JPH0213423A - Balloon for catheter and manufacture thereof - Google Patents

Abstract

PURPOSE:To enable transmission of a laser beam and to be seen through by fitting a transparent thin film body having an expansion portion formed at the forward end of a fixed portion in the same boby to the forward end of a catheter to let physiological salt water flow in the expansion portion to be expanded. CONSTITUTION:A transparent thin film body A has an expansible expansion portion 2 formed in one body at the forward end of a fixed portion 1 and elasticity. The fixed portion 1 is fixed to the forward end portion (b) of a catheter B where an endscope tube C is inserted, and the expansion portion 2 is projected from the forward end of the catheter B to cover the main body A. The expansion portion 2 comprises a spherical body having the elasticity, which is formed at the forward end of the fixed portion 1. When the main body A is fixed to the forward end portion (b) of the catheter B to be covered therewith, physiological salt water is let flow from a pouring port of a channel of an endsoope projected from the forward end and inserted in the catheter, thereby expanding the expansion portion to a designated size, so that film thickness is further decreased to enable seeing through and a laser beam such as argon laser can be transmitted.

Description

Detailed Description of the Invention (Field of Industrial Application) The present invention is applicable to intravascular and luminal organs (esophagus, stomach, bifatty intestine, large intestine, nasopharynx, biliary tract, abdominal cavity, urinary cavity, uterine shin, etc.). ) Manufacture a balloon to be used by attaching it to the tip of a catheter into which the tube of the endoscope is inserted to cover the endoscope for laser beam therapy (1) to observe and treat the inside of the body (2) for diagnosis and treatment. It's about how to do it. .

(Prior art and issues) Conventionally, within? Ji! There was no balloon for the catheter to insert and close the mirror duplex. Therefore, a catheter equipped with an endoscope is inserted into the blood vessel (intravascular system) or a luminal organ, and the inside is illuminated with a light guide at the tip of the endoscope duplex, and the objective lens is used to detect bleeding sites, lesions, and other affected areas. For observation and diagnosis, an optical fiber is inserted through a channel, which is a hole into which a treatment tool or the like is inserted, and the affected area is irradiated with a laser beam for treatment.

However, because the light guide, objective lens, or optical fiber at the tip of the endoscope is exposed, white fluid, body fluids, food, sarcoma secretions, etc. can easily adhere to it, making it difficult to see the affected area due to contamination. Or the irradiation was not sufficient. In addition, there was a risk that 1 liter of these materials would corrode and no longer function adequately.

Furthermore, as a balloon catheter, Japanese Patent Application Laid-Open No. 63-13
No. 9565, No. 139566, X139!1 (i7
Described in each bulletin of the issue! There is this b.

However, in the cases described in these publications, because the Cavendel main body has a triple tube structure of an outer tube, a middle tube, and an inner tube, or a knee tube structure, it is difficult to insert the endoscope into the body. It cannot be used as an endoscopic catheter. Moreover, these balloons are for occlusion and are made of elastic 41F material such as silicone rubber, polyurethane, or latex.
Although it was molded with I, there was no mention of transparency, and it was impossible to transmit or see through laser beams.

(Means for Solving Problems) The present invention has been made in view of the above-mentioned circumstances, and its means is to form a transparent thin film body by forming an inflatable part at the end of a fixed part in the same body with a rubber body. This is attached to the tip of a catheter, and physiological saline flows into the expansion section to inflate it.

(Function) The present invention is a thin rubber body, an inflatable part is formed in the same body at the end of a fixing part, a transparent thin film body is provided, and the fixing part is attached to the distal end of a catheter. It protects the light guide, objective lens, optical fiber, etc. at the tip of the endoscope tube inserted into the catheter.
By avoiding the flow of physiological saline into the inflatable part and not inflating the eye, the laser beam can pass through the eye and it becomes possible to see through the eye.

