CN218420634U

CN218420634U - Reinforced catheter with braided middle layer catheter

Info

Publication number: CN218420634U
Application number: CN202221662509.9U
Authority: CN
Inventors: 蔡国锋; 谢明臣; 陈玮; 梁晨辉; 王杨
Original assignee: Shanghai Yingweisi Medical Technology Co ltd
Current assignee: Shanghai Yingweisi Medical Technology Co ltd
Priority date: 2022-06-30
Filing date: 2022-06-30
Publication date: 2023-02-03
Anticipated expiration: 2032-06-30

Abstract

The utility model relates to the field of medical equipment, a reinforcing pipe with weave intermediate level pipe is provided, include: a catheter hub; the diffusion stress pipe is connected with one end of the conduit seat; the pipe main part includes inlayer pipe, intermediate level and the outer pipe that sets gradually by interior to exterior, the pipe main part sets up diffusion stress pipe keeps away from the one end of pipe seat, the one end that diffusion stress pipe is close to the pipe main part adopts spiral or interval fretwork design, the intermediate level is including keeping away from the section of weaving that diffusion stress pipe direction set up. The utility model discloses have better nature controlled and trafficability characteristic, still have fine compliance and security, adopt to have and weave the intermediate level pipe, can effectively reduce the damage such as buckling of pipe, but also can make the pipe main part have less through external diameter and great inner chamber.

Description

Reinforced catheter with braided middle layer catheter

Technical Field

The utility model relates to the field of medical equipment, in particular to reinforcing pipe with weave intermediate level pipe.

Background

Along with the improvement of the substance level, the change of the national life style, the acceleration of social rhythm, the diversification of psychological pressure and the annual increase of the incidence rate of cardiovascular diseases, more particularly the fatality rate represented by cerebrovascular diseases, exceed malignant tumors and become the first killer which harms the national health. The youth and diversification of cardiovascular diseases are also attracting increasing attention.

Common vascular diseases include ischemic stenosis and hemorrhagic aneurysm. With the popularization of minimally invasive intervention medicine, the technical progress of medical instruments, the improvement of national consciousness, small trauma, short operation time, quick postoperative recovery, low operation risk and cost and other advantages, the minimally invasive intervention gradually replaces the traditional surgical operation and is rapidly developed. The products of catheters, guide wires, balloons, stents and the like in the process of minimally invasive interventional operation cover most of the instruments for interventional or implantation in the operation. With the aid of medical imaging equipment, a blood vessel access is established through arterial or venous puncture, and the device is delivered to a target blood vessel position, so that the expansion of clinical common blood vessel stenosis, the removal of thrombus, the treatment of aneurysm occlusion and other diseases are finally realized.

Patent publication No. CN107376101A describes a microcatheter for Transcatheter Arterial Chemoembolization (TACE), the catheter including a tube base, a diffusive stress tube, a tube body, and a tip; the diffusion stress pipe is sleeved outside the joint of the pipe seat and the pipe body and is fixed with the pipe seat in an inverted manner; the pipe body comprises an inner liner, a reinforcing layer and an outer sleeve layer; the reinforcing layer includes a braided section, an overlapping section, and a helical section. Wherein the weaving section is close to the tube seat, the spiral section is close to the head end, and the lap joint section is positioned between the weaving section and the spiral section; the spiral section adopts a structure that a single spiral wire is made into a spiral spring. The patent describes microcatheters having both good pushability and good compliance and passability, while the tip has good shape retention. However, the distal end of the catheter is designed only by adopting a single spiral structure, so that the distal end of the catheter is easy to deform at the head end with tortuous lesion and loses the shape-retaining capability. The micro catheter is not provided with the reinforcing wire in the axial direction of the catheter, so that the control capability of the proximal end and the tensile resistance of the distal end of the catheter are low, and the effectiveness and the safety of the catheter in clinical use are influenced. The braided section and the spiral section adopt a 'lap joint' mode, so that the outer diameter of a lap joint part is larger, the transmission of the force at the near end of the catheter and the integral passing performance of the catheter are influenced, and even the separation of an inner layer pipe and an outer layer pipe at the lap joint point is caused, so that the safety is influenced.

