U.S. patent application number 12/171816 was filed with the patent office on 2010-01-14 for tissue fastener.
This patent application is currently assigned to OLYMPUS MEDICAL SYSTEMS CORP.. Invention is credited to Tatsutoshi HASHIMOTO, Kunihide KAJI, Masatoshi SATO, Shinji TAKAHASHI, Tetsuya YAMAMOTO.
Application Number | 20100010520 12/171816 |
Document ID | / |
Family ID | 41110980 |
Filed Date | 2010-01-14 |
United States Patent
Application |
20100010520 |
Kind Code |
A1 |
TAKAHASHI; Shinji ; et
al. |
January 14, 2010 |
TISSUE FASTENER
Abstract
This tissue fastening apparatus is a tissue fastener for
clamping first biological tissue and second biological tissue so as
to be in close contact with each other, including: a first tissue
fixation portion, made of an elastic wire wound in a coil, that is
locked on the first biological tissue; and a second tissue fixation
portion, made of an elastic wire wound in a coil, that is locked on
the second biological tissue, the second tissue fixation portion
continuing into the first tissue fixation portion, in which when
falling off first and second biological tissue necrotized by being
clamped between the first tissue fixation portion and the second
tissue fixation portion, the tissue fastener moves only from the
second tissue fixation portion to the first tissue fixation portion
side and falls off.
Inventors: |
TAKAHASHI; Shinji; (Tokyo,
JP) ; KAJI; Kunihide; (Tokyo, JP) ; SATO;
Masatoshi; (Yokohama-shi, JP) ; YAMAMOTO;
Tetsuya; (Hanno-shi, JP) ; HASHIMOTO; Tatsutoshi;
(Tokyo, 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: |
41110980 |
Appl. No.: |
12/171816 |
Filed: |
July 11, 2008 |
Current U.S.
Class: |
606/157 |
Current CPC
Class: |
A61B 17/068 20130101;
A61B 2017/00685 20130101; A61B 2017/320032 20130101; A61B 17/1114
20130101; A61B 2017/00867 20130101; A61B 2017/0649 20130101; A61B
17/064 20130101; A61B 17/32002 20130101; A61B 2017/320775
20130101 |
Class at
Publication: |
606/157 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, the second tissue fixation portion continuing
into the first tissue fixation portion, wherein when falling off
first and second biological tissue necrotized by being clamped
between the first tissue fixation portion and the second tissue
fixation portion, the tissue fastener moves only from the second
tissue fixation portion to the first tissue fixation portion side
and falls off.
2. The tissue fastener according to claim 1, wherein a diameter of
at least a part of the first tissue fixation portion is set to be
larger than a diameter of the second tissue fixation portion.
3. The tissue fastener according to claim 1, wherein a tip portion
of the first tissue fixation portion is inclined with respect to
other portions of the first tissue fixation portion.
4. The tissue fastener according to claim 1, wherein a number of
coil turns of the first tissue fixation portion is larger than that
of the second tissue fixation portion.
5. The tissue fastener according to claim 1, wherein a coil turn
density of the first tissue fixation portion is lower than that of
the second tissue fixation portion.
6. The tissue fastener according to claim 1, wherein an anchoring
body is attached around the first tissue fixation portion, the
anchoring body flowing along a surface of the first biological
tissue.
7. The tissue fastener according to claim 1, wherein a diameter of
the elastic wire of the first tissue fixation portion is larger
than that of the elastic wire of the second tissue fixation
portion.
8. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein an elastic wire of at least a linking
portion between the first tissue fixation portion and the second
tissue fixation portion is made of a multitude of thin wires being
stranded.
9. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein around an outer circumference of an
elastic wire of at least a linking portion between the first tissue
fixation portion and the second tissue fixation portion, a thin
wire is wound.
10. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein the first tissue fixation portion is
arranged around an outer circumference of the second tissue
fixation portion.
11. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in two-tier large and small coils, that is
locked on the first biological tissue; and a second tissue fixation
portion, made of an elastic wire wound in a coil, that is locked on
the second biological tissue, the second tissue fixation portion
continuing into the small coil of the first tissue fixation
portion.
12. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, the second tissue fixation portion continuing
into the first tissue fixation portion, wherein a linking portion
between the first tissue fixation portion and the second tissue
fixation portion passes through a central portion of the coil.
13. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue; and a cap formed in a cylindrical shape and
having a female thread portion to fit onto the first tissue
fixation portion therein and a ring-shaped stretching portion that
stretches toward the second tissue fixation portion side when the
female thread portion is fitted onto the first tissue fixation
portion.
14. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of a
tubular elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of a
tubular elastic wire wound in a coil, that is locked on the second
biological tissue.
15. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue; and an outer circumference spring portion that
extends from a tip of the first tissue fixation portion outwardly
in a radial direction and that returns to the second tissue
fixation portion side to press the first biological tissue.
16. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein a height of the coil of the first tissue
fixation portion is set to 1.5 mm or more.
17. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein a height of the coil of the second
tissue fixation portion is set to 0.5 mm or more.
18. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein an initial tension of a part of a tip
end side of the second tissue fixation portion is set to be smaller
than that of other portions of the second tissue portion.
19. The tissue fastener according to claim 18, wherein an initial
tension of substantially one turn of the second tissue fixation
portion is set to be smaller than that of other portions of the
second tissue portion.
20. A tissue fastener for clamping first biological tissue and
second biological tissue so as to be in close contact with each
other, comprising: a first tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the first
biological tissue; and a second tissue fixation portion, made of an
elastic wire wound in a coil, that is locked on the second
biological tissue, wherein a part of a tip end side of the second
tissue fixation portion is not closely wound.
21. The tissue fastener according to claim 20, wherein
substantially one turn of the tip end side of the second tissue
fixation portion is not closely wound.
22. The tissue fastener according to claim 15, wherein the outer
circumference spring portion presses the first biological tissue to
the second biological tissue side.
23. The tissue fastener according to claim 22, wherein an initial
tension of the coil of the first tissue fixation portion is set to
be stronger than an amount of force with which the outer
circumference spring portion presses the first tissue fixation
portion when the tissue fastener is placed in a living body.
24. The tissue fastener according to claim 22, wherein the outer
circumference spring portion is set to be smaller than that of the
first and second tissue fixation portions.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a tissue fastener for
fastening tissue through a natural orifice.
[0003] 2. Description of Related Art
[0004] As a technique for performing a treatment on a human organ
or the like, laparoscopic surgery is known in which a treatment
device is percutaneously inserted. This requires less invasion than
the case of incising an abdominal region. Therefore, an early
recovery is expectable.
[0005] A treatment device for use in laparoscopic surgery has a
hard shaft which is percutaneously inserted into a body. At a tip
of the shaft, forceps or the like are provided. For example,
Japanese Unexamined Patent Publication, First Publication No
2005-193044 discloses a treatment device for use in application for
joining hollow organs. In this intraluminal anastomosis apparatus,
a grip device that is freely opened/closed is attached to the tip
of the shaft. Into the shaft, a fastener is inserted. The fastener
is capable of being pushed out from the tip of the shaft with a
plunger mechanism on the hand side. The fastener is manufactured by
heat-treating a shape-memory alloy in a flat coil shape. It is
inserted into the shaft in an extended state. In application, the
fastener is pushed out with the plunger mechanism and piercingly
inserted into a body. The fastener is heated by body temperature
and is restored into its original coil shape. Hollow organs are
joined by the restored fastener.
[0006] Another example of providing a clamping apparatus is
disclosed in PCT International Patent Publication No. WO
2002/019923 pamphlet. Here, a fastener is pushed out from a needle
and is provided to tissue. Therefore, stoppers are provided for
controlling the amount of depth that the needle is piercingly
inserted into tissue and/or the amount of the fastener to be
supplied to the tissue. When a treatment is performed, a device
containing the fastener and the needle is placed against the
tissue. When the needle is moved forward and piercingly inserted
into the tissue, the position of the fastener is fixed with the
stoppers. After this, the needle is withdrawn from the tissue. The
fastener does not move due to the presence of the stoppers.
Therefore, a tip portion of the fastener is left inside the tissue.
When the device is detached from the tissue, the remaining part of
the fastener is left outside the tissue. When the fastener assumes
its original coil shape, the tissue is clamped.
SUMMARY OF THE INVENTION
[0007] A tissue fastener of the present invention is a tissue
fastener for clamping first biological tissue and second biological
tissue so as to be in close contact with each other, including: a
first tissue fixation portion, made of an elastic wire wound in a
coil, that is locked on the first biological tissue; and a second
tissue fixation portion, made of an elastic wire wound in a coil,
that is locked on the second biological tissue, the second tissue
fixation portion continuing into the first tissue fixation portion,
in which when falling off the first and second biological tissue
necrotized by being clamped between the first tissue fixation
portion and the second tissue fixation portion, the tissue fastener
moves only from the second tissue fixation portion to the first
tissue fixation portion side and falls off.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows a first embodiment of a tissue fastening
apparatus of the present invention. It is a cross-sectional view
showing internal structures of a tissue fastener, a stent, and an
applicator that constitute the apparatus.
[0009] FIG. 2 is a perspective view showing the tissue fastener
that constitutes the above tissue fastening apparatus.
[0010] FIG. 3 is a plan view of the above tissue fastener, seen in
a direction different from that of FIG. 2.
[0011] FIG. 4 shows an arrangement of first and second ring members
provided in the above applicator in the interior of the apparatus.
The upper half is a cross-sectional view showing a state in which
the first and second ring members are arranged close to a front end
of the applicator main unit. The lower half is a cross-sectional
view showing a state in which the first and second ring members are
arranged close to a rear end of the applicator main unit.
[0012] FIG. 5 is a cross-sectional view showing a structure of a
pin for restraining the above first ring member on the second ring
member.
[0013] FIG. 6 shows a state in which an insertion portion of the
applicator is inserted into a work channel of an endoscope.
[0014] FIG. 7 shows a state in which the insertion portion of the
endoscope is inserted into a duodenum.
[0015] FIG. 8 to FIG. 14 are cross-sectional views showing how an
applicator is used in the respective steps of performing a
manipulation for fixing a common bile duct onto a duodenum and
communicating both organs.
[0016] FIG. 15 to FIG. 42 show other forms of a tissue
fastener.
[0017] FIG. 43 to FIG. 48 show a procedure of placing the tissue
fastener shown in FIG. 42.
[0018] FIG. 49 to FIG. 64 show still other forms of a tissue
fastener.
[0019] FIG. 64 to FIG. 75 show forms of drainages.
[0020] FIG. 76 shows another form of a stylet.
[0021] FIG. 77 to FIG. 78 show another form of a piercing
device.
DETAILED DESCRIPTION OF THE INVENTION
[0022] A first embodiment of the present invention will be
described. A tissue fastening apparatus S1 of the present
embodiment is, as shown in FIG. 1, an apparatus for performing a
treatment of fixing second biological tissue onto first biological
tissue and communicating both organs. This apparatus includes: a
tissue fastener 10A; a stent 30A; and an applicator 50. Note that
the first biological tissue and the second biological tissue do not
necessarily refer to different organs. For example, a given region
of a given organ may be taken as first biological tissue and
another region of the same organ may be taken as second biological
tissue, and these two regions may be fixed. In the present
embodiment, a treatment of fixing a common bile duct as the second
biological tissue onto a duodenum as the first biological tissue
and communicating both organs will be described.
[0023] The tissue fastener 10A is a device for clamping the
duodenum and the common bile duct. It includes: a first tissue
fixation portion 11 that is locked on the duodenum; and a second
tissue fixation portion 12 that is locked on the common bile duct
adjacent to the duodenum, as shown in FIG. 2. The tissue fastener
10A is a device for clamping the duodenum and the common bile duct.