(Example) To explain several embodiments of the present invention with reference to the drawings, the transparent film body (A> has a film thickness of 010 to 0.40 nmr).
A transparent thin film made of natural rubber or silicone rubber with a Pi of 1 degree, and an inflatable part (2) that can be worn at the end of the fixing part (1).
) are formed in the same body and have elasticity, and the fixed part (1) is the distal end part (b) of the catheter (B) into which the endoscope (C) is inserted. The inflatable part (2) is made to protrude from the tip of the catheter and the main body (△
).

The fixed part (1) is open at all ends and has a diameter of 1.0 to 1.
It has a cylindrical shape of about 7.0 tnm, and its cross-sectional shape can be any shape such as circular, circular, triangular, quadrilateral, and other polygons, and if necessary, the inner or outer surface may have convexities, four parts, uneven stripes, etc. The tube (C) of the endoscope (C) is inserted into the fixing part (1) from the open part so that the inflatable part (2) protrudes from the other end. Insert the distal end (b) of the catheter (B) into which the catheter (B) is to be inserted, and tie it with surgical thread, use adhesive, or fix it by other means. At this time, It is effective to provide anti-slip unevenness on the outer surface of the tip (b) of the chichiru (B).

The expanding part (2) is formed from a stretchable spherical body (Fig. 1, Fig. 6), a bulging body (Fig. 8), or a cylindrical body (Fig. 7) formed at the end of the fixed part (1). When the main body (A) is covered and fixed to the distal end (b) of the catheter (B), the endoscope channel or air/water supply port or the catheter itself protrudes from the distal end and is inserted into the cab. When the raw 1!I! saline solution flows in from the injection port of J:, it expands to a predetermined size. It is optional to form it in a large diameter shape (FIGS. 6 and 8), or to make it slightly smaller in diameter than the fixing part (FIGS. 1 and 7), or to have approximately the same diameter, Moreover, the combination of shape and diameter is also arbitrary.

In addition, its diameter is approximately 09 to 35.0 mm, depending on the location of diagnosis and treatment. Becomes able to pass through laser beams such as Yag laser, argon laser, and argon dye laser. In addition, the bulge compresses and stops the affected area such as a bleeding site or lesion, or widens a stenotic area, and furthermore, within the blood vessel, the bulge comes into close contact with the inner surface of the blood vessel and stops the flow of white fluid. It is also true.

The natural rubber thin film contains 0.7 to 15 parts of powdered vulcanizing agent per 100 parts by weight of the rubber content of natural rubber latex.

Powder vulcanization (adhesive aid 0.2-05 parts, liquid vulcanization accelerator 0.5-2.0 parts, liquid anti-aging agent 05 parts)
A manufacturing mold having the same shape as the main body (A) is immersed in a solution containing ~2.0 parts by weight with the expanded part facing downward, and then pulled out to adhere natural rubber to the mold. After drying, the fixing part (1) and the expanding part (2) become one and the IC film thickness is 0.
．． This is responsible for the elasticity of the transparent thin film of 10 to 0.0 mm, and the top surface (2)' of the expansion part (2) has a platform that is somewhat thick.

As mentioned above, the basic concept of the present invention is that it consists of a transparent thin film body (A>) in which the expansion part (2) is integrally formed at the end of the fixing part (1), but the fixing part (1) and Install the constriction part (3) between the expansion part (2) (Fig. 1, Fig. 10)
, or the expansion part (2) is provided with a tear prevention film (4) (Figs. 9 and 10), or the constriction part (3) and a tear prevention film (4) are provided (Fig. 10). )? l- It is something that can be done.

That is, the constriction part (3) is a small diameter part formed between the cylindrical fixing part (1) and the spherical expansion part (2), and is about 75 to 85% (on average) of the diameter of the fixing part. 80%), and its thickness is slightly thicker than that of the fixed part and the expansion part.

Cylindrical fixed part (1) 2 spherical expansion part (2), top part (2>'
, the film thickness at the fin (3), the inner diameter (X) (Y) (Z) at each part, the overall length (J, and the length up to the fin (m)) Some examples of the relationship are shown below, but the relationship is not limited thereto.

