Braided structure, tube structure, catheter tube structure, method for manufacturing braided structure

Abstract

A catheter (100) includes a shaft member (106), a first wire (116) spirally wound around the shaft of the shaft member (106), and a second wire (118) wound around the shaft member (106) in the opposite direction to the first wire (116) in a first portion (112) and in the same direction as the first wire (116) in a second portion (114). Thus, a flexible braided structure or the like having different flexibility according to the axial position can be provided.

Description

Technical Field

[0001] This invention relates to braided structures, tubular structures, tubular structures for conduits, and methods for manufacturing braided structures. Background Technology

[0002] Previously, woven structures as described in Patent Document 1 were known.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2019-181271

[0006] In the structure described in Patent Document 1, a woven fabric is formed by intersecting each other at equal intervals along the entire axial length of the fiber filaments. Summary of the Invention

[0007] The purpose of this invention is to provide a flexible woven structure, etc., that varies depending on the location along the axial direction.

[0008] In one embodiment of the present invention, the device comprises: a shaft; a first wire wound in a spiral shape around the shaft; and a second wire wound in a first portion in a direction opposite to that of the first wire and in a second portion in the same direction as the first wire. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the catheter.

[0010] Figure 2 This is a cross-sectional view of the pipe.

[0011] Figure 3 This is a schematic diagram of the wire layer.

[0012] Figure 4 yes Figure 3 A cross-sectional view of the DD section.

[0013] Figure 5 This is a schematic diagram used to illustrate the manufacturing process of the catheter.

[0014] Figure 6 This is a schematic diagram used to illustrate the manufacturing process of the catheter.

[0015] Figure 7 It is a flowchart representing a series of processes in a manufacturing method.

[0016] Figure 8 This is a schematic diagram of a modified conduit.

[0017] Figure 9 This is a schematic diagram of another variation of the catheter. Detailed Implementation

[0018] The braided structure according to an embodiment of the present disclosure will now be described. The braided structure has a configuration in which a first braided section formed by crossing multiple strands of wire and a second braided section formed by arranging multiple strands of wire in a coil shape in the same direction are seamlessly connected. By seamlessly connecting multiple braided sections with different braiding methods, flexibility can be adjusted according to the location, and bending at the connection points between the braided sections can be reduced. The braided structure of the embodiment is assembled as part of a catheter. As a catheter, there are sheaths used to guide other medical devices (another catheter, balloon, etc.) into a treatment area inside the body (a treatment area inside the digestive organs, bile ducts, blood vessels, etc.), or electrode catheters with electrodes at their tips.

[0019] Figure 1 This is a schematic diagram of the catheter. (For example...) Figure 1 As shown, the conduit 100 has an elongated tube 102 and a base 104. Here, Figure 1 The X direction shown indicates the direction in which the tube 102 extends when it is straight. The X direction is also called the axial direction of the tube 102. In addition, the Y direction indicates the direction orthogonal to the X direction (orthogonal to the plane of the paper).

[0020] The catheter 100 can be either an adjustable (or manipulable) catheter that can be operated by the user (operator) near the tip of the tube 102, or a fixed catheter with a fixed shape (that is, it cannot be operated by the user).

[0021] The base 104 functions as an operating part for the user to manipulate the catheter 100. In this case, a handle (not shown) is provided on the base 104 for bending the vicinity of the tip of the tube 102 in a desired direction (one or both directions). The user inserts or removes the tube 102 into the body by holding the base 104 and moving the base 104. At this time, the user bends the vicinity of the tip of the tube 102 by operating the handle, thereby adapting the shape of the tube 102 to the shape of a tube.

[0022] The base 104 may also function as a connector between the catheter 100 and other medical devices. When the base 104 functions as a connector, auxiliary devices such as a female Luer valve or a hemostatic valve may be connected to its rear end. When the base 104 functions as a connector, guidewires or additional catheters may also be inserted into it.

[0023] Figure 2 This is a cross-sectional view of the pipe. Specifically, Figure 2 It is a cross-sectional view in the XY plane at a position along the axis of the tube. For example... Figure 2As shown, the wall of tube 102 has a three-layer structure. Tube 102 includes a shaft 106, a wire layer 108, and an outer layer 110. The internal space S of tube 102 functions as a cavity for the passage of other medical devices, including guidewires.