It includes: a first tissue fixation portion 11 that is locked on
the duodenum; and a second tissue fixation portion 12 that is
locked on the common bile duct adjacent to the duodenum, as shown
in FIG. 2. Furthermore, the tissue fastener 10A includes a linking
portion 13 between the first tissue fixation portion 11 and the
second tissue fixation portion 12 for linking the two.
[0024] The tissue fastener 10A is made of a string of highly
elastic metal wire 10 in which all the portions thereof that is,
the first tissue fixation portion 11, the second tissue fixation
portion 12, and the linking portion 13 are wound in a coil. Note
that in this specification, the phrase "wound in a coil" includes
all the cases of "wound in a cylinder," "wound in a frustum of a
cone," and "wound in a vortex." In the first tissue fixation
portion 11, the highly elastic metal wire 10 is wound in a vortex.
In the second tissue fixation portion 12, the highly elastic metal
wire 10 is wound in a cylinder. An inner diameter of the first
tissue fixation portion 11 is equal to that of the second tissue
fixation portion 12. An outer diameter of the first tissue fixation
portion 11 is larger than that of the second tissue fixation
portion.
[0025] In a part of the wire positioned between the first tissue
fixation portion 11 and the linking portion 13, a bent portion 14
is formed. Similarly, in a part of the wire positioned between the
linking portion 13 and the second tissue fixation portion 12, a
bent portion 15 is formed. The first tissue fixation portion 11 and
the second tissue fixation portion 12 form coils with the same
diameter. With the provision of the linking portion 13, a gap G is
formed between the two.
[0026] The central axis of the coil shape of the first tissue
fixation portion 11 coincides with that of the coil shape of the
second tissue fixation portion 12. As shown in FIG. 3, a wire
portion forming the linking portion 13 has, at the bent portion 14,
an angle .theta.1 with respect to a wire portion forming the coil
of the first tissue fixation portion 11. It also has, at the bent
portion 15, an angle .theta.2 with respect to a wire portion
forming the coil of the second tissue fixation portion 12. The
angle .theta.1 of the bent portion 14 is substantially the same as
the angle .theta.2 of the bent portion 15.
[0027] After the tissue fastener 10A is extended, one end thereof
is inserted into biological tissue. Then, the other tissue fixation
portion, for example the second tissue fixation portion 12, is
penetrated through an intestinal wall of the duodenum and a duct
wall of the common bile duct in this order. The second tissue
fixation portion 12, which has been penetrated through the
intestinal wall of the duodenum and the duct wall of the common
bile duct, has its restraint released in an inside of the common
bile duct to assume its original coil shape (cylindrical shape),
and is locked on the common bile duct. On the other hand, the first
tissue fixation portion 11 has its restraint released in an inside
of the duodenum to assume its original coil shape (vortex shape),
and is locked on the duodenum. With the first tissue fixation
portion 11 locked on the duodenum and the second tissue fixation
portion 12 locked on the common bile duct, the intestinal wall of
the duodenum and the duct wall of the common bile duct are clamped
so as to be pressed against each other. The linking portion 13 is
placed in the interiors of the clamped walls of both organs.
[0028] The stent 30A is, as shown in FIG. 1, a device for
communicating the intestinal wall of the duodenum with the duct
wall of the common bile duct that are clamped by the tissue
fastener 10A. It includes: an extension portion 31; a placement
portion 32; a slip-off prevention portion 33; and a through-hole
34, The extension portion 31 is of a cone shape whose diameter is
wider from its front end to its rear end. The placement portion 32
is of a cylindrical shape, and is disposed at the rear of the
extension portion 31. The placement portion 32 has a constant outer
diameter, which is smaller than the maximum outer diameter of the
extension portion 31. The slip-off prevention portion 33 is of a
cylindrical shape, and is disposed at the rear of the placement
portion 32. The slip-off prevention portion 33 has an outer
diameter larger than that of the placement portion 32. The
through-hole 34 penetrates through the extension portion 31 the
placement portion 32, and the slip-off prevention portion 33 in the
longitudinal direction of the stent 30A.
[0029] In the inside surface of the slip-off prevention portion 33,
protrusions 33a that are formed in the radial directions of the
stent 30A are provided. The protrusions 33a constitute a part of an
attachment portion for detachably attaching the stent 30A onto a
later-described sheath 54 of the applicator 50.
[0030] As a material for the stent 30A, any of stainless steel
(SUS), titanium (Ti), bioabsorbable magnesium, polyethylene (PE),
polyether ether ketone (PEEK), polysulfone, liquid crystal polymer,
polylactic acid, polyglycolic acid, polydioxanone,
polyhydroxyalkanoate, and caprolactone, or a polymer of these can
be adopted. These are excellent in biocompatibility. Therefore,
they will not impose an undue burden on a living body after
placement of the stent 30A in the living body. Especially
polylactic acid, polyglycolic acid, polydioxanone,
polyhydroxyalkanoate, and caprolactone are advantageous because
they are absorbed in a living body while they are placed in the
living body for a long period of time, and finally no foreign
matter is left in the living body.
[0031] The applicator 50 is a device for performing a treatment of
placing the tissue fastener 10A and the stent 30A within a body. It
includes: an applicator main unit 51; a piercing device 52; a
stylet (a fastener pusher) 53; a sheath 54; and a stent pusher 55,
as shown in FIG. 1. The applicator main unit 51 is of a cylindrical
shape. The piercing device 52 is of a needle tube shape. It is used
with the tissue fastener 10A being inserted thereinto. Note that
electrodes may be provided at a tip of the piercing device 52 and
that the piercing device 52 may be piercingly inserted into the
intestinal wall of the duodenum and the duct wall of the common
bile duct while burning the biological tissue. In this case, the
tip of the piercing device 52 is not required to be formed
sharp.
[0032] The stylet 53 is of a shaft shape. It is movably inserted
inside the piercing device 52, and pushes out the tissue fastener
10A inserted into the piercing device 52 from the tip of the
piercing device 52.
[0033] The sheath 54 has the piercing device 52 movably inserted
into the inside thereof, and moves the stent 30A that is detachably
attached onto the tip thereof, relatively to the piercing device
52.
[0034] The stent pusher 55 is of a sheath-like shape. It detaches
the stent 30A, into the inside of which the sheath 54 is movably
inserted and which is attached onto the front end thereof, from the
sheath 54.
[0035] In the applicator main unit 51, a piercing device operation
portion 56, a stylet operation portion (a fastener pusher operation
portion) 57, a sheath operation portion 58, and a stent pusher
operation portion 59 are provided. All of the piercing device 52,
the stylet 53, the sheath 54, and the stent pusher 55 have
flexibility, and are arranged coaxially. These constitute an
insertion portion 60 that is inserted through a work channel of an
endoscope. Obviously, the insertion portion 60 is longer than the
work channel of the endoscope.
[0036] A tip face of the piercing device 52 is formed diagonally
with respect to the longitudinal direction of the piercing device
52. As a result, a tip of the piercing device 52 is finished sharp.
A base end of the piercing device 52 is connected with the piercing
device operation portion 56, which is provided to a rear portion of
the applicator main unit 51.
[0037] A tip of the stylet 53 is formed into a shape not sharp but
smooth. A base end of the stylet 53 is connected with the stylet
operation portion 57, which is provided in an interior of the
piercing device operation portion 56.
[0038] A tip face of the sheath 54 is formed flat so as to
orthogonally cross the longitudinal direction of the sheath 54. In
the tip of the sheath 54, small holes 54a are provided and the
number of which is the same as or more than that of the protrusions
33a of the stent 30A. The small holes 54a are arranged in a
circumferential direction of the sheath 54. They penetrate through
a duct wall of the sheath 54. The small holes 54a constitute a part
of the attachment portion for detachably attaching the stent 30A on
the sheath 54. When the tip of the sheath 54 is inserted into the
through-hole 34 of the stent 30A from the rear end, the protrusions
33a are engaged in the small holes 54a. As a result, the stent 30A
is attached onto the tip of the sheath 54. Since the sheath 54 has
flexibility, when the sheath 54 is pulled in a rear direction with
the stent 30A retained in position, the sheath 54 is elastically
deformed and is detached from the small holes 54a. As a result, the
stent 30A is disengaged from the tip of the sheath 54. Note that if
the stent 30A is made of an elastic material, both of the sheath 54
and the protrusions of the stent 30A may be elastically deformed,
to thereby cause the stent 30A to be disengaged from the tip of the
sheath 54.
[0039] Incidentally, the small holes 54a need not penetrate through
the wall portion of the sheath 54. They may be recesses formed in
an outside surface of the sheath 54. Furthermore, small holes may
be formed in the stent 30A, and also protrusions may be formed in
the sheath 54, and then both may be engaged.
[0040] A base end of the sheath 54 is connected with a sheath
operation portion 58 provided in a front portion of the applicator
main unit 51.
[0041] A tip face of the stent pusher 55 is formed flat so as to
orthogonally cross the longitudinal direction of the stent pusher
55. A base end of the stent pusher 55 is connected with a stent
pusher operation portion 59 provided in the front portion of the
applicator main unit 51.
[0042] The piercing device operation portion 56 includes a
cylindrical first shaft 56a that is inserted into the inside of the
applicator main unit 51 from a rear end thereof. The first shaft
56a has an outer diameter slightly smaller than an inner diameter
of the rear portion of the applicator main unit 51. Therefore, the
first shaft 56a is slidable with respect to an inner surface of the
rear portion of the applicator main unit 51. The base end of the
piercing device 52 is fixedly attached to a tip face of the first
shaft 56a, which is inserted into the applicator main unit 51, so
as to coincide the longitudinal direction of the piercing device 52
with that of the first shaft 56a. The piercing device 52 is capable
of changing a relative position between itself and the applicator
main unit 51 by sliding the first shaft 56a with respect to the
applicator main unit 51.
[0043] In the rear portion of the applicator main unit 51, a female
thread hole is formed in a radial direction of the applicator main
unit 51. Into this female thread, a male thread 61 is screwed. A
tip of the male thread 61 protrudes inside the applicator main unit
51. On the other hand, in an outside surface of the first shaft
56a, a groove 56b is formed along the longitudinal direction of the
first shaft 56a. Into the groove 56b of the first shaft 56a
inserted into the applicator main unit 51, the tip of the male
thread 61 is loosely fitted. As a result, the groove 56b defines a
range of movement of the first shaft 56a with respect to the
applicator main unit 51. When the male thread 61 is further screwed
into the female thread hole to press the tip thereof against a
bottom surface of the groove 56b, it is possible to hold the first
shaft 56a at any position with respect to the applicator main unit
51.
[0044] The stylet operation portion 57 includes: a cylindrical
second shaft 62 that is inserted into an inside of the first shaft
56a from a rear end thereof; a lever 63 that is swingably supported
by the first shaft 56a supporting the piercing device 52; a torsion
coil spring 64 for biasing the lever 63 in a direction for spacing
the lever 63 away from the applicator main unit 51; and a link
mechanism 65 for transforming a swing of the lever 63 into a linear
movement along the piercing device 52 of the stylet 53.
[0045] The base end of the stylet 53 is inserted into an interior
of the second shaft 62 from the tip thereof. It is fixedly attached
to the second shaft 62 so that the longitudinal direction of the
stylet 53 is coincided with that of the second shaft 62. The stylet
53 is capable of changing a relative position between itself and
the piercing device 52 by sliding the second shaft 62 with respect
to the first shaft 56a.
