WO2022166539A1 - 一种导管加强层和导管 - Google Patents

一种导管加强层和导管 Download PDF

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Publication number
WO2022166539A1
WO2022166539A1 PCT/CN2022/071231 CN2022071231W WO2022166539A1 WO 2022166539 A1 WO2022166539 A1 WO 2022166539A1 CN 2022071231 W CN2022071231 W CN 2022071231W WO 2022166539 A1 WO2022166539 A1 WO 2022166539A1
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WIPO (PCT)
Prior art keywords
axial
catheter
conduit
spring member
spring
Prior art date
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PCT/CN2022/071231
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English (en)
French (fr)
Inventor
林恒
刘云云
王亦群
罗雪莉
Original Assignee
微创神通医疗科技（上海）有限公司
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Application filed by 微创神通医疗科技（上海）有限公司 filed Critical 微创神通医疗科技（上海）有限公司
Priority to JP2023547390A priority Critical patent/JP2024505309A/ja
Priority to KR1020237029363A priority patent/KR20230133918A/ko
Priority to US18/264,365 priority patent/US20240091495A1/en
Priority to EP22748818.6A priority patent/EP4272798A1/en
Priority to AU2022215675A priority patent/AU2022215675A1/en
Publication of WO2022166539A1 publication Critical patent/WO2022166539A1/zh

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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
    • 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 present invention relates to the technical field of medical devices, in particular to a catheter reinforcement layer and a catheter including the catheter reinforcement layer.
  • DSA Digital Subtraction Angiography
  • catheters have been widely used in various minimally invasive interventional treatments.
  • interventional procedures are usually formed by puncture of small blood vessels (eg, femoral artery, radial artery) to form the entrance.
  • the catheter is transported to the target lesion site with the help of sheath and guide wire along the blood vessel after passing through the inlet.
  • the catheter then acts as an access conduit for other devices such as stents, coils, other catheters, etc.
  • the existing medical catheters are usually designed with a hard proximal end and a softer distal end, for example, the hardness gradually decreases from the proximal end to the distal end.
  • the catheter consists of multiple segments of varying stiffness.
  • the outer or/and inner layers of the catheter are spliced (in the axial direction) by materials of different hardness.
  • the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs to have a good transition of softness.
  • the axial modulus of flexible conduits is lower, and the junctions of conduit segments (eg, where inner or outer layer segments join or where a property transitions) and The thin part of the catheter body is easy to become the weak point of force, which makes the catheter easy to deform axially under the action of axial force during clinical operations, or even be pulled off, which has serious adverse effects on clinical operations.
  • the purpose of the present invention is to provide a conduit reinforcement layer and conduit, so as to solve the problem of insufficient axial tensile properties of the existing conduits and failure modes of fracture in severe cases.
  • the present invention provides a catheter reinforcement layer, comprising a spring member and at least one axial member, the or each axial member is extended along the spring member from the proximal end to the distal end, and There is at least one point of intersection with the spring member.
  • the material of the axial component may be metal and/or polymer wire.
  • the axial member may be a filamentary structure whose shape is any one of linear, wavy, or helical, or a combination thereof.
  • the axial member is arranged parallel to the axial direction of the spring member
  • the axial member and the axial direction of the spring member are arranged at a certain angle, and the angle is 0-45°;
  • At least a part of the plurality of axial members is arranged at a certain angle with the axial direction of the spring member, and the angle is 0-45°, and other parts of the plurality of axial members are parallel to the The axial direction of the spring member is provided.
  • the axial member is attached to the inner surface or the outer surface of the spring member in a linear or helical shape from the proximal end to the distal end along the spring member;
  • the axial member is staggered and attached between the inner surface and the outer surface of the spring member in a wave shape from the proximal end to the distal end;
  • the axial member is disposed between the gaps of the spring member from the proximal end to the distal end along the spring member, and the axial member and the spring member are on the same plane.
  • the multiple axial members are arranged symmetrically or asymmetrically along the circumferential direction of the spring member;
  • the axial members are sequentially spaced along the axial direction of the spring member.
  • a plurality of the axial components are arranged symmetrically or asymmetrically along the circumferential direction of the spring component at a preset position;
  • the axial members are sequentially spaced apart along the axial direction of the spring member at preset positions.
  • the multiple axial members are helically arranged along the axial direction of the spring member.
  • the axial distances between the multiple axial components are the same or different
  • the circumferential angular spacings between the plurality of axial members are the same or different.
  • the axial distance between the axial components located at the proximal end is smaller than the axial distance between the axial components located at the distal end
  • the circumferential angular separation between the axial members at the proximal end is smaller than the axial separation between the axial members at the distal end.
  • the number of the axial components may range from 1 to 16,000.
  • the value range of the axial distance between the two adjacent axial members in the axial direction of the spring member may be 0.001 inch-0.1inch.
  • the material of at least one of the axial members may be a developing material.
  • the axial member 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 contained in the twisted wire may range from 1 to 20.
  • the axial component can be connected to the spring component by means of gluing, polymerization, bonding, or laser welding, or, the axial component and the spring component can be combined by cutting and forming. one.
  • the axial member may further comprise a control wire extending reversely on the side of the catheter close to the operator.
  • the present invention also provides a conduit, the conduit includes an inner layer, a reinforcement layer and an outer layer that are sequentially arranged from the inside to the outside and are all tubular, wherein the reinforcement layer comprises the above The conduit reinforcement layer.
