JP2006026155A - Tubular prosthesis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a tubular prosthesis which shows improved filling performance and forceps operability and is free from a strength reduction in an artificial blood vessel of a woven structure of a synthetic resin such as a polyester. <P>SOLUTION: This tubular prosthesis has a woven structure comprising the weft and warp. The warp of the tubular prosthesis has at least one part where (1)two yarns of the warp (warp A and warp B) adjacent in the peripheral direction satisfy formula (1) and is disposed in a manner that (2) the warp and the adjacent warp of the warp disposed in the peripheral direction from the warp B to the warp, in which two yarns of the warp adjacent in the peripheral direction satisfy the formula (1), also satisfy formulas (2) or (3). The formula (1):[(fineness of the warp A)×R<SP>1</SP>]≤ the warp B≤[(fineness of the warp A)×R<SP>2</SP>], the formula (2):[(fineness of the warp)×R<SP>3</SP>] is more than (fineness of the adjacent warp), and the formula (3):[(fineness of the warp)×R<SP>4</SP>] is less than (fineness of the adjacent warp). R<SP>1</SP>:0.9, R<SP>2</SP>:1.1, R<SP>3</SP>:0.9, and R<SP>4</SP>:1.1. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a tubular prosthesis such as an artificial blood vessel, and relates to a prosthesis excellent in handleability and sealability.

  Tubular prostheses such as various fabrics such as plain weave using polyester or the like are used as artificial blood vessels for transplantation.

Patent Document 1 discloses an artificial blood vessel that is substantially composed only of a polyester resin and has a porosity of 15 ml / cm ² · min · 120 mmHg or less measured with water at 37 ° C.
In Patent Document 2, in an artificial blood vessel in which a fiber is formed into a tubular shape by using any one or two of woven, knitted, braided, and entangled treatments, the fiber partially includes a fusion fiber. An artificial blood vessel characterized by this is disclosed.

JP-A-7-163635 JP-A-6-007387

  Artificial blood vessels manufactured by knitting or weaving need to have large stitches and weaves in order to improve flexibility and organization. However, if the stitches or weaves are enlarged, the strength of the resulting artificial blood vessel may be reduced, the sealing performance may be reduced, or forceps operation may be difficult.

  An object of the present invention is to provide a prosthetic device which is a plain-woven artificial blood vessel made of a synthetic resin such as polyester and has improved sealing properties, improved forceps operability, and no reduction in strength.

  The present invention uses warp yarns having different diameters in the circumferential direction so as to satisfy a specific condition, and creates a tubular artificial blood vessel having a woven structure such as a plain weave without increasing the weave. And found that an artificial blood vessel excellent in forceps operability can be obtained.

The present invention
It is a tubular prosthesis with a woven structure consisting of wefts and warps,
The warp of this tubular prosthesis
1) There are at least one portion where two warps adjacent to the circumferential direction (warp A and warp B) satisfy the relationship of formula (1),
2) In a warp in which two warps adjacent in the circumferential direction from warp B are arranged in the circumferential direction from the portion satisfying the relationship of formula (1), the warp and the adjacent warp are expressed by the formula ( It is to provide a prosthesis characterized by being arranged so as to satisfy the relationship of 2) or formula (3).

Furthermore, the present invention provides
It is a tubular prosthesis with a woven structure consisting of wefts and warps,
The warp of this tubular prosthesis
1) There are at least one portion where two warps adjacent to the circumferential direction (warp A and warp B) satisfy the relationship of formula (1),
2) In a warp in which two warps adjacent in the circumferential direction from warp B are arranged in the circumferential direction from the portion satisfying the relationship of formula (1), the warp and the adjacent warp are expressed by the formula ( It is to provide a prosthesis characterized by being arranged so as to satisfy the relationship alternately in the order of 2) and formula (3) or in the order of formula (3) and formula (2).

A preferred embodiment of the prosthesis of the present invention is shown.
The warp is preferably an odd number.
It is preferable that two or more warp yarns (warp yarn A and warp yarn B) adjacent to each other in the circumferential direction have an odd number of one or more odd numbers.
The woven structure is preferably a plain weave.

