JPH0722584B2 - Therapeutic device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Object of the Invention] (Field of Industrial Application) The present invention relates to a therapeutic device for releasing stricture of a tubular biological organ tube represented by a blood vessel or the like in the therapeutic field.

(Prior Art) A tubular biological organ represented by a blood vessel or the like is a stenosis such as a tissue or a reservoir that grows in the lumen, for example, a stenosis such as an atheroma or a thrombus in the blood vessel. When a stenosis is caused by an object and the transport function of the tubular body organ tube is obstructed, percutaneous angioplasty (percutaneous transluminal angioplasty) is used as a treatment method to secure this lumen.
gioplasty: PTA). In this case, in the treatment that represents a luminal organ such as a blood vessel wall, the blood vessel wall is very thin, and it is very important to perform the treatment without breaking the blood vessel wall.

The treatment method is described in, for example, Japanese Patent Laid-Open No. 62-133970, and for example, a catheter 1 as shown in FIG. 7 is used. The catheter 1 is made of a medical polymer material such as polyethylene, and is provided with a lumen (through hole) 3 for passing a metal guide wire 2 and a lumen (through hole) 4 for passing a pressure fluid such as physiological saline. An expandable and expandable balloon 5 communicating with this lumen 4.
(Balloon) is provided at the tip.

Then, as shown in FIG. 8 (A), the main blood vessel 7 of the human body 6, for example, a portion of the carotid artery or the femoral artery near the skin is incised, and the guide wire 2 is inserted from the incised portion into the lumen of the blood vessel 7. The distal end portion of the guide wire 2 is made to reach the stenosis portion 8 of the blood vessel 7 while selectively passing through each branch in the blood vessel 7 under the observation by fluoroscopy.

Next, as shown in FIG. 8 (B), the lumen 3 of the catheter 1 with the balloon 5 is fitted to the guide wire 2, and the balloon 5 at the tip of the catheter 1 is attached to the blood vessel 7 along the guide wire 2. Lead to the narrowed portion 8.

Then, as shown in FIG. 8 (C), by injecting a saline solution from the outside of the human body 6 into the balloon 5 at the tip of the catheter 1 via the lumen 4 using the syringe 9 or the like, the balloon 5 And expand it with the balloon 5.
The narrowed part 8 of the blood vessel 7 is pushed open, and thereafter, FIG. 8 (D)
The catheter 1 and the guide wire 2 are removed from the blood vessel 7 as shown in FIG.

However, even if the stenosis of the blood vessel 7 is released by this method,
Since the stenosis site 8 is simply expanded, the possibility of restenosis is as high as 30%, and therefore several other treatment methods have been tried recently.

Another method is described in, for example, JP-A-61-56639 and JP-A-62-233168, and uses a catheter 11 as shown in FIGS. 9 and 10. This catheter 11 has a drive shaft 12 inside, and a rotary blade 13 is attached to the tip of the drive shaft 12
An opening 14 is provided on one side of the distal end of the catheter 11 for the catheter 13, and a catheter for the opening 14 is provided.
A balloon 15 is provided on the other side of the distal end of 11, and a lumen 4 communicating with the balloon 15 is provided on the catheter 11.

Then, a guide wire (not shown) is provided from the outside of the human body 6 in the same manner as the guide wire 2 shown in FIG.
To reach the narrowed portion 8.

Next, the distal end of the simple tubular guide catheter 16 is guided to the narrowed portion 8 of the blood vessel 7 along the guide wire in the same manner as the catheter 1 of FIG. 8 (B).

Next, insert a guide wire (not shown) into the guide catheter 16
After removing from the guide wire, the catheter 11 with the rotary blade 13 is inserted into the guide catheter 16 instead of the guide wire, and the tip of the catheter 11 with the rotary blade 13 is inserted into the guide catheter 16
The guide wire (not shown) is replaced with the catheter 11 having the rotary blade 13 by guiding the guide wire to the narrowed portion 8 of the blood vessel 7 along.

Then, from the outside of the human body 6, with the opening 14 of the catheter 11 with the rotary blade 13 facing the narrowed object 8a of the narrowed portion 8,
The balloon 15 is expanded by injecting a cleaning saline into the balloon 15 at the tip of the catheter 11 having the rotary blade 13 through the lumen 4, and the balloon 15 expands the constricted object 8a of the blood vessel 7 to the catheter 8 having the rotary blade 13. The opening 14 of 11 is pressed, and in this state, by rotating the drive shaft 12 from the outside of the human body 6 using the rotary drive machine 17, the rotary blade 13 is rotated and the rotary blade 13 is rotated. The narrowed object 8a is cut off by the rotary blade 13 by moving the narrowed object 8a.

