U.S. patent application number 12/430442 was filed with the patent office on 2010-01-14 for tissue fastening tool.
This patent application is currently assigned to OLYMPUS MEDICAL SYSTEMS CORP.. Invention is credited to Tatsutoshi HASHIMOTO, Ayano ISHIOKA, Kazushi MURAKAMI, Yusuke NOMURA, Masatoshi SATO, Shinji TAKAHASHI.
Application Number | 20100010514 12/430442 |
Document ID | / |
Family ID | 42537447 |
Filed Date | 2010-01-14 |
United States Patent
Application |
20100010514 |
Kind Code |
A1 |
ISHIOKA; Ayano ; et
al. |
January 14, 2010 |
TISSUE FASTENING TOOL
Abstract
A tissue fastening instrument that fastens a first biological
tissue and a second biological tissue that is adjacent to the first
biological tissue so as to come into close contact, provided with a
first tissue fixing portion that consists of an elastic wire that
is wound into a coil shape and engaged on the first biological
tissue; a second tissue fixing portion that consists of an elastic
wire that is wound into a coil shape, is connected to a first end
portion of the first tissue fixing portion and engaged on the
second biological tissue; and a peripheral spring portion that is
connected to a second end portion of the first tissue fixing
portion and extends toward the second tissue fixing portion while
forming a loop on the outside of the first tissue fixing portion
and the second tissue fixing portion, in which the peripheral
spring portion has a spring portion that is connected to the second
end portion of the first tissue fixing portion and extends toward
the second tissue fixing portion, and an end turn portion that is
connected to the spring portion and forms, on the outside of the
spring portion, a loop that is approximately parallel with a base
loop that the first tissue fixing portion and the second tissue
fixing portion form; and the base loop, the loop that the spring
portion forms, and the loop that the end turn portion forms are
disposed so as not to mutually overlap in the diameter direction of
the base loop.
Inventors: |
ISHIOKA; Ayano; (Tokyo,
JP) ; SATO; Masatoshi; (Yokohama-shi, JP) ;
TAKAHASHI; Shinji; (Tokyo, JP) ; HASHIMOTO;
Tatsutoshi; (Tokyo, JP) ; NOMURA; Yusuke;
(Tokyo, JP) ; MURAKAMI; Kazushi; (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: |
42537447 |
Appl. No.: |
12/430442 |
Filed: |
April 27, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12171816 |
Jul 11, 2008 |
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12430442 |
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12171817 |
Jul 11, 2008 |
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12171816 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/0644 20130101;
A61B 2017/00867 20130101; A61B 2017/0649 20130101; A61B 17/068
20130101; A61B 2017/1139 20130101; A61B 17/1114 20130101; A61B
2017/0645 20130101; A61B 2017/0034 20130101; A61B 17/11
20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A tissue fastening instrument that fastens a first biological
tissue and a second biological tissue that is adjacent to the first
biological tissue so as to come into close contact, comprising: a
first tissue fixing portion that consists of an elastic wire that
is wound into a coil shape and engaged on the first biological
tissue; a second tissue fixing portion that consists of an elastic
wire that is wound into a coil shape, is connected to a first end
portion of the first tissue fixing portion and engaged on the
second biological tissue; and a peripheral spring portion that is
connected to a second end portion of the first tissue fixing
portion and extends toward the second tissue fixing portion while
forming a loop on the outside of the first tissue fixing portion
and the second tissue fixing portion, wherein the peripheral spring
portion has: a spring portion that is connected to the second end
portion of the first tissue fixing portion and extends toward the
second tissue fixing portion; and an end turn portion that is
connected to the spring portion and forms, on the outside of the
spring portion, a loop that is approximately parallel with a base
loop that the first tissue fixing portion and the second tissue
fixing portion form; and the base loop, the loop that the spring
portion forms, and the loop that the end turn portion forms are
disposed so as not to mutually overlap in the diameter direction of
the base loop.
2. The tissue fastening instrument according to claim 1, wherein
the loop that the peripheral spring forms is set to have an integer
winding of 1 or more.
3. The tissue fastening instrument according to claim 1, wherein
the end turn portion forms a loop of one or more turns.
4. The tissue fastening instrument according to claim 3, wherein
the end turn portion forms an essentially closed loop when abutting
at least the first biological tissue.
Description
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 12/171,816 "Tissue Fastening Portion"
filed Jul. 11, 2008, and U.S. patent application Ser. No.
12/171,817 "Tissue Fastening Instrument, Applicator for Placing the
Tool in a Human Body, and Trans-Natural Opening Based Tissue
Fastening Method" filed Jul. 11, 2008, and claims priority on the
aforementioned two applications.
TECHNICAL FIELD
[0002] The present invention relates to a tissue fastening
instrument that fixes tissue in a trans-natural opening manner and
an applicator that is used when placing this tissue fastening
instrument in a body.
BACKGROUND ART
[0003] As a method of performing a procedure on an internal organ
of a human body and the like, there is known a laparoscope
operation that involves percutaneously inserting a treatment tool.
This is because since the procedure can be completed with little
invasion compared to the case of cutting open the abdominal region,
an early recovery can be expected.
[0004] The treatment tool that is used in a laparoscope operation
has a hard shaft that is percutaneously inserted in a body, with
forceps or the like provided at the distal end of the shaft. For
example, Japanese Unexamined Patent Application Publication No.
2005-193044 discloses a treatment tool used for the application of
joining hollow organs. In this intraluminal anastomosis instrument,
a grasping tool that freely opens and closes is attached at the
distal end of a shaft, and a fastening instrument is inserted in
this shaft. The fastening instrument is capable of being pushed out
from the distal end of the shaft by a projection mechanism on the
proximal side. The fastening instrument is manufactured from a
shape memory alloy that is annealed in a coil shape and inserted in
the shaft in a straightened state. When using the fastening
instrument, it is inserted into a human body by pushing out with an
extrusion mechanism. The fastening instrument reverts to its coil
shape by being warmed by body heat. Hollow organs are then joined
by the restored fastening instrument.
[0005] Another example of supplying a fastening instrument is
disclosed in WO 2002/019923 "Surgical Fastener and Delivery
System". Here, the fastening instrument is delivered to the tissue
by being pushed out from a needle. For this reason, stops are
provided that control the amount of depth that the needle may be
inserted into the tissue and the amount of the fastening instrument
to be delivered to the tissue. When performing a procedure, a tool
that contains the fastening instrument and the needle is placed
against the tissue. When the needle has been moved forward to be
inserted in the tissue, the position of the fastening instrument is
fixed by the stop. Thereafter, the needle is pulled out from the
tissue. Since the fastening instrument does not move by the
existence of the stops, the distal end portion thereof is left on
the inner side of the tissue. When the instrument is removed from
the tissue, the remaining portion of the fastening instrument
remains on the outer side of the tissue. When the fastening
instrument reverts to the coil shape, the tissue is fastened.
DISCLOSURE OF THE INVENTION
[0006] The present invention is a tissue fastening instrument that
fastens a first biological tissue and a second biological tissue
that is adjacent to the first biological tissue so as to come into
close contact, provided with a first tissue fixing portion that
consists of an elastic wire that is wound into a coil shape and
engaged on the first biological tissue; a second tissue fixing
portion that consists of an elastic wire that is wound into a coil
shape, is connected to a first end portion of the first tissue
fixing portion and engaged on the second biological tissue; and a
peripheral spring portion that is connected to a second end portion
of the first tissue fixing portion and extends toward the second
tissue fixing portion while forming a loop on the outside of the
first tissue fixing portion and the second tissue fixing portion,
in which the peripheral spring portion has a spring portion that is
connected to the second end portion of the first tissue fixing
portion and extends toward the second tissue fixing portion, and an
end turn portion that is connected to the spring portion and forms,
on the outside of the spring portion, a loop that is approximately
parallel with a base loop that the first tissue fixing portion and
the second tissue fixing portion form; and the base loop, the loop
that the spring portion forms, and the loop that the end turn
portion forms are disposed so as not to mutually overlap in the
diameter direction of the base loop.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a cross-sectional view that shows the tissue
fastening instrument and applicator in accordance with one
embodiment of the present invention.
