CN218685686U - Reinforced catheter - Google Patents

Abstract

The utility model relates to the field of medical equipment, a reinforcing 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 section and the helical spring section of weaving that diffusion stress pipe direction set gradually. The utility model discloses have better nature controlled and trafficability characteristic, still have fine compliance and security. The diffusion stress tube and the catheter main body which are specially designed are adopted, so that the damages such as bending of the proximal end of the catheter can be effectively reduced, and the catheter main body can have a smaller passing outer diameter and a larger inner cavity.

Description

Reinforced catheter

Technical Field

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

Background

Common vascular diseases include ischemic stenosis and hemorrhagic aneurysm. With the popularization of minimally invasive interventional medicine, the improvement of medical instrument technology and the improvement of national consciousness, the advantages of small wound, short operation time, quick postoperative recovery, low operation risk and cost and the like, the minimally invasive intervention gradually replaces the traditional surgical operation and is developed rapidly. The products such as catheters, guide wires, balloons, stents and the like in the process of minimally invasive intervention surgery cover most of the interventional or implanting instruments in the surgery. 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 comprising a tube holder, a diffusion 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 buckling mode; 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 capability. 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 of the catheter 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: the head end is doped with developing materials, 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 strong pushing, bending and tracking properties, while the catheter becomes stiffer from the distal end to the proximal end, thus ensuring distal compliance and shape retention. 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 patent describes an intracranial support catheter that achieves good kink resistance and significant pushability through improvements in 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 knitting of distal end and weave and add the design of helical spring structure can influence its compliance, reduce its ability through pathological change, make sharp-end hardness increase, improved the risk of damage blood vessel inner wall. 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 affected.

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

a catheter hub;

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

the catheter main body comprises an inner layer pipe, a middle layer and an outer layer pipe which are sequentially arranged from inside to outside, and the catheter main body is arranged at one end, away from the catheter seat, of the diffusion stress pipe.

Optionally, one end of the diffusion stress tube close to the catheter main body is designed to be spiral or hollow at intervals.

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

Optionally, the inner layer tube material is a polymer material; the high polymer material is one or more of the following materials: etching polytetrafluoroethylene, high density polyethylene, polyamide or polyetheramide block copolymers; when the high polymer material is one, the polyamide or polyether amide segmented copolymer contains a lubricating material; or when the high polymer material is multiple, the double-layer pipe is composed of etched polytetrafluoroethylene, high-density polyethylene and/or polyamide block copolymer.

Optionally, the intermediate layer includes a braided section and a helical spring section sequentially arranged away from the direction of the diffusion stress tube.

Optionally, the intermediate layer is a metal material, and the metal material is one or more of the following materials: stainless steel, nitinol, platinum iridium, tungsten, or gold;

or, the intermediate layer is made of a high polymer material, and the high polymer material is one or more of the following materials: polyamide, polylactic acid, polypropylene, polyethylene, aramid fiber, kevlar fiber, polypropylene mesh nitrile fiber, polycaprolactone, polyglycolide or polyether ether ketone;

or the intermediate layer is formed by combining a metal material and a high polymer material, and the metal material is one or more of the following materials: stainless steel, nickel-titanium alloy, platinum-iridium alloy, tungsten or gold, wherein the high polymer material is one or more 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 intermediate layer is implemented by weaving: the high polymer material is woven by single-strand and/or multi-strand silk materials;

and/or the middle layer realizes the wire formed by the metal material and/or the high polymer material in a spiral spring mode.

Optionally, one end of the catheter main body, which is far away from the diffusion stress tube, is further provided with a developing section, and the developing section is designed by adopting a hollow metal ring or a spiral spring.

Optionally, the outer tube is made of 5-15 polymer materials with different hardness, the polymer materials comprise a plurality of polyamide, polyether amide block copolymer, polyurethane, polyolefin or developing materials, and the hardness of the outer tube is gradually reduced towards the direction far away from the diffusion stress tube.

