JP2003310626A - In-vivo tissue suturing device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an in-vivo tissue suturing device capable of easily executing the suturing work for in-vivo tissue, and certainly suturing a hole formed in the in-vivo tissue. <P>SOLUTION: This in-vivo tissue suturing device 1 is a device for suturing the percutaneously-pierced hole formed in an in-vivo tissue membrane 8. The suturing device 1 has: a main body part 2 which includes a tip part capable of being inserted into the in-vivo tissue from the hole; and an arm part 3 capable of having both a first form wherein the arm part 3 is stored in the main body part 2 and a second form wherein the arm part 3 partially projects from the main body part 2. The main body part 2 has a needle member 4 stored on the base end side of the arm part 3, a thread 5 provided in the needle member 4, and a needle member pusher 6 projecting the needle member 4 from a side face of the main body part 2 such that the pusher 6 arrives at the arm part 3. The arm part 3 has a needle member retention part 3a retaining the needle member 4 pushed by the pusher 6 to arrive at the arm part 3. <P>COPYRIGHT: (C)2004,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an in-vivo tissue suturing device for suturing a percutaneously penetrating hole formed in an in-vivo tissue film (for example, a blood vessel).

[0002]

2. Description of the Related Art Minimally invasive surgery for inserting a diagnostic or therapeutic device such as a catheter into a blood vessel or other internal structure is widely performed. For example, in the treatment of stenosis of the coronary arteries of the heart,
It is necessary to insert a device such as a catheter into a blood vessel in order to carry out a therapeutic procedure. The insertion of a catheter or the like into a blood vessel is usually performed from a puncture hole incised in the thigh. Therefore, after finishing the procedure, it is necessary to stop the bleeding of the puncture hole, but the blood pressure (bleeding pressure) at the time of bleeding from the femoral artery
It is very difficult to stop the bleeding, and in the past, a medical worker had to perform a harsh work such as holding it by hand for one hour. In recent years, in order to perform this hemostasis operation easily and surely, a device to be inserted through a wound hole has been developed for suturing a hole made in a blood vessel.

[0003]

2. Description of the Related Art As an example of a blood vessel suturing device, there is one shown in US Pat. No. 6,117,144. The suturing device includes a suture introducer housing for insertion into an opening in an arterial vessel wall, as shown in FIG. 2 of US Pat. No. 6,117,144. The suture introducer housing houses the suture clamp arm. In use, the arm is exposed outside the circumference of the suture introducer housing. Each arm has a suture clamp for fastening the suture. In addition, the entry mechanism includes a suture catching portion for removing the suture from the suture clamp and catching the suture at the distal end, and a needle capable of piercing the blood vessel wall by being pushed out. The needle acts to pull the suture captured by the suture capturing section through the blood vessel wall by piercing the blood vessel wall and then moving backward. After pulling the end of the suture outside the vessel wall, the introducer housing is removed,
The suture closes the opening of the blood vessel. That is, this suturing device includes an arm that opens in the blood vessel, and the suture thread is hooked on the arm in advance. The tip of the needle pushed out and pierced through the blood vessel wall catches the thread hooked on the arm and retracts the thread, so that the thread passes through the blood vessel wall.

[0004]

However, in the suturing device described above, the thread is exposed in the blood vessel and is in contact with blood, and the thread to which blood adheres must penetrate the blood vessel wall, which is preferable. But also exposed in the blood vessels,
There is also less certainty in capturing sutures that are exposed to the bloodstream, and there is a risk that the temporarily captured suture will become dislodged by the bloodstream. Therefore, an object of the present invention is to provide an in-vivo tissue suturing device which can easily suture in-vivo tissue and can surely suture holes formed in in-vivo tissue.

[0005]

[Means for Solving the Problems] What achieves the above object is as follows. (1) An in-vivo tissue suturing device for suturing a percutaneously pierced hole formed in an in-vivo tissue film, wherein the suturing device is a predetermined insertable into the in-vivo tissue through the hole. A main body having a length, a first form housed in a portion of the main body to be inserted into the in-vivo tissue, and a second form partially protruding from the main body can be adopted. An arm portion, and the main body portion includes at least one needle member housed inside the base end side of the arm portion, a thread provided on the needle member, and the needle member on a side surface of the main body portion. A needle member pusher that protrudes so as to reach the arm portion further, and the arm portion, in the second embodiment,
An in-vivo tissue suturing device comprising a needle member holding portion for holding a needle member that has been pushed out by the needle member pusher and has reached the arm portion.

