JP6372049B2 - Artificial blood vessel and method for forming artificial blood vessel - Google Patents

Description

  The present invention relates to an artificial blood vessel and a method for forming an artificial blood vessel.

  Artificial blood vessels may be used in various fields besides being used for transplantation into a living body. For example, a simulator in the shape of a human arm having an artificial blood vessel inside is used for a medical worker to perform training for puncture of a blood vessel.

  The artificial blood vessel is produced by molding silicone, for example. In addition, other than silicone, for example, a resin can be used. Various methods are known for molding such a resin. For example, fiber reinforced plastics (FRP: Fiber Reinforced Plastics) have a structure composed of fibers and resin, and have high strength characteristics.

  A VaRTM (Vacuum assist Resin Transfer Molding) method is known as a method for easily molding the FRP, and Patent Document 1 discloses the basis of the VaRTM method. Further, Patent Documents 2 and 3 disclose an improved VaRTM method.

JP 2002-307463 A (published on October 23, 2002) JP 2012-45863 A (published March 4, 2012) JP 2012-245623 A (released on December 13, 2012)

  The artificial blood vessel made of the above-mentioned silicone has a problem that the elastic modulus is greatly different from that of a human blood vessel, and the tear strength is weak. Moreover, when the wall thickness of the artificial blood vessel made of silicone is approximated to that of a human blood vessel, there is a problem that the wall thickness is biased.

  In order to solve the above problems, it is necessary to search for a new material as a material for the artificial blood vessel. Here, as the method for molding the new material, it is expected that the VaRTM method, which has been known as a method for simply molding a resin (for example, the FRP) so far, can be used. This is because, if this VaRTM method can be used, it is possible to easily form a strong artificial blood vessel using a newly found material. However, in the molding using the VaRTM method, only a plate-shaped molding example has been disclosed so far, and a tube-shaped molding example necessary for molding an artificial blood vessel is not shown.

  The present invention has been made in view of the above problems, and an object thereof is to provide an artificial blood vessel using FRP as a material and a method for forming the artificial blood vessel.

  In order to solve the above problems, the artificial blood vessel having a tubular shape according to the present invention is a block in which the material of the artificial blood vessel is composed of a polymer block mainly composed of styrene and a polymer block mainly composed of a conjugated diene compound. Any one of a copolymer, a polymer block mainly composed of a cyclic polymer material, and a polymer block mainly composed of urethane is included as a resin of a fiber reinforced resin.

  According to said structure, a strong artificial blood vessel can be provided. Furthermore, since the special elastomer is used as the fiber reinforced resin, the physical properties of the artificial blood vessel can be approximated to those of the human body.

  Furthermore, the artificial blood vessel having a tubular shape according to the present invention has a plurality of layer structures.

  According to the above configuration, since the laminate structure is provided using a special elastomer as a material, the physical properties and structure of the artificial blood vessel can be approximated to those of a human body.

  Further, the method for forming an artificial blood vessel having a tube shape according to the present invention is a method for forming an artificial blood vessel using a fiber reinforced resin obtained by impregnating a resin injected into a fiber material arranged in a mold under vacuum. The mold for artificial blood vessel is cylindrical, and the artificial blood vessel to be molded is made of a tube-shaped fiber reinforced resin.

  According to said structure, an artificial blood vessel provided with the FRP structure which suppressed containing of a bubble can be shape | molded easily, without requiring large facilities, such as an autoclave.

  Furthermore, the method for forming an artificial blood vessel having a tube shape according to the present invention is a method for forming an artificial blood vessel using an artificial blood vessel forming device, and the artificial blood vessel forming device includes an artificial blood vessel forming portion, and A resin diffusion ring for uniformly diffusing the resin may be provided in the vicinity of the resin injection port provided in the blood vessel forming portion.

  Furthermore, the simulator for pricking practice of the present invention includes the artificial blood vessel according to the present invention.