[0046] The link mechanism 65 includes: a base material 66; a
bracket 68; a bar 70; a plate member 72; and a compression coil
spring 74. The base material 66 is fixed onto an outside surface of
the first shaft 56a. The bracket 68 is pivotally supported by the
base material 66. The lever 63 has a lower end fixed in the bracket
68. The bar 70 has one end pivotally supported by the bracket 68
and the other end pivotally supported by the base material 66. A
pin 71 provided in the other end of the bar 70 is fitted into an
oval hole 66a with allowance, the oval hole 66a being formed in the
base material 66 along a sliding direction of the second shaft
62.
[0047] In the plate member 72, a hole 73 is formed with a diameter
larger than the outer diameter of the second shaft 62. The second
shaft 62 inserted into the first shaft 56a penetrates through this
hole 73. The difference between the outer diameter of the second
shaft 62 and the inner diameter of the hole 73 is very slight. When
the plate member 72 is moved in the longitudinal direction of the
second shaft 62, that is, in the insertion direction of the second
shaft 62 into the first shaft 56a, as if the plate member 72 is
inclined, an inner surface of the hole 73 interferes with an outer
surface of the second shaft 62, thus producing friction. Thereby,
the force applied to the plate member 72 acts on the second shaft
62.
[0048] The compression coil spring 74 is disposed in an interior of
the first shaft 56a. It biases the plate member 72 in a direction
opposite to the insertion direction of the second shaft 62 into the
first shaft 56a.
[0049] When the lever 63 is moved in a direction of going closer to
the applicator main unit 51, the bar 70 is pulled to the front
direction of the applicator main unit 51 via the bracket 68,
causing the other end of the bar 70 to move along the oval hole
66a. The plate member 72 is pressed forward by the other end of the
bar 70 to move in the insertion direction of the second shaft 62
into the first shaft 56a while resisting the compression coil
spring 74. At this time, the plate member 72 is slightly inclined
to produce friction between itself and the second shaft 62. As a
result, the force applied to the plate member 72 acts on the second
shaft 62, causing the second shaft 62 to be pushed into the first
shaft 56a. When the lever 63 is released, the torsion coil spring
64 spaces the lever 63 away from the applicator main unit 51. In
addition, the compression coil spring 74 pushes the plate member 72
back to an initial position without producing friction between the
plate member 72 and the second shaft 62.
[0050] A movement amount of the other end of the bar 70 for one
operation on the lever 63 is always constant. Accordingly, an
insertion length of the second shaft 62 into the first shaft 56a
for one operation on the lever 63 is always constant as well.
Therefore, it is possible to control the insertion length of the
second shaft 62 into the first shaft 56a, that is, the insertion
length of the stylet 53 into the piercing device 52 according to
the number of operations on the lever 63. This means that it is
possible to control the length of the tissue fastener 10A which is
pushed out from the tip of the piercing device 52 according to the
number of operations on the lever 63.
[0051] Here, when the tissue fastener 10A is of a coil shape as in
the present embodiment, it is preferable that the insertion length
of the stylet 53 for one operation on the lever 63 be substantially
n times or substantially 1/n (n is a natural number) the
circumference of the tissue fastener 10A. For example, if the
insertion length of the stylet 53 for one operation on the lever 63
is substantially equal to the circumference of the tissue fastener
10A, one turn amount of the tissue fastener 10A is pushed out from
the tip of the piercing device 52 for every one operation on the
lever 63. If the length of the second tissue fixation portion 12 is
equal to two turns of the tissue fastener 10A, it is possible to
push out only the second tissue fixation portion 12 from the tip of
the piercing device 52 through two operations on the lever 63. If
the insertion length of the stylet 53 for one operation on the
lever 63 is substantially equal to a half circumference of the
tissue fastener 10A, a half turn amount of the tissue fastener 10A
is pushed out from the tip of the piercing device 52 for every one
operation on the lever 63. Furthermore, if the length of the second
tissue fixation portion 12 is equal to two turns of the tissue
fastener 10A, it is possible to push out only the second tissue
fixation portion 12 from the tip of the piercing device 52 through
four operations on the lever 63.
[0052] The sheath operation portion 58 includes a first ring member
58a that is arranged in an interior of the applicator main unit 51
and through an internal hole of which the piercing device 52 is
inserted. The first ring member 58a has an outer diameter slightly
smaller than an inner diameter of the front portion of the
applicator main unit 51. The first ring member 58a has an inner
diameter substantially the same as that of the sheath 54.
Therefore, the first ring member 58a is slidable with respect to an
inner surface of the front portion of the applicator main unit 51.
The base end of the sheath 54 is fixedly attached to a front face
of the first ring member 58a so as to coincide the center of the
sheath 54 with that of the first ring member 58a. The sheath 54 is
capable of changing a relative position between itself and the
applicator main unit 51 by sliding the first ring member 58a with
respect to the applicator main unit 51.
[0053] The stent pusher operation portion 59 is arranged especially
in an anterior of the first ring member 58a in the interior of the
applicator main unit 51. It includes a second ring member 59a
through an internal hole of which the sheath 54 is inserted. The
second ring member 59a has an outer diameter slightly smaller than
an inner diameter of the front portion of the applicator main unit
51. The second ring member 59a has an inner diameter substantially
the same as that of the stent pusher 55 of a sheath tube shape.
Therefore, the second ring member 59a is slidable with respect to
an inner surface of the front portion of the applicator main unit
51. The base end of the stent pusher 55 is fixedly attached to a
front face of the second ring member 59a so as to coincide the
center of the stent pusher 55 with that of the second ring member
59a. The stent pusher 55 is capable of changing a relative position
between itself and the applicator main unit 51 by sliding the
second ring member 59a with respect to the applicator main unit
51.
[0054] As shown in FIG. 1, in an outside surface of the second ring
member 59a, a female thread hole is formed in a radial direction of
the second ring member 59a. On the other hand, in the front portion
of the applicator main unit 51, an oval hole 51a is formed along a
sliding direction of the second ring member 59a. Into the female
thread of the second ring member 59a, a male thread 76 is screwed
through the oval hole 51a. As a result, the oval hole 51a defines a
range of movement of the second ring member 59a with respect to the
applicator main unit 51. When the male thread 76 is further screwed
into the female thread hole to press the head portion of the thread
against the applicator main unit 51, it is possible to hold the
second ring member 59a at any position with respect to the
applicator main unit 51.
[0055] In an outside surface of the first ring member 58a, as shown
in FIG. 4, two recessed portions 58b are formed. On the other hand,
on the second ring member 59a, two bars 75 that protrude backward
are provided. In the respective two bars 75, an oval hole 75a is
formed along a sliding direction of the first ring member 58a with
respect to the applicator main unit 51. Furthermore, in the
applicator main unit 51, two oval holes 51b that extend parallel to
the oval hole 75a are formed. Into the two recessed portions 58b of
the first ring member 58a, the two pins 77 are inserted through the
oval hole 51b of the applicator main unit 51 and the oval hole 75a
of the second ring member 59a, respectively. As a result, the oval
hole 75a defines a range of movement of the first ring member 58a
with respect to the second ring member 59a. The second ring member
59a itself slides with respect to the applicator main unit 51.
Therefore, the oval hole 51b is formed longer than the oval hole
75a in consideration of not only the range of movement of the first
ring member 58a but also the range of movement of the second ring
member 59a.
[0056] Between the recessed portion 58b and a tip of the pin 77, a
compression spring 78 is interposed, as shown in FIG. 5. As a
result, the pin 77 is always biased outwardly in a radial direction
of the second ring member 59a. In the bar 75, a recessed portion
75b is formed with which a large diameter portion 77a of the pin 77
is engaged when the first ring member 58a is arranged at the
position closest to a tip face of the second ring member 59a.
[0057] When the first ring member 58a is arranged at the position
closest to the tip face of the second ring member 59a, the large
diameter portion 77a of the pin 77 is engaged with the recessed
portion 75b of the bar 75. Therefore, the first ring member 58a is
restrained by the second ring member 59a via the pin 77. When the
pin 77 is pushed into the applicator main unit 51 against a biasing
force of the compression spring 78, the large diameter portion 77a
of the pin 77 is detached from the recessed portion 75b.
Consequently, the first ring member 58a is released from the second
ring member 59a, and hence becomes capable of being moved toward a
rear end of the applicator main unit 51. Therefore, it is possible
to move the sheath 54 to the hand side with respect to the stent
pusher 55.
[0058] Into a tip of the applicator main unit 51, a pipe sleeve 80
is inserted. On the pipe sleeve 80, an inside screw is formed. By
screwing this inside screw into a pipe sleeve 8 of an endoscope 2,
it is possible to fix the applicator 50 to the endoscope 2. In an
outside surface of 80, a groove 81 is formed along a
circumferential direction. On the other hand, on the applicator
main unit 51, a female thread hole is formed in a radial direction
of the applicator main unit 51. Into this female thread hole, a
male thread 82 is screwed. A tip of the male thread 82 protrudes
inside the applicator main unit 51. Into the groove 81 of the pipe
sleeve 80, the tip of the male thread 82 is loosely fitted. As a
result, it is possible to freely rotate the applicator main unit 51
with respect to the pipe sleeve 80 fixed on the endoscope 2. When
the male thread 82 is further screwed into the female thread hole
to press the tip thereof against a bottom surface of the groove 81,
it is possible to hold the applicator main unit 51 at any position
with respect to the pipe sleeve 80.
[0059] FIG. 6 shows a linear scanning ultrasonic endoscope as an
endoscope 2 for use with the tissue fastening apparatus S1. This
endoscope 2 includes a flexible insertion portion 4 extending from
an operation portion 3 for use outside the body. To the operation
portion 3, a knob 3A for curving a tip portion of the insertion
portion 4 and various buttons 3B are disposed. To a tip of the
insertion portion 4, a cover 5 is attached. To this cover 5, an
ultrasonic apparatus 6 is attached. The ultrasonic apparatus 6
swells out on a plane including an axis line of the insertion
portion 4. It has a plurality of ultrasonic transducers arranged
along an arc-shaped outer circumference. Furthermore, the endoscope
2 is provided with an elevator 7 so that the tip of the applicator
50 can be sent out laterally. With an operation on the elevator 7
at hand, it is possible to adjust an orientation of an insertion
portion 60 of the applicator 50 which is sent out from the tip of
the insertion portion 4. Note that the endoscope 2 may be provided
with an ultrasonic apparatus of another probe type. In addition, an
endoscope without an ultrasonic apparatus 6 may be used. In this
case, an ultrasonic apparatus for use outside the body, or an X-ray
apparatus, a magnetic resonance imaging (MRI) system, or a CT
(Computerizing Tomography) apparatus is additionally used.
[0060] Next is a description of a manipulation in which the tissue
fastening apparatus S1 configured as above is used to fix a common
bile duct on a duodenum and to communicate both. Such a
manipulation is executed in the case where bile is mixed into blood
to develop jaundice as a result of inability to discharge bile due
to obstruction of a duodenal papilla Dp by a tumor Tr, as shown in
FIG. 7. With this manipulation, it is possible to discharge bile
directly from a common bile duct Cb to a duodenum Dd.
[0061] First, the insertion portion 4 of the endoscope 2 is
inserted from a mouth of a patient. The endoscope 2 is inserted
into the duodenum Dd, which is an upper gastrointestinal tract.
With the ultrasonic apparatus 6, a state of an outside of the
duodenum Dd is checked for a site appropriate for the manipulation,
the site being on a side closer to a stomach St than a duodenal
papilla Dp and being close to the common bile duct Cb.