[0008] FIG. 2 is a perspective view of the same tissue fastening
instrument.
[0009] FIG. 3 is an elevation view and a plan view of the same
tissue fastening instrument.
[0010] FIG. 4A and FIG. 4B are drawings that show the relationship
of the peripheral spring of the same tissue fastening instrument
and the force that acts.
[0011] FIG. 4C and FIG. 4D are drawings that show the state of the
tissue fastening instrument shown in FIG. 4A when placed in
tissue.
[0012] FIG. 5A and FIG. 5B are drawings that show the relationship
of the peripheral spring of the same tissue fastening instrument
and the force that acts.
[0013] FIG. 5C and FIG. 5D are drawings that show the state of the
tissue fastening instrument shown in FIG. 5A when placed in
tissue.
[0014] FIG. 6 is a drawing that shows the state of the same
applicator inserted in an endoscope.
[0015] FIG. 7 is a drawing that shows the operation of the same
endoscope during use of the same applicator.
[0016] FIG. 8A is a drawing that shows the operation during use of
the same tissue fastening instrument and the same applicator.
[0017] FIG. 8B is a cross-sectional view along line X-X of FIG.
5A.
[0018] FIG. 9 to FIG. 11 are drawings that show the operation
during use of the same tissue fastening instrument and the same
applicator.
[0019] FIG. 12A and FIG. 12B are drawings that show the operation
when the same tissue fastening instrument is pushed out from the
needle tube of the same applicator.
[0020] FIG. 13A to FIG. 13D are drawings that show the operation of
the same tissue fastening instrument and the same needle tube.
[0021] FIG. 14 to FIG. 16 are drawings that show the state of an
irregularity occurring during placement of the same tissue
fastening instrument.
[0022] FIG. 17 to FIG. 21 are drawings that show the operation of
the same tissue fastening instrument and the same needle tube in
order to suitably place the same tissue fastening instrument.
[0023] FIG. 22 is a drawing that shows the state of the end turn
portion having run onto the peripheral spring.
[0024] FIG. 23 is a drawing that shows the state of the same tissue
fastening instrument placed in tissue.
[0025] FIG. 24A is a drawing that describes the problem point when
placing a tissue fastening instrument with no peripheral
spring.
[0026] FIG. 24B is a drawing that describes the problem point when
placing a tissue fastening instrument in which the shape of the
same peripheral spring is not suitable.
[0027] FIG. 25A and FIG. 25B are drawings that show the shape in a
plan view of the end turn portion.
[0028] FIG. 26A and FIG. 26B are drawings that show other aspects
of the same end turn portion.
[0029] FIG. 27 is a drawing that shows another aspect of the same
end turn portion.
[0030] FIG. 28 is a drawing that show the state in which the
fastening force of the tissue fastening instrument being
insufficient.
[0031] FIG. 29A and FIG. 29B are drawings that show the joining
aspect of the tissue fastening instrument and the stylet in
accordance with a modification of the present invention.
[0032] FIG. 30A and FIG. 30B are drawings that show end portions of
the tissue fastening instrument in accordance with modifications of
the present invention.
[0033] FIG. 31 is a drawing that shows the end portion of the
tissue fastening instrument in accordance a modification of the
present embodiment.
[0034] FIG. 32A and FIG. 32B are drawings that show another example
of a joining aspect of the same tissue fastening instrument and the
same stylet.
[0035] FIG. 33 is a drawing that shows the end portion of the
stylet in accordance with a modification of the present
embodiment.
[0036] FIG. 34 to FIG. 36 are drawings that show another example of
a joining aspect of the same tissue fastening instrument and the
same stylet.
[0037] FIG. 37 is a drawing that shows another example of a joining
aspect of the same tissue fastening instrument and the same
stylet.
[0038] FIGS. 38A and 38B are drawings that show another example of
a joining aspect of the same tissue fastening instrument and the
same stylet.
[0039] FIG. 39A and FIG. 39B are drawings that show another example
of a joining aspect of the same tissue fastening instrument and the
same stylet.
[0040] FIG. 40A and FIG. 40B are drawings that show another example
of a joining aspect of the same tissue fastening instrument and the
same stylet.
BEST MODE FOR CARRYING OUT THE INVENTION
[0041] Hereinbelow an embodiment in accordance with the present
invention shall be described. A tissue fastening device S1 of the
present embodiment is a device that integrally fixes a first
biological tissue and a second biological tissue, and performs a
procedure that brings both tissues into communication. As shown in
FIG. 1, it is provided with a tissue fastening instrument 10A and
an applicator 50.
[0042] Here, the first and the second biological tissue do not
necessarily denote different organs. For example, the case is also
included in which a region of a certain organ serves as the first
biological tissue, and another region of this organ serves as the
second biological tissue, when these two regions being fixed. In
the present embodiment, a description shall be given using as an
example the procedure of the common bile duct serving as the second
biological tissue being fixed to the duodenum serving as the first
biological tissue, and bringing both organs into communication with
one another.
[0043] FIG. 2 and FIG. 3 are drawings that show the tissue
fastening instrument 10A of the present embodiment. The tissue
fastening instrument 10A is equipped with a first tissue fixing
portion 11 that is engaged on the duodenum, a second tissue fixing
portion 12 that is engaged on the common bile duct which is
adjacent to the duodenum, and a peripheral spring portion 13 that
is connected to the first tissue fixing portion 11 as shown in FIG.
2.
[0044] All of the sections of the tissue fastening instrument 10A,
that is, the first tissue fixing portion 11, the second tissue
fixing portion 12, and the peripheral spring portion 13, consist of
a single high elasticity metal wire (hereinbelow simply referred to
as a "metal wire") 10 that is wound in a coil shape. The first
tissue fixing portion 11 and the second tissue fixing portion 12
are formed so as to have the same loop diameter, and with each
other's loops being coaxial.
[0045] The peripheral spring portion 13 is provided with a spring
portion 14 that extends from the end portion of the first tissue
fixing portion 11, and an end turn portion 15 that extends from the
end portion of the spring portion 14.
[0046] The spring portion 14 is extended from the end of the first
tissue fixing portion 11 toward the second tissue fixing portion 12
while forming a loop that is larger than the first tissue fixing
portion 11 and the second tissue fixing portion 12. The loop that
the spring portion 14 forms gradually becomes large as it goes to
the side of the second tissue fixing portion 12. Note that that
shape is not essential to the present invention, and for example
the spring portion 14 may extend toward the second tissue fixing
portion 12 while forming a loop of the same diameter.
[0047] Since the spring portion 14 extends to the side of the
second tissue fixing portion 12, the metal wire 10 that forms the
spring portion 14, as shown in FIG. 3, has an angle so as to slope
with respect to the axial line of the loop of the first tissue
fixing portion 11 and the second tissue fixing portion 12
(hereinbelow called the "base loop").
[0048] The spring portion 14 is preferably formed so as to have an
integer winding of 1 or more. An "integer winding of 1 or more"
means that, when the tissue fastening instrument 10A is viewed from
above as shown in FIG. 4A, an end portion 14A of the spring portion
14 on the side of the first tissue fixing portion 11 and an end
portion 14B of the spring portion 14 on the side of the end turn
portion 15 are aligned on the same straight line with a center C of
a base loop L1 without sandwiching the center C.
