JPH0787850B2 - Manufacturing method of artificial prosthesis - Google Patents

Description

TECHNICAL FIELD The present invention relates to a method for manufacturing an artificial prosthesis used for artificial blood vessels, patches and the like.

[Prior Art] Various types of artificial prostheses used for artificial blood vessels, patches, and the like are on the market, and representative examples thereof include those made of woven fabric or knitted fabric. However, these have problems such as antithrombogenicity and frayed sutures. on the other hand,
There is also an artificial blood vessel made of poly (fluoroethylene) fiber, which has excellent antithrombogenicity, but it is difficult for fiber cells to form on the inner wall,
There are also problems such as poor biocompatibility.

Further, in Japanese Patent Laid-Open No. 61-92666, there is proposed an artificial blood vessel characterized by subjecting a woven fabric to a water jet punching treatment. The artificial blood vessel according to such a proposal raises the woven fabric. For this reason, there are drawbacks such that the napped fibers cannot be uniformly dispersed, the fiber pores are less likely to be uniform, and the porosity cannot be freely controlled.

[Problems to be Solved by the Invention] In view of the above-mentioned drawbacks of the conventional techniques, an object of the present invention is not to provide a method for easily manufacturing an artificial prosthesis that is excellent in biocompatibility, has no fraying, and has high strength. It is what

[Means for Solving the Problems] In order to achieve the above-mentioned object, the present invention has the following configurations.

That is, the method for producing an artificial prosthesis of the present invention comprises coating a tubular structure made of a woven or knitted fabric with a non-woven fabric, and further winding a fibrous or net-shaped product on the surface of the non-woven fabric to form a coated body. The method for producing an artificial prosthesis is characterized in that the tubular structure and the non-woven fabric are entangled with each other by subjecting the peripheral surface of the covering body to a water jet punching process.

Further, in the method for producing an artificial prosthesis of the present invention,
Preferably, when performing the water jet punching treatment on the peripheral surface of the coating body, a method characterized by performing the water jet punching treatment while rotating the coating body relative to the water jet, or, Preferably, after the water jet punching treatment, the fibrous or net-like material is removed, and again,
The method is characterized in that the peripheral surface of the coating is subjected to a water jet punching treatment, or, preferably, after the water jet punching treatment, the fibrous material or net-like material is removed, and the coating is further applied. On the other hand, it is a method characterized by performing a crimping process, or, preferably, after the water jet punching treatment, the coating is heat treated to fuse the fibrous material to the nonwoven fabric. This is a characteristic method. Furthermore, in the method of fusing the fibrous material to the nonwoven fabric by subjecting the coated body to a heat treatment after the water jet punching treatment, preferably, at least the outer surface portion of the fibrous material has a softening point of 200 ° C. A method characterized by using a fibrous material made of the following polymer, specifically, a method characterized in that the fibrous material is preferably of polypropylene type or polyester type. .

Alternatively, in the above-mentioned method of the present invention, preferably, the woven or knitted fabric, and / or the fibers constituting the non-woven fabric have a fineness of 1 denier or less, or the non-woven fabric is constructed. Fiber to
The method is characterized by having a strength of 2 g / d or more.

[Operation] Hereinafter, the present invention will be described in detail.

In the present invention, the artificial prosthesis typically refers to an artificial blood vessel for repairing a living body organ, which refers to a medical member such as various medical patches, but is not necessarily limited to this, and is a biological tissue. It is widely applied to all artificial members or materials for prosthesis of a defect.

The artificial prosthesis according to the method of the present invention has a structure in which two or more layers are formed by coating a non-woven fabric on a woven or knitted fabric having a substantially cylindrical structure in order to enhance biocompatibility. The essence of the production of the artificial prosthesis is that a cylindrical woven or knitted fabric is inserted with a columnar or cylindrical mandrel, and then the above-mentioned non-woven fabric is coated to form a coated body. A material or a net-like material is wrapped around, and then, the peripheral surface of the covering is subjected to a water jet punching treatment to entangle the fiber or knitted fabric and the non-woven fabric, and to entangle the constituent fibers of both the fibers three-dimensionally. It is in.

