JP2006130240A - Lubricant member and medical instrument using the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a lubricant member having a durable lubricant surface and rubber-like flexibility adaptable to a human tissue and having superior adaptability to a medical instrument in particular. <P>SOLUTION: This lubricant member 10 is formed of a composite material formed by mixing reinforcer and supersaturated amount of collagen with polyisoprene rubber and is so constituted that its surface expresses lubricating property by the contact with liquid. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a lubrication member having a lubrication surface and a medical instrument using the lubrication member.

  For example, in modern medicine, there are many types of medical instruments that are directly inserted into lumens such as body cavities and internal organs, such as catheters, fiberscope endoscopes, and artificial hearts, for diagnosis and treatment of diseases. in use. Recently, capsule endoscopes that are swallowed have also been developed. These medical devices are generally made of metal, plastic, etc., but the common and important problem required for them is that they do not cause pain or pain when inserted into a lumen. Also, it can be inserted smoothly and smoothly without damaging human tissue.

For this reason, conventionally, as shown in Patent Document 1, for example, the surface of a medical device is coated with a hydrophilic polymer having various components so that the surface has lubricity.
However, the hydrophilic layer formed by such a coating has low durability, and is liable to be peeled or eluted by contact with a human tissue.

In addition to the above-described surface lubricity, this type of medical device is also required to have a flexibility that conforms to the flexibility of human tissue, either on its surface or in its entirety. In particular, in the case of a tube-like medical instrument such as a catheter, it is inserted while being bent into a complicatedly branched or bent lumen such as a blood vessel or an organ, so that it is too strong with human tissue in the bent portion or the like. In preventing contact, the provision of flexibility is a very important factor.
However, when medical devices are made of plastic as in the past, the flexibility of plastic is fundamentally different from the softness of blood vessels and organs. It was very difficult to have.

On the other hand, rubber has flexibility different from plastic, and is similar to the softness of blood vessels and organs, so forming a medical instrument with this rubber eliminates the above-mentioned problems regarding flexibility. Can be considered. In this case, isoprene rubber having the same composition as natural rubber is known as a rubber material that does not cause allergies to the human body. Therefore, it is possible to use this isoprene rubber.
However, since the rubber surface is inferior in smoothness, it is very difficult to provide lubricity. The conventional method of coating the hydrophilic polymer has safety problems such as peeling and elution because the durability of the hydrophilic layer is low as described above.
JP 2003-144541 A

  SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a lubrication member having a durable lubrication surface and a rubbery flexibility that can be adapted to human tissue, and particularly excellent in adaptability to a medical device, and the lubrication member. To provide a medical instrument using a sex member.

  In order to achieve the above object, according to the present invention, the polyisoprene rubber is formed of a composite material obtained by blending a reinforcing agent and a supersaturated amount of collagen, and the surface exhibits lubricity by contact with a liquid. A lubricious member is provided.

  A vulcanizing agent is added to the composite material, and the composite material is molded into a predetermined shape and then vulcanized.

  Moreover, according to this invention, it has a body insertion part which contacts a human body tissue by insertion in a body, and at least surface layer part of this body insertion part is formed with the lubricating member of Claim 1 or 2. Thus, a medical instrument configured such that the surface exhibits lubricity by contact with body fluid is provided.

  The in-vivo insertion portion may be formed of the lubricating member as a whole, or the surface thereof may be covered with the lubricating member.

  In the medical instrument of the present invention, the in-vivo insertion portion has a tube shape or a capsule shape.

The lubrication member of the present invention exhibits lubricity due to contact with a liquid, so that the lubrication member is required to have a lubricity surface, for example, a medical instrument such as a catheter or a fiberscope endoscope. By using it in the body insertion part, it exhibits a superior effect.
That is, when the body insertion part comes into contact with a body fluid such as blood or saliva, the supersaturated amount of collagen elutes on the surface and becomes slimy, thereby forming a superior lubricity surface. Can be smoothly inserted into the lumen.
In addition, since the lubricating surface is formed by collagen blended with polyisoprene rubber, there is no problem of loss of function due to peeling or elution, as in the case of forming a hydrophilic layer by coating a hydrophilic polymer. The durability of the lubricating surface is superior. Moreover, since collagen is a kind of human body constituent and is not harmful, safety can be improved even when it is used in a medical instrument.
Furthermore, since polyisoprene rubber is superior in flexibility compared to plastic, it is possible to easily obtain rubber-like elasticity according to the application by changing the compounding ratio of the reinforcing agent and collagen. When used in the body insertion part of a medical instrument, it is possible to have various flexibility that matches the softness of blood vessels and organs.