[0049] When the spring portion 14 is an integer winding of 1 or
more, when the tissue fastening instrument 10A is viewed in cross
section in the axial direction that passes through the center C,
whichever cross section is taken, the spring portion 14 on the
outer side in the diameter direction of the base loop L1 is in a
state of being uniformly distributed as shown in FIG. 4B. Although
FIG. 4B shows the state in which the spring portion 14 is set to
one turn, provided it is an integer turn, the state is the same
even for two or more turns. Therefore, the force of the spring
portion 14 that acts in a direction perpendicular to the axial line
of the base loop L1 (direction of a cross-section) becomes equal
with respect to the first tissue fixing portion 11 and the second
tissue fixing portion 12, and as shown in FIG. 4C and FIG. 4D, even
when placed in tissue, the base loop of the first tissue fixing
portion 11 and the second tissue fixing portion 12 does not cause
axial discrepancy, and the shape is stable.
[0050] FIG. 5A to FIG. 5D show an example of the spring portion 14
set to 1/2 turn as an example of a non-integer turn. In this tissue
fastening instrument 110A, end portions 114A and 114B of a
peripheral spring 114 are aligned on the same straight line with
the center C of the base loop L1, sandwiching the center C.
[0051] In this case, as shown in FIG. 5B, depending on how the
cross-section in the axial direction passing through the center C
is taken, the balance of the quantity of the spring portion 14 that
exists on both sides of the first tissue fixing portion 11 and the
second tissue fixing portion 12 is upset. When the tissue fastening
instrument 110A that has such a spring portion 114 is placed in
tissue, as shown in FIG. 5C and FIG. 5D, an axial discrepancy will
arise between the base loop L1 and a loop L3 that the end turn
portion 15 forms. As a result, a force that is out of balance acts
in the cross-sectional direction, which becomes a hindrance to the
first tissue fixing portion 11 and the second tissue fixing portion
12 sufficiently exhibiting the tissue fastening force mentioned
later, which is not desirable.
[0052] The metal wire 10 changes its extension angle at the end
portion 14B that corresponds to the connection portion of the
spring portion 14 and the end turn portion 15, whereby the end turn
portion 15 forms a loop that is perpendicular to the axial line of
the base loop L1. Therefore, the loop of the end turn portion 15 is
parallel to the base loop L1. As shown in FIG. 2, a through-hole
15B is formed at the end portion 15A of the end turn portion 15,
and where the end turn portion 15 has formed a loop of one or more
turns, the degree of bending is adjusted so that the end portion
15A touches another portion of the end turn portion 15.
[0053] The loop that the end turn portion 15 forms has a larger
diameter than the loop that the spring portion 14 forms. Therefore,
when the tissue fastening instrument 10A is viewed from the axial
direction of the base loop L1 as shown by the plan view in FIG. 3,
the base loop L1 is furthest to the inside the second loop L2 that
the spring portion 14 forms is to the outside of that, and the
third loop L3 that the end turn portion 15 forms is still further
to the outside. The base loop L1, the second loop L2, and the third
loop L3 are not mutually superimposed in the diameter direction of
the base loop L1.
[0054] With the tissue fastening instrument 10A extended, one end
is inserted in a biological tissue, and one tissue fixing portion,
for example the second tissue fixing portion 12, is in turn passed
through the intestinal wall of the duodenum and a tubular wall of
the common bile duct. The shape of the second tissue fixing portion
12 that has passed through the intestinal wall of the duodenum and
the tubular wall of the common bile duct is restored to the
original coil shape by removing a restraint on the inner side of a
common bile duct, and thus becomes caught on the common bile duct.
The shape of the first tissue fixing portion 11 is restored to the
original coil shape by removing a restraint on the inner side of
the duodenum, and thus becomes caught on the duodenum. Due to the
first tissue fixing portion 11 being caught on the duodenum and the
second tissue fixing portion 12 being caught on the common bile
duct, the intestinal wall of the duodenum and the tubular wall of
the common bile duct are fastened and integrally fixed so as to be
pressed against each other. At this time, the end turn portion 15
of the peripheral spring portion 13 abuts the intestinal wall of
the duodenum around the first tissue fixing portion 11, and the
spring portion 14 biases the end turn portion 15 so as to press the
intestinal wall against the side of the common bile duct. These
points are explained in detail in the explanation of the operation
during use of the tissue fastening device S1.
[0055] The applicator 50 is an instrument for placing the tissue
fastening instrument 10A in a body, and is provided with a main
body 51, a needle tube 52, a stylet (fastening instrument pusher)
53, and a sheath 54 as shown in FIG. 1.
[0056] The main body 51 is formed in a cylindrical shape and has a
needle tube control portion 56, a stylet control portion 57, and a
ring member (sheath control portion) 58a for advancing and
retracting the sheath 54 with respect to the main body 51. The
needle tube 52, the stylet 53, and the sheath 54 all have
flexibility, and are placed in a mutually coaxial shape. These
constitute the insertion portion 60, which is pushed into a work
channel of an insertion portion of an endoscope, with the insertion
portion 60 naturally being longer than the work channel of the
endoscope.
[0057] The needle tube 52 is used by being accommodated in a cavity
with the tissue fastening instrument 10A in an extended state. The
distal end surface of the needle tube 52 is formed slanted with
respect to the lengthwise direction of the needle tube 52. Thereby,
the distal end of the needle tube 52 is finished sharp. The base
end of the needle tube 52 is connected to the needle tube control
portion 56 provided at the rear of the main body 51.
[0058] Note that an electrode is provided at the distal end of the
needle tube 52, and so the needle tube 52 may be inserted to pierce
the intestinal wall of the duodenum and the tubular wall of the
common bile duct while cauterizing biological tissue by passing
electricity to the distal end. In this case, the distal end of the
needle tube 52 may not be formed with a sharp tip.
[0059] The stylet 53 forms a shaft shape, is inserted inside the
needle tube 52 in a manner capable of moving, and pushes out the
tissue fastening instrument 10A that has been inserted in the
needle tube 52 from the distal end of the needle tube 52. A
projection 53B is formed at a distal end 53A of the stylet 53, and
as shown in FIG. 1, the tissue fastening instrument 10A is
accommodated in the needle tube 52 in the state of the through-hole
15B of the end turn portion 15 and the projection 53B being
engaged.
[0060] For this reason, the tissue fastening instrument 10A becomes
integrated with the stylet 53 and capable of moving forward and
backward in the needle tube 52, and when the stylet 53 is rotated
about the axis line, rotates together with the stylet 53. The gap
between the inner cavity of the needle tube 52 and the stylet 53 is
set to be smaller than the wire diameter of the metal wire 10 that
constitutes the tissue fastening instrument 10A. Therefore, the
engagement of the through-hole 15B and the projection 53B does not
come apart within the needle tube 52. In addition, in making the
gap between inner cavity of the needle tube 52 and the stylet 53
small, the diameter of the stylet 53 may be enlarged, and also the
projection length of the projection 53B may be lengthened.
Furthermore, instead of making the gap between inner cavity of the
needle tube 52 and the stylet 53 small, the maximum diameter of the
metal wire 10 may be enlarged, and so by restricting the movable
range of the metal wire 10 in the needle tube 52, the
aforementioned engagement release may be restricted.
[0061] The base end of the stylet 53 is connected to the stylet
control portion 57 provided in the inside of the needle tube
control portion 56 described below.
[0062] The sheath 54 is a tubular member that has flexibility, and
the needle tube 52 is inserted in the inner cavity in a movable
manner. The distal end face of the sheath 54 is formed flat so as
to be orthogonal to the lengthwise direction of the sheath 54.
[0063] The needle tube control portion 56 is provided with a
cylindrical first shaft 56a that is inserted in the inner side from
the rear end of the main body 51. The outer diameter of the first
shaft 56a is slightly smaller than the inner diameter of the rear
portion of the main body 51. Therefore, the first shaft 56a is
capable of sliding on the inner surface of the rear portion of the
main body 51. The base end of the needle tube 52 is fixed to the
distal end surface of the first shaft 56a that is inserted in the
main body 51 so as to cause the lengthwise direction of the needle
tube 52 to coincide with the lengthwise direction of the first
shaft 56a. The needle tube 52, by causing the first shaft 56a to
slide with respect to the main body 51, can change its relative
position with the main body 51.