(2) The in-vivo tissue according to the above (1), wherein the arm portion is provided with an arm operating wire and an operating portion for operating changes in the first form and the second form. Suture device. (3) The in-vivo tissue according to the above (1) or (2), wherein the needle member has a pusher tip end housing portion that detachably houses the tip end portion of the needle member pusher at a rear end. Suture device. (4) The in-vivo tissue suturing device according to any one of (1) to (3), wherein the in-vivo tissue suturing device includes a biasing member that biases the needle member pusher rearward. (5) The main body is housed inside the main body 2
One needle member, a thread provided on each needle member, and two needle member pushers for projecting each needle member from the side surface of the main body portion to reach the arm portion, Any one of the above (1) to (4), wherein the arm portion is provided with a needle member holding portion that holds the two needle members pushed out by the pusher in a second form that is partially exposed. The in-vivo tissue suturing device according to [4].

(6) The in-vivo tissue suturing device according to any one of (1) to (5), wherein the needle member holding portion of the arm portion has an engaging portion that engages with the needle member. . (7) The needle member holding portion of the arm portion has a space capable of receiving the needle member, and further, the needle member and the needle member holding portion have the needle member inserted into the needle member holding portion. The in-vivo tissue suturing device according to any one of (1) to (5) above, which has an engaging function of engaging and restricting withdrawal. (8) The in-vivo tissue suturing device according to any of (1) to (5) above, wherein the needle member holding portion of the arm portion is made of an elastic material that can be punctured by the needle member. (9) The in-vivo tissue suturing device according to (8), wherein the needle member includes a detachment preventing portion for restricting removal of the needle member holding portion made of the elastic body after puncturing. . (10) The in-vivo tissue suturing device according to (8), wherein the needle member holding portion has a viscosity that holds the punctured needle member in close contact. (11) The in-vivo tissue suturing device is for filling a liquid, which extends in the main body portion, one end of which is opened at a distal end side portion that can be inserted into in-vivo tissue, and the other end of which is opened at a proximal end side of the main body portion. A lumen, a three-way stopcock connected to the lumen, a pulsation confirmation member attached to one port of the three-way stopcock, and a liquid filling port formed by another port of the three-way stopcock, The three-way stopcock is the in-vivo tissue suturing device according to any one of (1) to (10), further including an operation unit for selectively communicating the lumen with one port and the other port.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment in which the in-vivo tissue suturing apparatus of the present invention is applied to a blood vessel suturing apparatus will be described. The in-vivo tissue suturing device of the present invention is not limited to the blood vessel suturing device and can be used for suturing holes formed in other in-vivo tissues. The in-vivo tissue suturing apparatus 1 of the present invention is an in-vivo tissue suturing apparatus for suturing a percutaneously penetrated hole formed in the in-vivo tissue film 8. The suturing device 1 has a main body 2 having a predetermined length, which has a distal end portion that can be inserted into the in-vivo tissue through a hole, and a first mode that is stored in a portion of the main body 2 that is inserted into the in-vivo tissue. , An arm portion 3 that can take a second form that partially protrudes from the body portion 2 in the in-vivo tissue. Body 2
Is at least one needle member 4 stored on the proximal end side of the arm portion 3, the thread 5 provided on the needle member 4, and the needle member 4
Is provided with a needle member pusher 6 that projects from the side surface of the main body portion 2 so as to reach the arm portion 3. In the second embodiment, the arm portion 3 includes a needle member holding portion 3a that holds the needle member 4 that has been pushed out by the needle member pusher 6 and reached the arm portion 3.

FIG. 1 is an external view of an embodiment of the in-vivo tissue suturing apparatus of the present invention. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the in-vivo tissue suturing device shown in FIG. FIG. 3 is an enlarged cross-sectional view of the main body near the needle member of the in-vivo tissue suturing apparatus shown in FIG. FIG. 4 is an enlarged plan view of the vicinity of the arm portion of the in-vivo tissue suturing apparatus shown in FIG. FIG. 5 is an enlarged cross-sectional view of the proximal end portion of the main body of the in-vivo tissue suturing device shown in FIG. In-vivo tissue suturing apparatus 1 of this embodiment
As shown in FIG. 1, a main body 2 having a predetermined length that can be inserted into the in-vivo tissue from the tip side, and a body part 2 that can be inserted into the in-vivo tissue and is inserted into the in-vivo tissue of the main-body part 2. Arm part 3 that can take a first form that is housed in a body part and a second form that partially protrudes from the body part 2 in the in-vivo tissue. An operation unit 9 is provided at the rear end of the main body 2. A tube 7 is attached to the tip of the main body 2.
Is provided. In-vivo tissue suturing apparatus 1 of this embodiment
Is provided with two needle members 4a and 4b, two needle member pushers 6a and 6b for pushing out the two needle members, and two storage portions 22a and 22b for storing these. The in-vivo tissue suturing device preferably includes a plurality of needles as described above, but may include only one needle member.