-9= The tear prevention film (4) is formed in the form of a thin film on the expansion part (2), and is coated with natural rubber, silicone rubber, synthetic rubber such as CR, SBR, etc. of the same quality as the expansion part (2). Or, it is attached to the expanded part (2) and has extremely good adhesion, expands and contracts together and does not peel off, and the top surface (2)' of the expanded part (2) is preferable, but it interferes with transparency and laser beam permeability. (If you press it, you can form it not only on the top surface but also on a wide area,
It may be somewhat thick. Even if the so-called inflatable part (2) were torn, the shrinking action would still work without any fragments being scattered.

In addition, as shown in Fig. 8, Fig. 12, and Fig. 13, the fixed part (1
) and the inflatable part (2), or on three sides of the tip of the inflatable part (2) or the inflatable part. It is also optional.

The balloon constructed as described above is attached to the tip (b) of the catheter (B) to which the tube (C) of the endoscope (C) is attached, and the catheter (B) is used in this type of technical field. Well-known 11 Urethane, polypropylene, vinyl chloride, rubber, silicone, etc. in one form and structure. A catheter (C) or an optical fiber (10) is inserted and attached, and a transparent fiber is attached to the distal end (b) of the catheter (B).
! I Fix the thin film body (△). The tip RJ of the endoscope (C) has an objective lens (6) and this objective lens (6).
) two lies 1 to guide (7) to illuminate the field of view (
7), the tunnel (8) or air/water supply port (9) for inserting treatment tools such as treatment instruments and forceps is open, and the catheter and endoscope (C) are opened. The tip of the laser beam is placed inside the organ or blood vessel and can be moved freely up, down, left and right, and the optical fiber (10) is inserted into the channel (8) of the platform where the laser beam is irradiated. 1. It is free to provide unevenness (11) such as protrusions, protrusions, or grooves on the outer surface of the distal end (b) of this catheter to prevent the catheter from slipping.

Irregularities (11H; L catheter (B) with many independent or continuous protrusions or grooves formed on the outer surface of the tip of the catheter (B), such as four parts, vertical stripes, horizontal stripes, ring shapes, etc.) The shape is arbitrary, and the fixing part (1
) can be securely attached by covering the sea urchin.

Next, to explain about FIGS. 17 to 20, the swelling part (
12) has a film thickness of 010 to 0, similar to the expansion part (2) described above.
It is a transparent stretchable thin film made of natural rubber or silicone rubber with a culm thickness of 4 mm, and is formed into a hollow shape. Physiological saline is injected into the hollow interior, and then it is engraved to an appropriate size. Transparency is further improved, improving visibility, and the transmission of laser beams from the optical fiber (10) is also improved, and this expanded portion (12)
Fix the mounting ring (14) to the inner surface of the frontage part (13),
The distal end (b) of the catheter (B) is removably screwed onto the fiber support (d).

The attachment ring (14) connects the inflatable part (12) to the catheter (B
), and a screw is cut into the inner surface of the ring so that it can be freely screwed onto the fiber support (d), and the outer surface has a bulging part -13= (12) Secure the opening (13) with adhesive or the like and inflate it.
The structure shall be integrated with the department.

The optical fiber (10) has a form and structure well known in this type of technical field, and an optical fiber (10) or a tube (C) of an endoscope (C) is inserted into the catheter (B). The optical fiber (10) can transmit laser beams such as YAG laser, argon laser, argon dye laser, etc., and is supported by a support (d) at the distal end (b) of the catheter (B). Fiber support (
d) adheres to the inner surface of the tip of catheter (B) and
It supports the fiber (io), and has a screw carved into the outside of the tip to engage with the screw of the attachment ring (14), and a groove or hole (C') on the inner surface that does not allow saline to pass through. Lay it out as appropriate [
Directly into the catheter (B) or through the endoscope (C) channel or air/water supply [1 to 1- Immediate saline is injected into the inflated part (12) through the catheter and hole (d'). Injection filling.

