JPH10118188A - Medical treatment appliance for insertion into celom and its production - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make it possible to maintain a low-friction characteristic and sliding characteristic and to improve safety by providing the front surface of a medical treatment appliance with fibrous rugged patterns by transfer of fiber structure tissues thereto. SOLUTION: A catheter tube is supplied onto a core body in a stage S1 and the fiber structure tissues are transferred onto the outside surface of the catheter tube in stages S2, S3. Grid-like tissues, etc., including weaves and sets known as braided structures are preferably used for the fiber structure tissues. The fiber structure tissues are then removed, by which the fibrous rugged patterns 2 are formed on the outside surface of the catheter tube 1 in a stage S4. The contact area with a guiding catheter and the inside of the celom is decreased by the rugged patterns 2, by which the friction resistance is decreased and the operability is improved. Since the appliance is uniform in a circumferential direction, the bending and twisting at the time of the insertion into the celom are suppressed. Further, the change of the patterns is made easy by changing the knitting and weaving of the fiber structure tissues.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical instrument for insertion into a body cavity, such as a catheter or a guide wire, inserted into a body cavity of a patient such as a blood vessel, a trachea, a digestive tract, and a urethra.

[0002]

2. Description of the Related Art In order to reliably insert a medical device such as a catheter or a guidewire into a target site, generally, frictional resistance between a blood vessel and an outer surface of the medical device and friction between a guidewire surface and an inner surface of the catheter are generally considered. It is preferable to reduce the resistance. Means for reducing the frictional resistance of the surface of such a medical device include (1) a method using a low-friction resin such as a fluororesin or a high-density polyethylene as a medical device substrate, and (2) a substrate. Silicon oil, olive oil on the surface,
A method of applying a lubricant such as glycerin and (3) a method of supporting a lubricating polymer on a substrate surface by grafting or the like are generally known.

[0003] Of these methods, the method using a low-friction resin as in (1) may be inadequate in lubricating properties or inadequate resin properties as a catheter such as hardness or kink resistance. There is a concern that the method of applying a lubricity-imparting substance to the surface as in (2) or (3) may cause peeling of the lubricity-imparting substance.

[0004] As a different means, there is known a method of reducing frictional resistance by reducing the contact area on the surface of a medical device. JP-A-8-24342 discloses a method for forming a minute projection on the inner surface of a catheter tube, in which a synthetic resin material is coated on an embossed core, and then the core is pulled out. Have been. In addition, JP-A-5-501506 and JP-A-6-511162 disclose a metal braid near the inner surface or outer surface of a catheter tube,
A device that forms projections on the surface by embedding particulate matter is disclosed.

In the tube after the melt extrusion,
There is known a method for producing a catheter tube having an uneven surface by using a system in which unevenness is caused by phase separation of a polymer alloy.

[0006]

However, in the method of forming a coating on a processed metal core as described in JP-A-8-24342, it is necessary to produce a special metal core. The protrusion obtained on the inner surface of the tube is uniformly determined by the core metal, and lacks flexibility such as changing the pattern of the protrusion depending on the application. In addition, there is a possibility that these projections may be scraped off when the core is pulled out. In the methods described in JP-A-5-501506 and JP-A-6-511162, since the physical properties such as the bending strength of the catheter shaft change depending on the embedded braid or the like, a flexible material is selected. For example, it is necessary to reduce the choice of materials such as necessity, or there may be a quality problem caused by delamination between the braid or the granular substance embedded near the outer surface and the surrounding resin.

[0007] In the method utilizing the phase separation of a polymer alloy, there are not found many alloy systems exhibiting such a specific phase separation behavior.

The present invention has been made in view of the above-mentioned prior art, and provides a highly safe medical device having low friction and slidability continuously when inserted into a body cavity. The purpose is to do. It is another object of the present invention to provide a low-friction, high-sliding medical device from a relatively wide range of options without problems such as peeling.

[0009]

In order to achieve the above object, a medical instrument for insertion into a body cavity of the present invention has the following configuration (1), and further has the configuration (2) or (3). Is preferred. Further, the object of the present invention is achieved by a method for manufacturing a medical instrument for insertion into a body cavity, the method including any one of (4) to (6).

(1) A medical device to be inserted into a body cavity, wherein at least a part of the surface of the medical device has a fibrous uneven pattern formed by transferring a fibrous structure. A medical instrument for insertion into a body cavity, characterized in that:

(2) The medical device according to (1), wherein the medical device is a catheter tube, and the concavo-convex pattern is formed on at least a part of an inner surface and / or an outer surface of the tube. .