[0064] A female screw hole is formed in the diameter direction of
the main body 51 at the rear portion of the main body 51, and a
external thread 61 is screwed into this female screw hole. The
distal end of the external thread 61 projects into the inner cavity
of the main body 51. A slot 56b is formed on the outer surface of
the first shaft 56a along the lengthwise direction of the first
shaft 56a. The distal end of the external thread 61 is loosely
fitted in the slot 56b. Thereby, the slot 56b regulates the movable
range of the first shaft 56a with respect to the main body 51. By
screwing the external thread 61 further into the female screw hole
to make the distal end thereof press against the bottom surface of
the slot 56b, it is possible to hold the first shaft 56a at any
position with respect to the main body 51.
[0065] The stylet control portion 57 has a cylindrical second shaft
62 that is inserted from the rear end of the first shaft 56a to the
inner side, a lever 63 that is swingably supported by the first
shaft 56a that supports the needle tube 52, a twisted coil spring
64 that biases the lever 63 in a direction away from the main body
51, and a link mechanism 65 that changes the swing movement of the
lever 63 to a linear movement along the piercing tool 52 of the
stylet 53.
[0066] The base end of the stylet 53 is inserted from the distal
end of the second shaft 62 to the inside thereof and fixed to the
second shaft 62 so as to make the lengthwise direction of the
stylet 53 coincide with the lengthwise direction of the second
shaft 62. The stylet 53, by causing the second shaft 62 to slide
with respect to the first shaft 56a, can change the relative
position with the needle tube 52.
[0067] A projection 90 is formed on the periphery of the needle
tube 52, and this projection 90 is fitted to a ring slot 91 formed
on the circumference of the distal end portion of the needle tube
control portion 56. By this, the needle tube 52 is capable of
relative rotation with respect to the needle tube control portion
56 while incapable of relative movement in the axial direction. A
spirally shaped slot 92 is formed on the outer circumferential
surface of the base end side of the needle tube 52 beyond the
projection 90.
[0068] A pin-shaped projection 93 is provided on the inner
circumferential surface of the second shaft 62 that faces the outer
circumferential surface of the needle tube 52, and this projection
93 engages with the spirally shaped slot 92 (hereinbelow referred
to as "spiral slot 92"). Moreover, a longitudinal groove 94 is
formed on the outer circumference of the second shaft 62, and a
plate member 72 is attached to the outer side of the second shaft
62 (refer to FIG. 8B). A projection 95 is formed in the inner
circumferential portion of the plate member 72, and this projection
95 is fitted in the longitudinal groove 94. Thereby, the second
shaft 62 is capable of relative movement in the axial direction in
the state of being prevented from rotating with respect to the
plate member 72. Due to the mutual correspondence of the ring slot
91 and the projection 90, and the spiral slot 92 and the projection
93, a rotation mechanism 96 is constituted that causes the needle
tube 52 to rotate when the second shaft 62 that is prevented from
rotating moves forward or backward along the axial direction.
[0069] The shape of the spiral slot 92 is set so that when the
needle tube 52 rotates with movement of the second shaft 62 in the
axial direction, the rotation direction of the needle tube 52 and
the coil winding direction of the tissue fastening instrument 10A
become reversed. Furthermore, although the stylet 53 pushes out the
tissue fastening instrument 10A from the distal end of the needle
tube 52 by movement of the second shaft 62 in the axial direction,
the shape of the spiral slot 92 is set so that the needle tube 52
completes one rotation each time the tissue fastening instrument
10A is pushed out by only the length of one coil portion from the
distal end of the needle tube 52. Therefore, the length of the
spiral slot per a rotation of the needle tube differs in the region
of the spiral slot 92 that is engaged with the projection 93 when
the first tissue fixing portion 11 and the second tissue fixing
portion 12 are being pushed out and the region of the spiral slot
92 that is engaged with the projection 93 when the peripheral
spring portion 13 is being pushed out.
[0070] In addition, although the present embodiment provides the
spiral slot 92 in the outer circumference of the needle tube 52 and
the projection 93 in the inner circumference of the second shaft
62, it is not limited thereto. Instead, a projection may be
provided on the outer circumference of the needle tube 52, the
spiral slot may be provided on the inner circumference of the
second shaft 62, the spiral shape may be a convexity instead of a
slot, and the rotation mechanism may be constituted using a
projection or the like that is capable of engagement therewith.
[0071] The link mechanism 65 is provided with a base member 66, a
bracket 68, a bar 70, a plate member 72, and a compression coil
spring 74. The base member 66 is fixed to the outside surface of
the first shaft 56a. The bracket 68 is pivotally supported by the
base member 66. The lever 63 is fixed to the lower end of the
bracket 68. The bar 70 is pivotally supported by the bracket 68 at
one end, and is pivotally supported by the base portion material 66
at the other end. A pin 71 provided at the other end of the bar 70
is fitted in a long hole 66a formed in the base member 66 along the
sliding direction of the second shaft 62 in a manner providing
play.
[0072] A hole 73 with a diameter that is larger than the outer
diameter of the second shaft 62 is formed in the plate member 72,
and the second shaft 62 that is inserted in the first shaft 56a is
passed through this hole 73. The difference of the outer diameter
of the second shaft 62 and the inner diameter of a hole 73 is
extremely small, and by leaning the plate member 72 to move in the
lengthwise direction of the second shaft 62, that is, the insertion
direction of the second shaft 62 in the first shaft 56a, the inner
surface of the hole 73 interferes with the outer surface of the
second shaft 62 to cause friction, whereby a force that is added to
the plate member 72 acts on the second shaft 62.
[0073] The compression coil spring 74 is disposed inside of the
first shaft 56a, and biases the plate member 72 in the opposite
direction of the insertion direction of the second shaft 62 in the
first shaft 56a.
[0074] When the lever 63 is moved in the direction of approaching
the main body 51, the bar 70 is pulled towards the front of the
main body 51 via the bracket 68, and the other end of the bar 70
moves along the long hole 66a. The plate member 72 is pushed by the
other end of the bar 70 and moves in the insertion direction of the
second shaft 62 in the first shaft 56a, resisting the compression
coil spring 74. Since friction is produced between the second shaft
62 and the plate member 72 as a result of the latter tilting
slightly, the force that is added to the plate member 72 acts on
the second shaft 62, and the second shaft 62 is thrust into the
first shaft 56a.
[0075] When the lever 63 is released, the twisted coil spring 64
causes the lever 63 to separate from the main body 51, and the
compression coil spring 74 pushes only the plate member 72 back to
its initial position without causing friction with the second shaft
62.
[0076] Since the amount of movement of the other end of the bar 70
per operation of the lever 63 is always constant, the insertion
length of the second shaft 62 into the first shaft 56a per
operation of a lever 63 is also always constant. 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 needle tube 52 according to the number of times
of operation of the lever 63. This means that it is possible to
control the length of the tissue fastening instrument 10A pushed
out from the distal end of the needle tube 52 according to the
number of times of operation of the lever 63.
[0077] When the tissue fastening instrument 10A forms a coil shape
that has a loop outside of the needle tube 52 as in the present
embodiment, the insertion length of the stylet 53 per operation of
the lever 63 is preferably about n times of the loop of the tissue
fastening instrument 10A or about 1/n times (n being a natural
number).
[0078] For example, if the insertion length of the stylet 53 per
operation of the lever 63 is almost equal to the circumference of
the tissue fastening instrument 10A, whenever the lever 63 is
operated once, the tissue fastening instrument 10A will be pushed
out from the distal end of the needle tube 52 by an amount
corresponding to one turn. Moreover, when the second tissue fixing
portion 12 is a two-turn portion of the tissue fastening instrument
10A, by operating the lever 63 two times, it is possible to push
out only the second tissue fixing portion 12 from the distal end of
the needle tube 52.
