WO2022166538A1 - 一种导管加强层和导管 - Google Patents
一种导管加强层和导管 Download PDFInfo
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- WO2022166538A1 WO2022166538A1 PCT/CN2022/071230 CN2022071230W WO2022166538A1 WO 2022166538 A1 WO2022166538 A1 WO 2022166538A1 CN 2022071230 W CN2022071230 W CN 2022071230W WO 2022166538 A1 WO2022166538 A1 WO 2022166538A1
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- Prior art keywords
- axial
- catheter
- component
- braided
- reinforcement layer
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
Definitions
- the axial components are sequentially spaced along the axial direction of the knitted component.
- the axial component is a monofilament or a twisted wire composed of a plurality of monofilaments.
- the present invention also provides a conduit, comprising an inner layer, a reinforcement layer and an outer layer which are sequentially arranged from the inside to the outside and are all tubular, and the reinforcement layer is the conduit reinforcement layer as described above. .
- the preset position is where the thickness of the inner layer or the outer layer is smaller, or the circumference of the braided component corresponding to the catheter segment with the higher flexibility of the inner layer or the outer layer To the surface or between the gaps of the braided wire;
- FIG. 2 is a schematic plan view of a conduit reinforcement layer in an embodiment provided by the present invention unfolded along an axial direction;
- FIG. 6 is a schematic structural diagram of a conduit reinforcement layer in another embodiment provided by the present invention.
- FIG. 8 is another schematic plan view of the conduit reinforcement layer in an embodiment provided by the present invention developed along the axial direction.
- the existing catheters are usually designed with segments with different hardnesses.
- the proximal end is stiffer and the distal end is softer, that is, the stiffness decreases gradually from the proximal end to the distal end.
- the design of softness and stiffness of different segments needs to be determined according to the vascular anatomy.
- the soft catheter at the distal end is easier to pass through the tortuous blood vessel and reduces the risk of damage to the blood vessel, but affected by the characteristics of the catheter material, the flexible catheter has a higher axial extension rate and is prone to shaft axis under the action of axial force.
- the tube of the catheter is subjected to axial shear stress. If the axial elongation rate of the tubular body of the catheter is too high, it is easier to stretch axially under the force of the device delivered therein. The tube body of the catheter may be deformed after being stretched, and it is difficult to release or recover the delivered instruments, which has serious adverse effects on clinical operations.
- the researchers of the present invention found that the overall mechanical properties of the catheter are related to the modulus and hardness of the polymer material, and the strength of the metal wire of the reinforcing layer and the metal coverage.
- the conduit is mainly composed of an inner layer, a reinforcing layer and an outer layer.
- the axial fracture resistance is strong, and it is not easy to be pulled off.
- the axial elongation of the catheter depends on the polymer material of the inner and outer layers.
- the inner and outer layers of the catheter are made of polymer materials with low hardness, such as thermoplastic elastomer (TPE), polyolefin (polyolefin) or polyolefin elastomer (polyolefin elastomer), due to the elasticity of the material
- TPE thermoplastic elastomer
- polyolefin polyolefin
- polyolefin elastomer polyolefin elastomer
- the present invention provides a catheter reinforcement layer and a catheter including the catheter reinforcement layer to solve the problem that the catheter is axially elongated when the device is transported in the catheter due to the high elongation rate of the existing catheter.
- FIG. 2 is a schematic plan view of a conduit reinforcement layer provided in an embodiment of the present invention developed along an axial direction.
- the knitted component 110 may include a mesh formed by cross-knitting a plurality of braided wires, and it is assumed that the intersecting position of the braided wires is a mesh intersection point a.
- All intersections between the axial components included in the knitted component 110 and the knitted component 110 may coincide with the grid intersection a of the knitted component 110, such as the intersection b1 between the axial component 120a and the knitted component 110; or, All intersections between the axial component and the knitted component 110 may not coincide with grid intersection a, such as the intersection b2 between the axial component 120b and the knitted component 110; A portion of the intersection between the knitted components 110 (eg, the intersection b3 of the axial component 120c and the knitted component 110 ) may coincide with the grid intersection a, and another portion of the intersection may not coincide with the grid intersection a of the knitted component 110 (eg, the axis of intersection a). Towards the intersection b4) of component 120c and knitted component 110.
- intersections between the axial component and the knitted component there may be 1-45,000 intersections between the axial component and the knitted component.
- the specific number of intersections between each axial component and the knitted component can be set according to actual needs, which is not specifically limited in the present invention.
- the axial components included in the knitted component 110 are extended along the proximal end to the distal end.
- the axial parts can be arranged in a manner parallel to the axial direction of the catheter, such as the axial part 120a and the axial part 120b; they can also be arranged in a certain angle with the axial direction of the catheter (such as the axial part 120c), and the The range of the certain angle can be any angle within 0-45°.
- the braided component 110 when the braided component 110 includes a plurality of axial components, some of the axial components may be arranged parallel to the axial direction of the catheter, and the other part may be arranged at a certain angle to the axial direction of the catheter, and all the axial components may be arranged at an angle to the axial direction of the catheter.
- the certain angle may include any angle within 0-45°, such as 3°, 5°, 10°, 15°, 30°, 45° and so on.
- the same axial component may have the same or different angles to the axial direction of the catheter in the longitudinal direction, and different axial components may have the same angle to the axial direction of the catheter.
- the material of the braided component of the catheter reinforcement layer can be metal, for example: any one or a combination of any of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and tungsten; or, the material of the braided component can also be Polymer filaments, for example: any one of polyethylene, polyamide, and liquid crystal polymer filaments or a combination of any of them; further alternatively, the material of the knitted component may be a combination of metal and polymer filaments.
- the material of the axial part of the conduit reinforcement layer may be metal and/or polymer wire.
- the material of the axial component can be any one or a combination of metals such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, tungsten, silver, and gold, etc. Any one or any combination of polymer filaments such as amide and liquid crystal; or, the material of the axial component can also be a combination of the metal and the polymer filament.
- the material of some of the axial members may be metal, and the material of some of the axial members may be polymer filaments.
- the material of at least one of the axial members is a developing material.
- the inner and outer layers of the existing catheter are kept unchanged to ensure the flexibility of the catheter, and at the same time, the axial direction of the braided component in the reinforcing layer of the existing catheter is One or more axial components are arranged on the catheter to increase the axial modulus of the catheter, thereby avoiding axial deformation of the catheter due to the axial shear stress of the catheter body when the device is transported in the catheter body, That is, the axial tensile capacity of the catheter is improved. Therefore, the elongation rate of the catheter is reduced, and the risk of fatigue failure caused by axial stretching of the catheter by the internal compatible device is ultimately avoided.