  According to said structure, the said simulator for puncture practice is equipped with the artificial blood vessel provided with the structure and physical property (elastic modulus) approximated to the blood vessel of the human body. Therefore, training for puncture practice in medical practice can be performed efficiently with a sense close to the blood vessels of the human body. Furthermore, special elastomers are richer in flexibility and stretchability than silicone, which is a conventional artificial blood vessel material. Therefore, it is difficult for the puncture training simulator to make a puncture hole. Therefore, the puncture training simulator has a strength that can withstand repeated use.

  The artificial blood vessel having a tubular shape according to the present invention includes a block copolymer, a ring-moving polymer material, in which the material of the artificial blood vessel is composed of a polymer block mainly composed of styrene and a polymer block mainly composed of a conjugated diene compound. Any one of a polymer block mainly composed of and a polymer block mainly composed of urethane is included as a fiber-reinforced resin.

  According to said structure, a strong artificial blood vessel can be provided. Furthermore, since the special elastomer is used as the fiber reinforced resin, the physical properties of the artificial blood vessel can be approximated to those of the human blood vessel.

It is the figure which showed an example of shaping | molding of the artificial blood vessel which concerns on one Embodiment of this invention. (A) has shown the whole extrusion molding apparatus, (b) has expanded and showed the area | region P in (a). It is the figure which showed another example of shaping | molding of the artificial blood vessel which concerns on one Embodiment of this invention. (A) has shown the whole 3 layer extrusion molding apparatus, (b) has expanded and shown the nozzle part in (a). It is the figure which showed another example of shaping | molding of the artificial blood vessel which concerns on other embodiment of this invention. (A) has shown the whole MT-VaRTM method shaping | molding apparatus. (B) has expanded and shown the MT-VaRTM shaping | molding part in (a). It is the figure which showed another example of shaping | molding of the artificial blood vessel which concerns on other embodiment of this invention. It is the figure which showed an example of the simulator for puncture practice using the artificial blood vessel which concerns on other embodiment of this invention.

Embodiment 1
An embodiment of the present invention will be described below with reference to FIG. FIG. 1 is a view showing an example of the formation of an artificial blood vessel by the extrusion molding apparatus 10a. FIG. 1 (a) shows the entire extrusion molding apparatus 10a, and FIG. 1 (b) is an enlarged view of the connecting region P in FIG. 1 (a).

  As shown in FIG. 1A, the extrusion molding apparatus 10 a includes a resin container 12 and a nozzle 13. Resin container 12 is filled with resin 14. The nozzle 13 includes an ejection part 133.

  As the resin used in the present invention, a special elastomer is preferable. For example, the special elastomer is a thermoplastic elastomer and a thermosetting elastomer. The thermoplastic elastomer is preferably a block copolymer composed of a polymer block mainly composed of styrene and a polymer block mainly composed of a conjugated diene compound, and has a hardness of 1 to 30 degrees (according to JIS K6253, A type). ) Is preferable.

  The thermosetting elastomer is preferably a polymer block mainly composed of a cyclic polymer material or urethane, and preferably has a hardness of 1 to 30 degrees (according to JIS K6253, A type).

  As shown in FIG. 1 (b), the ejection part 133 includes an ejection outer part 131 and an ejection inner part 132 at its tip part. A cylindrical ejection outer portion 131 is arranged around a cylindrical ejection inner portion 132. The length L1 of the ejection inner portion 132 is, for example, 5 mm to 20 mm. Moreover, the diameter L3 of the ejection inner portion 132 is, for example, 4 mm. Moreover, the diameter L2 of the cylindrical inner space of the ejection outer portion 131 is, for example, 6 mm.

  The tube forming part 2 includes a cored bar 21 on the inner side, and is connected to the ejection part 133 so that the center of the ejection inner part 132 and the center of the cored bar 21 overlap. The inner diameter of the tube forming portion 2 is preferably the same as the diameter L2 of the inner space of the ejection outer portion 131, and is, for example, 6 mm in the present embodiment. Moreover, it is preferable that the diameter of the metal core 21 is the same diameter as the diameter L3 of the ejection inner part 132, for example, 4 mm in this embodiment.

