WO2022142877A1 - 一种导管和导管过渡结构的制备方法 - Google Patents

一种导管和导管过渡结构的制备方法 Download PDF

Info

Publication number
WO2022142877A1
WO2022142877A1 PCT/CN2021/132608 CN2021132608W WO2022142877A1 WO 2022142877 A1 WO2022142877 A1 WO 2022142877A1 CN 2021132608 W CN2021132608 W CN 2021132608W WO 2022142877 A1 WO2022142877 A1 WO 2022142877A1
Authority
WO
WIPO (PCT)
Prior art keywords
polymer
region
catheter
transition structure
transition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/132608
Other languages
English (en)
French (fr)
Inventor
林恒
刘云云
刘庆龙
罗雪莉
刘玉梅
孙莉
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Microport Neurotech Shanghai Co Ltd
Original Assignee
Microport Neurotech Shanghai Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Microport Neurotech Shanghai Co Ltd filed Critical Microport Neurotech Shanghai Co Ltd
Priority to EP21913619.9A priority Critical patent/EP4252814A4/en
Priority to AU2021411539A priority patent/AU2021411539A1/en
Priority to KR1020237023184A priority patent/KR20230118914A/ko
Priority to JP2023539968A priority patent/JP2024502031A/ja
Priority to US18/270,576 priority patent/US20240293641A1/en
Publication of WO2022142877A1 publication Critical patent/WO2022142877A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61M25/0009—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
    • 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
    • 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
    • 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
    • A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • 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
    • A61M25/0054—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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • 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
    • A61M2205/0222—Materials for reducing friction