- the object of the present invention can be achieved as long as the axial member is arranged in various ways in the axial direction of the braided member, wherein the axial direction includes the axial direction of the catheter and the axial direction of the catheter at a certain angle. direction and the certain angle includes any angle in the range of 0-45°.
- FIGS. 3a-3c are schematic structural diagrams of a conduit reinforcement layer according to an embodiment of the present invention, as shown in FIGS. 3a-3c, and also referring to FIG. 1, the conduit reinforcement layer 100 includes a braided component 110 and axial component 120 extending from the proximal end to the distal end in the axial direction of knitted component 110 and integrally extending through said knitted component 110 .
- the axial component 120d can be attached between the braided component 110 and the inner layer (not shown) of the catheter in a linear or spiral shape from the proximal end to the distal end, that is, the attachment on the inner surface of the knitted component 110 .
- the axial member 120e may be linearly or helically attached between the braided member 110 and the outer layer (not shown) of the catheter from the proximal end to the distal end, ie, attached to the outer layer (not shown) of the catheter.
- the outer surface of the knitted component 110 may be attached to the inner surface and the outer surface of the knitted component 110 in a wavy staggered manner from the proximal end to the distal end.
- FIG. 4 is a schematic structural diagram of a conduit reinforcement layer according to another embodiment of the present invention.
- the axial component 120g may be disposed in the mesh of the knitted component 100 from the proximal end to the distal end, and the axial component 120g is in the same plane as the knitted component 110 (ie, The segments of the axial member are located in the corresponding woven mesh).
- the axial component 120g may be combined with the knitted component 110 by welding, bonding, or the like, or the axial component 120d and the knitted component 110 may be woven into one body by knitting.
- the advantage of the conduit reinforcement layer 110 shown in Fig. 4 is that the outer diameter of the conduit comprising the conduit reinforcement layer is not increased by the presence of the axial member 120 .
- the axial component 120 provided by the present invention is different from the braided component 110 in the manner described in the first and second embodiments above (that is, the knitted component 110 is completely penetrated from the proximal end to the distal end).
- the axial component 120 may also be combined with the braided component 110 to form the reinforcing layer 100 for the catheter in a manner of partially penetrating the braided component 110 .
- the invention is not specifically limited.
- two adjacent axial members may have no "overlapping" positions in the axial direction at all; in other embodiments, two adjacent axial members may have partial “overlaps” in the axial direction s position.
- the "overlapping" mentioned here means that at the same axial position, the cross-section of the reinforcing layer at this position has the cross-sections of the above-mentioned two adjacent axial parts at the same time.
- the catheter is usually hard at the proximal end and soft at the distal end, that is, the hardness gradually decreases from the proximal end to the distal end, and consists of a plurality of catheter segments with different hardness and/or thickness stitched together.
- the joints (joints or transition positions) of a plurality of catheter segments and the thinner parts of the catheter body are likely to become weak points of force.
- a plurality of the axial components 120 may also be arranged symmetrically or asymmetrically along the circumferential direction of the knitted component 110 at preset positions, and/or the axial components 120 are sequentially spaced at preset positions along the axial direction of the knitted component 110 .
- the preset position may be a junction of a plurality of conduit segments included in the conduit reinforcement layer (a splicing position or transition position of the inner layer or the outer layer), a position where the inner layer or the outer layer is relatively soft , where the thickness of the inner or outer layer is smaller, where the modulus of the catheter is smaller, and where the catheter body is thinner.
- FIG. 6 and FIG. 7 are schematic structural diagrams of a conduit reinforcement layer according to another embodiment of the present invention.
- multiple The axial member 120k or the axial member 120j may be arranged helically along the circumferential direction of the braided member 110, and the plurality of axial members 120k or the axial member 120j may be located at the corresponding seams of the adjacent catheter segments.
- the plurality of axial components 120k or the axial components 120j may be located in the inner or outer layer of the catheter with a smaller thickness. at a location, or alternatively, at a location where the softness of the inner or outer layer of the catheter is high.
- each axial component 120j or axial component 120k may be disposed between the braided component 110 and the inner layer of the catheter, or may be disposed between the braided component 110 and the outer layer 200 of the catheter , can also be partially arranged between the braided component 110 and the inner layer of the catheter and the other part is arranged between the braided component 110 and the outer layer of the catheter, or between the meshes of the braided component 110 .
- the axial length of each of the axial components 120 may be the axial distance of one woven mesh of the knitted component 110 .
- the axial distance of the plurality of woven meshes (the plurality of woven meshes includes a non-integer number of woven meshes), such as the axial component 120j shown in FIG. 6 , is not specifically limited in the present invention.
- a plurality of the axial components 120k or the axial components 120j may be helically arranged along the circumferential direction of the knitted component 110, and the axial spacing between the plurality of axial components 120k or the axial components 120j may be the same Alternatively, and/or, the circumferential angular spacing of the plurality of axial members 120k or axial members 120j may be the same or different.
- the axial distance between the axial components 120k or the axial components 120j located at the proximal end of the knitted component 110 may be smaller than that of all the axial components located at the distal end of the knitted component 110
- the axial spacing of the axial part 120k or axial part 120j, and/or the circumferential angular spacing of the axial part 120k or axial part 120j at the proximal end may be smaller than that of the axial part 120k at the distal end or Axial spacing of axial members 120j.
- a plurality of the axial components 120k or axial components 120j are arranged helically along the circumferential direction of the knitted component 110; in other embodiments, the plurality of axial components 120k or axial components
- the components 120j may be located in the same circumferential direction, but spaced apart in the axial direction. Since in this embodiment, one or more axial components can be arranged on the weak point of the catheter, stress concentration points can be prevented from being generated on the catheter, thereby preventing the deformation of the pipe body of the catheter during the delivery of the device.
- introducing one or more axial components extending in the axial direction into the reinforcing layer of the conduit can improve the transmission efficiency of the axial force of the conduit and optimize the transmission performance of the conduit.
- the axial member 120 may be a single wire or a twisted wire composed of a plurality of single wires.
- the diameter of the monofilament may range from 0.0005 inch to 0.003 inch, and the number of monofilaments included in the twisted wire may range from 1 to 20.