Another method is described in JP-A-62-231650, for example, a catheter 21 as shown in FIG.
Is used. This catheter 21 has a structure in which the rotary blade 13 of the catheter 11 shown in FIGS. 9 and 10 is changed to a drill 22 and the drill 22 is projected from the tip end portion of the catheter 21. , Catheter 11
By turning the drill 22 on the tip of the drill 22
The constricted material 8a is scraped off by a large number of abrasive particles such as diamond particles held on the surface of the.

However, the stenosis of the blood vessel 7 is caused by the size of the lumen of the blood vessel 7,
Since the shape and formation location of the stenosis 8a are various, like the catheter 11 with the rotary blade 13 and the catheter 21 with the drill 22 described above, the treatment device having a hard tip and no mobility,
Since it is difficult to deal with the position, shape, degree, site, etc. of the stenosis and the blood vessel 7 may be pierced, the operator must have a high degree of skill, and there is a problem that technically sufficient treatment cannot be performed.

In addition, recently, a treatment method in which a guide catheter is made to reach the stenosis portion 8 of the blood vessel 7 by a guide wire, and then the guide wire is replaced with an optical fiber, and the stenosis 8a is burned and vaporized by a laser is being studied. However, in the case of the method using this laser, since the laser instantly vaporizes the constricted object 8a, there is a high possibility that the laser penetrates the blood vessel 7,
Due to safety issues, it is still under consideration.

(Problems to be Solved by the Invention) As described above, as a treatment method for releasing the stricture of the lumen of a tubular body organ tube represented by a blood vessel or the like, a balloon dilatation method has been established in terms of safety and technology. However, it is generally performed widely, but it is not possible to reduce the stenosis only by expanding the stenosis, so there is a high possibility of restenosis.

The present invention has been made in view of the above points, and removes a stenosis from a stenosis site safely and easily by applying a balloon expansion method which is established in terms of safety and technology and which is generally performed. That is the purpose.

[Structure of Invention]

(Means for Solving the Problem) The treatment device of the present invention is guided from the outside of the living body by a guide wire inserted into a desired position of the inner lumen of the tubular living body organ, and the outer lumen of the living body is guided. A catheter capable of transmitting a mechanical motion from the outside of the living body to the tip portion, which is inserted into a desired position of the catheter, and an expansion / contraction deformable balloon provided at the tip portion of the catheter,
A balloon expansion balloon provided on the surface of the balloon and having a high hardness, and a balloon inflation lumen provided on the catheter for supplying inflation fluid to the balloon from the outside of the living body. Is.

(Operation) In the treatment device of the present invention, pressure fluid is applied to the balloon from outside the living body via the lumen for balloon expansion in a state where the balloon at the tip of the catheter is positioned at the narrowed portion of the lumen of the living body organ. By supplying, the balloon expands,
Abrasive particles provided on the surface of the balloon are pressed against the constricted object according to the shape of the balloon. Then, by transmitting the mechanical movement from the outside of the living body to the balloon via the catheter, the abrasive particles on the outside of the balloon scrape off the stenosis. Also, when the grinding particles scrape the stenosis, the balloon deforms along the shape of the stenosis, so the balloon deforms into a shape corresponding to the stenosis and makes surface contact, so the entire surface is ground and only the characteristic part It is possible to prevent contact with the inner wall of the body and prevent the inner lumen from being pierced.

(Example) The Example of the treatment device of this invention is described with reference to drawings.

FIG. 1 shows a first embodiment.

In FIG. 1, reference numeral 31 is a catheter made of a therapeutic polymer material such as polyethylene. The catheter 31 has a lumen 32 for expanding a balloon through which a pressure fluid such as a contrast medium or physiological saline is passed and is made of metal. It is provided integrally with the guide wire 33. And this guide wire 33 and catheter
At the tip of 31 is provided a latex expandable and expandable balloon 34 communicating with the lumen 32, and on the outer surface of the balloon 34, a large number of abrasive particles 35 made of high hardness ceramic are held. ing.

Then, in the first embodiment, as in the conventional example shown in FIGS. 9 and 10 described above, the guide wire is attached to the catheter.
By replacing the catheter 31 with the guide wire, the catheter 31 is indirectly guided by the guide wire, and the distal end of the catheter 31 comes from the outside of the human body 6 as a living body to form a blood vessel 7 as a tubular living body organ.
To reach the narrowed portion 8.

That is, a guide wire (not shown) is made to reach the stenosis portion 8 of the blood vessel 7 from the outside of the human body 6, similarly to the guide wire 2 in FIG. 8 (A).

Next, the distal end of the simple tubular guide catheter 16 is guided along the guide wire 2 to the narrowed portion 8 of the blood vessel 7 in the same manner as the catheter 1 of FIG. 8 (B).