[0079] Moreover, if the insertion length of the stylet 53 per
operation of the lever 63 is almost equal to half of the
circumference of the tissue fastening instrument 10A, whenever the
lever 63 is operated once, the tissue fastening instrument 10A will
be pushed out from the distal end of the needle tube 52 by an
amount corresponding to half a turn. Furthermore, when the second
tissue fixing portion 12 is a two-turn portion of the tissue
fastening instrument 10A, by operating the lever 63 four times, it
is possible to push out only the second tissue fixing portion 12
from the distal end of the needle tube 52.
[0080] Moreover, regarding the spring portion 14 and the end turn
portion 15 of the peripheral spring portion 13, by setting the
length thereof to an integral multiple of the insertion length of
the stylet 53 per single operation of the lever 63, it is possible
to push out only the spring portion 14 or the end turn portion 15
from the needle tube 52.
[0081] A mouth ring 80 is inserted at the distal end of the main
body 51. An inner screw 80A is formed in the mouth ring 80, and by
screwing the inner screw 80A into a cap of an endoscope, it is
possible to fix the applicator 50 to the endoscope. On the outer
surface of the mouth ring 80, a groove 81 is formed along the
circumferential direction. A female screw hole that extends in the
diameter direction is formed in the main body 51, and a external
thread 82 is screwed into this female screw hole. The distal end of
the external thread 82 projects to the inside of the main body 51.
The distal end of the external thread 82 loosely fits into the
groove 81 of the mouth ring 80. Thereby, it is possible to freely
rotate the entire applicator 50 with respect to the mouth ring 80
that is fixed to the endoscope. By further screwing the external
thread 82 into the female screw hole to make the distal end thereof
press against the bottom surface of the groove 81, it is possible
to position and hold the main body 51 at any position in the
circumferential direction with respect to the mouth ring 80.
[0082] FIG. 6 shows a linear scanning-type ultrasonic endoscope
(hereinbelow simply referred to as an "endoscope") 2 as an example
of an endoscope that is used together with the tissue fastening
device S1. The endoscope 2 is provided with a flexible insertion
portion 4 that extends from the control portion 3 that is used
outside a body.
[0083] A knob 3A and various buttons 3B that cause the distal end
portion of the insertion portion 4 to curve are provided in the
control portion 3. A cover 5 is attached to the distal end of the
insertion portion 4. An ultrasonic device 6 is attached to this
cover 5.
[0084] The ultrasonic device 6 bulges out on a plane that includes
the axial line of the insertion portion 4, and a plurality of
ultrasonic transducers are arranged along the circular periphery.
Moreover, an elevator base 7 is provided so as to feed the distal
end portion of the applicator 50 to the side. By operating the
elevator base 7 proximally, it is possible to adjust the direction
of the insertion portion 60 of the applicator 50 that is fed out
from the distal end of the insertion portion 4. Note that the
endoscope 2 may also be provided with another probe-type ultrasonic
endoscope. Also, it is possible to use an endoscope that does not
have the ultrasonic device 6. In this case, an ultrasonic device
that is used outside of the body, an X-ray device, a magnetic
resonance imaging device, or a computerized tomography device are
used in combination.
[0085] Next, a procedure shall be explained of placing the tissue
fastening instrument 10A in an abdominal cavity using the tissue
fastening device S1 constituted as mentioned above, integrally
fixing the duodenum and the common bile duct, and forming a hole
that brings both into communication. This kind of procedure, as
shown for example in FIG. 7, is carried out in the case of the
discharge of bile being prevented by blockage of the duodenal
papilla Dp by a tumor Tr, causing jaundice in which the bile is
absorbed into blood. By this procedure, it is possible to directly
discharge the bile from the common bile duct Cb to the duodenum
Dd.
[0086] First, the insertion portion 4 of the endoscope 2 is
inserted from a patient's mouth. The endoscope 2 is inserted in the
duodenum Dd which is the upper part of the gastrointestinal tract.
The state of the outer side of the duodenum Dd is investigated with
the ultrasonic endoscope 6, and a location suitable for the
procedure near the common bile duct Cb is searched for on the
stomach St side from the duodenal papilla Dp.
[0087] The operator in advance retracts the needle tube 52 with
respect to the main body 51 by operating the first shaft 56a of the
applicator 50, and retracts the stylet 53 with respect to the main
body 51 by operating the second shaft 62, as shown in FIG. 5A.
Furthermore, by operating the ring member 58a, the sheath 54 is
retracted with respect to the main body 51, In this state, the
distal end of the needle tube 52 in which the tissue fastening
instrument 10A has been inserted is drawn to the inside of the
sheath 54.
[0088] The operator inserts the insertion portion 60 of the
applicator 50 in the work channel of the endoscope 2 and makes it
move forward, and engages the mouth ring 80 with a forceps plug 8
of the endoscope to fix the applicator 50 to the endoscope 2.
Thereby, the distal end of the insertion portion 60 is protruded
from the distal end of the insertion portion 4 of the endoscope 2.
Then, the direction of the protruded insertion portion 60 is
adjusted by the elevator base 7.
[0089] The common bile duct Cb beyond the duodenum Dd is scanned
using the ultrasonic device 6 provided in the endoscope 2, and the
location to insert the needle tube 52 in the common bile duct Cb is
determined. As shown in FIG. 9, the external thread 61 is loosened,
the first shaft 56a is pushed into the main body 51, and the distal
end of the needle tube 52 is made to project from the distal end of
the sheath 54. Thereby, the sharp distal end of the needle tube 52
pierces through the intestinal wall Wd of the duodenum Dd from the
inside to the outside, and successively pierces through the wall Wc
of the common bile duct Cb from the outside to the inside. The
operator then tightens the external thread 61 to fix the first
shaft 56a to the main body 51.
[0090] The operator, as shown in FIG. 10, operates the lever 63 to
push the second shaft 62 into the first shaft 56a by a
predetermined amount. For example, the lever 63 may be operated a
definite number of times. Thereby, the stylet 53 changes the
relative position with the needle tube 52, and the second tissue
fixing portion 12 of the tissue fastening instrument 10A is pushed
out from the distal end of the needle tube 52. At this time, along
with the advance of the second shaft 62, the projection 93 provided
in the second shaft 62 moves along the spiral slot 92 of the needle
tube 52. Meanwhile, rotation of the second shaft 62 is restricted
by the projection 95 of the plate member 72 being engaged in the
longitudinal groove 94 formed in the outer circumference. As a
result, the needle tube 52 rotates with the advance of the second
shaft 62. Since the tissue fastening instrument 10A and the stylet
53 are united at this time by the projection 53B being engaged in
the through-hole 15B of the end turn portion 15, the advance and
retreat as well as rotation of the stylet are suitably transmitted
to the tissue fastening instrument 10A.
[0091] As the rotation direction of the needle tube 52 when viewed
from the base end side of the main body 51 becomes the opposite to
the coil winding direction of the tissue fastening instrument 10A
to be pushed out from the distal end of the needle tube 52, the
second tissue fixing portion 12 to be pushed out from the needle
tube 52 promptly reverts to the coil shape prior to being
accommodated in the needle tube 52 without twisting (this is
explained in detail below), and catches onto and holds the inner
side of the wall Wc of the common bile duct Cb.
[0092] The external thread 61 is loosened, the first shaft 56a is
pulled out a little from the main body 51, and the projection
length from the distal end of the sheath 54 of the needle tube 52
is shortened. Then, the external thread 61 is tightened to again
fix the first shaft 56a to the main body 51. Thereby the distal end
of the needle tube 52 is spaced a little away from the internal
surface of the intestinal wall Wd of the duodenum Dd.
[0093] As shown in FIG. 11, the lever 63 is again operated to push
the second shaft 62 into the first shaft 56 by a predetermined
amount. For example, the lever 63 may be operated a definite number
of times. Thereby, the stylet 53 changes the relative position with
the needle tube 52, and the first tissue fixing portion 11 of the
tissue fastening instrument 10A is pushed out from the distal end
of the needle tube 52. At this time, similarly to during the
pushing out of the second tissue fixing portion 12, the needle tube
52 rotates in the opposite direction to the coil winding direction
of the tissue fastening instrument 10A. As a result, when the first
tissue fixing portion 11 is pushed out from the needle tube 52, it
promptly reverts to the initial coil shape without twisting (this
is explained in detail below), and catches onto and holds the inner
side of the intestinal wall Wd of the duodenum Pd.
