CN117531093A

CN117531093A - Punching catheter

Info

Publication number: CN117531093A
Application number: CN202311819602.5A
Authority: CN
Inventors: 向东东; 周建; 王平; 夏钰明
Original assignee: Shenzhen Xinyeju Interventional Medical Technology Co ltd; Shenzhen Yeapro Industrial Co ltd
Current assignee: Shenzhen Xinyeju Interventional Medical Technology Co ltd; Shenzhen Yeapro Industrial Co ltd
Priority date: 2023-12-26
Filing date: 2023-12-26
Publication date: 2024-02-09

Abstract

The invention belongs to the field of medical equipment, and particularly relates to a through catheter, which comprises a catheter body, wherein a catheter body inner cavity which penetrates through the front section and the rear section of the catheter body is arranged in the catheter body; the pipe body comprises a through section and a torsion control section, and the rear end of the through section is connected with the front end of the torsion control section; the through section is deformable, when the torsion control section is twisted in one direction, the through section can be driven to deform, so that the cross section diameter of the through section is reduced. In the invention, based on the structural arrangement of the through section, the cross section diameter of the through section can be reduced by twisting the torsion control section, and the through catheter can pass through the small occlusion part of the micro-channel by the operation mode of rotary pushing, so that the guide wire exchange is realized.

Description

Punching catheter

Technical Field

The invention belongs to the field of medical equipment, and particularly relates to a through catheter.

Background

In the chronic occlusion interventional operation, the microcatheter is generally used for assisting a guide wire to pass through a lesion part and exchanging the guide wire, and has the characteristics of small outer diameter, good trafficability and the like. However, when a severe occlusion is encountered, the microcatheter cannot be pushed through the occlusion site due to its softer distal end, and no guidewire exchange action can be achieved. In view of the above, the microcatheter is rotated and pushed through the occlusion site by rotating the microcatheter and applying force generated during pushing. Microcatheters that can be torsionally pushed are often referred to clinically as punch-through catheters, which generally comprise a spring structure consisting essentially of an inner layer, a braid layer, a spring layer and an outer layer. The inner cavity of the micro catheter needs to ensure smooth passing of the guide wire, so that the micro catheter is required to have a certain size, the thickness of the wall of the micro catheter tube is large due to the multi-layer structure, the design of the inner diameter and the outer diameter of the micro catheter tube is limited, the diameter of the through catheter with the smallest clinical diameter is 2.1F, when the micro catheter is seriously blocked, the micro channel is smaller, the diameter of the through catheter is relatively larger, and the micro catheter cannot pass through the blocked part in a torsion pushing mode, so that the micro catheter which is finer and can be pushed by torsion is clinically needed to be used for realizing the exchange of the guide wire through a blood vessel with the serious blocked part, and the subsequent interventional operation is completed.

Disclosure of Invention

In order to achieve the above purpose, the invention provides a punching catheter which has small outer diameter and can perform torsion pushing operation, can pass through an occlusion part with small micro-channel in a rotating pushing operation mode during chronic occlusion interventional operation, can slightly expand an occlusion section vessel by utilizing the pipe diameter of the punching catheter, and better assists the passing of subsequent instruments such as a balloon, a stent and the like.

In order to achieve the above object, the present invention has the following technical scheme.

A penetrating catheter comprises a catheter body, wherein a catheter body inner cavity penetrating through the front section and the rear section of the catheter body is arranged in the catheter body; the pipe body comprises a through section and a torsion control section, wherein the rear end of the through section is connected with the front end of the torsion control section; the through section is deformable, when the torsion control section is twisted in one direction, the through section can be driven to deform, so that the cross section diameter of the through section is reduced.

In the communication conduit, based on the arrangement of the through section, the cross section diameter of the through section can be reduced by twisting the torsion control section, namely the outer diameter of the through section is reduced; the guidewire exchange can thus be achieved by rotating the push-through catheter through the small occlusion of the microchannel.

Further, the punching section comprises a deformable inner layer, a deformable layer and an outer layer, wherein the inner layer, the deformable layer and the outer layer are sequentially sleeved and fixed, and a pipe body inner cavity at the punching section is formed in the inner layer of the punching section.

Further, the cross-sectional diameter of the deformation layer of the through section can be reduced when the torsion control section is twisted in one direction, and the inner layer and the outer layer of the through section can be synchronously deformed, so that the cross-sectional diameter of the through section is reduced.

Specifically, the torsion control section is twisted in one direction, the deformation layer is thinned and drives the inner layer of the through section and the outer layer of the through section to synchronously deform, and the inner cavity of the pipe body at the inner layer of the through section is thinned to thin the through section;

the torsion control section is twisted in the other direction, the deformation layer thickens and drives the inner layer of the through section and the outer layer of the through section to deform synchronously, and the inner cavity of the pipe body at the inner layer of the through section thickens and thickens the through section. The above-mentioned tapering is the diameter is smaller, and the thickening is the diameter is larger.