[0062] In the applicator 50, the first shaft 56a is operated in
advance to move back the piercing device 52 with respect to the
applicator main unit 51, and the second shaft 62 is previously
operated to move back the stylet 53 with respect to the applicator
main unit 51, as shown in FIG. 8. Furthermore, the first ring
member 58a and the second ring member 59a are simultaneously
operated in advance to move back the sheath 54 and the stent pusher
55 with respect to the applicator main unit 51. However, the first
ring member 58a is arranged at a position closest to the second
ring member 59a. In this condition, the piercing device 52 with the
tissue fastener 10A inserted thereinto is pulled inside the sheath
54 until the tip thereof is arranged in the interior of the stent
30A.
[0063] The insertion portion 60 of the applicator 50 is inserted
into a work channel of the endoscope 2 and then is moved forward,
to thereby fix the applicator 50 onto the endoscope 2. As a result,
the tip of the insertion portion 60 is caused to protrude from the
tip of the insertion portion 4 of the endoscope 2. Then, the
orientation of the protruded insertion portion 60 is adjusted with
the elevator 7.
[0064] The ultrasonic apparatus 6 provided to the endoscope 2 is
used to scan the common bile duct Cb across the duodenum Dd to
determine a position at which the piercing device 52 is piercingly
inserted into the common bile duct Cb. Then, as shown in FIG. 9,
the male thread 61 is loosened and the first shaft 56a is pushed
into the applicator main unit 51 to protrude the tip of the
piercing device 52 from the tip of the stent 30A attached to the
tip of the sheath 54. As a result, the sharp tip of the piercing
device 52 is pierced through an intestinal wall Wd of the duodenum
Dd from the inside to the outside, and subsequently is pierced
through a duct wall Wc of the common bile duct Cb from the outside
to the inside. Then, the male thread 61 is tightened to fix the
first shaft 56a onto the applicator main unit 51.
[0065] As shown in FIG. 10, the lever 63 is operated to push the
second shaft 62 into the S first shaft 56a by a predetermined
amount. For example, the lever 63 is operated a predetermined
number of times. As a result, the stylet 53 changes its relative
position to the piercing device 52. Thereby, the second tissue
fixation portion 12 of the tissue fastener 10A is pushed out from
the tip of the piercing device 52. The second tissue fixation
portion 12, when pushed out from the piercing device 52, assumes
its original coil shape, and is locked on the inside of the duct
wall Wc of the common bile duct Cb.
[0066] Then, the male thread 61 is loosened, and the first shaft
56a is pulled out a little from the applicator main unit 51 to
shorten the protrusion length of the piercing device 52 from the
tip of the stent 30A. Furthermore, the male thread 61 is tightened
to fix the first shaft 56a onto the applicator main unit 51. As a
result, the tip of the piercing device 52 is spaced apart a little
from the inside surface of the intestinal wall Wd of the duodenum
Dd.
[0067] As shown in FIG. 11, the lever 63 is operated again to push
the second shaft 62 into the first shaft 56a by a predetermined
amount. For example, the lever 63 is operated a predetermined
number of times. As a result, the stylet 53 changes its relative
position to the piercing device 52. Thereby, the linking portion 13
and the first tissue fixation portion 11 of the tissue fastener 10A
are pushed out from the tip of the piercing device 52. The first
tissue fixation portion 11, when pushed out from the piercing
device 52, assumes its original coil shape, and is locked on the
inside of the intestinal wall Wd of the duodenum Dd.
[0068] The tissue fastener 10A, when pushed out from the piercing
device 52, clamps the duodenum Dd and the common bile duct Cb as if
to cause the intestinal wall Wd of the duodenum Dd locked on by the
first tissue fixation portion 11 and the duct wall Wc of the common
bile duct Cb locked on by the second tissue fixation portion 12 to
press against each other.
[0069] As shown in FIG. 12, the second shaft 62 is pulled a little
to retract the tip of the stylet 53 inside the piercing device 52.
Then, the male thread 61 is loosened, and the first shaft 56a is
again pushed into the applicator main unit 51 to protrude the tip
of the piercing device 52 from the tip of the stent 30A. As a
result, the sharp tip of the piercing device 52 is pierced through
the intestinal wall Wd of the duodenum Dd and the duct wall Wc of
the common bile duct Cb inside the tissue fastener 10A. Then, the
male thread 61 is tightened to fix the first shaft 56a onto the
applicator main unit 51. The lever 63 is further operated to push
the second shaft 62 completely into the first shaft 56a. As a
result, the smooth tip of the stylet 53 is protruded from the sharp
tip of the piercing device 52. Therefore, the possibility of the
sharp tip of the piercing device 52 carelessly injuring the
surrounding tissue is eliminated.
[0070] As shown in FIG. 13, the male thread 76 is loosened, and
then the first ring member 58a and the second ring member 59a are
moved toward the tip of the applicator main unit 51. This changes
relative positions of the sheath 54 and the stent pusher 55 with
respect to the piercing device 52 that is fixed onto the applicator
main unit 51 via the first shaft 56a. As a result, the stent 30A is
pressed forward along the piercing device 52. Then, the extension
portion 31 of the stent 30A is pierced through the intestinal wall
Wd of the duodenum Dd and the duct wall Wc of the common bile duct
Cb from the inside of the tissue fastener 10A so as to and widen a
bore that has been opened by the piercing device 52. When the
extension portion 31 has penetrated through the intestinal wall Wd
of the duodenum Dd and the duct wall Wc of the common bile duct Cb,
the stent 30A is placed in the intestinal wall Wd of the duodenum
Dd and the duct wall Wc of the common bile duct Cb in a state with
the placement portion 32 being arranged within the intestinal wall
Wd and the duct wall Wc, the extension portion 31 being protruded
inside the common bile duct Cb, and the slip-off prevention portion
33 being left inside the duodenum Dd. After the stent 30A is
placed, the male thread 76 is tightened to fix the second ring
member 59a onto the applicator main unit 51.
[0071] While pressing the pin 77 shown in FIG. 4 into the
applicator main unit 51, the first ring member 58a is moved toward
the rear end of the applicator main unit 51, as shown in FIG. 14.
At this time, the second ring member 59a is fixed onto the
applicator main unit 51. Therefore, the relative position between
the sheath 54 and the stent pusher 55 is changed, and hence the
sheath 54 is pulled to the hand side. However, the stent 30A tries
to stay in position because it is abutted with the tip face of the
stent pusher 55. As a result, the tip of the sheath 54 is
elastically deformed, causing the protrusions 33a of the stent 30A
to be detached from the small holes 54a of the sheath 54. When the
protrusions 33a are detached from the small holes 54a, the tip of
the sheath 54 is pulled into the stent pusher 55. As a result, the
stent 30A is disengaged from the tip of the insertion portion 60 of
the applicator 50.
[0072] Next, the male thread 61 is loosened, the first shaft 56a is
pulled out from the applicator main unit 51, and the tip of the
piercing device 52 is pulled into the tip of the sheath 54. Then,
the male thread 61 is tightened to fix the first shaft 56a onto the
applicator main unit 51. Subsequently, the applicator 50 is removed
from the endoscope 2. Thus, the fastening of the intestinal wall Wd
of the duodenum Dd and the duct wall Wc of the common bile duct Cb
by the tissue fastener 10A is finished, and also the placement of
the stent 30A in the interiors of the intestinal wall Wd of the
duodenum Dd and the duct wall Wc of the common bile duct Cb is
finished. As a result, the duodenum Dd and the common bile duct Cb
are communicated through the through-hole 34 of the stent 30A.
Thereby, bile is discharged from the common bile duct Cb to the
duodenum Dd.
[0073] When the tissue fastener 10A is left in a living body, the
intestinal wall Wd of the duodenum Dd and the duct wall Wc of the
common bile duct Cb are compressed by the tissue fastener 10A, thus
putting the biological tissue inside the tissue fastener 10A in an
ischemic state. A continued ischemic state necrotizes the
biological tissue. On the other hand, outside the tissue fastener
10A, the intestinal wall Wd and the duct wall Wc are adhered over
the entire circumference of the tissue fastener 10A. As a result,
the necrotized biological tissue and the tissue fastener 10A and
the stent 30A fall off from the intestinal wall Wd and the duct
wall Wc. The tissue fastener 10A and the stent 30A are excreted
later. In the intestinal wall Wd and the duct wall Wc from which
the necrotized biological tissue has fallen off, an anastomotic
fistula is formed. Through this anastomotic fistula, the duodenum
Dd and the common bile duct Cb are communicated, and hence bile is
discharged from the common bile duct Cb to the duodenum Dd. The
margin of the anastomotic fistula is adhered over the entire
circumference. Therefore, bile will not leak into the abdominal
cavity from between the intestinal wall Wd and the duct wall
Wc.
[0074] According to the applicator 50, an operation on the lever 63
as if to hold it lightly allows the tissue fastener 10A to be
pushed out from the piercing device 52 easily and accurately.
Furthermore, it is possible to separate the stent 30A from the tip
of the sheath 54 at a proper timing. As a result, it is possible to
suitably place the tissue fastener 10A and the stent 30A at a
desired position in a living body.
[0075] In addition, according to the applicator 50, when the sheath
54 and the stent pusher 55 are used to press the stent 30A against
the intestinal wall Wd of the duodenum Dd and the duct wall Wc of
the common bile duct Cb, the piercing device 52 is immovably held
in position. As a result, organs will not be injured unexpectedly
by the piercing device 52, and the safety operation can be
performed. Next is a description of a behavior of the tissue
fastener 10A that is pushed out from the tip of the piercing device
52.
[0076] The tissue fastener 10A is first pushed out so as to
protrude only the second tissue fixation portion 12 from the tip of
the piercing device 52 that has penetrated through the intestinal
wall Wd of the duodenum Dd and the duct wall Wc of the common bile
duct Cb. The second tissue fixation portion 12, in the process of
being pushed out from the tip of the piercing device 52,
successively assumes its original coil shape, and is locked on the
duct wall Wc of the common bile duct Cb.
[0077] The second tissue fixation portion 12, in the process of
being pushed out from the tip of the piercing device 52, generates
force for restoring its own shape to its original coil shape. With
this force acting on the duct wall Wc of the common bile duct Cb,
the tissue fastener 10A may be pulled inside the common bile duct
Cb by an amount more than the push-out amount of the stylet 53.
However, the tissue fastener 10A is provided with the linking
portion 13 between the first tissue fixation portion 11 and the
second tissue fixation portion 12. In addition, the bent portion 15
is formed between the second tissue fixation portion 12 and the
linking portion 13. As a result, if the whole of the second tissue
fixation portion 12 is pushed out, the second tissue fixation
portion 12 changes orbit from one in the process of being pushed
out from the tip of the piercing device 52, as shown in FIG. 10.
This is because when the bent portion 15 of the tissue fastener 10A
is pushed out from the tip of the piercing device 52, the second
tissue fixation portion 12 that is released from the restraint by
the piercing device 52 changes its orientation depending on the
angle of the bent portion 15. With the change in orientation of the
second tissue fixation portion 12, even if force is generated in
the second tissue fixation portion 12 for restoring its own shape
to its original coil shape, the force ceases to act on the duct
wall Wc of the common bile duct Cb. Therefore, the tissue fastener
10A will not be pulled inside the common bile duct Cb by more than
a push-out amount of the stylet 53.
[0078] After that, the whole tissue fastener 10A including the
remaining first tissue fixation portion 11 is pushed out from the
tip of the piercing device 52, which has been pulled out from the
intestinal wall Wd of the duodenum Dd and the duct wall Wc of the
common bile duct Cb. The first tissue fixation portion 11, in the
process of being pushed out from the tip of the piercing device 52,
successively assumes its original coil shape, and is locked on the
intestinal wall Wd of the duodenum Dd.
[0079] With the first tissue fixation portion 11 locked on the
intestinal wall Wd of the duodenum Dd and the second tissue
fixation portion 12 locked on the duct wall Wc of the common bile
duct Cb, the intestinal wall Wd and the duct wall Wc are clamped.
