JP2001129096A - Shape memory alloy wire for repairing blood vessel and device for transporting that into blood vessel - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood vessel repairing material preventing a hump produced in a blood vessel from rupturing and carry out expansion or the like of a constricted blood vessel. SOLUTION: A flexible wire having flexibility at temperatures lower than a bloodstream temperature in a blood vessel, the wire is treated so as to have a shape memory at a transformation temperature equivalent to the bloodstream temperature in the blood vessel so that it may be transformed into a cylinder of a prescribed size suitable to treatment of a lesion.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a shape memory alloy wire used for preventing rupture of aneurysms such as aneurysms and varicose veins, expanding blood vessels narrowed by depositing cholesterol and the like, and repairing various other blood vessels. And a device for transferring the alloy wire to a position to be repaired in a blood vessel.

[0002]

2. Description of the Related Art Conventionally, for example, there is a method of treating an aortic aneurysm by transplanting an artificial blood vessel in place of a blood vessel having an aneurysm. Also, for treating a stenotic blood vessel, a balloon is inflated to a narrowed portion of the blood vessel to expand the blood vessel. Although a ballooning method to expand the balloon is known, all methods require a high degree of skill in implementation, and in the latter ballooning method, in particular, the balloon can only temporarily expand a stenotic blood vessel using a balloon. There is no guarantee that the expansion will be maintained on an ongoing basis.

[0003]

SUMMARY OF THE INVENTION The invention of claim 1 of the present application inhibits the inflow of blood flow into an aneurysm generated in a blood vessel to suppress its rupture, and physically expands a stenotic blood vessel to prevent its rupture. An object of the present invention is to provide a blood vessel repair material that can reliably achieve a normal blood flow and the like.

[0004] It is an object of the present invention to provide an apparatus for transferring the above-mentioned vascular repair material through a blood vessel to a lesion.

[0005]

As means for achieving the above object, the invention of claim 1 of the present application is a flexible linear body having flexibility at a temperature lower than the blood flow temperature in a blood vessel, At a transformation temperature corresponding to the blood flow temperature in the blood vessel, the linear body is subjected to shape memory processing so as to transform into a cylindrical shape having a predetermined size suitable for treatment of a diseased part. Propose,

According to a second aspect of the present invention, there is provided a flexible hose having flexibility and to be inserted into a blood vessel in a state where the shape memory alloy wire according to the first aspect is inserted. An induction hose having a slightly larger inner diameter, a liquid pumping device connected to a base end of the induction hose via a branch hose, and a transformation of the shape memory alloy wire to be pumped into the induction hose by the pumping device. 2. The transfer of a shape memory alloy wire into a blood vessel according to claim 1, comprising: a transformation suppressing liquid at a temperature lower than a point; and means for pushing the shape memory alloy wire in the guide hose out of the hose from the tip of the guide hose. Suggest a device.

As the "shape memory alloy" in the first aspect of the present invention, a nickel-titanium-based alloy, a nickel-aluminum-based alloy, and various other types are selectively used. The “cylindrical shape” formed by transformation of the shape memory alloy wire includes, as shown in developed views in FIGS. 6 and 7,
A cylindrical shape formed by spirally winding the above alloy wire (FIG. 6)
(A)), a cylindrical shape formed by spirally winding the above-mentioned alloy wire while bending it in a zigzag manner (FIG. 6 (B)), and a cylindrical shape formed by bending the alloy wire in various ways (FIG. 6 (C)). ),
(D) and FIGS. 7 (e) and (f)).

In the invention of claim 2 of the present application, the “induction hose” includes polyurethane, nylon, polyethylene,
A hose made of synthetic resin such as polyvinyl chloride is used. In addition, the above-mentioned "liquid pressure feeding device" is a general term for a liquid pump, a device utilizing a head pressure, and the like. Furthermore, physiological saline, heparinized physiological saline, and the like are used as the “transformation suppression liquid”. In addition, the thickness of the shape memory alloy wire is appropriately selected according to the application, but generally, the diameter is 0.025 to
0.5 mm. Hereinafter, embodiments of the present invention will be described with reference to the drawings.

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 (a) shows a nickel-titanium-based shape memory alloy wire (1) adjusted to be a flexible linear shape having flexibility so that it can be inserted deeply into an irregularly bent blood vessel. In this example, since the blood flow temperature in the blood vessel is 32 ° C. or higher,
Shape memory processing is performed so that the alloy wire (1) turns spirally and transforms into a cylindrical body (2) having a predetermined size without any gap as shown in FIG. It has been rubbed. In this case, both ends of the cylindrical body (2) are slightly larger diameter portions (3) and (3) (for example, 10% of the diameter of the intermediate portion).
The larger the diameter).