- the axial member 120 in the embodiment is made of polyamide polymer filaments with a monofilament size of 0.001 inch, it has an excellent effect on the flexible conduit of the braided member 110 .
- the researchers of the present invention obtained the following table through experiments to explain the effects of the axial components provided by the present invention on various parameters of the catheter including the catheter reinforcement layer provided in the embodiments of the present invention.
- the specific arrangement of the axial component is shown in FIG. 3 a , that is, the axial component extends from the proximal end to the distal end along the axial direction of the knitted component 110 and runs through the knitted component 110 as a whole.
- the axial elongation of the catheter gradually decreases, but the outer diameter and softness of the catheter remain basically unchanged. That is, the axial components added to the catheter can effectively reduce the axial elongation rate of the catheter, and at the same time, have little influence on the outer diameter and flexibility of the catheter, and can be ignored.
- the conduit reinforcement layer and conduit provided by the present invention have a new type of reinforcement layer structure, which increases the axial modulus of the conduit by introducing axial components into the reinforcement layer of the existing conduit, thereby increasing the axial modulus of the conduit.
- the axial deformation of the catheter caused by the axial shear stress on the tube body of the catheter is avoided. Therefore, the axial tensile strength of the catheter is improved, thereby reducing the elongation rate of the catheter, and finally avoiding the risk of fatigue failure caused by axial stretching of the catheter by the internal compatible device.
- disposing one or more axial components on the mechanical weak point of the catheter can prevent stress concentration points from being generated on the catheter, thereby preventing the deformation of the tube body of the catheter during the delivery of the device.
- introducing one or more axial components extending in the axial direction into the reinforcing layer of the conduit can improve the transmission efficiency of the axial force of the conduit and optimize the transmission performance of the conduit.
Abstract
一种导管加强层（100）和包括其的导管。导管加强层（100）包括编织部件（110）和至少一个轴向部件（120a，120b，120c，120d，120e，120f，120g，120h，120j，120k，120l，120m，120n），编织部件（110）为丝线交叉编织形成的网状管结构，轴向部件（120a，120b，120c，120d，120e，120f，120g，120h，120j，120k，120l，120m，120n）沿编织部件（110）从近端向远端延伸设置，且与编织部件（110）至少存在一个交点。导管加强层（100）结构通过在现有导管的加强层中引入一个或多个轴向部件（120a，120b，120c，120d，120e，120f，120g，120h，120j，120k，120l，120m，120n）而增加了导管的轴向模量，从而避免了在输送器械时导管的管体由于受到轴向剪切应力而发生轴向变形。
Description
本发明涉及医疗器械技术领域，特别涉及一种导管加强层和包括该导管加强层的导管。
微创介入手术是在数字减影血管造影(Digital Subtraction Angiography，DSA)系统的支持下，通过血管内的导管输送系统，以最小创伤将植入类医疗器械或治疗药物输送到病变位置，以对病变进行机械或化学治疗。导管作为输送系统的重要组成部分，已经被广泛应用于各类微创介入治疗。目前，此类介入手术通常由小血管处(如股动脉、桡动脉)穿刺形成入口。导管通过入口后沿着血管，在鞘管、导丝的辅助下输送至目标病变位置。然后，导管作为其他器械(如支架、弹簧圈、其他导管等)的通路管道。