[0024] Shaft 106 is formed of a flexible tube. Shaft 106 is primarily used to help maintain the tube shape of wire layer 108 and / or to define the internal space S. Shaft 106 is formed of a resin material (e.g., a thermoplastic elastomer such as PEBAX (registered trademark)) having a cylindrical shape. The inner circumferential surface of shaft 106 (that is, the surface defining the internal space S) preferably has a certain degree of sliding property (i.e., a low coefficient of friction).

[0025] The wire layer 108 is a layer formed by winding at least two wires around the outer periphery of the shaft 106. Since the wire layer 108 is formed from multiple wires, it is not a dense layer made of a single material like a resin layer, but rather a layer with spaces between the wires. The wire layer 108 can also be described as a structure formed by braiding the wires into a tubular or cylindrical shape. The wire layer 108 can also be described as a braided layer formed from the braided wires. The detailed structure of the wire layer 108 will be described later.

[0026] The outer layer 110 protects the wire layer 108. The outer layer 110 is formed of a biocompatible material such as an elastomeric resin. In the illustrated example, the outer layer 110 has a tubular structure covering the outer surface of the wire layer 108. The outer layer 110 can also be formed integrally with the wire layer 108. That is, the wire layer 108 can be formed integrally within the outer layer 110. Alternatively, a tip that prevents tissue damage when the tip of the tube 102 comes into contact with tissue can be integrally formed with the outer layer 110.

[0027] The wire is preferably made of biocompatible metals (such as tungsten, stainless steel, nickel-titanium, etc.) or alloys, or other biocompatible materials (nylon, PEEK, LCP resin). The wire can also be obtained by coating a specified material with a biocompatible material. The material of the wire can be appropriately selected according to the intended use of the braided structure. Multiple wires can also be made of different materials. The wire can have either a circular or rectangular cross-section.

[0028] Figure 3 This is a schematic diagram of the wire layer. Specifically, Figure 3This is a schematic top view of the wire layer (viewed from the Y direction). It should be noted that, for simplicity, the following description assumes the wire layer consists of two wires. The wire layer only needs to consist of at least two wires; the number of wires is not limited to two. That is, the "first wire" can be multiple, or the "second wire" can be multiple, or the number of "first wires" and "second wires" can be different.

[0029] like Figure 3 As shown, the wire layer 108 has a first portion 112 and a second portion 114 along the axial direction. In the first portion 112 and the second portion 114, the two wires (hereinafter sometimes referred to as "first wire 116" and "second wire 118") are wound in different ways. Therefore, the tube 102 in the first portion 112 (see...) Figure 1 The flexibility (at least one of flexural modulus [MPa] and minimum bending radius [mm]) of the first part 112 differs from that of the tube 102 in the second part 114. Furthermore, the torque characteristics (torsional strength about the axis: [N·m]) differ between the first part 112 and the second part 114. In the first part 112, the first wire 116 and the second wire 118 are oriented in different directions, therefore the torque characteristics of the first part 112 are higher than those of the second part 114. On the other hand, in the second part 114, the first wire 116 and the second wire 118 are oriented in the same direction, therefore the second part 114 is easier to bend than the first part 112 (that is, it has higher flexibility).

[0030] The first portion 112 and the second portion 114 are axially adjacent areas, and the two portions are seamlessly connected. Seamless connection means that the first portion 112 and the second portion 114 are constructed of the same wire. Therefore, there are no wire ends between the first portion 112 and the second portion 114. The configuration of the first portion 112 and the second portion 114 is not particularly limited; the first portion 112 may be located further forward, and the second portion 114 may also be located further forward. Multiple first portions 112 and second portions 114 may also be provided. The axial configuration of the first portion 112 and the second portion 114 can be appropriately selected to achieve physical characteristics (flexibility and / or torque) suitable for the application of the conduit 100.

