JP2600709Y2 - Treatment device for tubular organs - Google Patents

Description

[Detailed description of the invention]

[0001]

Industrial Applicability The present invention is applied to a tubular organ of a human body.
For example, the present invention relates to a treatment device for a tubular organ used for appropriately inserting an indwelling device for treating an aneurysm, a blood obstruction device for preventing a large amount of bleeding, a stent for expanding a tubular organ, and the like. .

[0002]

2. Description of the Related Art In the case where various tubular organs exist in the human body and cannot be reached by external surgery, or when external surgery is complicated, the affected part is reached from inside through the tubular organ. In addition, a method has been adopted in which a drug, a dilator, an embolic material, or the like is placed and treatment is performed. For example, when treating an aneurysm formed in a blood vessel, a catheter is guided through the blood vessel into the aneurysm, a metal coil or the like is inserted into the aneurysm through the catheter, and the thrombus is filled by filling the aneurysm with the metal coil or the like. A method of preventing the inflow of blood and preventing the rupture of the aneurysm has been adopted.

FIG. 9 shows an example of the above-described treatment method. That is, the parent catheter 2 is inserted into the blood vessel 1 in which the aneurysm 1a is formed, and when the distal end of the parent catheter 2 reaches the vicinity of the aneurysm 1a, the balloon 3 attached to the outer periphery of the distal end of the parent catheter 2 is removed. Inflate to fix the distal end position of the parent catheter 2.

In this state, the child catheter 4 is inserted through the parent catheter 2 and the distal end of the child catheter 4 is connected to the aneurysm 1.
Place at the entrance of a. Then, the coil 5 such as platinum is inserted into the child catheter 4, and the coil 5 is pushed out from the distal end of the child catheter 4 into the aneurysm 1 a by the guide wire 6 as a pusher. Thus, the aneurysm 1a is closed by inserting many coils 5 into the aneurysm 1a.

[0005] As another method, a metal coil to be placed in the aneurysm is attached to the distal end of the guide wire, and the metal is electrolyzed while the distal end of the guide wire is inserted into the aneurysm. There has also been proposed a therapeutic device in which a coil is separated from a distal end of a guide wire and is placed in an aneurysm (for example, Patent Application Publication No. 5-5003).
No. 22).

[0006] Further, a method of inserting a microballoon into an aneurysm to occlude it is also known. That is, a method in which a balloon is attached to the tip of a microcatheter, guided into an aneurysm, the balloon is inflated with a sclerosing agent, and then separated.

Further, other methods of closing an aneurysm include a method of inserting a silk thread into the aneurysm, a method of inserting beads made of an ethylene-vinyl acetate copolymer, and a method of injecting a liquid occluding material. Proposed.

[0008]

However, in the method shown in FIG. 9, when the coil 5 is pushed out from the child catheter 4, the coil 5 does not completely enter the aneurysm 1a.
If the coil 5 protrudes toward the flow path side of the blood vessel 1, the flow path of the blood vessel 1 may be blocked by the coil 5. In this case, once the coil 5 is pushed out of the child catheter 4, it cannot be pulled back to the child catheter 5, so that the doctor has to spend a lot of time to carefully push out the coil 5.

In the method of attaching a metal coil to the tip of a guide wire and separating the coil by electrolysis, after confirming that the metal coil has been placed in the aneurysm, it is possible to cut off the guide wire by applying a current. However, the energization time required to separate the metal coil is very long, and FIG.
As shown in (1), since the blood flow in the blood vessel 1 is temporarily stopped by using the balloon 3, there is a time limitation, and there is a problem that the device becomes large-scale. Further, there is a possibility that metal ions are eluted into blood due to electrolysis, which may adversely affect the human body.

Furthermore, in the method of inserting a microballoon into an aneurysm to occlude the balloon, the shape of the balloon and the aneurysm do not match, so that the balloon may deform the aneurysm and apply stress, or the balloon may be erroneously detached. was there.
Also, if the balloon ruptures inside the aneurysm, it is very likely that the aneurysm itself will also rupture.