目前，为了满足临床使用时导管顺利输送至病变位置的需求，现有的医用导管通常设计为具有不同硬度的节段。例如，近端较硬，远端较柔软，即从近端到远端硬度逐渐降低。不同段的软硬度的设计需要依照血管解剖学而定。虽然，远端柔软的导管更容易通过迂曲的血管，且降低了损伤血管的风险，但是受导管材料特性的影响，柔软的导管轴向延伸率较高，易在轴向力的作用下发生轴向变形，如被拉伸变长。因此，在临床手术时，当在导管内输送其他器械时，导管的管体会受到轴向剪切应力。若导管的管体的轴向延长率过高，更容易在其内所输送的器械的作用力下被轴向拉伸。导管的管体被拉伸后可能发生形变，出现所输送的器械难以释放或回收的问题，对临床手术产生严重的不良影响。
发明内容
本发明的目的在于提供一种导管加强层和导管，以解决由于现有的导管延伸率高，在导管的管内输送器械时，导管被轴向拉长的问题。
为解决上述技术问题，本发明提供一种导管加强层，包括编织部件和至 少一个轴向部件，所述编织部件为丝线交叉编织形成的网状管结构，所述轴向部件沿所述编织部件从近端向远端延伸设置，且与所述编织部件至少存在一个交点。
可选的，所述轴向部件的材料可以为金属和/或高分子丝。
可选的，所述轴向部件可以为丝状结构，其形状呈直线形、波浪形或螺旋形中的任一种或其组合。
可选的，所述轴向部件可以平行于所述编织部件的轴向方向设置；
或者，所述轴向部件可以与所述编织部件的轴向方向呈一定角度设置，所述角度可以为0-45°；
或者，所述轴向部件中的至少一部分与所述编织部件的轴向方向呈一定角度设置，所述角度为0-45°，所述轴向部件的其他部分平行于所述编织部件的轴向方向设置。
可选的，所述轴向部件可以与所述编织部件之间存在1-45000个交点。
可选的，所述编织部件的编织丝材交叉编织形成网格，所述编织丝材的交叉位置处形成网格交点，所述轴向部件与所述编织部件之间的全部交点与网格交点重合；
或者，所述轴向部件可以与所述编织部件之间的部分交点与网格交点重合；
或者，所述轴向部件可以与所述编织部件之间的交点不与网格交点重合。
可选的，所述轴向部件从近端向远端以直线形或螺旋形贴附于所述编织部件的内表面或外表面；
或者，所述轴向部件从近端向远端以波浪形交错贴附于所述编织部件的内表面和外表面之间；
或者，所述轴向部件从近端向远端设于所述编织部件的网格中，所述轴向部件与所述编织部件处于同一平面。
可选的，当所述轴向部件的数目可以为多个时，多个所述轴向部件沿所述编织部件的周向对称或非对称设置；
和/或，
所述轴向部件沿所述编织部件的轴向依次间隔设置。
可选的，当所述轴向部件的数目为多个时，所述多个轴向部件沿所述编织部件的轴向螺旋排布。
可选的，所述多个轴向部件的轴向间距相同或不同，和/或,
所述多个轴向部件的周向角度间距相同或不同。
可选的，在所述多个轴向部件中，位于近端的所述轴向部件的轴向间距小于位于远端的所述轴向部件的轴向间距，
和/或,
位于近端的所述轴向部件的周向角度间距小于位于远端的所述轴向部件的轴向间距。
可选的，所述轴向部件的数量的取值范围可以为1～16000个。
可选的，在所述编织部件的轴向方向上相邻的两个所述轴向部件之间的轴向间距的取值范围为0.001inch-0.1inch。
可选的，至少一个所述轴向部件的材料可以为显影材料。
可选的，所述轴向部件为单丝或由多根单丝组成的绞丝。
可选的，所述单丝的直径的取值范围可以为0.0005inch～0.003inch，所述绞丝包含的单丝的数目的取值范围可以为1～20根。
可选的，所述轴向部件采用胶粘、聚合、焊接或加热的方式与所述编织部件连接，或者，采用编织的方式与所述编织部件结合为一体。
基于如上所述的导管加强层，本发明还提供了一种导管，包括由内向外依次设置且均呈管状的内层、加强层和外层，所述加强层为如上所述的导管加强层。
可选的，所述导管包括依次连接的多个导管节段，所述轴向部件可以设置可在预设位置处；
所述预设位置为与相邻所述导管节段的内层拼接缝或外层拼接缝对应的编织部件的周向表面或编织丝材的间隙之间；
或者，所述预设位置为与模量值小于相邻两侧或一侧所述导管节段的模量值的导管节段对应的编织部件的周向表面或编织丝材的间隙之间；
或者，所述预设位置为所述内层或所述外层的厚度较小处，或者，与所述内层或所述外层的柔软度较高的导管节段对应的编织部件的周向表面或编织丝材的间隙之间；
再或者，所述预设位置为与径向直径小于相邻两侧或一侧所述导管节段的径向直径的导管节段对应的编织部件的周向表面或编织丝材的间隙之间。
可选的，所述内层为高分子材料层，所述内层的厚度可以为0.0001inch-0.002inch。
可选的，所述内层的厚度可以为0.0003inch-0.0006inch。
与现有技术相比，本发明技术方案至少具有如下有益效果：
1.本发明提供的导管加强层和导管具有一种新型的加强层结构，其通过在现有导管的加强层中引入轴向部件而增加了导管的轴向模量，进而在导管的管体内输送器械时，避免了由于导管的管体受到轴向剪切应力，而引起的导管的轴向变形。因此，导管的轴向抗拉能力提高，进而降低了导管的延伸率，最终避免了导管存在被内兼容器械轴向拉伸引起疲劳失效的风险。
2.在导管的力学薄弱点上设置一个或多个轴向部件，可以防止导管上产生应力集中点，从而防止导管在输送器械过程中发生管体变形。
3.在导管加强层中引入一个或多个沿轴向方向延伸的轴向部件，可以提高导管轴向力的传递效率，优化导管的传递性能。
图1为本发明提供的一实施例中的导管加强层和使用该导管加强层的导管的结构示意图；
图2为本发明提供的一实施例中的导管加强层沿轴向方向展开的平面示意图；
图3a-图3c为本发明提供的另一实施例中的导管加强层的结构示意图；
图4为本发明提供的另一实施例中的导管加强层的结构示意图；
图5为本发明提供的另一实施例中的导管加强层的结构示意图；
图6为本发明提供的另一实施例中的导管加强层的结构示意图；
图7为本发明提供的另一实施例中的导管加强层的结构示意图；
图8为本发明提供的一实施例中的导管加强层沿轴向方向展开的另一平面示意图。
其中，附图标记如下：
100-导管加强层； 200-外层；
110-编织结构； 120-轴向部件。
以下将对本发明的导管加强层和包含该导管加强层的导管作进一步的详细描述。下面将参照附图对本发明进行更详细的描述，其中表示了本发明的优选实施例。应该理解，本领域技术人员可以修改在此描述的本发明而仍然实现本发明的有利效果。因此，下列描述应当被理解为对于本领域技术人员的广泛知道，而并不作为对本发明的限制。
为了清楚，不描述实际实施例的全部特征。在下列描述中，不详细描述公知的功能，因为它们会使本发明由于不必要的细节而混乱。应当认为在任何实际实施例的开发中，必须做出大量实施细节以实现开发者的特定目标，例如按照有关系统或有关商业的限制，由一个实施例改变为另一个实施例。另外，应当认为这种开发工作可能是复杂和耗费时间的，但是对于本领域技术人员来说仅仅是常规工作。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。术语“多个”通常是以包括两个或两个以上的含义而进行使用的，除非内容另外明确指出外。术语“若干”通常是以包括数量不确定的含义而进行使用的，除非内容另外明确指出外。术语“近端”通常是指靠近医疗器械操作者的一端，“远端”通常是指器械首先进入人体的一端，除非内容另外明确指出外。