Definitions

  • the invention relates to the technical field of medical devices, in particular to a catheter used for intracranial vascular intervention therapy.
  • Minimally invasive interventional surgery is a surgical method in which implanted medical devices or therapeutic drugs are delivered to the lesion site with minimal trauma through an intravascular catheter delivery system with the support of an imaging system for mechanical or chemical treatment.
  • catheters have been widely used in various minimally invasive interventional procedures.
  • this type of interventional surgery usually uses small blood vessels (such as femoral artery and radial artery) as the entrance, and the catheter is delivered to the target lesion site with the help of sheath and guide wire along the blood vessel through the entrance.
  • small blood vessels such as femoral artery and radial artery
  • the catheter is delivered to the target lesion site with the help of sheath and guide wire along the blood vessel through the entrance.
  • the establishment of the access system requires the operator to spend a certain amount of time due to the tortuous blood vessels.
  • tortuous vascular locations such as the type III arch of the aortic arch and the ophthalmic artery of the intracranial artery, if the catheter can still be successfully delivered here, the intraoperative time can be greatly saved.
  • the catheter consists of an inner layer, a reinforcing layer and an outer layer to form a three-layer structure.
  • the inner and outer layers of the catheter are usually made of polymer pipes, and the reinforcement layer is usually a reinforcement structure made of metal wires or polymer wires. , the reinforcement layer is embedded between the inner layer and the outer layer.
  • inner layer hardness the inner layer hardness
  • reinforcing layer wire strength and coverage density the outer layer hardness.
  • the catheter has segments with different hardness. The proximal end is harder and the distal end is softer. The hardness gradually decreases from the proximal end to the distal end.
  • the catheter can be delivered to the lesion site.
  • the transition between soft and hard is usually adjusted by adjusting the type and hardness of the polymer material of the splicing section, and the strength or pitch of the wire of the reinforcing layer.
  • the polymer raw materials commonly used in the catheter body include PTFE, polyurethane, polyamide, polyolefin, etc.
  • the distal end uses a softer polymer material (such as pebax25D)
  • the proximal end uses a harder polymer material (such as Pebax 72D, Nylon).
  • the purpose of the present invention is to provide a preparation method of a catheter and a catheter transition structure, to solve the technical problem that in the existing catheter, the splicing method makes the mechanical property transition of the catheter not smooth enough, thereby affecting the delivery performance and safety performance of the catheter.
  • a catheter which includes:
  • the polymer layer contains at least one transition structure, the transition structure is a tubular structure, and the transition structure includes a single material region and a mixed material region, any one continuous closed region in the single material region is called the first subregion, and the mixed material region is Any continuous closed region in the material region is called a second subregion, any section of the transition structure in the axial direction includes at least one second subregion, and the initial section and/or the end section of the transition structure includes at least one first subregion region and at least one second subregion.
  • any section of the transition structure in the axial direction includes at least one first sub-region and at least one second sub-region.
  • the outer surface area ratio of the single-material region to the mixed-material region is gradually reduced from the start and/or end position of the transition structure in the axial direction from the end to the middle region of the transition structure.
  • the outer surface area ratio of the single-material region to the mixed-material region gradually decreases to a minimum value and then gradually increases.
  • the edge of at least one end of the mixed material zone is an inclined surface inclined to the axial direction of the conduit.
  • the inclination angle between the inclined surface and the axial direction of the catheter is 5°-60°.
  • the edge of at least one end of the mixed material zone is a wavy structure.
  • the axial length of the mixed material region is uniform, and the axial length of the mixed material region is 1-15 mm.
  • the axial length of the mixed material zone is not uniform, the axial length of the mixed material zone is 3-20 mm at the maximum, and the axial length of the mixed material zone is 0.5-15 mm at the minimum.
  • the single-material region includes a first polymer region and a second polymer region, the first polymer region and the second polymer region are distributed on both sides of the mixed material region, and the first polymer region is composed of the first polymer material.
  • the second polymer region is composed of a second polymer material, and the hardness of the first polymer material is greater than that of the second polymer material.
  • the hardness of the mixed material region is smaller than that of the first polymer region, and the hardness of the mixed material region is greater than that of the second polymer material region.
  • the edge of at least one end of the mixed material region is an inclined surface with an inclination angle to the axial direction of the conduit, and the greater the difference in hardness between the first polymer material and the second polymer material, the smaller the inclination angle.
  • the mixed material region is formed by blending and fusing the first polymer material and the second polymer material.
  • the mixed material region is formed by overlapping and splicing the first polymer material and the second polymer material.
  • the first polymer material is any one of polytetrafluoroethylene, polyolefin, polyurethane, polyether block polyamide, and polyamide
  • the second polymer material is polytetrafluoroethylene, polyolefin, polyurethane , any one of polyether block polyamide and polyamide.
  • the conduit also includes a reinforcement layer.
  • the conduit has a three-layer structure, from the inside to the outside, an inner layer, a reinforcing layer, and an outer layer, the inner layer and the outer layer are polymer layers, and the inner layer and/or the outer layer includes at least one transition structure.
  • the inner layer contains at least one transition structure.
  • the distal end of the inner layer contains at least one transition structure.
  • the outer layer contains at least one transition structure.
  • the present invention also provides a preparation method of a conduit transition structure, the preparation method comprising: cutting the head ends of the first polymer pipe and the second polymer pipe to make the first polymer pipe and/or the second high polymer pipe
  • the circumferential extension of the head end of the molecular pipe is less than one circumferential direction
  • the first polymer pipe is composed of a first polymer material
  • the second polymer pipe is composed of a second polymer material
  • the hardness of the first polymer material is When the hardness is greater than that of the second polymer material, the head end of the first polymer pipe material and the head end of the second polymer pipe material are at least partially overlapped and spliced, and then heat-shrinked.
  • the temperature of heat shrinking is higher than the melting points of the first polymer material and the second polymer material.
  • the temperature of heat shrinkage is between the melting point of the first polymer material and the melting point of the second polymer material.
  • the head end of the first polymer pipe material and/or the second polymer pipe material is also stretched, so that the thickness of the head end of the first polymer pipe material and/or the second polymer pipe material is less than Body thickness.
  • the catheter provided by the present invention includes at least one polymer layer, the polymer layer includes at least one transition structure, the transition structure is a tubular structure, and the transition structure includes a single-material region and a mixed-material region, and any one of the single-material regions is continuous
  • the closed region is called the first subregion
  • any continuous closed region in the mixed material region is called the second subregion.
  • Any section of the transition structure in the axial direction includes at least one second subregion.
  • the initial section of the transition structure and /or the end segment contains at least one first subregion and at least one second subregion.
  • the present invention also provides a preparation method of the transition structure.
  • the preparation method of the conduit and the transition structure provided by the present invention has at least the following advantages:
  • the transition position of polymer material in the catheter is soft and hard and the transition of mechanical properties is smooth, which makes the overall mechanical properties of the catheter better, and improves the delivery performance and safety performance of the catheter.
  • the two materials with large difference in hardness are not easy to generate stress concentration points after splicing, and can reduce the number of polymer materials in the catheter and the number of spliced segments.
  • the existence of the mixed material area is conducive to improving the splicing strength of the splicing position and improving the safety performance of the catheter.
  • FIG. 1 is a schematic diagram of a catheter provided by a preferred embodiment of the present invention.
  • FIG. 2 is an axial projection view of a transition structure in a conduit provided by a preferred embodiment of the present invention
  • FIG. 3 is a cross-sectional view of a section of a catheter provided by a preferred embodiment of the present invention.
  • FIG. 4 is an expanded view of a transition structure in a conduit provided by a preferred embodiment of the present invention.
  • FIG. 5 is an expanded view of a transition structure in a conduit provided by a preferred embodiment of the present invention.
  • FIG. 6 is an expanded view of a transition structure in a conduit provided by a preferred embodiment of the present invention.
  • FIG. 7 is an axial projection view of a transition structure in a conduit provided by a preferred embodiment of the present invention.
  • FIG. 8 is an expanded view of a transition structure in a conduit provided by a preferred embodiment of the present invention.
  • FIG. 9 is a cross-sectional view of a catheter provided by a preferred embodiment of the present invention.
  • Embodiment 1 provides a catheter 100 .
  • the catheter 100 includes at least one polymer layer, and the polymer layer includes at least one transition structure 200 .
  • FIG. 1 is a schematic diagram of the catheter 100 provided in the first embodiment.
  • the transition structure 200 is a tubular structure from the start position 201 to the end position 202 .
  • the start position 201 and the end position The region between locations 202 is an intermediate region, and the transition structure 200 includes a single material region 1 and a mixed material region 2 .
  • FIG. 2 is an axial projection view of a specific surface of the transition structure 200 in the conduit 100 .
  • the transition structure 200 is symmetrical in front and rear. In other embodiments, the transition structure 200 may also have no front-to-back symmetrical projection viewing angles.
  • the single-material region 1 further includes a first polymer region 101 and a second polymer region 102 , the first polymer region 101 is composed of a first polymer material, and the second polymer region 102 is composed of a second polymer material, and the hardness of the first polymer material is greater than that of the second polymer material. In some other embodiments, the hardness of the first polymer material may also be smaller than the hardness of the second polymer material.
  • any continuous closed area in the transition structure 200 is called a sub area, the transition structure 200 is actually a tubular structure, and the sub area is defined as: select any continuous closed shape on the outer surface of the tubular structure, and the closed shape is perpendicular to the pipe wall "cut "The resulting continuous closed volume is a subregion.
  • Any one continuous closed region in the single-material zone 1 is referred to as the first sub-region 1011 (or 1021 ), and any one continuous closed region in the mixed-material zone 2 is referred to as the second sub-region 2001 .
  • the dotted circle area is a sub-area
  • the quadrilateral area defined by the two oblique lines is the mixed material area 2
  • the two triangular areas are the single-material area 1.
  • the single-material area 1 includes the first polymer area 101 and In the second polymer region 102, any one continuous closed region in the first polymer region 101 and the second polymer region 102 is a first sub-region 1011 and a first sub-region 1021, respectively, and the first sub-region 1011 is located in the first polymer region 1011.
  • the first subregion 1021 is located in the second polymer region 102
  • any continuous closed region in the mixed material region 2 is the second subregion 2001 .
  • an axial segment of any length is selected, such as the range defined by the dotted line in FIG. 2 , in the selected segment, at least one second sub-region is included 2001; at the same time, from the axial end of the transition structure 200 where the first polymer region 101 is located (located at the starting position 201 of the transition structure 200 ) to the end position of the first polymer region 101 (located in the middle region of the transition structure 200 ) ) in the axial region of the 2001; similarly, the axial region starting from the axial end of the second polymer region 102 (located at the end position of the transition structure 200 ) to the end position of the second polymer region 102 (located in the middle region of the transition structure 200 ) Inside, optionally an axial segment of any length, the segment includes at least one first sub-region 1021 and at least one second sub-region 2001 .