[0094] Below, the action of the tissue fastening instrument 10A
pushed out from the distal end of the needle tube 52 in the
procedure mentioned above is explained in detail.
[0095] First, the tissue fastening instrument 10A is pushed out
from the distal end of the needle tube 52 that has penetrated the
intestinal wall Wd of the duodenum Dd and the wall Wc of the common
bile duct Cb, so that only the second tissue fixing portion 12 is
projected. The second tissue fixing portion 12, in the process of
being pushed out from the distal end of the needle tube 52,
successively reverts to its original coil shape and catches onto
and holds the wall Wc of the common bile duct Cb.
[0096] The tissue fastening instrument 10A that is loaded in the
extended state in the needle tube 52 always tries to return to its
original coil shape outside of the needle tube 52 due to the
elastic force. As a result, when pushed out from the distal end of
the needle tube 52, as shown in FIG. 12A and FIG. 12B, it is pushed
out at an opening portion 100 that is closest to the root side at
the distal end of the needle tube 52 while heading to the surface
that becomes the inside of the loop. Here, in the case of the
distal end of the needle tube 52 having a sloped opening 52a that
obliquely slopes like a hypodermic needle, the tissue fastening
instrument 10A is pushed out from the most root side of the sloped
opening 52a, and so tries to return to the original shape while
existing on a plane that is approximately perpendicular with
respect to a sloped opening plane 52aa.
[0097] Therefore, if the needle tube 52 is rotated simultaneously
while pushing out the tissue fastening instrument 10A from the
sloped opening 52a of the needle tube 52, the tissue fastening
instrument 10A will rotate united with the needle tube 52.
[0098] In the event of pushing out the tissue fastening instrument
10A from the needle tube 52, when the tissue fastening instrument
10A cannot make contact with the surrounding common bile duct wall
Wc, the tissue fastening instrument 10A correctly returns to its
original shape. However, when the tissue fastening instrument 10A
can make contact with the surrounding common bile duct wall Wc and
the like, the tissue fastening instrument 10A may be unable to
return to the original shape.
[0099] This phenomenon shall be described using as an example the
case where the tissue fastening instrument 10A is a clockwise-wound
(Z winding) coils If the tissue fastening instrument 10A is further
pushed out from the needle tube 52 from the state of FIGS. 12A and
12B, ordinarily it returns to the original clockwise-wound coil as
shown in FIG. 13A. However, in the case of the tissue fastening
instrument 10A making contact with the common bile duct wall Wc as
shown in FIG. 13B, there is a possibility of the tissue fastening
instrument 10A being pushed by the common bile duct wall Wc and
becoming a counterclockwise-wound coil (S winding) coil that is the
opposite from the original.
[0100] In order to prevent this, as shown in FIG. 13C, the tissue
fastening instrument 10A should be pushed out from the needle tube
52 while causing it to rotate integrally with the needle tube 52 so
as to rotate in the opposite direction from the winding direction
of the tissue fastening instrument 10A as shown in FIG. 13C, that
is, if the tissue fastening instrument 10A is a clockwise-wound
coil, to rotate to the left if viewing the needle tube 52 from the
base end. By doing so, the tissue fastening instrument 10A will
rotate to the left with the needle tube 52, and push the common
bile duct wall Wc. Thereby, the tissue fastening instrument 10A
returns to the original clockwise winding coil.
[0101] In the applicator 50 of the present embodiment, the shape of
the spiral slot 92 is set so that the rotation direction of the
needle tube 52 may rotate in a counterclockwise manner toward the
distal end side, which is the opposite from the winding direction
of the tissue fastening instrument 10A. Accordingly, when letting
out the tissue fastening instrument 10A, the needle tube 52 and the
stylet 53 are rotated in the counterclockwise direction.
Furthermore, since the tissue fastening instrument 10A and the
stylet 53 are engaged, rotation of the stylet 53 is favorably
transmitted to the tissue fastening instrument 10A, whereby the
tissue fastening instrument 10A is let out from the needle tube 52
while being reliably rotated. By these actions, as shown in FIG.
13), the tissue fastening instrument 10A that is pushed out to the
outside of the needle tube 52 favorably reverts to the original
clockwise wound loop shape, and so tangling and a reduction in
tissue fastening strength due to changes in the winding direction
are prevented.
[0102] After the second tissue fixing portion 12 of the tissue
fastening instrument 10A is pushed out from the needle tube 52 in
the common bile duct Cd, the first tissue fixing portion 11 is
pushed out from the distal end of the needle tube 52 that has been
pulled out from the intestinal wall Wd of the duodenum Dd and the
wall Wc of the common bile duct Cb. At this time as well, since the
needle tube 52 is rotated simultaneously while pushing out the
tissue fastening instrument 10A from the sloped opening 52a of the
needle tube 52, the portion of the base loop of the tissue
fastening instrument 10A is smoothly placed.
[0103] After the tissue fastening instrument 10A is latched onto
the second biological tissue, FIG. 14 to FIG. 16 are drawings that
explain the problem when being latched onto the first biological
tissue. As shown in these drawings, after the tissue fastening
instrument 10A is latched onto, for example, the wall Wc of the
common bile duct Cd that is the second biological tissue, when
being latched onto for example the intestinal wall Wd of duodenum
Dd that is the first biological tissue, due to the force of the
tissue fastening instrument 10A trying to return to its original
coil shape, a twisted portion 131 occurs as shown in FIG. 15, and
finally as shown in FIG. 16, the tissue fastening instrument 10A
may be placed in a tangled state starting from the twisted portion
131.
[0104] In the tissue fastening instrument 10A and the applicator 50
of present embodiment, the above tangling is suitably prevented.
This is explained in detail below.
[0105] Since the motion of the tissue fastening instrument 10A
returning to the coil shape on the intestinal wall Wd of the
duodenum Dd at the time of placing is also a rotating motion above
the intestinal wall Wd as shown in FIG. 17 to FIG. 21, if the
motion of this tissue fastening instrument 10A and the rotation of
the needle tube 52 are synchronized, placing of the tissue
fastening instrument 10A goes smoothly.
[0106] Specifically, in the case of the tissue fastening instrument
10A being wound clockwise, the metal wire 10 that constitutes the
tissue fastening instrument 10A, when viewed from the base end
side, extends in the counterclockwise direction toward the base end
side. Therefore, as shown in FIG. 17 from FIG. 21, as a result of
the needle tube 52 rotating counterclockwise when viewed from the
base end side, the rear end side of the tissue fastening instrument
10A is smoothly let out to the outside of the needle tube 52, and
reverts to the clockwise loop shape as shown in FIG. 21 without
causing twisting or tangling. Furthermore, since the rotating
mechanism 96 is set so that the needle tube 52 rotates
approximately one revolution when the tissue fastening instrument
10A is pushed out by a length equivalent to approximately one turn
of a loop from the distal end of the needle tube 52, when the
needle tube 52 completes one revolution, one turn of the loop of
the tissue fastening instrument 10A is reverted outside the needle
tube 52. As a result, the rotation operation of the needle tube 52
and the placement operation of the tissue fastening instrument 10A
are synchronized at a high level, and the placement becomes
easier.
[0107] After placement of the first tissue fixing portion 11 is
completed, the spring portion 14 and the end turn portion 15 are
let out to the outside of the needle tube 52 continuously. Also at
this time, since the needle tube 52 is rotated in the
counterclockwise direction as mentioned above when viewed from the
base end, each part of the peripheral spring portion 13 is smoothly
let out and reverts to the loop shape of prior to being
accommodated in the needle tube 52. Since the loop diameter of the
end turn portion 15 is larger than the loop diameter of the spring
portion 14, as shown in FIG. 22, the end turn portion 15 runs onto
the spring portion 14, and there is no reduction in the amount of
pressing-down force of the intestinal wall Wd described below.