The main body 2 includes two needle members 4a and 4b,
Threads 5a, 5b provided on each needle member 4a, 4b and two needle member pushers 6a for projecting each needle member 4a, 4b from the side surface of the main body portion 2 and pushing it into the arm portion 3, 6b
Is equipped with. Then, the arm portion 3 described later is arranged in the cavity of the in-vivo tissue such as the inside of the blood vessel, and is in the second form in which the arm portion 3 partially projects from the main body portion.
It is provided with a needle member holding portion 3a that receives and holds the two needle members 4a and 4b pushed in by. In particular,
As shown in FIGS. 3 and 4, the main body 2 includes a shaft 21 having two axially extending storage portions 22a and 22b formed on a side surface thereof, and a main body hub provided at a proximal end of the shaft 21. A (shaft hub) 26 is provided. Storage 22
It is preferable that a and 22b are lumens as shown in FIGS. In addition, the storage portions 22a, 2
2b may be a groove instead of a lumen. Further, the shaft 21 has another lumen extending in the axial direction.

The shaft 21 has a length of 30 to 50.
It is preferably 0 mm. Also, the outer diameter is 1.0 to
It is preferably 8.0 mm. Also, the shaft 21
The tip end side of is provided so as to be inclined at a predetermined angle with respect to the central axis of the shaft 21 on the base end side. This angle is preferably about 5 to 60 degrees. An arm accommodating portion for accommodating the arm portion 3 is formed inside the base end side of the portion of the body portion 2 inserted into the body of the shaft 21.
As shown in, the arm is stored in the storage portion. This is the first form of the arm portion. Examples of materials for forming the shaft and the tip member include polyolefins such as polypropylene and polyethylene, and olefin elastomers (for example, polyethylene elastomer and polypropylene elastomer), polyesters such as polyethylene terephthalate, and soft polyvinyl chloride.
Polyurethane and urethane elastomers, polyamide and amide elastomers (for example, polyamide elastomers), polytetrafluoroethylene and fluororesin elastomers, polyimides, ethylene-vinyl acetate copolymers, polymeric materials such as silicone rubber, and stainless steel, Ni -Ti alloy, Cu-Zn alloy, Ni-A
Various metals such as 1-alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, and tantalum, or a combination thereof can be used.

The in-vivo tissue suturing apparatus 1 includes a storage portion 22a,
It is provided with needle members 4a, 4b housed in 22b and pushers 6a, 6b for pushing out the needle members 4a, 4b. The needle members 4a and 4b are provided with through holes for penetrating the threads 5a and 5b, and the threads penetrate the through holes. The yarns 5a and 5b extend in the storage portion and are exposed from the storage portion at the proximal end side of the shaft 21 and are wound around the outer circumference of the shaft, or a part thereof is stored inside the shaft (not shown). .

The accommodating portions 22a and 22b are formed on the side surface of the shaft 21, and are provided with pushers 6a and 6b and needle members 4a and 4b.
It extends axially to accommodate b. Storage 22
a and 22b have needle members 4a and 4b and a pusher 6 at the tip.
The guide portions 23a and 23b for projecting the a and 6b obliquely forward from the side surface of the main body 2 are provided. Guidance unit 23
The a and 23b are formed by making the inner surfaces of the tips of the storage portions 22a and 22b inclined surfaces toward the side surface of the shaft 21. The distance between the tips of the guiding portions 23a and 23b and the bent portion of the main body 2 is preferably 3.0 to 60.0 mm.

Further, as shown in FIGS. 2 and 3, the guide portion 23b of the second storage portion 22b is the first storage portion 22b.
The needle member 4b and the pusher 6b are located slightly on the base end side so that the needle member 4b and the pusher 6b project slightly to the base end side of the main body part 2 from the guide part 23a. That is, the tip of the second guide portion 23b is located closer to the base end side of the main body 2 than the tip of the first guide portion 23a. Such a configuration is usually diagonal (eg 30 °
Suitable for suturing blood vessels through percutaneously penetrated holes formed at -60 °).

The needle members 4a and 4b are, as shown in FIG.
A puncture section 41 for puncturing the intimal membrane at the tip and a pusher 6 at the rear end
A concave portion 42 for receiving the tips of a and 6b is provided. The needle members 4a and 4b have through holes for penetrating the threads 5a and 5b. The thread may be fixed to the outer surface of the needle member without providing such a through hole. In this embodiment, the needle member is provided with a small-diameter step portion 44 formed at the rear end of the puncture portion 41 in order to prevent the arm member 3 from being detached after being grasped by the needle member holding portion. ing. The needle members 4a and 4b may be solid needles or hollow needles. The outer diameter of the needle members 4a and 4b is 0.1 to 1.0.
About mm is suitable. Further, the length of the needle members 4a and 4b is preferably about 1.0 to 5.0 mm. Further, as a material for forming the needle members 4a and 4b, various metals such as stainless steel, Ni-Ti alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum, etc. , Relatively high rigidity polymer materials such as polyamide, polyimide, ultra high molecular weight polyethylene, polypropylene, fluorine resin,
Alternatively, a combination of these may be used.

