U.S. patent application number 11/710732 was filed with the patent office on 2008-08-28 for applicator and tissue fastening method through natural orifice.
This patent application is currently assigned to Olympus Medical Systems Corp.. Invention is credited to Kunihide Kaji, Masatoshi Sato.
Application Number | 20080208214 11/710732 |
Document ID | / |
Family ID | 39535157 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080208214 |
Kind Code |
A1 |
Sato; Masatoshi ; et
al. |
August 28, 2008 |
Applicator and tissue fastening method through natural orifice
Abstract
The applicator related to the present invention is provided with
a flexible sheath longer than the overall length of an instrument
channel of a flexible endoscope; an operation part used outside the
instrument channel; a deployed section that can be made to protrude
from the front end of the sheath by operating the operation part
and to pierce a tissue; a tissue fastening tool made of a
superelastic wire formed in coil shape and housed inside the
deployed section in a substantially extended condition; and a
pusher that pushes out the tissue fastening tool from the deployed
section when the operation part is operated.
Inventors: |
Sato; Masatoshi;
(Yokohama-shi, JP) ; Kaji; Kunihide;
(Hachioji-shi, JP) |
Correspondence
Address: |
SCULLY SCOTT MURPHY & PRESSER, PC
400 GARDEN CITY PLAZA, SUITE 300
GARDEN CITY
NY
11530
US
|
Assignee: |
Olympus Medical Systems
Corp.
Tokyo
JP
|
Family ID: |
39535157 |
Appl. No.: |
11/710732 |
Filed: |
February 26, 2007 |
Current U.S.
Class: |
606/139 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 17/1114 20130101; A61B 17/115 20130101; A61B 17/068 20130101;
A61B 2017/00867 20130101; A61B 2017/1139 20130101; A61B 2017/0649
20130101; A61B 2017/1117 20130101; A61B 17/11 20130101; A61B 17/064
20130101 |
Class at
Publication: |
606/139 |
International
Class: |
A61B 17/10 20060101
A61B017/10 |
Claims
1. An applicator comprising: a flexible sheath longer than the
overall length of instrument channel of a flexible endoscope; an
operation part used outside the instrument channel; a deployed
section that can be made to protrude from the front end of the
sheath by operating the operation part and to pierce tissues; a
tissue fastening tool made of a superelastic wire formed in coil
shape and housed inside the deployed section in a substantially
extended condition; and a pusher that pushes out the tissue
fastening tool from the deployed section when the operation part is
operated.
2. The applicator according to claim 1, wherein the tissue
fastening tool comprises a first part wound in coil shape, and a
second part in coil shape with a winding diameter greater than that
of the first part.
3. The applicator according to claim 1, wherein a part of the
tissue fastening tool is wound over by a double winding with a slit
in the radial direction.
4. The applicator according to claim 1, wherein the operation part
is provided with a stopper that stops the pusher once it has pushed
an amount equivalent to substantially half the overall length of
the substantially extended tissue fastening tool.
5. The applicator according to claim 1, further comprising: a stent
disposed on the outside of the deployed section; and a stent
push-out tool in contact with the stent used for pushing out the
stent.
6. The applicator according to claim 5, wherein: the front end of
the stent has a reduced diameter.
7. The applicator according to claim 5, wherein: a thread protrudes
from the outer periphery of the stent.
8. The applicator according to claim 5, wherein the cross section
in the radial direction of the stent is smaller than the inside
diameter when the tissue fastening tool is restored to its original
coil shape.
9. The applicator according to claim 5, wherein the stent is
provided with part that protrudes wider than the inside diameter of
the tissue fastening tool when its original coil shape is
restored.
10. The applicator according to claim 5, wherein the stent push-out
tool is disposed more to the outside than the deployed section.
11. The applicator according to claim 1, wherein the deployed
section is processed for ultrasonic wave reflection.
12. The applicator according to claim 1, wherein the tissue
fastening tool is made of tightly wound coil.
13. The applicator according to claim 1, wherein the end of the
element wire of the tissue fastening part is chamfered.
14. The applicator according to claim 1, wherein the ends of the
tissue fastening tool have a substantial spherical shape of
diameter larger than the element wire diameter.
15. The applicator according to claim 1, wherein the tissue
fastening tool has ends that are folded back.
16. The applicator according to claim 1, wherein the tissue
fastening tool has ends that are folded back so as to enable
grasping.
17. A tissue fastening method through a natural orifice comprising
the steps of: inserting a deployed section housed with a tissue
fastening tool made of superelastic wire formed in coil shape in
the substantially extended condition into the body through a
flexible endoscope; piercing the tissues to be fastened by the
deployed section; penetrating the tissues with a part of the tissue
fastening tool housed in the deployed section and thereafter
pushing it out from the deployed section and restoring to its
original coil shape; and pulling out the deployed section from the
tissues, pushing out the remaining part of the tissue fastening
tool, and restoring it to its original coil shape;
18. The tissue fastening method through the natural orifice
according to claim 17, further comprising the steps of: piercing
the tissues, which includes penetrating a second tissue after
penetrating a first tissue; and pushing out a part of the tissue
fastening tool after penetrating the second tissue.
19. The tissue fastening method through the natural orifice
according to claim 18, wherein the first tissue comprises a first
organ, and the second tissue comprises a second organ.
20. The tissue fastening method through the natural orifice
according to claim 19, wherein the first and the second organs are
two different hollow organs; and the first and the second tissues
are walls of hollow organs.
21. The tissue fastening method through the natural orifice
according to claim 17, further comprising the steps of: restoring
the tissue fastening tool to its original coil shape; and forming a
through hole in the tissues at the center of the tissue fastening
tool.
22. The tissue fastening method through the natural orifice
according to claim 18, further comprising the steps of: passing a
stent through the hole penetrating the tissues and formed at the
center of the tissue fastening tool.
23. The tissue fastening method through the natural orifice
according to claim 22, further comprising the steps of: restoring
the tissue fastening tool to its original coil shape; and
compressing and necrotizing the tissues fastened by the tissue
fastening tool.
24. The tissue fastening method through the natural orifice
according to claim 23, wherein the tissue fastening tool and the
stent are removed from the detention locations by falling off the
necrotized tissue from the body.
25. The tissue fastening method through the natural orifice
according to claim 21, further comprising the steps of: restoring
the tissue fastening tool to its original coil shape; and
compressing and necrotizing the tissues fastened by the tissue
fastening tool.