The linking portion 13 is placed in the interiors of the intestinal
wall Wd and the duct wall Wc that are clamped. Because the gap G is
provided between the first tissue fixation portion 11 and the
second tissue fixation portion 12, the intestinal wall Wd and the
duct wall Wc are clamped so that they press against each other with
uniform force.
[0080] It is preferable that the angle .theta.1 of the linking
portion 13 with respect to the first tissue fixation portion 11 and
the angle .theta.2 of the linking portion 13 with respect to the
second tissue fixation portion 12 be both 45.degree. or less (see
FIG. 3). when the angles .theta.1, .theta.2 are larger than
45.degree., the bent portion 14 forming the angle .theta.1 and the
bent portion 15 forming the angle .theta.2 come into contact with
the inner surface of the piercing device 52 in the process of
pushing out the tissue fastener 10A from the tip of the piercing
device 52, resulting in production of strong frictional force. This
makes it difficult to smoothly push out the tissue fastener 10A
from the piercing device 52.
[0081] It is preferable that the gap G between the first tissue
fixation portion 11 and the second tissue fixation portion 12 be 15
mm or less. When the gap G is 15 mm or less, it is possible to fix
biological tissue by use of the applicator 50, in substantially all
the organs which can be approached using the endoscope 2.
[0082] However, plural types of tissue fastener 10A with difference
in the size of the gap G are provided in order to offer an optional
selection according to the thickness of the organ to be treated or
to characteristics of individual patients. Appropriate selection
and use of these makes it possible to perform a suitable treatment
in various situations.
[0083] As described above, the portion of the intestinal wall Wd of
the duodenum Dd and the duct wall Wc of the common bile duct Cb
inside the tissue fastener 10A is compressed by the tissue fastener
10A into an ischemic state. Later, the portion is necrotized and
the tissue fastener 10A and the stent 30A fall off the other
portions of the intestinal wall Wd and the duct wall Wc. At that
time, as shown in FIG. 15B, there are cases where the tissue
fastener 10A and/or the stent 30 fall(s) off to the intestinal wall
Wd side of the duodenum Dd and to the duct wall Wc side of the
common bile duct Cb. If the tissue fastener 10A and/or the stent 30
fall(s) off to the intestinal wall Wd side of the duodenum Dd, they
are (it is) excreted out of the body via the small intestine and
the large intestine as a result of natural processes. Therefore,
this poses no problem. However, if the tissue fastener 10A and/or
the stent 30 fall(s) off to the duct wall Wc side of the common
bile duct Cb, they are (it is) left there.
[0084] To avoid such inconvenience, the outer diameter of the first
tissue fixation portion 11 is made larger than that of second
tissue fixation portion 12 in this embodiment, as shown in FIG. 2.
That is, as shown in FIG. 15C, an inner diameter of a anastomotic
fistula K formed after living tissue, which has been clamped by the
tissue fastener 10A into necrosis, falls off becomes substantially
the same as an outer diameter of the second tissue fixation portion
2 (in FIG. 15C, the stent 30A is omitted.). The second tissue
fixation portion 12 is capable of passing through this anastomotic
fistula K, but the first tissue fixation portion 11 is not.
Therefore, when the tissue fastener 10A and the necrotized tissue
fall off from the intestinal wall Wd and the duct wall Wc, there is
a higher probability that the tissue fastener 10A moves only to the
intestinal wall Wd side of the duodenum Dd and falls off.
[0085] Note that in the above embodiment, the first tissue fixation
portion 12 is made of a highly elastic metal wire wound in a
vortex. However, the shape is not limited to this.
[0086] As shown in FIGS. 16A, 16B, the first tissue fixation
portion 12 may be made of a highly elastic metal wire wound in a
frustum of a cone, or may be made by outwardly protruding a part of
a highly elastic metal wire wound in a cylinder. It is essential
only that at least a part of the above first tissue fixation
portion 11 be protruded outward more than the outer diameter of the
second tissue fixation portion 12.
Modifications
[0087] Hereunder is a description of modifications of the above
embodiment. For convenience of description, like constituent parts
to those described in the above embodiment may be designated with
like reference numerals to omit repetitious explanation.
[0088] The structure of the tissue fastener is not limited to one
described in the above embodiment. For example, a tissue fastener
10B shown in FIGS. 17A, 17B has a first tissue fixation portion 101
and a second tissue fixation portion 102, both of which are made of
a highly elastic metal wire 10 wound in a coil. A tip portion of
the first tissue fixation portion 101, for example one turn portion
101A at the tip is inclined approximately 90 degrees with respect
to the other portion of the first tissue fixation portion 101.
[0089] In this modification, for example, food S passes through a
duodenum Dd on which the first tissue fixation portion 101 is
locked. When passing along an intestinal wall Wd, this food S hits
a tip portion 101A of the first tissue fixation portion 101 to
thereby press the tip portion 101A to a small intestine side. As a
result, when the tissue fastener 10B and the necrotized tissue fall
off from the intestinal wall Wd and the duct wall Wc, there is a
higher probability that the tissue fastener 10B moves to the
intestinal wall Wd side of the duodenum Dd and falls off.
[0090] In the case where the tip portion 101A of the first tissue
fixation portion 101 is inclined, the number of turns at the tip
need not be one. For example, it may be one and a half or two.
Furthermore, the inclination angle of the tip portion 101A need not
be 90 degrees. The angle at which the tip portion 101A is inclined
may be for example in the range of 45 degrees to 135 degrees. It is
essential only that the food S hits the tip portion of the first
tissue fixation portion 101.
[0091] Furthermore, in the case of this modification, no linking
portion is provided between the first tissue fixation portion 101
and the second tissue fixation portion 102. The first tissue
fixation portion 101 is directly linked with the second tissue
fixation portion 102. However, there may be provided a linking
portion 13 between the two, as shown in FIG. 2. This may be
employed in the following modifications.
[0092] A tissue fastener 10C shown in FIGS. 18A, 18B has a first
tissue fixation portion 111 and a second tissue fixation portion
112, both of which are made of a highly elastic metal wire 10 wound
in a coil (a cylinder). The number of coil turns of the first
tissue fixation portion 111 is larger than that of the second
tissue fixation portion 112.
[0093] In this modification, the first tissue fixation portion 111
is heavier than the second tissue fixation portion 112 by the
increased number of coil turns. Therefore, when the tissue fastener
10C and the necrotized tissue fall off from the intestinal wall Wd
and the duct wall Wc, there is a higher probability that the tissue
fastener 10A moves to the side of the first tissue fixation portion
111 which is set heavier, that is, to the intestinal wall Wd side
of the duodenum Dd and falls off.
[0094] When the number of coil turns of the first tissue fixation
portion 111 is set to larger than that of the second tissue
fixation portion 111, it is preferable that the number be set to a
degree such that the difference in weight between these tissue
fixation portions is evident, for example to 1.5 or more times than
that of the second tissue fixation portion 111.
[0095] A tissue fastener 10D shown in FIGS. 19A, 19B has a first
tissue fixation portion 121 and a second tissue fixation portion
122, both of which are made of a highly elastic metal wire 10 wound
in a coil (a cylinder). The coil turn density of the first tissue
fixation portion 121 is less than that of the second tissue
fixation portion 122. That is, the coil of the highly elastic metal
wire of the first tissue fixation portion 121 is roughly wound, and
the coil of the highly elastic metal wire of the second tissue
fixation portion 121 is densely wound.
[0096] In this embodiment, when food S passes along the intestinal
wall Wd of the duodenum Dd, there is a higher probability that the
food hits the roughly-wound first tissue fixation portion 121. As a
result, when the tissue fastener 10D and the necrotized tissue fall
off from the intestinal wall Wd and the duct wall Wc, the tissue
fastener 10D moves to the intestinal wall Wd side of the duodenum
Dd and falls off.
[0097] A tissue fastener 10E shown in FIG. 20 has a first tissue
fixation portion 131 and a second tissue fixation portion 132, both
of which are made of a highly elastic metal wire wound in a coil (a
cylinder). To the first tissue fixation portion 131, a resisting
entity (anchoring body) 134 is linked via a string member 133. The
resisting entity 134 is of a cylindrical shape a part of which is
cut out along an axis line direction for easy load in the
applicator, as will be described later.
[0098] In this modification, when food passes along the intestinal
wall Wd of the duodenum Dd, there is a higher probability that this
food hits the resisting entity 134. As a result when the tissue
fastener 10E and the necrotized tissue fall off from the intestinal
wall Wd and the duct wall Wc, there is a higher probability that
the tissue fastener 10E moves to the intestinal wall Wd side of the
duodenum Dd and falls off. Furthermore, the resisting entity 134
has a weight of its own to some degree. Also due to this weight,
there is a higher probability that the tissue fastener 10E moves to
the intestinal wall Wd side of the duodenum Dd and falls off.
[0099] When the resisting entity 134 is loaded in the applicator, a
gap between a piercing device 52 and a sheath 54 is utilized as
shown in FIG. 21 and FIG. 22. Therefore, a radius of the resisting
entity 134 is set between an outer radius of the piercing device 52
and an inner radius of the sheath 54. Furthermore, in the piercing
device 52, a slit 52a is formed from its tip to its base end. The
string member 133 is arranged by being pulled out from this slit
52a. Thereby, it is loaded on the applicator in a state with the
first and second tissue fixation portions 131, 132 loaded inside
the piercing device 52 being linked with the resisting entity 134
loaded outside the piercing device.
[0100] A tissue fastener 10F shown in FIGS. 23A, 23B has a first
tissue fixation portion 141 and a second tissue fixation portion
142, both of which are made of a highly elastic metal wire 10 wound
in a coil (a cylinder). The first tissue fixation portion 141 and
the second tissue fixation portion 142 have substantially the same
length. However, a diameter of the highly elastic metal wire
constituting the first tissue fixation portion 141 is set to be
larger than a diameter of the highly elastic metal wire, which is
made of the same material as that for the above, constituting the
second tissue fixation portion 142.
[0101] In this modification, the first tissue fixation portion 141
is heavier than the second tissue fixation portion 142 by the
difference in wire diameter, the former being set to be larger than
the latter. Therefore, when the tissue fastener 10F and the
necrotized tissue fall off from the intestinal wall Wd and the duct
wall Wc, there is a higher probability that the tissue fastener 10A
moves to the side of the first tissue fixation portion 141 which is
set heavier, that is, to the intestinal wall Wd side of the
duodenum Dd and falls off.
[0102] FIG. 24 shows a problem when the tissue fastener 10A is
placed in a living body.
[0103] That is, when the tissue fastener 10A is placed in a living
body by clamping first biological tissue and second biological
tissue so as to be in close contact with each other, firstly a tip
of a piercing device 52 of a needle tube shape is piercingly
inserted into the intestinal wall Wd and the duct wall Wc. Then, a
second tissue fixation portion 12, which is a part of the tissue
fastener 10A, is placed in the second biological tissue. After
that, when the piercing device 52 is pulled back from these
intestinal wall Wd and duct wall Wc, a gap Ga is formed between a
hole We that is formed in the intestinal wall Wd and the duct wall
Wc when the piercing device 52 is piercingly inserted, and the wire
10 that constitutes the tissue fastener 10A. In the case where
liquid is filled in the second biological tissue, which is a lumen,
a phenomenon occurs in which the liquid flows through this gap Ga,
and further flows through a gap Gb between the intestinal wall Wd
and the duct wall Wc, to thereby leak into an abdominal cavity.
This situation occurs even after the tissue fastener 10A is placed
in the living body. Here, if the liquid that leaks into the
abdominal cavity is for example bile, which shows strong
alkalinity, there is a possibility of producing bile peritonitis.