  • the conduit comprises a plurality of conduit segments connected in sequence, and the axial member can be arranged at a preset position;
  • the preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the inner layer splicing or the outer layer splicing of the adjacent catheter segments;
  • the preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the conduit segment whose modulus value is smaller than the modulus value of the conduit segments on two adjacent sides or one side;
  • the preset position is where the thickness of the inner layer or the outer layer is smaller, or the circumference of the spring member corresponding to the catheter segment with higher flexibility of the inner layer or the outer layer To the surface or between the gap of the spring wire;
  • the preset position is between the circumferential surfaces of the spring components or the gaps of the spring wires corresponding to the conduit segments whose radial diameter is smaller than the radial diameter of the conduit segments on two adjacent sides or one side.
  • the axial component may further include a control wire extended in the opposite direction on the side close to the operator of the catheter, so that the catheter operator can adjust the rotation direction of the catheter through the control wire.
  • the inner layer is a polymer material, and the thickness of the inner layer is 0.0001 inch-0.002 inch.
  • the thickness of the inner layer is 0.0003 inch-0.0006 inch.
  • the technical solution of the present invention has at least one of the following beneficial effects:
  • 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 one or more axial components into the reinforcement layer of the existing conduit spring structure, It avoids the axial deformation of the catheter caused by the axial force on the pipe body of the catheter, and the problem of fracture in severe cases.
  • Disposing one or more axial components on the weak point of the catheter can prevent stress concentration points on the catheter, thereby preventing the catheter from breaking during the delivery of the device or the pulling back.
  • introducing one or more axial components extending in the axial direction into the reinforcement layer of the catheter can not only ensure the softness of the catheter, but also prevent the axial deformation of the catheter and fracture.
  • FIG. 1 is a schematic structural diagram of a conduit reinforcement layer and a conduit using the conduit reinforcement layer in an embodiment provided by the present invention
  • FIGS. 2a-2c are schematic structural diagrams of a conduit reinforcement layer in another embodiment provided by the present invention.
  • FIG. 3 is a schematic structural diagram of a conduit reinforcement layer in another embodiment provided by the present invention.
  • FIG. 4 is a schematic structural diagram of a conduit reinforcement layer in another embodiment provided by the present invention.
  • FIG. 5 is a schematic structural diagram of a conduit reinforcement layer in another embodiment provided by the present invention.
  • FIG. 6 is a schematic structural diagram of a conduit reinforcement layer in another embodiment provided by the present invention.
  • FIG. 7 is a schematic diagram of the overall structure of a catheter in an embodiment provided by the present invention.
  • a conduit reinforcement layer of the present invention and a conduit comprising the conduit reinforcement layer will be described in further detail below.
  • the present invention will be described in more detail below with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, and it should be understood that those skilled in the art can modify the invention described herein and still achieve the advantageous effects of the invention. Therefore, the following description should be construed as widely known to those skilled in the art and not as a limitation of the present invention.
  • proximal end generally refers to the end closest to the operator of the medical device, and “distal end” generally refers to the end of the device that first enters the body, unless the context clearly indicates otherwise.
  • the existing catheter is usually designed with a hard proximal end and a softer distal end, such as hardness from the proximal end to the distal end. Gradually decreases.
  • the catheter consists of multiple segments of varying stiffness.
  • the outer or/and inner layers of the catheter are spliced (in the axial direction) of segments made of materials of different hardness.
  • the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs to have a good transition of softness.
  • flexible catheters have lower axial modulus, and the junctions of multiple catheter segments (such as the splices of segments in the inner or outer layers or at the transition of a property) ) and the thinner parts of the catheter body are likely to become weak points of force, so that the catheter is easily deformed axially under the action of axial force during clinical operations, or even pulled off, 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 reinforcement layer is a spring structure
  • the contribution of the reinforcement layer of the spring structure to the overall resistance to axial deformation of the catheter is very low.
  • the axial tensile resistance of the catheter with the reinforcement layer of the spring structure mainly depends on the strength of the polymer material of the inner and outer layers.
  • the inner and outer layers are made of low-hardness polymer materials, or when there is an axial transition structure between the inner and outer layers, the axial tensile properties of the catheter are insufficient, and in severe cases, the failure mode of fracture will occur.
  • the present invention provides a conduit reinforcement layer and a conduit including the conduit reinforcement layer, so as to solve the problem of insufficient axial tensile properties of the existing conduits and failure modes of fracture in severe cases.
  • FIG. 1 is a schematic structural diagram of a conduit reinforcement layer and a conduit using the conduit reinforcement layer according to an embodiment of the present invention.
  • the present invention provides a catheter, which can be used as a delivery catheter and can also be used for other medical purposes.
  • the catheter is, for example, a hollow tube, and in this embodiment, the catheter is, for example, a delivery catheter, which is used to provide a delivery path for the intravascular interventional device, release and recovery of the intravascular interventional device, and the like.
  • the diameter of the catheter includes, but is not limited to, between 6F-12F to facilitate the catheter to deliver interventional instruments into blood vessels during neurointerventional, cardiac interventional, aortic interventional or peripheral vascular interventional procedures. In other embodiments, the diameter of the conduit can be modified according to actual needs.
  • the present invention provides a conduit reinforcement layer and a conduit using the conduit reinforcement layer.