26. The tissue fastening method through the natural orifice
according to claim 25, wherein the tissue fastening tool is removed
from the detention location by falling off the necrotized tissues
from the body.
27. The tissue fastening method through the natural orifice
according to claim 18, further comprising the steps of: compressing
the tissues with the tissue fastening tool; coalescing and joining
the tissues around the outside diameter of the tissue fastening
tool; and compressing and necrotizing the tissues on the inner
periphery of the tissue fastening tool.
28. The tissue fastening method through the natural orifice
according to claim 27, wherein the tissue fastening tool is removed
from the detention location by falling off the necrotized tissues
from the body and coalesced fistulous opening is formed between the
first and the second tissues.
29. The tissue fastening method through the natural orifice
according to claim 28, wherein the tissue fastening tool falls off
to a specified side of either the first tissue or the second tissue
when the tissue fastening tool is removed.
30. The method of manufacturing a double coil spring comprising the
steps of: winding the element wire on the core; covering the
element wire wound over the core by a spacer containing a slit;
taking the element wire from the slit to the outer periphery of the
spacer, and winding the element wire around the outer periphery of
the spacer; and heat treating the element wire in the wound
condition over the core and the spacer.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to an applicator and tissue
fastening method to perform the procedure for fastening tissues
through a natural orifice.
[0003] 2. Description of Related Art
[0004] Transcutaneous insertion of medical instruments as a
treatment of body organs is well known. This method is less
invasive compared to incising the abdomen, and quick recovery is
anticipated.
[0005] A medical instrument used for transcutaneous procedures has
a shaft made of hard material inserted in the body
transcutaneously, with a forceps and so on provided at the front
end of the shaft. For instance, a treatment instrument used in
applications such as connecting hollow organs is disclosed in
Japanese Unexamined Patent Application, First Publication No.
2005-193044. This intraluminal anastomosis device has a grasper
fitted to the front end of the shaft that can freely open and
close, and an anastomosis clamp inserted in the shaft. The
anastomosis clamp can be pushed out from the front end of the shaft
by the protruding device located at proximally to the operator. The
anastomosis clamp is formed by annealing shape memory alloy into
flat coil shape and inserting it in the shaft in the elongated
condition. When the anastomosis clamp is used, the clamp is pushed
out from the protruding device and inserted into the body. The
surgical clamp is heated by body temperature and restored to its
original coil shape. The hollow organs are joined by the restored
anastomosis clamp.
[0006] Other examples of dispensing the anastomosis clamp are
disclosed in the international publication number WO2002/019923.
Here, the anastomosis clamp is pushed out from the needle and
dispensed to the tissue. For this reason, a stopper is provided to
control the depth to which the needle pierces the tissue and the
amount of the anastomosis clamp is dispensed into the tissue. When
performing the procedure, the instrument containing the anastomosis
clamp and the needle is deployed to the tissue. The needle is
advanced to pierce the blood vessel, and the position of the
anastomosis clamp is fixed by the stopper. Thereafter, the needle
is pulled out of the blood vessel and the tissue. The anastomosis
clamp does not move because of the stopper; therefore, its front
end part remains inside the blood vessel. When the instrument is
removed from the tissue, the rest of the anastomosis clamp remains
outside the tissue. When the coil shape of the anastomosis clamp is
restored, the blood vessel and layers of the tissue are
anastomosed.
SUMMARY OF THE INVENTION
[0007] The main object of the present invention is to fasten
tissues through a natural orifice in comparison to the conventional
procedures of fixing tissues transcutaneously so that invasiveness
is reduced further and quick recovery can be anticipated.
[0008] The applicator related to the first aspect of the present
invention is provided with: a flexible sheath longer than the
overall length of an instrument channel of a flexible endoscope; an
operation part used outside the instrument channel; a deployed
section that can be made to protrude from the front end of the
sheath by operating the operation part and to pierce tissues; a
tissue fastening tool made of a superelastic wire formed in coil
shape and housed inside the deployed section in a substantially
extended condition; and a pusher that pushes out the tissue
fastening tool from the deployed section when the operation part is
operated.
[0009] The tissue fastening method through a natural orifice
related to the second aspect of the present invention includes:
inserting a deployed section housed in a substantially extended
condition in a tissue fastening tool made of a superelastic wire
formed in coil shape into the body through a flexible endoscope;
piercing the deployed section into a tissue to be fastened;
penetrating a tissue with a part of the tissue fastening tool
housed in the deployed section and thereafter pushing it out of the
deployed section to restore its original coil shape; and pulling
out the deployed section from the tissue and thereafter pushing out
the remaining part of the tissue fastening tool to restore its
original coil shape.
[0010] The method of manufacture of double coil spring related to
the third aspect of the present invention includes: winding an
element wire on the core; covering the element wire wound on the
core by a spacer with a slit; pulling out the element wire from the
slit to the outer periphery of the spacer and winding the element
wire around the periphery of the spacer; and heat treating the
element wire wound over the core and the spacer.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 shows the usage status of applicator inserted in an
endoscope.
[0012] FIG. 2 is a cross sectional view showing the applicator
configuration.
[0013] FIG. 3 is an external view of the tissue fastening tool.
[0014] FIG. 4 shows an endoscope inserted in the duodenum.
[0015] FIG. 5 is a cross sectional view showing the deployed
section protruding from the front end of the applicator.
[0016] FIG. 6 shows the penetrated deployed section extending from
the duodenum toward the common bile duct.
[0017] FIG. 7 shows the view when the stylet has been advanced to
push out the tissue fastening tool halfway.
[0018] FIG. 8 shows the disposition of the tissue fastening tool
when it has been pushed out halfway.
[0019] FIG. 9 shows the common bile duct pulled up in the duodenum
with the deployed section pulled back from the condition in FIG.
8.
[0020] FIG. 10 shows the fully pushed out tissue fastening
tool.
[0021] FIG. 11 is the external view of the tissue fastening tool
detained in the tissue.
[0022] FIG. 12 shows the closed area formed by the tissue fastening
tool pierced by the deployed section.
[0023] FIG. 13 shows the anastomosis hole formed by the deployed
section.
[0024] FIG. 14 shows a schematic drawing of the status of bile
draining into the duodenum from the anastomosis hole.
[0025] FIG. 15 is an explanatory drawing showing the formation of
the anastomosis hole using a high-frequency knife.
[0026] FIG. 16 is an example of modification showing a hole for
delivering the tissue fastening tool to the side of the deployed
section.