To prevent such an undesirable situation, a variety of contrivances
are adopted as follows:
[0104] FIG. 25A, 25B shows a structure in which a highly elastic
metal wire constituting a tissue fastener 10G is made of a
multitude of highly elastic thin wires 150, not of a single highly
elastic thin wire. That is, a first tissue fixation portion 151 and
a second tissue fixation portion 152 are made of the multitude of
highly elastic thin wires 150 being stranded.
[0105] Here, a stranded wire has less elasticity than a single
wire. Therefore, supposing that tissue fasteners with the same
spring strength are formed, one made of stranded wires allows use
of a wire with larger diameter than one made of a single wire.
[0106] In this modification, the tissue fastener 10G is made of a
multitude of highly elastic thin wires 150, not of a single highly
elastic thin wire. This allows use of wires with a diameter larger
by that much, for example wires with a diameter substantially the
same as an inner diameter of the piercing device 52, for wires
constituting the tissue fastener 10G. Thereby, the gap Ga between
the hole We of the intestinal wall Wd and the duct wall Wc formed
when the piercing device 52 is piercingly inserted can be made as
small as possible. As a result, it is possible to prevent a body
fluid such as bile from leaking out into an abdominal cavity
through this gap Ga.
[0107] Note that one shown in FIGS. 25A, 25B has a structure in
which the multitude of highly elastic thin wires 150 are stranded
over an entire region of the tissue fastener 10G. However, the
structure is not limited to this. It will suffice that at least
only a linking portion between the first tissue fixation portion
151 and the second tissue fixation portion 152, more specifically,
a portion that penetrates through the duct wall Wc and its
neighboring area be made of the multitude of highly elastic thin
wires 150 being stranded Therefore, the other portions may be made
of a single wire.
[0108] A tissue fastener 10H shown in FIG. 26 has a first tissue
fixation portion 161 and a second tissue fixation portion 162, both
of which are made of a highly elastic metal wire 10 wound in a coil
Around an outer circumference of a linking portion 163 between the
first tissue fixation portion 161 and the second tissue fixation
portion 162, a thin wire 164 is wound with a smaller diameter than
that of the highly elastic metal wire 10. The substantial diameter
thereof is set to be approximately equal to an inner diameter of
the piercing device.
[0109] In this modification, the thin wire 164 is wound around the
linking portion 163 between the first tissue fixation portion 161
and the second tissue fixation portion 162 of the tissue fastener
10H, to thereby make its substantial diameter larger. As a result,
the gap Ga between the hole We of the intestinal wall Wd and the
duct wall Wc formed when the piercing device 52 is piercingly
inserted can be made as small as possible, to thereby make it
possible to prevent a body fluid such as bile from leaking out into
an abdominal cavity through this gap Ga.
[0110] Note that in one shown in FIG. 26, the thin wire 164 is
wound around a part of the tissue fastener 10H. However the
structure is not limited to this. The thin wire 164 may be wound
around an entire region of the tissue fastener 10H.
[0111] Fixation methods of the thin wire 164 onto the highly
elastic metal wire 10 include: a method in which the thin wire 164
is wound around the outer circumference of the highly elastic metal
wire 10 for fixation by friction between the two; a method in which
after the thin wire 164 is wound, the highly elastic metal wire 10
is fixed onto the thin wire 164 at a plurality of points on the
outer circumference by welding or with an adhesive harmless to a
human body, as shown in FIG. 27; and a method in which a hole 165
is bored in the highly elastic metal wire 10 and a tip of the thin
wire 164 is inserted into this hole 165 for fixation, as shown in
FIGS. 28A, 28B.
[0112] Furthermore, the thin wire 164 is of a coil shape.
Therefore, the end portion of the thin wire 164 is unlikely to come
off the hole 165. However, other methods of making the end portion
further unlikely to come off are conceivable. They include: a
method of press-inserting the end portion of the thin wire 164; a
method of fixedly attaching the end portion with an adhesive; a
method of applying external force on the highly elastic metal wire
10 in a state with the end portion of the thin wire 164 inserted,
to thereby deform the end portion (caulking); and a method of
welding the insertion portion.
[0113] A tissue fastener 101 shown in FIGS. 29A, 29B has a first
tissue fixation portion 171 and a second tissue fixation portion
172, both of which are made of a highly elastic metal wire 10 wound
in a coil (a cylinder). Around an outer circumference of the second
tissue fixation portion 172, the first tissue fixation portion 171
is arranged. That is, the tissue fastener 10I is of a double coil
shape made of an inner and outer coils.
[0114] In this modification, as shown in FIG. 30, the second tissue
fixation portion 172 on the inner circumference side is locked on
the duct wall Wc of the common bile duct Cb as second biological
tissue, and the first tissue fixation portion 171 on the outer
circumference side is locked on the intestinal wall Wd of the
duodenum Dd. In this case, the intestinal wall Wd and the duct wall
Wc are brought into close contact with each other by the first
tissue fixation portion 171 and the second tissue fixation portion
172, and are clamped in a radial direction. As a result, the
intestinal wall Wd and the duct wall Wc, which are on the outer
circumference side than the hole We formed when a piercing device
52 is piercingly inserted, that is, on the outer circumference side
of an area through which the wire of the tissue fastener 10I
penetrates, are clamped into close contact with each other.
Therefore, a body fluid such as bile will not leak out from between
the intestinal wall Wd and the duct wall Wc into a body cavity
through the hole We.
[0115] A tissue fastener 10J shown in FIG. 31 has a first tissue
fixation portion 181 and a second tissue fixation portion 182, both
of which are made of a highly elastic metal wire 10 wound in a coil
(a cylinder). The first tissue fixation portion 181 has a large
coil-shaped portion 181A formed of two-tier large and small coils,
and a small coil-shaped portion 181B. The large coil-shaped portion
181A and the small coil-shaped portion 181B have their upper ends
at the same height. However, at their lower ends, the large
coil-shaped portion 181A stretches out over the small coil-shaped
portion 181B. The second tissue fixation portion 182 has the same
diameter as the small coil-shaped portion 181B so as to continue
into the small coil-shaped portion. This tissue fastener 10J is the
same in general shape as the one shown in FIG. 29A, 29B. The
difference lies in the position at the tissue fastener is locked on
the first tissue and the second biological tissue.
[0116] In this modification, when the tissue fastener is placed in
living tissue, the intestinal wall Wd and the duct wall Wc are
sandwiched between the small coil-shaped portion 181B of the first
tissue fixation portion and the second tissue fixation portion 182,
and also on the outer circumference side thereof, the lower end of
the large coil-shaped portion 181 on the outer circumference side
of the first tissue fixation portion 181 presses the intestinal
wall Wd of the duodenum Dd in the downward direction in the figure.
As a result, the intestinal wall Wd and the duct wall Wc are
clamped into close contact with each other on the outer
circumference side than the hole We formed when the piercing device
52 is piercingly inserted. Therefore, a body fluid such as bile
will not leak out from between the intestinal wall Wd and the duct
wall Wc into a body cavity through the hole We, similarly to the
one shown in FIG. 30 described above.
[0117] A tissue fastener 10K shown in FIGS. 32A, 32B has a first
tissue fixation portion 191 and a second tissue fixation portion
192, both are made of a highly elastic metal wire 10 wound in a
coil (a cylinder). A linking portion 193 for linking the first
tissue fixation portion 191 and the second tissue fixation portion
192 is bent in an S shape so as to pass through a central portion
between those coil-shaped portions.
[0118] In this modification, when the tissue fastener is placed in
a living body as shown in FIGS. 33A, 33B, the hole We formed when
the piercing device 52 is piercingly inserted, that is, an area
through a wire of the tissue fastener 10K penetrates is inside the
intestinal wall Wd and duct wall Wc portions clamped by the first
tissue fixation portion 191 and the second tissue fixation portion
192. As a result, the intestinal wall Wd and the duct wall Wc are
clamped into close contact with each other on the outer
circumference side than the hole We formed when the piercing device
52 is piercingly inserted. Therefore, a body fluid such as bile
will not leak out from between the intestinal wall Wd and the duct
wall Wc into a body cavity through the hole We, similarly to the
ones shown in FIG. 30 and FIG. 31 described above.
[0119] A tissue fastener 10L shown in FIG. 34 has: a first tissue
fixation portion 201 and a second tissue fixation portion 202, both
are made of a highly elastic metal wire wound in a coil (a
cylinder); and a cap 203 (see FIG. 37). The cap 203 is formed in a
cylindrical shape. An outer diameter thereof is set to be larger
than that of the first tissue fixation portion 201 and the second
tissue fixation portion 202. In a central portion of the cap 203, a
small diameter portion 204 is formed. In an inner circumference
thereof, a female thread portion 205 is formed to be fit onto the
coil-shaped first tissue fixation portion 201. In the cap 203, an
upper opening portion functions as a fitting portion 203A to be fit
into a tip of an endoscope N, and a lower end portion functions as
a ring-shaped stretching portion 203B that stretches toward the
second tissue fixation portion 202 side when the lower end portion
fits the female thread portion onto the first tissue fixation
portion 201.
[0120] To place the tissue fastener 10L of this modification in a
living body, the fitting portion 203A of the cap 203 is previously
fitted onto the tip of the endoscope N, as shown in FIG. 35. Then,
as shown in FIG. 36, the first tissue fixation portion 201 and the
second tissue fixation portion 202 are placed in a living body so
as to clamp the intestinal wall Wd and the duct wall Wc, as
described in the above embodiment.
[0121] Next, the prepared endoscope N with the cap is inserted into
the living body. Then, as shown in FIG. 37, the cap 203 fitted onto
the tip is abutted against the first tissue fixation portion 201
while positioning the cap 203 so as to be coaxial with the first
tissue fixation portion 201. In this condition, the cap 203 is
rotated to screw the female thread portion 205 onto the first
tissue fixation portion 201. At this time, the more the female
thread portion 205 is screwed, the more the first tissue fixation
portion 201 penetrates into the cap 203. As a result, the
intestinal wall Wd and the duct wall Wc are drawn into the cap 203
side while being clamped by the first tissue fixation portion 201
and the second tissue fixation portion 202. Then, the outer
circumference side of the portion of the intestinal wall W that is
locked on by the first tissue fixation portion 201 is strongly
pressed to the duct wall Wc side by the stretching portion 203B of
the cap 203. As a result, the intestinal wall Wd and the duct wall
Wc are clamped into close contact with each other on the outer
circumference side than the hole We formed when the piercing device
is piercingly inserted. Therefore, a body fluid such as bile will
not leak out from between the intestinal wall Wd and the duct wall
Wc into a body cavity through the hole We.
[0122] Note that after the cap 203 is screwed onto the first tissue
fixation portion 201, the endoscope N is detached from the cap 203,
and the endoscope N is pulled out with the cap 203 being placed in
the living body, as shown in FIG. 38.
[0123] A tissue fastener 10M shown in FIG. 39A to FIG. 41 has: a
first tissue fixation portion 201 and a second tissue fixation
portion 202, both are made of a highly elastic metal wire 10 wound
in a coil (a cylinder); and a cap 213. The cap 213 has: an internal
barrel portion 214; and a hemisphere portion 215 that expands down
from an upper portion of the internal barrel portion 214 while
gradually extending outwardly. In an inner circumferential lower
end portion of the internal barrel portion 214, a female thread
portion 216 is formed. This female thread portion 216 fits onto the
coil-shaped first tissue fixation portion 201. A lower end of the
hemisphere portion 215 extends lower than a lower end of the
internal barrel portion 214. Therefore, this lower end functions as
a ring-shaped stretching portion 215B that outwardly stretches
toward the second tissue fixation portion 202, when the female
thread portion 214 is fitted onto the first tissue fixation portion
201. Furthermore, an upper portion of the hemisphere portion 213 is
made flat. On this flat portion, knob portions 217 that extend in a
straight line are formed.