  • both ends of the transition structure 200 include the single-material region 1.
  • only one end of the transition structure 200 may include a first polymer region 101, or, only One end contains a second polymer region 102 .
  • the end where the first polymer region 101 is located is the starting position 201 of the transition structure 200, and the segment close to the starting position 201 is the starting segment 210.
  • the starting segment 210 is A section of shorter length near the start position 201
  • the start section 210 represents a section from the start position 201 to a selected position located in the middle region of the transition structure 200 but close to the start position 201 .
  • the end where the second polymer region 102 is located is the end position 202 of the transition structure 200
  • the segment close to the end position 202 is the end segment 220 .
  • the end segment 220 is the one that is close to the end position 202 and has a shorter length. Segment, end segment 220 represents a segment from end location 202 to a selected location located in the middle region of transition structure 200 but near end location 202 .
  • the transition structure 200 in the conduit 100 provided by this embodiment includes at least one first sub-region 1011 (and/or first sub-region 1021) and at least one second sub-region 2001 in both the starting section 210 and the ending section 220;
  • the start section 210 of the transition structure 200 includes at least one first sub-region 1011 (or first sub-region 1021 ) and at least one second sub-region 2001
  • the end section 220 includes only at least one second sub-region 2001 . region 2001; or, in some other embodiments, the end section 220 of the transition structure 200 includes at least one first sub-region 1011 (or first sub-region 1021) and at least one second sub-region 2001, while the beginning section 210 only contains At least one second sub-region 2001 is included.
  • the mixed material zone 2 forms a section of oblique tube structure, that is, the edges of both ends of the mixed material zone 2 are inclined planes with an inclination to the axial direction of the conduit, and the edges of both ends of the mixed material zone 2 are parallel to the axial direction of the conduit.
  • the angle of the formed inclination angle may be the same or different, and the angle may be 5-60°.
  • only one edge of the mixed material zone 2 may be an inclined surface inclined to the axial direction of the conduit, and the edge of the other end may be a right-angled surface perpendicular to the axial direction of the conduit.
  • the material of the mixed material zone 2 can be a blended material obtained by blending the first polymer material and the second polymer material; for example, in the catheter preparation process, it is necessary to obtain an integrated pipe material by heat shrinking.
  • heat shrinking different materials are mutually On the contact surface, if the heat shrinkage temperature reaches above the melting point of two or more materials, the materials can melt and penetrate each other to obtain a blended material.
  • the material of the mixed material zone 2 can also be a composite material formed by overlapping and splicing the first polymer material and the second polymer material; In another polymer material on the corner end face, during the heat shrinking process, the heat shrinkage temperature is controlled not to be higher than the melting point temperature of the high melting point material, but higher than the melting point temperature of the low melting point material, and no blending will be formed after heat shrinking. material, but a composite layer in which two materials are superimposed and bonded.
  • the mixed material zone 2 may be formed by blending the first polymer material and the second polymer material, while in other embodiments, the mixed material zone 2 may be formed by the first polymer material A composite material layer that is overlapped and spliced with the second high-scoring material.
  • the hardness of the mixed material region 2 is between the hardness of the first polymer material and the hardness of the second polymer material; in other embodiments, the hardness of the mixed material region 2 is slightly higher than that of the first polymer material The hardness of the polymer material and the hardness of the second polymer material.
  • the existence of the mixed material zone 2 is beneficial to improve the splicing strength of the splicing position and improve the safety performance of the catheter.
  • the first polymer region 101 or the second polymer region 102 and the mixed material region As shown in FIG. 2 , in this embodiment, from the start position 201 and the end position 202 of the transition structure 200 to the middle region of the transition structure 200 , the first polymer region 101 or the second polymer region 102 and the mixed material region The outer surface area ratio of 2 is gradually reduced; and there is a section in the middle region of the transition structure 200 that has only the mixed material region 2 in the axial direction.
  • the ratio of the outer surface area of the first polymer region 101 (or the second polymer region 102 ) to the mixed material region 2 gradually decreases; or, in other embodiments
  • the outer surface area ratio of the first polymer region 101 (or/and the second polymer region 102 ) to the mixed material region 2 first decreases to a minimum value and then gradually increases.
  • the transition structure 200 exists in the polymer layer of the catheter 100 provided in this embodiment, which can smooth the transition between the hardness and the mechanical properties of the catheter 100, make the overall mechanical properties of the catheter 100 better, and improve the delivery performance and safety of the catheter 100. performance.
  • the catheter 100 needs to have different hardnesses at different positions, so it needs to be spliced with a variety of different hardness and/or different types of polymer materials. If the hardness difference is large, the catheter 100 is likely to be bent at the splicing position, resulting in a smaller or even permanent deformation of the lumen.
  • At least one polymer layer of the catheter 100 often requires multiple polymer materials to be spliced multiple times, thereby It meets the requirements of mechanical properties of different blood vessel positions and realizes a smooth transition of mechanical properties; and the transition structure 200 described in this embodiment is adopted for the splicing position, so that two materials with a large difference in hardness are not easy to generate stress concentration points after splicing. , and can reduce the number of polymer materials in the catheter and the number of spliced segments, and can also meet the smooth transition of mechanical properties.
  • FIG. 3 A partial axial cross-sectional view of the conduit 100 including the transition structure 200 is shown in FIG. 3 .
  • the area framed by the rectangular frame is the transition structure 200 .
  • the proximal end of the transition structure 200 is the proximal tube 3
  • the distal end of the transition structure 200 is the distal tube 4
  • the material of the proximal tube 3 is the first polymer material
  • the material of the distal tube 4 is the second A polymer material
  • the hardness of the first polymer material is greater than that of the second polymer material.
  • the first polymer region 101 is the region where the proximal tube 3 extends to the distal end
  • the second polymer region 102 is the region where the distal tube 4 extends proximally
  • the mixed material region 2 is the proximal tube 3 and the distal tube 4 areas of contact or mixing.
  • FIG. 3 takes the material of the mixed material area 2 as an example of a composite material layer obtained by overlapping and bonding the first polymer material and the second polymer material.
  • the material of the mixed material area 2 may be The first polymer material and the second polymer material are blended and fused to obtain a blended material.
  • the edge of the mixed material region 2 and the single material region 1 is an inclined plane with an inclination angle to the axial direction of the conduit, and the inclination angle of the inclined plane between the edge of the mixed material region 2 and the first polymer region 101 and the axial direction of the conduit is ⁇ , the inclination angle of the inclined plane between the edge of the mixed material region 2 and the second polymer region 102 and the axial direction of the catheter is ⁇ ;
  • the minimum value of the axial length of the mixed material region 2 is L1, and the maximum value of the axial length of the mixed material region 2 is L2;
  • the size of ⁇ and ⁇ can be the same or different, the size of L1 and L2 can be the same or different, when ⁇ and ⁇ are the same, L1 and L2 are the same.
  • L1 and L2 are preferably 1 mm to 3 mm, and ⁇ and ⁇ are preferably 45° to 60°; when the inner diameter of the catheter 100 is 0.055" to 0.090", L1 and L2 are preferably It is 6 mm to 15 mm, and ⁇ and ⁇ are preferably 5° to 60°. In some other embodiments, L1 and L2 may be 0.5-20 mm.
  • the axial length of the mixed material zone is uniform, ie, L1 and L2 are the same, and L1 and L2 have a value of 1-15 mm, such as 1 mm, 3 mm, 5 mm, 7.5 mm, 10 mm, 12 mm, 15 mm, etc.; in some In the embodiment, the axial length of the mixed material area is not uniform, that is, L1 and L2 are different, and the value of L1 is 0.5-15mm, such as 0.5mm, 2mm, 5mm, 6mm, 8mm, 11mm, 12.5mm, 15mm, etc., L2 The value of 3-20mm, such as 3mm, 5mm, 7mm, 10mm, 12mm, 15mm, 17.5mm, 20mm, etc.
  • FIG. 4 The developed view of the transition structure 200 in FIG. 3 after being cut along the axial direction is shown in FIG. 4 .
  • FIG. 4 more intuitively shows the positions and relationships between L1, L2, ⁇ , and ⁇ .
  • the cut-away position is the position where the axial length of the mixed material zone 2 is the smallest.
  • the transition structure 200 is a symmetrical structure.
  • the expanded view of the transition structure 200 is symmetrical up and down; as shown in FIG. 5 , in other embodiments,
  • the transition structure 200 may not be a symmetrical structure, such as the connection between the end position of the first polymer region 101 (the right vertex of the left triangle in FIG.
  • an axial segment of any length is selected in the transition structure 200, and the selected segment must contain a second sub-region 2001; from the first macromolecule of the transition structure 200 In the axial region from the axial end of the region 101 (located at the starting position 201 of the transition structure 200 ) to the end position of the first polymer region 101 (located in the middle region of the transition structure 200 ), any length of An axial segment, in which the segment includes at least one first sub-region 1011 and at least one second sub-region 2001; at the axial end where the second macromolecular region 102 is located (located at the end position 202 of the transition structure 200 ) in the axial region from the beginning of the second polymer region 102 to the end position of the second polymer region 102 (located in the middle region of the transition structure 200 ), optionally an axial segment of any length is selected in the transition structure 200, and the selected segment must contain a second sub-region 2001; from the first macromolecule of the transition structure 200 In the axial region from the axial end of the
  • the angles of ⁇ and ⁇ are different, but neither is 90°. In other embodiments, the angles of ⁇ and ⁇ may be the same, but neither is 90°. In other embodiments, when ⁇ is not 90°, ⁇ may be 90°.
  • the transition structure 200 has only the first polymer region 101 and the mixed material region 2 at the axial end where the first polymer region 101 is located. In the axial region from the portion (located at the starting position 201 of the transition structure 200 ) to the end position of the first polymer region 101 (located in the middle region of the transition structure 200 ), an axial segment of any length can be selected. The segment includes at least one first sub-region 1011 and at least one second sub-region 2001 .
  • ⁇ when ⁇ is not 90°, ⁇ can be 90°.
  • there are only the second polymer region 102 and the mixed material region 2 in the transition structure 200 from the axial direction where the second polymer region 102 of the transition structure 200 is located In the axial region from the end (located at the end position 202 of the transition structure 200 ) to the end position of the second polymer region 102 (located in the middle region of the transition structure 200 ), an axial segment of any length is optional, in this The segment includes at least one first sub-region 1021 and at least one second sub-region 2001 .
  • the orientations of ⁇ and ⁇ are the same; in other embodiments, the orientations of ⁇ and ⁇ may be different, for example, ⁇ is towards the end position 202 of the transition structure 200, ⁇ is towards the start position 201 of the transition structure 200, Or the other way around.
  • ⁇ and ⁇ refer to the inclination angle of the inclined plane between the end edge of the mixed material region 2 and the axial direction of the catheter, the inclination angle is an acute angle, and ⁇ and ⁇ do not refer to the inclination angle complementary to the inclination angle. obtuse angle.
  • the catheter 100 is placed to bend at the transition position.
  • Control the inclination angle ⁇ and/or ⁇ to be smaller. The smaller the control angle ⁇ and/or ⁇ is, the smoother the change of the material at the transition position of the catheter 100 can be, and the smoother the change trend of the mechanical properties of the catheter 100 is, which is beneficial to the pushing performance and safety of the catheter 100 in tortuous blood vessels.