Further, the side surface or outer surface of the needle members 4a, 4b may be coated with a low friction resin for increasing the lubricity.
As the low friction resin, fluorine resin, nylon 66,
Examples include polyether ether ketone and high-density polyethylene. Among these, fluororesins are more preferable. Examples of the fluorine-based resin include polytetrafluoroethylene, polyvinylidene fluoride, ethylene tetrafluoroethylene, and perfluoroalkoxy resin. Among them, polytetrafluoroethylene is more preferable. Further, coating with silicone or various hydrophilic resins may be used.

As described above, the ends of the threads 5a and 5b pass through the through holes of the needle members 4a and 4b, and as shown in FIG. 3, along the side surfaces of the pushers 6a and 6b, the storage portions 22a, Two
2b and extends rearward, and extends outward from the storage portion at the rear end portion of the shaft 21 and is wound around the outer periphery of the shaft 21 as shown in FIG. 5, or a portion is stored inside the shaft ( (Not shown). A known suture can be used as the thread. The suture thread may be bioabsorbable or non-bioabsorbable.
A thread having a thickness of 0.01 to 1.0 mm is suitable, and a thread having a thickness of 100 to 1500 mm is suitable.

The body 2 is, as shown in FIGS. 1 and 5,
The hub 26 is provided with a main body hub 26 provided at its base end.
Has a passage for accommodating the base ends of the pushers 6a and 6b. The hub 26 includes a flange portion 26a for operation. The pushers 6a and 6b are, as shown in FIGS. 2 and 5,
The shaft 21 extends to the rear end side in the storage portion of the shaft 21,
It projects from the rear end and extends in the passage of the hub 26. Furthermore, the rear end of the pushers 6a and 6b has one pusher operating portion 61.
It is fixed to. The pusher operating section 61 is provided in the main body hub 26.
It is slidable in the passage. Therefore, by pushing the pusher operating portion 61 forward, the pushers 6a and 6b are pushed.
Moves to the tip side, and the needle member can be pushed out from the main body 2. The pusher operating section 61 is not one integrated as described above, but the pushers 6a, 6a.
b may be provided individually. Further, the pushers 6a and 6b are preferably biased by the biasing member in the non-projecting direction of the needle member. Specifically, the pusher operating portion 61 is biased rearward by the elastic member 27 housed in the passage of the main body hub 26. As the elastic member 27, a coil spring member as shown is preferable. The elastic member may be provided between the flange portion 61 a of the pusher operating portion 61 and the main body hub 26.

The tips of the pushers 6a and 6b are provided with tips for pressing the needle members 4a and 4b toward the tips, as shown in FIG. Specifically, the tip end portions of the pushers 6a and 6b are small-diameter portions and can enter the rear end portions of the needle members 4a and 4b. However, the pusher only pushes the needle member, and the two do not firmly engage with each other. Therefore, if the pusher is moved rearward, the pusher is separated from the needle member. The pushers 6a and 6b have a thickness of 0.1.
It is preferably about 2.0 mm, and the length is 30
It is preferably about 600 mm. Also, the pushers 6a, 6
b may be solid or hollow. Further, as materials for forming the pushers 6a and 6b, various metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum, and the like, and , Relatively high rigidity polymer materials such as polyamide, polyimide, ultra high molecular weight polyethylene, polypropylene, fluorine resin,
Alternatively, a combination of these may be used. Further, the side surfaces of the pushers 6a and 6b may be coated with a low-friction resin that increases lubricity. As a low friction resin,
What was mentioned above can be used.

The arm portion 3 having the needle member storage portion 3a is
It is possible to change from the first mode shown in FIG. 2 to the second mode shown in FIG. 11 for explaining the operation of the in-vivo tissue suturing apparatus 1 of the present invention. As shown in FIG. 2, the arm portion 3 has needle member holding portions 3a and 3b at both ends, and has a bent shape. Specifically, one needle member holding portion 3a side is bent with respect to the central portion 3c. The width of the central portion 3c is narrower than that of the other portions so that the central portion 3c can be stored in the main body portion. Further, the bending angle of the needle holding portion 3a with respect to the central portion 3c is formed to be substantially the same as the bending angle of the tip member 24 with respect to the central axis of the shaft 21. The arm portion 3 is formed in a flat plate shape as shown in FIG. Further, the needle member holding portion 3
As shown in FIG. 11, a and 3b are formed so as to face the rear end side of the main body in the second configuration. Therefore, the needle member pushed out by the needle member pusher and reaching the arm portion can be received and held.

In this embodiment, the needle member holders 3a and 3b are made of an elastic material which can be punctured by the needle member. Then, the small-diameter step portion 4 of the needle member described above.
4 prevents separation after puncture. Examples of elastic materials include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, natural rubber such as latex rubber, olefin elastomers (polyethylene elastomer,
Polypropylene elastomer), amide elastomer (polyamide elastomer), styrene elastomer (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane elastomer (for example, heat Plastic polyether polyurethane, thermoplastic polyester polyurethane) and the like can be used.