(3) The medical instrument is a guide wire having a resin coating on the surface of a core material, and the uneven pattern is formed on at least a part of an outer surface of the resin coating. The medical device according to 1).

(4) In the method of manufacturing a medical device to be inserted into a body cavity, the surface of the medical device is molded with a resin, and a fibrous structural tissue is formed in close contact with at least a part of the surface of the medical device. Heating the fibrous tissue and / or the medical device to bury the fibrous tissue in the medical device, and then removing the buried fibrous tissue; Manufacturing method.

(5) In the method of manufacturing a medical device to be inserted into a body cavity, the surface of the medical device is molded with a resin, and a fibrous structural tissue is formed in close contact with at least a part of the surface of the medical device. A method for producing a medical device for insertion into a body cavity, comprising coating the surface of a fiber structure tissue with a resin solution or melt compatible with the resin, and then removing the coating and the fiber structure tissue.

(6) In the method for manufacturing a medical device to be inserted into a body cavity, a fibrous structure is formed in close contact with at least a part of the core, and the surface of the core in which the fibrous structure is formed is catheterized. A method for producing a medical device for insertion into a body cavity, comprising forming a coating with a resin as a tube material, and then removing the core material and the fibrous structure.

The fibrous structure in the present invention is desirably formed by weaving or knitting wires or filaments of metal or synthetic resin.

[0017]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, specific embodiments of the present invention will be described in detail.

Specific examples of the medical instrument for insertion into a body cavity of the present invention include the following.

(1) A microcatheter for a blood vessel such as a catheter for PTCA vasodilation, a microcatheter for a cerebral blood vessel or an abdominal blood vessel, a microcatheter with a guide wire at the tip, etc. Or guide wires for these catheters.

(2) Catheters to be inserted or placed in ordinary blood vessels, such as angiographic catheters, introducer sheaths or dilators, indwelling needles, IVH catheters, and thermodilution catheters. Or guidewires, stylets, etc. for these catheters.

(3) gastric tube catheter, feeding catheter,
Catheters that are inserted or placed in the gastrointestinal tract orally or nasally, such as tube feeding tubes and endoscopes (gastroscopes).

(4) Oxygen catheters, oxygen cannulas, endotracheal tube tubes and cuffs, tracheostomy tube tubes and cuffs, and catheters inserted or placed in the airways or trachea, such as intratracheal suction catheters.

(5) Urethral catheter, urinary catheter,
Catheters to be inserted or placed in the urethra or ureter such as balloon catheters and balloons.

(6) Suction catheter, drainage catheter,
Catheters inserted or placed in various body cavities, organs, and tissues such as rectal catheters.

Of the above catheters, the present invention is preferably applied to a microcatheter which is required to be accessible in peripheral blood vessels, and a relatively small diameter angiographic catheter. These are PTCA dilatation catheters and brain / abdominal microcatheters in which the catheter front portion is made of a plurality of materials.

Typical resins used for catheter tubes and guidewire surfaces include polyolefins, modified polyolefins, halogenated polyolefins, polyvinyl chloride, polystyrene, various poly (meth) acrylates, polyacrylates, polyacrylonitriles, polyurethanes, and the like. Various engineering polymers such as polyamide (polyamide elastomer), polyester (polyester elastomer), polycarbonate, polyimide, polyamide polyimide, polyester polyimide, polyester amide imide, polysulfone, polyether phenoxy resin, phenol resin, amino-epoxy resin, cellulose derivative, Resins that are commonly used as catheter materials, such as silicone or various rubber materials, Block or ground polymer, as a combination of polymer alloy or multilayer tubes and their, also, may be exemplified by blending fillers or pigments such as contrast medium as required compounds, and the like.

FIG. 1 is a view for explaining a manufacturing process for providing an uneven pattern on the outer surface of a catheter tube. In FIG. 1, S1 indicates a step of supplying a catheter tube coated on a core. The supply of the catheter tube is not limited to the coating on the core, but can also be obtained by hollow extrusion or injection molding in the case of a relatively short tube. In these cases, it is desirable to prevent the collapse by inserting a core material before going to the next step.For example, in the case of a hard polyimide tube, which is hard to collapse such as a thick and small diameter, The core material can be omitted.