  • the transition structure 200 has a section in the axial direction, and in this section, there is only the second sub-region 2001 without the first sub-region 1011 (or 1021 ). As shown in FIG. 6 , in some other embodiments, any axial segment in the transition structure 200 includes at least one first sub-region 1011 (and/or first sub-region 1021 ) and at least one second sub-region 2001.
  • the conduit 100 provided in the third embodiment includes at least one transition structure 200.
  • the schematic diagram of the transition structure 200 is shown in FIG. 7.
  • the transition structure 200 provided in the third embodiment includes a single-material region 1 and a mixed-material region 2, and the single-material region 1 is further It includes a first polymer region 101 and a second polymer region 102, the first polymer region 101 is composed of a first polymer material, the second polymer region 102 is composed of a second polymer material, and the first polymer region 102 is composed of a second polymer material.
  • the hardness of a polymer material is higher than that of the second polymer material, and the first polymer region 101 and the second polymer region 102 are located on both sides of the mixed material region 2 .
  • the edge of the mixed material region 2 in the transition structure 200 presents a stepped structure (or referred to as a rectangular wave-like structure) in the axial projection direction of a specific plane.
  • the edges of both ends of the mixed material region 2 in the axial direction include stepped structures.
  • the mixed material region 2 of the transition structure 200 may only include a stepped structure at one edge of one end. .
  • An axial segment is arbitrarily selected from the transition structure 200 in the conduit 100 provided in the third embodiment, and the range defined by the dotted line in FIG. 7 includes at least one second sub-region 2001 in the selected segment; At the same time, from the axial end of the transition structure 200 where the first polymer region 101 is located (located at the starting position 201 of the transition structure 200 ) to the end position of the first polymer region 101 (located in the middle region of the transition structure 200 ) In the axial region, optionally an axial segment of any length, as defined by the dotted line in the figure, in this segment, at least one first sub-region 1011 and at least one second sub-region 2001 are included; similar , in the axial region from the axial end of the second polymer region 102 (located at the end position 202 of the transition structure 200 ) to the end position of the second polymer region 102 (located in the middle region of the transition structure 200 ), An axial segment of any length is optional, and the segment includes at least one first sub-region 1021
  • FIG. 8 The developed view of the transition structure 200 in FIG. 7 after being cut along the axial direction is shown in FIG. 8 .
  • the transition structure 200 in FIG. 7 is a front-to-rear symmetrical tube structure.
  • the transition structure 200 is a front-to-back asymmetric tube structure.
  • the edge of any one end or the edges of both ends of the mixed material zone 2 may be a wavy structure, and the wavy structure may be, but not limited to, a triangular wavy structure, a rectangular wavy structure, a square wavy structure, a sinusoidal wavy structure, a Regular wave structure and other structures.
  • FIG. 9 The axial cross-sectional view and radial cross-sectional view of the catheter 100 provided in the fourth embodiment are shown in FIG. 9 .
  • an inner layer 1001 , a reinforcing layer 1002 , and an outer layer 1003 are sequentially arranged along the radial direction of the catheter 100 from the inside to the outside.
  • the reinforcing layer 1002 is sleeved outside the inner layer 1001, the outer layer 1003 covers the reinforcing layer 1002, the inner layer 1001 defines the inner cavity 1004 of the catheter 100, and the inner layer 1001 and the outer layer 1003 are polymer layers.
  • the catheter 100 includes only the outer layer 1003 and the inner layer 1001, and does not include the reinforcement layer 1002; alternatively, the catheter 100 includes only one polymer layer; or, the catheter 100 includes only one polymer layer and the reinforcement layer 1002 .
  • the outer layer 1003 is a polymer layer.
  • the material of the outer layer 1003 is selected from at least one of polyamide, polyolefin, polyether block polyamide, and polyurethane; in this embodiment, The material of the outer layer 1003 includes polyamide, polyether block polyamide, polyurethane, and polyolefin, and the outer layer 1003 is formed by splicing the above materials.
  • the reinforcing layer 1002 is composed of a metal material or a polymer material, and its function is to improve the strength, support performance, anti-collapse level of the lumen, force transmission and torsion control transmission of the catheter 100; in this In the embodiment, the reinforcing layer 1002 is composed of a metal material; the inner layer 1001 is a polymer layer.
  • the material of the inner layer 1001 includes polytetrafluoroethylene, polyolefin, polyurethane, polyether block polyamide At least one of; in this embodiment, the material of the inner layer 1001 includes polytetrafluoroethylene and polyolefin, and the material splicing position in the inner layer 1001 includes any one of the transitions described in Embodiment 1 to Embodiment 3 Structure 200.
  • the catheter 100 includes at least one polymer layer, and at least one polymer layer includes any one of the transition structures 200 described in Embodiments 1 to 3.
  • the catheter 100 includes only one polymer layer, and the polymer layer includes any one of the transition structures 200 described in Embodiments 1 to 3; or, the catheter 100 includes two polymer layers: the inner The layer 1001 and the outer layer 1003, the inner layer 1001 and/or the outer layer 1003 include any one of the transition structures 200 described in Embodiments 1 to 3; or, the conduit 100 includes two or more polymer layers, at least one high The molecular layer includes any one of the transition structures 200 described in Embodiments 1 to 3.
  • the inner layer 1001 is divided into a first inner layer segment located at the proximal end and a second inner layer segment located at the distal end, the material of the first inner layer segment is a first polymer material, and the second inner layer segment The material is a second polymer material, and the hardness of the first polymer material is greater than that of the second polymer material.
  • the hardness of the first polymer material is 40D-70D, and its material can be but not limited to polytetrafluoroethylene; in this embodiment, the hardness of the first polymer material is 60D, and its material In other embodiments, the hardness of the first polymer material may be 40D, 45D, 50D, 54D, 62D, 65D, 66D, 68D, and 70D.
  • the hardness of the second polymer material is 30A-55D, and its material can be, but not limited to, any one of polyolefin, polyether block polyamide, and polyurethane or a mixture thereof; in this embodiment, the second polymer material is a polyolefin with a hardness of 35D; in some other embodiments, the second polymer material is a linear low density polyethylene or polyolefin elastomer, a lubricant-added polyether block polyamide, or a lubricant-added polyurethane In some other embodiments, the hardness of the second polymer material may be 30A, 40A, 45A, 60A, 70A, 80A, 90A, 30D, 35D, 38D, 40D, 50D, 55D.
  • the length of the first inner layer section is 1000-1550mm, and the length of the second inner layer section is 50-600mm; in this embodiment, the length of the first inner layer section is 1100mm, the second The length of the inner layer section is 350mm.
  • the constituent material of the first inner layer segment and/or the second inner layer segment may also be a blended material of several polymer materials, or a polymer mixed with inorganic substances such as developing metal powder; in other
  • the material of the first inner layer segment and/or the second inner layer segment is a blended material of polyolefin and polyether block polyamide, and the material ratio is 1:1; in other embodiments, The material of the first inner layer section and/or the second inner layer section is a blended material of polyolefin and polyurethane, and the material ratio thereof is 2:1; in some other embodiments, the first inner layer section and/or the second inner layer section is The material of the inner layer segment is a blended material of polyether block polyamide and polyurethane, and the ratio of the materials is 1:2; in some other embodiments, the material of the first inner layer segment and/or the second inner layer segment is It is a blended material of polyolefin, polyether block polyamide, and polyurethane, and the material ratio is 1:1:1
  • the material of the first inner layer segment and/or the second inner layer segment is a polyether block polyamide with added lubricant; in some other embodiments, the material of the first inner layer segment and/or The material of the second inner layer segment is a lubricant added polyurethane; in some other embodiments, the material of the first inner layer segment and/or the second inner layer segment is a lubricant added polyether block polyamide and polyurethane A mixture of materials in a ratio of 1:1.
  • the length of the first inner layer section is 1000mm, and the length of the second inner layer section is 170mm; in other embodiments, the length of the first inner layer section is 1550mm, and the length of the second inner layer section is 1550mm. in other embodiments, the length of the first inner layer section is 1150 mm, and the length of the second inner layer section is 600 mm; in other embodiments, the length of the first inner layer section is 200 mm, and the second inner layer section is 200 mm in length.
  • the length of the layers is 1200mm.
  • Embodiment 5 provides the preparation method of the transition structure 200 in any one of the conduits 100 described in Embodiment 1 to Embodiment 4.
  • the preparation method provided in Embodiment 5 is as follows: The head end is cut so that the circumferential extension of the head end of the first polymer pipe material and/or the second polymer pipe material is less than one circumferential direction, the first polymer pipe material is composed of the first polymer material, and the second high polymer pipe material is composed of the first polymer material.
  • the molecular tube is composed of a second polymer material, the hardness of the first polymer material is greater than that of the second polymer material, and the head end of the first polymer tube and the head end of the second polymer tube are at least partially overlapped and spliced, and then heated.
  • the transition structure 200 is obtained by shrinking.
  • the preparation method provided in Example 5 is the preparation method of the transition structure 200, in fact, the transition structure 200 is produced during the preparation of the conduit 100 (or the polymer layer of the conduit 100), and is not used for the conduit 100 after being prepared separately.
  • the first polymer tube is actually the proximal tube (raw material) of the catheter inner layer 1001
  • the second polymer tube is actually the distal tube (raw material) of the catheter inner layer 1001.
  • the inner layer 1001 of the catheter 100 is actually obtained, and the transition structure 200 exists at the material transition position of the inner layer 1001;
  • the head end of the polymer pipe with a polymer layer is cut, it is assembled and heat-shrinked as a whole. After heat-shrinking, the overall structure of the catheter 100 is actually obtained, and the transition structure 200 exists in the catheter 100.
  • the polymer layer material transition position is actually the proximal tube (raw material) of the catheter inner layer 1001
  • the second polymer tube is actually the distal tube (raw material) of the catheter inner layer 1001.
  • the heat shrinking temperature is between the melting point of the first polymer material and the melting point of the second polymer material.
  • the mixed material region 2 in the transition structure 200 is made of the first polymer material.
  • the material and the second polymer material are overlapped and spliced, and the material of the mixed material zone 2 is a composite material; in other embodiments, the heat shrinkage temperature is higher than the melting point of the first polymer material and the second polymer material, and the heat shrinkage Afterwards, the mixed material area 2 is formed by blending and fusing the first polymer material and the second polymer material, and the material of the mixed material area 2 is a blended material.
  • the head end of the first polymer material and/or the second polymer pipe material can be stretched first, so that the first polymer pipe material and/or the second polymer pipe material are The thickness of the head end is less than the thickness of the pipe body.
  • the thickness of the stretched head end is smaller than the thickness of the pipe body, so that after the head ends of the pipes are spliced, the thickness of the splicing position is smaller, and controlling the thickness of the splicing position can make the overall size of the catheter 100 more uniform, and there will be no more abrupt outer diameter.
  • the position of the duct 100 is set in this way, which can further smooth the transition of the overall mechanical properties of the catheter 100 , which is beneficial to improve the pushing performance of the catheter 100 .
  • stretching the material within a certain range can improve the strength of the material, and splicing after stretching is conducive to the strength of the transition position of the material, so that the transition position of the material is not easily broken.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