[0027] FIG. 17 is an external view showing an example of
modification of the tissue fastening tool.
[0028] FIG. 18 is an external view showing an example of
modification of the tissue fastening tool.
[0029] FIG. 19 is an external view showing an example of
modification of the tissue fastening tool.
[0030] FIG. 20 is an external view showing an example of
modification of the tissue fastening tool.
[0031] FIG. 21 is an external view showing an example of
modification of the tissue fastening tool.
[0032] FIG. 22 is an external view showing an example of
modification of the tissue fastening tool.
[0033] FIG. 23 shows the rounded ends of the tissue fastening
tool.
[0034] FIG. 24 shows the spherical ends of the tissue fastening
tool.
[0035] FIG. 25 shows an example of modification of the end of the
tissue fastening tool.
[0036] FIG. 26 shows a schematic explanatory drawing of the process
of restoring the tissue fastening tool.
[0037] FIG. 27 shows the detention of the tissue fastening tool
when its clamping force is large.
[0038] FIG. 28 shows the necrotized tissue fastened by the tissue
fastening tool.
[0039] FIG. 29 shows the status of the fistulous opening formed
when the tissue fastening tool and the necrotized tissue have
fallen into the duodenum side.
[0040] FIG. 30 is a tissue fastening tool with coil shapes of
varying winding diameters.
[0041] FIG. 31 shows the tissue fastening tool shown in FIG. 30
detained in the tissue.
[0042] FIG. 32 shows the tissue fastening tool and the necrotized
tissue fallen into the duodenum side.
[0043] FIG. 33 shows the coil shaped tissue fastening tool
partially overlapping in the radial direction.
[0044] FIG. 34 shows the coil shaped tissue fastening tool
partially overlapping in the radial direction as seen from A in
FIG. 33.
[0045] FIG. 35 is an external view of the spacer used when
manufacturing the coil of FIG. 33.
[0046] FIG. 36 is a cross sectional view as seen from the line B-B
in FIG. 35.
[0047] FIG. 37 is an explanatory drawing of the procedure for
forming the coil shape of the tissue fastening tool.
[0048] FIG. 38 shows the tissue fastening tool detained in the
tissue and fastening forces acting in the radial direction.
[0049] FIG. 39 is a cross sectional view of the applicator when a
tissue fastening tool and a stent are used together.
[0050] FIG. 40 shows the deployed section protruded by pushing the
slider.
[0051] FIG. 41 shows the tissue fastening tool pushed out halfway
by pushing the stylet.
[0052] FIG. 42 shows the status of detention of the tissue
fastening tool.
[0053] FIG. 43 shows the deployed section piercing the location
where the tissue fastening tool is detained, and the stent pressing
against a tissue.
[0054] FIG. 44 shows the applicator retracted after a stent has
been twisted into the tissue.
[0055] FIG. 45 shows the bile drainage opening formed after
detaining the tissue fastening tool.
[0056] FIG. 46 is an explanatory drawing showing the rotation of
duodenum wall and common bile duct wall, and the misalignment of
the drainage opening.
[0057] FIG. 47 shows the state when the tissue fastening tool,
stent, and necrotized tissue have fallen into the duodenum
side.
[0058] FIG. 48 shows the aligned condition of the stent screw pitch
and coil pitch of the tissue fastening tool.
[0059] FIG. 49 shows the stent with flap.
[0060] FIG. 50 shows the deployed section processed for ultrasonic
wave reflection.
[0061] FIG. 51 is an explanatory drawing of the mode of using the
dilator.
[0062] FIG. 52 is an external view of the dilator.
[0063] FIG. 53 shows an example of modification of the dilator.
[0064] FIG. 54 is an external view of the tissue fastening tool
with a grasping part.
[0065] FIG. 55 is an external view of the tissue fastening tool
with a grasping part.
[0066] FIG. 56 shows the recovery operation of the tissue fastening
tool using a grasping forceps.
[0067] FIG. 57 shows a plurality of tissue fastening tools detained
adjacent to each other.
[0068] FIG. 58 shows the procedure for joining fistulous openings
using a high-frequency knife after the tissue fastening tools has
fallen off.
[0069] FIG. 59 shows an elongated hole formed by joining the
fistulous openings.
[0070] FIG. 60 shows tissue fastening tool detained in one tissue
and distended.
DETAILED DESCRIPTION OF THE INVENTION
[0071] Embodiments are described here. The same reference numbers
are affixed to the same elements in each mode of the embodiments.
Duplication of explanations is omitted.
FIRST EMBODIMENT
[0072] As shown in FIG. 1, the applicator, which is a flexible
treatment instrument, is provided with an insertion portion 3 that
passes through an instrument channel of an endoscope 2. The
insertion portion 3 has a flexible hollow sheath 4 longer than the
instrument channel. The base end of the sheath 4 placed outside the
body has an operation part 5 fitted thereto. A surgical portion 6
is disposed at the front end of the sheath 4 drawn out from the
front end of the endoscope 2 and led into the body.
[0073] As shown in FIG. 2, the surgical portion 6 is formed from a
deployed section 11A at the front end of a needle tube 11 that can
be freely advanced/retraced through the sheath 4. The needle tube
11 is hollow, passes through sheath 4 and connects with the
operation part 5. The needle tube 11 cannot be expanded/contracted,
but it has the flexibility to bend to a certain extent when it is
inserted into the body. The needle tube 11 has only a deployed
section 11A at the front end; only the deployed section 11A may be
free to protrude in the sheath 4. If the operation tube 5 is
connected to the deployed section 11A made of material with higher
flexibility than the needle tube 11, the insertability can be
enhanced further.
[0074] The front end of the deployed section 11A is cut incisively,
and an opening is formed at the front end. A tissue fastening tool
21 is housed within the deployed section 11A. The tissue fastening
tool 21 is inserted after substantially stretching the element wire
21A. As shown in FIG. 3, the tissue fastening tool 21 has a coil
shape when it is in the no-load condition. If it is taken out of
the deployed section 11A, it returns to its original coil shape by
its self-restoring force. In this tissue fastening tool 21, a
tightly wound coil spring made of a superelastic alloy such as NiTi
may be used. The superelastic alloy exhibits superelasticity when a
specific temperature is exceeded; it maintains its properties of
shape memory in environments below a specific temperature.