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

and/or the Shore hardness range of the outer layer tube material at one end far away from the diffusion stress tube is 40-85A;

and/or the addition amount of the developing material is in the range of 30-50 wt%;

and/or the combination mode of the materials with different hardness of the outer layer pipe is seamless butt joint;

and/or the combination mode of the inner layer pipe, the middle layer and the outer layer pipe is thermal shrinkage welding and/or co-extrusion;

and/or the surface of the outer pipe contains a hydrophilic coating, and the hydrophilic coating is polyvinylpyrrolidone and/or hyaluronic acid;

and/or the outer diameter of the catheter main body ranges from 0.30 mm to 3.00mm, and the inner diameter ranges from

0.20-2.30mm。

The utility model has the advantages that: has better control and passing performance, and also has good flexibility and safety. The diffusion stress tube and the catheter main body which are specially designed are adopted, so that the damages such as bending of the proximal end of the catheter can be effectively reduced, and the catheter main body can have a smaller passing outer diameter and a larger inner cavity.

Drawings

FIG. 1 is a schematic view of the overall construction of a reinforced catheter;

FIGS. 2 (a) and 2 (b) are schematic structural views of a diffusion stressed tube in a reinforced conduit;

FIG. 3 (a), FIG. 3 (b), FIG. 3 (c) and FIG. 3 (d) are schematic structural views of an intermediate layer in a reinforcement catheter;

FIGS. 4 (a) and 4 (b) are schematic views of the braid structure of the intermediate layer braid segment of the reinforcement catheter;

FIG. 5 (base:Sub>A), FIG. 5 (b), FIG. 5 (c) and FIG. 5 (d) are schematic views of the cross-sectional structure A-A of the proximal braided section of the intermediate layer of the stiffening catheter;

FIG. 6 (a), FIG. 6 (B), FIG. 6 (c) and FIG. 6 (d) are schematic B-B cross-sectional views of the distal spring segment of the intermediate layer of the reinforcing catheter;

FIGS. 7 (a) and 7 (b) are schematic structural views of the distal hollow development ring of the middle layer of the reinforcing catheter;

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

fig. 9 (a) and 9 (b) are schematic cross-sectional C-C structures of inner tubes in a reinforcement catheter.

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-development stage.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying 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, 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 catheter is in the range of 0.30-3.00mm, and the inner diameter of the catheter 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 may 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 adopts 16 strands of 0.002in round wires, variable-density braiding is carried out according to a one-over-one 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 with the length of 0.7mm and the regular hollow design, for example, a developing ring. 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 layer tube 6 is formed by 7 high polymer materials with different hardness in a seamless butt joint mode, and the polyamide, the polyether-amide block copolymer, the polyurethane and the developing material mixture are respectively arranged from the near end to the far end of the catheter 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 weaving section 8 adopts 16 strands of flat wires of 0.001 multiplied by 0.002in, and carries out 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 70-110, and the weaving 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 monofils 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. The two ends of the braided section 8 are heated, and the 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 layer 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 ester (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 the 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 the 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.

Example 4

The catheter base 1 in this embodiment is made of medical Polycarbonate (PC), and the diffusive stress tube 2 is made of Polyolefin (PO) spiral design a (see fig. 2 (a)), and is fixed to the catheter base 1 by heat shrinkage. The inner layer tube 4 is designed by adopting a double-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), the near end of the outer layer is ether amide block copolymer (PEBAX), the far end is Polyurethane (PU), and the unilateral wall thickness of the inner layer tube is 0.023mm. The middle layer weaving section 8 adopts 16 strands of 0.002in round wires, the density-variable weaving is carried out according to the weaving mode of two upper parts and two lower parts, the range of the PPI from the near end to the far end of the catheter is 60-100, and the weaving density of the near end is larger than that of the far end. The spiral spring section 9 adopts a nickel titanium flat wire of 0.001 multiplied by 0.004in 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 to 3 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 18cm. The developing section 10 adopts a hollow platinum-iridium alloy developing ring with the length of 0.8 mm. The diameter of the aramid fiber monofilament is 0.01mm, a mode of 6 strands of gapless side-by-side tows is adopted, and 8 groups of tows penetrate through the whole body of the conduit. Two ends of the weaving section 8 are subjected to heating treatment, and two ends of the spiral spring are fixed by ultraviolet curing glue. The outer layer tube 6 is formed by 15 high polymer materials with different hardness in a seamless butt joint mode, the mixture of polyamide, polyether amide block copolymer, polyurethane and developing materials 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-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 achieved; the shore hardness of the distal polyurethane is 55A, and the content of the developing material bismuth oxide is 45wt%. The inner layer and the outer layer of the conduit are welded in a thermal shrinkage mode to realize the reflux integrated welding of the outer layer and the inner 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 5