Step S2 represents a step of applying the fiber structure to the outer surface of the tube. As the fiber structure structure, a woven structure called a blade structure, a lattice structure including a set, or a knitting structure is preferable. As a method of applying such a fiber structure, there are a method of directly winding a filament on the surface of a catheter tube, and a method of coating a previously prepared hollow fiber structure with a catheter tube. A fiber material such as a filament (wire) for forming a fiber structure can be selected according to the purpose. Representative examples include (1) stainless steel wire, copper wire (plated copper wire), tungsten wire, boron wire, shape memory / superelastic alloy (NiTi) wire, and various surface treatments and coated wires of these wires. Examples include metal fiber materials, (2) inorganic fiber materials such as alumina fibers, silicon carbide fibers, and carbon fibers, and (3) organic fiber materials such as nylon, polyester, polyethylene, and engineering plastics. In the case where shallow irregularities are obtained using a normal wire having a cross section close to a perfect circle such as an organic fiber, the strength during processing may not be sufficient. In such a case, by adopting a flat or slit tape-like fiber form, a fiber having a certain cross-sectional area can be obtained while suppressing the thickness, so that the strength required for processing or the like can be secured.

Step S3 represents a step of transferring the fiber structure applied to the tube to the outer surface of the tube. Two methods are conceivable as the transfer means. The first method is
This method uses heat. When the fiber structure, such as organic fibers, is thermally shrunk, the fiber structure is melted on the outer surface of the tube and pressed by contact with a predetermined heating atmosphere or a hot plate. Is removed and removed. When the fiber structure is metal, the inner diameter of the fiber structure is made to be slightly smaller than the outer diameter of the tube, and by coating this so as to press it against the tube, transfer by heating can be similarly realized. . In addition, if a fiber structure having a shape memory property that shrinks by heating is used, the same operation can be repeatedly realized with one fiber structure.

The second method of transfer is a method of further applying an outer layer coating to the outer surface of the tube coated with the fiber structure. That is, the outer surface of the catheter tube is coated with a resin solution or melt compatible with the resin, and then the coating and the fibrous structure are removed to melt a portion where the coating is not covered by the fibrous structure. That is, the transfer is completed.

S4 indicates a step of removing the fiber structure. The removal is a part of the transfer process, but is separately described here for convenience. As an operation, first, by removing the core in the tube, the fibrous structure on the outer surface can be easily removed. Even if the core is not removed, if the fiber is not reused, the fiber structure may be destroyed.

FIG. 2 is an external view of the catheter tube 1 completed through the above-described steps. The fibrous concave-convex pattern 2 formed on the outer surface of the tube 1 reduces the contact area with the guiding catheter and the body cavity, so that the frictional resistance is reduced and the operability is improved. In addition, since the fibrous uneven pattern 2 is obtained by transferring a fibrous structure,
It is uniform in the circumferential direction, and is less likely to bend or twist in unexpected directions when inserted into a body cavity. Also, changes to suit the application, such as changing the pattern in the axial direction,
All that is required is to change the knitting or weaving of the fibrous structure, which is easy.

FIG. 3 is a view for explaining a manufacturing process for providing an uneven pattern on the inner surface of the catheter tube. In FIG. 3, S1 indicates a step of forming a fiber structure on the outer periphery of the core. In this step, a method in which a filament is wound directly on a core and a method in which a fiber structure formed in advance is covered on the core can be considered. S2 shows a step of coating the resin obtained as the raw material of the catheter tube on the core obtained in S1. The transfer of the fibrous concavo-convex pattern to the inner surface proceeds almost simultaneously with this step. S3 is a step of removing the core and the fiber structure. In operation, the fiber structure can be easily removed by first removing the core in the tube. A release agent may be applied to the fiber structure or the surface of the core in advance so as to facilitate removal.

FIG. 4 is a partial perspective view of the catheter tube 3 completed through the above-described steps. The fibrous concave-convex pattern 4 formed on the outer surface of the tube 3 reduces the contact area with a small-diameter catheter or a guide wire passing through the tube lumen, so that friction resistance is reduced and operability is improved.

In the above-described step of transferring to the inner surface, a core material coated with a resin on the core material is used, and after the fiber structure is applied on the core material, if the resin coating is further performed, the inner surface becomes A catheter tube having a fibrous uneven pattern and a catheter tube having a fibrous uneven pattern on the outer surface can be obtained at the same time. The advantage in this case is that the gap between the inner and outer layer tubes corresponds to the thickness of the fibrous structure, so that it can always be stably manufactured within a certain range. The above method is extremely useful for producing such a combination tube requiring strict control of the inner and outer diameters.