[0124] This modification is the same as the one described above in
that the first tissue fixation portion 201 and the second tissue
fixation portion 202 are placed in a living body so as to clamp the
intestinal wall Wd and the duct wall Wc.
[0125] Here, next, an endoscope is used to insert the cap 213 into
the living body. The knob portions 217 of the cap 213 are held by
straight grasping forceps O that are inserted into the living body
via a channel of the endoscope The cap 213 is rotated while being
positioned so as to be coaxial with the first tissue fixation
portion 201, to thereby screw the female thread portion 216 onto
the first tissue fixation portion 201. At this time, similarly to
the above, the outer circumference side of the portion that is
locked on by the first tissue fixation portion 201 of the
intestinal wall W is strongly pressed to the duct wall Wc side by
the stretching portion 215B of the cap 203. As a result, the
intestinal wall Wd and the duct wall Wc which are clamped into
close contact with each other on the outer circumference side than
the hole We formed when the piercing device is piercingly inserted.
As a result a body fluid such as bile will not leak out from
between the intestinal wall Wd and the duct wall Wc into a body
cavity through the hole We.
[0126] A tissue fastener 10N shown in FIG. 42 has a first tissue
fixation portion 221 and a second tissue fixation portion 222, both
are made of a highly elastic material 220 wound in a coil (a
cylinder). Here, the highly elastic material 220 is tubular in
shape, and an inner diameter thereof is set to be larger than an
outer diameter of the piercing device 52 of the applicator.
Furthermore, a tip portion of the highly elastic material 220 is
formed into a tapered portion 223 that is gradually narrowed.
[0127] To place this tissue fastener 10N in a living body, the
tissue fastener 10N is first arranged around an outer circumference
of the piercing device 52, as shown in FIG. 43. At this time, a
base end side of the tissue fastener 10N is previously fitted into
a sheath 54 by friction. Next, as shown in FIG. 44, a piercing
device operation portion 56 is moved forward to piercingly insert
the piercing device 52 into first biological tissue and second
biological tissue, here, into an intestinal wall Wd of a duodenum
and a duct wall Wc of a common bile duct. Next, as shown in FIG.
45, a stylet 53 is moved forward to protrude past a tip of the
piercing device 52.
[0128] Next, as shown in FIG. 46, the sheath 54 and a pusher 55 are
moved forward to place a part of the tissue fastener 10N in the
duct wall Wc of the common bile duct. A portion of the tissue
fastener 10N exposed in the common bile duct returns its original
coil shape by its own elastic action, and is placed therein.
Subsequently, as shown in FIG. 47, the piercing device 52 and the
stylet 53 are pulled back from the first and the second biological
tissue Wd to the hand side. Next, as shown in FIG. 48, the sheath
54 is moved backward to the hand side, to thereby separate the
applicator from the tissue fastener 10N.
[0129] As a result, it is possible to place the tissue fastener 10N
in the living body.
[0130] Here, the outer diameter of the tissue fastener 10N is
larger than that of the piercing device, that is, larger than a
hole We in the living tissue formed by the piercing device.
Consequently, no gap is produced between the hole and the tissue
fastener. Therefore, a body fluid will not leak out from the gap
between the hole and the tissue Fastener.
[0131] In addition, the tissue fastener 10N is made of a tubular
material. Therefore, it is possible to allow a body fluid such as
bile to flow from the duct wall Wc side of the common bile duct to
the intestinal wall Wd side of the duodenum through a lumen of the
tubular material, without using a stent.
[0132] A tissue fastener 10O shown in FIG. 49 has a first tissue
fixation portion 231 and a second tissue fixation portion 232, both
of which are made of a highly elastic metal wire 230 wound in a
coil (a cylinder). The first tissue fixation portion 231 and the
second tissue fixation portion 232, in a state with the first
tissue fixation portion 231 being locked on an intestinal wall Wd
of a duodenum and the second fixation portion 232 being locked on a
duct wall Wc of a common bile duct, clamp these intestinal wall Wd
and duct wall Wc so as to be brought in close contact with each
other. To be more specific, the first tissue fixation portion 231
is made of a first inner circumference spring portion 231a to be
locked on the intestinal wall Wd of the duodenum, and the second
tissue fixation portion 232 is made of a second inner circumference
spring portion 232a to be locked on the duct wall Wc of the common
bile duct. From a tip of the first inner circumference spring
portion 231a, an outer circumference spring portion 233 is provided
so as to extend outwardly in a radial direction and also to return
to the second inner circumference spring portion 232a side to be
locked on the intestinal wall Wd of the duodenum.
[0133] Furthermore, the inner circumference spring portions 231a,
232a are provided with an initial tension. This initial tension is
set to a degree such that in placing the tissue fastener 10O in a
living body, even if a tip of the outer circumference spring
portion 233 presses the intestinal wall Wd downwardly and then
receives a reaction force from there, the first inner circumference
spring portion 231a is not pulled away from the intestinal wall Wd,
and that no gap is produced between the portions of the highly
elastic metal wire 230 as shown in FIG. 50. A description of this
will be given later. Furthermore, a height H1 of the first inner
circumference spring portion 231a and a height H2 of the second
inner circumference spring portion 232a are set to heights such
that when the tissue fastener 10O is placed in the living body, the
two spring portions protrude past the living tissue as the
placement target moves outwardly in an axial direction. For
example, in the case of the first inner circumference spring
portion 231a that is placed in the intestinal wall Wd of the
duodenum, the height H1 is set to 1.5 mm or more. The duct wall Wc
of the common bile duct is thinner than the intestinal wall Wd of
the duodenum. Therefore, the height H2 of the second inner
circumference spring portion 232a that is placed in the duct wall
Wc of the common bile duct is 0.5 mm or more.
[0134] In the tissue fastener 10O with the above structure, as
shown in FIG. 50, the first inner circumference spring portion 231a
is locked on the intestinal wall Wd of the duodenum and the second
inner circumference spring portion 232a is locked on the duct wall
Wc of the common bile duct. Thereby, the intestinal wall Wd and the
duct wall Wc are clamped so as to be brought in close contact with
each other by those inner circumference spring portions 231a, 232a.
Furthermore, the outer circumference spring portion 233 presses the
intestinal wall Wd of the duodenum to the duct wall Wc side of the
common bile duct.
[0135] Here, the case without the outer circumference spring
portion 233 will be described. When the tissue fastener is placed
in a living body, the highly elastic metal wire 230 is previously
inserted and set in the piercing device 52 in an extended manner,
as shown in FIG. 51. This piercing device 52 is then piercingly
inserted into the intestinal wall Wd of duodenum and the duct wall
Wc of the common bile duct, and the highly elastic metal wire 230
is pushed out from a tip thereof to place the tissue fastener. As a
result, a gap Ga is formed between the hole We formed in the duct
wall Wc of the common bile duct when the piercing device 52 is
piercingly inserted and the highly elastic metal wire 230 is
penetrated and arranged through this hole We. Therefore, there
arises a phenomenon in which a body fluid such as bile flows out
through this gap Ga, and furthermore flows through a gap Gb between
the intestinal wall Wd of the duodenum and the duct wall Wc of the
common bile duct, to thereby leak into an abdominal cavity. If the
body fluid is bile, there is a possibility of producing bile
peritonitis.
[0136] However, in this modification, the outer circumference side
of the portion of the intestinal wall Wd of the duodenum clamped by
the first and second inner circumference spring portions 231a, 232a
is pressed to the duct wall Wc side of the common bile duct by the
outer circumference spring portion 233, as shown in FIG. 50.
Therefore, no gap is produced between the intestinal wall Wd of the
duodenum and the duct wall Wc of the common bile duct. As a result,
even if a body fluid such as bile leaks out through the gap Ga,
this body fluid will not leak into an abdominal cavity through the
gap between the intestinal wall Wd of the duodenum and the duct
wall Wc of the common bile duct.
[0137] Furthermore, the insides of the portions of the intestinal
wall Wd of the duodenum and the duct wall Wc of the common bile
duct clamped by the inner circumference spring portions 231a, 232a
have a flow of blood prevented and develops pressure necrosis. At
the same time, around the inner circumference spring portions, the
intestinal wall Wd and the duct wall Wc are adhered and joined.
Then, the tissue fastener and the necrotized tissue fall off from
the other tissue. At this time, the inner circumference spring
portions 231a, 232a are always biased to a duodenal lumen side by
the outer circumference spring portion 233. Therefore, when the
tissue fastener falls off, the tissue fastener inevitably falls off
to the lumen side of the duodenum. As a result, the tissue fastener
is promptly excreted out of the body through the small intestine
and the large intestine.
[0138] As described above, the outer circumference spring portion
233 presses the intestinal wall Wd of the duodenum to the duct wall
Wc side of the common bile duct. The reactive force at that time
also functions as force to separate the first inner circumference
spring portion 231a from the intestinal wall Wd. Therefore, if an
initial tension of the inner circumference spring portion is
smaller than a biasing force of the outer circumference spring
portion, a clamping force between the first inner circumference
spring portion 231a and the second inner circumference spring
portion 232a is weakened, and also a gap is produced between the
portions of the highly elastic metal wire 230 of the first inner
circumference spring portion 231a, as shown in FIG. 53.
[0139] In this manner, if the force generated between the inner
circumference spring portions 231a, 232a for clamping the
intestinal wall Wd and the duct wall Wc is weakened, it is not
possible to sufficiently prevent a flow of blood in the intestinal
wall Wd and the duct wall Wc. Furthermore, if a gap is produced
between the portions of the highly elastic metal wire 230
constituting the inner circumference spring portion, tissue
surrounded by the inner circumference spring portion is brought
into contact with tissue outside thereof through the gap between
the portions of the highly elastic metal wire 230, allowing a flow
of blood to occur between the two. It follows that the tissue
surrounded by the inner circumference spring portion will not be
necrotized. Therefore, the tissue will not fall off, and it is not
possible to form a subsequent healed hole.
[0140] In this modification, the initial tension of the inner
circumference spring portion, especially of the first inner
circumference spring portion, is set to a degree such that in
placing the tissue fastener 10O in a living body, even if a tip of
the outer circumference spring portion 233 presses the intestinal
wall Wd downwardly and then receives a reaction force from there,
the first inner circumference spring portion 231a is not pulled
away from the intestinal wall Wd, and that no gap is produced
between the portions of the highly elastic metal wire 230, as shown
in FIG. 50. Therefore, when the tissue fastener is placed, no gap
is produced between the portions of the highly elastic metal wire
230 of the inner circumference spring portion, and hence it is
possible to maintain the close contact condition. As a result, a
flow of blood is prevented between the tissue surrounded by the
inner circumference spring portions 231a, 232a and the outside
tissue, and then the tissue surrounded by the inner circumference
spring portions 231a, 232a is necrotized. Subsequently, the tissue
fastener and the necrotized tissue fall off, and a healed hole for
communicating the intestinal wall Wd of the duodenum and the duct
wall Wc of the common bile duct is formed.
[0141] In this modification, the initial tension of the inner
circumference spring portions 231a, 232a is increased. It is set to
a degree such that when the tissue fastener is placed, the first
inner circumference spring portion 231a is not separated from the
intestinal wall Wd and that no gap is produced between the portions
of the highly elastic metal wire 230. However, the structure is not
limited to this. As shown in FIG. 54, a wire diameter of a highly
elastic metal wire constituting an outer circumference spring
portion 233 is set to be smaller than a wire diameter of a highly
elastic metal wire constituting an inner circumference spring
portion, to thereby make it possible to weaken a reactive force
generated by the outer circumference spring portion 233. Therefore,
it is possible to produce an effect similar to the one as described
above.