  The prosthesis of the present invention is excellent in flexibility, easy to handle and organize, excellent in curability, excellent in sealing performance by a coating agent or pro-clotting treatment, and easily blocked by forceps.

  Embodiments of the present invention will be described below in detail with reference to the drawings. However, the present invention is not limited to these embodiments.

FIG. 1 is a schematic diagram showing a circumferential arrangement of warp yarns in a partially cut-away portion of an axial longitudinal section of a plain weave tubular artificial blood vessel 10 which is an example of the present invention, and wefts are omitted. Yes. The number of warps of the artificial blood vessel 10 is an odd number.
In the circumferential arrangement of the warp of the artificial blood vessel 10, the warps in the clockwise circumferential direction from the warp 1 a are warps (1 b, 2 a, 1 c, 2 b, 1 d,..., 1 y, 2 x, 1 z, 2 y). Arranged in order.
The two warp yarns (1a, 1b) arranged in the circumferential direction satisfy warp A as warp A and warp B as warp B, and satisfy the condition of the following formula (1). The warp yarn 1b and the warp yarn 2a adjacent in the clockwise direction satisfy the relationship of the formula (3), and the warp yarn 2a and the warp yarn 1c adjacent in the clockwise direction satisfy the relationship of the equation (2). Furthermore, the warp 1c and the warp 2b satisfy the relationship of the formula (3), and the warp 2b and the warp 1d adjacent in the clockwise direction satisfy the relationship of the formula (2). As described above, the warp yarns arranged in the clockwise direction from the warp yarn 1b satisfying the condition of the formula (1) are arranged in the order of the formulas (3) and (2). Are arranged so as to satisfy the relationship alternately. Further, regarding the relationship between the warp 1a and the warp 2y arranged counterclockwise, the warp 2y and the warp 1a adjacent in the clockwise direction satisfy the relationship of the formula (2).
The warps used in the artificial blood vessel 10 are thicker than the warps (1a, 1b, 1c, 1d,..., 1y, 1z) of the same thickness (for example, the first group). There are two types of warp yarns (2a, 2b, 2c,..., 2x, 2y, 2z) (for example, the second group) having a moderate thickness.
In the artificial blood vessel 10, two warps arranged in the circumferential direction can have a plurality of portions that satisfy the condition of the following formula (1), and can have, for example, one or more odd numbers.

FIG. 2 is a schematic view showing a circumferential arrangement of warp yarns in a partially cut-out portion of an axial longitudinal section of a plain weave tubular artificial blood vessel 50 which is another example of the present invention, and wefts are omitted. Has been. The number of warps of the artificial blood vessel 50 is an odd number.
The circumferential arrangement of the warps of the artificial blood vessel 50 is that warps in the clockwise circumferential direction from the warps 3a are warps (3b, 4a, 3c, 4b, 3d,..., 3y, 4x, 3z, 4y). Arranged in order.
The two warps (3a, 3b) arranged in the circumferential direction satisfy the condition of the following formula (1) when the warp 3a is a warp A and the warp 3b is a warp B.
The warp yarn 3b and the warp yarn 4a adjacent in the clockwise direction satisfy the relationship of the equation (2), and the warp yarn 4a and the warp yarn 3c adjacent in the clockwise direction satisfy the relationship of the equation (3). Furthermore, the warp 3c and the warp 4b satisfy the relationship of the formula (2), and the warp 4b and the warp 3d adjacent in the clockwise direction satisfy the relationship of the formula (3). As described above, the warp yarns arranged in the clockwise direction from the warp yarn 3b satisfying the condition of the following equation (1), and the warp yarns adjacent in the clockwise direction are expressed by the equations (2) and (3). They are arranged so as to satisfy the relationship alternately in order. Further, regarding the relationship between the warp 3a and the warp 4y arranged counterclockwise, the warp 4y and the warp 3a adjacent in the clockwise direction satisfy the relationship of the expression (3).
The warp used in the artificial blood vessel 50 is the same as the warp (3a, 3b, 3c, 3d,..., 3y, 3z) (for example, the second group) having the same thickness. There are two types of warp yarns (4a, 4b, 4c,..., 4x, 4y, 4z) (for example, the first group) of about a certain thickness. In the artificial blood vessel 50, two warps arranged in the circumferential direction can have a plurality of portions that satisfy the condition of the following formula (1), and can have, for example, one or more odd numbers.