[0031] In the first part 112, the first wire 116 and the second wire 118 are wound around the shaft 106 in a manner that forms an intersecting braided structure. The repeating order (i.e., the radial arrangement) of the first wire 116 and the second wire 118 can be suitably chosen, either being the same at all intersections or different at each intersection. A repeating order different at each intersection means that the sequence is patterned such that at one intersection the first wire 116 is radially outward, at an adjacent intersection the second wire 118 is radially outward, and at a further adjacent intersection the first wire 116 is radially outward. The first wire 116 is wound spirally around the shaft 106 in a first direction A1 (clockwise about the axis of the shaft 106). Generally, a spiral shape refers to a shape that moves in a direction perpendicular to the plane of rotation (the circular cross-section of the shaft 106) (the component along the X-axis). When "spiral" is mentioned in this disclosure, the amount of movement in a certain direction of the perpendicular component may not be constant.

[0032] In the first part 112, the second wire 118 is spirally wound around the shaft 106 in a second direction A2 (counterclockwise around the axis of the shaft 106) opposite to the first wire 116. If the winding interval (the amount of the component along the X-axis) of the first wire 116 and the second wire 118 is the same, then in the first part 112, the first wire 116 and the second wire 118 cross at equal intervals.

[0033] In the second section 114, the first wire 116 and the second wire 118 are wound in a spiral shape relative to the axis of the shaft 106 in the same direction (first direction A1). That is, in the second section 114, the first wire 116 and the second wire 118 are wound around the shaft 106 in a manner that forms a generally parallel braided structure. The first wire 116 is wound in the same direction (first direction A1) from the first section 112 to the second section 114. The second wire 118 is wound in the second section 114 in the opposite direction to the first section 112. In the second section 114, the first wire 116 and the second wire 118 are arranged alternately along the axis of the guide tube 100 without crossing. The first wire 116 and the second wire 118 extend in a generally parallel manner. The term "generally parallel" here means that the first wire 116 and the second wire 118 do not cross, and does not necessarily mean that the spacing between the two wires is constant. It can also be said that the second wire 118 is wound in the opposite direction in the first section 112 and the second section 114.

[0034] In the first part 112 and the second part 114, the winding intervals of the first wire 116 and / or the second wire can also be different. This allows for adjustment of the physical properties between the first part 112 and the second part 114.

[0035] A transition section 120 is provided between the first portion 112 and the second portion 114. The transition section 120 seamlessly connects the first portion 112 and the second portion 114. Seamless connection means that the connection is made without the ends of the first wire 116 or the second wire 118. Without ends means that there are no ends of the first wire 116 or the second wire 118 in this section, and for example, if the first wire 116 is a wire formed by welding the ends of two wires together, there are no welded portions in this section. By seamlessly connecting the first wire 116 and the second wire 118, the conduit 100 is less likely to break between the first portion 112 and the second portion 114.

[0036] When the winding interval of the first wire 116 differs in the first portion 112 and the second portion 114, it is preferable that the winding interval of the first wire 116 gradually changes in the variation portion 120. This prevents abrupt changes in physical properties within the variation portion 120. Alternatively, the winding interval of the first wire 116 can be reduced in the variation portion 120 (it can also be narrower than the winding intervals in the first portion 112 and the second portion 114). This reduces the bending ease of the variation portion 120, making the variation portion 120 stiffer (that is, increasing the bending elasticity).

[0037] In the changing section 120, the winding direction of the second wire 118 changes. The winding direction of the second wire 118 becomes the opposite direction within the changing section 120. The second wire 118 includes a first wire portion 118A extending along a first direction A1, a second wire portion 118B extending along a second direction, and a third wire portion 118C between the first wire portion 118A and the second wire portion 118B. The third wire portion 118C has a curved shape (approximately U-shaped). The third wire portion 118C has a component parallel to the X-axis at a microscopic level. That is, the third wire portion 118C has a component with an inclination of 0 or approximately 0 relative to the X-axis. Through the third wire portion 118C, axial force can be easily transmitted from the first wire portion 118A to the second wire portion 118B.