诚如背景技术所述，目前，为了满足临床使用时导管顺利输送至病变位 置的需求，现有的导管通常设计为具有不同硬度的节段。例如，近端较硬，远端较柔软，即从近端到远端硬度逐渐降低。不同段软硬度的设计需要依照血管解剖学而定。虽然，远端柔软的导管更容易通过迂曲的血管，且降低了损伤血管的风险，但是受导管材料特性的影响，柔软的导管轴向延伸率较高，易在轴向力的作用下发生轴向变形，如被拉伸变长。因此，在临床治疗过程中，当在导管内输送其他器械时，导管的管体会受到轴向剪切应力。若导管的管体的轴向延长率过高，更容易在其内所输送的器械的作用力下轴向拉伸。导管的管体被拉伸后可能发生形变，出现所输送的器械难以释放或回收的问题，对临床手术产生严重的不良影响。
针对上述问题，本发明研究人员发现，导管的整体力学特性与高分子材料的模量与硬度、加强层的金属丝强度与金属覆盖率相关。而在现有技术中，导管主要由内层、加强层和外层三层结构组成。对于加强层为编织结构的导管，轴向抗断裂的能力较强，不易被拉断。导管的轴向延伸率取决于内层和外层的高分子材料。因此，当导管的内层和外层结构选用了硬度低的高分子材料，如热塑性弹性体(TPE)、聚烯烃(polyolefin)或聚烯烃弹性体(polyolefin elastomer)等材料时，由于材料的弹性体的特性，可实现导管的低硬度性质。同时，导管的轴向延伸率较高，在轴向力下极易被拉伸变细，从而在临床使用时易引发内兼容器械无法推送、释放或回撤的情况，影响手术效果。
为此，本发明提供了一种导管加强层和包括该导管加强层的导管，以解决现有的导管由于延伸率高，在导管的管内输送器械时，导管被轴向拉长的问题。
参考图1，图1为本发明提供的一实施例的导管加强层和使用该导管加强层的导管的结构示意图。如图1所示，本发明提供了一种导管，所述导管可以作为输送导管，也可以用于其他医疗用途。所述导管例如具有中空的管道。在本实施例中，所述导管例如是输送导管，其用于提供血管内介入器械的输送路径，血管内介入器械的释放和回收等。所述导管的直径包括但不限于在6F-12F之间，以便于所述导管在神经介入手术、心脏介入手术、主动脉介入手术或外周血管介入手术中输送介入器械进入血管。在其他实施例中，所述 导管的直径可以根据实际需求进行修改。
如图1所述，本发明提供了一种导管加强层和使用该导管加强层的导管。所述导管包括由内向外依次设置且均呈管状的内层、加强层和外层。所述导管的加强层包含导管加强层，所述导管加强层包括编织部件和至少一个轴向部件。所述编织部件为编织丝线交叉编织形成的网状管结构，且该网状管结构包括多个编织丝材交叉编织形成的网格，所述编织丝材交叉的位置形成网格交点。所述轴向部件沿所述编织部件从近端向远端延伸设置，且与所述编织部件至少存在一个交点。
具体的，参考图2，图2为本发明一实施例中提供的导管加强层沿轴向方向展开的平面示意图。如图2所示，所述编织部件110可以包含多个编织丝材交叉编织形成的网格，且假设所述编织丝材交叉的位置为网格交点a。所述编织部件110包含的轴向部件与所述编织部件110之间的全部交点可以与编织部件110的网格交点a重合，如轴向部件120a与编织部件110之间的交点b1；或者，所述轴向部件可以与所述编织部件110之间的全部交点都不与网格交点a重合，如轴向部件120b与编织部件110之间的交点b2；再或者，所述轴向部件与所述编织部件110之间的部分交点(如轴向部件120c与编织部件110的交点b3)可以与网格交点a重合，以及另一部分交点与编织部件110的网格交点a不重合(如轴向部件120c与编织部件110的交点b4)。
可选的，在本发明的实施例中，所述轴向部件与编织部件之间可以存在1-45000个交点。每个轴向部件与所述编织部件之间交点的具体个数可根据实际需要设置，本发明不对此做具体限定。
继续参考图2，假设所述图2的左边为近端，则编织部件110中包含的轴向部件沿所述近端向远端延伸设置。所述轴向部件可以沿平行于导管轴向方向的方式设置，如轴向部件120a和轴向部件120b；也可以与导管轴向呈一定角度的方式设置(如轴向部件120c)，且所述一定角度的范围可以为0-45°内的任意角度。并且，当编织部件110包含多个轴向部件时，其还可以有部分轴向部件以平行于导管轴向的方式设置，而另一部分则以与导管轴向呈一定角度的方式设置，且所述一定角度可以包括0-45°内的任意角度，例如3°、 5°、10°、15°、30°、45°等。当轴向部件的一部分或者全部与导管轴向呈一定角度设置时，同一个轴向部件在长度方向上与导管轴向的角度可以相同或者不同，不同轴向部件与导管轴向的角度可以相同或者不同。其中，所述编织部件包括依次连接的多个编织网孔，网孔的顶点为编织部件中丝与丝之间的网格交点；并且，至少一个所述轴向部件部分穿过所述编织部件的至少一个所述编织网孔，和/或，至少一个所述轴向部件完全穿过所述编织部件的一个所述编织网孔或者多个连续的所述编织网孔。所述轴向部件可以为丝状结构，其形状具体可以呈直线形，波浪形或螺旋形中的一种或其组合。并且，所述编织部件可以沿所述导管的轴向方向均匀或非均匀的设置，对此本发明不做具体限定。
所述导管内层的材料可以为聚四氟乙烯、聚氨酯、聚酰胺、聚烯烃、聚烯烃弹性体和热塑性弹性体中的任一种或任意几种的组合。所述导管外层的材料可以为聚氨酯、聚烯烃、聚烯烃弹性体、热塑性弹性体和聚酰胺等中的任一种或任意几种的组合。在本发明的一个示例性实施例中，所述内层的材料和外层的材料均优选为热塑性弹性体。所述导管加强层的编织部件的材料可以为金属，例如：不锈钢、镍钛合金、钴铬合金和钨中的任一种或任意几种的组合；或者，所述编织部件的材料还可以为高分子丝，例如：聚乙烯、聚酰胺、液态结晶高分子丝中的任一种或任意几种的组合；再或者，所述编织部件的材料可以为金属与高分子丝的组合。并且，所述导管加强层的轴向部件的材料可以为金属和/或高分子丝。具体的，所述轴向部件的材料可以为如不锈钢、镍钛合金、钴铬合金、钨、银和金等金属中的任一种或任意几种的组合，还可以为如聚乙烯、聚酰胺和液态结晶等高分子丝中的任一种或任意几种的组合；或者，所述轴向部件的材料还可以为所述金属与所述高分子丝的组合。在轴向部件为多个的情况下，可以部分轴向部件的材料为金属，部分轴向部件的材料为高分子丝。在本发明的一个示例性实施例中，至少一个所述轴向部件的材料为显影材料。
需要说明的是，本发明提供的导管是在保持现有的导管的内层和外层材料不变以保证导管的柔软度的同时，在现有导管的加强层中的编织部件的轴 向方向上设置一个或多个轴向部件，从而增加所述导管的轴向模量，进而在导管的管体内输送器械时避免由于导管的管体受到轴向剪切应力而引起导管的轴向变形，即，提升导管的轴向抗拉能力。因此，降低了导管的延伸率，最终避免了导管被内兼容器械轴向拉伸引起疲劳失效的风险。因此，只要在编织部件的轴向方向上以各种方式设置轴向部件，都可以实现本发明的发明目的，其中，轴向方向包括沿着导管轴向方向和与导管轴向呈一定角度的方向且所述一定角度包括0-45°范围内的任意角度。