In the above formula (1), formula (2) and formula (3),
R ¹ is 0.9, preferably 0.92, more preferably 0.95, particularly preferably 0.98,
R ² is 1.1, preferably 1.2, more preferably 1.3, particularly preferably 1.4,
R ³ is 0.9, preferably 0.8, particularly preferably 0.7,
R ⁴ is 1.1, preferably 1.2, more preferably 1.3, and particularly preferably 1.4.

In the prosthesis, the warp to be used should be at least two types of warp (first group) and thicker warp (second group). Is preferred.
As an example, the warp used in the prosthesis
(I) A combination in which the warp satisfying formula (1) is the first group of warps, the warp of formula (2) is the second group of warps, and the warp adjacent to this is the first group,
(Ii) A combination in which the warp satisfying formula (1) is the second group of warps, the warp of formula (2) is the first group of warps, and the warp adjacent to this is the second group,
(Iii) The warp satisfying formula (1) is the first group of warps, the warp of formula (2) is the first group of warps, and the warp adjacent to this is the second group,
(Iv) The warp satisfying the formula (1) is the second group of warps, the warp of the formula (2) is the second group of warps, and the combination in which the warp adjacent to the second group is the first group. I can do it.

In the prosthesis, when the main yarn thickness consists of two types (for example, the first group and the second group) as the warp to be used, the thickness of the first group warp is preferably 20 to 300 denier, More preferably, it is in the range of 30 to 250 denier, more preferably 40 to 200 denier, particularly preferably 45 to 170 denier.
The thickness of the second group of warps is preferably in the range of 80 to 800 denier, more preferably 85 to 750 denier, more preferably 90 to 700 denier, and particularly preferably 95 to 650 denier.
In the prosthesis, when the main thread thickness is two types (for example, the first group and the second group), the variation in the thickness of the first group is preferably within 20 denier. More preferably within 15 denier, more preferably within 10 denier, particularly preferably within 5 denier,
The thickness of the second group of warp yarns is preferably within 50 denier, more preferably within 40 denier, more preferably within 30 denier, and particularly preferably within 20 denier.

  In the prosthesis, the diameter of the weft to be used is not particularly limited as long as there is no practical problem, but is preferably 20 to 300 denier, more preferably 30 to 250 denier, more preferably 40 to 200 denier, and particularly preferably 45 to 170. A denier range is preferred.

The weft and the warp constituting the prosthesis of the present invention are fibers made of synthetic or natural resin or protein.
As the synthetic resin, a thermoplastic synthetic resin can be used. Polyolefin such as polyethylene, polypropylene, ethylene-α-olefin copolymer, polyamide, polyurethane, polyethylene terephthalate, polybutylene terephthalate, polycyclohexane terephthalate, polyethylene-2, Fluorine resins such as polyesters such as 6-naphthalate, fluorinated polyolefins such as tetrafluoroethylene (PTFE) and ETFE can be used. More preferably, fluorine resin such as PTFE and ETFE, which is chemically stable and has high durability and little tissue reaction, chemically stable and has high durability, little tissue reaction, and excellent mechanical properties such as tensile strength Polyesters such as polyethylene terephthalate are preferred. Particularly preferred is a polyester such as polyethylene terephthalate having a glass transition temperature of 60 ° C. or higher because the strength of the polyester resin may be reduced by body temperature.

  Examples of the natural resin include polylactic acid obtained from plants such as corn.

  The synthetic resin used for the synthetic resin fiber is non-stretchable, and a resin having a characteristic that does not have great elasticity can be used.