Patent publication No. CN109498957A describes a novel microcatheter, which comprises a head end, a tube body, a diffusion stress tube and a needle seat arranged in sequence from a distal end to a proximal end, wherein: developing materials are doped in the head end, and a developing ring is arranged between the head end and the tube body; the pipe body sequentially comprises an outer sleeve layer, a woven reinforcing layer, a woven layer and an inner liner layer from outside to inside; and the near end of the tube body is fixedly connected with the needle seat, and the joint of the near end of the tube body and the needle seat is sleeved with the diffusion stress tube. The novel microcatheter described in this patent has very strong pushing, bending and tracking properties, while the catheter becomes stiffer from the distal end to the proximal end, thus ensuring flexibility and shape retention of the distal end. Publication No. CN108904007A describes an intracranial support catheter, comprising a tube for constructing an intracranial thrombectomy channel, the tube comprising an inner liner and an outer shell, one section of the tube being a reinforcing section, at least two layers of reinforcing layers being arranged between the inner liner and the outer shell, at least one layer being a helical coil structure, and at least one layer being a mesh structure. The intracranial support catheter described in this patent achieves good kink resistance and significant pushability through the modification of the stiffening layer.

The whole body of the publication No. CN109498957A adopts a braided structure design, and in the patent CN108904007A, the middle layer adopts a structure design with more than two layers. The requirements of the clinical far-end tensile resistance and the near-end manipulation performance are seemingly solved, but the intermediate layer of the two structural designs can cause the increase of the whole outer diameter of the catheter and influence the trafficability characteristic. The flexibility of the far-end knitting and knitting plus spiral spring structure design can be influenced, the ability of the far-end knitting and knitting plus spiral spring structure through pathological changes is reduced, the hardness of the tip is increased, and the risk of damaging the inner wall of a blood vessel is improved. Although the distal end is made of a material with lower hardness, the bonding performance of the soft material and the inner layer tube of the catheter is reduced due to the adoption of a braided structure, so that the distal end of the catheter is easily layered, and the safety and the effectiveness of the catheter are influenced.

Although a plurality of catheter products are used clinically, most of the catheter products have some defects, and the requirements on the comprehensive performances such as the safety, the effectiveness and the like of the catheter in the operation process cannot be effectively met. In the operation process, the near end of the catheter needs to have good controllability, so that the near end force is effectively transferred to the far end force, and the far end of the catheter needs to have good flexibility, so that the catheter is easier to pass through tortuous lesions, and the damage of the head end to the inner wall of the blood vessel is reduced to the maximum extent.

Disclosure of Invention

The utility model provides a reinforcing pipe with weave intermediate level pipe has better nature controlled and trafficability characteristic, still has fine compliance and security simultaneously. In order to solve the above technical problem, the utility model provides a reinforcing pipe with weave intermediate level pipe, include:

a catheter hub;

the diffusion stress pipe is connected with one end of the conduit seat;

the pipe main part includes inlayer pipe, intermediate level and the outer pipe that sets gradually by interior to exterior, the pipe main part sets up diffusion stress pipe keeps away from the one end of pipe seat, the one end that diffusion stress pipe is close to the pipe main part adopts spiral or interval fretwork design, the intermediate level is including keeping away from the section of weaving that diffusion stress pipe direction set up.

Optionally, the diffusion stress tube is made of one of the following materials: polyurethane, polyolefin, polyamide or silicone.

Optionally, the intermediate layer is a polymer material.

Optionally, the polymer material is one of the following materials: polyamide, polylactic acid, polypropylene, polyethylene, aramid fiber, kevlar fiber, polypropylene mesh nitrile fiber, polycaprolactone, polyglycolide or polyether ether ketone.

Optionally, the polymer material is woven from single and/or multiple strands of filaments.

Optionally, a developing section is further disposed at an end of the catheter main body away from the diffusive stress tube.

Optionally, the developing section is designed by a hollow metal ring or a spiral spring.

Optionally, the developing material of the developing section comprises one of the following materials: barium sulfate, bismuth oxide or tungsten powder.

Optionally, the surface of the outer tube comprises a hydrophilic coating.

Optionally, the hydrophilic coating is polyvinylpyrrolidone or hyaluronic acid.