一种导管(100)和一种导管过渡结构(200)的制备方法，导管(100)至少包含一个高分子层，高分子层至少包含一个过渡结构(200)，过渡结构(200)为管状结构，过渡结构(200)包括单材料区(1)和混合材料区(2)，单材料区(1)中的任意一个连续闭合区域称为第一子区域(1011)，混合材料区(2)中的任意一个连续闭合区域称为第二子区域(2001)，过渡结构(200)在轴向上任意一段都包含至少一个第二子区域(2001)，过渡结构(200)的起始段和/或结束段包含至少一个第一子区域(1011)和至少一个第二子区域(2001)。可以使导管的软硬和力学性能过渡平滑，有利于提高导管的推送性能。

Description

一种导管和导管过渡结构的制备方法 技术领域
本发明涉及医疗器械技术领域，具体涉及用于颅内血管介入治疗的导管。
背景技术
微创伤介入手术是在影像系统的支持下，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，以对其进行机械或化学治疗的手术方法。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伤介入治疗手术中。
目前此类介入手术通常由小血管(如股动脉、桡动脉)处穿刺作为入口，导管通过入口沿着血管，在鞘管、导丝的辅助下输送至目标病变位置。临床手术时，由于血管迂曲，通路系统的建立需要术者耗费一定的时间。对于特别迂曲的血管位置，如主动脉弓的III型弓、颅内动脉血管眼动脉处，若导管在此处仍能顺利输送到位，可大大节约术中时间。
通常情况下，导管由内层、加强层、外层组成三层结构，导管的内层和外层通常采用高分子管材制成，而加强层通常为金属丝或高分子丝制成的加强结构，加强层嵌入内层与外层之间。从结构上看，影响导管柔软度的因素有三个：内层硬度、加强层丝材强度及覆盖密度、外层硬度。导管具有不同硬度的节段，近端较硬，远端较柔软，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，这样的设计结构能够满足临床使用时导管能够输送至病变位置。软硬过渡通常通过调节拼接段的高分子材料种类与硬度、加强层的金属丝强度或节距进行调整。导管主体常用的高分子原材料有聚四氟乙烯、聚氨酯、聚酰胺、聚烯烃等，远端使用较软的高分子材料(如pebax25D)，近端使用较硬的高分子材料(如Pebax 72D、Nylon)。从结构上看，当相邻两段的节段硬度相差过大时，导管的柔顺性会受到影响，此类设计不利于导管在迂曲的血管中推送，且一定程度上存在损伤血管的风险。
为了满足导管的输送性能，需要通过拼接不同硬度的高分子使导管满足 不同血管位置的力学性能要求，现有技术中导管的拼接方法使导管的力学性能过渡不够平滑，从而影响了导管的输送性能和安全性能。
发明内容
本发明的目的在于提供一种导管和导管过渡结构的制备方法，以解决现有导管中，拼接方法使导管的力学性能过渡不够平滑，从而影响了导管的输送性能和安全性能的技术问题。
为解决上述技术问题，本发明提供了一种导管，其包括：
至少一个高分子层，高分子层至少包含一个过渡结构，过渡结构为管状结构，过渡结构包括单材料区和混合材料区，单材料区中的任意一个连续闭合区域称为第一子区域，混合材料区中的任意一个连续闭合区域称为第二子区域，过渡结构在轴向上任意一段都包含至少一个第二子区域，过渡结构的起始段和/或结束段包含至少一个第一子区域和至少一个第二子区域。
可选地，过渡结构在轴向上的任意一段都包含至少一个第一子区域和至少一个第二子区域。
可选地，从过渡结构的起始位置和/或结束位置在轴向上从端部至过渡结构的中间区域，单材料区与混合材料区的外表面积比逐渐减小。
可选地，过渡结构从一端至另一端，单材料区与混合材料区的外表面积比逐渐减小至最小值后逐渐增大。
可选地，混合材料区的至少一端的边缘为一个与导管轴向有倾角的斜面。
可选地，斜面与导管轴向的倾角为5°-60°。
可选地，混合材料区的至少一端的边缘为波浪形结构。
可选地，混合材料区的轴向长度均匀，混合材料区的轴向长度为1-15mm。
可选地，混合材料区的轴向长度不均匀，混合材料区的轴向长度在最大处为3-20mm，混合材料区的轴向长度在最小处为0.5-15mm。
可选地，单材料区包括第一高分子区和第二高分子区，第一高分子区和第二高分子区分布在混合材料区的两边，第一高分子区由第一高分子材料组成，第二高分子区由第二高分子材料组成，第一高分子材料的硬度大于第二 高分子材料。
可选地，混合材料区的硬度小于第一高分子区的硬度，混合材料区的硬度大于第二高分子材料区的硬度。
可选地，混合材料区的至少一端的边缘为一个与导管轴向有倾角的斜面，第一高分子材料与第二高分子材料之间的硬度差越大，倾角越小。
可选地，混合材料区由第一高分子材料和第二高分子材料共混融合而成。
可选地，混合材料区由第一高分子材料和第二高分子材料重叠拼接而成。
可选地，第一高分子材料为聚四氟乙烯、聚烯烃、聚氨酯、聚醚嵌段聚酰胺、聚酰胺中的任意一种，第二高分子材料为聚四氟乙烯、聚烯烃、聚氨酯、聚醚嵌段聚酰胺、聚酰胺中的任意一种。
可选地，导管还包含加强层。
可选地，导管为三层结构，从内至外为内层、加强层、外层，内层和外层为高分子层，内层和/或外层包含至少一个过渡结构。
可选地，内层包含至少一个过渡结构。
可选地，内层的远端包含至少一个过渡结构。
可选地，外层包含至少一个过渡结构。
此外，本发明还提供一种导管过渡结构的制备方法，该制备方法包括：对第一高分子管材和第二高分子管材的头端进行切割，使第一高分子管材和/或第二高分子管材的头端端部的周向延伸范围小于一个周向，第一高分子管材由第一高分子材料组成，第二高分子管材由第二高分子材料组成，第一高分子材料的硬度大于第二高分子材料的硬度，第一高分子管材的头端和第二高分子管材的头端至少部分重叠拼接后进行热缩。
可选地，热缩的温度高于第一高分子材料和第二高分子材料的熔点。
可选地，热缩的温度处于第一高分子材料的熔点和第二高分子材料的熔点之间。
可选地，在重叠拼接之前，还对第一高分子管材和/或第二高分子管材的头端进行拉伸，使第一高分子管材和/或第二高分子管材的头端厚度小于管体厚度。
综上，本发明提供的导管，包括至少一个高分子层，高分子层至少包含一个过渡结构，过渡结构为管状结构，过渡结构包括单材料区和混合材料区，单材料区中的任意一个连续闭合区域称为第一子区域，混合材料区中的任意一个连续闭合区域称为第二子区域，过渡结构在轴向上任意一段都包含至少一个第二子区域，过渡结构的起始段和/或结束段包含至少一个第一子区域和至少一个第二子区域。此外，本发明还提供过渡结构的制备方法。本发明提供的导管、过渡结构的制备方法至少具有以下优点：
1、导管中高分子材料过渡的位置软硬和力学性能的过渡平滑，使得导管整体的力学性能较好，提高了导管的输送性能和安全性能。
2、满足导管在不同血管位置的力学性能需求，力学性能变化的位置不容易发生弯折。
3、使硬度差较大的两种材料在拼接后也不容易产生应力集中点，并可以减少导管中高分子材料的数量以及拼接的段数。
4、对高分子管材的头端进行拉伸，使拼接头端的厚度小于管体厚度，可以控制拼接位置的厚度，从而使导管的外径不会过大。
5、混合材料区的存在有利于提高拼接位置的拼接强度，提高导管的安全性能。
附图说明
图1是本发明一优选实施例提供的导管的示意图；
图2是本发明一优选实施例提供的导管中过渡结构的轴向投影图；
图3是本发明一优选实施例提供的导管中一段的截面图；
图4是本发明一优选实施例提供的导管中过渡结构的展开图；
图5是本发明一优选实施例提供的导管中过渡结构的展开图；
图6是本发明一优选实施例提供的导管中过渡结构的展开图；
图7是本发明一优选实施例提供的导管中过渡结构的轴向投影图；
图8是本发明一优选实施例提供的导管中过渡结构的展开图；
图9是本发明一优选实施例提供的导管的截面图。
图中：
100-导管；200-过渡结构；201-起始位置；202-结束位置；210-起始段；220-结束段；1-单材料区；2-混合材料区；101-第一高分子区；102-第二高分子区；1011、1021-第一子区域；2001-第二子区域；3-近端管；4-远端管；1001-内层；1002-加强层；1003-外层；1004-内腔。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
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，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，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；以及术语“近端”通常是靠近操作者的一端，术语“远端”通常是靠近患者靠近病灶的一端，除非内容另外明确指出外。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
实施例一
实施例一提供一种导管100，导管100至少包含一个高分子层，该高分子层至少包括一个过渡结构200。图1为实施例一提供的导管100的示意图，如图1所示，过渡结构200为从起始位置201至结束位置202之间的管状结构，在过渡结构200中，起始位置201和结束位置202之间的区域为中间区域，过渡结构200包括单材料区1和混合材料区2。
图2是导管100中的过渡结构200的一个特定面的轴向投影图，在图2所示的投影视角上，过渡结构200是前后对称的。在其他实施例中，过渡结构200也可以是不存在前后对称的投影视角的。如图2所示，单材料区1还进一步包括第一高分子区101和第二高分子区102，所述第一高分子区101由第一高分子材料组成，所述第二高分子区102由第二高分子材料组成，第一 高分子材料的硬度大于所述第二高分子材料的硬度。在其他一些实施例中，第一高分子材料的硬度也可以小于第二高分子材料的硬度。
过渡结构200中任意一个连续闭合区域称为子区域，过渡结构200实际上为管状结构，子区域限定为：在管状结构的外表面上选取任意连续闭合形状，该闭合形状垂直于管壁“切割”所得到的连续闭合体为子区域。单材料区1中的任意一个连续闭合区域称为第一子区域1011(或1021)，混合材料区2中的任意一个连续闭合区域称为第二子区域2001。
在图2中，圆形虚线区域为子区域，两条斜线所限定的四边形区域为混合材料区2，两个三角形区域为单材料区1，单材料区1包括第一高分子区101和第二高分子区102，第一高分子区101和第二高分子区102中任意一个连续闭合区分别为第一子区域1011和第一子区域1021，第一子区域1011位于第一高分子区101中，第一子区域1021位于第二高分子区102中，混合材料区2中任意一个连续闭合区为第二子区域2001。从图2中可以看出，在过渡结构200上任选一个任意长度的轴向节段，如图2中虚直线所限定的范围，在选定的节段中，包含至少一个第二子区域2001；同时，从过渡结构200的第一高分子区101所在的轴向端部(位于过渡结构200的起始位置201)开始至第一高分子区101结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，如图2中虚直线所限定的范围，在该节段中，包含至少一个第一子区域1011和至少一个第二子区域2001；类似的，在第二高分子区102所在的轴向端部(位于过渡结构200的结束位置)开始至第二高分子区102结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，该节段内包含至少一个第一子区域1021和至少一个第二子区域2001。在该实施例中，过渡结构200的两个端部都包含了单材料区1，在其他一些实施例中，过渡结构200中可以只有一个端部包含一个第一高分子区101，或者，只有一个端部包含一个第二高分子区102。在该实施例中，第一高分子区101所在的端部为过渡结构200的起始位置201，靠近起始位置201的节段为起始段210，需要说明的是，起始段210为靠近起始位 置201且长度较短的一个节段，起始段210代表从起始位置201至一选择位置的一个节段，该选择位置位于过渡结构200的中间区域但靠近起始位置201。第二高分子区102所在的端部为过渡结构200的结束位置202，靠近结束位置202的节段为结束段220，需要说明的是，结束段220为靠近结束位置202且长度较短的一个节段，结束段220代表从结束位置202至一选择位置的一个节段，该选择位置位于过渡结构200的中间区域但靠近结束位置202。该实施例提供的导管100中的过渡结构200在起始段210和结束段220都包含至少一个第一子区域1011(和/或第一子区域1021)和至少一个第二子区域2001；在其他一些实施例中，过渡结构200的起始段210包含至少一个第一子区域1011(或第一子区域1021)和至少一个第二子区域2001，而结束段220只包含至少一个第二子区域2001；或者，在其他一些实施例中，过渡结构200的结束段220包含至少一个第一子区域1011(或第一子区域1021)和至少一个第二子区域2001，而起始段210只包含至少一个第二子区域2001。
在该实施例中，混合材料区2形成了一段斜向的管结构，即混合材料区2的两端的边缘为与导管轴向有倾角的斜面，混合材料区2的两端的边缘与导管轴向形成的倾角的角度可以相同也可以不相同，所述角度可以为5-60°。在其他一些实施例中，混合材料区2可以只有一端的边缘为与导管轴向有倾角的斜面，而另一端的边缘为与导管轴向垂直的直角面。
混合材料区2的材料可以是第一高分子材料与第二高分子材料共混得到共混材料；如在导管制备工艺中，需要通过热缩得到一体的管材，在热缩时，不同材料相互接触的接触面上，如果热缩温度达到了两种或多种材料的熔点之上，材料与材料之间可以相互熔融渗透得到共混材料。混合材料区2的材料还可以是第一高分子材料与第二高分子材料重叠拼接形成的复合材料；如带有斜角端面的一种高分子材料插入带有斜角端面或不带有斜角端面的另一种高分子材料内，热缩工艺时，控制热缩温度不高于其中高熔点材料的熔点温度，而高于其中低熔点材料的熔点温度，热缩后不会形成共混材料，而是两种材料叠加且粘接的复合材料层。在一些实施例中，混合材料区2可以由 第一高分子材料与第二高分子材料的共混融合而成，而在另一些实施例中，混合材料区2可以是由第一高分子材料与第二高分材料重叠拼接且粘接的复合材料层。
在该实施例中，混合材料区2的硬度介于第一高分子材料的硬度和第二高分子材料的硬度之间；在其他一些实施例中，混合材料区2的硬度略高于第一高分子材料的硬度和第二高分子材料的硬度。混合材料区2的存在有利于提高拼接位置的拼接强度，提高导管的安全性能。
如图2所示，在本实施例中，从过渡结构200的起始位置201和结束位置202至过渡结构200的中间区域，第一高分子区101或第二高分子区102与混合材料区2的外表面积比逐渐减小；而过渡结构200的中间区域中存在一段在轴向上只有混合材料区2的面积。在其他实施例中，从过渡结构200的一端至另一端，第一高分子区101(或第二高分子区102)与混合材料区2的外表面积比逐渐减小；或者，在其他一些实施例中，从过渡结构200的一端至另一端，第一高分子区101(或/和第二高分子区102)与混合材料区2的外表面积比先减小至最小值后逐渐增大。
本实施例提供的导管100的高分子层中存在过渡结构200，可以使导管100的软硬和力学性能的过渡平滑，使得导管100整体的力学性能较好，提高了导管100的输送性能和安全性能。