The needle member holders 3a and 3b are not limited to those described above. For example, the needle member holding portion may be formed of a material having a viscosity for closely holding the punctured needle member. In this case, in FIG.
As shown in FIG. 4, it is preferable to provide a film 35 for preventing blood adhesion on the surfaces of the needle member holding portions 3a, 3b. As the viscous material that holds in close contact, gel-like or highly viscous liquid polyurethane, silicone or the like can be used. Further, as the film 35, any film capable of forming a thin film can be used, and the materials described as the material for forming the shaft 21 described above and the materials described as the low friction resin can be used. As the film 35,
Hard or semi-rigid materials are preferred. Further, also in the above-described embodiment in which the elastic material is used as the needle member holding portions 3a and 3b, the film may be provided on the surface as described above. Also in this case, a hard or semi-hard film is preferable as the film.

Further, the needle member holding portion may be provided with an engaging portion that engages with the needle member. Specifically, as shown in FIG. 15, the needle member holders 3a and 3b are
The needle member and the needle member holding portion have a gap capable of receiving the needle member, and further, the needle member and the needle member holding portion are provided with an engaging function that engages when the needle member is inserted into the needle member holding portion and restricts withdrawal. preferable. In this embodiment, as shown in FIG. 15, the needle member holding portions 3a, 3b are formed on the arm portion, and the needle members 4a, 3b.
It is composed of a concave portion capable of receiving 4b. A rib 36 protruding inward is provided near the opening end of the recess. When the puncture portion 41 of the needle members 4a and 4b gets over the rib 36 and enters the recess, the puncture portion 41
The rear end, in other words, the tip of the small-diameter portion 44 and the rib 36 are engaged with each other to prevent the needle members 4a and 4b from being separated from the arm portion 3. An annular rib is suitable as the rib 36.

Further, the in-vivo tissue suturing apparatus 1 is provided with an arm part pulling wire 31 extending in the main body part 2 and having one end fixed to the arm part 3. Wire for pulling arm 31
A wire operation unit 32 is provided at the other end. As shown in FIG. 2, the pulling wire 31 penetrates a lumen (not shown) formed in the shaft 21, and one end of the pulling wire 31 is formed through a diagonally extending through hole formed in the center of the arm 3. Has reached the bottom surface and is fixed to the bottom surface of the arm portion 3. As shown in FIG. 5, the other end of the pulling wire 31 projects from the side surface of the rear end portion of the shaft 21, passes through the passage 28 provided in the hub 26, and is fixed to the operating portion 32. Then, by pulling the pulling wire 31 to the rear end side, in other words, moving the wire operating portion 32 to the proximal end side, the arm portion 3 is moved from the state shown in FIG.
As shown in FIG. 11, while moving slightly rearward, the needle member holding portion moves to a second mode in which it projects from the side surface of the main body 2. Further, by returning the wire operation part 32 to the tip side, the arm part 3 can return from the state shown in FIG. 11 to the state shown in FIG. For this purpose, the pulling wire 31 having a certain degree of transmitting force of the pushing force is used.

The arm portion 3 has a length of 2.0 to 8.0 mm.
Those having a thickness of 0.8 to 8.0 mm are preferable, and those having a width of 0.5 to 7.0 mm are preferable. As a material for forming the arm portion, stainless steel, N
Various metals such as i-Ti alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum, polyamide, polyimide, ultra high molecular weight polyethylene, polypropylene,
A relatively high-rigidity polymer material such as a fluorine-based resin or a combination thereof may be used.

As a material for forming the pulling wire 31, a stainless steel wire (preferably high-tensile stainless steel for spring), a piano wire (preferably nickel-plated or chrome-plated piano wire), or a superelastic alloy is used. Wires made of various metals such as wires, Ni-Ti alloys, Cu-Zn alloys, Ni-Al alloys, tungsten, tungsten alloys, titanium, titanium alloys, cobalt alloys, tantalum, polyamides, polyimides, and ultra-high molecular weight polyethylenes. , A polymer material having a relatively high rigidity such as polypropylene or a fluorine-based resin, or a combination thereof as appropriate. Further, the side surface of the pulling wire may be coated with a low-friction resin that increases lubricity. As the low friction resin, those mentioned above can be used.

In the in-vivo tissue suturing apparatus 1 of this embodiment, the tube 7 is provided at the tip of the tip member 21. The tube 7 has a tip opening 7a and a side opening 7b. This tube 7 is for inserting a guide wire. The tube 7 has a length of 50 to 60
It is preferably 0 mm. The outer diameter of the tube 7 is preferably 1.0 to 8.0 mm.
Further, as the material for forming the tube, the flexible resin material as described for the shaft 21 can be used.

