JPH066165B2 - Shape memory balloon catheter - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Industrial field of application) The present invention is useful for shape memory balloon catheters, especially for self-diagnosis of rectal cancer, etc. The present invention relates to a balloon catheter that is solidified to memorize the shape of an affected part state.

(Prior Art) In recent years, most of gastric cancer and the like have been detected early due to the development of preventive medicine, but early detection of colon cancer and the like is only 7.5% of gastric cancer. This is because 1) patients do not receive subjective symptoms due to ignorance of psychological factors or illness. 2) human doctors, because colon cancer is not usually examined in physical examinations. Is a large psychological burden on patients except that colon cancer tests are performed by fecal occult blood test, digital rectal examination, rectoscopy, rectal angiography, and colonoscopy.
This is because there are few examinees.

Therefore, the development of a device that allows a patient to perform self-examination by himself is being advanced, but a satisfactory device has not been obtained yet.

(Structure of the Invention) The present invention relates to a shape memory balloon catheter which can meet such a request, and has a vinyl group-containing organopolysiloxane on the outer surface of a hollow tubular elastic body which can be expanded by the introduction of a fluid. B consisting of a chamber filled with the liquid A from the catalyst and a platinum catalyst, and a vinyl group-containing organopolysiloxane and an organohydrogenpolysiloxane
It is characterized in that the chamber filled with the liquid is covered with a barrier layer that is destroyed when the medium space elastic body is expanded.

That is, the present inventors have conducted various studies on catheters for carrying out screening for rectal cancer, and as a result, the above-mentioned A on the outside of the hollow tubular elastic body which can be inflated by air inflow.
When a liquid and a liquid B are packaged through a barrier layer, and air is sent into the package, the chambers filled with the liquids A and B that are packaged expand as the hollow tube expands. Then, it was found that the barrier layer is destroyed and the liquid A and the liquid B are mixed to form an organopolysiloxane composition that is curable at room temperature, and the curing causes the formation of a silicone rubber layer on the outside of the hollow tube. , For example, if this is inserted into the rectum from the anus and then air is blown in, the silicone rubber layer formed on the outside of this hollow tube is in close contact with the inner wall of the rectum The present invention has been completed by confirming that it is possible to make a mold.

The hollow tubular elastic body constituting the balloon catheter of the present invention may be made of a material that expands when a fluid such as air is introduced, and therefore, this is, for example, vinyl chloride resin,
Thermoplastic resin such as polyethylene, polypropylene, nylon, natural rubber or NBR, SR, EPD
It may be inflatable made of synthetic rubber such as M, IR, CR, silicone rubber, etc., but this is a drug and it is necessary to have a large inflating force. From natural rubber or silicone rubber. It should be noted that this is, for example, inserted from the anus into the rectum for early screening for rectal cancer, so that the diameter is 10 to 20 m before use.
m, length 100-500mm, diameter 40-5 when expanded
It is good to have a size of 0 mm,
Of course, this has one end sealed, but it is preferable that the other end has a valve for introducing air.

The above-mentioned hollow tubular elastic body for a balloon catheter is provided with two chambers filled with the above-mentioned liquids A and B via a barrier layer, which is destroyed when expanded. Need to be. Therefore, this jacket is preferably made of non-expandable or low-expansion film, and therefore it may be made of, for example, metal foil, aluminum sheet, low-expansion plastic film, etc. Since it is necessary that the aluminum foil and the B liquid are not reactive and that they are destroyed when expanded, an aluminum foil or a thin plastic film may be used.

The liquid A has at least one vinyl group bonded to a silicon atom in one molecule, and preferably has a general formula containing 0.05 to 3.0 mol% of vinyl group. R is an alkyl group such as a methyl group, an ethyl group, a propyl group or a butyl group, an alkenyl group such as a vinyl group or an allyl group, an aryl group such as a phenyl group or a tolyl group, a cycloalkyl group such as a cyclohexyl group, Or an unsubstituted or substituted monovalent carbon atom selected from a chloromethyl group, a trifluoropropyl group, a cyanoethyl group, etc., in which some or all of the hydrogen atoms bonded to the carbon atoms of these groups are substituted with a halogen atom, a cyano group or the like. A in hydrogen is 1.8
To 2.1, wherein at least 50 mol% of R is a methyl group, the vinyl group-containing organopolysiloxane in solution A and the organohydrogenpolysiloxane in solution B described below. Platinum-based catalysts as catalysts for addition reaction, such as platinum black, platinum supported on silica, chloroplatinic acid, alcoholic solution of chloroplatinic acid, double salt of chloroplatinic acid with olefin or vinylsiloxane, etc. This liquid B may be a mixture of the above-mentioned vinyl group-containing organopolysiloxane and a hydrogen atom (≡) bonded to a silicon atom in one molecule.
Formula containing at least 3 SiH) And R is the same as above, b and c are 1 or 2 and 2 ≦ b
It may be a mixture with an organohydrogensiloxane that satisfies + c ≦ 4. The liquid A and the liquid B are mixed by breaking the barrier layer to form a room temperature curable organopolysiloxane composition, which after 60 to 180 seconds becomes a cured silicone rubber product by the addition reaction. It is necessary to add 1-10 parts of B solution to 100 parts by weight of A solution.
It is necessary to mix the silicone rubber so that it is in the range of parts by weight, but since the silicone rubber elastic body formed here needs to be molded from the wart-like polybe in the rectum, for example, this silicone rubber is used. The amount of the elastic body is preferably 30 g or more.

