CN112156324B

CN112156324B - Medical catheter and preparation method thereof

Info

Publication number: CN112156324B
Application number: CN202011138210.9A
Authority: CN
Inventors: 吕怡然
Original assignee: Aike Medical Devices Beijing Co ltd
Current assignee: Eco Medical Devices Beijing Co ltd
Priority date: 2020-10-22
Filing date: 2020-10-22
Publication date: 2022-05-13
Anticipated expiration: 2040-10-22
Also published as: CN112156324A

Abstract

The present disclosure relates to a medical catheter and a method of making the same. The medical catheter tube body (2) comprises an outer layer tube (4) and an inner layer tube (6), the inner wall of the inner layer tube (6) limits a catheter inner cavity, a reinforcing layer (5) is arranged in the outer layer tube (4), and the far end of the inner layer tube (6) is provided with at least one slit (7) and/or at least one weld mark (9) which extend along the axial direction. The medical catheter disclosed by the invention is simple in preparation method, the flexibility of the catheter can be effectively adjusted according to actual requirements by the slit or the weld mark, the flexibility of the tip of the catheter can be improved, the injury of the distal end of the catheter to a blood vessel is avoided, and the performance of the catheter passing through a tortuous blood vessel is improved.

Description

Medical catheter and preparation method thereof

Technical Field

The disclosure relates to the field of medical instruments, in particular to a medical catheter and a preparation method thereof.

Background

The softness of different positions of the medical catheter is important for operation, the proximal catheter body is usually hard and is convenient for force conduction, and the distal end of the catheter is soft and is convenient for passing through tortuous blood vessels and avoiding damaging the blood vessels.

The method for adjusting the hardness of different positions of the catheter commonly used at present is to use polymer pipes with different hardness in sections, the polymer pipes with different hardness are butted together in a hot melting connection mode, the polymer pipes with higher hardness are used at the proximal end of the catheter, and the hardness of the polymer pipes used is lower as the proximal end of the catheter is closer to the distal end of the catheter.

Some catheters are provided with a reinforcing layer, which results in another way of adjusting the stiffness of the catheter at different locations, i.e. by adjusting the density between the braided filaments in the reinforcing layer, the softness of the catheter at different locations is adjusted.

Disclosure of Invention

The technical problem to be solved by the present disclosure is that the method for adjusting the softness of the catheter only by using pipes with different hardness is limited to the properties of the raw material of the pipe; there is a problem of reducing the coaxiality of the guide tube, the conduction of force, and the bending resistance only by adjusting the density of the reinforcing layer.

The inventor utilizes the condition that the polymer pipe and the reinforcing layer which can be used at present have certain density, and processes the far end of the inner pipe to form a slit or further processes the slit to form a weld mark, so that the flexibility of the far end of the conduit can be effectively adjusted. The inventor further coats the outer surface of the catheter with a hydrophilic coating to increase the permeability of the catheter in the blood vessel.

Specifically, the present disclosure proposes the following technical solutions:

in one aspect, some embodiments of the present disclosure provide a medical catheter, a catheter body of the medical catheter includes an outer tube and an inner tube, an inner wall of the inner tube defines a catheter lumen, a reinforcing layer is arranged in the outer tube, and a distal end of the inner tube is provided with at least one slit and/or at least one weld mark extending along an axial direction.

The medical catheter provided in the above embodiment, wherein the slits are arranged equidistantly along the circumference of the inner tube, and preferably, two ends of adjacent slits are aligned or offset forward and backward;

or the welding marks are arranged equidistantly along the circumferential direction of the inner-layer pipe, and preferably, two ends of the adjacent welding marks are aligned or offset front and back.

Any of the embodiments above provides a medical catheter, wherein one or more of the slits are interrupted slits; alternatively, one or more of the weld marks are intermittent weld marks.

The medical catheter provided in any one of the above embodiments, wherein the slit is a linear slit or a wavy linear slit; preferably, the wavy line-shaped slit is a sine wave-shaped slit;

or the welding marks are linear welding marks or wavy linear welding marks; preferably, the wavy linear weld mark is a sine wave-shaped weld mark.