As mentioned above in the section of the prior art, it has been known to use a water jet punching process in the production of an artificial blood vessel, but in the prior art, a non-woven fabric is uniformly entangled with a cylindrical woven or knitted fabric instead of a flat plate-shaped one. It was quite difficult to get it done.

This is because when a non-woven fabric is simply wrapped around a tubular structure made of woven or knitted fabric and water jet punching is applied, the point of action of the water flow of the water jet punch is the center line of the cylinder (the center axis of the cylinder and the water jet nozzle). This is because when the surface passing through the center of the injection hole is out of the line (intersecting the cylindrical peripheral surface), it acts as a shearing force and acts to peel off the nonwoven fabric. In order to prevent this peeling, the non-woven fabric is a water-soluble glue,
For example, it was adhered to a tubular structure with polyvinyl alcohol, and an attempt was made to dissolve the sizing agent with the water jet punch and simultaneously entangle the constituent fibers of the non-woven fabric with the woven or knitted fabric. However, since it is difficult to match the timing of both melting and entanglement, it does not work well, and there is also the disadvantage that a special adhesive that does not adversely affect the adhesive must be selected.

As a result of earnest studies on such points, the present inventors have arrived at the present invention, that is, in the method of the present invention, in particular, a cylindrical woven fabric or knitted fabric is wrapped with a nonwoven fabric once to be coated. After forming the body, it was found that a woven material can be effectively entangled by lightly winding a fibrous material or a net-shaped material on the nonwoven fabric and water jet punching in that state.

Particularly, when performing the water jet punching treatment on the peripheral surface of the coating body, the water jet punching treatment is performed while rotating the coating body relative to the water jet, so that the entanglement can be performed particularly well. Was understood. Moreover, since a uniform non-woven fabric is wound, it is easy to control porosity.

The fibrous material and net material used in the present invention are, as described above, used for temporarily fixing the woven or knitted fabric and the non-woven fabric together, and the fibrous material and the net material. Any material can be used without particular limitation, but it is preferable to use a material whose fibers are not extremely damaged by the water jet punch.

Examples of such materials include ordinary synthetic fibers, natural fibers, regenerated fibers, metal fibers such as stainless steel, copper and iron, and inorganic fibers such as alumina and carbon fibers.

The fibrous material may be monofilament, multifilament, or staple.

Regarding the net-like material, the thickness of the fibers may be any without any particular limitation, but if the fibers are too thick, the effect of the water jet punch will be weakened, so the total thickness of the fibers will be It is preferably 10 denier (D) to 2000D, more preferably 10D to 1000D.

As for the coarseness of the net-like material, if the eyes are too large, the effect of pressing the non-woven fabric is weak, and if the eyes are too small, the effect of the water jet punch is weakened, and it becomes difficult to uniformly entangle the two. Therefore, it is preferable to select appropriate conditions from the diameter of the artificial prosthesis, the thickness of the nonwoven fabric, and the like.

A preferred example is a size range of about 1 mm square to about 2 cm square, but is not particularly limited thereto.

A more useful and more useful form of use of the fibrous material of the present invention will be described.

That is, it means that the heat-sealing fibers are used as the fibrous material and further used as it is as the final product.
That is, by wrapping the heat-sealing fibers, performing a water jet punching process, and then performing a heat treatment, the fibrous materials are fused or fused together with shrinkage to maintain the shape of the artificial prosthesis, that is, for example, This method is also used to prevent kinking.

Further, the shape retention method is not only a method of winding and fusing the heat fusion fiber but also a shape retention by crimping after removing the fibrous material for fixing after the water jet punch. There are also ways.

Removing the fibrous material on the way is effective when the nonwoven fabric is brought inside the prosthesis. That is, the same tubular structure obtained by water jet punching is inverted,
It is possible to use the outer nonwoven fabric as the inner fabric, but this operation becomes difficult if the fibrous material is wound. Therefore, at this time, it is necessary to remove the fibrous material.

As an example of such a fibrous material, since it is finally used for fixing the shape of an artificial prosthesis after heat treatment, the fibrous material is
Synthetic fibers, natural fibers, and regenerated fibers that are harmless to the human body can be more preferably used.