同时，为了满足不同血管位置的力学性能的需求，导管100在不同位置需要有不同的硬度，因此需要用多种不同硬度和/或不同种类的高分子材料进行拼接，如果拼接的两种高分子硬度差较大，则导管100在拼接位置容易发生弯折，造成管腔的体积变小甚至永久形变，因此导管100的至少一个高分子层中往往需要多种高分子材料进行多次拼接，从而满足不同血管位置的力学性能的需求并且实现力学性能的平滑过渡；而拼接位置采用本实施例所描述的过渡结构200可以使硬度差较大的两种材料在拼接后也不容易产生应力集中点，并可以减少导管中高分子材料的数量以及拼接的段数，同时也能满足力学性能的平滑过渡。
实施例二
一种包含过渡结构200的导管100的部分轴向截面图见图3，图3中，长方形边框所框定的范围为过渡结构200。过渡结构200的近端为近端管3，过渡结构200的远端为远端管4，所述近端管3的材料为第一高分子材料，所述远端管4的材料为第二高分子材料，所述第一高分子材料的硬度大于所述第二高分子材料。第一高分子区101为近端管3向远端延伸的区域，第二高分子区102为远端管4向近端延伸的区域，混合材料区2为近端管3和远端管4接触或混合的区域。为了方便区分，图3以混合材料区2的材料为第一高分子材料和第二高分子材料重叠粘接所得的复合材料层为例，在其他实施例中，混合材料区2的材料可以是第一高分子材料和第二高分子材料共混融合所得的共混材料。过渡结构200中，混合材料区2与单材料区1的边缘为一个与导管轴向有倾角的斜面，混合材料区2与第一高分子区101的边缘与导管轴向之间的斜面的倾角为β，混合材料区2与第二高分子区102的边缘与导管轴向之间的斜面的倾角为α；混合材料区2轴向长度最小值为L1，混合材料区2轴向长度最大值为L2；β与α的大小可以相同也可以不相同，L1与L2的大小可以相同也可以不同，当β与α相同时，L1与L2相同。当导管100的内径为0.013”～0.029”时，L1与L2优选为1mm～3mm，α与β优选为45°～60°；当导管100的内径为0.055”～0.090”时，L1与L2优选为6mm～15mm，α与β优选为5°～60°。在其他一些实施例中，L1与L2可以为0.5-20mm。在一些实施例中，混合材料区的轴向长度均匀，即L1与L2相同，L1与L2的值为1-15mm，例如1mm、3mm、5mm、7.5mm、10mm、12mm、15mm等；在一些实施例中，混合材料区的轴向长度不均匀，即L1与L2不相同，L1的值为0.5-15mm，例如0.5mm、2mm、5mm、6mm、8mm、11mm、12.5mm、15mm等，L2的值为3-20mm，例如3mm、5mm、7mm、10mm、12mm、15mm、17.5mm、20mm等。
图3中的过渡结构200沿轴向剖开后的展开图见图4，图4更加直观地显 示了L1、L2、α、β所在的位置和之间关系，图4中，沿轴向的剖开位置为混合材料区2的轴向长度最小的位置。在该实施例中，过渡结构200为对称结构，从图4中可以看出，沿轴向剖开后，过渡结构200的展开图上下对称；如图5所示，在其他一些实施例中，过渡结构200可以不是对称结构，如第一高分子区101的结束位置(图5中左边三角形的右顶点)与第二高分子区102的端部位置(图5中最右边的交点)的连线与导管轴向不平行。从图4中也可以看出，在过渡结构200中选取一段任意长度的轴向节段，在选定的节段中，必然包含一个第二子区域2001；从过渡结构200的第一高分子区101所在的轴向端部(位于过渡结构200的起始位置201)开始至第一高分子区101结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，在该节段中，包含至少一个第一子区域1011和至少一个第二子区域2001；在第二高分子区102所在的轴向端部(位于过渡结构200的结束位置202)开始至第二高分子区102结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，该节段内包含至少一个第一子区域1021和至少一个第二子区域2001。在该实施例中，α与β的角度不同，但都不是90°。在其他实施例中，α与β的角度可以相同，但都不是90°。在其它实施例中，β不是90°时，α可以为90°，此时，过渡结构200中只有第一高分子区101和混合材料区2，在第一高分子区101所在的轴向端部(位于过渡结构200的起始位置201)开始至第一高分子区101结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，该节段内包含至少一个第一子区域1011和至少一个第二子区域2001。同理，α不是90°时，β可以为90°，此时，过渡结构200中只有第二高分子区102和混合材料区2，从过渡结构200的第二高分子区102所在的轴向端部(位于过渡结构200的结束位置202)开始至第二高分子区102结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，在该节段中，包含至少一个第一子区域1021和至少一个第二子区域2001。在该实施例中，α与β的朝向相同；在其他一些实施例中，α与β的朝向可以 不同，例如α朝向过渡结构200的结束位置202，β朝向过渡结构200的起始位置201，或者相反。需要说明的是，在该实施例中，α与β指的混合材料区2的端部边缘与导管轴向之间的斜面的倾角，该倾角为锐角，α与β不指代与该倾角互补的钝角。
在相同的导管内径的情况下，α和β的角度差值越大，L1和L2之间的差值越大。为了使导管100的软硬过渡平滑，放置导管100在过渡位置发生弯折，在本发明的优选实施例中，当第一高分子材料与第二高分子材料之间的硬度差越大时，控制倾角α和/或β越小。控制倾角α和/或β越小时，可以使导管100的过渡位置材料的变化越平缓，导管100的力学性能的变化趋势越平滑，有利于导管100在迂曲血管中的推送性能和安全性。
在该实施例中，过渡结构200在轴向上存在一个节段，在该节段中，只有第二子区域2001，而没有第一子区域1011(或1021)。如图6所示，在其他一些实施例中，在过渡结构200中的任意轴向节段都包含至少一个第一子区域1011(和/或第一子区域1021)和至少一个第二子区域2001。
实施例三
实施例三提供的导管100包括至少一个过渡结构200，过渡结构200的示意图见图7，实施例三提供的过渡结构200包括单材料区1和混合材料区2，所述单材料区1还进一步包括第一高分子区101和第二高分子区102，所述第一高分子区101由第一高分子材料组成，所述第二高分子区102由第二高分子材料组成，所述第一高分子材料的硬度高于所述第二高分子材料的硬度，所述第一高分子区101和第二高分子区102位于混合材料区2的两边。
过渡结构200中的混合材料区2的边缘在一个特定面的轴向投影方向上呈现阶梯状结构(或称为矩形波浪状结构)。在该实施例中，混合材料区2在轴向上的两端的边缘都包含了阶梯状结构，在其他实施例中，过渡结构200的混合材料区2可以只在一端的边缘包含一个阶梯状结构。
在实施例三提供的导管100中的过渡结构200中任意选取一个轴向节段， 如图7中虚直线所限定的范围，在选定的节段中，包含至少一个第二子区域2001；同时，从过渡结构200的第一高分子区101所在的轴向端部(位于过渡结构200的起始位置201)开始至第一高分子区101结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，如图中虚直线所限定的范围，在该节段中，包含至少一个第一子区域1011和至少一个第二子区域2001；类似的，在第二高分子区102所在的轴向端部(位于过渡结构200的结束位置202)开始至第二高分子区102结束位置(位于过渡结构200的中间区域)的轴向区域内，任选一个任意长度的轴向节段，该节段内包含至少一个第一子区域1021和至少一个第二子区域2001。
图7中的过渡结构200沿轴向剖开后的展开图见图8，从图8中可以看出，图7中的过渡结构200为前后对称的管结构。在其他一些实施例中，过渡结构200为前后不对称的管结构。
在其他一些实施例中，混合材料区2的任意一端的边缘或两端的边缘可以为波浪形结构，波浪形结构可以但不限于三角形波浪结构、矩形波浪结构、正方形波浪结构、正弦波浪结构、不规则波浪结构等结构。
其他结构与实施例一相似，在此不再赘述。
实施例四
实施例四提供的导管100的轴向截面图和径向截面图见图9，如图9所示，沿导管100的径向自内向外依次设置有内层1001、加强层1002、外层1003，加强层1002套设于内层1001外部，外层1003覆盖加强层1002，内层1001限定导管100的内腔1004，内层1001与外层1003为高分子层。在其他一些实施例中，导管100只包括外层1003和内层1001，不包括加强层1002；或者，导管100只包括一个高分子层；或者，导管100只包括一个高分子层和加强层1002。
外层1003为高分子层，在本发明的实施例中，外层1003的材料选自聚酰胺、聚烯烃类、聚醚嵌段聚酰胺、聚氨酯中的至少一种；在该实施例中， 外层1003的材料包括聚酰胺、聚醚嵌段聚酰胺、聚氨酯、聚烯烃，外层1003由上述材料拼接而成。在本发明的实施例中，加强层1002由金属材料或高分子材料组成，其作用为提高导管100的强度、支撑性能、管腔抗塌陷水平、力的传递性和扭控传递性；在该实施例中，加强层1002由金属材料组成；内层1001为高分子层，在本发明的实施例中，内层1001的材料包括聚四氟乙烯、聚烯烃、聚氨酯、聚醚嵌段聚酰胺中的至少一种；在该实施例中，内层1001的材料包括聚四氟乙烯和聚烯烃，且内层1001中的材料拼接位置包含实施例一至实施例三中所述的任意一种过渡结构200。在本发明的实施例中，导管100至少包含一个高分子层，至少一个高分子层中包含实施例一至实施例三中所述的任意一种过渡结构200。在其他一些实施例中，导管100只包含一个高分子层，该高分子层包含实施例一至实施例三中所述的任意一种过渡结构200；或者，导管100包含两个高分子层：内层1001和外层1003，内层1001和/或外层1003包含实施例一至实施例三中所述的任意一种过渡结构200；或者，导管100包含两个以上的高分子层，至少一个高分子层中包含实施例一至实施例三中所述的任意一种过渡结构200。
在该实施例中，内层1001分为位于近端的第一内层段和位于远端的第二内层段，第一内层段的材料为第一高分子材料，第二内层段的材料为第二高分子材料，第一高分子材料的硬度大于第二高分子材料的硬度。在本发明的实施例中，第一高分子材料的硬度为40D-70D，其材料可为但不限于聚四氟乙烯；在该实施例中，第一高分子材料的硬度为60D，其材料为聚四氟乙烯；在其他一些实施例中，第一高分子材料的硬度可以为40D、45D、50D、54D、62D、65D、66D、68D、70D。第二高分子材料的硬度为30A-55D，其材料可为但不限于聚烯烃、聚醚嵌段聚酰胺、聚氨酯中的任意一种或其混合物；在该实施例中，第二高分子材料为聚烯烃，其硬度为35D；在其他一些实施例中，第二高分子材料为线性低密度聚乙烯或聚烯烃弹性体、添加了润滑剂的聚醚嵌段聚酰胺或添加了润滑剂聚氨酯；在其他一些实施例中，第二高分子材料的硬度可以为30A、40A、45A、60A、70A、80A、90A、30D、35D、38D、 40D、50D、55D。在本发明的实施例中，第一内层段的长度为1000-1550mm，第二内层段的长度为50-600mm；在该实施例中，第一内层段的长度为1100mm，第二内层段的长度为350mm。
在其他实施例中，第一内层段和/或第二内层段的组成材料也可为几种高分子材料的共混材料，或者是混入无机物如显影金属粉末的高分子；在其他一些实施例中，第一内层段和/或第二内层段的材料为聚烯烃和聚醚嵌段聚酰胺的共混材料，其材料比例为1:1；在其他一些实施例中，第一内层段和/或第二内层段的材料为聚烯烃和聚氨酯的共混材料，其材料比例为2:1；在其他一些实施例中，第一内层段和/或第二内层段的材料为聚醚嵌段聚酰胺和聚氨酯的共混材料，其材料的比例为1:2；在其他一些实施例中，第一内层段和/或第二内层段的材料为聚烯烃、聚醚嵌段聚酰胺、聚氨酯的共混材料，其材料的比例为1:1:1；在其他一些实施例中，第一内层段和/或第二内层段的材料为线性低密度聚乙烯和聚烯烃弹性体的共混材料，其材料的比例为1:1；在其他一些实施例中，第一内层段和/或第二内层段的材料为混合了钨粉的线性低密度聚乙烯，混合钨粉的高分子可以提供导管100主体的显影性能。在其他一些实施例中，第一内层段和/或第二内层段的材料为添加了润滑剂的聚醚嵌段聚酰胺；在其他一些实施例中，第一内层段和/或第二内层段的材料为添加了润滑剂聚氨酯；在其他一些实施例中，第一内层段和/或第二内层段的材料为添加了润滑剂的聚醚嵌段聚酰胺和聚氨酯中的混合物，其材料的比例为1:1。
在一个实施例中，第一内层段的长度为1000mm，第二内层段的长度为170mm；在其他一些实施例中，第一内层段的长度为1550mm，第二内层段的长度为50mm；在其他一些实施例中，第一内层段的长度为1150mm，第二内层段的长度为600mm；在其他一些实施例中，第一内层段的长度为200mm，第二内层段的长度为1200mm。
实施例五
实施例五提供实施例一至实施例四中所述的任意一种导管100中的过渡 结构200的制备方法，实施例五提供的制备方法如下：对第一高分子管材和第二高分子管材的头端进行切割，使第一高分子管材和/或第二高分子管材的头端端部的周向延伸范围小于一个周向，第一高分子管材由第一高分子材料组成，第二高分子管材由第二高分子材料组成，第一高分子材料的硬度大于第二高分子材料的硬度，第一高分子管材的头端和第二高分子管材的头端至少部分重叠拼接后进行热缩得到过渡结构200。
实施例五提供的制备方法虽然是过渡结构200的制备方法，实际上，过渡结构200是在导管100(或导管100的高分子层)的制备中产生的，并非单独制备后用于导管100。如：第一高分子管材实际上是导管内层1001的近端管材(原材料)，第二高分子管材实际上是导管内层1001的远端管材(原材料)，对第一高分子管材和第二高分子管材进行上述的制备方法处理后，实际上得到了导管100的内层1001，而过渡结构200存在于内层1001的材料过渡位置上；或者，对于多层导管结构，可以对其中任意一个高分子层的高分子管材的头端进行切割处理后，进行整体组装并热缩，热缩后，实际上得到了导管100的整体结构，而过渡结构200存在于导管100中该高分子层的材料过渡位置上。
在该实施例中，热缩温度处于所述第一高分子材料的熔点和所述第二高分子材料的熔点之间，热缩后，过渡结构200中的混合材料区2由第一高分子材料和第二高分子材料重叠拼接而成，混合材料区2的材料为复合材料；在其他一些实施例中，热缩温度高于第一高分子材料和第二高分子材料的熔点，热缩后，混合材料区2由第一高分子材料和第二高分子材料共混融合而成，混合材料区2的材料为共混材料。
在其他一些实施中，在对第一高分子管材和第二高分子管材的头端进行切割之前，或者，在对第一高分子管材和第二高分子管材的头端进行切割之后、第一高分子管材和第二高分子管材重叠之前，可以先对第一高分子材和/或第二高分子管材的头端进行拉伸，使第一高分子管材和/或第二高分子管材的头端厚度小于管体厚度。拉伸后的头端厚度小于管体厚度，可以使管材的 头端拼接后，拼接位置的厚度较小，控制拼接位置的厚度可以使导管100的整体尺寸较均匀，不会有外径较突兀的位置，如此设置，可以进一步使导管100的整体力学性能的过渡平缓，有利于提高导管100的推送性能。此外，对于一些特定材料，对材料进行一定范围内的拉伸可以提高材料的强度，拉伸后拼接有利于材料过渡位置的强度，使材料过渡位置不容易被拉断。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (24)