  Next, a process for forming an artificial blood vessel by the extrusion molding apparatus 10a will be described. By increasing the pressure in the resin container 12, the resin 14 is injected into the tube forming part 2 through the nozzle 13. The special elastomer is preferably dissolved at a temperature of 130 ° C. or higher, which is higher than its melting point, and at a temperature of 200 ° C. or lower that can suppress the temperature deterioration of the special elastomer. The extrusion speed of the resin 14 from the nozzle 13 to the tube forming portion 2 is, for example, 100 mm / min at about 170 ° C. (150 to 180 ° C.) in order to make the thickness of the wall of the artificial blood vessel to be formed uniform. It is preferable. Furthermore, the temperature in the tube forming portion 2 at the time of injecting the resin 14 is preferably maintained at 130 ° C. to 200 ° C. in order to stabilize the viscosity that affects the flow of the resin 14.

  In order to measure the elastic modulus of the artificial blood vessel formed by the forming step, an artificial blood vessel made of the special elastomer and silicone formed by the forming step was formed. The elastic modulus of each molded artificial blood vessel was measured by a tensile test. As a result of the tensile test, the elastic modulus of the artificial blood vessel made of a special elastomer was 50 kPa. On the other hand, when silicone was used as the material, the elastic modulus was 3000 kPa. It is known that the elasticity of human blood vessels is 1 kPa to 1000 kPa. That is, the elasticity of artificial blood vessels made of silicone was outside the range of elasticity of human blood vessels, while the elasticity of artificial blood vessels made of special elastomers was within the range of elasticity of human blood vessels. Met.

  According to said structure, the artificial blood vessel which uses as a raw material the special elastomer which was difficult to shape | mold conventionally can be shape | molded. Further, the artificial blood vessel can have physical properties (elastic modulus) similar to those of a human blood vessel by using a special elastomer as a material. Further, in the above molding method, even if the thickness of the artificial blood vessel is approximated to that of a human blood vessel, the thickness of the artificial blood vessel can be prevented from being uneven by using a special elastomer as a material.

(Modification 1)
While the first embodiment is an example of molding an artificial blood vessel having a single layer structure, the present modification shows an example of molding an artificial blood vessel having a laminated structure. In addition, in this modification, although the example of shaping | molding of the artificial blood vessel of 3 layer structure is shown for convenience, there is no restriction | limiting in particular in the number of layers. For convenience of explanation, members having the same functions as those described in the first embodiment are given the same reference numerals and description thereof is omitted. This modification will be described below with reference to FIG.

  FIG. 2 is a diagram showing an example of artificial blood vessel molding by the three-layer extrusion molding apparatus 10b. FIG. 2 (a) shows the entire three-layer extrusion molding apparatus 10b, and FIG. 2 (b) shows an example of the nozzle 130 in FIG. 2 (a).

  As shown in FIG. 2A, the three-layer extrusion molding apparatus 10b includes three resin containers 12a, a resin container 12b, a resin container 12c, and a nozzle 130 including three nozzles 13a, a nozzle 13b, and a nozzle 13c. Prepare. The resin container 12a is connected to the nozzle 13a.

  The resin container 12b is connected to the flow path 15b, and the resin container 12c is connected to the flow path 15c. The flow path 15b is connected to the nozzle 13b, and the flow path 15c is connected to the nozzle 13c. Resin 14a, resin 14b, and resin 14c filled in resin container 12a, resin container 12b, and resin container 12c are injected into nozzle 13a, nozzle 13b, and nozzle 13c, respectively. The resin 14a, the resin 14b, and the resin 14c may be the same resin or different resins.