The thickness of the shape memory alloy wire (1) and the outer diameter and axial length of the cylindrical body (2) to be stored are as follows:
It is appropriately designed according to the thickness of the blood vessel to be repaired, the size of the repaired part, and the like.

An apparatus for transferring the shape memory alloy wire (1) to a site to be repaired in a blood vessel will be described below. In FIG. 2, a guide hose (4) having substantially the same length as the alloy wire (1) for guiding the alloy wire (1) into a blood vessel while holding the alloy wire (1) in a linear shape is inserted into an irregularly bent blood vessel. A flexible, flexible hose made of nylon so that it can be inserted deeply, the inner diameter of which is slightly larger than the outer diameter of the alloy wire (1), so that the alloy wire (4) is inserted into the induction hose (4). When 1) is inserted, an annular gap is created between the hose (4) and the alloy wire (1).

The thickness of the guide hose (4) is appropriately designed according to the thickness of the blood vessel to be inserted, but is always larger than the inner diameter of the blood vessel so as not to interfere with the blood flow of the actually inserted blood vessel. Make it thinner.

[0013] At the base end of the guide hose (4) as described above,
A hard Y-shaped pipe (5) made of metal or synthetic resin is connected, and the Y-shaped pipe (5) is composed of a base pipe (6) and a branch pipe (6 ') branched from the base pipe (6). (6 ') is connected to the discharge port of the liquid pump (7) by a discharge hose (8), and the suction port of the pump (7) is connected to the supply port of the transformation suppression liquid tank (9) by a supply hose (10). Connected.

A physiological saline (11) is injected into the transformation inhibiting liquid tank (9), and a cooling pipe (12) for circulating a refrigerant is piped into the tank (9). ) To cool the physiological saline (11) to a desired transformation suppression temperature.

The other end of the base pipe (6) of the Y-shaped pipe (5) has a thin connection port (1) through a rotary cock (13).
4) is projected, and the above-mentioned guide hose (4) is connected to the connection port (14). As means for pushing out the alloy wire (1) inserted into the guide hose (4), a push rod (15) slightly longer than the guide hose (4) is partially inserted from the rear end of the base pipe (6). And the push rod (15)
Is a flexible thin flexible rod made of nylon so that it can be inserted into an irregularly bent guide hose (4), the outer diameter of which is slightly smaller than the inner diameter of the guide hose (4). When the push rod (15) is inserted into the base pipe (6) and the guide hose (4), the push rod (15)
And an annular gap is formed between them and (6) and (4).

At the rear end of the base pipe (6), a Y-shaped pipe (5)
A backflow prevention device (16) for the transformation suppressing liquid fed into the inside is provided, and as shown in FIG. 3, the structure thereof is provided at the rear end of the base tube (6) and at the rear end having a larger diameter than the rear end. Male screw (1
A cylindrical casing (17) having a cylindrical elastic seal (19) made of a flexible elastic material such as rubber is provided at the front end inside the casing (17).
A rigid washer (20) is fitted on the rear side, and a cap (21) having a female screw (22) is screwed into the male screw (18) of the casing (17), and the center of the bottom surface of the cap (21) is fitted. Vertical through-hole (24)
A push pin (23) is slidably pushed into the casing (17) from the rear end so that the front end of the pin (23) faces the washer (20).

The push rod (15) is connected to the push pin (2).
3) Insert through the vertical through hole (24), the washer (20) and the through hole of the elastic sealing material (19) into the base tube (6), and turn the cap (21) in this state to press. Pin (2
When the washer (20) is pushed forward by 3), the elastic sealing material (19) is compressed in the vertical direction (axial direction) and simultaneously expanded in the horizontal direction, whereby the elastic sealing material (19) is pushed. The rear end of the base pipe (6) is closed by pressing against the rod (15).

An example of performing a blood vessel repair treatment using the shape memory alloy wire (1) and the transfer device as described above will be described. First, the case of rupture prevention processing of an aneurysm will be described. The physiological saline (11) in the transformation inhibition liquid tank (9) is cooled to about 5 ° C. by the cooling pipe (12). Insert the alloy wire (1) into the guide hose (4), position the tip of the alloy wire (1) near the tip of the guide hose (4), and then stop the tip of the push rod (15) against backflow. The device (16) is inserted into the base pipe (6) of the Y-tube (5), and then the cap (21) is turned to the backflow stop state. After the rotary cock (13) is opened in this state, the pump (7)
Is started, and the physiological saline in the tank (9) is pumped into the base pipe (6) through the hose (8) and the branch pipe (6 '),
Thereby, the salt solution is transferred to the alloy wire (1) and the induction hose (4).
The guiding hose (4) is inserted into the blood vessel while the alloy wire (1) is cooled to about 5 ° C. by supplying the alloy wire (1) to the annular gap. The saline solution supplied into the guide hose (4) flows out from the distal end of the guide hose into the blood vessel.