  • the conduit includes an inner layer, a reinforcing layer and an outer layer which are arranged in sequence from the inside to the outside and are all tubular, wherein the reinforcing layer of the conduit includes a conduit reinforcing layer.
  • the conduit reinforcement layer comprises a spring member and at least one axial member, the or each of the axial members extending from the proximal end to the distal end along the spring member and having at least one intersection point with the spring member.
  • the arrangement of the axial components in the axial direction may include being arranged parallel to the axial direction of the catheter, or may include being arranged at a certain angle with the axial direction of the catheter, and the certain angle includes within 0-45°.
  • any angle such as 3°, 5°, 10°, 15°, 30°, 45°, etc; is arranged, wherein the angle is 0-45°, and other parts of the plurality of the axial members are arranged along the axial direction parallel to the spring member.
  • the axial member can be a filamentary structure, and its shape can be any one or a combination of linear, wave or spiral.
  • the spring member may be arranged between the inner layer and the outer layer of the conduit in a clockwise spiral winding shape, or may be arranged in other curved shapes such as counterclockwise spiral winding and the like. between the inner layer and the outer layer of the conduit; and, the spring components may be uniformly or non-uniformly arranged along the axial direction of the conduit, which is not specifically limited in the present invention.
  • the material of the inner layer of the catheter can be any one or any combination of polymer materials such as polytetrafluoroethylene, polyurethane, polyamide, polyolefin, polyolefin elastomer and thermoplastic elastomer.
  • the thickness of the inner layer can range from 0.0001 inch to 0.002 inch.
  • the thickness of the inner layer may also range from 0.0003 inch to 0.0006 inch.
  • the outer layer material of the catheter can be any one or any combination of polymer materials such as polyurethane, polyolefin, polyolefin elastomer, thermoplastic elastomer and polyamide.
  • both the material of the inner layer and the material of the outer layer are preferably thermoplastic elastomers.
  • the material of the spring part of the reinforcing layer can be metal, such as any one of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and tungsten; or, the material of the spring part can also be polymer wire, such as: poly Ethylene, polyamide, liquid crystal polymer filament, or, alternatively, the material of the spring component can be a combination of metal and polymer filament.
  • the material of the axial part of the reinforcing layer may be metal and/or polymer wire.
  • the material of the axial component can be any one of metals such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, tungsten, silver, and gold, and can also be made of high-grade materials such as polyethylene, polyamide, and liquid crystal. Any one of molecular filaments; or, the material of the axial component may 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 may be a developing material.
  • intersection points between the axial member and the spring member there may be 1-80,000 intersection points between the axial member and the spring member.
  • the catheter provided by the present invention keeps the inner and outer layers of the existing catheter unchanged, that is, while ensuring the flexibility of the catheter, through the reinforcement layer (catheter reinforcement layer) of the existing catheter at the same time.
  • One or more axial components are arranged in the axial direction of the spring component to increase the axial modulus of the catheter, so as to avoid the axial deformation of the catheter caused by the axial force on the pipe body of the catheter. There is a breakage problem. Therefore, as long as the axial member is arranged in various ways in the axial direction of the spring member, the object of the present invention can be achieved.
  • the catheter reinforcement layer (reinforcing layer) in its three-layer structure
  • the following will focus on the structure of the catheter reinforcement layer, and its spring components are arranged in a clockwise spiral winding manner.
  • Figs. 2a-2c are schematic structural diagrams of a conduit reinforcement layer according to an embodiment of the present invention.
  • the catheter reinforcement layer 100 includes a spring member 110 and an axial member extending from the proximal end to the distal end along the spring member 110 and passing through the spring member 110 as a whole. 120.
  • the axial member 120a may be attached to (the inner surface) and the inner layer (not shown).
  • the axial member 120b may be linearly or helically attached between (the outer surface of) the spring member 110 and the outer layer (not shown) from the proximal end to the distal end.
  • the axial members 120c may be staggered and attached between the inner surface and the outer surface of the spring member 110 in a wave shape from the proximal end to the distal end.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • FIG. 3 is a schematic structural diagram of a conduit reinforcement layer according to another embodiment of the present invention.
  • the conduit reinforcement layer 100 is a combination of the spring member 110 and the axial member 120d.
  • the axial part 120d may be disposed between the gaps of the spring part 100 along the spring part 100 from the proximal end to the distal end, and the axial part 120d and the spring part 110 are in the same plane.
  • the advantage of the conduit reinforcement layer 110 shown in FIG. increase.
  • the axial member 120 provided by the present invention is combined with the spring member 110 in a manner that the entirety of the axial member 120 as described in the first embodiment and the second embodiment described above is combined with the spring member 110 as a conduit reinforcement
  • the axial member 120 may also be combined with the spring member 110 to form a conduit reinforcement layer 100 in a manner of partially passing through the spring member 110 , which is not specifically limited in the present invention.
  • the number of the axial components 120 may be one or more. Preferably, the number of the axial components may range from 1 to 16000, for example, 20, 100, 800, 2000, 5000, 10000, 12000, 16000.
  • the axial member 120 may be disposed in a single-sided manner in the first and second embodiments as described above, that is, the axial member 120 is disposed on the spring member One side of the spring member 110; when the number of the axial members 120 is plural, the plurality of the axial members 120 may be arranged symmetrically or asymmetrically along the circumferential direction of the spring member 110, and/or the shaft The direction members 120 are arranged at intervals along the axial direction of the spring member 110 .