[0108] When the entire tissue fastening instrument 10A is pushed
out to the outside of the needle tube 52, the engagement of the
through-hole 15B in the end portion 15A of the end turn portion 15
and the projection 53B of the stylet 53 will naturally be released,
and the tissue fastening instrument 10A will be separated from the
stylet 53. In this way as shown in FIG. 11 and FIG. 23, placement
of the tissue fastening instrument 10A is completed. By placement
of the tissue fastening instrument 10A, the first tissue fixing
portion 11 and the second tissue fixing portion 12 fasten the
intestinal wall Wd of the duodenum and the wall Wc of the common
bile duct so as to be firmly attached, and the peripheral spring
portion 13 presses the intestinal wall Wd to the side of the duct
wall Wc.
[0109] When the tissue fastening instrument 10A is not provided
with the peripheral spring portion 13, as shown in FIG. 24A, when
punctured by the needle tube 52, a gap Ga is formed between a hole
We that is formed in the wall Wc of the common bile duct and the
metal wire 10 that is arranged to pass through the hole We, and a
phenomenon occurs in which a bodily fluid such as bile or the like
flows out through this gap Ga and leaks into the abdominal cavity
through a gap Gb between the intestinal wall Wd of the duodenum and
the wall We of the common bile duct. In the case of the bodily
fluid being bile, there is the possibility of causing bile
peritonitis. Also, even if the peripheral spring portion is
present, when the end turn portion 15 that is firmly attached to
the intestinal wall Wd does not form a closed loop, as shown in
FIG. 24B, a gap arises in the intestinal wall Wd being pressed, and
so there is a possibility of a leakage of a bodily fluid similarly
occurring.
[0110] In the tissue fastening instrument 10A of the present
embodiment, since the end portion 15A of the end turn portion 15 is
in contact with a portion of the end turn portion 15 that has
completed at least one rotation, as shown in FIG. 25A, a loop
closed by the end turn portion 15 is formed. As a result, since the
intestinal wall Wd on the outside of the base loop L1 is pressed in
the shape of a closed ring, even if the tissue fastening instrument
10A is placed without generating the gap Gb, and bodily fluid such
as bile does leak out through the gap Ga, this bodily fluid does
not leak from the gap between the intestinal wall Wd of the
duodenum and the wall Wc of the common bile duct into the abdominal
cavity.
[0111] Provided the end turn portion 15 forms a closed loop, there
is no particular restriction on the aspect of connection between
the end portion 15A and another section of the end turn portion 15.
Therefore, as shown in FIG. 26A, the end portion 15A may tuck under
another portion of the end turn portion 15, and as shown in FIG.
26B, the end portion 15A may run onto the top of another portion of
the end turn portion 15. Furthermore, as shown in FIG. 27, the end
portion 14B of the peripheral spring that serves as a boundary
point of the spring portion 14 and the end turn portion 15 may be
located inside the third loop L3 that the end turn portion 15
forms. Also, when the end turn portion 15 forms a loop of one or
more turns, the section that extends from after the first turn may
be completely superimposed on another end turn portion in the
diameter direction of the third loop L3.
[0112] Note that the end portion 15A does not need to touch the end
turn portion 15 with certainty, and provided the gap between the
end portion 15A and another portion of the end turn portion 15 is
small enough as shown in FIG. 25B, as the entire end turn portion
15, it can press down the intestinal wall Wd without a gap. Even in
such a case, the end turn portion 15 can be said to substantially
form the closed loop, and so there is no problem. Furthermore, the
shape of the peripheral spring portion 13 may be set so as to form
an essentially closed loop when the tissue fastening instrument 10A
has been placed in tissue and the end turn portion 15 abuts the
first biological tissue, with the end portion 15A and another
portion of the turn portion 15 not making contact when the tissue
fastening instrument 10A has not been placed.
[0113] After the tissue fastening instrument 10A has been placed,
the operator recovers the needle tube 52 of the applicator 50 into
the sheath 54, removes the applicator 50 and the endoscope 2 to
outside of the body, and ends the procedure.
[0114] The intestinal wall Wd of the duodenum and the wall Wc of
the common bile duct that are located in the base loop L1 are bound
tight by the first tissue fixing portion 11 and the second tissue
fixing portion 12, whereby the flow of blood is blocked, and in due
time pressure necrosis is caused, Simultaneously, the intestinal
wall Wd and the duct wall We carry out adhesion bonding around the
base loop L1.
[0115] The necrosed tissue and the tissue fastening instrument 10A
drop out of the placement position. Since the first tissue fixing
portion 11 and the second tissue fixing portion 12 are always
biased by the peripheral spring portion 13 to the side of the
cavity of the duodenum, when the tissue fastening instrument 10A
drops from the other tissue, it always drops to the side of the
cavity in the duodenum, and the tissue fastening instrument 10A is
quickly excreted out of the body through the small intestine and
the large intestine. Since the end portion 15A of the end turn
portion 15 which was engaged with the stylet 53 extends to another
portion of the end turn portion 15, there is no damage to other
tissue in the body during the excretion process.
[0116] Although the peripheral spring portion 13 presses the
intestinal wall Wd of the duodenum onto the duct wall We side of
the common bile duct, the reaction force at this time acts as a
force that pulls the first tissue fixing portion 11 away from the
intestinal wall Wd. Therefore, when the initial tension of the
first tissue fixing portion 11 is less than the biasing force of
the peripheral spring portion 13, as shown in FIG. 28, the
fastening force between the first tissue fixing portion 11 and the
second tissue fixing portion 12 weakens, and gaps form between the
metal wire 10 of the first tissue fixing portion 11.
[0117] In this way, if the force that binds the intestinal wall Wd
and the duct wall Wc becomes weak, the flow of the blood between
the intestinal wall Wd and the duct wall Wc cannot be sufficiently
blocked. Moreover if gaps appear between the metal wire 10 that
constitutes the first tissue fixing portion 11, flow of blood will
occur between the tissue in the base loop L1 and the tissue outside
thereof. For that reason, the tissue in the base loop L1 will not
necrose. Accordingly, the tissue fastening instrument 10A will not
drop and so it will subsequently also not be possible to form a
fistula.
[0118] In the tissue fastening instrument 10A of the present
embodiment, the initial tension of the first tissue fixing portion
11 is set to such an extent that, in the event of the tissue
fastening instrument 10A of present embodiment being placed in the
body, in the case of receiving the reaction force when the distal
end of the peripheral spring portion 13 has pressed down the
intestinal wall Wd, the first tissue fixing portion 11 is not
pulled away from the intestinal wall Wd as shown in FIG. 23, and
gaps do not form between the metal wire 10. As a result, at the
time of placement, it is possible to maintain the joined state
without gaps appearing between the metal wire 10 of the first
tissue fixing portion 11. Therefore, the flow of blood to the
tissue in the base loop L1 is favorably blocked, and the tissue
concerned reliably necroses. Thereafter, the tissue fastening
instrument 10A and the necrosed tissue fall out, and a fistula that
connects the intestinal wall Wd of the duodenum and the duct wall
Wc of the common bile duct is formed.
[0119] According to the tissue fastening instrument 10A of the
present embodiment, the first tissue fixing portion 11 and the
second tissue fixing portion 12 favorably fasten the first
biological tissue and the second biological tissue, and necrose a
portion of both while bonding another portion of both, and so it is
possible to readily form a fistula that brings the first biological
tissue and the second biological tissue into communication.
[0120] Moreover, in the peripheral spring portion 13, the second
loop L2 that the spring portion 14 forms is larger than the base
loop L1 that the first tissue fixing portion 11 and the second
tissue fixing portion 12 form, and the third loop L3 that the end
turn portion 15 forms is set to be larger than the second loop L2,
and these loops are set so as not to mutually overlap in the
diameter direction of the base loop L1.