Among them, a polymer that shrinks or softens to some extent by heat is more preferable for fixing.

Examples of these include thermoplastic fibers such as polypropylene, polyethylene terephthalate, polyethylene, polyamide, and polyester-based fusion fibers, which have a lower softening point than the woven or knitted fabrics and nonwoven fabrics constituting the artificial prosthesis. However, polypropylene fibers are more preferable. However, it does not matter if the polymer has a softening point of 200 ° C. or lower without being particular about this.

For example, the fibers that make up woven, knitted, and non-woven fabrics have softening points.
In the case of polyester at 250 ° C., it is possible to use, as the fibrous material, the same polyester having a low softening point by copolymerizing another unit component.

On the other hand, even if the entire fibrous material does not have softening properties, it can be used as long as at least part of the outer peripheral portion of the core-sheath yarn or the like has the above characteristics.

It is preferable that the artificial prosthesis according to the present invention has a tubular shape because it can be applied to various artificial prostheses such as artificial blood vessels and patches. In the case of an artificial blood vessel, it can be used in its original shape.

Further, in the case of a patch or the like, since it can be cut open for use and the prosthesis itself is rounded, it has an advantage that it fits well to a biological organ tube and is easily sutured. Further, it is preferable since it has an advantage that it can be easily applied even when collagen is applied as a post-treatment.

In the present invention, the fiber material constituting the tubular structure made of a woven or knitted material, when embedded in a living body,
Any substance can be used as appropriate as long as it has few rejection reactions in the living body and is unlikely to deteriorate in the living body. The fibers constituting the woven or knitted fabric may be of one type, or may be a mixed fiber or an alignment of two or more types of fibers. In addition, although one type of yarn may be used in the basic composition, it is more preferable to use two or more types of yarn.

As woven or knitted fibers, in the case of woven fabric, plain weave,
Aya, Suko's basic organization can be anything, but double or triple
Heavy fabrics may be used. In the case of knitting, circular knitting, warp knitting, thread insertion and the like are preferable.

Further, the polymer used as the fiber constituting the woven or knitted material is preferably polyester, polyamide,
Polytetrafluoroethylene, polyolefin, polyarylate, polysulfone, polyphenylsulfad, and the like, and the type thereof is not particularly limited, but polyester is particularly preferable among them.

The fibrous material constituting the nonwoven fabric of the present invention can be appropriately used as long as it has little rejection reaction of the living body when implanted in the living body and hardly deteriorates in the living body.

A specific example of this is a fibrous material made of polyester, polyurethane, polysulfone, polyamide, polyolefin, polyvinyl chloride, fluorine resin, polyacetal, polyphenylene sulfide, or the like.

Of these, polyesters mainly composed of polyethylene terephthalate and polybutylene terephthalate are particularly preferable.

The nonwoven fabric used in the present invention has a single yarn strength of 2 g of the fibers constituting the nonwoven fabric in terms of the strength of the artificial prosthesis and the like.
It is preferably / d or less.

In addition, it is preferable to use ultrafine fibers having a single fiber fineness of 1.0 d or less because the effect of three-dimensional entanglement with a nonwoven fabric described later is enhanced and a very flexible artificial prosthesis is obtained.

It is preferable to use ultrafine fibers as at least a part of the fibers constituting the woven or knitted fabric and the nonwoven fabric because the three-dimensional entanglement effect is enhanced and the artificial prosthesis becomes very flexible.

Regarding the above ultrafine fibers, in forming an artificial prosthesis, fibers already in the form of such ultrafine fibers may be used as they are, but by a scientific or physical means, a tubular structure using fibers that can be made ultrafine. It is also possible that the tubular structure is formed from the ultrafine fibers as a result by forming and then ultrafine.

Examples of fibers that can be made into ultrafine particles by post-processing include, for example, Japanese Patent Publication Sho
It is possible to use a fiber of the type that is fibrillated or ultrafine by means such as removing or exfoliating a part of the multi-component fiber as seen in 48-22126 and Japanese Patent Publication No. 53-22593. .

The ultrafine fibers in the present invention are those having a single fiber fineness of 1.0 d or less, more preferably 0.5 d or less, and further preferably 0.2 d or less.