  As the synthetic resin fiber, a spinnable, circular, elliptical, U-shaped, hollow, ribbon-like, cross-sectional shape such as a different diameter that is not circular or elliptical, and a spinnable thread can be used. Preferably 0.01 to 5 denier, more preferably 0.1 to 3 denier, more preferably 0.2 to 2 denier, particularly preferably 0.3 to 1 denier monofilaments, preferably several to several hundreds. More preferably 10 to 700 yarns, particularly preferably 10 to 100 yarns twisted or bundled yarns can be used.

  The prosthesis, synthetic resin fiber, synthetic resin, etc. of the present invention are coated with an antithrombotic material such as heparin, collagen, acetylsalicylic acid, gelatin, etc. that are not coated with a biological component such as heparin, collagen, gelatin, etc. What was processed can be used.

  The prosthesis of the present invention is a tubular prosthesis having a woven structure composed of wefts and warps, and is crimped between an uncrimped part or an uncrimped part and an uncrimped part Those having a portion, and those having an end portion that is not crimped (may have a portion that is not crimped except for the end portion) can be preferably used.

  As the crimping process, a method of processing the surface of a tube of a woven or knitted fabric such as a plain weave of thermoplastic resin fibers into an uneven shape can be used. For example, the method described in U.S. Pat. No. 3,337,673, that is, a plain woven tube of thermoplastic resin fibers is fitted on the surface of a round bar, and yarns are wound spirally from above the tube at equal intervals, and the tube is directly pivoted. A method of forming a wrinkle by compressing and shrinking in the direction, heating and heat setting. The method described in Japanese Patent Application Laid-Open No. 1-155860, that is, a plain-woven tube of thermoplastic resin fibers is fitted into a screw rod whose surface is sufficiently polished, and an appropriate thread is wound around the thread groove, and the state is left as it is. For example, a method of heat-setting and heat-setting may be preferably used.

  The tensile strength of the prosthesis of the present invention is not particularly limited as long as there is no practical problem, but preferably 5 kg or more, more preferably 7 kg to 100 kg, and particularly preferably 8 kg to 70 kg.

  The outer diameter of the prosthesis of the present invention is not particularly limited as long as there is no practical problem, but it is 4 mm or more, preferably 4.5 mm or more, more preferably 5 mm or more, particularly preferably 6 mm or more to 60 mm or less, preferably 55 mm or less. More preferably, a material in the range of 50 mm or less, particularly preferably 45 mm or less can be used.

  The length of the prosthesis of the present invention is not particularly limited as long as there is no practical problem. However, a length of 2 cm or more, preferably 2.5 to 50 cm, more preferably 3 to 40 cm, and particularly preferably 4 to 30 cm is used. I can do it.

  The thickness of the prosthesis of the present invention is not particularly limited as long as there is no practical problem, but it is preferably 100 to 800 μm, more preferably 120 μm to 700 μm, and particularly preferably 150 μm to 600 μm.

  The porosity of the prosthesis of the present invention is not particularly limited as long as there is no practical problem.

  The artificial organ of the present invention can be used for tubular structures such as artificial blood vessels, artificial esophagus, and artificial trachea.

The evaluation method of characteristics is shown.
(1) Porosity: 120 mmHg of water is allowed to flow through the tubular material at 37 ° C., and the porosity is calculated from the weight of the outflowed water, the surface area of the tubular material, and the time.
(2) Tensile strength: The tensile strength is measured at a temperature of 23 ° C., a tensile speed of 10 mm / min, and the sample is 1 cm in the radial direction (width) and 2 cm in the axial direction (length). The tensile strength is an average value of 5 measurement samples.

  For example, in the case of a plain woven fabric of synthetic resin fibers, the tensile strength in the weft direction is measured.

[Examples 1 to 14]
The warp and the warp adjacent to the warp used were those having a thickness shown in Table 1 in which a plurality of 0.7 denier polyethylene terephthalate monofilaments were twisted, and the weft was a plurality of 0.7 denier polyethylene terephthalate monofilaments. A 100 denier thread was used.
There is one portion where two warp yarns adjacent in the circumferential direction satisfy the relationship of formula (1), warp α is used as the warp of this portion, warp β is used as the adjacent warp, and warp α and warp thereafter. By alternately arranging β, a seam-free tubular plain weave prosthesis as shown in FIG. 1 was produced. The total number of warps is an odd number.
3 and 4 show micrographs of the surface and cross section of the prosthesis of Example 12.
As the warp of the prosthesis of Examples 1 to 14, two types of thicknesses of warp α and warp β were used.