[0121] Therefore, it is possible to safely use in a manner such
that each section reliably exhibits the respective predetermined
fastening force or biasing force without twisting or tangling of
the metal wires in the loops occurring.
[0122] Furthermore, since the end portion 15A of the end turn
portion 15 extends toward another part of the end turn portion 15,
the end turn portion 15 forms a closed loop, and in addition to
suitably preventing leakage of a bodily fluid as mentioned above,
the end portion 15A is not exposed, and injury to other tissue is
hindered in the process of the tissue fastening instrument 10A
being discharged to outside of the body.
[0123] Moreover, according to the applicator 50 of the present
embodiment, in the state of the tissue fastening instrument 10A
being accommodated in the needle tube 52, since the tissue
fastening instrument 10A and the stylet 53 are engaged,
forward/backward movement and rotation of the stylet 53 are
suitably transmitted to the tissue fastening instrument 10A as
mentioned above.
[0124] When the stylet 53 and the tissue fastening instrument 10A
are not engaged, due to the restoring force of the tissue fastening
instrument 10A trying to return to its original form outside the
needle tube 52, it may deviate to outside of the needle tube 52 to
a region not intended, and so the tissue fastening instrument 10A
may not return to its shape of before accommodation. If the stylet
53 and the tissue fastening instrument 10A are connected, such
unintended deviation of the tissue fastening instrument 10A is
suppressed, and the tissue fastening instrument 10A reliably
reverts to the shape of prior to being accommodated and is
placed.
[0125] Moreover, when the tissue fastening instrument 10A and the
stylet 53 can be engaged, by retracting the stylet 53 in the needle
tube 52 while causing it to rotate, it is possible to readily
accommodate the tissue fastening instrument 10A in the needle tube
52.
[0126] Furthermore, as for the tissue fastening instrument 10A and
the stylet 53, since the engagement is naturally released outside
of the needle tube 52, it is possible to carry out placement of the
tissue fastening instrument 10A without requiring the operator to
perform a special operation for releasing the engagement.
[0127] The joining aspect of the tissue fastening instrument 10A
and the stylet 53 is not limited to that mentioned above, and
various aspects may be adopted. For example, as shown by the
modification in FIGS. 29A and 29B, hooks 21 that are mutually
engagable are provided at the distal end 53A of the stylet 53 and
the end portion 15A of the end turn portion 15 of the tissue
fastening instrument 10A, and both may be detachably connected in
the needle tube 52. In providing the hooks 21, grinding or the like
may be performed on the distal end 53A and the end portion 15A, or
a member is shaped like the hook 21 may be attached to the distal
end 53A and the end portion 15A by caulking or welding and the
like. Moreover, in the above-mentioned modification, although the
example was described of the distal end 53A and the end portion 15A
having the identical hooks 21, as long as engagement/disengagement
is possible, hooks of different shapes may be respectively
attached. However, if identical hooks are used, by reducing the
number of parts, it is possible to raise manufacturing
efficiency.
[0128] Moreover, when providing a through-hole in the end portion
15A, in the manner of the modification shown in FIG. 30A, the end
portion 15A may be lengthened, and a through-hole 22 may be formed,
and in the manner of the modification shown in FIG. 30B, a step
portion 23 may be formed by grinding or the like, and a
through-hole 23A may be formed in the step portion 23. Furthermore,
in the manner of the modification shown in FIG. 31, a bottomed
concavity 24 may be provided in place of a through-hole.
[0129] Moreover, the distal end of a projection that is provided on
the stylet 53 may be formed sloping to the base end side in the
manner of a projection 25 shown in FIG. 32A. By doing so, when
moving the stylet 53 in the direction of arrow A1 shown in FIG.
32B, since the engagement with the tissue fastening instrument 10A
is hindered from separating, it is easy to accommodate the tissue
fastening instrument 10A in the needle tube 52 at the time of
manufacture etc. When moving the stylet 53 in the direction of
arrow A2, the engagement of both is easily separated, and smooth
operation during placement is possible. In this case as sell, by
suitably setting the dimensions of the stylet 53 and the tissue
fastening instrument 10A with respect to the needle tube 52, it is
possible to suitably prevent the engagement from coming apart in
the needle tube 52 by reducing the movable width in the
cross-sectional direction of the stylet 53 and the tissue fastening
instrument 10A in the needle tube 52. The above-mentioned effect
can be similarly obtained even in the case of forming at the base
end side a projection 26 so as to have a slope 26A that forms an
acute angle with the axial line of the stylet 53 as in the
modification shown in FIG. 33.
[0130] Furthermore, in the manner of the modification shown in FIG.
34 and FIG. 35 (a sectional view along line A-A of FIG. 34), an
engaging portion 27 and an engaged portion 28 may be formed so as
to respectively have restriction portions 27A and 28A that enable
engagement/disengagement of the tissue fastening instrument 10A and
the stylet 53 and restrict their relative movement in the width
direction. By doing so, as shown in FIG. 36, since movement of the
tissue fastening instrument 10A and the stylet 53 in the width
direction (the direction shown by the arrows in FIG. 36) is
restricted, it is easy to accommodate the tissue fastening
instrument 10A in the needle tube 52 while engaged with the stylet
53 during manufacturing. The shapes of the restriction portions are
not particularly limited provided they are capable of restricting
movement of the tissue fastening instrument 10A and the stylet 53
in the width direction. For example, an engaging portion 29 and an
engaged portion 30 that have as restriction portions a convex
portion 29A and a concave portion 30A, respectively, as shown in
FIG. 37 may be provided in the tissue fastening instrument 10A and
the stylet 53, respectively.
[0131] Furthermore, as shown in FIG. 38A, a region of a fixed
length on the distal end side of at least a stylet 153 may be
formed in a hollow shape that has an inner cavity, and a
through-hole 31 may be formed on the outer periphery surface, and
by causing the end portion 15A of the end turn portion 15 of the
tissue fastening instrument 10A to enter the inner cavity and
project from the through-hole 31, the stylet 153 and the tissue
fastening instrument 10A may be engaged. However, in this case,
when an opening end face 153A at the distal end of the stylet 153
is shaped so as to be perpendicular to the axial line of the stylet
153, as shown in FIG. 38B, the peripheral surface of the end
portion 15A may catch on the inner surface of the stylet 153, and
the engagement may be hindered from release outside of the needle
tube 52. For this reason, as shown in FIG. 39A, it is good to set
the shape of an opening end face 153B so that the length of the
stylet 153 is shortest at the position facing the through-hole 31,
sandwiching the axial line of the stylet 153. When doing so, as
shown in FIG. 39B, during the release of the engagement, it is
preferred to hinder the peripheral surface of the end portion 15A
from abutting the inner surface of the stylet 153 in order to
facilitate release of the engagement outside of the needle tube
52.
[0132] Note that in the modification shown from FIG. 38A to FIG.
39B, the end portion 15A of the end turn portion 15 of the tissue
fastening instrument 10A may be bent so as to facilitate engagement
in the through-hole 31.
[0133] Also, instead of providing a projection on one of the tissue
fastening instrument 10A or the stylet 53, the end portion of one
may be bent and engaged in a through-hole 32A or 32B that is
provided in the end portion of the other and has a larger diameter
than the wire diameter of the other shown in FIG. 40A and FIG. 40B.
In this case, in order to enable entry of the end portion of one, a
through-hole with a diameter that is comparatively larger is
required, so it is good to provide the though-hole 22 or the like
by the method shown in FIG. 30A in the tissue fastening instrument
10A or the stylet 53.
[0134] While preferred embodiments of the invention have been
described and illustrated above, it should be understood that these
are exemplary of the invention and are not to be considered as
limiting. Additions, omissions, substitutions, and other
modifications can be made without departing from the spirit or
scope of the present invention. Accordingly, the invention is not
to be considered as being limited by the foregoing description, and
is only limited by the scope of the appended claims.
* * * * *