[0038] Figure 4 yes Figure 3 A cross-sectional view of the DD section. (See attached image.) Figure 4As shown, the thickness of the wire layer 108 differs in the first portion 112 and the second portion 114. The thickness of the wire layer 108 referred to here depends on the thicknesses of the first wire 116 and the second wire 118 (referring to the radial thickness of the shaft 106, or the wire diameter if the wire has a circular cross-section). In the first portion 112, there are overlapping (crossing when viewed from above) and non-overlapping portions of the first wire 116 and the second wire 118. The thickness of the wire layer 108 in the first portion 112 refers to the portion with the smallest thickness (length in the Y-axis direction) among the overlapping portions of the first wire 116 and the second wire 118. That is, the thickness of the wire layer 108 in the first portion 112 is measured at the portion where the first wire 116, the second wire 118, and the shaft 106 are in close contact. Therefore, the thickness of the wire layer 108 in the first portion 112 is equivalent to the sum of the thicknesses of the first wire 116 and the second wire 118. When considering the thickness of the wire layer 108 in the first portion 112, although the first wire 116 and the second wire 118 overlap, portions where there are gaps on the outer surfaces of the first wire 116, the second wire 118, or the shaft 106 should not be considered. In the second portion 114, only portions where the first wire 116 and the second wire 118 do not overlap exist. Therefore, the thickness of the wire layer 108 in the second portion 114 is equivalent to the thickness of either the first wire 116 or the second wire 118.

[0039] It can be seen that the first part 112 is thicker than the second part 114. The first part 112 being thicker than the second part 114 means that, according to the above definition, at least one portion of the first part 112 is thicker than at least one portion of the second part 114. When the first wire 116 and the second wire 118 have the same thickness, the thickness of the first part 112 is twice the thickness of the second part 114.

[0040] The first portion 112 and the second portion 114 have different thicknesses, therefore the diameter of the entire conduit 100 varies depending on the location. That is, the diameter is relatively larger in the first portion 112 and relatively smaller in the second portion 114. Therefore, according to the embodiment, the diameter of the conduit 100 can also be adjusted by changing the winding direction of the first wire 116 and the second wire 118.

[0041] In this embodiment, the wire layer 108 is composed of two wires, so the thickness of the variation section 120 is the same as the thickness of the first section 112. However, if the number of wires increases, depending on the bending method of the wires, it is also conceivable that the wires overlap each other and the thickness of the variation section 120 increases.

[0042] As described above, according to the embodiment, the flexibility of the first part 112 and the second part 114 can be different.

[0043] The manufacturing method of the conduit, which is a braided structure, will be described below. Figure 5 and Figure 6 This is a schematic diagram used to illustrate the manufacturing process of the catheter. Figure 7 It is a flowchart representing a series of processes in a manufacturing method.

[0044] like Figure 5 and Figure 6 As shown, two braiding machines (a first wire supply mechanism 200 and a second wire supply mechanism 202) are prepared to manufacture the guide tube 100. Each wire supply mechanism 200 and wire supply mechanism 202 rotates independently about the axis of the shaft 106. When the shaft 106 has a tubular structure, the shaft 106 can also be fixed to the mandrel.

[0045] Reference Figures 5 to 7 The method for manufacturing catheter 100 includes the following steps:

[0046] Step S1: Using the first wire supply mechanism 200, the first wire 116 is wound in a spiral shape around the shaft of the shaft member 106;

[0047] Step S2: Using the second wire supply mechanism 202, the second wire 118 is wound onto the shaft 106 in the opposite direction to the first wire.

[0048] Step S3 involves changing the rotation direction of the second wire supply mechanism 202, thereby changing the rotation direction of the spiral of the second wire 118; and

[0049] Step S4: The second wire 118 is wound around the shaft 106 in the same direction as the first wire 116.

[0050] In step S1, the first wire supply mechanism 200 is rotated about the axis of the shaft 106, and the first wire 116 is wound around the shaft 106. The first wire supply mechanism 200 rotates about the axis of the shaft 106 while moving axially in the shaft 106. Step S1 continues until the series of processes is completed.

[0051] In step S2, the second wire supply mechanism 202 is rotated about the axis of the shaft 106, and the second wire 118 is wound around the shaft 106. The second wire supply mechanism 202 rotates about the axis of the shaft 106 while moving axially along the shaft 106, which is delayed compared to the first wire supply mechanism 200. The rotation direction of the second wire supply mechanism 202 is opposite to the rotation direction of the first wire supply mechanism 200.