Further, in the in-vivo tissue suturing device 1 of this embodiment, as shown in FIGS. 1, 5 and 8, at the distal end side portion which extends through the main body portion 2 and one end of which can be inserted into the in-vivo tissue. The opening 25a is opened, and the other end is the main body 2
A liquid-filling lumen 25 that opens at the proximal end side, a three-way stopcock 11 connected to the lumen 25, and a pulsation confirmation member 13 attached to one port of the three-way stopcock 11.
A liquid filling port 16 formed by another port of the three-way stopcock 11 is preferably provided. The three-way stopcock 11 includes an operating portion 14 for selectively communicating the lumen 25 with one port and the other port. The three-way stopcock 11 is connected to the main body 2 by a connection tube 15. The pulsation confirmation member 13 is the inside 11 of the three-way stopcock.
A liquid whose surface changes depending on the pressure applied to the liquid filled inside is visible from the outside is used. In addition,
The pulsation confirmation member 13 may include a pressure-sensitive membrane that is deformed by a pressure change applied to the liquid filled inside the three-way stopcock 11. As the filling liquid, a physiological isotonic solution such as physiological saline is suitable.

Next, the operation of the in-vivo tissue suturing apparatus 1 of the present invention will be described with reference to FIGS. 8 to 13. First, Fig. 6
As shown in FIG. 3, the liquid filling port 18 of the three-way stopcock 11 is attached with the liquid injecting device 18 containing the filling liquid, and the detachable pulsation confirmation member 13 is removed. 16 and liquid filling lumen 25
Are communicated with each other, and the plunger of the liquid injecting device 18 is pressed to fill the lumen 25 with the liquid. Then, attach the pulsation confirmation member 13 to the pulsation confirmation member mounting port,
The operation unit 14 is switched to connect the pulsation confirmation member mounting port and the liquid filling lumen 25. By thus filling the lumen with the liquid, it is possible to prevent the blood from being exposed to the outside from the three-way stopcock, and to prevent the blood from being wasted because the lumen 25 and the three-way stopcock are not filled with blood. It can be prevented.

Next, an introducer sheath (not shown) used for treatment or diagnosis inserted into a living body and having its tip reaching the inside of the living body tissue through a hole formed in the living body tissue film. ), Insert a guide wire (not shown), and remove the introducer sheath. The tip opening 7 of the tube 7 at the tip of the in-vivo tissue suturing apparatus 1
A guide wire is passed through the tube 7 from a, and the guide wire is further extended from the side port 7b. After inserting the tube 7 into the living body up to the side opening 7b, the guide wire is pulled out, and as shown in FIG. 8, the in-vivo tissue suturing apparatus 1 is used for pulsation confirmation on a puncture site (in-vivo tissue having a hole). The in-vivo tissue suturing device 1 until the pulsation of the filling liquid in the member 13 (in other words, the pulsation indicator cap) and the air interface appears, in other words, the distal end opening 25a of the lumen 25 of the main body reaches the blood vessel. Is inserted into the blood vessel through the puncture site. This state is the state shown in FIG. The broken line 8 indicates the blood vessel wall which is the in-vivo tissue film. In this state, the arm 3, the tip member 24, and the tip of the shaft 21 are located inside the blood vessel. The insertion of the in-vivo tissue suturing apparatus 1 into the puncture site is stopped when the pulsation is confirmed by the pulsation confirmation member, and the arm-pulling wire operating section 32 is pulled toward you, as shown in FIG. , The arm 3 is projected from the main body 2. Then, while maintaining this state, the in-vivo tissue suturing device 1 is pulled toward the front until the pulsation is not confirmed by the pulsation confirmation member 13.

Subsequently, as shown in FIG. 10, the pusher operating portion 61 is pushed toward the tip side (in the direction of the arrow) to cause the needle members 4a and 4b to project obliquely from the side surface on the tip side of the shaft 21 of the main body 2. , The blood vessel wall 8 is penetrated. Thereby, the needle member 4
Threads 5a and 5b provided on a and 4b also penetrate the blood vessel wall 8. When the pusher operating section 61 is pushed further in,
As shown in FIG. 11, the pushers 6 a and 6 b also penetrate the blood vessel wall 8, and the needle members 4 a and 4 b are the storage portions 3 a and 3 of the arm portion 3.
Reach within b. When the pusher operating section 61 is further pushed (specifically, to the maximum pushable position), the needle members 4a and 4b are stored in the storage sections 3a and 3b of the arm section 3. When the pushing operation of the pusher operating portion 61 is completed, the pusher operating portion 61 is urged rearward by the urging member 27, so that the pusher operating portion 61 returns to the non-pressed state position, and the pushers 6a and 6b become the main body portion. It is stored in 2. In this in-vivo tissue suturing apparatus 1, the needle members 4a and 4b located slightly outside the blood vessel wall 8 are housed in the housing parts 3a and 3b of the arm portion 3 located slightly inside the blood vessel wall 8. The operation of puncturing the blood vessel wall with the needle members 4a and 4b and inserting the thread into the punctured portion can be performed by a short stroke operation of pushing the pusher toward the distal end side, so that the suturing operation as a whole becomes easy.

