CN218420636U

CN218420636U - Reinforced catheter with spiral diffusion stress tube

Info

Publication number: CN218420636U
Application number: CN202221665552.0U
Authority: CN
Inventors: 蔡国锋; 谢明臣; 陈玮; 梁晨辉; 娄婷婷
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 provides a reinforcing pipe with spiral diffusion stress 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 from inside to outside, 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 design, the one end that diffusion stress pipe is close to the pipe seat is the body. The utility model discloses have better nature controlled and trafficability characteristic, still have fine compliance and security, adopt the diffusion stress tube of spiral design, can effectively reduce the damage such as buckling of pipe main part near-end.

Description

Reinforced catheter with spiral diffusion stress tube

Technical Field

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

Background

Along with the improvement of substance level, the change of national life style, the acceleration of social rhythm, the diversification of psychological pressure, the annual increase of the incidence of cardiovascular diseases, and the fatality rate represented by cerebrovascular diseases, which exceeds malignant tumors, become the first killer endangering the health of the nation. 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 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), which includes 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. The braided 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 braided 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, even the separation of an inner layer tube and an outer layer tube at the lap joint point is caused, and the safety is influenced.

Patent publication No. CN109498957a describes a novel microcatheter, a head end, a tube body, a diffusion stress tube and a needle seat sequentially arranged 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. The patent publication No. CN108904007A describes an intracranial support catheter, which comprises a tube body for constructing an intracranial embolectomy channel, wherein the tube body comprises an inner lining and an outer shell, one section of the tube body is a reinforcing section, at least two layers of reinforcing layers are arranged in the reinforcing section and positioned between the inner lining and the outer shell, at least one layer of the reinforcing layers is of a spiral coil structure, and at least one layer of the reinforcing layers is of a net 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 woven structure design, the patent CN108904007A adopts a structure design with more than two layers in the middle layer. The requirements of the clinical distal tensile property and the clinical proximal manipulation property are seemingly solved, but the intermediate layer of the two structural designs can cause the increase of the overall 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 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 with spiral diffusion stress 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 with spiral diffusion stress 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 from inside to outside, 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 design, the one end that diffusion stress pipe is close to the pipe seat is the body.

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

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

Optionally, the inner layer tube material is a polymeric material.

Optionally, the intermediate layer is a polymer material.

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, the hydrophilic coating being polyvinylpyrrolidone or hyaluronic acid.

Optionally, the shore hardness of the material of the outer layer pipe at the end far away from the diffusion stress pipe is in the range of 40A-85A;

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.

The beneficial effects of the utility model are that: the utility model discloses have better nature controlled and trafficability characteristic, still have fine compliance and security. The adoption of the spiral design of the diffusion stress tube can effectively reduce the damages such as bending of the near end of the catheter main body.

Drawings

FIG. 1 is a schematic view of the overall structure of a reinforced pipe with a helical diffusive stress tube;

FIG. 2 is a schematic structural view of a diffusion stress tube in a reinforced conduit having a helical diffusion stress tube;

FIG. 3 (a), FIG. 3 (b), FIG. 3 (c) and FIG. 3 (d) are schematic structural views of an intermediate layer in a reinforcement duct having a helical diffusive stress tube;

FIGS. 4 (a) and 4 (b) are schematic views of the braided structure of the intermediate layer braided section of a reinforcing duct having a helical diffusive stress tube;

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 ofbase:Sub>A middle layer ofbase:Sub>A reinforcing catheter havingbase:Sub>A helical diffusive stress tube;

FIG. 6 (a), FIG. 6 (B), FIG. 6 (c) and FIG. 6 (d) are schematic B-B cross-sectional structures of spring segments at the distal end of a reinforcing catheter intermediate layer with helical diffusive stress tube;

FIGS. 7 (a) and 7 (b) are schematic structural diagrams of a distal hollow development ring of an intermediate layer of a reinforcing catheter with a helical diffusive stress tube;

FIG. 8 is a schematic structural view of a reinforcing catheter intermediate layer distal developing coil with helical diffusive stress tube;

fig. 9 (a) and 9 (b) are schematic cross-sectional C-C structures of inner tubes in a reinforced duct with a helical diffusive stress 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 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 with a spiral type diffusion stress tube, which includes a catheter hub 1, a diffusion stress tube 2 and a catheter main 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 the embodiment adopts medical Polycarbonate (PC), the diffusion stress tube 2 adopts Polyolefin (PO) spiral design A (as shown in figure 2), and is fixed with the catheter base 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 0.023mm. The middle layer weaving section 8 adopts 16 strands of 0.002in round wires, variable density weaving is carried out according to a two-over-two-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 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 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 2

The catheter base 1 in the embodiment adopts medical Polycarbonate (PC), the diffusion stress tube 2 adopts a Polyolefin (PO) spiral design A, and is fixed with the catheter base 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 to 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 heated, and two ends of the spiral spring are fixed by ultraviolet curing glue. The outer layer tube 6 is formed by 13 high polymer materials with different hardness in a seamless butt joint mode, 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 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 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 dipped and 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

1. A reinforced conduit having a helical diffusion stressed tube, comprising:

a catheter hub;

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

2. The reinforced pipe with the helical diffusion stressed pipe of claim 1, wherein the diffusion stressed pipe is made of one of the following materials: polyurethane, polyolefin, polyamide or silicone.

3. The reinforced pipe with the helical diffusive stress tube of claim 1 or 2, wherein the intermediate layer is a metallic material, the metallic material being one of the following: stainless steel, nitinol, platinum iridium, tungsten, or gold.

4. A reinforced catheter with a helical diffusive stress tube as in claim 1 or 2, wherein said inner tube material is a polymeric material.

5. A reinforced conduit with a helical diffusive stress tube as in claim 1 or 2, wherein said intermediate layer is a polymeric material.

6. The reinforced catheter with the helical diffusive stress tube of claim 5, wherein an end of the catheter body distal from the diffusive stress tube is further provided with a visualization section.

7. The reinforced pipe with spiral diffusive stress tube of claim 6, wherein said development section is designed with a hollowed-out metal ring or a spiral spring.

8. The reinforced pipe with helical diffusive stress tube of claim 7, wherein the developer material of said developer section comprises one of the following materials: barium sulfate, bismuth oxide or tungsten powder.

9. A reinforced catheter with a helical diffusive stress tube as in claim 1 or 2, wherein the surface of the outer tube comprises a hydrophilic coating of polyvinylpyrrolidone or hyaluronic acid.

10. The reinforced pipe with the helical diffusion stressed pipe of claim 8, wherein the shore hardness of the outer layer pipe material at the end away from the diffusion stressed pipe is in the range of 40A-85A;