, when the
cartridge is in a spaced or open position, by means of a separate
gripping instrument. Because of the unobstructed access towards the
concave inner faces of the cartridge and the anvil, the gripping
instrument can be used easily, effectively and safely. Afterwards,
the cartridge is moved towards the anvil in order to clamp the
tissue. A particular advantage is that the surgeon can well
observer the clamping procedure when the movable cartridge
approaches the resting anvil. When the cartridge has reached the
closed position, the surgeon can "fire" the instrument, which means
that the staples are driven out of the cartridge, penetrate the
tissue, whereupon their ends are bent by the anvil, and the knife
is moved towards the anvil in order to cut the tissue. When the
instrument is retracted, the completely excised tissue stays in the
staple fastening assembly and can thus be safely removed from the
patient's body.
The surgical stapling instrument according to the invention allows,
e.g., the removal of a peduncular polyp and surrounding mucosa for
optimal histological examination. Moreover, a valuable trace in the
form of staples is left in the patient's body which allows to find
the site of the operation at a later time easily if a subsequent
examination is required. In this case of sessile polyps, the
advantages of the instrument are the rapid deployment of sterile
sealing means (i.e. staples) and a low blood loss. Optimal
histological examination results are possible because a good
definition of possible muscular and perirectal infiltration of
neoplastic cells is allowed. In the case of benign polyps and early
diagnosed rectal cancer, the surgical procedure can be considered
curative.
Examples for other applications of the surgical stapling instrument
according to the invention are the treatment of mucosa prolapses of
the rectum, rectoceles, anterior prolapses of the rectum, rectal
prolapses, rectal ulcers, stenoses (e.g., at an anastomic site),
Meckel diverticulum, esophageal pathologies, the transrectal
stapling of trauma wounds, the intussusception of the rectum, and
the resection of polyps via service enterotomy.
Preferably, the outer faces of the cartridge and the anvil are
ergonomically shaped to match the anatomy of the internal lumen of
the digestive track. The cartridge and the anvil can have a
generally arc-like shape in the cross-sectional plane, the arc
extending over an angle in the range 90.degree. to 270.degree..
In an advantageous version, the staple fastening assembly includes
a curved guide portion, wherein the cartridge is mounted for
movement between the distal end of the guide portion and the anvil.
Preferably, the shape of the guide portion is arc-like in the
cross-sectional plane and is similar to that of the cartridge and
the anvil, allowing an unobstructed access towards the concave
inner face of the guide portion as well. Preferably, the guide
portion and the anvil are rigidly connected by means of at least
one arm extending from at least one end of the anvil and generally
running in parallel to the longitudinal axis of the body portion of
the instrument. This arm does not interfere with surgical
instruments used for manipulating the tissue to be excised and does
not block the surgeon's view. A staple fastening assembly designed
in this way greatly facilitates the surgical applications of the
instrument.
In an advantageous embodiment, there is at least one row of staples
on each side of the knife. The advantage of this arrangement is
that the tissue is safely held on both sides of the knife when the
knife cuts the tissue, thus ensuring a clean excision of the
tissue. Another advantage is that hemostasis of the resected site
is maintained during the procedure. The staples sticking in the
excised tissue are removed from the patient's body together with
that tissue specimen.
The distance between the cartridge and the anvil in the closed
position is preferably adjustable. For example, the cartridge
moving device can comprise an adjustable stop in order to prevent
the cartridge from moving beyond the stop position and from
clamping the tissue too much. Or a series of cartridges with
different built-in tissue stops can be used according to the tissue
thickness. It is also conceivable to use a series of cartridges
which have different longitudinal dimensions which are adapted to
the desired distance between the cartridge and the anvil in the
closed position. By adjusting the distance between the cartridge
and the anvil in the closed position, the instrument can be matched
to the thickness and type of tissue to be excised.
In an advantageous version, the staple driving device is adapted to
simultaneously drive the staples out of the cartridge towards the
anvil, and the knife actuating device is adapted to cause the knife
to protrude from the cartridge after the staple points have been
driven out of the cartridge. In this design, pre-ferably the staple
driving device and the knife actuating device are mechanically
coupled for operation via a common trigger. This way of controlling
the operation of the staples and the knife ensures a well-defined
and clean cutting line in the tissue, while the handling is
easy.
Preferably, the cartridge is removable so that a used cartridge
without staples can be replaced with a fresh one, if required. This
is particularly advantageous if the instrument is to be used
several times during the same surgical procedure. It is also
conceivable to design the instrument as a re-usable instrument
which is sterilized after each surgical procedure. In this case, a
fresh and sterile cartridge can be inserted during the next
surgical procedure.
When the cartridge is removable, it can be mounted, e.g., in a
cartridge holder which embraces the cartridge along the periphery
of an arc-like shape in the cross-sectional plane. This design
still allows an unobstructed access towards the concave inner face
of the cartridge, i.e. up to the concave inner face of the
cartridge holder, which matches the shape of the cartridge in the
cross-sectional plane.
In another advantageous version, the knife is removable. This
allows the selection of a knife of given dimensions or cutting
properties, which is optimized to the surgical procedure in
question, e.g., to the timing required when the staples penetrate
the tissue and the tissue is cut, or simply a replacement of the
knife if desired.
Preferably, the cartridge moving device includes a trigger lever
(preferably close to the handle) for actuating the movement of the
cartridge. Alternatively, the cartridge moving device can include a
threaded shaft which is mounted in the body portion and coupled to
a rotatable knob. In this case, the longitudinal movement of the
cartridge for approaching the anvil is activated by rotating the
knob. Mechanisms for effecting these kinds of movements are
generally known in the prior art, see, e.g., U.S. Pat. No.
4,527,724.
Preferably, the anvil has an atraumatically shaped distal end
region, which facilitates, e.g., the insertion of the instrument
into the rectum and the advancement of the instrument inside the
lumen.
In an advantageous embodiment of the invention, the staple
fastening assembly is removably mounted in the distal end region of
the body portion. This allows the frame of the instrument and many
parts of the cartridge moving device, the staple driving device and
the knife actuating device to be designed as re-usable components,
which are sterilized after each surgical procedure, whereas the
staple fastening assembly can be replaced after each surgical
procedure.
In the following, some advantages of the surgical stapling
instrument according to the invention are summarized: It is
possible to perform a surgical procedure under local anaesthetics
or spinal sedation. Generally, the procedures are fast and
relatively easy. The blood loss tends to be low. It is possible to
apply sterile staples in a septic field, which reduces the
incidence of dehiscence and abscesses. Tumors with a diameter of up
to about 3 cm can be excised. It is possible to identify the type
of locally advanced tumors and to determine the tumor "T" level
because the tumor site is visible when the instrument is used and
the excised tissue can be safely removed by means of the instrument
for pathological examination. Moreover, possible mucosa or muscular
infiltration can be identified (in the case of lower carcinomas,
the infiltration stage is a useful tool in the decision to proceed
with anterior resection or amputation). The surgical site where the
staples have been left behind can be quickly identified, e.g., by
using X-rays. The instrument provides the ability to remove
advanced growing or stenotic rectal neoplasias via a minimal
invasive approach in poor condition patients for which a radical
procedure is not indicated. It is also conceivable to use the
instrument as a suturing device after the completion of a transanal
endoscopic microsurgery.
Moreover, the instrument can be used as a distal stump suturing
device in the lower anterior resection when a double stapling
technique is performed. To this end, the instrument allows rectal
stump closure with the instrument introduced via a laparoscopic
approach. The instrument also allows an improved rectal stump
closure, which is useful because it eliminates the "Dog Ears"
effect after colorectal anastomosis. Finally, the instrument allows
the sealing of the specimen with a line of staples.
The surgical stapling instrument according to the invention can be
even used for the excision of tumors larger than 3 cm. In this
case, tissue wall mobilization is required, which can be achieved
via a laparoscopic approach, via an anterior perineal access for
the anterior wall, or via a posterior perineal access for the
posterior wall and multiple applications of the reloadable device
(i.e. of the instrument having the cartridge replaced after each
firing of staples out of several actuations).
In the following, the invention is described in more detail by
means of an embodiment. The drawings show in
FIG. 1 an isometric view of an embodiment of the surgical stapling
instrument according to the invention, which includes a frame and a
staple fastening assembly with a cartridge and an anvil, the
cartridge being spaced from the anvil,
FIG. 2 an isometric view of the instrument after moving the
cartridge into a closed position,
FIG. 3 an isometric view of the instrument after firing the
staples,
FIG. 4 a magnified isometric view of the staple fastening assembly
of the instrument, the cartridge being unlocked from the cartridge
holder,
FIG. 5 a view as in FIG. 4 with the cartridge fully inserted,
FIG. 6 an isometric view onto the staple forming surface of the
anvil of the instrument,
FIG. 7 an isometric view of the cartridge of the instrument,
FIG. 8 a longitudinal section through the staple fastening assembly
along the line V-V in FIG. 5 after moving the cartridge into a
closed position, but before firing the staples,
FIG. 9 a longitudinal section as in FIG. 8, but after firing the
staples and cutting the tissue, and
FIG. 10 a schematic isometric view of the use of the instrument for
removing a polyp in a patient's rectum.
FIG. 1 illustrates a preferred embodiment of a surgical stapling
instrument 1. The instrument 1 has a frame comprising a body
portion, which includes a proximal section 2 and a shaft 3, and a
handle 4. The handle 4 extends from the proximal end region of the
body portion and is close to a lever 5 and a trigger 6 for
actuating the instrument 1, as explained below in more detail.
Whereas the proximal section 2, the handle 4, the lever 5, and the
trigger 6 are ergonomically shaped for facilitating the handling
and manipulation of the instrument 1, the shaft 3 has a small
cross-sectional area so that it does not block a surgeon's view
onto a staple fastening assembly 8, which is mounted at the distal
end 9 of the shaft 3, and provides sufficient support for the
distal end region of the instrument.
FIG. 1, FIG. 2, and FIG. 3 show the instrument 1 in three different
operating states which can be achieved by actuating (i.e. turning
towards the handle 4) the lever 5 and the trigger 6, respectively.
The details of the different states of the staple fastening
assembly 8 are explained below.
FIG. 4 is a magnified view of the staple fastening assembly 8. It
includes a curved cartridge 10 which has an arc-like shape in the
cross-sectional plane, the arc extending over an angle of about
180.degree. in the embodiment. The cartridge 10 can be removed from
the rest of the staple fastening assembly 8 and is mounted in a
cartridge holder 12 by means of a bayonet locking 14. In FIG. 4,
the cartridge 10 is shown in an unlocked state, slightly pulled out
of the cartridge holder 12. The cartridge holder 12 is matched to
the arc-like shape of the cartridge 10 in the cross-sectional plane
and extends over an arc angle of about 180.degree. as well. In FIG.
5, the cartridge 10 has been fully inserted into the cartridge
holder 12 and is locked in the bayonet locking 14.
The proximal portion of the cartridge holder 12 is designed as a
slider 16 which is narrower (seen in radial direction) than the
distal portion of the cartridge holder 12. The slider 16 is
slidably mounted in a guide portion 18, as is evident from FIGS. 4
and 5. By shifting the slider 16 inside the guide portion 18, the
cartridge holder 12 including the cartridge 10 can be moved in the
direction of the longitudinal axis L of the shaft 3. FIGS. 1 and 5
display a spaced position, when the shoulder of the cartridge
holder 12 comes in close proximity to the distal end 19 of the
guide portion 18.
The outer periphery of the guide portion 18 is similar to that of
the distal portion of the cartridge holder 12, but because of an
arm 20, its angle of arc is slightly larger than that of the
cartridge 10. The arm 20 is rigidly connected to one end of the
guide portion 18 and runs in parallel to the longitudinal axis L.
It supports an anvil 22 having an atraumatically shaped distal end
region 24 and a staple forming plane or surface 26, see FIG. 6. In
the embodiment, the staple forming plane 26 is arranged at an angle
of 90.degree. with respect to the longitudinal axis L of the shaft
3. However, different transversal angles are conceivable as well.
Moreover, it is possible to imagine the use of two arms to support
the anvil, e.g., one arm at each of both ends of the guide
portion.
As shown in FIG. 6, the staple forming plane 26 of anvil 22
includes a plurality of staple forming depressions 28, which are
arranged in three curved or arc-like open rows. In between the
innermost row and the middle row, there is a continuous arc-like
depression 30 for accommodating the end of an arc-like knife (see
below).
As illustrated in FIG. 7, the cartridge 10 is provided with a
plurality of slots 32 which are arranged for cooperation with the
staple forming depressions 28 and run in three curved or arc-like
open rows 34, 35, and 36. A knife guide 38, which is aligned to the
knife depression 30 in the mounted state of the cartridge 10, is
visible in between rows 34 and 35.
Before continuing with the description of the details of staple
fastening assembly 8 by means of FIGS. 8 and 9, the overall
geometry of the staple fastening assembly 8 is emphasized once
again. Because of the generally arc-like shape (in the
cross-sectional plane) of the guide portion 18, the cartridge
holder 12, the cartridge 10, as well as the anvil 22 and the
arrangement of the arm 20, the staple fastening assembly 8 allows a
free and unobstructed access towards the concave inner faces 40 of
the cartridge holder 12 (and thus towards the concave inner face 41
of the cartridge 10), 42 of the anvil 22 and 44 of the guide
portion 18, see FIG. 5. Consequently, tissue in the area of the gap
between the cartridge 10 and the anvil 22, when the cartridge 10 is
in the spaced or open position as shown in FIG. 5, can be easily
accessed and manipulated by means of separate surgical
instruments.
FIGS. 8 and 9 are sectional views of the staple fastening assembly
8 along the line V-V of FIG. 5. FIG. 8 illustrates how the slider
16 of the cartridge holder 12 is guided inside the guide portion
18, which enables a longitudinal movement of the cartridge holder
12 including the cartridge 10. In this way, by actuating lever 5,
the cartridge 10 can be moved towards the anvil 22 from the open
position shown in FIGS. 1 and 5 in a closed position as shown in
FIGS. 2 and 8. A mechanism for effecting this movement by means of
the lever 5 is described, e.g., in U.S. Pat. No. 5,605,272. During
the movement, the cartridge 10 maintains its parallel relationship
with respect to the staple forming plane 26 of anvil 22.
In the closed position, tissue can be clamped in between the
cartridge 10 and the anvil 22. It is advantageous, when the
residual gap between the distal end of cartridge 10 and the staple
forming plane 26 can be adjusted in order to prevent the tissue
from being excessively compressed. Details on the mechanism of an
adjustment device can be found, e.g., in U.S. Pat. No. 4,527,724.
As an alternative to an adjustment device in the mechanism of the
instrument, it is possible to use a set of cartridges in which each
cartridge is designed for a different residual gap. This can be
achieved, e.g., by different thicknesses (i.e. dimensions along the
direction of the longitudinal axis L) of the distal section of a
guide 50 (see next paragraph).
As shown in FIGS. 7 and 8, the cartridge 10 comprises a guide
provided with the slots 32 and the knife guide 38. At its proximal
or bottom side, the cartridge 10 is open so that a pusher 52 can be
shifted by means of a bar 53 which is guided inside the slider 16.
The pusher 52 holds staples 54, 55, and 56, i.e. the staples of the
rows 34, 35, and 36, as well as an arc-like knife 58.
When the trigger 6 is actuated by drawing it towards the handle 4
(see FIG. 3), the bar 53 and the pusher 52 are moved in distal
direction, see FIG. 9. In this way, the staples 54, 55, and 56 are
expelled from the cartridge 10. Moreover, the knife 58 is moved in
distal direction as well. Since the distal edge of the knife 58
runs behind the pointed ends of the staples 54, 55, 56 (see FIG.
8), the knife 58 reaches the tissue clamped in between the
cartridge 10 and the anvil 22 after the staples 54, 55, 56 have
penetrated the tissue. This prevents the tissue from being
displaced during the cutting process. After the knife 58 has cut
the tissue, the excised tissue specimen contains the row 34 of
staples 54, whereas the tissue remaining in the patient is held
approximated by two rows 35, 36 of staggered staples 55, 56.
An embodiment of a possible mechanism for achieving the movement of
bar 53 when the trigger 6 is actuated, is described in U.S. Pat.
No. 5,605,272. This document also discloses some safety features
which prevent the instrument 1 from being actuated or fired
accidentally.
FIG. 10 illustrates in a schematic way how the instrument 1 can be
used in order to resect a polyp 62 from a patient's rectum 60. The
instrument 1 is inserted via the anal canal, the cartridge 10 being
in the spaced or open position with respect to the anvil 22, as
shown in FIG. 10. Now the polyp, or more precisely, healthy tissue
in the area surrounding the polyp, can be pulled into the gap
between the cartridge 10 and the anvil 22 by means of a separate
surgical gripping instrument or traction sutures previously
applied. This procedure is greatly facilitated by the curved shape
of the guide portion 18, the cartridge 10, and the anvil 22 as well
as the small cross-sectional area of the shaft 3, as already
explained above. A separate endoscopic optical system can be
helpful, but is not required. After the polyp has been secured, the
cartridge 10 is moved towards the anvil 22 up to the closed
position in order to clamp the tissue, as described above.
Afterwards, the instrument 1 is fired, i.e. the trigger 6 is
actuated which causes the staples to be expelled and the knife 58
to cut the tissue. The pointed ends of the staples are bent by the
anvil 22. When the instrument 1 is retracted from the patient, the
excised polyp 62 including the row 34 of staples is removed
together with the staple fastening assembly 8 for pathological
examination.
Other surgical procedures using the instrument 1 as well as the
advantages thereof have already been mentioned in the introductory
part of the description.
In special embodiments, the radius of curvature (e.g., of the
cartridge, the cartridge holder, the open row(s) of staples, the
knife, and/or the anvil) can be large or very large, up to
infinite.
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