Again, until the pulsation is confirmed by the pulsation confirmation member 13, the in-vivo tissue suturing device 1 is inserted into the living body, and after the confirmation, the arm pull wire operating section 32 is shown in FIG. As described above, after the arm portion 3 is housed in the main body portion 2 by moving it forward, the device 1 is pulled out from the puncture site, the arm portion 3 appears on the skin, and the two threads 5
Stop when a and 5b are visually confirmed. continue,
Two threads 5 stored in the storage portion 3a of the arm portion 3
Cut a and 5b, tie the second thread to the first thread,
Make a knot Then, while pulling the two threads, the suturing device 1 is completely removed from the living body. Further, after pulling the two yarns sufficiently, the knot made of the second yarn is advanced to the blood vessel puncture hole along the first yarn with the pushing device 19 as shown in FIG. The pushing device 19 is removed, the two threads are cut as close as possible to the skin, and the suture is completed. The implanting device 19 of FIG. 7 includes a tip opening 19a and a side opening 19b, and the tip opening and the side opening communicate with each other so that a thread can pass therethrough. Tip portion 19c of the implanting device 19
The outer diameter of is preferably 1.0 to 5.0 mm, and the length of the tip portion 19c is preferably 10.0 to 100.0 mm.

[0033]

The in-vivo tissue suturing apparatus of the present invention is an in-vivo tissue suturing apparatus for suturing a percutaneously penetrating hole formed in an in-vivo tissue film, the suturing apparatus comprising: A main body having a predetermined length that can be inserted into the in-vivo tissue through a hole, a first form housed in a portion of the main body that is inserted into the in-vivo tissue, and partially from the main body An arm portion that can take a second form that projects; and the main body portion is provided on the needle member and at least one needle member housed inside the base end side of the arm portion. A thread and a needle member pusher for projecting the needle member from the side surface of the main body portion so as to reach the arm portion, wherein the arm portion is formed by the needle member pusher in the second embodiment. Needle member holding part that holds the needle member that has been pushed out and reached the arm Eteiru.

In this in-vivo tissue suturing device, after exposing the arm portion in the in-vivo, the needle member located slightly outside the in-vivo tissue film (for example, blood vessel wall) is moved to the in-vivo tissue film (for example, blood vessel wall). ) A puncture of the in-vivo tissue film by the needle member and insertion of a thread into the puncture portion by a short stroke operation of pushing the pusher toward the tip side so that it is stored in the storage portion of the arm portion located slightly inside Since this operation can be performed, the in-vivo tissue can be easily sutured, and the hole formed in the in-vivo tissue can be surely sutured. In addition, the thread is an in-vivo tissue film and reaches the inside of the blood vessel from the outside of the blood vessel wall so as to penetrate the blood vessel wall, so that the thread to which blood adheres does not penetrate the blood vessel wall.

Further, the arm portion is provided with an arm operating wire and an operating portion for operating the change of the first form and the second form,
The operation of the arm part becomes easy. Further, by providing the biasing member that biases the pusher backward, it is not necessary to pull back the pusher after pressing the pusher, and the sewing operation is facilitated. Further, the main body portion reaches the arm portion by projecting the two needle members housed in the main body portion, the threads provided on the respective needle members, and the needle members from the side surface of the main body portion. Two needle member pushers for causing the arm portion to be disposed in the in-vivo tissue and partially exposed in the second form. By providing the needle member holding portion for holding the needle member, the hole formed in the intimal tissue of the living body can be reliably sutured.

Further, since the needle member holding portion of the arm portion is provided with an engaging portion that engages with the needle member, the needle member can be held more reliably. Also,
The needle member holding portion of the arm portion has a space capable of receiving the needle member, and further, the needle member and the needle member holding portion are associated with each other when the needle member is inserted into the needle member holding portion. The needle member is more reliably held by providing the engaging function of restricting the mating and withdrawing. Further, the needle member holding portion of the arm portion is made of an elastic material that can be punctured by the needle member, so that the needle member can be easily inserted into the needle member gripping portion. Further, the needle member holding portion is provided with a separation preventing portion for restricting withdrawal after the puncture into the needle member holding portion formed of the elastic body, so that the needle member can be held. Be more certain. Further, the in-vivo tissue suturing device,
A liquid-filling lumen that extends in the main body portion and has one end opening at a distal end side portion that can be inserted into in-vivo tissue and the other end opening at the proximal end side of the main body portion, and a three-way stopcock connected to the lumen And a pulsation confirmation member attached to one port of the three-way stopcock, and a liquid filling port formed by another port of the three-way stopcock, the three-way stopcock includes the lumen as one port and By providing the operation unit for selectively communicating with the other port, the arrival of the main body in the blood vessel can be confirmed without directly inflowing the blood into the device.