FIG. 4A shows the tip of the induction hose (4).
As shown in (2), the blood vessel (a) is inserted until it reaches a position corresponding to the aneurysm (b), and the push rod (15) is sequentially pushed into the base tube (6), and the tip of the push rod (15) is Alloy wire (1)
By pushing the rear end, the alloy wire (1) is pushed out from the distal end of the guide hose (4) into the blood vessel (a). The extruded alloy wire (1) is brought into contact with a blood flow of 32 ° C. or higher and transforms into a tightly coiled cylinder with no memorized space. The obtained cylinder (2) closes the entrance of the aneurysm (b) as shown in FIG. 2 (b) to prevent the blood flow from being injected into the aneurysm (b).
Thereby, the rupture of the bump (b) is reliably prevented for a long period of time.

The cylindrical body (2) is pressed against the inner surface of the blood vessel (a) by designing its outer diameter to be slightly larger than the inner diameter of the blood vessel (a). Is further pressed against the inner surface of the blood vessel (a), so that it is securely held at the above-described aneurysm occlusion position.

Next, in the case of dilation processing of a narrowed blood vessel,
As shown in FIG. 5 (a), the guide hose (4) into which the alloy wire (1) is inserted is passed through a physiological saline solution at 5 ° C. in the same manner as in the above example, as shown in FIG. When the alloy wire (1) is pushed out of the guide hose (4) into the blood vessel (a) by the push rod (15), the alloy wire (1) comes into contact with a blood flow of 32 ° C. or more. It transforms into a tightly coiled cylinder without any gap, and expands the constriction (c) as shown in FIG.

In each of the above usage examples, the alloy wire (1)
The blood flow is not hindered when inserting the guide hose (4) into which the blood is passed, and after the blood is transformed into the cylindrical body (2), the blood flow passes through the cylindrical body (2). .

The shape memory alloy wire used for dilating the stenotic blood vessel may have been subjected to shape memory processing so that the alloy wire transforms into a coiled cylinder with a slight gap.

[0024]

The shape memory alloy wire according to the first aspect of the present invention is transformed into a cylindrical shape by guiding the shape memory alloy wire to a repair position in a blood vessel and coming into contact with a blood flow temperature which is a transformation point.
In the case of an aneurysm, the entrance can be closed, and in the case of a stenosis of the blood vessel, the constriction can be expanded and repaired. It is possible to easily lead to the repair site.

According to the transfer device of the second aspect of the present invention,
The shape memory alloy wire can be transported to the desired site in the blood vessel while reliably suppressing transformation, and the same shape memory alloy wire is inserted and held in a flexible guide hose with flexibility, so it bends irregularly It can be easily transported to a repair site of a thin blood vessel, and its use value is extremely high.

[Brief description of the drawings]

FIG. 1A is a partially omitted front view of a shape memory alloy wire. (B) It is a front view of the cylinder after transformation.

FIG. 2 is a partially cutaway front view of the transfer device.

FIG. 3 is an enlarged vertical sectional view of a backflow prevention device for a Y-shaped tube.

FIG. 4A is a schematic view showing a state in which a shape memory alloy wire is transferred to a site of an aneurysm. (B) It is a schematic diagram of an entrance blockage state of an aneurysm.

FIG. 5A is a schematic view showing a state in which a shape memory alloy wire has been transferred to a blood vessel constriction. (B) A schematic diagram of a state in which a blood vessel constriction is expanded.

FIGS. 6 (a), (b), (c) and (d) are schematic developments of a cylindrical shape whose shape is memorized.

FIGS. 7 (e) and 7 (f) are schematic development views of a cylindrical shape whose shape is memorized, respectively.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Shape memory alloy wire 2 Cylindrical body 4 Induction hose 7 Liquid pump 11 Physiological saline 14 Push rod

Claims (2)

[Claims] 1. A flexible linear body having flexibility at a temperature lower than a blood flow temperature in a blood vessel, wherein the linear body has a lesion at a transformation temperature corresponding to the blood flow temperature in the blood vessel. A shape memory alloy wire for blood vessel repair, which has been subjected to shape memory processing so as to be transformed into a cylindrical shape having a predetermined size suitable for treatment of a part. 2. A flexible hose having flexibility which is to be inserted into a blood vessel while the shape memory alloy wire according to claim 1 is inserted, and has an inner diameter slightly larger than the shape memory alloy wire. A hose, a liquid pumping device connected to a base end of the guide hose via a branch hose, and a transformation at a temperature lower than a transformation point of the shape memory alloy wire to be pumped into the guide hose by the pumping device. The apparatus for transferring a shape memory alloy wire into a blood vessel according to claim 1, comprising: a suppression liquid; and means for pushing out the shape memory alloy wire in the guide hose from the distal end of the guide hose to the outside of the hose.