[0142] On the other hand, if the heights of the second inner
circumference spring portions 231a, 232a are too low, a flow of
blood may be maintained as a result of the tissue surrounded by
those first and second inner circumference spring portions 231a,
232a being brought into contact with the outside tissue through an
upper side portion of the inner circumference spring portion. If
the flow of blood is maintained, the tissue surrounded by the inner
circumference spring portion will not be necrotized, and hence will
not fall off.
[0143] However, in this modification, the heights H1, H2 of the
first and second inner circumference spring portions 231a, 232a are
set to heights such that when the tissue fastener 10O is placed in
the living body, the two portions protrude past the living tissue
as the placement target outwardly. For example, in the case of the
first inner circumference spring portion 231a being placed in the
intestinal wall Wd of the duodenum, the height H1 is 1.5 mm or
more. In addition, because the duct wall Wc of the common bile duct
is thinner than the intestinal wall Wd of the duodenum, the height
H2 of the second inner circumference spring portion 232a placed in
the duct wall Wc of the common bile duct is 0.5 mm or more. As a
result, when the tissue fastener is placed, it is possible to
prevent a flow of blood between the tissue surrounded by those
first and second inner circumference spring portions 231a, 232a and
the outside tissue. Therefore, it is possible to necrotize the
tissue surrounded by the inner circumference spring portion and to
let it fall off.
[0144] A tissue fastener 10P shown in FIG. 55 has a first tissue
fixation portion (first inner circumference spring portion) 231 and
a second tissue fixation portion (second inner circumference spring
portion) 242, both of which are made of a highly elastic metal wire
230 wound in a coil (a cylinder), and furthermore has an outer
circumference spring portion 233 that extends from a tip of the
first inner circumference spring portion outwardly in a radial
direction. In this point, this modification is similar to the
modification described above.
[0145] In this modification, a tip portion of the second inner
circumference spring portion 242, for example substantially one
turn 242A is not closely wound but is wound so as to be spaced
apart from the other portions.
[0146] Incidentally, the first and second inner circumference
spring portions are provided with an initial tension, and hence are
not capable of shrinking any more. In the case where the second
inner circumference spring portion is closely wound to its tip,
when for example the inner circumference spring portion of a right
wound coil is pushed out from the piercing device 52, the inner
circumference spring portion assumes its original right wound coil
shape as shown in FIG. 56, if the coil is not provided with an
initial tension. However, if the inner circumference spring portion
is provided with an initial tension, the coil tries to shrink.
Therefore, its tip may be wound on the opposite side (on the left
wound side), as shown by a double-dot line in FIG. 56. Once this
occurs, the inner circumference spring portion, when pushed out
from the piercing device, is forced to be of a left wound shape,
although it is originally of a right wound shape. Such a situation
is not preferable because the inner circumference spring portion
will not assume its original coil shape, and hence will be
incapable of exerting an expected biasing force.
[0147] In this modification, a tip portion of the second inner
circumference spring portion 242, for example the substantially one
turn 242A is not closely wound but is wound so as to be spaced
apart from the other portions. Therefore, when the second inner
circumference spring portion 242 is pushed out from the piercing
device, no extra force acts on the one turn of the inner
circumference spring portion, and hence the one turn is wound in
its original shape. If the first portion is wound in its original
coil shape, the subsequent portion is followingly wound in its
original coil shape even if a strong initial tension is
provided.
[0148] Note that the above modification is configured such that the
tip portion 242A of the second inner circumference spring portion
242 is not closely wound but is wound so as to be spaced apart from
the other portions. However, the structure is not limited to this.
It may be configured such that a tip portion, for example
substantially one turn portion 242A on the tip side, of the second
inner circumference spring portion 242 is not provided with an
initial tension, or is provided with a weaker initial tension than
that of the other portions.
[0149] A tissue fastener 10Q shown in FIGS. 57A, 57B is provided
with a stopper 253 between a first tissue fixation portion 251 and
a second tissue fixation portion 252, aside from its main unit
(that is, a highly elastic metal wire 10). A thin wire 253A with a
diameter smaller than that of the wire 10 in a linking portion is
inserted into a tube member 253B which is fitted onto the wire 10.
Thereby, the stopper 253 is attached while being curved in a coil
so as to be positioned inside the first and second tissue fixation
portions 251, 252.
[0150] As a precondition, a diameter of the thin wire 253A at its
curved portions is made smaller than an inner diameter of the coils
of the first and second tissue fixation portions 251, 252. In
addition, for placing a stent 30A, it is set to be larger than an
outer diameter of the stent 30A, as shown in FIG. 58.
Alternatively, it is set as small as possible, as shown in FIG. 59.
In the latter case, this is for securing a sufficient space for
placing the stent 30A between the thin wire 253A and the first and
second tissue fixation portions 251, 252.
[0151] The stopper 253 is one that is locked on an intestinal wall
Wd of a duodenum Dd to prevent a phenomenon where a tissue fastener
10B is pulled inside a common bile duct Cb, thus resulting in
placement with an imbalance in number of coil turns between the
first tissue fixation portion 251 locked on the intestinal wall Wd
side of the duodenum Dd and the second tissue fixation portion 252
locked on the duct wall of the common bile duct.
[0152] As methods of fixing the thin wire 253A onto the highly
elastic metal wire 10 in the linking portion between the first
tissue fixation portion 251 and the second tissue fixation portion
252, the following can be listed.
[0153] A method of winding the thin wire 253A around an outer
circumference of the highly elastic metal wire 10 for fixation by
friction, as shown in FIG. 60; a method of winding the thin wire
253A and welding the entire region or a plurality of points thereof
as shown in FIG. 61; a method of utilizing the tube member 253B
that is fitted onto the highly elastic metal wire 10, in which the
tip of the thin wire 253A is inserted into the tube member 253B,
and an adhesive is used or the tube member 253B is subjected to
plastic deformation such as caulking for fixation, as shown in FIG.
62; and a method in which a hole 254 is bored in the highly elastic
metal wire 10, and an end of the thin wire 253A is inserted into
this hole to be fixed by known means such as an adhesive or
caulking, as shown in FIG. 63 can be listed.
[0154] FIG. 64 shows a modification of a stylet of the applicator.
A stylet, when inserted into a piercing device 2, originally has a
function of pushing out a tissue fastener 10A at a tip of the
piercing device 2 from the tip.
[0155] In a stylet 53B shown here, a hemispheric protrusion 262 is
provided on a tip of a bar member 261, and an elastic coil 263
capable of expanding its diameter is wound around a small diameter
portion 261A of the bar member 261 on a side closer to a base end
than the protrusion. Furthermore, the elastic coil 263 functions as
an electrode. It is configured such that to this electrode,
high-frequency current is supplied from a power source (not shown
in the figure) as required.
[0156] According to the stylet 53B with such a structure, forward
movement causes a tissue fastener 10A inserted into the piercing
device 52 to be pushed out. After that, as shown in FIG. 65, the
protrusion 262 on the tip and the elastic coil 263 is protruded
from the tip of the piercing device 52. At this time, the elastic
coil 263 is expanded in diameter by its own elasticity. Then, in
this condition, high-frequency current is supplied to the elastic
coil 263 expanded in diameter. In this condition, the stylet 53B is
pulled back to the hand side as shown in FIG. 66 and FIG. 67.
Thereby, it is possible to burn off the intestinal wall Wd of the
duodenum and the duct wall Wc of the common bile duct, which are
clamped by the tissue fastener 10A, to form a drainage hole
264.
[0157] After that, as described above, the tissue fastener 10A
falls off after the necrosis of the tissue, to thereby form an
anastomotic fistula 265 as shown in FIG. 68.
[0158] In a stylet 53C shown in FIG. 69, a hemispheric protrusion
262 is provided on a tip of a bar member 261, and cutting blades
271 are provided on the bar member 261 on a side closer to a base
end than the protrusion. In a rear portion of each cutting blade
271, a blade portion 271A is provided in an inclined manner.
Furthermore, the cutting blades 271 are elastic enough to be
retractable in a piercing device 52 in a vortex manner seen from
the front, as shown in FIG. 70.
[0159] According to the stylet 53C with the above structure, when
the cutting blades 271 are protruded forward from the tip of the
piercing device 52 as shown in FIG. 71 after the tissue fastener
10A inserted into the piercing device 52 is pushed out, the cutting
blades 271 extend in a flat plate shape by their own elasticity.
Then, they are pulled back to the hand side in this condition. As a
result, it is possible to cut in the intestinal wall Wd of the
duodenum and the duct wall Wc of the common bile duct with the
blade portions 271A in the rear portion, to thereby form a drainage
hole 273.
[0160] It is not configured such that high-frequency current is
supplied to these cutting blades 271. However, it may be configured
such that high-frequency current is supplied as required.
[0161] In a stylet 53D shown in FIG. 73, a hemispheric protrusion
262 is provided on a tip of a bar member 261, and cutting blades
281 are provided on the bar member 261 on a side closer to a base
end than the protrusion. The cutting blades 281 are curved in an
arc shape. It is configured such that the outlines thereof draw a
circle as a whole. In a rear portion of each blade, a blade portion
281A is provided in an obliquely inclined manner. Furthermore, the
cutting blades 281 are elastic enough to be retractable in a
piercing device 52 in a vortex manner seen from the front, as shown
in FIG. 74.
[0162] According to the stylet 53D with the above structure, when
the cutting blades 281 are protruded forward from the tip of the
piercing device 52 after the tissue fastener inserted into the
piercing device is pushed out, each of the cutting blades 271
extends in an arc shape by its own elasticity so that they draw a
circle as a whole. Then, they are pulled back to the hand side in
this condition. As a result, it is possible to cut in the
intestinal wall Wd of the duodenum and the duct wall Wc of the
common bile duct with the blade portions 281A in the rear portion,
to thereby form a circular drainage hole 283.
[0163] In a stylet 53E shown in FIG. 76, a spiral groove 291 is
formed in a tip of the stylet.
[0164] When a common bile duct has an increased internal pressure
due to retention of bile, it is preferable that a hole be provided
in the common bile duct in advance, and that the manipulation be
conducted in a state of a reduced internal pressure after the
suction of the bile from this hole.
[0165] According to the stylet 53E with this structure, a base end
side of the stylet 53E is connected with a suction mechanism, and
the spiral groove 291 formed between the piercing device 52 and the
stylet 53E can be utilized to suck the bile. In the case of using a
simple stick-shaped stylet, there arise contradictory problems as
follows. If to secure a bile suction passage, a gap between the
stylet and the piercing device is made larger by making the
diameter of the stylet smaller, it becomes difficult to push out
the tissue fastener. On the contrary, if the diameter of the stylet
is made larger to make the push-out of the tissue fastener
favorable, it becomes difficult to secure a bile suction
passage.
[0166] FIG. 77 and FIG. 78 show a modification of the piercing
device.
[0167] In a piercing device 300 shown here, a tip portion 301 is a
separate entity from a piercing device main unit 302, and hence is
detachable by being threadingly fitted into the piercing device
main unit 302.
[0168] When a tissue fastener 10A is previously inserted into a tip
portion 301 of this piercing device to be used as a cartridge, it
is possible to reuse the piercing device main unit 302 as a common
portion by replacing a tip portion into which a tissue fastener 10A
is inserted, as required. Furthermore, a needle tip portion 301A on
the tip of the tip portion of the piercing device 300 is renewed
for every use. Therefore, it is possible to secure a sharp
edge.
* * * * *