  FIG. 1 and FIG. 2 are a partial side view and a sectional view showing a first embodiment of a lubricating member according to the present invention, and the lubricating member 10 is elongated and flexible in a circular or elliptical cross section. It is formed in a tubular shape and is suitably used as an in-vivo insertion portion in a medical instrument such as a catheter or a fiberscope endoscope. Therefore, these drawings also show the first embodiment of the medical instrument using the lubrication member 10 as an in-vivo insertion portion. The “lubricating member” and the “in-body insertion portion” are substantially the same. In the following description, they are denoted by the same reference numeral “10”.

  The body insertion portion 10 is a portion that comes into contact with human tissue by being inserted into a body cavity such as a body cavity or internal organs in a human body, specifically, a lumen such as a blood vessel, urethra, esophagus, stomach, or intestine. In the inside, a medical instrument or a medical solution or the like is inserted.

  The lubricating member 10 is made of polyisoprene rubber as a main material, and is integrally molded as a whole by a composite material in which a reinforcing agent and a supersaturated amount of collagen are blended, and rubber elasticity is given by vulcanization treatment. Yes. Specifically, for example, with respect to the polyisoprene rubber 100, a supersaturated amount of about 2 to 50 parts of powdered silica as a reinforcing agent and 100 parts or more of collagen, that is, an amount adsorbed by the polyisoprene rubber and the powdered silica. Is blended in an amount exceeding the above, and kneaded with a kneader until the viscosity becomes sufficiently low. Next, an appropriate amount of sulfur, peroxide, or other vulcanizing agent is added to the kneaded compound, and after kneading again, this composite material is extruded into a tube having the required shape and dimensions, and heat and pressure are applied. The lubricating member 10 is obtained by vulcanization.

The lubrication member 10 is suitably used as the in-vivo insertion part in a medical instrument such as a catheter or a fiberscope endoscope after the necessary finishing or additional processing is performed after the vulcanization treatment. In diagnosing or treating a disease, the body insertion portion 10 is inserted into a lumen such as a body cavity or a viscera. At this time, when the body insertion portion 10 comes into contact with a body fluid such as blood or saliva, the collagen containing the supersaturated amount is mixed with the body fluid and eluted on the surface, resulting in a slimy state. The surface of 10 exhibits excellent lubricity and can be smoothly inserted into lumens such as body cavities and internal organs.
In addition, since the surface of the body insertion portion 10 does not yet exhibit lubricity at the stage of starting insertion, for example, the body insertion portion 10 is immersed in physiological saline or the like heated to a human body temperature, and the lubricated surface is previously applied. It is desirable to use after expression.

The preferable diameter, length, thickness, and the like of the internal body insertion portion 10 vary depending on the type and use of the medical instrument, but the thickness is about 1 to 2 mm as a guide. Further, the blending ratio of the polyisoprene rubber, the reinforcing agent, and collagen also varies depending on the type and use of the medical instrument. By changing the blending ratio of the reinforcing material, the flexibility of the in-body insertion portion 10 can be adjusted according to the application. That is, the polyisoprene rubber is superior in flexibility to plastic and has basic softness that is easy to adapt to blood vessels, organs, etc., so the flexibility is adjusted by changing the blending ratio of the reinforcing agent. This makes it possible to give the body insertion portion 10 various flexibility that matches the softness of the blood vessels and organs to be used. As a result, the body insertion portion 10 smoothly moves along the complicatedly curved lumen. Good operability and followability can be obtained, such as being able to be inserted while being bent. In addition, the surface flexibility absorbs shock when coming into contact with human tissue and prevents excessive contact, thereby preventing damage to the tissue.
As the reinforcing material, polyethylene powder can be used in addition to the powdered silica.

  Further, the lubricity of the surface of the lubricating member 10 (in-body insertion portion 10) can be adjusted by changing the blending ratio of collagen. This collagen has a good compatibility with the polyisoprene rubber, and reduces the function of the silica as a hardener when adsorbed to the reinforcing material, that is, silica, so that it also functions as a softening agent. Therefore, by blending this collagen in a supersaturated amount that exceeds the amount adsorbed on the polyisoprene rubber and powdered silica, the supersaturated collagen is eluted on the surface by contact with moisture and expresses a lubricating surface. .

  In addition, since the said collagen is a kind of constituent substance of the human body and is not harmful, it is safe to elute. In addition, this collagen is blended in polyisoprene rubber and forms a lubricious surface by appearing on the surface of the body insertion part 10 one after another, so that a hydrophilic layer is formed by coating a hydrophilic polymer. There is no problem of loss of function due to such peeling or elution, and the durability of the lubricating surface can be improved.