Next, insert a guide wire (not shown) into the guide catheter 16
After removal from the guide wire, a catheter 31 with a balloon 34 for grinding is inserted into the guide catheter 16 instead of the guide wire, and the distal end of the catheter 31 is guided along the guide catheter 16 to the narrowed site 8 of the blood vessel 7. A guide wire (not shown) is replaced with a catheter 31 having a balloon 34 for grinding.

Then, by injecting a pressure fluid such as a contrast agent or a saline solution into the balloon 34 at the tip of the catheter 31 from the outside of the human body 6 via the lumen 32, the balloon 34 is expanded and the outer surface of the balloon 34 is ground. Particle 35 is a constriction of blood vessel 7.
As shown in FIG. 1, the surface of the guide wire 33 is pressed against the surface 8a to make a surface contact, and in this surface contact, the guide wire 33 is vibrated outside the human body 6 to move the balloon 34 in the longitudinal direction of the guide wire 33. By moving forward and backward, rubbing the constricted object 8a with the abrasive particles 35, the pressing force becomes stronger as the protruding portion of the constricted object 8a becomes stronger, and as the constricted object 8a is shaved, it becomes a flat polishing, and the constricted object 8a It is something that is scraped off as a whole. Therefore, unlike the conventional case where a hard object comes into contact, line contact or point contact does not occur.
It is possible to evenly scrape the surface of the constricted object 8a while preventing punch-through due to stress concentration at points.

Depending on the state of stenosis, the vibration applied to the balloon 34 is about 10 to 1000 Hz per second in frequency and about 1 to 20 mm in amplitude.
The diameter of the abrasive particles 35 to be used can be changed within a range of
Select in the range of 10 to 1000 μm and grind particles
The density of 35 is also selected appropriately.

Further, the mechanical movement given to the balloon 34 is not limited to vibration but may be rotation, and it is also possible to combine slow vibration with rotation.

Then, as the grinding of the narrowed object 8a progresses, the balloon
Good results can be obtained by increasing the amount of the pressure fluid injected into 34 to keep the contact pressure between the abrasive particles 35 and the constriction 8a constant.

Further, as the material of the balloon 34, natural rubber can be used in addition to the synthetic rubber such as the latex described above.
As the material of 35, a stable substance such as the above-mentioned ceramics and metals may be used, and a meltable / absorbable substance typified by calcium phosphate may be used. It is necessary to devise so that the abrasive particles 35 do not burst.

2 is a modified example of the first embodiment shown in FIG. 1, in which the distal end portion 33a of the guide wire 33 is projected from the balloon 34 and bent, and in this case, a plurality of narrowed portions are formed. It becomes easy to move the balloon 34 to 8.

FIG. 3 is another modification of the first embodiment shown in FIG. 1 and has a structure in which the guide wire 33 of the first embodiment is omitted.

And FIG. 4 shows a second embodiment.

In this embodiment, the catheter 41 has a lumen 44 through which a metallic guide wire 43 is passed, in addition to a lumen 42 for balloon expansion through which a pressure fluid such as a contrast medium or physiological saline passes.
As in the first embodiment, the catheter 41 is provided with the balloon 34 communicating with the lumen 42 for expanding the balloon, and a large number of grinding particles 35 are held on the outer surface of the balloon 34. Has been done.

Then, in the second embodiment, the catheter 41 is directly guided by the guide wire 43 in the same manner as the conventional example shown in FIGS. From the outside of the human body 6 as a living body to reach the narrowed portion 8 of the blood vessel 7 as a tubular living body organ.

That is, like the guide wire 2 of FIG. 8 (A), the guide wire 43 is applied from the outside of the human body 6 to the narrowed portion 8 of the blood vessel 7.
To reach.

Next, along the guide wire 43, the distal end portion of the catheter 41 is made similar to the catheter 1 of FIG. 8 (B),
The blood vessel 7 is guided to the narrowed portion 8.

Then, by injecting a pressure fluid such as a contrast agent or a saline solution into the balloon 34 at the tip of the catheter 41 from the outside of the human body 6 via the lumen 42, the balloon 34 is expanded and the outer surface of the balloon 34 is ground. Particle 35 is a constriction of blood vessel 7.
8a, and in this state, by vibrating the guide wire 33 outside the human body 6, the balloon 34 is advanced and retracted in the length direction of the guide wire 33, thereby rubbing the constricted object 8a with the abrasive particles 35, The stenosis 8a is scraped off.

Further, FIG. 5 is a modification of the second embodiment shown in FIG. 4, and is a cylindrical grinding body that is expandable and expandable outside the balloon 34 at the tip of the catheter 41, like the balloon 34. 46
The grinding particles 35 are held on the outer surface of the grinding body 46.