  1. 一种导管，其特征在于：至少包含一个高分子层，所述高分子层至少包含一个过渡结构，所述过渡结构为管状结构，所述过渡结构包括单材料区和混合材料区，所述单材料区中的任意一个连续闭合区域称为第一子区域，所述混合材料区中的任意一个连续闭合区域称为第二子区域，所述过渡结构在轴向上任意一段都包含至少一个所述第二子区域，所述过渡结构的起始段和/或结束段包含至少一个所述第一子区域和至少一个所述第二子区域。
  2. 如权利要求1所述的导管，其特征在于，所述过渡结构在轴向上的任意一段都包含至少一个所述第一子区域和至少一个所述第二子区域。
  3. 如权利要求1所述的导管，其特征在于，从所述过渡结构的起始位置和/或结束位置在轴向上从端部至过渡结构的中间区域，所述单材料区与所述混合材料区的外表面积比逐渐减小。
  4. 如权利要求2所述的导管，其特征在于，所述过渡结构从一端至另一端，所述单材料区与所述混合材料区的外表面积比逐渐减小至最小值后逐渐增大。
  5. 如权利要求1所述的导管，其特征在于，所述混合材料区的至少一端的边缘为一个与导管轴向有倾角的斜面。
  6. 如权利要求5所述的导管，其特征在于，所述斜面与导管轴向的倾角为5°-60°。
  7. 如权利要求1所述的导管，其特征在于，所述混合材料区的至少一端的边缘为波浪形结构。
  8. 如权利要求1所述的导管，其特征在于，所述混合材料区的轴向长度均匀，所述混合材料区的轴向长度为1-15mm。
  9. 如权利要求1所述的导管，其特征在于，所述混合材料区的轴向长度不均匀，所述混合材料区的轴向长度在最大处为3-20mm，所述混合材料区的轴向长度在最小处为0.5-15mm。
  10. 如权利要求1-9中任意一项所述的导管，其特征在于，所述单材料区包括第一高分子区和第二高分子区，所述第一高分子区和所述第二高分子区 分布在所述混合材料区的两边，所述第一高分子区由第一高分子材料组成，所述第二高分子区由第二高分子材料组成，所述第一高分子材料的硬度大于所述第二高分子材料。
  11. 如权利要求10所述的导管，其特征在于，所述混合材料区的硬度小于所述第一高分子区的硬度，所述混合材料区的硬度大于所述第二高分子材料区的硬度。
  12. 如权利要求10所述的导管，其特征在于，所述混合材料区的至少一端的边缘为一个与导管轴向有倾角的斜面，所述第一高分子材料与所述第二高分子材料之间的硬度差越大，所述倾角越小。
  13. 如权利要求10所述的导管，其特征在于，所述混合材料区由所述第一高分子材料和所述第二高分子材料共混融合而成。
  14. 如权利要求10所述的导管，其特征在于，所述混合材料区由所述第一高分子材料和所述第二高分子材料重叠拼接而成。
  15. 如权利要求10所述的导管，其特征在于，所述第一高分子材料为聚四氟乙烯、聚烯烃、聚氨酯、聚醚嵌段聚酰胺、聚酰胺中的任意一种，所述第二高分子材料为聚四氟乙烯、聚烯烃、聚氨酯、聚醚嵌段聚酰胺、聚酰胺中的任意一种。
  16. 如权利要求1所述的导管，其特征在于，所述导管还包含加强层。
  17. 如权利要求1所述的导管，其特征在于，所述导管为三层结构，从内至外为内层、加强层、外层，所述内层和所述外层为高分子层，所述内层和/或所述外层包含至少一个所述过渡结构。
  18. 如权利要求17所述的导管，其特征在于，所述内层包含至少一个所述过渡结构。
  19. 如权利要求18所述的导管，其特征在于，所述内层的远端包含至少一个所述过渡结构。
  20. 如权利要求17所述的导管，其特征在于，所述外层包含至少一个所述过渡结构。
  21. 一种导管过渡结构的制备方法，其特征在于，对第一高分子管材和第 二高分子管材的头端进行切割，使所述第一高分子管材和/或所述第二高分子管材的头端端部的周向延伸范围小于一个周向，所述第一高分子管材由第一高分子材料组成，所述第二高分子管材由第二高分子材料组成，所述第一高分子材料的硬度大于所述第二高分子材料的硬度，所述第一高分子管材的头端和所述第二高分子管材的头端至少部分重叠拼接后进行热缩。
  22. 如权利要求21所述的导管过渡结构的制备方法，其特征在于，所述热缩的温度高于所述第一高分子材料和所述第二高分子材料的熔点。
  23. 如权利要求21所述的导管过渡结构的制备方法，其特征在于，所述热缩的温度处于所述第一高分子材料的熔点和所述第二高分子材料的熔点之间。
  24. 根据权利要求21所述的导管过渡结构的制备方法，其特征在于，在所述重叠拼接之前，还对所述第一高分子管材和/或所述第二高分子管材的头端进行拉伸，使所述第一高分子管材和/或所述第二高分子管材的头端厚度小于管体厚度。
PCT/CN2021/132608 2020-12-31 2021-11-24 一种导管和导管过渡结构的制备方法 Ceased WO2022142877A1 (zh)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP21913619.9A EP4252814A4 (en) 2020-12-31 2021-11-24 CATHETER AND METHOD FOR PRODUCING A CATHETER TRANSITION STRUCTURE
AU2021411539A AU2021411539A1 (en) 2020-12-31 2021-11-24 Catheter and method for preparing catheter transition structure
KR1020237023184A KR20230118914A (ko) 2020-12-31 2021-11-24 카테터 및 카테터 전이 구조를 준비하기 위한 방법
JP2023539968A JP2024502031A (ja) 2020-12-31 2021-11-24 カテーテルおよびカテーテル遷移構造体を準備する方法
US18/270,576 US20240293641A1 (en) 2020-12-31 2021-11-24 Catheter and method for preparing catheter transition structure