  • the spaced arrangement mentioned in this specification means that the proximal ends of two adjacent axial components are not in the same axial position, but are arranged in an axially staggered manner.
  • 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.
  • a plurality of the axial members 120 can be arranged symmetrically or asymmetrically along the circumferential direction of the spring member 110 to introduce the positional relationship between the axial members and the spring member 110 when there are multiple axial members.
  • a plurality of the axial members 120 can be arranged symmetrically or asymmetrically along the circumferential direction of the spring member 110 to introduce the positional relationship between the axial members and the spring member 110 when there are multiple axial members.
  • Examples are as follows.
  • FIG. 4 is a schematic structural diagram of a conduit reinforcement layer according to another embodiment of the present invention.
  • the conduit reinforcement layer 100 includes a spring member 110 and a plurality of The proximal end to the distal end integrally penetrates the axial part 120e of the spring part 110 and is arranged symmetrically. Since the axial members 120e are disposed on the surface of the spring member 100 in a symmetrical manner, the structural stability of the catheter including the catheter reinforcement layer can be ensured.
  • the number of the axial components 120e may range from 2 to 10, for example, 2, 3, 5, 6, 8, and 10.
  • the catheter is usually designed to have a hard proximal end and a soft distal end, for example, the hardness gradually decreases from the proximal end to the distal end, and the catheter is composed of multiple segments with different softness and hardness.
  • the outer or/and inner layers are spliced by segments made of materials of different hardness.
  • the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs to have a good transition of softness.
  • flexible catheters have lower axial modulus and are at the junction of multiple catheter segments (eg, where segments of inner or outer layers splices or where a property transitions).
  • the thinner part of the catheter body is easy to become the weak point of force, so that the catheter is prone to axial deformation under the action of axial force during clinical operations, or even to be pulled off.
  • the axial members 120 symmetrically or asymmetrically along the circumference of the spring member 110 of the catheter at preset positions, and/or the axial members 120 are arranged at predetermined positions at intervals along the axial direction of the spring member 110 in sequence.
  • the preset position may be a junction of a plurality of conduit segments included in the conduit reinforcement layer (a joint of inner or outer layer segments or a transition position of a certain characteristic), an inner layer or an outer layer
  • a joint of inner or outer layer segments or a transition position of a certain characteristic a joint of inner or outer layer segments or a transition position of a certain characteristic
  • an inner layer or an outer layer The position where the softness of the duct is relatively high, the position where the thickness of the inner layer or the outer layer is relatively small, the position where the modulus value of the catheter is relatively small, and the position where the catheter tube body is relatively thin, see the following examples for details.
  • FIG. 5 and FIG. 6 are schematic structural diagrams of a conduit reinforcement layer according to another embodiment of the present invention.
  • multiple axial members 120 g or 120 f may be helically arranged along the circumferential direction of the spring member 110 , and the multiple axial members 120 g or 120 f
  • Each of the axial parts 120g or 120f may be located between the circumferential surfaces of the corresponding spring parts 110 or the gaps of the spring wires at the inner layer junctions or outer layer splices of adjacent catheter segments, and each of the axial parts 120g or 120f
  • the non-end points of the part 120g or 120f are connected with the circumferential surface or the spring wire of the spring part 110 corresponding to the splicing point;
  • the modulus value of the conduit segment on both sides or one side is between the circumferential surface of the conduit segment corresponding to the spring member 110 or the gap between the spring wires, and the
  • each axial member 120g or axial member 120f may be disposed between the spring member 110 and the inner layer of the conduit, or may be disposed between the spring member 110 and the outer layer 200 of the conduit , can also be arranged between the gaps of the spring components 110 .
  • the axial length of each of the axial members 120 may be a pitch between two adjacent single waves of the clockwise spirally wound spring member 110, such as the axial member 120g shown in FIG. 6 .
  • the axial distances between the multiple axial components 120 may be the same or different, and/or the distance between the multiple axial components 120 may be the same or different.
  • the circumferential angular spacing can be the same or different.
  • the axial spacing between the axial members 120 located at the proximal end is smaller than the axial spacing between the axial members located at the distal end, and/or, The circumferential angular separation between the axial members at the proximal end is smaller than the axial separation between the axial members at the distal end.
  • the value range of the axial spacing can be 0.001inch ⁇ 0.1inch.
  • the axial distance mentioned in this specification refers to the distance between the proximal ends of the two axial components in the direction parallel to the axial direction, such as D1 and D2 as shown in FIG.
  • the circumferential angular spacing of the two axial parts along the axial direction of the axial part is a radian corresponding to L (ie, the central angle formed by two points on the two axial parts located on the same circumference).
  • the axial member 110 is a monofilament or a twisted wire composed of multiple monofilaments.
  • the diameter of the monofilament can range from 0.0005 inch to 0.003 inch, and the number of monofilaments contained in the twisted wire can range from 1 to 20.
  • the researchers of the present invention obtained the following table through experiments, which is used to explain the effects of the axial component provided by the present invention on various parameters of the catheter in the prior art.
  • 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 tensile breaking force of the catheter gradually increases, but the outer diameter and softness of the catheter are basically maintained. constant. That is, the axial component added to the catheter can effectively increase the tensile breaking force of the catheter, and at the same time, the influence on the outer diameter and softness of the catheter is small and can be ignored.