下面将通过附图具体说明本发明提供的导管包含的导管加强层中的编织部件和轴向部件的多种组合。
实施例一：
参见图3a-图3c，图3a-图3c为本发明一实施例的导管加强层的结构示意图，如图3a-图3c所示，同时请参阅图1，所述导管加强层100包括编织部件110和沿编织部件110的轴向方向从近端向远端延伸设置且整体贯穿所述编织部件110的轴向部件120。具体的，如图3a所示，轴向部件120d可以从近端向远端以直线形或螺旋形贴附于所述编织部件110与导管的内层(未图示)之间，即贴附于所述编织部件110的内表面。或者，如图3b所示，轴向部件120e可以从近端向远端以直线形或螺旋形贴附于所述编织部件110与导管的外层(未图示)之间，即贴附于所述编织部件110的外表面。再或者，如图3c所示，轴向部件120f可以从近端向远端以波浪形交错贴附于所述编织部件110的内表面和外表面。
实施例二：
参见图4，图4为本发明另一实施例的导管加强层的结构示意图。如图4所示，所述轴向部件120g可以从近端向远端设于所述编织部件100的网格中，且所述轴向部件120g与所述编织部件110处于同一平面(即，所述轴向部件的各段位于相应的编织网孔中)。在实施例二中，轴向部件120g可以通过焊接、粘接等方式与编织部件110结合，或者通过编织的方式将轴向部件120d与编织部件110编织为一体。相比于图3a-图3c所示的导管加强层100，图4所示的导管加强层110的优势在于所述包含该导管加强层的导管的外径尺寸 不会因为其导管加强层中包含的轴向部件120的存在而增大。
需要说明的是，本发明提供的轴向部件120除了以如上所述的实施例一和实施例二中所描述的方式(即，从近端向远端全部贯穿所述编织部件110)与编织部件110一起组合为所述导管的加强层100之外，所述轴向部件120还可以以部分贯穿所述编织部件110的方式与编织部件110一起组合为所述导管加强层100，对此本发明不做具体限定。
此外，所述轴向部件120的数目可以为一个，也可以为多个。具体的，当所述轴向部件120的数目为一个时，轴向部件120可以以如上所述的实施例一和实施例二中所述的单侧放置的方式设置；当所述轴向部件120的数目为多个时，多个所述轴向部件120可以沿所述编织部件110的周向对称或非对称设置，和/或，轴向部件120沿编织部件110的轴向依次间隔设置。需要强调的是，在该说明书中提到的间隔设置指的是相邻两个轴向部件的近端不在同一个轴向位置上，而在轴向上错落布置。在一些实施例中，相邻两个轴向部件可以在轴向上完全没有“重叠”的位置；在另一些实施例中，相邻两个轴向部件可以在轴向上具有部分“重叠”的位置。这里所述的“重叠”指的是在同一个轴向位置上，加强层在该位置的横切面同时有上述相邻两个轴向部件的截面。
下面以多个所述轴向部件120沿所述编织部件110的周向对称或非对称设置为例，来介绍轴向部件为多个时，其与编织部件110的位置关系，具体详见如下实施例。
实施例三：
参见图5，图5为本发明另一实施例的导管加强层的结构示意图。如图5所示，优选地，所述导管加强层100包括编织部件110和多个沿所述编织部件110的轴向方向从近端到远端整体贯穿所述编织部件110且对称设置的轴向部件120h。由于轴向部件120以对称放置的方式设置在编织部件100的表面上，可以保证包含该导管加强层的导管的结构稳定性。同时，与实施例一和实施例二相似的是，当在该导管的管体内输送器械时，避免了由于导管的管体受到轴向剪切应力而引起的导管的轴向变形，进而降低了导管的延伸率， 最终避免了导管存在被内兼容器械轴向拉伸引起疲劳失效的风险。
可选的，本发明实施例中的轴向部件的数量的取值范围可以为2～10个，例如2、3、5、6、8、10个。
可以理解的是，当所述轴向部件120的数目为多个时，多个所述轴向部件120可以在任意位置沿所述编织部件110的周向对称或非对称设置。但是，在现有技术中，所述导管通常近端较硬，远端较柔软，即从近端到远端硬度逐渐降低，且由软硬度不同和/或粗细不同的多个导管节段拼接而成。此时，多个导管节段的连接处(拼接缝或者过渡位置)以及导管管体较细的部位容易成为受力薄弱点。该受力薄弱点在临床手术中容易在轴向力的作用下发生轴向变形，甚至被拉断。因此，在本发明的实施例中，还可以将多个所述轴向部件120在预设位置处沿所述编织部件110的周向对称或非对称设置，和/或，所述轴向部件120在预设位置处沿所述编织部件110的轴向依次间隔设置。其中，所述预设位置可以为所述导管加强层包含的多个导管节段的连接处(内层或外层的拼接处或者过渡位置)、内层或外层的柔软度较高的位置、内层或外层的厚度较小的位置、导管模量值较小的位置以及导管管体较细的部位。
实施例四：
参见图6和图7，图6和图7为本发明另一实施例的导管加强层的结构示意图，如图6或者图7所示，当所述轴向部件120为多个时，多个轴向部件120k或者轴向部件120j可以沿所述编织部件110的周向方向螺旋排列，且所述多个轴向部件120k或者轴向部件120j可以位于相邻导管节段的拼接缝对应的编织部件110的周向表面或编织丝材的间隙之间；或者，所述多个轴向部件120k或者轴向部件120j可以位于模量值小于相邻两侧或一侧所述导管节段的模量值的导管节段包括的编织部件110的周向表面或编织丝材的间隙之间，以及径向直径小于相邻两侧或一侧所述导管节段的径向直径的导管节段包括的编织部件110的周向表面或编织丝材的间隙之间；再或者，所述多个轴向部件120k或者轴向部件120j可以位于所述导管的内层或外层的厚度较小的位置处，或者，所述导管的内层或外层的柔软度较高的位置处。
具体的，所述各个轴向部件120j或者轴向部件120k可以设置在所述编织部件110与导管的内层之间，也可以设置在所述编织部件110与所述导管的外层200之间，也可以部分设置在所述编织部件110与导管的内层之间而另一部分设置在所述编织部件110与导管的外层之间，还可以设置在所述编织部件110的网格之间。并且，各所述轴向部件120的轴向长度可以为所述编织部件110的一个编织网孔的轴向距离，如图7所示的轴向部件120k，也可以为所述编织部件110的多个编织网孔的轴向距离(多个编织网孔包括非整数的编织网孔数)，如图6所示的轴向部件120j，对此本发明不做具体限定。且多个所述轴向部件120k或者轴向部件120j可以沿所述编织部件110的周向方向螺旋排列，以及所述多个轴向部件120k或者轴向部件120j之间的轴向间距可以相同或不同，和/或，所述多个轴向部件120k或者轴向部件120j的周向角度间距可以相同或不同。并且，在所述多个轴向部件120k或者轴向部件120j中，位于编织部件110近端的所述轴向部件120k或者轴向部件120j的轴向间距可以小于位于编织部件110远端的所述轴向部件120k或者轴向部件120j的轴向间距，和/或，近端的所述轴向部件120k或者轴向部件120j的周向角度间距可以小于远端的所述轴向部件120k或者轴向部件120j的轴向间距。
在该实施例中，多个所述轴向部件120k或者轴向部件120j沿所述编织部件110的周向方向螺旋排列；在其他一些实施例中，所述多个轴向部件120k或者轴向部件120j可以位于同一个周向方向，但是在轴向上间隔设置。由于在本实施例中，可以在导管的力学薄弱点上设置一个或多个轴向部件，可以防止导管上产生应力集中点，从而防止导管在输送器械过程中发生管体变形。并且，在导管加强层中引入一个或多个轴向方向延伸的轴向部件，可以提高导管轴向力的传递效率，优化导管的传递性能。
可选的，本发明实施例中的轴向部件的数量的取值范围可以为1～16000个，例如1、2、4、8、20、100、800、2000、5000、10000、12000、16000个。
需要说明的是，所述编织部件的近端指的是靠近包含所述导管加强层的 导管的操作者一侧，即导管的近端同时为编织部件、导管加强层、轴向部件的近端，同理，编织部件的远端指的是远离包含所述导管加强层的导管的操作者一侧。
可选的，具体参考图8，图8为本发明一实施例中的导管加强层沿轴向方向展开的另一平面示意图。如图8所示，假设编织部件110的左边为近端，则在所述编织部件110的轴向方向上相邻的两个所述轴向部件120l和轴向部件120m之间的轴向间距D1，或者相邻的轴向部件120m和轴向部件120n之间的轴向间距为D2的取值范围可以为0.001inch～0.1inch。
其中，轴向间距是两个轴向部件的近端在平行于轴向的方向上的间距，且周向角度间距为L1对应的弧度(即，两个轴向部件上的位于同一圆周的两个点形成的圆心角)。
可选的，所述轴向部件120可以为单丝或由多根单丝组成的绞丝。其中，所述单丝的直径的取值范围为0.0005inch～0.003inch，所述绞丝包含单丝的数目的取值范围可以为1～20根。优选的，当所述实施例中轴向部件120选用由单丝尺寸为0.001inch的聚酰胺高分子丝聚合成的轴向部件时，对于编织部件110的柔软导管起到的效果极佳。
示例性的，本发明研究人员通过实验得到如下表格，用于解释本发明提供的轴向部件对包括本发明实施例中提供的导管加强层的导管的各项参数所产生的影响。在该实验中，轴向部件的具体设置方式如图3a所示，即将轴向部件沿编织部件110的轴向方向从近端向远端延伸设置且整体贯穿所述编部件110。当轴向部件的数量为多根(例如，N＝2或3)时，多根轴向部件相互平行设置。
表1
| 轴向部件数量 | 延伸率 | 外径 | 柔软度 |
| N＝1 | -38.0％ | +0.1％ | -3.1％ |
| N＝2 | -44.0％ | +0.2％ | -4.0％ |
| N＝3 | -56.0％ | +0.4％ | -7.0％ |
由上述表1可知，与不设置轴向部件的导管相对比，随着轴向部件数目 的增加，所述导管的轴向延伸率逐渐降低，但导管的外径和柔软度基本保持不变，即，所述导管中添加的轴向部件在有效的降低导管的轴向延伸率的同时，对所述导管的外径和柔软度的影响较小，可以忽略不计。
可以理解的是，上述各附图描述的轴向部件120均可以采用胶粘、聚合、焊接或加热的方式与所述编织部件100连接，或者，还可以采用编织(一些特定编织方法，如三轴向编织Triaxial Braiding)的方式与所述编织部件110结合为一体。
综上所述，本发明提供的导管加强层和导管具有一种新型的加强层结构，其通过在现有导管的加强层中引入轴向部件而增加了导管的轴向模量，进而在导管的管体内输送器械时，避免了由于导管的管体受到轴向剪切应力，而引起的导管的轴向变形。因此，导管的轴向抗拉能力提高，进而降低了导管的延伸率，最终避免了导管存在被内兼容器械轴向拉伸引起疲劳失效的风险。
进一步的，在导管的力学薄弱点上设置一个或多个轴向部件，可以防止导管上产生应力集中点，从而防止导管在输送器械过程中发生管体变形。并且，在导管加强层中引入一个或多个沿轴向方向延伸的轴向部件，可以提高导管轴向力的传递效率，优化导管的传递性能。
需要说明的是，虽然本发明已以较佳实施例披露如上，然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言，在不脱离本发明的技术方案范围情况下，都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰，或修改为等同变化的等效实施例。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰，均仍属于本发明技术方案保护的范围。
还应当理解的是，除非特别说明或者指出，否则说明书中的术语“第一”、“第二”、“第三”等描述仅仅用于区分说明书中的各个组件、元素、步骤等，而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。
此外还应该认识到，此处描述的术语仅仅用来描述特定实施例，而不是用来限制本发明的范围。必须注意的是，此处的以及所附权利要求中使用的单数形式“一个”和“一种”包括复数含义，除非上下文明确表示相反意思。 例如，对“一个步骤”或“一个装置”的引述意味着对一个或多个步骤或装置的引述，并且可能包括次级步骤以及次级装置。应该以最广义的含义来理解使用的所有连词。以及，词语“或”应该被理解为具有逻辑“或”的定义，而不是逻辑“异或”的定义，除非上下文明确表示相反意思。此外，本发明实施例中的方法和/或设备的实现可包括手动、自动或组合地执行所选任务。
Claims (21)
- 一种导管加强层，其特征在于，包括编织部件和至少一个轴向部件，所述编织部件为丝线交叉编织形成的网状管结构，所述轴向部件沿所述编织部件从近端向远端延伸设置，且与所述编织部件至少存在一个交点。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件的材料为金属和/或高分子丝。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件为丝状结构，其形状呈直线形、波浪形或螺旋形中的任一种或其组合。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件平行于所述编织部件的轴向方向设置；或者，所述轴向部件与所述编织部件的轴向方向呈一定角度设置，所述角度为0-45°；或者，所述轴向部件中的至少一部分与所述编织部件的轴向方向呈一定角度设置，所述角度为0-45°，所述轴向部件的其他部分平行于所述编织部件的轴向方向设置。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件与所述编织部件之间存在1-45000个交点。
- 如权利要求1所述的导管加强层，其特征在于，所述编织部件的编织丝材交叉编织形成网格，所述编织丝材的交叉位置形成网格交点，其中，所述轴向部件与所述编织部件之间的交点全部与网格交点重合；或者，所述轴向部件与所述编织部件之间的部分交点与网格交点重合；或者，所述轴向部件与所述编织部件之间的交点不与网格交点重合。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件从近端向远端以直线形或螺旋形贴附于所述编织部件的内表面或外表面；或者，所述轴向部件从近端向远端以波浪形交错贴附于所述编织部件的内表面和外表面之间；或者，所述轴向部件从近端向远端设于所述编织部件的网格中，所述轴向部件与所述编织部件处于同一平面。