  As shown in FIG. 2 (b), the ejection portion 133b of the nozzle 13b is disposed inside the ejection portion 133c of the nozzle 13c, and further, the nozzle 13a is disposed inside the ejection portion 133b of the nozzle 13b. The ejection part 133a is arranged. By increasing the pressure in the resin container 12a, the resin 14a filled in the resin container 12a is pushed out from the ejection part 133a and injected into a tube forming part (not shown). The same applies to the resin 14b and the resin 14b. The tube forming part may have the same configuration as the tube forming part 2 shown in the first embodiment. By increasing the pressure in the resin container 12a, the resin container 12b, and the resin container 12c in this order, the resin extruded from each of the above-described ejection parts is placed inside the outermost layer made of the resin 14c and the layer made of the resin 14c. A three-layer structure of a layer made of the resin 14b located and a layer made of the resin 14a located inside the layer made of the resin 14b is molded. That is, the artificial blood vessel formed by the above process has a three-layer structure.

  In addition, you may shape | mold said 3 layer structure by raising simultaneously the pressure in the resin container 12a, the resin container 12b, and the resin container 12c.

  According to said structure, the artificial blood vessel shape | molded by the said shaping | molding process is equipped with the laminated structure and physical property (elastic modulus) which approximated the blood vessel of the human body.

[Embodiment 2]
In the present embodiment, an example of molding an artificial blood vessel having a fiber reinforced resin (FRP) structure made of a special elastomer as a raw material by the VaRTM method is shown. For convenience of explanation, members having the same functions as those described in the first embodiment and the first modification are given the same reference numerals and description thereof is omitted. The present embodiment will be described as follows with reference to FIG.

  FIG. 3 is a view showing an example of forming an artificial blood vessel by an MT-VaRTM (Mini Tube-Vacuum assist Resin Transfer Molding) method molding apparatus 100. FIG. 3A shows the entire MT-VaRTM method molding apparatus 100. FIG. 3B shows the MT-VaRTM molded part 40 in FIG. As shown to (a) of FIG. 3, the MT-VaRTM method shaping | molding apparatus 100 is provided with the extrusion molding apparatus 10a, the resin injection pipe 3, and the MT-VaRTM shaping | molding part 40. As shown in FIG.

  The resin injection tube 3 spatially connects the extrusion molding apparatus 10a and the MT-VaRTM molding unit 40, and a flow path for injecting the resin 14 extruded from the extrusion molding apparatus 10a into the MT-VaRTM molding unit 40. It is.

  As shown in FIG. 3B, the MT-VaRTM molded part 40 includes a hole pipe 41, a resin diffusion ring 42, and a vacuum back 43.

  The hole pipe 41 is a mold and has holes at predetermined intervals in the longitudinal direction of the hole pipe 41. For example, in the present embodiment, the predetermined interval is 10 mm. The holes are provided at equal intervals on the circumference centered on the center of the hole pipe 41. In the present embodiment, the diameter of the hole is 2 mm, and eight holes are provided on the same circumference. Each of the number and size of the holes on the circumference is not particularly limited. The hole pipe 41 has a cylindrical shape and has a hollow inside, and can be connected to a vacuum pump or the like.

  The resin diffusion ring 42 is for uniformly diffusing the resin injected into the MT-VaRTM molded part 40 into the resin injection region Q. The resin diffusion ring 42 is disposed in the vicinity of the resin injection port 47. That is, it arrange | positions between the resin injection port 47 and the area | region in which the fiber 45 which comprises FRP is installed. The resin diffusion ring 42 has a ring shape, and has a hole on the circumference centering on the center of the ring. The injected resin diffuses into the resin injection region Q through the hole.

  The vacuum back 43 covers the entire resin injection region Q. The space covered with the vacuum back 43 is brought into a vacuum state by vacuum suction from the hole pipe 41 connected to a vacuum pump or the like. The vacuum back 43 maintains the vacuum state of the resin injection region Q by blocking the resin injection region Q into which the resin 14 is injected and the external space. Further, the vacuum back 43 includes a resin injection port 47 connected to the resin injection tube 3.