FIG. 5 is an external view of the guide wire 5 having the fibrous uneven pattern of the present invention on the outer surface. The method of providing the fibrous uneven pattern on the outer surface of the guide wire 5 is as follows.
Since the method is almost the same as the method of providing on the outer surface of the catheter tube shown in FIG. 1, the description is omitted. Since the guide wire 5 has a metal core inside such as NiTi alloy or stainless steel and has a resin coating on its surface, the step S1 in FIG.
Becomes unnecessary. The fibrous uneven pattern 6 formed on the outer surface of the guide wire 5 reduces the contact area with the catheter and the body cavity, so that the frictional resistance is reduced and the operability is improved.

In general, a medical instrument for insertion into a body cavity such as a catheter tube or a guide wire is required to be relatively rigid at the base side and excellent in kink resistance and flexible at the distal end side. It is also important that the diameter is very small for a blood vessel. Depending on the selection of the preferred fiber structure of the present invention, the formation of the uneven pattern can control the kink resistance and the hardness of the shaft. The contribution of the concavo-convex pattern to the physical properties of the medical device is controlled by the concavo-convex depth, pattern shape, pattern density, and the like. In addition, if a concavo-convex pattern having a pleated cross section is provided as shown in FIG. This is extremely useful for certain applications, such as indwelling a catheter.

[0038]

As described above, according to the present invention, it is possible to reduce the resistance at the time of insertion into a body cavity or a catheter, to obtain a medical device having excellent running properties, and to improve operability.
It is very useful because it has the effects of reducing damage to the mucous membrane of the tissue in the body cavity and reducing the pain of the patient. In addition, since the transfer is performed, no fibrous structure remains, and the physical properties and quality of the medical device itself are not adversely affected. Furthermore, by changing the configuration of the knitting and weaving patterns of the fiber structure, the uneven pattern on the surface of the medical device can be easily changed, so that the pattern can be formed flexibly according to the application. is there.

[Brief description of the drawings]

FIG. 1 is a diagram showing a flow of transferring an uneven pattern onto an outer surface of a catheter tube.

FIG. 2 is a view showing a catheter tube in which an uneven pattern is transferred to an outer surface.

FIG. 3 is a diagram showing a flow of transferring an uneven pattern onto an inner surface of a catheter tube.

FIG. 4 is a view showing a catheter tube in which an uneven pattern is transferred to an inner surface.

FIG. 5 is a view showing an example in which the medical device of the present invention is used as a guide wire.

FIG. 6 is a diagram showing an uneven pattern having a pleated cross section.

[Explanation of symbols]

 1,3 catheter tube 2,4 uneven pattern 5 guide wire 6 uneven pattern

Claims (6)

[Claims] 1. A medical device to be inserted into a body cavity, wherein at least a part of the surface of the medical device has a fibrous uneven pattern formed by transferring a fibrous structural tissue. A medical device for insertion into a body cavity. 2. The medical device according to claim 1, wherein the medical device is a catheter tube, and the uneven pattern is formed on at least a part of an inner surface and / or an outer surface of the tube. 3. The medical device according to claim 1, wherein the medical device is a guide wire having a resin coating on a surface of a core material, and the uneven pattern is formed on at least a part of an outer surface of the resin coating. 2. The medical device according to 1. 4. A method of manufacturing a medical device to be inserted into a body cavity, wherein the surface of the medical device is molded with a resin,
A fibrous structure is formed in close contact with at least a part of the surface of the medical device, and the fibrous structure is embedded in the medical device by heating the fibrous structure and / or the medical device, and then buried. A method for producing a medical device for insertion into a body cavity, comprising removing the fibrous structure tissue. 5. A method for manufacturing a medical device to be inserted into a body cavity, wherein the surface of the medical device is molded with a resin,
A fibrous structure is formed on at least a part of the surface of the medical device, and the surface of the fibrous structure is coated with a resin solution or melt compatible with the resin, and then the coating and the fibrous structure are removed. A method for producing a medical instrument for insertion into a body cavity, characterized in that: 6. A method of manufacturing a medical device to be inserted into a body cavity, wherein a fibrous structure is formed in close contact with at least a part of the core, and the surface of the core in which the fibrous structure is formed in close contact with the catheter tube. A method for producing a medical device for insertion into a body cavity, comprising forming a coating with a resin as a material, and then removing the core material and the fibrous structure.