The beneficial effects of the utility model are that: have better nature controlled and trafficability characteristic, still have fine compliance and security, adopt to have and weave intermediate level pipe, can effectively reduce the damage such as buckling of pipe, but also can make the pipe main part have less external diameter and great inner chamber of passing through.

Drawings

FIG. 1 is a schematic view of the overall construction of a reinforced duct having a braided intermediate layer of ducts;

FIGS. 2 (a) and 2 (b) are schematic structural views of a diffusive stress tube in a reinforced catheter with braided intermediate layer conduits;

FIG. 3 (a), FIG. 3 (b), FIG. 3 (c) and FIG. 3 (d) are schematic structural views of the intermediate layer in a reinforcement conduit having a braided intermediate layer conduit;

FIGS. 4 (a) and 4 (b) are schematic illustrations of the braid structure of a reinforcing catheter intermediate layer braid segment having a braided intermediate layer catheter;

FIG. 5 (base:Sub>A), FIG. 5 (b), FIG. 5 (c) and FIG. 5 (d) are schematic A-A cross-sectional views ofbase:Sub>A proximal braided segment of an intermediate layer ofbase:Sub>A reinforcing catheter havingbase:Sub>A braided intermediate layer catheter;

FIGS. 6 (a), 6 (B), 6 (c) and 6 (d) are schematic B-B cross-sectional views of spring segments at the distal end of the middle layer of a reinforcing catheter with a braided middle layer catheter;

FIGS. 7 (a) and 7 (b) are schematic structural diagrams of a distal hollow development ring of an intermediate layer of a reinforcing conduit having a braided intermediate layer conduit;

FIG. 8 is a schematic structural view of a reinforcing catheter intermediate layer distal developing coil with a braided intermediate layer catheter;

fig. 9 (a) and 9 (b) are schematic cross-sectional C-C structures of inner tubes in a reinforced duct with a braided middle tube.

Wherein the figures of the drawings are numbered as follows:

1-a catheter hub; 2-diffusion stress tube; 3-a catheter body; 4-inner layer tube; 5-an intermediate layer; 6-outer layer tube;

7-a hydrophilic coating; 8-weaving section; 9-a helical spring section; 10-developing section.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

As shown in fig. 1-9, the present embodiment provides a reinforced catheter with a braided middle layer catheter, which includes a catheter hub 1, a diffusive stress tube 2 and a catheter body 3. The catheter body 3 is composed of an inner tube 4, an intermediate layer 5, an outer tube 6 and a hydrophilic coating 7. Wherein the intermediate layer 5 consists of a braiding section 8, a helical spring section 9 and a developing section 10. The outer diameter of the conduit is in the range of 0.30-3.00mm and the inner diameter is in the range of 0.20-2.30mm. The catheter main body 3 comprises an inner layer pipe 4, a middle layer 5 and an outer layer pipe 6 which are sequentially arranged from inside to outside, and the catheter main body 3 is arranged at one end, far away from the catheter seat 1, of the diffusion stress pipe 2. The middle layer 5 comprises a braided section 8 and a spiral spring section 9 which are sequentially arranged in the direction away from the diffusion stress pipe 2. The one end that pipe main part 3 kept away from diffusion stress tube 2 still is provided with development section 10, development section 10 adopts fretwork becket or coil spring design.

The utility model adopts the above embodiment have better nature controlled and trafficability characteristic, and the design of diffusion stress pipe and catheter main body can effectively reduce the damage such as buckling of pipe near-end, can make the catheter main body have less external diameter and great inner chamber of passing through moreover.

The following describes how the various modules or components described above can be implemented:

example 1

The catheter base 1 in this embodiment is made of medical Polycarbonate (PC), and the diffusion stress tube 2 is made of a Polyurethane (PU) spiral hollow structure design a (see fig. 2 (b)), and is fixed to the catheter base 1 in an inverted manner. The inner layer tube 4 adopts single-layer etching polytetrafluoroethylene (e-PTFE), and the wall thickness of a single side is 0.02mm. The braiding section 8 of the middle layer is braided in a variable density manner by adopting 16 strands of 0.002in round wires in an upper-lower braiding mode, the variation range of the braiding density PPI from the near end to the far end of the catheter is 80-120, and the braiding density of the near end is larger than that of the far end. The spiral spring section 9 adopts a nickel titanium flat wire with the thickness of 0.001 multiplied by 0.005in to carry out variable density single-layer spring winding, the variation range of the spring distance from the near end to the far end of the catheter is 2-5 times of the width of the flat wire, the spring distance of the near end is smaller than that of the far end, and the length of the spiral spring section is 20cm. The tip of one end of the catheter main body 3, which is far away from the diffusion stress tube 2, adopts a developing section 10 which is 0.7mm in length and is designed regularly in a hollow mode, for example, a developing ring is adopted. The polymer material can adopt polylactic acid, the monofilament diameter is 0.01mm, the mode of 30 strands of gapless parallel tows is adopted, the polymer tows penetrate through the whole body of the catheter and can be embedded with the wall thickness of the outer layer pipe 6, the outer diameter of the catheter main body 3 cannot be increased, and the axial peak tension of the catheter main body 3 can be greatly improved. Two ends of the weaving section 8 are heated, and two ends of the spiral spring section 9 are fixed in a laser welding mode. The outer tube 6 is formed by 7 kinds of high polymer materials with different hardness in a seamless butt joint mode, and polyamide, polyether amide block copolymer, polyurethane and developing material mixtures are respectively arranged from the near end to the far end along the catheter main body. As an alternative embodiment, the Shore hardness of the polyamide and the polyether amide block copolymer ranges from 35D to 80D, the hardness of the material of the outer layer tube 6 gradually decreases from the proximal end to the distal end, and the hardness is smoothly transited; for example, the shore hardness of the distal polyurethane is 70A, and the barium sulfate content of the imaging material is 40wt%. The outer layer pipe 6 and the inner layer pipe 4 are welded in a thermal shrinkage mode to realize the reflow integrated welding of the outer layer pipe and the inner layer pipe, and a thermal shrinkage pipe made of perfluoro ethylene propylene copolymer (FEP) is adopted in the welding process. The outer surface of the processed catheter main body is dip-coated with a polyvinylpyrrolidone (PVP) coating with a proper length, and the curing is realized through a heating mode.

Example 2

The catheter base 1 in the embodiment adopts medical Polyamide (PA), the diffusion stress tube 2 adopts Polyolefin (PO) regular interval hollow design B, and the diffusion stress tube is fixed with the catheter base 1 in a thermal shrinkage mode. The inner tube 4 is designed to have a double-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), the outer layer is an ether amide block copolymer (PEBAX), and the unilateral wall thickness is 0.025mm. The middle layer braided section 8 adopts 16 strands of flat wires with 0.001 multiplied by 0.002in, and is braided in a density-variable manner, the PPI can be 70-110 along the range from the near end to the far end of the catheter, and the braiding density of the near end is larger than that of the far end. The spiral spring section 9 adopts nickel titanium parallel flat wires of 0.001 multiplied by 0.003in and 0.001 multiplied by 0.002in to perform uniform-pitch single-layer winding, the pitch is 1-3 times of the width of the parallel flat wires, and the length of the spiral spring is 15cm. The developing section 10 adopts a platinum-iridium alloy developing tight spring ring with the length of 1.0mm and the wire diameter of 0.02mm. The diameter of the polycaprolactone monofil is 0.015mm, a mode of 10 gapless side-by-side tows is adopted, and 4 groups of tows penetrate through the whole body of the catheter. Two ends of the weaving section 8 are heated, and two ends of the spiral spring section 9 are fixed by medical instant adhesive. The outer layer tube 6 is formed by seamlessly butting 10 high polymer materials with different hardness, the mixture of polyamide, polyether amide block copolymer, polyurethane and developing material is respectively arranged along the near end to the far end of the catheter, furthermore, the Shore hardness change range of the polyamide and polyether amide block copolymer is 25D-80D, the hardness of the outer layer material of the catheter is gradually reduced from the near end to the far end, and the smooth transition is realized; the Shore hardness of the distal polyurethane is 50A, and the content of barium sulfate in the developing material is 35wt%. The inner layer and the outer layer of the catheter are welded in a thermal shrinkage mode to realize the reflux integrated welding of the outer layer and the inner layer and the outer layer, and a thermal shrinkage pipe made of perfluoroethylene propylene copolymer (FEP) is adopted in the welding process. The outer surface of the processed catheter main body is coated with a Hyaluronic Acid (HA) coating with a proper length in a dip-coating mode, and curing is achieved through a heating mode.