  • the axial member 120 described in the above figures can be connected with the spring member 100 by means of gluing, polymerization, bonding or laser welding, or, the The axial member 120 is integrated with the spring member 110 , that is, a structure in which the axial member 120 and the spring member 110 are combined is integrally formed by cutting a pipe material.
  • the axial member 120 may further include a control wire 130 (ie, the control wire 130 extending from the spring member in reverse) on the side close to the catheter operator. one end close to the operator, and the extending direction is opposite to the helical direction of the spring member), so that the catheter operator can dynamically adjust the rotation direction of the catheter 10 through the control wire 130, thereby making the catheter easier to pass tortuous vascular area.
  • the length of the control wire 130 can be specifically set according to actual needs, which is not specifically limited in the present invention.
  • the conduit reinforcement layer and conduit provided by the present invention have a new type of reinforcement layer structure, which increases the axial direction of the conduit by introducing one or more axial components into the reinforcement layer of the spring structure of the existing conduit Modulus, avoiding the axial deformation of the catheter due to the axial force on the pipe body of the catheter, and the problem of fracture in severe cases.
  • arranging one or more axial members on the mechanical weak point of the catheter can prevent stress concentration points on the catheter and prevent the catheter from breaking during the delivery of the device or the pullback process.
  • 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 introduction of one or more axial components extending in the axial direction into the reinforcement layer of the catheter can not only ensure the flexibility of the catheter, but also prevent the axial deformation and fracture of the catheter. .

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Abstract

一种导管加强层(100)和导管(10),导管加强层(100)包括弹簧部件(110)和至少一个轴向部件(120)，至少一个轴向部件(120)沿弹簧部件(110)从近端向远端延伸设置，且与弹簧部件(110)至少存在一个交点。导管加强层(100)通过在现有弹簧部件(110)的加强层中引入一个或多个轴向部件(120)而增加了导管(10)的轴向模量，避免了导管(10)的管体由于受到轴向力而发生轴向变形甚至断裂。

Description

一种导管加强层和导管 技术领域
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。
背景技术
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能顺利的输送至病变位置的需求，现有的医用导管通常设计为近端较硬，远端较柔软，例如从近端到远端硬度逐渐降低。导管由软硬度不同的多个节段组成。为了实现导管的远近端的柔软度的不同，通常导管外层或/和内层会通过不同硬度的材料(沿轴向)拼接。并且，导管的远端需要尽可能的柔软，且导管整体需要良好的柔软度过渡。然而，受材料和设计特性的影响，柔软的导管的轴向模量较低，并且导管节段的连接处(如内层或外层的节段拼接处或者某一特性的过渡位置处)以及导管管体较细的部位容易成为受力薄弱点，从而使得在临床手术中，导管容易在轴向力的作用下发生轴向变形，甚至被拉断，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，以解决现有的导管的轴向抗拉性能不足，严重情形下会出现断裂的失效模式的问题。
为解决上述技术问题，本发明提供一种导管加强层，包括弹簧部件和至 少一个轴向部件，所述或各个所述轴向部件均沿所述弹簧部件从近端向远端延伸设置，且与所述弹簧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，所述轴向部件平行于所述弹簧部件的轴向方向设置；
或者，所述轴向部件与所述弹簧部件的轴向方向呈一定角度设置，所述角度为0-45°；
或者，多个所述轴向部件中的至少一部分与所述弹簧部件的轴向方向呈一定角度设置，所述角度为0-45°，多个所述轴向部件的其他部分平行于所述弹簧部件的轴向方向设置。
可选的，所述轴向部件与所述弹簧部件之间存在1-80000个交点。
可选的，所述轴向部件沿所述弹簧部件从近端向远端以直线形或螺旋形贴附于所述弹簧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弹簧部件的内表面和外表面之间；
再或者，所述轴向部件沿所述弹簧部件从近端向远端设于所述弹簧部件的空隙之间，所述轴向部件与所述弹簧部件处于同一平面。
可选的，当所述轴向部件的数目为多个时，多个所述轴向部件沿所述弹簧部件的周向对称或非对称设置；
和/或，
所述轴向部件沿所述弹簧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，多个所述轴向部件在预设位置处沿所述弹簧部件的周向对称或非对称设置；
和/或，
所述轴向部件在预设位置处沿所述弹簧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弹簧部件的轴向螺旋排布。
可选的，所述多个轴向部件之间的轴向间距相同或不同，
和/或,
所述多个轴向部件之间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。