[0052] In step S3, the rotational direction of the second wire supply mechanism 202 is changed. During this period, the axial movement speed of the second wire supply mechanism 202 is the same as the movement speed in step S2. As a result, a curved third wire portion 118C (see reference) is formed on the second wire 118. Figure 3 ).

[0053] In step S4, the second wire supply mechanism 202 is rotated about the axis of the shaft 106, and the second wire 118 is wound around the shaft 106. The rotation direction of the second wire supply mechanism 202 at this time is the same as the direction after the rotation direction change in step S3. By maintaining the delay of the second wire supply mechanism 202, the first wire 116 and the second wire 118 are wound in parallel. With the shaft 106 formed on the outer periphery of the mandrel, the mandrel is pulled out from the shaft 106, thereby obtaining the guide tube 100.

[0054] This invention is not limited to the above-described embodiments, and the configuration of the embodiments may be appropriately modified without departing from the spirit of this disclosure.

[0055] The material of the wire can be appropriately selected according to the intended use of the braided structure. For example, carbon fiber can be used as the wire in applications requiring both strength and flexibility (such as golf club shafts, fishing rod shafts, etc.). Various other types of wires, such as metal wires and resin wires, can also be used.

[0056] Shafts can also be solid. When a shaft is solid, it can function as a mandrel itself, so a mandrel is not needed in the manufacturing process.

[0057] The following variations are also within the scope of the present invention. A variation of the braided structure has a configuration in which a first braided section formed by crossing multiple strands of wire and a second braided section formed by oriented multiple strands of wire in the same direction are seamlessly connected. Unlike the embodiment, in the variation, the second braided section is not formed by winding the wires into a coil, but rather by changing the winding direction of only a portion of the multiple strands of the first braided section.

[0058] Figure 8 This is a schematic diagram of a modified conduit. For example... Figure 8As shown, the conduit 200 is constructed by seamlessly connecting the first portion 112 and the second portion 114 via a change section 120. The first portion 112 includes a first wire 116 wound in a first direction and two second wires 118A and 118B wound in a second direction. In the change section 120, only the winding direction of one of the second wires 118A and 118B (second wire 118A in the illustrated example) changes. In the second portion 114, the first wire 116 and the second wire 118A are wound in the first direction, and the second wire 118B is wound in the second direction. That is, the first wire 116 is wound in the same direction from the first portion 112 to the second portion 114, and only the winding direction of a portion of the multiple second wires (second wire 118A in the illustrated example) changes in the change section 120.

[0059] The first part 112 and the second part 114 have different fabric structures, therefore the flexibility of the first part 112 and the second part 114 is different. More specifically, the flexibility in the ±Y direction is different in the first part 112 and the second part 114. That is, in the first part 112, the flexibility in the +Y direction is greater than the flexibility in the -Y direction. On the other hand, in the second part 114, the flexibility in the -Y direction is greater than the flexibility in the +Y direction.

[0060] Figure 9 This is a schematic diagram of another variation of the conduit. For example... Figure 9 As shown, the conduit 300 is constructed by seamlessly connecting the first portion 112 and the second portion 114 via a change section 120. The first portion 112 includes four first wires 116A to 116D wound in a first direction and four second wires 118A to 118D wound in a second direction. In the change section 120, only a portion of the second wires 118A to 118D (in the illustrated example, second wires 118B and 118D) has a changed winding direction. In the second portion 114, the first wires 116A to 116D and the second wires 118B and 118D are wound in the first direction, while the second wires 118A and 118C are wound in the second direction. That is, the first wires 116 are wound in the same direction from the first portion 112 to the second portion 114, and only a portion of the multiple second wires (in the illustrated example, second wires 118B and 118D) have a changed winding direction in the change section 120. It should be noted that the direction of the winding of the wire can be changed appropriately. For example, the winding direction of the second wires 118A and 118D can also be changed.