Furthermore, in the method of inserting a silk thread, a synthetic resin bead, or a liquid occluding material into the aneurysm to close the aneurysm, all of these materials are easily washed away by the blood flow, so that other parts of the blood vessel may be removed. And the flow path may be blocked.

Accordingly, an object of the present invention is to provide a tube which can be quickly separated after confirming that a device such as a coil to be placed in the body is safely and securely placed at a desired position. An object of the present invention is to provide a device for treating an organ.

[0013]

In order to achieve the above object, the present invention provides a treatment device for a tubular organ in which an indwelling device is detachably attached to a distal end portion of a linear member. A first engaging portion provided at a distal end portion, and a second engaging portion provided at a proximal end portion of the indwelling device and engaged with the first engaging portion. The first engaging portion is made of a shape memory alloy, and is configured to be deformed and disengaged from the second engaging portion when the temperature becomes equal to or higher than the transformation point of the shape memory alloy. At least the proximal end of the coil forms a coil, and the second engaging portion is attached to the inside of the coil at the proximal end of the indwelling device, and is configured to protrude from the end of the coil by an external force. It is characterized by having.

In the present invention, the linear member includes:
It is preferable to use a core wire having a tip portion gradually narrowed and a coil fixed to the outer periphery of the tip portion of the core wire. It is more preferable that the tip of the coil has radiopaque properties. To make the tip of the coil radiopaque, the tip of the coil should be made of X-ray such as gold or platinum. A method of forming a transparent material, a method of plating an X-ray opaque material such as gold or platinum on the tip of the coil, and the like are employed. However, in addition to the above, a member in which a metal core wire is covered with a synthetic resin film can be used as the linear member. In this case, it is preferable that the engaging portion is joined to the tip of the core wire.

According to a preferred aspect of the present invention, a pitch of a coil forming a base end of the indwelling device is elongated, and the second engagement portion has a base end. The second engaging portion is fixed to the inside of the coil, and is configured to protrude from an end of the coil when the coil is compressed and brought into a close contact state.

Further, according to another preferred embodiment of the present invention, an inner coil having a smaller diameter is inserted into a coil forming a base end of the indwelling device, and an inner end of the inner coil is formed. Part is fixed to the inner periphery of the coil, the second engagement part is connected to an outer end of the inner coil, and the inner coil is pulled by pulling the second engagement part. Are extended so that the second engagement portion projects from the end of the coil.

[0017]

In order to occlude an aneurysm of a blood vessel, for example, using the therapeutic device of the present invention, a catheter is first inserted into a blood vessel, and the distal end of the catheter is placed at the entrance of the aneurysm. Then, the therapeutic device of the present invention is inserted through the catheter, and the indwelling device connected to the distal end of the linear member via the engaging portion is inserted into the aneurysm.

After confirming that the indwelling device has been completely inserted into the aneurysm by, for example, an X-ray fluoroscope,
Hot water or the like is injected through the catheter to heat the first engaging portion at the distal end of the linear member. In addition, as a heating method, means such as high-frequency induction heating can be adopted. When the first engagement portion is heated in this manner, the first engagement portion made of a shape memory alloy returns to its original shape, and the first engagement portion and the second engagement portion are disengaged. The device is placed in the aneurysm.

When the indwelling device is placed in the aneurysm in this way, the indwelling device fills the aneurysm and forms a thrombus, so that the inflow of blood into the aneurysm is prevented and the rupture of the aneurysm is prevented. Can be prevented.

According to the present invention, the in-vivo indwelling device can be separated after confirming that the in-vivo indwelling device is located at a predetermined position as described above. By pulling the linear member and pulling the indwelling device back into the catheter, the operation can be performed again.

Further, according to the present invention, at least the proximal end of the indwelling device forms a coil, and the second engaging portion is mounted inside the coil, and projects from the end of the coil by an external force. The first engagement portion and the second engagement portion
When the in-vivo indwelling device is left inside the body after disengaging from the engaging portion, the second engaging portion is pulled into the coil, and the tissue in the body is damaged by the second engaging portion. For example, there is no fear that the second engagement portion protrudes from the aneurysm and obstructs the blood vessel, and the safety can be improved.

[0022]

1 to 5 show one embodiment of a treatment device for a tubular organ according to the present invention. As shown in FIG. 1, this treatment device for a tubular organ includes a linear member 11 and an indwelling device 21 that is detachably connected to a distal end portion thereof. The linear member 11 has an elongated core wire 12 made of a metal wire having elasticity. The base end side of the core wire 12 forms an enlarged diameter portion 12a, and a narrow diameter portion 12b extends from the middle to the distal end portion.
I am doing. As the material of the core wire 12, for example, an elastic metal wire such as stainless steel, piano wire, amorphous alloy, shape memory alloy, or the like is preferably used. Core wire 12
The thickness of the small diameter portion 12b is preferably about 0.05 to 0.4 mm, more preferably 0.2 mm or less.

On the outer periphery of the small diameter portion 12b of the core wire 12,
A first coil 13 made of stainless steel, a piano wire, an amorphous alloy, a shape memory alloy or the like is arranged on a base side of the core wire 12, and a second coil 13 made of an X-ray opaque material such as gold or platinum is provided on a tip side of the core wire 12. Are arranged. These coils 13, 14 have brazing material 15 at their ends.
To the core wire 12. Each coil 13, 1
The diameter of 4 is preferably 0.25 to 0.45 mm. Second coil 1
4 has a first engaging portion 1 made of a shape memory alloy.
The base of 6 is also fixed by the brazing material 15.
The distal end of the first engagement portion 16 is
a and 16b, and when the temperature reaches or exceeds the transformation point of the shape memory alloy, the shape returns to its original shape, and as shown in FIG.
Shape memory processing is performed so that a and b open. In this case, it is preferable to use a two-way shape memory alloy in order to increase the holding force of the first engagement portion 16 at a low temperature.

The outer circumference of each of the coils 13 and 14 may be coated with a synthetic resin film such as polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polyurethane, polystyrene, fluororesin, and silicone rubber. Further, the surface of the synthetic resin film may be coated with a hydrophilic polymer by, for example, forming a functional group such as an isocyanate group and bonding a hydrophilic polymer such as polyethylene glycol to the functional group. Examples of such a hydrophilic polymer include a resin as disclosed in Japanese Patent Publication No. 4-14991.

On the other hand, the indwelling device 21 is composed of a double coil 22 made of an X-ray opaque material such as platinum, a platinum alloy, or a metal whose surface is plated with gold. The coil 22 preferably has a diameter of 0.25 to 0.4 mm and a length of 50 to 400 mm in a state of being extended into a primary coil.
mm is preferred. The tip of the coil 22 is brazed,
The head 23 is formed in a round shape by means such as melting.

Referring also to FIGS.
The main part 22a is wound tightly, but the coil 2
The second base end 22b is in a state of being stretched at intervals of the coil pitch. The second engagement portion 24 is disposed inside the base end 22 b of the coil 22, and the base end 24 b is fixed to the inner periphery of the base end 22 b of the coil 22 by brazing. Also, the second engaging portion 2
4 is formed in a loop shape having an engagement hole 24a.

As shown in FIG. 2, the second engaging portion 24
In a state where there is no external force, the coil 22 is retracted inside the base end 22b. However, as shown in FIG. 3, when the base end 22b of the coil 22 is compressed, the end having the engagement hole 24a becomes the coil end. 22 protrudes from the base end 22b.

As shown in FIG. 4, a first engaging portion 16 formed at the tip of the linear member 11 has a finger-like portion 16a,
16b is connected to the second engaging portion 2 formed in the indwelling device 21.
4 is engaged with the second engagement portion 24 by being inserted into the engagement hole 24a and being closed. At this time, by compressing the proximal end portion 22b of the coil 22 of the indwelling device 21, the engagement hole 24a of the second engagement portion 24 is formed.
Is projected from the base end 22b of the coil 22.

In this state, when a heated physiological saline solution or the like is injected and heated to a temperature higher than the transformation temperature of the shape memory alloy, as shown in FIG.
6a and 16b are opened, the first engagement portion 16 and the second engagement portion 24 are disengaged, and the indwelling device 21 is separated from the linear member 11.

Next, a method of closing an aneurysm of a blood vessel using the treatment device for a tubular organ shown in FIGS. 1 to 5 will be described.

First, a catheter is percutaneously inserted into a blood vessel using a puncture needle, and the catheter is placed so that the tip of the catheter reaches the entrance of the aneurysm. Next, the therapeutic device of the present invention is inserted into the catheter with the double coil 22 of the indwelling device 21 linearly extended, and the indwelling device 21 is inserted from the distal end of the catheter by the linear member 11 into the aneurysm. Extrude in. When pushed out of the catheter, the indwelling device 21 returns to its shape and assumes a three-dimensionally entangled shape. In addition, the second engaging portion 24 of the indwelling device 21
Since it is connected to the distal end of the linear member 11 via the engaging portion 16, even if it is once pushed out of the catheter, if the position is not appropriate, it can be pulled back into the catheter and the operation can be performed again. .

Next, after confirming that the indwelling device has been securely inserted into the aneurysm, a heated physiological saline or the like is poured through a catheter, or the device is heated by a heater or high-frequency induction. The first engaging portion 16 is heated. As a result, the shape of the first engagement portion 16 made of the shape memory alloy is restored, and as shown in FIG.
a, 16b are opened, and the engagement with the second engagement portion 24 is released. As a result, the indwelling device 21 is separated from the linear member 11 and is placed in the aneurysm. In this way, when the indwelling device 21 is placed in the aneurysm, it returns to a double coil and fills the aneurysm, forms a thrombus, and prevents blood from flowing into the aneurysm. Burst can be prevented.

The treatment device of the present invention can be used according to
Other indwelling devices of various shapes can be connected and used. This can be used not only for the treatment of the aneurysm as described above, but also for insertion of a blood path obstruction device for closing a blood vessel in order to prevent a large amount of bleeding when the blood vessel is damaged in an accident or the like. It can also be used to insert a stent to expand a tubular organ.

6 to 8 show another embodiment of the treatment device for a tubular organ according to the present invention. It is to be noted that the same reference numerals are given to substantially the same portions as those in the above-described embodiment, and description thereof will be omitted.

This treatment device for a tubular organ comprises a linear member 11 and an indwelling device 31 in the same manner as in the above embodiment.
A first engaging portion 16 similar to that of the above embodiment is attached to the distal end of the linear member 11. In addition, the indwelling device 31
The second embodiment is also configured with a double coil 32 as in the previous embodiment, but differs in the structure of attaching the second engaging portion 34 to the base end thereof.

That is, an inner coil 33 having a smaller diameter is disposed inside the base end of the double coil 32, and the inner end of the inner coil 33 is fixed to the inner periphery of the double coil 32 by a brazing material 35. Have been. A second engagement portion 34 is similarly fixed to the outer end of the inner coil 33 by a brazing material 35. The second engaging portion 34 has an engaging hole 34a at an end thereof.

Accordingly, as shown in FIG. 6, when there is no external force, the second engaging portion 34 is retracted inside the double coil 32, and as shown in FIG.
When the engaging portion 34 is pulled, the inner coil 33 is extended, and the portion of the second engaging portion 34 having the engaging hole 34 a projects from the base of the double coil 32.

Then, as shown in FIG.
4a, the finger-like portion 1 of the first engagement portion 16 of the linear member 11
6a and 16b are inserted into the closed shape, so that the first engagement portion 16 and the second engagement portion 34 are engaged,
The in-vivo indwelling device 31 is detachably attached to the distal end of the linear member 11.

Since the method of using the treatment device for a tubular organ is exactly the same as that of the above-described embodiment, the description thereof will be omitted.

[0040]

As described above, according to the tubular organ treatment tool of the present invention, the in-dwelling device is attached to the distal end of the linear member by the shape restoring force of the shape memory alloy. If the insertion position is to be corrected even after being once pushed out of the catheter, it can be pulled back into the catheter and the operation can be performed again. Then, after confirming that the indwelling device is placed at an appropriate position, the indwelling device can be instantaneously separated by, for example, flowing heated physiological saline or inducing high frequency. Therefore, the insertion operation can be performed safely and reliably in a short time.

Further, at least the proximal end of the indwelling device is a coil, and a second engaging portion made of a shape memory alloy provided at the distal end of the linear member is engaged in the coil.
And the second engaging portion is configured to protrude from the end of the coil by an external force. Therefore, when the in-vivo indwelling device is separated from the linear member and is indwelled in the body, the second Is retracted into the coil. For this reason, it is possible to prevent the risk that the body tissue is damaged by the second engaging portion or that the second engaging portion protrudes from, for example, an aneurysm and blocks a blood vessel.

[Brief description of the drawings]

FIG. 1 is an explanatory view showing a treatment device for a tubular organ according to an embodiment of the present invention.

FIG. 2 is a partial cross-sectional view showing a state in which a second engaging portion of the indwelling device used in the treatment tool is retracted.

FIG. 3 is a partial cross-sectional view showing a state where a second engaging portion of the indwelling device used in the treatment tool is protruded.

FIG. 4 is a partial cross-sectional view showing a state where a first engagement portion and a second engagement portion of the treatment tool are engaged.

FIG. 5 is a partial cross-sectional view showing a state in which a first engagement portion and a second engagement portion of the treatment tool are disengaged.

FIG. 6 is a partial cross-sectional view showing a state in which a second engaging portion of an indwelling device used in a treatment device for a tubular organ according to another embodiment of the present invention is retracted.

FIG. 7 is a partial cross-sectional view showing a state in which a second engaging portion of the indwelling device used in the treatment tool is retracted.

FIG. 8 is a partial cross-sectional view showing a state where a first engagement portion and a second engagement portion of the treatment tool are engaged.

FIG. 9 is an explanatory view showing an operation of inserting a coil placed in the body into an aneurysm of a blood vessel using a conventional treatment tool for a tubular organ.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 11 Linear member 16 1st engagement part 21, 31 Indwelling device 22, 32 Double coil 22b Base end 24, 34 Second engagement part 24a, 34a Engagement hole 33 Inner coil

──────────────────────────────────────────────────続 き Continuation of front page (58) Fields investigated (Int. Cl. ⁶ , DB name) A61M 25/00 A61M 31/00 A61M 29/00-29/04 A61B 17/00 A61B 17/12

Claims (3)

(57) [Scope of request for utility model registration] 1. A treatment tool for a tubular organ in which an indwelling device is detachably attached to a distal end of a linear member, a first engaging portion provided at a distal end of the linear member, A second engaging portion provided at a base end portion of the indwelling device and engaging with the first engaging portion, wherein the first engaging portion is made of a shape memory alloy, When the temperature is equal to or higher than the transformation point of the alloy, the alloy is configured to be deformed and disengaged from the second engagement portion, and at least the proximal end of the indwelling device forms a coil, Wherein the engaging portion is mounted inside the coil at the proximal end of the indwelling device, and is configured to protrude from the end of the coil by an external force. 2. A pitch of a coil forming a base end of the indwelling device is elongated, and a base end of the second engaging portion is fixed to the inside of the coil. The treatment device for a tubular organ according to claim 1, wherein the second engagement portion is configured to protrude from an end of the coil when the compression member is compressed and brought into a close contact state. 3. An inner coil having a smaller diameter is inserted into a coil forming a base end of the indwelling device, and an inner end of the inner coil is fixed to an inner periphery of the coil. The second engagement portion is connected to an outer end of the inner coil, and by pulling the second engagement portion, the inner coil is extended and the second engagement portion is The treatment device for a tubular organ according to claim 1, wherein the treatment device is configured to protrude from an end of the coil.