Further, the tubular shape in the present invention is preferably one having a circular cross section, but the tubular shape is not limited to a circular shape, and may be an ellipse, a triangle, a rectangle, a polygon, or the like as appropriate. Combination application cross-sections and the like can also be used.

The method of winding the fibrous material in the present invention may be winding at an appropriate pitch interval.At this time, the pitch interval of the fibrous material depends on the diameter of the cylindrical artificial prosthesis and the thickness of the non-woven fabric, but 1 mm or more and 30 mm. The following is preferred, 2 mm or more 10
mm or less is more preferable. As for the winding method, the winding may be performed while sequentially shifting in one direction, but may be performed by reciprocating so as to uniformly entangle without surface roughness.

In the present invention, the water jet punch is usually
Water jet of water with a pressure of 5 to 200 kg / cm ² from a small hole with a diameter of 0.05 mm to 1.0 mm, a tubular structure covered with a non-woven fabric and further wrapped with a fibrous or net-like material. The point of action of the water flow of the punch hits the center line of the cylinder (the line formed by the plane passing through the center axis of the cylinder and the center of the injection hole of the water jet nozzle intersecting the cylinder peripheral surface), and It is preferable to inject so as to be perpendicular to the tangent to the circular cross-section circle of the cylinder at the point of contact.

If this position shifts, the water jet punch flow becomes
The action acting as a shearing force is generated, the non-woven fabric is removed from the tubular woven or knitted fabric, and the fibers of the non-woven fabric may not be entangled with the tubular woven or knitted fabric, which is not preferable.

If the injection pressure is too weak, the entanglement does not occur, but if it is too strong, the fibers are cut, which is not preferable. Within this range, the strength of the fibers, the thickness of the fiber bundle, and the flexibility of the artificial prosthesis may be taken into consideration to make an appropriate determination.

The water jet punching process is preferably applied to the peripheral surface of the cover. In particular, it is preferable that the water jet punching treatment is performed while the coated body is rotated relative to the water jet. That is, for a fixed jet of water jet,
Apply a water jet while rotating the covering,
Alternatively, the water jet may be applied while rotating the water jet device around the coating body without rotating the coating body, or alternatively, by combining these two aspects. You may make it process it together. That is, in the present invention, the relative rotational movement means that, as a specific mode, the position of the fluid ejecting portion is limited to cause the cylindrical structure itself to rotate (rotate), or vice versa. It means a mode of moving (combined motion of revolution and rotation) while rotating the fluid ejecting unit on the outer peripheral orbit of the object, and a mode of combination thereof.

In the artificial prosthesis of the present invention, when the fibrous material is removed during the water jet punching, crimping may be applied as another means for maintaining the shape. This makes it possible to prevent the tubular structure from becoming flat and difficult to handle, or to prevent problems such as blockage and poor handleability due to insufficient elongation even after transplantation.

As a method of performing such crimping processing on a cylindrical structure, for example, a mold having a corrugated groove is inserted into the cylindrical structure, and the cylindrical structure is sequentially formed along the corrugated groove. Although a method of performing heat treatment after pressing the groove into the groove can be used, the method is not necessarily limited to this, and an appropriate method can be used.

Although a general example has been described above, as a further preferable example, a non-woven fabric is once subjected to water jet punching, the inside and the outside are turned over, and the non-punched surface is subjected to water jet punching. is there.

Further, a more preferable example is a case where both surfaces of a woven or knitted fabric are covered with a non-woven fabric.

In this case, for example, after inserting a slightly smaller cylindrical mandrel or the like into the woven or knitted fabric, it is covered with a non-woven fabric, and the fibrous or net-shaped product is wound around the surface of the non-woven fabric,
A non-woven fabric is subjected to a strong water jet punching process so that it enters the inside of the woven or knitted fabric and entangles both, and as a result, a product similar to the case where both sides of the woven or knitted fabric are covered with the nonwoven fabric can be obtained. is there.