[0061] The first part 112 and the second part 114 have different fabric structures, therefore the flexibility of the first part 112 and the second part 114 is different. More specifically, the flexibility in the ±Y direction is different in the first part 112 and the second part 114. That is, in the first part 112, the flexibility in the +Y direction is greater than the flexibility in the -Y direction. On the other hand, in the second part 114, the flexibility in the -Y direction is greater than the flexibility in the +Y direction.

[0062] Industrial availability

[0063] This disclosure can be used in the fields of braided structures, tubular structures, tubular structures for conduits, and methods for manufacturing braided structures.

[0064] Explanation of reference numerals in the attached figures

[0065] 100: Conduit; 102: Tube; 104: Base; 106: Shaft; 108: Wire layer; 112: First part; 114: Second part; 116: First wire; 118: Second wire; 120: Variation section.

Claims

1. A woven structure, wherein, The woven structure has: Shafts; The first wire is wound in a spiral shape around the axis of the shaft; and Multiple second wires are wound around the shaft in a direction opposite to that of the first wires in a first portion arranged along the shaft. A portion of the plurality of second wires is wound around the shaft in the same direction as the first wires in a second portion arranged along the axis of the shaft. The other second wires of the plurality of second wires are wound around the shaft in the second portion in the opposite direction to the first wires. In a portion of the plurality of second wires, a section is provided between the first portion and the second portion to change the direction of rotation of the spiral.

2. The woven structure according to claim 1, wherein, The second wire does not have an end in at least the first portion and the second portion.

3. The woven structure according to claim 1 or 2, wherein, The first wire and the second wire form a wire layer around the shaft. The thickness of the wire layer in the first part is greater than the thickness of the wire layer in the second part.

4. The woven structure according to claim 3, wherein, The difference between the thickness of the wire layer in the first part and the thickness of the wire layer in the second part is approximately equal to the thickness of the second wire.

5. The woven structure according to claim 1 or 2, wherein, The winding interval of the first wire is different in the first part and the second part.

6. A woven structure, wherein, The woven structure has: Shafts; Multiple first wires are spirally wound around the axis of the shaft; and Multiple second wires are wound around the shaft in a direction opposite to that of the multiple first wires in a first portion arranged along the shaft. A portion of the plurality of second wires is wound around the shaft in the same direction as the first wires in a second portion arranged along the axis of the shaft. The other second wires of the plurality of second wires are wound around the shaft in the second portion in the opposite direction to the first wires. In a portion of the plurality of second wires, a section is provided between the first portion and the second portion to change the direction of rotation of the spiral.

7. A tubular structure, wherein, The tubular structure comprises: Cylindrical shaft components; The first wire is wound in a spiral shape around the axis of the shaft; and Multiple second wires are wound around the shaft in a direction opposite to that of the first wires in a first portion arranged along the shaft. A portion of the plurality of second wires is wound around the shaft in the same direction as the first wires in a second portion arranged along the axis of the shaft. The other second wires of the plurality of second wires are wound around the shaft in the second portion in the opposite direction to the first wires. In a portion of the plurality of second wires, a section is provided between the first portion and the second portion to change the direction of rotation of the spiral.

8. A tubular structure for a conduit, wherein, The catheter tubular structure comprises: A shaft component that has an internal cavity; The first wire is wound in a spiral shape around the shaft; and Multiple second wires are wound around the shaft in a direction opposite to that of the first wires in a first portion arranged along the shaft. A portion of the plurality of second wires is wound around the shaft in the same direction as the first wires in a second portion arranged along the axis of the shaft. The other second wires of the plurality of second wires are wound around the shaft in the second portion in the opposite direction to the first wires. In a portion of the plurality of second wires, a section is provided between the first portion and the second portion to change the direction of rotation of the spiral.

9. A woven structure, wherein, Along the axis of the shaft member are: a first portion in which a first wire and a plurality of second wires are wound around the shaft member in a cross manner; and a second portion in which the first wire and a portion of the plurality of second wires are wound around the shaft member in the same direction. A changing section, disposed between the first portion and the second portion, wherein the direction of a portion of the plurality of second wires changes to the opposite direction. The other second wires of the plurality of second wires are wound around the shaft in the second portion in the opposite direction to the first wire.

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