Next, description will be given based on the accompanying drawings of this embodiment.
FIG. 1 is a vertical cross-sectional view of the balloon catheter of the present invention before use, which has a room temperature curable silicone rubber KE-45RTV (trade name of Shin-Etsu Chemical Co., Ltd.). Sealed with the rubber stopper 1 made, the inner diameter is 8 mm, the outer diameter is 12 mm, and the length is 300 mm.
A contact between the hollow silicone rubber tube 2 and the silicone rubber liquid A or a mixed liquid of A and B described later is provided in the middle portion of the hollow silicone rubber tube 2 having a hole 13 of 0.5 mmφ in mm pitch. Inner diameter 12 to prevent
mm, the outer diameter is 12.2 mm, and the length is 200 mm. The silicone rubber tube 3 is externally packaged. The silicone rubber tube 3 has an inner diameter of 12.41 which forms the outermost layer with the silicone rubber tube 3.
mm, outer diameter 12.61 mm, length 200 mm Silicone rubber tube 4 Addition reaction type silicone rubber KE-
1925 [trade name of Shin-Etsu Chemical Co., Ltd.] A liquid 5 and B
Liquid 6 is filled and held through a barrier layer 7 made of aluminum foil having an inner diameter of 12.3 mm, a thickness of 10 μm and a length of 200 mm, and these silicone rubber tubes 3 and 4 are room temperature curable silicone rubber KE-42. It is adhered to silicone rubber tube 2 with a trade name of Shin-Etsu Chemical Co., Ltd.

Further, silicone rubber balloons 8 and 9 having a diameter of 12 mm, an outer diameter of 12.2 mm and a length of 20 mm are provided above and below the intermediate portion of the hollow silicone rubber tube 2, and the ends thereof are also provided. A manual air pump 11 having a cock 10 at its part is provided, and the balloon 9 described above is provided.
A grip 12 made of silicone rubber is attached to the lower part of the.

FIG. 2 is a longitudinal sectional view of the balloon catheter shown in FIG. 1 in use (when inflated).
In the use of the balloon catheter shown in the figure, the patient grasps the grip portion 12 and inserts this into the self-diagnosis portion, for example, the anus portion, and then operates the manual air pump 11 to operate the hollow silicone rubber tube 2 When air is introduced into the balloons, the silicone rubber balloons 8 and 9 are inflated as shown in FIG. 2 and fixed in the anus. Then, when the air feeding is further continued, the silicone rubber tube 4 forming the outermost layer of the catheter intermediate portion and the silicone rubber tube 3 inscribed in the hollow silicone rubber tube 2 inflates, accompanied by this. After that, the barrier layer 7 also expands, but since this barrier layer 7 does not have elasticity, it is destroyed by this expansion, and the A liquids 5 and B contained therein are stored.
Mix with liquid 6. When the A liquid 5 and the B liquid 6 are mixed, they immediately undergo an addition reaction and are vulcanized at room temperature for 60 to 180 seconds to become a silicone rubber elastic body, but the silicone rubber elastic body expands. Since it cures in the silicone rubber tube 4 pressed against the rectal wall in the anus, if wart-shaped polybes or the like are present in the rectal wall, the silicone rubber tube 4 will mold the wart-like polybe.

Note that FIG. 3 is a vertical cross-sectional view showing the molding state in the human body. In this case, when the wart-shaped polyp 15 is formed on the rectal wall of the human body 14, this is a silicone rubber. It is modeled by the tube 4.

This modeled balloon catheter can then be withdrawn from the anus and presented to the doctor for diagnosis by the doctor, but in some cases, after the model is finished, the manual air pump 11 is used. When the hollow silicone rubber tube 2 is decompressed, the air expansion part 16 shrinks until the silicone rubber hardens, so if you take it out and present it to the doctor, the doctor will re-inject air into it. If so, the shape in the rectum is reproduced as it is, and the doctor may make a diagnosis based on this.

Since the shape memory balloon catheter of the present invention is configured as described above, a patient suspected of having rectal cancer can visually check it by working at home by using it. It is said to be useful for diagnosis, and it can be submitted to a doctor for diagnosis by a doctor, but it can also be used for detecting polybe in a dining room, a uterus, etc.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of the shape memory balloon catheter of the present invention before use, FIG. 2 is a vertical cross-sectional view of the shape memory balloon catheter during use (when inflated), and FIG. 2 is a vertical sectional view of FIG. DESCRIPTION OF SYMBOLS 1 ... Rubber stopper, 2 ... Hollow silicone rubber tube, 3, 4 ... Silicone rubber tube, 5 ... A liquid layer chamber, 6 ... B liquid layer chamber, 7 ... Barrier layer, 8, 9 ... Balloon part, 10 ... Kok, 11 ... Manual air pump, 14 ... Human body part, 15 ... Wart-shaped probe, 16 ... Air expansion part.

Claims (3)

[Claims] 1. A chamber in which a liquid A containing a vinyl group-containing organopolysiloxane and a platinum-based catalyst is filled on the outer surface of a hollow tubular elastic body which can be expanded by feeding a fluid, a vinyl group-containing organopolysiloxane, and an organohydro. A shape memory balloon catheter, characterized in that a chamber filled with a liquid B composed of diene polysiloxane is exteriorly provided via a barrier layer that is destroyed when the hollow tubular elastic body is expanded. 2. The shape memory balloon catheter according to claim 1, wherein the barrier layer is an aluminum foil. 3. The shape memory balloon catheter according to claim 1, wherein the barrier layer is a thin plastic film.