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，当所述轴向部件的数目为多个时，在所述弹簧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可以为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，所述轴向部件可以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，所述轴向部件可以采用胶黏、聚合、粘接、激光焊接的方式与所述弹簧部件连接，或者，采用切割成型的方式将所述轴向部件与所述弹簧部件结合为一体。
可选的，所述轴向部件还可以包括在靠近导管的操作者的一侧反向延长的控制线。
同时，基于如上所述的导管加强层，本发明还提供了一种导管，该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，其中，所述加强层包含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处或外层拼接处对应的弹簧部件的周向表面或弹簧丝的间隙之间；
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弹簧部件的周向表面或弹簧丝的间隙之间；
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弹簧部件的周向表面或弹簧丝的间隙之间；
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弹簧部件的周向表面或弹簧丝的间隙之间。
可选的，所述轴向部件还可以包括在靠近导管的操作者的一侧反向延长的控制线，以使所述导管操作者通过所述控制线调整所述导管的转动方向。
可选的，所述内层为高分子材料，所述内层的厚度为0.0001inch-0.002inch。
可选的，所述内层的厚度为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之一：
1.本发明提供的导管加强层和导管具有一种新型加强层结构，其通过在现有导管的弹簧结构的加强层中引入一个或多个轴向部件而增加了导管的轴向模量，避免了由于导管的管体受到轴向力，而引起导管的轴向变形，严重情形下会出现断裂的问题。
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或者回拉过程中发生断裂。
3.在导管的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。
4.在导管的内层厚度特别薄的情况下在导管的加强层中引入一个或多个轴向方向延伸的轴向部件，可以既保证导管的柔软性能，又能防止导管的轴向变形和断裂。
附图说明
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2a-图2c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3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为本发明提供的一实施例中的导管的整体结构示意图。
其中，附图标记如下：
10-导管；                   100-导管加强层；
200-外层；                  110-弹簧部件；
120-轴向部件；              130-控制线。
具体实施方式
以下将对本发明的一种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能顺利的输送至病变位置的需求，现有的导管通常设计为近端较硬，远端较柔软，例如从近端到远端硬度逐渐降低。导管由软硬度不同的多个节段组成。为了实现导管的远近端的柔软度的不同，通常导管的外层或/和内层会通过由不同硬度的材料制成的节段(沿轴向)拼接而成。并且，导管的远端需要尽可能的柔软，且导管整体需要良好的柔软度过渡。然而，受材料和设计特性的影响，柔软的导管的轴向模量较低，并且多个导管节段的连接处(如内层或外层的节段拼接处或者某一特性的过渡位置处)以及导管管体较细的部位容易成为受力薄弱点，从而使得在临床手术中导管容易在轴向力的作用下发生轴向变形，甚至被拉断，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。对于加强层为弹簧结构的导管，由于其结构的特殊性，可实现高柔软度导管的需求，但同时，弹簧结构加强层对导管整体抵抗轴向变形的贡献度很低。具有弹簧结构加强层的导管的轴向抗拉伸的能力主要依赖内层和外层的高分子材料强度。当内外层选用硬度较低的高分子材料时，或者内外层存在轴向过渡结构时，导管的轴向抗拉性能不足，严重情形下会出现断裂的失效模式。
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，以解决现有的导管的轴向抗拉性能不足，严重情形下会出现断裂的失效模式的问题。
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。所述导管例如是中空的管道，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，其中，所述导管的加强层包含导管加强层。所述导管加强层包括弹簧部件和至少一个轴向部件，所述或各个所述轴向部件均沿所述弹簧部件从近端向远端延伸设置，且与所述弹簧部件至少存在一个交点。具体的，所述轴向部件以所述轴向方向的方式设置可以包括沿着导管轴向方向平行设置，也可以包括与导管轴向呈一定角度设置，所述一定角度包括0-45°内的任意角度，例如3°、5°、10°、15°、30°、45°等；或者，还可以是多个轴向部件中的至少一部分与所述弹簧部件的轴向方向呈一定角度设置，其中，所述角度为0-45°，而多个所述轴向部件中的其他部分则沿平行于所述弹簧部件的轴向方向设置。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任一种或组合。在一个示例性的实施例中，所述弹簧部件可以呈顺时针螺旋缠绕的形状设置在所述导管的内层和外层之间，也可以呈逆时针螺旋缠绕等其他弯曲形状设置在所述导管的内层和外层之间；并且，所述弹簧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。
具体的，所述导管的内层的材料可以为如聚四氟乙烯、聚氨酯、聚酰胺、聚烯烃、聚烯烃弹性体和热塑性弹性体等高分子材料中的任一种或任意几种的组合，且所述内层的厚度的取值范围可以为0.0001inch-0.002inch。可选的，所述内层的厚度的取值范围还可以为0.0003inch-0.0006inch。所述导管的外层材料可以为如聚氨酯、聚烯烃、聚烯烃弹性体、热塑性弹性体和聚酰胺等高分子材料中的任一种或任意几种的组合。在一个示例性的实施例中，所述内层的材料和外层的材料均可优选为热塑性弹性体。所述加强层的弹簧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；或者，所述弹簧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，再或者，所述弹簧部件的材料可以为金属与高分子丝的组合。并且，所述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，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。在一个示例性的实施例中，当所述轴向部件为多个时，至少一个所述轴向部件的材料可以为显影材料。
可选的，所述轴向部件与所述弹簧部件之间可以存在1-80000个交点。例如1、4、10、100、200、500、1000、2000、5000、10000、20000、40000、60000、80000个交点。