- 如权利要求1所述的导管加强层，其特征在于，当所述轴向部件的数目为多个时，所述多个轴向部件沿所述编织部件的周向对称或非对称设置；和/或，所述轴向部件沿所述编织部件的轴向依次间隔设置。
- 如权利要求1所述的导管加强层，其特征在于，当所述轴向部件的数目为多个时，所述多个轴向部件沿所述编织部件的轴向螺旋排布。
- 如权利要求9所述的导管加强层，其特征在于，所述多个轴向部件的轴向间距相同或不同，和/或,所述多个轴向部件的周向角度间距相同或不同。
- 如权利要求10所述的导管加强层，其特征在于，在所述多个轴向部件中，位于近端的所述轴向部件之间的轴向间距小于位于远端的所述轴向部件之间的轴向间距，和/或,位于近端的所述轴向部件之间的周向角度间距小于位于远端的所述轴向部件之间的轴向间距。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件的数量的取值范围为1～16000个。
- 如权利要求1所述的导管加强层，其特征在于，在所述编织部件的轴向方向上相邻的两个所述轴向部件之间的轴向间距的取值范围为0.001inch-0.1inch。
- 如权利要求1所述的导管加强层，其特征在于，至少一个所述轴向部件的材料为显影材料。
- 如权利要求1-14中的任一项所述的导管加强层，其特征在于，所述轴向部件为单丝或由多根单丝组成的绞丝。
- 如权利要求15所述的导管加强层，其特征在于，所述单丝的直径的取值范围为0.0005inch～0.003inch，所述绞丝包含的单丝的数目的取值范围为1～20根。
- 如权利要求1所述的导管加强层，其特征在于，所述轴向部件采用胶粘、聚合、焊接或加热的方式与所述编织部件连接，或者，采用编织的方式与所述编织部件结合为一体。
- 一种导管，其特征在于，包括由内向外依次设置且均呈管状的内层、加强层和外层，所述加强层包含权利要求1-17中的任一项所述的导管加强层。
- 如权利要求18所述的导管，其特征在于，所述导管包括依次连接的多个导管节段，所述轴向部件设置在预设位置处；所述预设位置为与相邻所述导管节段的内层拼接缝或外层拼接缝对应的编织部件的周向表面或编织丝材的间隙；或者，所述预设位置为与模量值小于相邻两侧或一侧所述导管节段的模量值的导管节段对应的编织部件的周向表面或编织丝材的间隙；或者，所述预设位置为所述内层或所述外层的厚度较小处，或者，与所述内层或所述外层的柔软度较高的导管节段对应的编织部件的周向表面或编织丝材的间隙；或者，所述预设位置为与径向直径小于相邻两侧或一侧所述导管节段的径向直径的导管节段对应的编织部件的周向表面或编织丝材的间隙。
- 如权利要求18所述的导管，其特征在于，所述内层为高分子材料层，所述内层的厚度为0.0001inch-0.002inch。
- 如权利要求18所述的导管，其特征在于，所述内层的厚度为0.0003inch-0.0006inch。
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| US18/264,349 US20240091494A1 (en) | 2021-02-05 | 2022-01-11 | Catheter reinforcement layer and catheter |
| AU2022216649A AU2022216649A1 (en) | 2021-02-05 | 2022-01-11 | Catheter reinforcement layer and catheter |
| JP2023547385A JP2024505308A (ja) | 2021-02-05 | 2022-01-11 | カテーテル補強層およびカテーテル |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000043061A1 (en) * | 1999-01-20 | 2000-07-27 | Boston Scientific Limited | Intravascular catheter with composite reinforcement |
| CN105105894A (zh) * | 2015-07-20 | 2015-12-02 | 宁波琳盛高分子材料有限公司 | 增强复合型鞘管及其制备方法与用途 |
| CN105943210A (zh) * | 2015-12-23 | 2016-09-21 | 微创心脉医疗科技（上海）有限公司 | 介入器械用鞘管及其制造方法 |
| CN209019072U (zh) * | 2018-04-09 | 2019-06-25 | 浙江巴泰医疗科技有限公司 | 一种多强度多密度鞘管 |
| CN215083906U (zh) * | 2021-02-05 | 2021-12-10 | 微创神通医疗科技（上海）有限公司 | 一种导管加强层和导管 |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000043061A1 (en) * | 1999-01-20 | 2000-07-27 | Boston Scientific Limited | Intravascular catheter with composite reinforcement |
| CN105105894A (zh) * | 2015-07-20 | 2015-12-02 | 宁波琳盛高分子材料有限公司 | 增强复合型鞘管及其制备方法与用途 |
| CN105943210A (zh) * | 2015-12-23 | 2016-09-21 | 微创心脉医疗科技（上海）有限公司 | 介入器械用鞘管及其制造方法 |
| CN209019072U (zh) * | 2018-04-09 | 2019-06-25 | 浙江巴泰医疗科技有限公司 | 一种多强度多密度鞘管 |
| CN215083906U (zh) * | 2021-02-05 | 2021-12-10 | 微创神通医疗科技（上海）有限公司 | 一种导管加强层和导管 |
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| AU2022216649A1 (en) | 2023-08-24 |
| JP2024505308A (ja) | 2024-02-05 |
| EP4272797A1 (en) | 2023-11-08 |
| KR20230133917A (ko) | 2023-09-19 |
| CN114870200A (zh) | 2022-08-09 |
| US20240091494A1 (en) | 2024-03-21 |
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