The engraving is performed by injecting physiological saline into the expanded portion (12), which improves the transparency and improves the visibility of the V-glazer, Al-inlay 11-. It also improves the penetration of laser beams such as argon dye laser. This bulge also presses on bleeding sites or lesions, widens stenotic areas, or comes into close contact with the inner surface of blood vessels to stop blood flow.

Next, to explain the manufacturing method of the balloon with the above structure, a small amount of powdered vulcanizing agent and powdered vulcanization accelerator are blended into natural rubber latex, the amount of powder additives is suppressed as much as possible, and liquid vulcanization accelerator and liquid aged The mold is immersed in a mixed solution containing an inhibitor.

The blended solution should contain 07 to 1.5 parts of the powder vulcanizing agent per 1 () 0,000 parts of rubber of the natural rubber latex, preferably 08 parts.
~12 parts by weight, 0.2-05 parts of powder vulcanization accelerator, preferably 03-04 parts, and 05-2 parts of liquid vulcanization accelerator
0 parts by weight, and 05 to 20 parts by weight of a liquid anti-aging agent. ii! The mixing method is to add the dispersed vulcanizing agent and vulcanization accelerator to natural rubber latex, mix and stir, and then add the vulcanization accelerator and anti-aging agent.
・After being left in a constant temperature bath at ~1;)℃ for 12 to 24 hours,
Furthermore, it is left to mature for 24 to 48 hours in a constant temperature bath at 25 to 35 degrees Celsius. Ru.

The mold is a so-called oil immersion mold for obtaining a single body with a predetermined size and shape, and this mold is immersed in a coagulant and then immersed in the mixed solution for about 30 to 60 seconds, and then Slowly pull up natural rubber 0.10-10,40
After forming a layer of 1x11, heat and vulcanize at 80 to 90°C for 30 minutes to form a thin film, remove the mold using release powder, wash the mold, dry it, and re-immerse it in the original coagulant. This is done repeatedly.

After washing the demolded pleural body, it was treated with silylone emulsion to give it a transparent appearance, and dried at 80°C for about 60 minutes.
Perform one-piece cutting to the specified length. This transparent thin film main body (A) has a telescopic and inflatable inflatable part (2) disposed at the end of the fixed part (1) in the same body. Conditioned inner diameter 10-17.0m
It has a cylindrical shape of about m in diameter, and when seen through the expansion part (2),
By injecting physiological saline through the channel (8) formed on the endoscope to be installed in the catheter, the air/water supply port (9), or the injection port of the catheter itself, the transparent inflatable portion (2) is injected. ) is a spherical body, a bulging body, or a cylindrical body that expands the fat to a predetermined size. In this case, as described above, the inflatable portion may be formed to have a larger diameter, smaller diameter, or the same diameter than the fixed cylindrical portion, or a small diameter constriction may be formed between the inflatable portion and the fixed cylindrical portion. Alternatively, it is also possible to provide the reinforcing convex ring in the same body. Its inner diameter is also 0.9~35.
Choose a human-sized one depending on the location of diagnosis and treatment, such as a culm size of 0 mm, and in any case, it will swell by injecting physiological saline, making the thin film even thinner, making it even better to see through, and allowing the laser beam to pass through. It is.

Specific embodiments Natural rubber latex Rubber content (cis-1,4-polyisoprene) 100,000 parts Vulcanizing agent (colloidal sulfur) 1.2 parts by weight Powder vulcanization accelerator (zinc oxide) 0.35 parts by weight A blended solution consisting of 1 part vulcanization accelerator (didiocarbame 1-based), 087 parts by weight anti-aging agent (paraffin emulsion) 10 parts by weight is used.