[Comparative Example 1]
The warp is a 150 denier yarn made by twisting a plurality of 0.7-denier polyethylene terephthalate monofilaments, and the weft is a 100-denier yarn made by twisting a plurality of 0.7-denier polyethylene terephthalate monofilaments. Created no tubular, plain weave prosthesis.
5 and 6 show micrographs of the surface and cross section of the prosthesis of Comparative Example 1.

Comparing the cross-sectional photograph of Example 12 (FIG. 4) and the cross-sectional photograph of Comparative Example 1 (FIG. 6), the cross-section of Example 12 was fully woven with the warp compared to the cross-section of Comparative Example 1. Even in the cross sections of the prostheses of Examples 1 to 14 except Example 12, all the warp yarns were fully woven.
The prostheses of Examples 1 to 14 were all superior to the prosthesis of Comparative Example 1 in flexibility and excellent sealing performance by the gelatin coating treatment.
The light transmission from the inside of the artificial blood vessel of the artificial organs of Examples 1 to 14 and Comparative Example 1 was visually observed. There was no light leakage in the artificial organs of Examples 1 to 14, and the artificial body of Comparative Example 1 There was a little light leaking in the organ. The prosthetic devices of Examples 1 to 14 have a greater clogging effect than Comparative Example 1.
4 and 6 are cross sections in the circumferential direction of the prosthesis, and the arrangement of the warps can be understood.

FIG. 2 is a schematic diagram showing an arrangement in the circumferential direction of warp yarns in a partially cut-away portion of a longitudinal cross section in the axial direction of a plain weave tubular artificial blood vessel that is an example of the present invention. It is a schematic diagram which shows the arrangement | sequence of the circumferential direction of the warp in the partial notch part of the longitudinal cross section of the axial direction of the plain woven tubular artificial blood vessel which is another example of this invention. 1 is a surface micrograph showing an embodiment of the prosthesis of the present invention. It is the microscope picture of the cross section cut | disconnected in the circumferential direction which shows one Embodiment of the prosthesis of this invention. It is the surface micrograph which shows one Embodiment of the prosthesis of a comparative example. It is the microscope picture of the cross section cut | disconnected in the circumferential direction which shows one Embodiment of the prosthesis of a comparative example.

Explanation of symbols

1, 2, 3, 4: Warp, 10, 50: Artificial blood vessel.

Claims (4)

It is a tubular prosthesis with a woven structure consisting of wefts and warps,
The warp of this tubular prosthesis
1) There are at least one portion where two warps adjacent to the circumferential direction (warp A and warp B) satisfy the relationship of formula (1),
2) In a warp in which two warps adjacent in the circumferential direction from warp B are arranged in the circumferential direction from the portion satisfying the relationship of formula (1), the warp and the adjacent warp are expressed by the formula ( A prosthesis characterized by being arranged so as to satisfy the relationship of 2) or formula (3).

It is a tubular prosthesis with a woven structure consisting of wefts and warps,
The warp of this tubular prosthesis
1) There are at least one portion where two warps adjacent to the circumferential direction (warp A and warp B) satisfy the relationship of formula (1),
2) In a warp in which two warps adjacent in the circumferential direction from warp B are arranged in the circumferential direction from the portion satisfying the relationship of formula (1), the warp and the adjacent warp are expressed by the formula ( 2. A prosthesis characterized by being arranged so as to satisfy the relationship alternately in the order of 2) and formula (3) or in the order of formula (3) and formula (2).

  The prosthesis according to claim 1 or 2, wherein the warp is an odd number. The part where two warp yarns (warp yarn A and warp yarn B) adjacent in the circumferential direction satisfy the relationship of the formula (1) is owned by one or more odd numbers. The described prosthesis.

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