[Brief description of drawings]

FIG. 1 is an external view of an embodiment of the in-vivo tissue suturing apparatus of the present invention.

FIG. 2 is an enlarged cross-sectional view of a tip portion of the in-vivo tissue suturing device shown in FIG.

FIG. 3 is an enlarged cross-sectional view of a main body portion near a needle member of the in-vivo tissue suturing apparatus shown in FIG.

FIG. 4 is an enlarged plane near the arm portion of the in-vivo tissue suturing device shown in FIG.

5 is an enlarged cross-sectional view of the proximal end portion of the main body of the in-vivo tissue suturing device shown in FIG.

FIG. 6 is an explanatory diagram for explaining a pressure detection function provided in the in-vivo tissue suturing device of the present invention.

FIG. 7 is an external view of a pushing instrument for pushing a suture thread into a living body after suturing with the in-vivo tissue suturing apparatus of the present invention.

FIG. 8 is an explanatory diagram for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 9 is an explanatory view for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 10 is an explanatory view for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 11 is an explanatory view for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 12 is an explanatory view for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 13 is an explanatory view for explaining the operation of the in-vivo tissue suturing device of the present invention.

FIG. 14 is an explanatory diagram for explaining another in-vivo tissue suturing device of the present invention.

FIG. 15 is an explanatory diagram for explaining another in-vivo tissue suturing device of the present invention.

[Explanation of symbols]

1 In-vivo tissue suturing device 2 body 3 arm 4 (4a, 4b) Needle member 5 (5a, 5b) thread 6 (6a, 6b) Presser 7 tubes 8 In vivo tissue membrane (vascular wall) 21 shaft

Claims (11)

[Claims] 1. An in-vivo tissue suturing device for suturing a percutaneously penetrated hole formed in an in-vivo tissue film, comprising:
The suturing device has a main body having a predetermined length that can be inserted into the in-vivo tissue through the hole, a first form accommodated in a portion of the main body that is inserted into the in-vivo tissue, and a portion. And an arm portion that can take a second form that protrudes from the main body portion, the main body portion including at least one needle member housed inside the base end side of the arm portion, A thread provided on the needle member, and a needle member pusher for projecting the needle member from the side surface of the main body portion so as to reach the arm portion, the arm portion, in the second mode, An in-vivo tissue suturing apparatus, comprising: a needle member holding portion that holds a needle member that has been pushed out by a needle member pusher and has reached an arm portion. 2. The in-vivo tissue suturing apparatus according to claim 1, wherein the arm portion includes an arm operating wire and an operating portion for operating the change between the first form and the second form. . 3. The in-vivo tissue suture according to claim 1, wherein the needle member is provided with a pusher tip end portion accommodating portion for detachably accommodating the tip end portion of the needle member pusher at a rear end thereof. apparatus. 4. The in-vivo tissue suturing device comprises a biasing member for biasing the needle member pusher rearward.
4. The in-vivo tissue suturing device according to any one of 3 to 3. 5. The main body section comprises two needle members housed inside the main body section, threads provided on each of the needle members, and each needle member protruding from a side surface of the main body section. Two needle member pushers for reaching the arm portion are provided, and the arm portion holds the two needle members pushed out by the pusher in a partially exposed second form. The in-vivo tissue suturing device according to any one of claims 1 to 4, further comprising a needle member holding portion. 6. The in-vivo tissue suturing device according to claim 1, wherein the needle member holding portion of the arm portion includes an engaging portion that engages with the needle member. 7. The needle member holding portion of the arm portion has a space capable of receiving the needle member, and further, the needle member and the needle member holding portion have the needle member holding portion provided with the needle member. The in-vivo tissue suturing device according to any one of claims 1 to 5, which has an engaging function of engaging when inserted and limiting withdrawal. 8. The in-vivo tissue suturing device according to claim 1, wherein the needle member holding portion of the arm portion is made of an elastic material that can be punctured by the needle member. 9. The in-vivo tissue suture according to claim 8, wherein the needle member includes a detachment preventing portion for restricting withdrawal after the puncture into the needle member holding portion formed of the elastic body. apparatus. 10. The in-vivo tissue suturing apparatus according to claim 8, wherein the needle member holding portion has a viscosity for closely holding the punctured needle member. 11. The in-vivo tissue suturing device is a liquid which extends inside the main body part, one end of which is opened at a distal end side portion which can be inserted into the in-vivo tissue, and the other end of which is opened at a proximal end side of the main body part. A filling lumen, a three-way stopcock connected to the lumen, a pulsation confirmation member attached to one port of the three-way stopcock, and a liquid filling port formed by another port of the three-way stopcock The in-vivo tissue suturing device according to any one of claims 1 to 10, wherein the three-way stopcock includes an operation portion for selectively communicating the lumen with one port and the other port.