The mold was slowly immersed in a coagulant solution containing 10% calcium nitrate and methanol at room temperature, immediately pulled up slowly, and then slowly immersed in the above-mentioned mixed solution for 3 hours at room temperature.
After 0 to 60 seconds, slowly lift it up and attach natural rubber.8
After heating and vulcanizing at 0℃ for 30 minutes, a fixed part with a film thickness of 0.1f3g and an inner diameter of 1.94mm was formed, and a film thickness of 0.22mm was formed beyond that.
m, the film thickness is o, 1 through the constriction with an inner diameter of 154
6, the spherical swelling part with an inner diameter of 1.81 m is the same, and the film thickness on the top surface of the swelling part is 0.19 m, and the thin film material is removed using peeling powder. Mold 40”-50°
After extraction for about 24 hours in Q's circulating dry water, soak it in a 10% silicone emulsion at room temperature.
After drying for a few minutes, a transparent thin film body with poor transparency was obtained.

The transparent thin film main body (A) dip-molded as described above is not limited to the above dimensions and wall thickness, and as shown in the drawing, a swelling part (2) is attached to the tip of the fixing part (1). It is of any shape, size, and thickness, with a constriction (3) or reinforcing protrusion (/I) between the two (1) and (2) as necessary. Insert the sea urchin body (A) into the catheter (
It is fixed to the tip (b) of B) so that the engraved part protrudes (=J+).

(Effects of the Invention) The present invention provides a transparent thin film main body by forming an engraved part at the end of a fixing part in the same body, and attaches this main body to the tip of a catheter so that the engraved part protrudes from the tip. By engraving the coating and flowing physiological saline into the engraved part, the body was engraved to allow the laser beam to pass through and to be seen through.The body was attached to the tip of the catheter (by pulling it), and the inside of the body was engraved. Is the tube of the endoscope attached to the body directly connected to blood or the body?
i! It is hygienic because it does not come into contact with other substances such as 2, etc., and only -6
1 Lie at the tip 1 ~ guide, objective lens, light) i
・It protects the blood and secretions and allows the body to perform its functions without being covered by blood or secretions. Also, insert it into the cabo-al and 7. - By inflating the engraving by infusing physiological saline through the channel of the endoscope, the air and water supply port, or the inlet of the catheter, a predetermined space is created and the field of view becomes wider, making it easier for observation and diagnosis, or Treatment can be performed easily and reliably. Therefore, for example, by diagnosing a focus of thrombotic disease, etc., by irradiating the focus with a laser beam, or by compressing the focus of esophageal varices or the focus of the stomach, duodenum, etc., to suppress bleeding and stop the bleeding. 1. Laser beams such as Yag laser, argon ray, and argon dye laser that pass through optical fibers are irradiated to the affected area in the Sendai organ to prevent bleeding. It can be treated by stopping the disease, cauterizing the lesion, or by injecting or administering a medicinal solution to the affected area, which is useful in providing new treatment methods.

In addition, since the flow of blood can be stopped within the blood vessel, there is no need to make an incision at another location to prevent blood flow, and there is no need to insert a catheter for blood vessels.

Furthermore, a spherical expanded portion is formed on one of the cylindrical solid portions through a constricted portion by infiltration molding of the transparent thin film body, and the film thickness of the constricted portion is made thicker than that of the fixed portion and the expanded portion. Because it is arranged in a shape, the shaping of the main body is extremely good, and when engraving the spherical swelling part, the constriction has a tightening effect, and the swelling part located at the tip of the spherical swelling part has a tightening effect. can be easily inflated.

Furthermore, by installing a tear-prevention film on the engraving area, when using a single needle when injecting or administering a drug solution, or when using an optical fiber for laser beam irradiation, In addition, even if the optical fiber hits the engraving, it is less likely to rupture, and even if it ruptures, the fragments can be prevented from scattering into the blood vessels or organs, and the engraving can be carried out. This will prevent the printing plate from shrinking.

In addition, the present invention uses 0.7''-1.5 parts by weight of a powder vulcanizing agent, 0.2 to 05 parts by weight of a powder vulcanization accelerator, and a liquid granulation accelerator for 100,000 parts of rubber content of natural rubber latex. Agent 05-2
The mold is immersed in a mixed solution containing 0 parts by weight and 0.5 to 20 parts by weight of a liquid anti-aging agent and vulcanized and dried, resulting in a thin film body that is transparent and has great strength. It is possible to achieve this without overlooking the discovery of lesions, and to achieve great results in treatment through laser beam irradiation.The laser beam has an extremely high transmittance and is durable.