After the punching section passes through the occlusion section, the torsion control section can be reversely twisted, so that after the section diameter of the punching section is recovered, the self pipe diameter is utilized to slightly expand the blood vessel of the occlusion section, the smooth passing of the subsequent balloon, stent and other instruments is facilitated, and the success rate of the operation can be effectively improved

Further, the deformation layer is a through section spring layer; the diameter of the through section is cut off, the through section spring layer in the section of the through section comprises a plurality of metal areas, and a gap area is formed between every two adjacent metal areas;

the torsion control section is twisted in one direction, the distance of a clearance area is shortened, so that the through section spring layer is thinned, the inner layer of the through section and the outer layer of the through section are driven to synchronously deform, and the inner cavity of a pipe body at the inner layer of the through section is thinned, so that the through section is thinned;

the torsion control section is twisted in the other direction, the distance between the clearance areas is prolonged, the spring layer of the through section is thickened, the inner layer of the through section and the outer layer of the through section are driven to deform synchronously, and the inner cavity of the pipe body at the inner layer of the through section is thickened, so that the through section is thickened.

Further, the spring layer is formed by winding a plurality of strands of metal wires, and the metal area is formed by arranging the sections of the strands of metal wires in parallel.

Further, the torsion control section comprises a torsion control section inner layer, a braiding layer, a torsion control section spring layer and a torsion control section outer layer; the braiding layers and the torsion control section spring layers are sequentially sleeved and fixed on the outer sides of the torsion control section inner layers, and the torsion control section outer layers are melted and permeated in gaps between the braiding layers and the spring layers and finally connected with the inner layers.

Further, the torsion control section spring layer is connected with the through section spring layer, and the torsion control section spring layer and the through section spring layer are integrally formed.

Further, the braiding layer is formed by braiding a plurality of strands of filaments.

Further, the inner layer of the torsion control section is made of a polymer material with a low friction coefficient. Can facilitate the smooth passage of the instrument.

Further, the catheter also comprises a head end, a head end inner cavity penetrating through the front end and the rear end of the head end is arranged in the head end, the head end is fixedly arranged at the front end of the penetrating section, and the front end of the inner cavity of the tube body is communicated with the head end inner cavity.

Further, the head end is a structure with a developing function.

Furthermore, the catheter also comprises a stress removing pipe and a catheter seat, wherein the catheter seat is connected with the torsion control section through the stress removing pipe, a catheter seat inner cavity is arranged in the catheter seat, and the catheter seat inner cavity is communicated with the rear end of the catheter body inner cavity.

Compared with the prior art, the invention has the beneficial effects that the through catheter is based on the structural arrangement of the through section, so that the through catheter can reduce the outer diameter of the through section in a torsion control section mode, and the through catheter passes through the small occlusion part of the micro-channel in a rotary pushing operation mode, thereby realizing the guide wire exchange.

Drawings

Fig. 1 is a schematic structural view of the present invention.

Fig. 2 is a cross-sectional view of the present invention.

Fig. 3 is a cross-sectional view of a schematic feedthrough segment, a torque control segment, according to the present invention.

Fig. 4 is a cross-sectional view of the pass-through section.

Fig. 5 is a cross-sectional view of the torque control section.

Fig. 6 is a schematic view of the punch-through catheter prior to twisting.

Fig. 7 is a schematic view of the punch-through catheter after twisting.

Fig. 8 is a schematic diagram of a spring layer winding process.

Detailed Description

The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

Referring to fig. 1-2, the present embodiment provides a feedthrough catheter comprising a head end 1, a shaft 2, a catheter hub 4 and a distressing tube 3. A head end inner cavity 10 is arranged in the head end 1, a catheter seat inner cavity 40 is arranged in the catheter seat 4, and a tube body inner cavity 20 is arranged in the tube body 2;

the head end 1 is of a cone-shaped structure and is connected with the pipe body 2, the pipe body 2 is connected with the pipe seat 4, and the destressing pipe 3 is coated on the surface of the joint of the pipe body 2 and the pipe seat 4.

The head end inner cavity 10 is communicated with the pipe body inner cavity 20, and the pipe body inner cavity 20 is communicated with the catheter seat inner cavity 40; during the operation, the guide wire 5 can enter the tube body cavity 20 through the catheter seat cavity 40 until the head end cavity 10 extends out of the micro-catheter.

The outer part of the destressing tube 3 is of a conical structure and is coated on the outer surface of the joint of the tube body 2 and the catheter seat 4, so that an operator can hold the tube conveniently to twist the tube, and the stress is prevented from being concentrated on the joint of the tube body 2 and the catheter seat 4 to be folded or broken in the twisting operation process. The destressing tube 3 is made of plastic elastomer material such as polyurethane elastomer, polyolefin or polyethylene elastomer.

The catheter hub cavity 40 is a conical inclined surface, facilitates the introduction of the guide wire 5 or the injection of a solution, and is terminated by a luer connector for connecting with other external access instruments. The catheter seat 4 can be connected with the catheter body 2 by adopting a glue bonding or over-molding mode. Materials such as hard polycarbonates, polyurethanes, polyamides and the like are generally selected.

Referring to fig. 3, the head end 1 is integrally in a cone structure, and the head end 1 also has a developing performance, so that an operator can position the head end under X-rays in the operation process. The head end 1 can be made of a polymer material with a developing material, or can be made of a developing ring and a developing spring embedded in the polymer of the head end. Or the head end 1 adopts an all-metal structure to strengthen the hardness of the head end and strengthen the breakthrough capability on intravascular lesions.

Specifically, in the present embodiment, the head end 1 is embedded in the developing ring 11.

Referring to fig. 3-5, in this embodiment, the pipe body 2 includes a through section 21 and a torsion control section 22;

the head end 1 is connected with a through section 21 of the pipe body 2, and the through section 21 comprises a through section inner layer 211, a deformation layer and a through section outer layer 213. The inner layer 211 and the outer layer 213 are made of deformable elastic polymer material, and are attached to the inner and outer surfaces of the deformation layer.

The inner layer 211 and the outer layer 213 of the through section can be made of polyurethane material with better elasticity.

The deformation layer is specifically a through segment spring layer 212; the through segment spring layer 212 includes a plurality of metal regions 2121, and a gap region 2122 is formed between adjacent metal regions 2121, wherein the through segment spring layer 212 is formed by winding a plurality of wires, and the metal regions 2121 are formed by arranging the plurality of wires in parallel.

Specifically, referring to fig. 3, the metal region 2121 is formed by arranging nine sections of metal wires in parallel; a gap region 2122 is formed between two adjacent metal regions 2121.

The gap regions 2122 allow a displaceable space for each metal region 2121 of the through-segment spring layer 212; the metal wire can be made of metal materials such as stainless steel or nickel titanium, and the cross section of the metal wire is rectangular or circular.

Referring to fig. 6 to 7, in the interventional procedure, the operator can make the gap 2122 of the through section 21 shorter by twisting the tube body 2, the through section spring layer 212 becomes thinner and longer, the through section inner layer 211 and the through section outer layer 213 become thinner and longer according to the deformation of the through section spring layer 212, the diameter of the tube body cavity 20 at the through section 21 becomes smaller, the through section inner layer 211 is attached to the surface of the guide wire 5, and when the through section inner layer 211 is attached to the surface of the guide wire 5, the through section 21 obtains excellent passing performance at this time and can smoothly pass through the narrow lesion part along with the guide wire 5. After the through section 21 passes through the narrow lesion site, the operator reversely twists the tube body, the distance of the clearance area 2122 of the through section spring layer 212 is longer, the spring layer is thicker and shorter, the inner layer 211 of the through section and the outer layer 213 of the through section are thicker and shorter according to the deformation of the through section spring layer 212, the diameter of the tube body cavity 20 at the position of the through section tube 21 is larger, the outer diameter of the through section 21 is larger, the through section 21 can slightly expand the narrow lesion site, the channel of the lesion site is enlarged, and the subsequent instrument can smoothly pass through conveniently.

In this embodiment, the torsion control section 22 includes a torsion control section inner layer 221, a braid 222, a torsion control section spring layer 223, and a torsion control section outer layer 224. The inner layer 221 of the torsion control section is made of a polymer material with a low friction coefficient, so that a device can conveniently and smoothly pass through, the braiding layer 222 is woven by a plurality of strands of wires, the spring layer 223 of the torsion control section is wound by a plurality of strands of wires, the outer layer 224 of the torsion control section is made of a polymer layer, and the polymer material on the outer layer melts and permeates into a gap between the braiding layer 222 and the spring layer 223 of the torsion control section in a welding mode, so that the torsion control section is finally connected with the inner layer 211 of the torsion control section.

The inner layer of the torsion control section 22 can be made of high-density polyethylene, polytetrafluoroethylene, polyimide and other polymer materials with low friction coefficients. The braiding layer 222 is braided by 16 strands of monofilaments or 32 strands of double wires, the braiding wires can be rectangular or round stainless steel wires, nickel titanium wires and other materials, the braiding layer 222 can effectively improve pushing force, torsion control performance and folding resistance of the torsion control section 22, and torsion and pushing force can be well transmitted to the punching section and the pipe body is not easy to damage and fold when the rotary pushing operation is required by the apparatus. The outer layer 224 of the torsion control section is a polymer layer, and is made of polyamide, polyurethane, polyolefin, etc. The torsion control section 22 fuses the torsion control section inner layer 221, the braiding layer 222, the torsion control section spring layer 223 and the torsion control section outer layer 224 into a whole in a hot melting mode, the torsion control section 22 cannot deform and be folded during torsion operation, and torsion and thrust can be smoothly conducted to the through section 21.

Referring to fig. 8, the torsion control section spring layer 223 is a tightly wound structure or a less open wound structure with smaller gaps, and the through section spring layer 212 and the torsion control section spring layer 223 are an integral structure; namely, the torsion control section spring layer 223 also comprises a plurality of metal regions 2121, and a gap region 2122 is formed between adjacent metal regions 2121; the torsion control section spring layer 223 and the through section spring layer 212 are formed by winding a plurality of wires (more than or equal to 3), and the intercept from the torsion control section spring layer 223 to the through section spring layer 212 is increased (namely the gap area 2122 is increased), so that the distal end of the tube body is soft and the proximal end has stronger pushing force when passing through a tortuous blood vessel. Before winding the through section spring layer 212 and the torsion control section spring layer 223, the wires are respectively wound on different bobbins 6, then the wires are respectively arranged on the mandrels in sequence, the wires are wound on the mandrels through mandrel rotation or bobbin 6 rotation, and different relative movement speeds of the mandrels and the bobbins 6 are required to be set to realize different intercepts in order to ensure different intercepts from the torsion control section to the through section. After winding is completed, stress relief treatment is needed to be carried out on the through section spring layer 212 and the torsion control section spring layer 223, so that the intercept of the wound spring layer is stable, and rebound does not occur in size. The core shaft can be made of metal materials with certain strength, so that the core shaft can not be broken during winding, and also can be made of polymer core shafts, and the polymer core shafts are gasified at high temperature during stress relieving heat treatment, so that core pulling operation is not needed.

In another spring layer winding method, a plurality of wires are respectively wound on different wire shafts 6, then the wires are respectively arranged on the core shafts in sequence, the winding wire intercept is set to be equal-diameter intercept, stress relief treatment is needed to be carried out on the spring layer after winding is completed, the wound spring layer intercept is ensured to be stable, and then the spring layer intercept is changed through a stretching process, so that the torsion control section spring layer intercept 223 is increased. The intercept is gap region 2122.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims

1. A penetrating catheter comprises a catheter body, wherein a catheter body inner cavity penetrating through the front section and the rear section of the catheter body is arranged in the catheter body; the pipe body comprises a through section and a torsion control section, wherein the rear end of the through section is connected with the front end of the torsion control section; the through section is deformable, when the torsion control section is twisted in one direction, the through section can be driven to deform, so that the cross section diameter of the through section is reduced.

2. The through catheter of claim 1, wherein the through section comprises a deformable inner layer, a deformable layer and an outer layer, the inner layer, the deformable layer and the outer layer are sequentially sleeved and fixed, and a tubular body inner cavity at the through section is formed in the inner layer of the through section.

3. A feedthrough catheter as in claim 2, wherein the deformable layer of the feedthrough segment has a reduced cross-sectional diameter when the torque control segment is twisted in one direction, and the inner and outer layers of the feedthrough segment are synchronously deformable such that the feedthrough segment has a reduced cross-sectional diameter.

4. A feedthrough catheter as in claim 3, wherein the deformation layer is a feedthrough segment spring layer; the diameter of the through section is cut off, the through section spring layer in the section of the through section comprises a plurality of metal areas, and a gap area is formed between every two adjacent metal areas;

5. A feedthrough catheter as in claim 4, wherein the spring layer is wound from a plurality of strands of wire, and the metal region is formed by a parallel arrangement of cross-sections of the strands of wire.

6. The feedthrough catheter of claim 4, wherein the torsion control segment comprises a torsion control segment inner layer, a braid, a torsion control segment spring layer, and a torsion control segment outer layer; the braiding layers and the torsion control section spring layers are sequentially sleeved and fixed on the outer sides of the torsion control section inner layers, and the torsion control section outer layers are melted and permeated in gaps between the braiding layers and the spring layers and finally connected with the inner layers.

7. The feedthrough catheter of claim 6, wherein the torsion control section spring layer and the feedthrough section spring layer are integrally formed.

8. The feedthrough catheter of claim 6, wherein the braid is woven from a plurality of strands.

9. The feedthrough catheter of claim 6, wherein the inner layer of the torque control section comprises a polymeric material having a low coefficient of friction.

10. The through catheter according to claim 1, further comprising a head end having a head end cavity disposed therein through both front and rear ends thereof, the head end being fixedly disposed at the front end of the through section and the front end of the body cavity being in communication with the head end cavity;

the head end is a structure with a developing function.