The catheter base 1 in the embodiment adopts polyethylene terephthalate-1, 4-cyclohexane dimethanol ester (PCTG), the diffusion stress tube 2 adopts Polyolefin (PO) regular interval hollow design B, and is fixed with the catheter base 1 in an inverted manner. 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 0.01mm. The middle layer weaving section 8 adopts 16 strands of 0.002in round wires and carries out equal-density weaving according to a one-over-one weaving mode. The spiral spring section 9 adopts a nickel titanium flat wire of 0.001 multiplied by 0.005in to perform equal-density single-layer spring winding, the density of the spring winding is 3 to 5 times of the width of the flat wire, and the length of the spiral spring is 30cm. The developing section 10 adopts a hollow platinum-iridium alloy developing ring with the length of 0.8 mm. The diameter of the aramid fiber monofilament is 0.01mm, a mode of 6 strands of gapless side-by-side tows is adopted, and 4 groups of tows penetrate through the whole body of the conduit. Two ends of the weaving section 8 are subjected to heating treatment, and two ends of the spiral spring are fixed by adopting laser tube welding. The outer layer tube 6 is made of 7 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 25D-72D, 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 was 45A. The outer layer high polymer material with various hardness is melted, and the inner layer and the outer layer of the catheter are processed through integral continuous co-extrusion through a plurality of groups of co-extrusion machine heads. 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 6

The catheter base 1 in the embodiment adopts medical Polyamide (PA), the diffusion stress tube 2 adopts polyurethane (TPU), the regular interval hollow design B is adopted, and the catheter base 1 is fixed in an inverted buckle mode. The inner tube 4 is made of single-layer etched polytetrafluoroethylene (e-PTFE) with a single-side wall thickness of 0.025mm. The middle layer weaving section 8 adopts 16 strands of flat wires of 0.001 multiplied by 0.002in, the density-variable weaving is carried out according to the weaving mode of two strands of flat wires, the range of the PPI from the near end to the far end of the catheter is 70-90, and the weaving density of the near end is larger than that of the far end. The spiral spring section 9 adopts a nickel titanium flat wire of 0.001 multiplied by 0.005in to perform equal-density winding, the density of the winding spring is 1 to 3 times of the width of the flat wire, and the length of the spiral spring is 20cm. The developing section 10 adopts a platinum-iridium alloy developing tight spring ring with the length of 1.0mm and the wire diameter of 0.05 mm. The diameter of the aramid fiber monofilament is 0.005mm, a mode of 20 strands of gapless side-by-side tows is adopted, and 4 groups of tows penetrate through the whole body of the conduit. Two ends of the weaving section 8 are subjected to heating treatment, and two ends of the spiral spring are fixed by adopting laser tube welding. The outer layer tube 6 is made of 10 high polymer materials with different hardness, polyamide, polyether amide block copolymer, polyurethane and a developing material mixture are respectively arranged along the near end to the far end of the catheter, furthermore, the Shore hardness change range of the polyamide and the polyether amide block copolymer is 30D-72D, 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 far-end polyurethane is 60A, and the content of the tungsten powder of the developing material is 45wt%. The outer layer high polymer material with various hardness is melted, and the inner layer and the outer layer of the catheter are processed through integral continuous co-extrusion through a plurality of groups of co-extrusion machine heads. 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 7

The catheter base 1 in the embodiment adopts medical Polycarbonate (PC), the diffusion stress tube 2 adopts polyurethane (TPU), the regular interval hollow design B is adopted, and the back-off mode is adopted to be fixed with the catheter base 1. The inner layer tube 4 adopts single-layer etching polytetrafluoroethylene (e-PTFE), and the wall thickness of a single side is 0.025mm. The middle layer weaving section 8 adopts 16 strands of flat wires of 0.001 multiplied by 0.002in, and carries out variable density weaving according to a one-over-one-under weaving mode, the range of PPI from the near end to the far end of the catheter is 70-110, and the weaving density of the near end is larger than that of the far end. The spiral spring section 9 adopts a nickel titanium flat wire of 0.001 multiplied by 0.005in to carry out equal-density double-spiral winding spring, the density of the winding spring is 1-4 times of the width of the flat wire, and the length of the spiral spring is 25cm. The developing section 10 adopts a gold developing tight spring ring with the length of 1.0mm and the wire diameter of 0.05 mm. The diameter of the aramid fiber monofilament is 0.005mm, a mode of 10 gapless parallel tows is adopted, and 2 groups of tows penetrate through the whole body of the conduit. Two ends of the weaving section 8 are subjected to heating treatment, and two ends of the spiral spring are fixed by adopting laser tube welding. The outer layer tube 6 is made of 8 high polymer materials with different hardness, and is respectively a mixture of polyamide, polyether amide block copolymer, polyurethane and a developing material from the near end to the far end of the catheter, further, the Shore hardness change range of the polyamide and the 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 the smooth transition is realized; the shore hardness of the distal polyurethane is 55A, and the content of barium sulfate in the developing material is 35wt%. The inner layer and the outer layer of the conduit are welded in a thermal shrinkage mode to realize the reflux integrated welding of the outer layer and the inner 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 polyvinylpyrrolidone (PVP) and Hyaluronic Acid (HA) coatings with proper lengths, wherein the hyaluronic acid coating is positioned at a far end and is solidified in a heating mode.

Example 8

The catheter holder 1 in the embodiment adopts medical Polycarbonate (PC), the diffusion stress tube 2 adopts Polyolefin (PO) spiral design A, and is fixed with the catheter holder 1 in a thermal shrinkage mode. The inner layer tube 4 is designed by adopting a double-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), the near end of the outer layer is ether amide block copolymer (PEBAX), the far end is Polyurethane (PU), and the unilateral wall thickness of the inner layer tube is 0.025mm. The middle layer weaving section 8 adopts 16 strands of 0.002in round wires, variable density weaving is carried out according to a one-over-one-under weaving mode, the range of PPI from the near end to the far end of the catheter is 60-100, and the weaving density of the near end is larger than that of the far end. The spiral spring section 9 adopts a nickel-titanium flat wire of 0.001 multiplied by 0.004in to carry out variable-density double-spiral 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 is 30cm. The developing section 10 adopts a hollow platinum-iridium alloy developing ring with the length of 0.8 mm. The diameter of the polyethylene monofilament is 0.01mm, a mode of 6 strands of 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 subjected to heating treatment, and two ends of the spiral spring are fixed by ultraviolet curing glue. The outer layer tube 6 is formed by seamless butt joint of 13 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 25D-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 45A. 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 polyvinylpyrrolidone (PVP) with 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 (10)

1. A reinforced catheter, comprising:

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 section and the helical spring section of weaving that diffusion stress pipe direction set gradually.

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

3. The reinforced conduit of claim 1 or 2, wherein the intermediate layer is a metallic material, the metallic material being one of: stainless steel, nitinol, platinum iridium, tungsten, or gold.

4. The reinforced catheter of claim 1 or 2, wherein the inner layer tube material is a polymeric material; the high polymer material is one of the following materials: etching polytetrafluoroethylene, high density polyethylene, polyamide or polyetheramide block copolymers.

5. The reinforced catheter of claim 1 or 2, wherein the intermediate layer is a polymeric material, the polymeric material being one of the following: polyamide, polylactic acid, polypropylene, polyethylene, aramid fiber, kevlar fiber, polypropylene mesh nitrile fiber, polycaprolactone, polyglycolide or polyether ether ketone.

6. The reinforced conduit according to claim 5, wherein the intermediate layer is woven to: the high polymer material is woven by single-strand and/or multi-strand silk materials.

7. The reinforced catheter of claim 1 or 6, wherein a development section is further arranged at one end of the catheter main body, which is far away from the diffusion stress tube, and the development section is designed by adopting a hollow metal ring or a spiral spring.

8. The reinforced catheter of claim 7, wherein the visualization material of the visualization section comprises one of the following materials: barium sulfate, bismuth oxide or tungsten powder.

9. The reinforced catheter of claim 1 or claim 2, wherein the outer tube has a hydrophilic coating on its surface, the hydrophilic coating being polyvinylpyrrolidone or hyaluronic acid.

10. The reinforced catheter of claim 8, wherein the shore hardness of the outer tube material at the end distal to the diffusively stressed tube is in the range of 40A-85A;

and/or the combination mode of the materials with different hardness of the outer layer pipe is seamless butt joint;

and/or, the outer diameter of the catheter body ranges from 0.30 mm to 3.00mm, and the inner diameter of the catheter body ranges from 0.20 mm to 2.30mm.

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