  FIG. 3 shows a cross-section of the in-vivo insertion portion in the second embodiment of the medical instrument according to the present invention. The in-body insertion portion 20 of the second embodiment is the first embodiment shown in FIG. 1 and FIG. The difference from the in-vivo insertion portion 10 in the medical device of the embodiment is that the in-vivo insertion portion 10 of the first embodiment is formed integrally with the lubrication member, whereas in the second embodiment. The body insertion part 20 is that the surface is covered with the lubricating member 10. That is, the in-vivo insertion portion 20 is formed in a multilayer shape by a tube-shaped insertion portion main body 21 and the tube-like lubrication member 10 attached to the surface thereof, and the surface layer portion thereof is lubricated. It is covered with the sex member 10. In this case, the lubricating member 10 is formed of the composite material formed by blending a reinforcing agent and a supersaturated amount of collagen with polyisoprene rubber. Are made of another flexible material such as synthetic resin or polyisoprene rubber not containing collagen.

  The internal insertion portion 20 is formed by extruding the insertion portion main body 21 made of synthetic resin or polyisoprene rubber and the lubrication member 10 made of the above-described composite material twice, and then applying heat and pressure thereto. It can be formed by applying a sulfur treatment. Alternatively, after the above-mentioned lubrication member 10 is extruded and formed into a tube shape, the lubrication member 10 is attached to a separately formed insertion portion main body 21 or around the previously formed insertion portion main body 21. It can also be formed by applying vulcanization after each is deposited by extrusion molding. Further, the lubricating member 10 may be extruded and formed into a tube shape by itself, vulcanized, and attached to a separately formed insertion portion main body 21 for use.

  Thus, even when the lubrication member 10 is provided on the surface of the insertion portion main body 21 to form the in-body insertion portion 20, a superior lubricity surface can be obtained by the lubrication member 10. In addition, the flexibility of the lubricating member 10 mainly composed of polyisoprene rubber can prevent excessive contact with the human tissue and prevent damage to the tissue.

  FIG. 4 shows a third embodiment of the medical instrument according to the present invention. This medical instrument has a lubrication member 10 provided on the outer surface of a capsule endoscope 31 to be swallowed. The whole is a capsule-type internal insertion portion 30. The endoscope 31 incorporates a camera, a flashlight, and an oscillator inside a short columnar container, and has an imaging port 32 and a light projection port 33 at one end in the axial direction. The inside of the organ is imaged through the imaging port 32 while intermittently projecting light from the light, and the information is transmitted to an external receiving device by an oscillator.

  The lubrication member 10 is prepared by rolling the above-mentioned composite material in which a reinforcing agent and a supersaturated amount of collagen are blended with polyisoprene rubber and further adding an appropriate amount of vulcanizing agent into a sheet, and applying heat and pressure thereto. The vulcanization process is performed, and the shape as shown in FIG. 5, that is, a part having a cut 34 is processed into a cylindrical shape, which is wound around the outer surface of the endoscope 31 and bonded and fixed with an adhesive or the like. By doing so, it is placed on the surface of the endoscope 31.

Also in the medical instrument according to the third embodiment, an excellent lubricating surface can be obtained by the lubricating member 10 provided on the outer surface of the endoscope 31. In addition, the flexibility of the lubricating member 10 prevents the tissue from being damaged due to flexible contact with the esophagus, stomach or intestine.
The lubricating member 10 can be formed in any shape other than the tube shape or the sheet shape.

It is a partial side view showing a 1st embodiment of a lubrication member concerning the present invention, or a medical instrument to which it is applied. It is an expanded sectional view of FIG. It is an expanded sectional view similar to FIG. 2 which shows 2nd Embodiment of the medical instrument which concerns on this invention. It is a fragmentary sectional view showing a 3rd embodiment of a medical instrument concerning the present invention. It is a perspective view which shows the state before adherence of the lubricating member in 3rd Embodiment.

Explanation of symbols

10 Lubricating member 10, 20, 30 Internal insertion part

Claims (6)

  A lubricating member formed of a composite material comprising a polyisoprene rubber blended with a reinforcing agent and a supersaturated amount of collagen, and the surface exhibits lubricity upon contact with a liquid.   The lubricating member according to claim 1, wherein a vulcanizing agent is added to the composite material, and the composite material is vulcanized after being molded into a predetermined shape.   It has a body insertion portion that comes into contact with human tissue by insertion into the body, and at least a surface layer portion of the body insertion portion is formed of the lubricating member according to claim 1 or 2, so that the surface is brought into contact with body fluid. A medical instrument characterized in that is configured to exhibit lubricity.   The medical instrument according to claim 3, wherein the in-vivo insertion portion is formed of the lubricating member as a whole.   The medical instrument according to claim 3, wherein a surface of the in-vivo insertion portion is covered with the lubricating member.   The medical instrument according to any one of claims 3 to 5, wherein the internal insertion portion has a tube shape or a capsule shape.

Images