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，即保证导管的柔软度的同时，通过在现有导管的加强层(导管加强层)中的弹簧部件的轴向方向上设置一个或多个轴向部件来增加所述导管的轴向模量，避免了由于导管的管体受到轴向力而引起导管的轴向变形，严重情形下会出现断裂的问题。因此，只要是在弹簧部件的轴向方向以各种方式设置轴向部件，都可以实现本发明的发明目的。
由于本发明的导管的主要改进点在其三层结构中的导管加强层(加强层)，因此，下面将重点介绍导管加强层的结构，且以其弹簧部件呈顺时针螺旋缠绕的方式设置在导管的内层和外层之间为例，并结合附图具体说明本发明提供的导管的加强层中弹簧部件和轴向部件的多种组合。
实施例一：
参见图2a-图2c，图2a-图2c为本发明一实施例的导管加强层的结构示意图。如图2a-图2c所示，同时请参阅图1，所述导管加强层100包括弹簧部件110和沿弹簧部件110从近端向远端延伸设置且整体贯穿所述弹簧部件110的轴向部件120。具体的，如图2a所示，轴向部件120a可以沿所述弹簧部件110从近端向远端以直线形或螺旋形贴附于在所述弹簧部件110(的内表面)与内层(未图示)之间。或者，如图2b所示，轴向部件120b可以从近端向远端 以直线形或螺旋形贴附于在所述弹簧部件110(的外表面)与外层(未图示)之间。再或者，如图2c所示，轴向部件120c可以从近端向远端以波浪形交错贴附于所述弹簧部件110的内表面和外表面之间。
实施例二：
参见图3，图3为本发明另一实施例的导管加强层的结构示意图。如图3所示，所述导管加强层100为弹簧部件110与轴向部件120d的结合体。所述轴向部件120d可以沿所述弹簧部件100从近端向远端设于所述弹簧部件100的空隙之间，且所述轴向部件120d与所述弹簧部件110处于同一平面。相比于图2a-图2c所示的导管加强层100，图3所示的导管加强层110的优势在于包括所述导管加强层的导管的外径尺寸不会因为轴向部件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以其全部贯穿所述弹簧部件110的方式与弹簧部件110一起组合为导管加强层100之外，所述轴向部件120还可以部分穿过所述弹簧部件110的方式与弹簧部件110一起组合为导管加强层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，优选的，所述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。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单侧放置的方式设置，即轴向部件120设置于弹簧部件110的单侧；当所述轴向部件120的数目为多个时，多个所述轴向部件120可以沿所述弹簧部件110的周向对称或非对称设置，和/或，所述轴向部件120沿所述弹簧部件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可以沿所述弹簧部件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，其与弹簧部件110的位置关系，具体详见如下实施例。
实施例三：
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，优选的，所述导管加强层100包括弹簧部件110和多个沿所述弹簧部件110从近端向远端整体贯穿所述弹簧部件110且对称设置的轴向部件120e。由于轴向部件120e以对称放置的方式设置在弹簧部件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地，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，即，提升了导管的轴向抗拉能力，进而降低了导管的延伸率，最终避免了导管在被内兼容器械轴向拉伸引起疲劳失效的风险。
可选的，所述轴向部件120e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可以在沿所述弹簧部件110的周向的表面上的任意位置处对称或非对称设置。但是，由于在现有技术中，所述导管通常设计为近端较硬，远端较柔软，例如从近端到远端硬度逐渐降低，且导管由软硬度不同的多个节段组成。为了实现导管的远近端的柔软度的不同，通常外层或/和内层会通过由不同硬度的材料制成的节段拼接而成。并且，导管的远端需要尽可能的柔软，且导管整体需要良好的柔软度过渡。然而，受材料和设计特性的影响，柔软的导管轴向模量较低，并且多个导管节段的连接处(如内层或外层的节段拼接处或者某一特性的过渡位置处)以及导管管体较细的部位容易成为受力薄弱点，从而使得在临床手术中导管容易在轴向力的作用下发生轴向变形，甚至被拉断。因此，在本发明实施例中，首选将多个所述轴向部件120在预设位置处沿导管的所述弹簧部件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弹簧部件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(内层或外层节段的拼接处或者某一特性的过渡位置处)、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，具体详见如下实施例。
实施例四：
参见图5和图6，图5和图6为本发明另一实施例的导管加强层的结构示意图。如图5或者图6所示，当所述轴向部件120为多个时，多个轴向部件120g或者轴向部件120f可以沿所述弹簧部件110的周向方向螺旋排列，且所述多个轴向部件120g或者轴向部件120f可以位于相邻导管节段的内层连接处或外层拼接处对应的弹簧部件110的周向表面或弹簧丝的间隙之间，且各个所述轴向部件120g或者120f的非端点与所述拼接处对应的弹簧部件110的周向表面或弹簧丝连接；或者，所述多个轴向部件120g或者轴向部件120f可以位于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弹簧部件110的周向表面或弹簧丝的间隙之间，以及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弹簧部件110的周向表面弹簧丝的间隙之间；再或者，所述多个轴向部件120g或者轴向部件120f可以位于所述导管内层或所述导管外层的厚度较小处，或者，与所述导管内层或所述导管外层的柔软度较高的导管节段对应的弹簧部件的周向表面或弹簧丝的间隙之间。
具体的，所述各个轴向部件120g或者轴向部件120f可以设置在所述弹簧部件110与导管的内层之间，也可以设置在所述弹簧部件110与所述导管的外层200之间，还可以设置在所述弹簧部件110的空隙之间。并且，各所述轴向部件120的轴向长度可以为所述呈顺时针螺旋缠绕的弹簧部件110的相邻两个单波之间的一个节距，如图6所示的轴向部件120g，也可以为所述呈正弦波状的弹簧部件110的多个单波之间的节距，如图5所示的轴向部件120f，对此本发明不做具体限定。
可以理解的是，当所述轴向部件为多个时，所述多个轴向部件120之间的轴向间距可以相同或不同，和/或，所述多个轴向部件120之间的周向角度 间距可以相同或不同。或者，在所述多个轴向部件120中，位于近端的所述轴向部件120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。其中，当所述轴向部件的数目为多个时，在所述弹簧部件110的轴向方向上相邻的两个所述轴向部件120g(或者相邻两个轴向部件120f)之间的轴向间距的取值范围可以为0.001inch～0.1inch。
需要强调的是，在该说明书中提到的轴向间距指的是两个轴向部件的近端在平行于轴向的方向上的间距，如图5所示的D1和D2，且相邻两个轴向部件沿轴向部件的轴向方向的周向角度间距为L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110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，所述绞丝包含的单丝的数目的取值范围可以为1～20根。
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现有技术中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 断裂力 外径 柔软度