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202011619560.7A CN114681753B (zh) 2020-12-31 2020-12-31 一种导管和导管过渡结构的制备方法
CN202011619560.7 2020-12-31

Publications (1)

Publication Number Publication Date
WO2022142877A1 true WO2022142877A1 (zh) 2022-07-07

Family

ID=82135304

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/132608 Ceased WO2022142877A1 (zh) 2020-12-31 2021-11-24 一种导管和导管过渡结构的制备方法

Country Status (7)

Country Link
US (1) US20240293641A1 (zh)
EP (1) EP4252814A4 (zh)
JP (1) JP2024502031A (zh)
KR (1) KR20230118914A (zh)
CN (2) CN121775290A (zh)
AU (1) AU2021411539A1 (zh)
WO (1) WO2022142877A1 (zh)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20250036990A (ko) 2023-09-07 2025-03-17 주식회사 엘지에너지솔루션 발열 기능이 구비된 전지 모듈

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4636272A (en) * 1985-02-19 1987-01-13 Cordis Corporation Process for thermally bonding plastic tubes
JPH05329214A (ja) * 1992-06-03 1993-12-14 Hitachi Cable Ltd カテーテルの製造方法
CN201246551Y (zh) * 2008-08-29 2009-05-27 镇江飞达医疗器材有限公司 医用高分子管材
US20170215918A1 (en) * 2016-01-29 2017-08-03 Abiomed, Inc. Thermoform cannula with variable cannula body stiffness
CN210078572U (zh) * 2019-05-09 2020-02-18 东莞市迪凯医疗科技有限公司 一种中心静脉导管
CN215083900U (zh) * 2020-12-31 2021-12-10 微创神通医疗科技（上海）有限公司 一种导管
CN113855991A (zh) * 2020-06-30 2021-12-31 微创神通医疗科技（上海）有限公司 一种导管

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5509910A (en) * 1994-05-02 1996-04-23 Medtronic, Inc. Method of soft tip attachment for thin walled catheters
US5772641A (en) * 1995-12-12 1998-06-30 Medi-Dyne Inc. Overlapping welds for catheter constructions
US5836926A (en) * 1996-05-13 1998-11-17 Schneider (Usa) Inc Intravascular catheter
US6197015B1 (en) * 1998-12-09 2001-03-06 Medi-Dyne Inc. Angiography catheter with sections having different mechanical properties
US6918882B2 (en) * 2001-10-05 2005-07-19 Scimed Life Systems, Inc. Guidewire with stiffness blending connection
US6652508B2 (en) * 2001-11-09 2003-11-25 Scimed Life Systems, Inc. Intravascular microcatheter having hypotube proximal shaft with transition
US6866642B2 (en) * 2002-11-25 2005-03-15 Advanced Cardiovascular Systems, Inc. Enhanced method for joining two core wires
JP4362536B2 (ja) * 2008-04-11 2009-11-11 日本ライフライン株式会社 カテーテル
JP2010162290A (ja) * 2009-01-19 2010-07-29 Asahi Intecc Co Ltd カテーテル及びその製造方法
JP5497068B2 (ja) * 2009-12-11 2014-05-21 株式会社グツドマン カテーテル
WO2012162651A1 (en) * 2011-05-26 2012-11-29 Abbott Cardiovascular Systems Inc. Catheter with stepped skived hypotube
CA2982823A1 (en) * 2015-04-24 2016-10-27 Shifamed Holdings, Llc Steerable medical devices, systems, and methods of use
CN113350656A (zh) * 2016-02-24 2021-09-07 禾木（中国）生物工程有限公司 柔性增强的神经血管导管
JP6731688B2 (ja) * 2016-05-10 2020-07-29 英孝 和田 マイクロカテーテル
EP3263167B1 (en) * 2016-06-30 2023-06-28 Wellspect AB Urinary catheter with varying properties
WO2018092386A1 (ja) * 2016-11-21 2018-05-24 テルモ株式会社 カテーテルおよびカテーテルの製造方法
EP3470105B1 (de) * 2017-10-13 2020-04-22 BIOTRONIK SE & Co. KG Einführelement für eine medizinische einführeinrichtung

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4636272A (en) * 1985-02-19 1987-01-13 Cordis Corporation Process for thermally bonding plastic tubes
JPH05329214A (ja) * 1992-06-03 1993-12-14 Hitachi Cable Ltd カテーテルの製造方法
CN201246551Y (zh) * 2008-08-29 2009-05-27 镇江飞达医疗器材有限公司 医用高分子管材
US20170215918A1 (en) * 2016-01-29 2017-08-03 Abiomed, Inc. Thermoform cannula with variable cannula body stiffness
CN210078572U (zh) * 2019-05-09 2020-02-18 东莞市迪凯医疗科技有限公司 一种中心静脉导管
CN113855991A (zh) * 2020-06-30 2021-12-31 微创神通医疗科技（上海）有限公司 一种导管
CN215083900U (zh) * 2020-12-31 2021-12-10 微创神通医疗科技（上海）有限公司 一种导管

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4252814A4 *

Also Published As

Publication number Publication date
EP4252814A4 (en) 2024-09-04
KR20230118914A (ko) 2023-08-14
EP4252814A1 (en) 2023-10-04
JP2024502031A (ja) 2024-01-17
CN114681753B (zh) 2026-02-03
CN121775290A (zh) 2026-04-03
AU2021411539A1 (en) 2023-07-06
CN114681753A (zh) 2022-07-01
US20240293641A1 (en) 2024-09-05

Similar Documents

Publication Publication Date Title
CN107376101B (zh) 用于经导管动脉化疗栓塞术(tace)的微导管
KR101588097B1 (ko) 말단부 접근 흡인 유도 카테터
US7850675B2 (en) Reinforced venous access catheter
US12226592B2 (en) Catheter designs for enhanced column strength
US6591472B1 (en) Multiple segment catheter and method of fabrication
US20120116350A1 (en) Translation dilator and stand alone vascular guide catheter
JP6033861B2 (ja) 遠位アクセス吸引ガイドカテーテル
US6648874B2 (en) Guide catheter with lubricious inner liner
WO2011000264A1 (zh) 一种微导管
US20170000977A1 (en) Medical device having outer polymeric member including one or more cuts
US20240001089A1 (en) Balloon catheter
CN110538373A (zh) 一种栓塞微导管
Mishra et al. Mini versus ultra-mini percutaneous nephrolithotomy in a paediatric population
WO2022142877A1 (zh) 一种导管和导管过渡结构的制备方法
US20120065621A1 (en) Double lumen tubing with improved kinking resistance
WO2024090107A1 (ja) カテーテル
CN215083900U (zh) 一种导管
CN216858626U (zh) 一种海波管及具有该海波管的介入导管
CN114309974A (zh) 一种海波管及具有该海波管的介入导管
US20260020870A1 (en) Insert catheter with side port
CN221130706U (zh) 球囊导管装置
US20250387595A1 (en) Insert catheter with pre-shaped tip
WO2024022041A1 (zh) 医疗导管
JP2010051738A (ja) 医療用チューブ

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21913619

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2023539968

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 18270576

Country of ref document: US

ENP Entry into the national phase

Ref document number: 2021913619

Country of ref document: EP

Effective date: 20230627

ENP Entry into the national phase

Ref document number: 2021411539

Country of ref document: AU

Date of ref document: 20211124

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 20237023184

Country of ref document: KR

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE