JP2605559Y2 - 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 . 5 shows an example of such a 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, according to the method shown in FIG. 5 , 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, which comprises an indwelling device having a ball-shaped inflatable end at a distal end of a linear member at a base end. in the treatment tool of the tubular organ consisting mounted removably freely, the linear member is made of a wire or tube of the shape memory alloy, in the axial direction at the tip portion of the linear member, the rear
Part slit which is enlarged in a circular shape are formed one or more, the distal end portion of the linear member is divided into a plurality by the slits, spherical base end portion of the intracorporeal indwelling equipment in the back portion of the divided portions
The bulging end is engaged and held, and when the temperature is equal to or higher than the transformation point of the shape memory alloy, the split portion is opened to separate the in-dwelling device. And

In a preferred embodiment of the present invention, two slits are formed in the distal end portion of the linear member along the axial direction in a cross shape, and the slits define the distal end portion of the linear member. Is divided into four parts.
In which the end of the proximal end of the indwelling device is engaged and held at the back of the body .

[0015]

Further, as the indwelling device in the body, a double coil is preferably employed. However, not limited thereto, various shapes and materials having a shape like a test tube brush or a material in which fibers are interposed between coil pitches can be used. The indwelling device is preferably one having radiopaque properties, such as one made of gold, platinum, or the like, or one made of stainless steel, a shape memory alloy, or the like plated with gold, platinum, or the like. Used.

[0017]

In order to treat 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 treatment device of the present invention is inserted through the catheter, and the indwelling device connected to the distal end of the linear member 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 a catheter to heat 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 distal end is heated in this manner, the distal end of the linear member made of the shape memory alloy is deformed and expanded, and the indwelling device is separated and 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. The operation can be performed again by pulling the linear member and pulling the indwelling device back into the catheter.

Further, by injecting hot water or the like, the distal end of the linear member made of the shape memory alloy can be instantaneously deformed, and the indwelling device can be separated. Therefore, the insertion operation of the indwelling device can be performed reliably and safely, and the burden on doctors and patients is reduced.

[0022] The present invention smell Te, when the linear member is made of one wire or tube shape memory alloy is the superelastic shape-memory alloy, kink (bending) when inserting into the tubular organ It is unlikely to occur. Also, when composed of a single shape memory alloy wire or tube is processed also easy to form a slit on the tip, it is not necessary tasks such as connecting the retaining member to the distal end portion of the linear member Excellent in productivity.

[0023]

1 to 4 show one embodiment of a treatment device for a tubular organ according to the present invention. As shown in FIG. 1, the treatment device for a tubular organ includes a linear member 11 and a distal end portion 11 thereof.
c and the in-vivo indwelling device 21 which is separably connected to the body c. The linear member 11 is made of a single wire made of a shape memory alloy, and the base end side forms an enlarged diameter portion 11a. From the middle to the distal end portion 11c, the diameter is gradually reduced and the tapered portion 1a is formed.
1b. The total length of the linear member 11 is 1500 to 2000 mm
Is preferable, and the length of the tapered portion 11b is 30 to 350 mm.
The degree is preferred. The diameter of the enlarged diameter portion 11a is 0.35 to 0.
It is preferably about 45 mm, and the thickness of the tip portion 11c is 0.25-0.
About 35 mm is preferable. The linear member may be a tube having a hollow inside.

The outer periphery of the linear member 11 may be coated with a synthetic resin film such as polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polyurethane, polystyrene, fluororesin, silicon rubber, or the like. 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, for example, Japanese Patent Publication No. 4-149.
No. 91, for example. Preferably, at least the vicinity of the distal end of the linear member 11 is provided with X-ray opacity by applying gold plating or the like to the surface.

On the other hand, the indwelling device 21 is composed of a double coil 22 made of an X-ray opaque material such as gold, platinum, or a metal whose surface is plated with gold. The head 23 of the double coil 22 is formed in a round shape by means such as brazing or melting so that the tubular organ can be easily inserted into the tubular organ without damaging it. In addition, the base end 24 extends linearly, and the end thereof is formed in a spherical shape. The diameter of the primary coil of the double coil 22 is preferably 0.25 to 0.4 mm, and the length thereof is preferably 50 to 400 mm. The diameter of the secondary coil of the double coil 22 is preferably 3 to 8 mm.

FIG. 2 shows a front end portion 11c of the linear member 11,
The state of connection with the proximal end 24 of the indwelling device 21 is shown. Referring also to FIG. 3, the tip 1 of the linear member 11
1c is divided into four by two slits 12, 12 formed in a cross shape along the axial direction. The inner part 12a of each slit 12 is expanded in a circular shape. Then, the base end 24 of the indwelling device 21 is inserted into the divided portion, is gripped by the distal end 11c, and the spherically swelled end 24a of the base end 24 is inserted into the inner end 1 of the slit 12.
By engaging with 2a, it is in a state of being linearly connected. The engagement prevents the indwelling device 21 from easily detaching due to impact or the like. The processing of the slit 12 can be easily performed by, for example, a known wire cutting.

As described above, the tip 11 of the linear member 11
2c, as shown in FIGS. 2 and 3, the divided portion is closed to hold the proximal end portion 24 of the indwelling device 21. Then, for example, when hot water is injected and heated to a temperature higher than the transformation temperature of the shape memory alloy, the distal end is expanded in all directions as shown in FIG. The part 24 is released. In this case, the transformation point of the shape memory alloy is 35
The temperature is preferably about 90C. Further, in order to increase the holding force of the indwelling device 21 at a low temperature, a two-way shape memory alloy is preferable as the shape memory alloy constituting the linear member 11.

Next, a method of treating a vascular aneurysm using the treatment device for a tubular organ shown in FIGS. 1 to 4 will be described.

First, a catheter is inserted into a blood vessel percutaneously using a puncture needle, and the catheter is placed so that the tip of the catheter reaches the entrance of the aneurysm. As the catheter, any commercially available catheter may be used. 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 pushed out from the distal end of the catheter to enter the aneurysm. Deploy. When the indwelling device 21 is pushed out of the catheter, the double coil 22 returns to its shape and assumes a shape that is three-dimensionally entangled. Since the proximal end 24 of the indwelling device 21 remains connected to the distal end 11c of the linear member 11, if the position is not appropriate after being once pushed out of the catheter, it is pulled back into the catheter. Operation can be redone.

Next, after confirming that the indwelling device 21 has been securely inserted into the aneurysm, a heated physiological saline solution is poured through a catheter, or a wire is heated by means of heater heating, high-frequency induction, or the like. The tip 11c of the shaped member 11 is heated. As a result, the distal end portion 11c returns to its shape, and as shown in FIG.
The proximal end 24 of the indwelling device 21 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
Various shapes of indwelling devices 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 the 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.

[0032]

As described above, according to the tubular organ treatment tool of the present invention, the indwelling device is held in the slit formed at the distal end of the linear member, and the shape restoring force of the shape memory alloy is maintained. Therefore, if the insertion position is to be corrected after being once pushed out of the catheter, it can be pulled back into the catheter and the operation can be performed again. And
After confirming that the indwelling device is placed at the appropriate position, for example, by flowing heated physiological saline or conducting high-frequency induction, the indwelling device can be instantaneously separated. In addition, the insertion operation can be performed safely and reliably in a short time.

[Brief description of the drawings]

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

FIG. 2 is a partial cross-sectional view showing a connecting portion of the treatment tool.

FIG. 3 is a perspective view showing a distal end portion of a linear member used in the treatment tool.

FIG. 4 is a perspective view showing the operation of the distal end of the linear member.

FIG. 5 is an explanatory view showing an operation of inserting an indwelling coil into a blood vessel aneurysm using a conventional treatment tool.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 11 Linear member 12 Slit 21 Indwelling device 22 Double coil

──────────────────────────────────────────────────続 き Continued on the front page (58) Fields investigated (Int.Cl. ⁷ , DB name) A61M 25/00 A61M 29/00-29/04 A61M 31/00 A61B 17/00 A61B 17/12 A61F 2 / 04

Claims (3)

(57) [Scope of request for utility model registration] A spherical member is provided at a distal end of a linear member and at a proximal end thereof.
In the treatment device for a tubular organ, in which an indwelling device having a curved end is detachably attached, the linear member is made of a shape memory alloy wire or a tube, and is attached to a distal end of the linear member in an axial direction. Along the line , the inside of which
One or more lits are formed, and the distal end of the linear member is divided into a plurality by the slit, and the spherically bulging end of the proximal end of the indwelling device is engaged with the inner part of the divided part. A treatment device for treating a tubular organ, wherein when the temperature reaches a transformation point of the shape memory alloy or higher, the dividing portion is opened and the indwelling device is separated. 2. A slit is formed in the tip of the linear member in a cross shape along the axial direction, and the tip of the linear member is divided into four by the slit. 2. The treatment device for a tubular organ according to claim 1, wherein the end of the proximal end portion of the indwelling device is engaged with and held by the portion. 3. The treatment device for a tubular organ according to claim 1, wherein the indwelling device is a double coil.