N＝1 +0.6％ +0.1％ -0.6％
N＝2 +2.4％ +0.2％ -1.1％
N＝3 +5.6％ +0.4％ -1.6％
N＝10 +49.9％ +0.41％ -6.43％
N＝15 +57.3％ +0.46％ -9.07％
由上述表1可知，与不设有轴向部件的导管相对比，随着轴向部件数目的增加，所述导管的轴向拉伸断裂力逐渐提升，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提升导管的拉伸断裂力 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、粘接或激光焊接的方式与所述弹簧部件100连接，或者，还可以采用切割成型的方式将所述轴向部件120与所述弹簧部件110结合为一体，即通过切割管材的方式一体成型为轴向部件120与所述弹簧部件110结合的结构。
此外，请参见图7，7为本发明提供的一实施例中的导管的整体结构示意图。如图7所示，在如上所述的任何一个实施例中，所述轴向部件120还可以包括在靠近导管操作者的一侧反向延长的控制线130(即，控制线130自弹簧部件靠近操作者的一端延伸，且延伸方向与弹簧部件的螺旋方向相反)，以使所述导管操作者可以通过所述控制线130来动态调整所述导管10的转动方向，从而使导管更易于通过迂曲的血管区域。其中，所述控制线130的长度可以根据实际需要具体设定，本发明对此不做具体限定。
综上所述，本发明提供的导管加强层和导管具有一种新型加强层结构，其通过在现有导管的弹簧结构的加强层中引入一个或多个轴向部件而增加了导管的轴向模量，避免了由于导管的管体受到轴向力，而引起导管的轴向变形，严重情形下会出现断裂的问题。此外，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，防止导管在输送器械或者回拉过程中发生断裂。
进一步的，在导管的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。且在导管的内层厚度特别薄的情况下在导管的加强层中引入一个或多个轴向方向延伸的轴向部件，可以既保证导管的柔软性能，又能防止导管的轴向变形和断裂。
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做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”包括复数基准，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 (23)

  1. 一种导管加强层，其特征在于，包括弹簧部件和至少一个轴向部件，所述或各个所述轴向部件均沿所述弹簧部件从近端向远端延伸设置，且与所述弹簧部件至少存在一个交点。
  2. 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。
  3. 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。
  4. 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弹簧部件的轴向方向设置；
    或者，所述轴向部件与所述弹簧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弹簧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弹簧部件的轴向方向设置。
  5. 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弹簧部件之间存在1-80000个交点。
  6. 如权利要求1所述的导管加强层，其特征在于，所述轴向部件沿所述弹簧部件从近端向远端以直线形或螺旋形贴附于所述弹簧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弹簧部件的内表面和外表面之间；
    或者，所述轴向部件沿所述弹簧部件从近端向远端设于所述弹簧部件的空隙之间，所述轴向部件与所述弹簧部件处于同一平面。
  7. 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，多个所述轴向部件沿所述弹簧部件的周向对称或非对称设置；
    和/或，
    所述轴向部件沿所述弹簧部件的轴向依次间隔设置。
  8. 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，多个所述轴向部件在预设位置处沿所述弹簧部件的周向对称或非对称设置；
    和/或，
    所述轴向部件在预设位置处沿所述弹簧部件的轴向依次间隔设置。
  9. 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弹簧部件的轴向螺旋排布。
  10. 如权利要求9所述的导管加强层，其特征在于，所述多个轴向部件之间的轴向间距相同或不同，
    和/或，
    所述多个轴向部件之间的周向角度间距相同或不同。
  11. 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。
  12. 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。
  13. 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，在所述弹簧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。
  14. 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。
  15. 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。
  16. 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。
  17. 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黏、聚合、粘接、激光焊接的方式与所述弹簧部件连接，或者，采用切割成型的方式将所述轴向部件与所述弹簧部件结合为一体。
  18. 如权利要求1所述的导管加强层，其特征在于，所述轴向部件还包括在靠近导管的操作者的一侧反向延长的控制线。
  19. 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。
  20. 如权利要求19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处或外层拼接处对应的弹簧部件的周向表面或弹簧丝的间隙之间；
    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弹簧部件的周向表面或弹簧丝的间隙之间；
    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弹簧部件的周向表面或弹簧丝的间隙之间；
    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弹簧部件的周向表面或弹簧丝的间隙之间。
  21. 如权利要求19所述的导管，其特征在于，所述轴向部件还包括在靠近导管的操作者的一侧反向延长的控制线，以使所述导管操作者通过所述控制线调整所述导管的转动方向。
  22. 如权利要求19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。
  23. 如权利要求22所述的导管，其特征在于，所述内层的厚度为0.0003inch-0.0006inch。
PCT/CN2022/071231 2021-02-05 2022-01-11 一种导管加强层和导管 WO2022166539A1 (zh)

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