  Next, a process for molding an artificial blood vessel using a special elastomer as a material by the MT-VaRTM molding unit 40 will be described with reference to FIG. In the resin injection region Q, the peel ply 44 is wound around the surface of the hole pipe 41, and the fibers 45 are fixed around the peel ply 44. As the fiber 45, for example, polyamide fiber, vinylon fiber, polyethylene fiber, polypropylene fiber, acrylic fiber, aramid fiber, glass fiber, carbon fiber, and metal fiber can be used. Among these, inexpensive, relatively high strength fibers, polyester fibers, and polyamide fibers are preferable. Further, the fiber 45 may be fixed by an aluminum jig or the like (not shown).

  Next, in order to maintain the shape of the fiber 45, the semi-circle plate (pressing plate) 46 on the semi-cylinder is set so as to cover the fiber 45. Further, the periphery of the semi-circle plate 46 is covered with a non-illustrated nonwoven fabric.

  Next, the vacuum bag is fixed to the resin injection tube 3 with a sealant, and the resin injection port 47 is secured. Moreover, in order to stabilize the viscosity which affects the flow of the resin 14 at the time of injection, the MT-VaRTM molded part 40 is maintained at about 170 ° C. (150 to 180 ° C.). The temperature may be maintained using, for example, a heating wire heater or a small environmental chamber.

  Next, vacuum suction of the resin injection region Q is performed by a vacuum pump or the like connected to the hole pipe 41 while injecting the resin 14 from the extrusion molding apparatus 10a into the resin injection region Q. Bubbles contained in the resin 14 can be removed by the vacuum suction. The extrusion conditions in the extrusion molding apparatus 10a may be the extrusion conditions shown in the first embodiment. Further, the injection rate of the resin into the resin injection region Q may be adjusted by changing the vacuum pressure. In addition, the elasticity modulus of the artificial blood vessel made of the special elastomer formed by the present embodiment is the same value as that of the artificial blood vessel made of the special air laster formed by the extrusion molding shown in the first embodiment. .

  According to said structure, an artificial blood vessel provided with the FRP structure which suppressed containing of a bubble can be shape | molded easily, without requiring large facilities, such as an autoclave. Furthermore, an artificial blood vessel can be formed using a special elastomer including a thermoplastic elastomer that is generally not used in the VaRTM method. In addition, since a special elastomer is used as a material, the physical properties of the artificial blood vessel can be approximated to those of a human body.

(Modification 2)
While the second embodiment is an example of molding a single-layer artificial blood vessel by the MT-VaRTM method, this modification is an example of molding an artificial blood vessel having a laminated structure by the MT-VaRTM method. Indicates. In addition, in this modification, although the example of shaping | molding of the artificial blood vessel of 3 layer structure is shown for convenience, there is no restriction | limiting in particular in the number of layers. For convenience of explanation, members having the same functions as those described in the second embodiment are denoted by the same reference numerals and description thereof is omitted. This modification will be described below with reference to FIG.

  FIG. 4 is a view showing an example of the formation of an artificial blood vessel by the three-layer MT-VaRTM method forming apparatus 101. FIG. 4A shows the entire three-layer MT-VaRTM method molding apparatus 101. As shown in FIG. 4A, the three-layer MT-VaRTM molding apparatus 101 includes a three-layer extrusion molding apparatus 10b, a resin injection tube 3, and an MT-VaRTM molding unit 40. In the present modification, the “artificial blood vessel molding process using a special elastomer as a material by the MT-VaRTM molding unit 40” described in the second embodiment is repeated. By repeating the above steps, an artificial blood vessel having a laminated structure is formed.

  For example, the resin container 12a, the resin container 12b, and the resin container 12c are filled with a desired resin. Next, the pressure in the resin container 12a is increased, and the resin 14a filled in the resin container 12a is injected into the MT-VaRTM molding unit 40 to mold the first tubular shape FRP. Next, the pressure inside the resin container 12b is increased, and the resin 14b filled in the resin container 12b is injected into the MT-VaRTM molding portion 40, and the second FRP tube-shaped FRP is placed outside the first tube shape. Mold. Next, the pressure in the resin container 12c is increased, and the resin 14c filled in the resin container 12c is injected into the MT-VaRTM molding unit 40, and the third FRP tube-shaped FRP is placed outside the second tube shape. Mold.