EXAMPLE 3

The catheter hub 1 in this example used polyethylene terephthalate-1, 4-cyclohexanedimethanol (PCTG). The diffusion stress tube 2 is designed by silica gel (Silicon) at regular intervals in a hollow mode B, and is fixed with the catheter seat 1 in a back-off mode. The inner layer tube 4 adopts etched polytetrafluoroethylene (e-PTFE) of a single-layer silver-plated copper mandrel, and the thickness of a single-side wall is 0.015mm. The middle layer weaving section 8 adopts 8 strands of flat wires of 0.001 multiplied by 0.002in and 8 strands of round wires of 0.002in to carry out mixed variable density weaving according to a one-over-one-under weaving mode, the range of the PPI from the near end to the far end of the catheter is 80-100, and the weaving density of the near end is greater than that of the far end. The spiral spring section 9 adopts a nickel titanium flat wire with the thickness of 0.001 multiplied by 0.005in to carry out variable density single-layer spring winding, the variation range of the spring distance from the near end to the far end of the catheter is 1 to 4 times of the width of the flat wire, the spring distance of the near end is smaller than that of the far end, and the length of the spiral spring is 25cm. The developing section 10 adopts a gold developing tight spring ring with the length of 0.8mm and the wire diameter of 0.03 mm. The diameter of each polypropylene reticular nitrile fiber monofilament is 0.01mm, a mode of 10 gapless side-by-side tows is adopted, and 4 groups of tows are positioned in a spiral spring area at the far end of the catheter. The two ends of the braided section 8 are heated, and the two ends of the spiral spring are fixed by laser welding. The outer layer tube 6 is formed by seamless butt joint of 12 high polymer materials with different hardness, polyamide, polyether amide block copolymer and polyurethane are respectively arranged along the near end to the far end of the catheter, furthermore, the Shore hardness change range of the polyamide and polyether amide block copolymer is 30D-74D, the hardness of the outer layer material of the catheter is gradually reduced from the near end to the far end, and smooth transition is realized; the shore hardness of the distal polyurethane was 55A. The inner layer and the outer layer of the catheter are welded in a thermal shrinkage mode to realize the reflux integrated welding of the outer layer and the inner layer and the outer layer, and a thermal shrinkage pipe made of perfluoroethylene propylene copolymer (FEP) is adopted in the welding process. The outer surface of the processed catheter main body is dip-coated with a polyvinylpyrrolidone (PVP) coating with a proper length, and the curing is realized through a heating mode.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. A reinforced conduit having a braided intermediate layer conduit, comprising:

a catheter hub;

the diffusion stress pipe is connected with one end of the conduit seat;

2. The reinforced conduit with braided interlayer conduit of claim 1, wherein said diffusion stressed tube is one of the following materials: polyurethane, polyolefin, polyamide or silicone.

3. The reinforced conduit with a braided interlayer conduit of claim 1 or 2, wherein the interlayer is a polymeric material.

4. The reinforced conduit with braided intermediate conduit of claim 3 wherein the polymeric material is one of the following: polyamide, polylactic acid, polypropylene, polyethylene, aramid fiber, kevlar fiber, polypropylene mesh nitrile fiber, polycaprolactone, polyglycolide or polyether ether ketone.

5. A reinforced conduit with a braided innerlayer conduit as claimed in claim 4, wherein said polymeric material is braided from single and/or multiple strands of wire.

6. The reinforced catheter with braided intermediate layer catheter of claim 5, wherein the end of the catheter body distal to the diffuse stress tube is further provided with a visualization section.

7. The reinforced catheter with braided intermediate layer catheter of claim 6 wherein said development section is designed with an open metal loop or a coil spring.

8. The reinforced conduit with braided interlayer conduit of claim 6 or 7, wherein the developer material of the developer section comprises one of the following materials: barium sulfate, bismuth oxide or tungsten powder.

9. A reinforced catheter having a braided intermediate layer of catheter according to claim 1 or claim 2, in which the outer tube has a hydrophilic coating on its surface.

10. The reinforced catheter with a braided intermediate catheter of claim 9, wherein said hydrophilic coating is polyvinylpyrrolidone or hyaluronic acid.