Accordingly, if the coil spring is extended in temperature
environments at which shape memory characteristics are active, the
extended state can be retained. If inserted in the deployed section
11A in this state, assembly can be easily performed. The method of
insertion in the deployed section 1 IA is not limited only to the
method mentioned above. Moreover, the tight winding is not limited
to the coil spring only.
[0075] As shown in FIG. 2, a stylet 22 is inserted in the deployed
section 1 A in addition to the tissue fastening tool 21. The stylet
22 is inserted to the base end side relative to the tissue
fastening tool 21 such that it can be freely advanced/retracted. It
is a pusher that pushes the tissue fastening tool 21 from the
deployed section 11A by operating the operation part 5 through the
needle tube 11.
[0076] The operation part 5 has a hollow operation part body 31 to
which the sheath 4 is fixed. A connector 32 is inserted on the side
of the front end in the operation part body 31, and is fixed by the
securing screw 33. A slider 34 is fitted on the base end side of
the operation part body 31 such that it can be advanced/retracted
freely.
[0077] Internal thread 41 is formed in the connector 32, and it can
be connected to the connector 42 (refer to FIG. 1) of the
instrument channel of the endoscope 2. One annular groove 32A is
formed in the part of the connector 32 inserted in the operation
part body 31. If the tip of the securing screw 33 is tightened when
fitted in the groove 32A, the operation part body 31 and the
connector 32 become fixed, and they can no longer rotate or
advance/retract in the axial direction. If the securing screw 33 is
loosened slightly, the connector 32 can be rotated along the groove
32A. If the securing screw 33 is loosened further and taken off
from the groove 32A, the connector 32 can be rotated and
advanced/retracted.
[0078] The slider 34 is a member for advancing/retracting the
needle tube 11; it is fitted such that it can move only in the
advancing/retracting direction in the operation part body 31. A
protective tube 43 and the needle tube 11 are fixed on the inside
of the slider. The protective tube 43 is fixed more to the outside
than the needle tube 11; it prevents deflection of the needle tube
11. Furthermore, the protective tube 43 is attached to the O-ring
45 supported on the side of the operation part body 31 by a
friction fit. It offers the feel of the operation by generating
resistance when the slider 34 is advanced/ retracted, and also
prevents the backflow of air or mucus from the body. The O-ring 45
is made of a flexible material such as silicone rubber.
[0079] The stylet 22 that passes through the needle tube 11 is
pulled out penetrating through the slider 34. A stylet knob 46 is
fitted at its end. A first groove 22A and a second groove 22B are
carved onto the stylet 22 at specific spacing in the
advancing/retracting direction. These grooves 22A, 22B give a
`click` feeling when they form a friction fit with the O-ring 47
supported on the side of the slider 34. The second groove 22B is
installed to correspond to the position at which the tissue
fastening tool 21 starts to get pushed out; it has the role of
preventing the tissue fastening tool 21 from being needlessly
pushed out and of enhancing operability. The first groove 22A is
placed between the start of the push-out and the completion of
push-out of the tissue fastening tool 21. For example, it may be at
a position corresponding to the position at which the tissue
fastening tool 21 is pushed out halfway. The first groove 22A gives
a "click" feeling to the advance/retraction of the stylet 22, and
also has the role of controlling the push-out amount of the tissue
fastening tool 21. Although only one first groove 22A is
illustrated, the position of the first groove 22A may be shifted
and two grooves may be provided. The O-ring 47 prevents the
backflow of air or mucus from the body, and is made of a soft
material such as silicone rubber.
[0080] The stylet 22 is provided with flexibility that enables it
to be inserted in the instrument channel of the flexible endoscope
2, but if the flexibility of the exposed part outside the slider 34
at the front side is reduced, operability can be improved.
[0081] FIG. 1 shows the linear scanning type ultrasonic endoscope
as the endoscope 2 used together with the applicator 1. The
endoscope 2 is provided with a flexible insertion portion 26 that
extends from the operation part 25 used outside the body. A knob
25A for bending the front end part of the insertion portion 26 into
a curve and various buttons 25B are provided in the operation part
25. A cover 27 is fitted at the front end of the insertion portion
26. An ultrasonic probe 28 is fitted to the cover 27. The
ultrasonic probe 28 is placed on the flat plane passed through the
axial line of the insertion portion 26. A plurality of ultrasonic
transducers are disposed along the periphery of the circular arc
shape. Furthermore, the endoscope 2 is provided with a forceps
elevator 29 for delivery of the front end of the applicator 1 in
the lateral direction, and the direction of delivery of the
applicator 1 can be adjusted at a portion located proximally to the
operator. The endoscope 2 may be provided with ultrasonic probe of
other types. Moreover, an endoscope not provided with the
ultrasonic probe 28 may also be used. In this case, an ultrasonic
probe used outside the body, an X-ray device, a magnetic resonance
imaging (MRI) device, or a computerizing tomography (CT) device may
be used jointly.
[0082] Next, the procedure to make bypass between common bile duct
and duodenum after joining them is described here. As shown in FIG.
4, this kind of procedure is performed when the duodenal papilla Dp
is obstructed by a tumor Tr preventing bile drainage, consequently
the bile assimilates in the blood and causes jaundice. This
procedure enables the direct drainage of bile from the common bile
duct Cb to the duodenum Dd. First, the endoscope 2 is inserted from
the patient's mouth. The endoscope 2 is inserted in the duodenum
Dd, which is the upper alimentary tract. The condition outside the
duodenum Dd is examined by the ultrasonic probe 28, and an
appropriate location proximally to the common bile duct Cb for the
procedure is searched around the stomach St side in relation to the
duodenal papilla Dp.
[0083] The applicator 1 is advanced through the instrument channel,
and the protruding direction is adjusted with the forceps elevator
29. As shown in FIG. 5, the slider 34 of the operation part 5 is
pushed into the operation part body 31. The needle tube 11 fixed in
the slider 34 advances, and the deployed section 11A protrudes from
the front end of the sheath 4. Since the second groove 22B is
joined to the slider 34 through the O-ring 47, the stylet 22
advances together with the needle tube 11.
[0084] As a result, the deployed section 11A passes completely
through from the inside to the outside of the duodenum wall Wd, as
shown in FIG. 6, and furthermore, passes through the outside to the
inside of the common bile duct wall Wc.
[0085] As shown in FIG. 7, a first groove 22A is joined by friction
with the O-ring 47 by pushing the stylet knob 46. The stylet 22
pushes out the tissue fastening tool 21 into the common bile duct
Cb from the front end opening of the deployed section 11A only for
a length substantially equal to the distance the stylet knob 46 has
moved. The push-out distance at this stage should preferably be a
length equivalent to substantially half the total length of the
tissue fastening tool 21. As shown in FIG. 7 and FIG. 8, a part of
the tissue fastening tool 21 pushed into the common bile duct Cb
restores itself into coil shape because of superelasticity.
[0086] Thereafter, the applicator I is retracted, the deployed
section 11A is pulled out of the common bile duct Cb, and is pulled
back into the duodenum Dd. As shown in FIG. 9, the tissue fastening
tool 21 restored to its original coil shape, forms a closed space
and comes into annular contact with the inner wall of the common
bile duct Cb. This part becomes the anchor, and the common bile
duct Cb is pulled toward the duodenum Dd so as to form an
anastomosis.
[0087] The stylet knob 46 is advanced further, and the remaining
part of the tissue fastening tool 21 is pushed out from the
deployed section 11A by the stylet 22. As shown in FIG. 10, the
tissue fastening tool 21 is completely released from the applicator
1, and the part on the side of the duodenum Dd is also restored to
its original coil shape because of the superelasticity. As a
result, the duodenum wall Wd and the common bile duct wall Wc are
fastened by the tissue fastening tool 21 in a close contact
condition. As shown in FIG. 10 and FIG. 11, the tissue fastening
tool 21 is detained in coil shape on both the duodenum Dd side and
the common bile duct Cb side, that is, when viewed from the axial
direction of the coil, the tissue fastening tool 21 is detained in
an annular contact condition with the tissue.
[0088] At this stage, the area of tissue other than the area where
the tissue fastening tool 21 penetrates through the duodenum wall
Wd and the common bile duct wall Wc are joined; therefore, the
deployed section 11A is again advanced, and passed completely
through the tissue of the closed area Rc formed by the tissue
fastening tool from the duodenum wall Wd to the inside of the
common bile duct wall Wc, as shown in FIG. 12. At this stage, the
stylet 22 is slightly pulled back beforehand, and the incisive
front end of the deployed section I1 A is used to pierce the area
Rc. When the deployed section 11A is pulled out, as shown in FIG.
13, the anastomosis hole Hc is formed in the closed area Rc
fastened by the tissue fastening tool 21. As shown in FIG. 14, the
bile Lb drains from the common bile duct Cb to the duodenum Dd
through the anastomosis hole Hc, and jaundice is treated.
[0089] The area of the anastomosis hole Hc can be adjusted by
puncturing the deployed section 11A several times, or by moving the
deployed section 11A in the punctured state. Also, as shown in FIG.
15, a large fistulous opening Hc2 may be formed by incising with
the high-frequency knife 51. The high-frequency knife 51 may be
inserted instead of the applicator 1 or approached through a
separate instrument channel.
[0090] According to the present embodiment, the duodenum Dd and the
common bile duct Cd can be joined by procedure through a natural
orifice. Moreover, a bypass procedure for linking both organs can
be performed. By selecting the duodenum Dd as the first hollow
organ and the common bile duct Cb as the second hollow organ, the
drainage path of the bile can be ensured when the duodenal papilla
Dp is obstructed. In the conventional procedure through a natural
orifice, a stent was inserted in the duodenal papilla Dp, but in
cases of advanced obstruction, stent could not be inserted.
According to this embodiment, treatment of jaundice can be
correctly performed. Compared to transcutaneous procedures, the
invasiveness can be reduced. Even locations that are difficult to
perform transcutaneously, can be easily treated. In the
conventional procedure, open abdominal surgery has been performed
to anastomose the common bile duct and the duodenum. However, the
physical burden on the patient was heavy; sometimes the bile is
leaked out from a slight gap in the sutured section between the
common bile duct and the duodenum into the abdominal cavity,
causing a serious side effect called bile peritonitis. When an
anastomosis is formed between the common bile duct and the duodenum
according to the present invention, bile does not leak out into the
abdominal cavity from between the common bile duct and the
duodenum. Accordingly, there is no concern of bile peritonitis to
occur.
[0091] Furthermore, long term patency of the bypass is anticipated
by this embodiment. In the conventional procedure for inserting
stent, a foreign object was detained in the body; therefore, as
early as one month, and latest by three months to about six months,
the internal hole for the stent becomes obstructed and bile can no
longer be drained. Thus, periodic stent replacement was necessary,
placing a heavy burden on patients. According to the present
embodiment, the bypass hole through which the bile drains does not
obstruct easily because it is a luminal tissue.
[0092] The first hollow organ in the treatment of jaundice may be
in the upper alimentary tract. The upper alimentary tract includes
the stomach St in addition to the duodenum Dd. The second hollow
organ may be the gall bladder Gb, cystic duct or extrahepatic bile
duct.
[0093] As shown in FIG. 16, an opening 52 may be provided at the
side of the deployed section 11A, and the tissue fastening tool 21
may be pushed in from this opening. The coil spring of the tissue
fastening tool 21 can be formed laterally with the tissue in the
penetrated condition. At this stage, if the guide wire 53 is
delivered from the front end opening of the deployed section 11A,
two procedures can be performed with one penetration: detention of
the tissue fastening tool 21 and the pass-through of the guide wire
53. The second additional procedure is not limited to the
pass-through of the guide wire 53 only. Procedures such as
injection of a drug solution, a contrast agent, and so on may be
performed.
[0094] FIG. 17 to FIG. 22 show the other embodiments of the tissue
fastening tool.
[0095] The tissue fastening tool 61 shown in FIG. 17 has both ends
of the element wire in convolute form. The part that mainly
penetrates the tissue is straight.
[0096] The tissue fastening tool 62 shown in FIG. 18 has a coils of
varying winding diameter. The winding diameter is the smallest at
the central part in the axial direction and the diameter gradually
increases as it approaches either end.
[0097] The tissue fastening tool 63 shown in FIG. 19 has a part
that extends in a straight line in the axial direction. From both
ends of this part, a spiral shape loops back toward the central
part. The loop-back part has a winding diameter that gradually
increases as it approaches the central part.
[0098] The tissue fastening tool 64 shown in FIG. 20 has an
elliptical shape when viewed in the axial direction. If the longer
axis of the elliptical shape is aligned in the longitudinal
direction of the hollow organ, large puncture area can be ensured
even for narrow hollow organs as shown by the broken lines. The
shape is not limited to elliptical shape; a shape long on one side
such as oblong shape or rectangular shape may also be used. The
same effects can be obtained for these shapes also.
[0099] The tissue fastening tool 65 shown in FIG. 21 has non-slip
convex parts 65A provided intermittently on the element wire. The
convex part 65A is provided in a protruding condition facing the
tissue when detained in the body. As shown in the tissue fastening
tool 66 in FIG. 22, the convex part 66A may be formed by shaping a
part of the element wire in wavy form.
SECOND EMBODIMENT
[0100] As shown in FIG. 23, the two ends 71 of the element wire 21A
in the tissue fastening tool 21 are of rounded shape obtained by
chamfering the corners. As shown in FIG. 25, the end 73 may be
folded back in a U-shape also. Spherical shapes larger than the
element wire diameter may be used, as in the two ends 72 shown in
FIG. 24. In this case, the spherical parts may be formed integrally
during manufacture, or may be made by caulking and fixing the
separate members into this structure. The fixation method used may
be brazing, soldering, bonding, or tight fit. When housed in the
deployed section 11A or when pushing with the stylet 22, jamming
the tissue fastening tool 21 inside the deployed section 11A or the
friction between the tissue fastening tool 21 and the deployed
section 11A is reduced.
[0101] According to the embodiment shown in FIG. 24, by making the
angle between the inside wall of the deployed section 11A and the
element wire 21A as small as possible, the sliding motion can be
improved. Furthermore, for example, as shown by the detention state
when the end 72 exists as in FIG. 26, when the tissue fastening
tool restores its original coil shape in the body, the end 72 of
the element wire 21A moves on the surface of the tissue as
mentioned above. However, it becomes difficult for the end 72 of
the element wire 21A to engage with the tissue, and is thus easy
for the original coil shape to be restored. Similar effects can be
obtained at the other ends 71, 73.
THIRD EMBODIMENT
[0102] FIG. 27 shows the tissue fastening tool 21 detained in the
tissue, and the drainage route for bile is ensured. The fastening
force of the tissue fastening tool 21 of the present embodiment is
strong; the duodenum wall Wd and the common bile duct wall Wd are
compressed by the element wire 21A, the tissue inside the area Rc
fastened by the tissue fastening tool 21 becomes ischemic condition
due to poor blood circulation into the area Rc.
[0103] As shown in FIG. 28, when the ischemic condition continues,
the tissue within the area Rc becomes necrotized. On the other
hand, the duodenum wall Wd and the common bile duct wall Wc
coalesce and join with each other all around at the outer periphery
of the tissue fastening tool 21. When this occurs, the necrotized
tissue and the tissue fastening tool 21 fall off, as shown in FIG.
29. The tissue fastening tool 21 is later discharged. After the
tissue falls off, a large diameter anastomosis hole (fistulous
opening) Hd is formed. At this stage, the portion all around the
anastomosis hole Hd connecting the common bile duct Cb and the
duodenum Dd has coalesced; therefore, the bile cannot leak out
between the common bile duct Cb and the duodenum Dd to the
abdominal cavity. Accordingly, there is no concern of bile
peritonitis to occur. According to this embodiment also, similar to
the first embodiment, long term patency of the anastomosis hole Hd
as the bypass is anticipated. According to this embodiment, since
the tissue fastening tool 21 falls off and the bypass hole becomes
larger, a longer period of patency than that according to the first
embodiment may be anticipated.
[0104] The tissue fastening tool 21 is not detained for a long
period in the body according to the present embodiment. A fistulous
opening Hc of size substantially equal to the size of the tissue
fastening tool 21 can be formed.
FOURTH EMBODIMENT
[0105] As shown in FIG. 30, the tissue fastening tool 81 is
provided with a first part 82 of winding diameter d1 in coil shape,
and a second part 83 of winding diameter d2 larger than the first
part 82. The material and the method of manufacture of the tissue
fastening tool 81 are the same as in the first embodiment.
[0106] When housing the tissue fastening tool 81 in the deployed
section 11A, the portion corresponding to the second part 83 is
inserted first. When fastening the tissue, substantially half the
first part 82 is delivered from the deployed section 11A within the
common bile duct Cb, and the original coil shape is restored.
Subsequently, the deployed section 11A is pulled back into the
duodenum Dd, and the remaining substantial half of the first part
82 and the part equivalent to the second part 83 are delivered, and
the original coil shape is restored. As shown in FIG. 31, the part
82 with small winding diameter holds and detains the duodenum wall
Wd and the common bile duct wall Wc, while the part 83 with the
large winding diameter is detained in the duodenum Dd.
[0107] The coil spring is tightly coiled, and the tissue is
compressed by the tissue fastening tool 81; therefore, with the
passage of time, the tissue is necrotized, and the tissue falls off
in the closed area Rc formed by the coil. At this stage, as shown
in FIG. 32, the second part 83 with large winding diameter is
larger than the first part 82, so the tissue fastening tool 81 and
the tissue fall off into the second part 83 side, that is, into the
duodenum Dd side. A fistulous opening Hc2 of size substantially
equivalent to the winding diameter of the first part 82 is formed
between the duodenum Dd and the common bile duct Cb, and from this
opening, the bile is drained. Until the tissue is necrotized, the
surrounding tissue coalesces; therefore, the common bile duct Cb
does not separate from the duodenum Dd. The fallen-off tissue
fastening tool 81 is discharged outside the body together with
foodstuff.
[0108] According to this embodiment, the direction in which the
tissue fastening tool 81 falls off is prescribed by varying the
winding diameter. If the fall-off direction is set to the duodenum
Dd side, then the tissue fastening tool 81 can be correctly
discharged out of the body without any additional
manipulations.
FIFTH EMBODIMENT
[0109] As shown in FIG. 33 and FIG. 34, the tissue fastening tool
91 is provided with a first part 92 wound in coil shape, and a
second part 93 extended to a specific diameter and wound on the
outside of the first part 92. The material and the method of
manufacturing the tissue fastening tool 91 are the same as in the
first embodiment.
[0110] When forming the second part 93, a spacer 95 is used as
shown in FIG. 35 and FIG. 36. The spacer 95 has a cylindrical
shape, and a stepped bore 96 is formed in it. A slit 97 is formed
parallel to the axial direction in the part 96A with large diameter
of stepped bore 96. During manufacture, as shown in FIG. 37, the
element wire 91A, which forms the tissue fastening tool 91, is
wound over a core 98 to make the first part 92. Subsequently, it is
covered by the spacer 95. In the spacer 95, a small diameter part
96B of bore 96 is passed through the core 98 and the first part 92
is inserted into a large diameter part 96A. The second part 93 is
made by pulling out the element wire 91A from the slit 97 and
winding it along the outside diameter of the spacer 95. The winding
diameter of the second part 93 is decided by the outside diameter
of the spacer 95. The two ends of the element wire 91 A are fixed
so that they do not become loose, and are then shaped by heat
treatment.
[0111] When housing the tissue fastening tool 91 in the deployed
section 11A, the portion corresponding to the second part 93 is
inserted first. When fastening the tissue, the portion
corresponding to the first part 92 is delivered from the deployed
section 11A within the common bile duct Cb, and the original coil
shape is restored. The deployed section 11A is pulled back into the
duodenum Dd, the portion corresponding to the second part 93 is
delivered and the original coil shape is restored. As shown in FIG.
38, the fastening tool is placed such that the duodenum wall Wd and
the common bile duct wall Wc are held between the second part 93
and the first part 91. In addition to the spring force generated
when the coil spring is stretched, in the tissue fastening tool 91,
a force generated in the radial direction to reduce the diameter
also acts on the tissue. The fastening force in the radial
direction is generally greater than the spring force in the axial
direction, so the tissue can be secured more firmly. If the tissue
has been necrotized because of the fastening, the tissue fastening
tool 91 and the tissue fall off into the second part 93 side with
large diameter. A large diameter opening can be formed and also the
tissue fastening tool 91 can be made to fall off with certainty
into the duodenum Dd side.
[0112] According to the present embodiment, by overlapping a part
of the element wire 91A wound in coil shape in the radial
direction, the force for fastening the tissue is increased. Also,
by forming a large diameter part, the direction in which the tissue
fastening tool 91 falls off is specified. If the fall-off direction
is set to the duodenum Dd side, then the tissue fastening tool 91
can be discharged out of the body without any additional
manipulation.
[0113] The tissue fastening tool 91 according to the present
embodiment can be made easily by using the method of manufacturing
the double coil spring using the spacer 95.
SIXTH EMBODIMENT
[0114] As shown in FIG. 39, the applicator 101 has a double-tube
construction with a pusher tube 102 provided on the outside of the
sheath 4 that covers the insertion portion 3. A stent 103 is
friction fitted at the front end of the sheath 4.
[0115] The pusher tube 102 is flexible, and has substantially the
same outside diameter as the stent 103. The inside diameter of the
pusher tube 102 is slightly larger than the inside diameter of the
stent 103, and is not engaged with the stent 103.
[0116] The stent 103 has a cylindrical shape, and its front end has
a tapered surface enabling it to be smoothly connected to the
outside diameter part of the deployed section 11A. Moreover, a
thread 104 formed by ridges in spiral shape is provided on the
outer periphery.
[0117] When a detention tool 105 made of the tissue fastening tool
21 and stent 103 is detained in the body, as shown in FIG. 40, the
deployed section 11A is protruded more to the front end side than
the stent 103, and thereafter, the common bile duct wall Wc is
pierced from the duodenum wall Wd. In this case, the stent 103 is
detained in the duodenum Dd side. As shown in FIG. 41, the stylet
22 is advanced until the first groove 22A engages with the O-ring
47 of the slider 34, and it pushes substantially half of the front
end side of the tissue fastening tool 21 in the common bile duct
Cb. Next, the deployed section 11A is pulled back to the duodenum
Dd side, and the remaining part of the tissue fastening tool 21 is
pushed with the stylet 22. As shown in FIG. 42, the tissue
fastening tool holds the duodenum wall Wd and the common bile duct
wall Wc, restoring its coil shape.
[0118] As shown in FIG. 43, the area Rc fastened by the tissue
fastening tool 21 is pierced by the deployed section 11A, and the
front end of the stent 103 is deployed to the tissue. At this
stage, the stylet 22 is slightly pulled back beforehand, and the
incisive front end of the deployed section 11A is used to pierce
the area Rc.
[0119] The securing screw 33 on the side of the operation part 5 is
loosened slightly. The operation part body 31 is rotated around the
axial direction with respect to the connector 32 in the direction
shown by the arrow AAI. The sheath 4 fixed to the operation part
body 31 rotates, and the stent 103 friction fitted to it also
rotates. Thread 104 is formed on the outer periphery of the stent
103. If the stent 103 is rotated while pressing it against the
duodenum wall Wd, the stent 103 is screwed into the duodenum wall
Wd and the common bile duct wall Wc using the through hole formed
by the deployed section 11A as a guide. At this stage, by keeping
the stylet 22 pushed in completely, the front end of the stylet 22
protrudes slightly from the front end of the deployed section 11A;
therefore, the body cavity tissues are not damaged by the incisive
front end of the deployed section 11A.
[0120] When the stent 103 is adequately screwed into the duodenum
wall Wd and the common bile duct wall Wc, and the common bile duct
Cd and the duodenum Dd are linked, the stent 103 is separated from
the applicator 101. Initially, the deployed section 11A is pulled
back and stored in the sheath 4. The securing screw 33 is further
loosened such that the operation part body 31 becomes movable in
the axial direction after crossing the groove 32A of the connector
32. As shown by the arrow AA2 in FIG. 44, the operation part body
31 is pulled away from the connector 32, and the sheath 4 is
retracted. The pusher tube 102 is in contact with the connector 32
and it does not retract. Since the pusher tube 102 does not move,
the stent 103 disposed at the front end of the pusher tube 102 also
does not move from its position. As a result, the friction fit of
the stent 103 and the sheath 4 is released, and only the stent 103
is detained. The bile will thus drain through the route ensured by
the stent 103 from the common bile duct Cb to the duodenum Dd.
[0121] As shown in FIG. 45, the duodenum wall Wd and the common
bile duct wall Wc are fastened by the tissue fastening tool 21.
When the bile drain opening is formed by the anastomosis hole Hc
penetrating both walls Wd and Wc, the duodenum Dd and the common
bile duct Cb may rotate, as shown in FIG. 46, around the center at
point Pp through which the element wire 21A penetrates the tissue.
In this case, the positions of the bile drain openings punctured in
each of the two walls Wd and Wc may become misaligned, and bile
drainage cannot take place. When the stent 103 is made to penetrate
the walls Wd and Wc, the positional relationship between the
duodenum Dd and the common bile duct Cb becomes stable, thereby
stable bile drainage opening can be ensured.
[0122] Moreover, the stent 103 can be easily inserted in the tissue
because its front end has a reduced diameter. The stent 103 can be
screwed in easily but it does not come off easily because a ridged
thread 104 is formed on the outer periphery of the stent 103.
Either a fine, the reduced diameter of the front end or thread 104
may be provided, or both may not be provided.
[0123] When the fastening force of the tissue fastening tool 21 is
large, as shown in FIG. 47, the necrotized tissue T2, and the
tissue fastening tool 21 and stent 103 fall off, and the fistulous
opening Hc2 is formed. In this embodiment also, long term patency
of the fistulous opening Hc2 for bypass is possible because the
tissue fastening tool 21 and the stent 103 fall off.
[0124] The coil pitch of the tissue fastening tool 21 and the pitch
of the thread 104 may be made to substantially coincide, as in the
stent 103A shown in FIG. 48. The stent 103 is fitted into the
tissue fastening tool 21, so fall-off can be prevented further. In
this case, the diameter at one end of the detention tool 105 is
generally large, while that at the other end is small. When the
tissue is necrotized, it falls off into the large diameter side, so
the large diameter side is detained such that it is disposed in the
duodenum Dd.
[0125] As shown in FIG. 49, it is preferable to provide at least
one flap 108 on the side of one end of the stent 103B. The width d3
with the flap 108 in the open condition is larger than the inside
diameter d4 of the coil of the tissue fastening tool 21. The
detention tool 105 falls off in the direction in which the flap 108
is provided. The present invention is not limited to this flap 108,
and a convex part such as a flange may be provided instead.
SEVENTH EMBODIMENT
[0126] As shown in FIG. 50, the front end of the deployed section
11A may be processed for ultrasonic wave reflection. The surface of
this processed part 110 is roughened by dimples or by sand
blasting, so as to diffuse the reflection of ultrasonic waves.
During the procedure, the amount pierced by the deployed section
11A can be easily confirmed by ultrasonic wave observation.
[0127] The processed part 110 can also be used in the applicator 1
in which stent 103 and pusher tube 102 are not provided.
EIGHTH EMBODIMENT
[0128] As shown in FIG. 51, the applicator 111 is provided with a
dilator 113 to assist in inserting the stent 112 in the tissue. The
dilator 113 is of cylindrical shape such that the deployed section
11A can pass through. The front end has a convex part 113A that
protrudes in the direction of the enlarged diameter. The front end
side and the base end side of the convex part 113A are both
inclined. As shown in FIG. 52, at least one slit 114 is formed in
the axial direction.
[0129] When the detention tool 105 is inserted in the body, the
convex part I 13A of the dilator 113 becomes a stopper and prevents
the stent 112 from falling off. The deployed section 11A is
disposed on the inside of the dilator 113 and it prevents
deformation of the dilator 113. Therefore, the stent 112 does not
move by crossing over the convex part 113A.
[0130] Similar to the embodiment mentioned above, when the common
bile duct Cb is fixed to the duodenum Dd by the tissue fastening
tool 21, a through hole is formed by the deployed section 11A in
the area Rc fastened by the tissue fastening tool 21, and the
dilator is advanced. The dilator 113 enters the common bile duct Cb
while widening the through hole. When the front end of the stent
enters the common bile duct Cb, the deployed section 11A is
retracted and pulled out from the tissue. The deployed section 11A
is retracted toward the base end side passing the convex part 113A
of the dilator 113.
[0131] The pusher tube 102 is pushed to push out the stent 112 so
that it crosses over the convex part 113A of the dilator 113. At
this stage, the deployed section 11A is not on the inside of the
dilator 113. The dilator 113 deforms in the direction of the
reduced diameter with the slit 114 as the starting point, and
allows the stent 112 to move. When the detention of the stent 112
is complete, the applicator 111 is pulled out together with the
entire dilator 113.
[0132] As shown in FIG. 53, the slit 114 of the dilator 113 may be
opened up to the front end. The front end part of the dilator 113
becomes more deformable, and the stent 112 becomes more easy to
push out.
NINTH EMBODIMENT
[0133] As shown in FIG. 54 and FIG. 55, the tissue fastening tool
21 has grasping parts 121 and 122 formed at the ends of the element
wire 21A. These grasping parts 121 and 122 become the starting
points for removal of the tissue fastening tool 21. For example, as
shown in FIG. 56, if the grasping part 122 is held by the grasping
forceps 123 through the endoscope 2 and rotated, the tissue
fastening tool 21 wound in coil shape can be easily pulled out from
the tissue. When they are to be used in combination with the stent
103, the grasping parts 121 and 122 are formed at positions and of
sizes that do not interfere with the stent 103.
TENTH EMBODIMENT
[0134] As shown in FIG. 57, a plurality of tissue fastening tools
21 are detained in the tissue in a straight line. The tissue
fastening tool 21 used is one in which the fastening force can
necrotize the tissue. If applicator 1 is used, the tissue fastening
tool 21 can be disposed at the desired position, and a plurality of
tissue fastening tools 21 can be brought in proximity to each other
and disposed. Accordingly, when each tissue fastening tool 21 falls
off together with the tissue that it necrotized, a continuously
long hole is formed in the direction in which the tissue fastening
tools 21 are arrayed.
[0135] As shown in FIG. 58, if the fistulous openings Hc2 formed by
the tissue fastening tool 21 are not linked, the high-frequency
knife 51 is used to dissect the coalesced portions. The area around
the fistulous opening Hc2 becomes the coalesced range shown by
dotted line in FIG. 56. Even if dissection is performed within the
coalesced range, the bile does not leak from between tissue and
tissue. As shown in FIG. 59, a continuous long hole Hc3 can be
formed. The long hole Hc3 is not limited to a straight line shaped
hole. The preferred embodiments have been described as above.
However, the present invention is not limited to the descriptions
above; they are limited only by the scope of claims appended here.
The tissues fixed by the tissue fastening tool or detention tool in
each of the embodiments are not limited to two separate tissues or
organs. The deployed section 11A is passed through all layers of
tissues sequentially when fixing two tissues, but when one tissue
is to be fixed, a part of the layers are penetrated. As shown in
FIG. 60, manipulation may be performed so as to distend the tissue
with the center as the location that is partially penetrated.
* * * * *