  In forming an artificial blood vessel having a laminated structure, an artificial blood vessel having a laminated structure may be formed by repeating the forming of each layer using the extrusion molding apparatus 10a shown in FIG. Further, an FRP laminated structure made of different resins may be formed by changing the type of resin filled in the extrusion molding apparatus 10a when forming each layer.

  According to the above configuration, an artificial blood vessel having a laminated FRP structure made of a special elastomer can be easily formed without requiring a large facility such as an autoclave. In addition, since a special elastomer is used as a raw material and a laminated structure is provided, the physical properties and structure of the artificial blood vessel can be approximated to those of a human body.

[Embodiment 3]
In this embodiment, an example of a puncture training simulator using an artificial blood vessel formed by the forming process of Embodiment 1 and Embodiment 2 will be shown. For convenience of explanation, members having the same functions as those described in the first and second embodiments are denoted by the same reference numerals, and description thereof is omitted. The present embodiment will be described below with reference to FIG.

  FIG. 5 is a diagram showing an example of a puncture training simulator using an artificial blood vessel formed by the forming process of the first and second embodiments. As shown in FIG. 5, the puncture training simulator 50 is in the form of a human arm. Furthermore, an artificial blood vessel 51 is provided inside the puncture training simulator 50. The artificial blood vessel 51 may have a configuration in which simulated blood circulates. The medical worker 70 performs puncture practice using the syringe 60 or the like with respect to the puncture practice simulator 50.

  According to said structure, the simulator for puncture practice is provided with the artificial blood vessel provided with the structure and physical property (elastic modulus) approximated to the blood vessel of the human body. Therefore, training for puncture practice in medical practice can be performed efficiently with a sense close to the blood vessels of the human body. Furthermore, special elastomers are richer in flexibility and stretchability than silicone, which is a conventional artificial blood vessel material. Therefore, it is difficult for the puncture training simulator to make a puncture hole. Therefore, the puncture training simulator has a strength that can withstand repeated use.

  The present invention is not limited to the above-described embodiments and modifications, and various modifications are possible within the scope of the claims, and technical means disclosed in different embodiments are appropriately combined. The obtained embodiment is also included in the technical scope of the present invention.

  INDUSTRIAL APPLICABILITY The present invention can be used for a method for forming an artificial blood vessel and a puncture training simulator provided with an artificial blood vessel.

  14, 14a, 14b, 14c Resin (material), 40 MT-VaRTM molding part (artificial blood vessel molding part), 41 Hole pipe (molding die), 42 Resin diffusion ring, 45 Fiber (fiber material), 47 Resin inlet, 50 Puncture practice simulator, 51 Artificial blood vessel, 100 MT-VaRTM (Mini Tube-Vacuum assist Resin Transfer Molding) molding device (artificial blood vessel molding device), 101 3-layer MT-VaRTM method molding device (artificial blood vessel molding device)

Claims (5)

An artificial blood vessel having a tubular shape,
The artificial blood vessel is characterized in that the material of the artificial blood vessel includes a polymer block mainly composed of a moving polymer material as a resin of a fiber reinforced resin.   The artificial blood vessel according to claim 1, comprising a plurality of layer structures. The method for molding an artificial blood vessel according to claim 1, wherein the material is a fiber reinforced resin obtained by impregnating a resin injected into a fiber material arranged in a mold under vacuum.
The artificial blood vessel mold is cylindrical,
A method for forming an artificial blood vessel, wherein the artificial blood vessel to be formed is made of a tube-shaped fiber reinforced resin. The method for forming an artificial blood vessel according to claim 3, wherein the artificial blood vessel forming device is used.
The artificial blood vessel shaping device includes an artificial blood vessel shaping unit,
A method for forming an artificial blood vessel, comprising a resin diffusion ring for uniformly diffusing a resin in the vicinity of a resin injection port provided in the artificial blood vessel forming portion.   A puncture training simulator comprising the artificial blood vessel according to claim 1.

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