Therefore, if several grinding bodies 45 having different particle diameters, materials, and densities of the grinding particles 35 are prepared, an appropriate grinding body 46 can be selected according to the constricted state.

Further, FIG. 6 is another modification of the second embodiment shown in FIG. 4, in which grinding particles 35 are held on a part of the outer side surface of the balloon 34, as shown in FIG. And the stenosis 8a is the blood vessel 7.
If the position and direction of the abrasive particles 35 can be confirmed by fluoroscopy when they are offset to a part of the inner cavity of the balloon, the mechanical movement given to the balloon 34 is limited to vibration, so that Stenosis 8a without damaging the luminal mucosa
It is possible to scrape off only.

As described above, the treatment device of the present invention allows the expansion of the balloon 34 to cause the abrasive particles 35 held on the outside of the balloon 34 to become the constricted object 8a.
When the balloon 34 is mechanically vibrated or rotated in this surface contact state, the constricted object 8a can be scraped off by the grinding particles 35.

Then, the speed at which the constricted object 8a is scraped off is determined by the pressure with which the grinding particles 35 are pressed, the diameter, density, type, movement state, etc. of the grinding particles 35, but temporarily, the pressure with which the grinding particles 35 are pressed, the grinding particles If the density, type, etc. of 35 are constant, the speed at which the stenosis 8a is scraped off can be extremely slowed down by controlling the diameter of the grinding particles 35 and the motion state, and there is a risk of puncturing the blood vessel 7. Can be eliminated.

Moreover, since the size of the stenosis material 8a scraped off by the grinding particles 35 is also small, it is possible to reduce the possibility of restenosis in the peripheral portion of the blood vessel 7 due to the scraped off stenosis material 8a particles.

In addition, since the balloon 34 holding the grinding particles 35 has elasticity, the balloon 34 and the grinding particles 35 are soft and in surface contact with the inner surface of the blood vessel 7 and the stenosis 8a, and carelessly make a hole in the blood vessel 7. There is less risk of opening or damaging the inner surface of the blood vessel 7. Therefore, compared with the conventional method using a hard drill cutter, the safety is improved and the size of the lumen of the blood vessel 7 in actual clinical use is It is easy to deal with the position, shape, degree, site, etc. of the stenosis, and technically sufficient treatment can be performed.

〔The invention's effect〕

As described above, according to the treatment device of the present invention, the balloon provided with the abrasive particles is elastically deformable, and the balloon and the abrasive particles correspond to the inner wall and the stenosis of the tubular biological organ represented by the blood vessel. It is transformed into a shape that is soft, and
Since the stenosis is entirely scraped by mechanical movement by surface contact, it does not become line contact or point contact as in the past, so there is less risk of puncturing or scratching the living organ, and safety In addition, the size of the lumen of the tubular organ, the position, shape, degree, site, etc. of the stenosis can be easily dealt with in actual clinical practice, and technically sufficient treatment can be performed.

And since it can be used with a technique similar to the generally widely used balloon dilatation method, it can be used with a simple operative method without requiring a high degree of skill, and moreover, stenosis can be performed. Since it is scraped off, the possibility of restenosis is reduced.

[Brief description of drawings]

1 to 6 show an embodiment of the therapeutic device of the present invention,
FIG. 1 is a sectional view of the first embodiment in use, and FIGS. 2 and 3 are sectional views of a modification of the first embodiment, respectively.
FIG. 7 is a sectional view of the second embodiment, FIGS. 5 and 6 are sectional views of modified examples of the second embodiment, and FIG. 7 is a perspective view of a conventional treatment device, and FIG. FIGS. (A) to (D) are explanatory views of the method of use, FIG. 9 is a cross-sectional view of another conventional treatment device, FIG. 10 is a cross-sectional view of the usage state, and FIG. 11 is another conventional treatment. It is sectional drawing of the use condition of a container. 6 ... Human body as living body, 7 ... Blood vessel as tubular living body organ, 31, 41 ... Catheter, 32, 42 ... Lumen, 3
3,43 …… Guide wire, 34 …… Balloon, 35 …… Grinding particles.

Claims (1)

[Claims] 1. Guided by a guide wire inserted from the outside of a living body into a desired position of a lumen of a tubular living body organ,
From the outside of the living body is inserted into a desired position of the lumen,
A catheter capable of transmitting a mechanical movement from the outside of the living body to the tip, a balloon capable of expansion and contraction deformation provided at the tip of the catheter, and a hardness provided on the surface of the balloon And a large number of highly ground particles, and a balloon dilatation lumen provided on the catheter for supplying dilatation pressure fluid to the balloon from the outside of the living body.