[Brief explanation of the drawing]

The drawings show several embodiments of the catheter balloon of the present invention, and FIG. 1 is a longitudinal sectional front view, and FIGS. 2 and 3 are lines (2)-(2) and (3)=(3). A cross-sectional view along the line, Figure 4 is a diagram with the endoscope duplex attached to the tip of the catheter attached inside, Figure 5 is a diagram with the endoscope inserted into a blood vessel and the engraved part is inflated, Figures 6 to 13 are views of other embodiments, Figure 14 is a front view of the endoscope duplex attached to the tip of the catheter, and Figures 15 and 16 are embodiments of the endoscope attached to the tip of the catheter. Fig. 17 is a longitudinal sectional front view with the endoscope omitted and the optical fiber attached.
Figure 8 is a cross-sectional view taken along line (18)-(18), Figure 19 is a cross-sectional view of the disassembled state, and Figure 20 is an enlarged view of the vJ@ section inserted into the blood vessel -22= and inflated. In the figure, (A> is the transparent thin film body, (B) is NoJ Chichiru, (
C) is an endoscope, (c) is its tube, (1) is a fixed part, (2) is an inflatable part, (3) is a constriction part, and (4) is a torn waterproof membrane. Patent applicant Okamo 1 ~ Co., Ltd.

Claims (7)

[Claims] (1) A transparent thin film main body is provided by forming a stretchable inflatable part at the tip of the fixed part in the same body, and this main body is attached to the distal end of the catheter so that the inflatable part covers the distal end in a protruding manner, 1. A balloon for a catheter, which is inflated by flowing physiological saline into the inflatable portion through a tube of an endoscope, and is transparent to a laser beam and can be seen through the balloon. (2) An inflatable part is formed in the same body at the tip of the fixing part, and a transparent thin film body is provided, and the fixing part is made into a cylindrical shape with an arbitrary cross-sectional shape, and the inflatable part is made into a hollow spherical body or a bulging body. Alternatively, the catheter balloon according to item 1, which is formed into a cylindrical body. (3) A spherical expanding part is formed on one side of the cylindrical fixing part through a constriction part by dip molding the transparent thin film main body, and the film thickness of the constriction part is made larger than the film thickness of the fixing part and the expanding part. 2. The balloon for a catheter according to claim 1 or 2, characterized in that the balloon has a thick wall. (4) A catheter according to items 1 to 3, characterized in that the main body is made of a transparent stretchable thin film, and an inflatable part is formed in the same body at the tip of the fixing part, and a tear-preventing film is provided on the inflatable part. balloon. (5) The main body is made of a transparent stretchable thin film, and a spherical expansion part is formed on one side of the cylindrical fixed part through a constriction part, and the film thickness of the constriction part is made thicker than that of the fixed part and the expansion part. 3. The balloon for a catheter according to items 1 and 2, wherein the balloon is thick, the diameter of the inflatable part is smaller than the diameter of the fixed part, and the inflatable part is provided with a tear-preventing membrane. (6) A catheter in which a hollow expansion part is formed with a transparent stretchable thin film, a mounting ring is fixed to the inner surface of the opening of the expansion part, and the mounting ring can be freely screwed into the mounting part formed at the tip of the catheter. balloon. (7) Per 100 parts by weight of the rubber content of natural rubber latex, 0.7 to 1.5 parts by weight of powder vulcanizing agent, 0.2 to 0.5 parts by weight of powder vulcanization accelerator, and liquid vulcanization accelerator 0.5-2.0
parts by weight, and 0.5 to 2.0 parts by weight of a liquid anti-aging agent are added to form a compounded solution, a mold is immersed in this solution to adhere natural rubber, and after vulcanization and drying, the mold is demolded. A method for manufacturing a catheter balloon comprising a transparent thin film main body in which an inflatable part is integrally formed at the tip of a cylindrical fixing part.