In addition, after covering the woven or knitted fabric with a non-woven fabric, wrapping the fibrous or net-like material around the surface of the non-woven fabric and subjecting it to a water jet punch treatment, the fibrous substance is removed and the non-woven fabric is brought inside the prosthesis. , The outside is again covered with a non-woven fabric, and water jet punch is applied again to cover both sides of the woven or knitted fabric with the non-woven fabric. In this case, the inner and outer non-woven fabrics are entangled well and the strength is also strengthened.

[Examples] The present invention will be described below with reference to Examples.

The validity and scope of rights of the present invention are not limited or restricted by this.

Example 1 Polyester fiber of 50D-48 filament (f) was used for the warp, and seaweed type multi-component fiber of 120D-40f, sea component polyethylene terephthalate 80 parts, number of islands 36 islands / f were used as weft, and satin weave. Thus, a tubular structure having an inner diameter of 6.2 mmφ and a length of 15 cm was formed.

The sea component polystyrene was removed by immersing this in trichlene. Then, it dried.

On the other hand, 3d (denier) sea-island type multi-component fiber, 85 parts of sea component polyethylene terephthalate, 16 islands / f of raw cotton are laid on a card to make a non-woven fabric sheet, which is immersed in trichlene to form polystyrene of sea component. Was similarly removed. Then, it dried.

A 6 mmφ mandrel made of stainless steel was inserted into the tubular structure and then covered with the nonwoven fabric.

In order to temporarily fix this coated nonwoven fabric, a coated body was obtained in which polypropylene monofilaments having a fineness of 120d were reciprocally wound around with a pitch interval of 3 mm.

While rotating the coating obtained in this way, discharge diameter diameter
A water jet was jetted from a water jet nozzle having a diameter of 0.25 mm and a discharge diameter interval of 2.5 mm. At this time, the pressure was sequentially increased from 10 kg / cm ² and finally a water jet punch treatment was performed at a pressure of 80 kg / cm ² . After further drying, it was heated and dried with a hot air dryer.

After cooling, when the mandrel was removed, the non-woven fabric and the woven fabric were uniformly entangled with each other, and an artificial blood vessel excellent in fraying resistance, strength, and shape retention could be manufactured.

Example 2 Using the woven fabric and the nonwoven fabric used in Example 1, a stainless mandrel was inserted in the same manner as in Example 1, and then reciprocally wound with 0.2 mmφ stainless fiber at a pitch interval of 5 mm, and then the same as in Example 1. Using the nozzle of the condition, jet the water flow,
At this time, the pressure is gradually increased from 10 kg / cm ² and finally 50
Water jet punching treatment was performed at a pressure of kg / cm ² . In addition, remove the stainless fiber and re-apply 80kg / cm ²
Then, a water jet punch was applied to remove the mandrel, and the inner and outer surfaces of the treated tubular material were reversed, and the mandrel was inserted again to perform a water jet punch treatment of 50 kg / cm ² . Further, with the non-woven fabric surface as the inner wall, polypropylene monofilaments having a fineness of 120d were sequentially shifted in one direction with a pitch interval of 3 mm, and wound, and heated with a hot air dryer. After cooling
When the mandrel was removed, the non-woven fabric and the woven fabric were uniformly entangled with each other, and it was possible to manufacture an artificial blood vessel having excellent fraying resistance, high strength, and excellent shape retention.

Example 3 Polyester fiber of 50D-48f was used for the warp, 120D-40f of sea-island type multi-component fiber, 80 parts of sea-component polyethylene terephthalate, and 36 islands / f of sea component were used as weft, and satin weave had an inner diameter of 12.5 mmφ. , A tubular structure having a length of 15 cm was formed. The sea component polystyrene was removed by immersing this in trichlene.

On the other hand, 6d of sea-island type multi-component fiber, 78 parts of sea-component polyethylene terephthalate, and raw cotton of 36 islands / f of raw cotton are laid on a card to make a non-woven sheet, and by dipping this in trichlene, the polystyrene of sea-component is similarly made. Removed.

After inserting a stainless steel 12 mmφ mandrel into the cylindrical structure, the structure was covered with the non-woven fabric.

Further, in order to temporarily fix the coated nonwoven fabric, a polyethylene net having a mesh size of 3 mm square was wrapped around the whole to obtain a coated body.

While rotating this, discharge diameter diameter 0.25mm, discharge diameter interval
A water stream is jetted from a 2.5 mm water jet nozzle, at which time the pressure is sequentially increased from 10 kg / cm ² and finally
Water jet punching treatment was applied at 50 kg / cm ² .
Further, the above net was removed, water jet punching treatment was performed again under the condition of 80 kg / cm ² , and the mandrel was pulled out.

Next, the obtained cylindrical product was further 12 mmφ in pitch 1.75.
A mandrel having a corrugated groove of mm was inserted, stainless steel fiber was wound along the corrugated groove, and then heat treatment was performed to perform crimping.

After that, when the stainless fiber and the mandrel are removed, the non-woven fabric and the woven fabric are uniformly entangled with each other, which has excellent fraying resistance, strong strength, and excellent cylindrical shape-retaining property with an appropriate elongation. A patch with good properties could be manufactured.

Comparative Example 1 Using the same woven fabric and nonwoven fabric as in Example 1, the mandrel was inserted into the woven fabric as in Example 1, and then the nonwoven fabric was wound.

While rotating this, discharge diameter diameter 0.25mm, discharge diameter interval
From a 2.5mm water jet nozzle, pressure 10kg / cm ²
When the water jet punching process was applied in, the wound non-woven fabric was peeled off from the woven fabric and the two could not be entangled.

Comparative Example 2 Using the same woven fabric and non-woven fabric as in Example 1, the mandrel was inserted into the woven fabric in the same manner as in Example 1, and then the non-woven fabric was adhered to the woven fabric with polyvinyl alcohol.

While rotating this, discharge diameter diameter 0.25mm, discharge diameter interval
From 2.5mm water jet nozzle, pressure 10kg / c
When water jet punching was applied under the conditions of m ² and then 30 kg / cm ² , the wound non-woven fabric peeled off from the woven fabric, resulting in non-uniform entanglement between the non-woven fabric and easiness of fraying and shape retention. It was bad.

[Effects of the Invention] According to the method for producing an artificial prosthesis of the present invention as described above, a cylindrical woven / knitted base material and a non-woven fabric in which fibers are uniformly dispersed, which have not been conventionally achieved, are good. Therefore, it becomes possible to easily manufacture an artificial prosthesis which is integrated with, has excellent biocompatibility, is free from fraying, has high strength, and can easily control porosity.

Claims (10)

[Claims] 1. A tubular structure made of a woven or knitted fabric is covered with a non-woven fabric, and a fibrous substance or a net-like substance is further wound around the surface of the non-woven fabric to form a covered body, and the peripheral surface of the covered body is covered. A method for manufacturing an artificial prosthesis, which comprises subjecting the tubular structure and a non-woven fabric to each other by performing a water jet punch process. 2. The water jet punching treatment is performed while rotating the coating body relative to the water jet when the water jet punching treatment is applied to the peripheral surface of the coating body. A method for manufacturing the described artificial prosthesis. 3. The method according to claim 1, wherein after the water jet punching treatment, the fibrous substance or the net-like substance is removed and the water jet punching treatment is performed again on the peripheral surface of the covering body. Manufacturing method of artificial prosthesis. 4. The artificial prosthesis according to claim 1, wherein the fibrous or net-like material is removed after the water jet punching treatment, and the crimping treatment is further applied to the covering body. Manufacturing method. 5. The method for producing an artificial prosthesis according to claim 1, wherein the fibrous material is fused to the non-woven fabric by subjecting the covering to heat treatment after the water jet punching treatment. 6. The method for producing an artificial prosthesis according to claim 5, wherein at least the outer surface portion of the fibrous material is made of a polymer having a softening point of 200 ° C. or lower. 7. The method for producing an artificial prosthesis according to claim 5, wherein the fibrous material is a polypropylene-based material. 8. The method for producing an artificial prosthesis according to claim 5, wherein the fibrous material is a polyester material. 9. The method for producing an artificial prosthesis according to claim 1, wherein the fibers constituting the woven or knitted fabric and / or the nonwoven fabric have a fineness of 1 denier or less. 10. The method for producing an artificial prosthesis according to claim 1, wherein the fibers constituting the non-woven fabric have a strength of 2 g / d or more.