The medical catheter provided in any one of the above embodiments, wherein the distance L1 between the distal end of the slit and the distal end of the inner tube is more than 2 times the inner diameter of the catheter at the distal end of the slit; or the distance L1 between the far end of the weld mark and the tail end of the inner-layer pipe is more than 2 times of the inner diameter of the conduit at the position of the far end of the weld mark;

preferably, the length L2 of the slit or the weld mark is 5mm or more and 1500mm or less;

preferably, the width of the slit or the weld mark is 0.05-0.2 mm.

The medical catheter of any of the above embodiments of the present disclosure, wherein the outer tube is provided with at least one slit and/or at least one weld mark extending along the axial direction;

preferably, the slits and/or weld marks on the outer layer pipe are arranged equidistantly along the circumferential direction of the outer layer pipe;

optionally, the slits on the outer layer pipe are intermittent slits, and the weld marks on the outer layer pipe are intermittent weld marks;

optionally, the slits on the outer layer pipe are linear slits or wavy linear slits, and the weld marks on the outer layer pipe are linear weld marks or wavy linear weld marks.

The medical catheter of any one of the above embodiments, wherein the reinforcement layer is located on the outer wall of the inner tube, optionally the reinforcement layer is a spring coil or a mesh braided tube.

The medical catheter provided in any of the above embodiments, wherein the medical catheter further comprises a visualization section at the distal end and a hub at the proximal end, optionally the proximal end of the visualization section is connected to the distal end of the outer tube;

optionally, wherein the medical catheter further comprises a hydrophilic coating disposed on the outer wall of the outer tube;

optionally, the inner layer pipe is a single-layer or multi-layer pipe, and the outer layer pipe is a single-layer or multi-layer pipe;

optionally, the inner layer pipe is an integrally formed pipe or a multi-section welded pipe, and the outer layer pipe is an integrally formed pipe or a multi-section welded pipe.

In another aspect, the present disclosure provides a method for manufacturing a medical catheter according to any one of the above embodiments, including the steps of: making a slit on the inner-layer pipe;

preferably, the method further comprises the steps of: carrying out hot melting treatment on the slit to form a welding mark;

preferably, the method further comprises the steps of: connecting the developing section and the outer layer pipe together;

preferably, the method further comprises the steps of: connecting the medical catheter and the tube seat together;

preferably, the method further comprises the steps of: and coating a hydrophilic coating on the outermost layer of the medical catheter.

In another aspect, the present disclosure provides a method for manufacturing a medical catheter according to any one of the above embodiments, including the steps of:

making a slit on the inner-layer pipe, and optionally, scribing the slit on the inner-layer pipe by a blade or cutting the slit on the inner-layer pipe by laser;

assembling a reinforcing layer outside the inner layer pipe with the slit;

an outer pipe is sleeved outside the reinforcing layer; optionally, the method further comprises the steps of: manufacturing a slit on the outer layer pipe; optionally, a slit is scribed on the outer tube by a blade or cut on the outer tube by a laser;

and carrying out hot melting treatment on the outer layer pipe, the reinforcing layer and the inner layer pipe integrally, so that the outer layer pipe, the reinforcing layer and the inner layer pipe are combined, and the slit is welded into a weld mark.

The beneficial effects of this disclosure include:

1. according to the slit or the weld mark of the medical catheter in some embodiments of the disclosure, the flexibility of the catheter can be effectively adjusted according to actual requirements, especially the flexibility of the distal end of the catheter can be effectively improved, the injury of the distal end of the catheter to a blood vessel is avoided, and the performance of the catheter passing through a tortuous blood vessel is increased; in some embodiments, medical catheters that employ weld marks may be advantageous over catheters that employ slits to balance catheter flexibility and force conductivity while avoiding interference between components.

2. The hydrophilic coating on the outer surface of the medical catheter of some embodiments of the present disclosure improves the passability of the catheter in blood vessels.

3. Some embodiments of the present disclosure provide methods of preparation that are easy to operate.

Drawings

FIG. 1 is a schematic view of an inner tube according to some embodiments of the present disclosure;

fig. 2 is an overall schematic view of a medical catheter according to example 1 of the present disclosure;

FIG. 3 is a partial cross-sectional view taken at the location labeled B in FIG. 2;

FIG. 4 is an enlarged view of a portion of FIG. 3 at the location marked C;

FIG. 5 is a schematic view of the slit of the inner tube in example 1 of the present disclosure;

FIG. 6 is a schematic view of an inner tube and a reinforcement layer of example 1 of the present disclosure;

FIG. 7 is a schematic view of the slit of the inner tube according to example 2 of the present disclosure;

FIG. 8 is a schematic view of the slit of the inner tube in accordance with example 3 of the present disclosure;

FIG. 9 is a schematic view of the slit of the inner tube according to example 4 of the present disclosure;

FIG. 10 is a schematic view of a medical catheter weld mark according to example 5 of the present disclosure;

FIG. 11 is a schematic view of an inner pipe weld mark according to example 6 of the present disclosure;

FIG. 12 is a schematic view of an inner pipe weld mark according to example 7 of the present disclosure;

FIG. 13 is a schematic view of a slit of a medical catheter according to example 8 of the present disclosure;

FIG. 14 is a schematic view of a medical catheter weld mark according to example 9 of the present disclosure;

in the figure: 1-development section, 2-tube body, 3-tube seat, 4-outer tube, 5-reinforcing layer, 6-inner tube, 7-slit, 71-continuous slit, 72-discontinuous slit, 73-sine wave slit, 8-hydrophilic coating, 9-weld mark, 91-discontinuous weld mark and 92-sine wave weld mark.

Detailed Description

The technical scheme of the disclosure is clearly and completely described in the following with reference to the accompanying drawings. Obviously, based on the specific embodiments in the present disclosure, all other embodiments obtained by a person with ordinary skill in the art without making creative efforts belong to the protection scope of the present disclosure.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present disclosure.

The utility model provides a medical catheter, its inner chamber intercommunication, the body includes outer pipe, enhancement layer and inlayer pipe, and inlayer pipe distal end is equipped with along a plurality of slits and/or a plurality of weld mark of axial extension. In some embodiments, the distal end of the outer tube is provided with a plurality of slits and/or a plurality of weld marks extending along the axial direction. When the slits or weld marks extend in the axial direction, the force is better transmitted than in a medical catheter provided with circumferentially extending slits, facilitating transmission of the force at the proximal end of the catheter in the axial direction of the catheter to the distal end of the catheter.

In some embodiments, the distal end of the tube may be connected to the visualization section and the proximal end of the tube may be connected to the hub. The inner layer pipe and the outer layer pipe can be made of high polymer materials, and can be single-layer or multi-layer. The inner layer pipe and the outer layer pipe can be formed through pipes made of the same high polymer material or can be pipelines formed by hot-melt butt joint of a plurality of sections of high polymer material pipes with different hardness. The reinforcing layer may be a coil woven or wound from metal wire, organic polymer wire, or composite wire.

In some embodiments of the disclosure, the distal end of the outer tube may be coupled to a development stage, which is a metal developed under X-rays or a polymeric material containing a developed metal. The inner tube is provided with a plurality of parallel slits or weld marks extending in the axial direction, and in some embodiments, as shown in FIG. 1, the distance of the distal ends of the slits or weld marks from the distal end L1 of the conduit is more than 2 times the inner diameter of the conduit at the position of the distal end of the slits or weld marks, typically L1 is more than 1mm, and the length of the slits or weld marks is 5mm L2 mm 1500 mm. In some embodiments of the present disclosure, the width of the slit or weld mark is 0.05-0.2 mm.

In some embodiments of the present disclosure, the hydrophilic coating is disposed on the outside of the tube body, for example, the hydrophilic coating can be formed by applying polyvinylpyrrolidone (PVP) to form an anticoagulant, which can increase the permeability of the catheter in the blood vessel.

Some embodiments of the present disclosure provide a method of making a medical catheter, comprising the steps of:

slits are made in the inner tube of a formed medical catheter, for example by a blade or laser.

In the above embodiment, a slit may be further formed in the outer tube of the medical catheter.

In the above embodiment, the slit-cut medical catheter may be further subjected to a heat-fusion treatment so that the slit is fused to a weld mark, for example, by a general heat-fusion laminator.

making a slit on the inner-layer tube, for example, the slit can be cut on the inner-layer tube by a blade, or the slit can be cut on the inner-layer tube by laser;

assembling a reinforcing layer outside the inner layer pipe with the slit;

an outer pipe is sleeved outside the reinforcing layer; alternatively, slits may be made in the outer tube, for example, by cutting the outer tube with a blade, or by cutting the outer tube with a laser;

In any of the above embodiments, further comprising the steps of: the developing section and the outer tube are joined together, for example, by heat fusion or by adhesive bonding.

In any of the above embodiments, further comprising the steps of: the medical tube and hub are joined together, for example, by heat staking or adhesive bonding.

In any of the above embodiments, further comprising the steps of: and coating a hydrophilic coating on the outermost layer of the medical catheter.

The technical solution of the present disclosure is further illustrated by the following specific examples.

Example 1

As shown in fig. 2, the medical catheter of this embodiment includes a tubular body 2, a distal end of the tubular body 2 is connected to the developing section 1 by heat fusion, and a proximal end of the tubular body 2 is bonded to the hub 3. Fig. 3 is a partial cross-sectional view of the catheter body 2 at the location of the distal end marker B of the medical catheter in fig. 2, from which it can be seen that the catheter body 2 comprises an outer tube 4, a reinforcing layer 5 and an inner tube 6, the distal end of the outer tube 4 being connected to the proximal end of the visualization section 1. The inner tube 6 is provided with a plurality of parallel slits 7, the slits 7 extend axially on the inner tube 6, the distance L1 between the distal ends of the slits 7 and the end of the inner tube 6 is 3mm, and the length L2 of the slits 7 is 50 mm. Fig. 4 is an enlarged partial view of fig. 3 at the position marked C, showing the hydrophilic coating 8 on the outside of the outer tube 4. Fig. 5 shows the inner tube 6 alone to further view the plurality of continuous slits 71 in the inner tube 6. Fig. 6 is a schematic view of the reinforcing layer 5 and the inner tube 6 remaining after the outer tube 4 of the tubular body 2 is removed, and the reinforcing layer 5 is a mesh-like coil formed by weaving a metal wire.

Example 2

As shown in fig. 7, the medical catheter of the present embodiment is different from the medical catheter of embodiment 1 in that a plurality of parallel intermittent slits 72 are provided in the inner tube 6, and both ends of the adjacent slits 72 are aligned.

With the aligned interrupted slits of example 2, when the distal end of the catheter encounters a large resistance, the stress transmitted axially at the slits is easily released in stages from the distal end of the catheter to the proximal end.

Example 3

As shown in fig. 8, the medical catheter of the present embodiment is different from the medical catheter of embodiment 1 in that a plurality of parallel intermittent slits 72 are provided in the inner tube 6, and both ends of the adjacent slits 72 are offset forward and backward by a certain distance.

With the staggered interrupted slits of example 3, the stress transmission capability of the catheter is further improved over the medical catheter of example 2.

Example 4

As shown in fig. 9, the medical catheter of the present embodiment is different from the medical catheter of embodiment 1 in that a plurality of sinusoidal slits 73 are provided in the inner tube 6, and the peaks and valleys of each slit correspond to one another. Compared with the first 3 embodiments, the sinusoidal slits 73 can improve the flexibility of the catheter tube, and ensure the force transmission in the axial direction and the force transmission in the circumferential direction (coaxial rotation capability).

Example 5

As shown in fig. 10, the medical catheter of the present example is different from the medical catheter of example 1 in that the slit 7 of the inner tube 6 is welded by a heat-fusion process to form a weld mark 9. The medical catheter with weld marks 9 is less flexible than the medical catheter with slits 7, but more easily conducts thrust in the axial direction of the medical catheter, and the use of weld marks helps balance the flexibility and stress conductivity of the catheter. In addition, the medical catheter adopting the weld marks 9 can avoid hooking the slit on the inner-layer tube 6 when the components placed in the medical catheter move, and avoid the peeling of the inner-layer tube 6 and the catheter body under certain conditions.

Example 6

As shown in fig. 11, the medical catheter of the present example is different from the medical catheter of example 2 in that the intermittent slits 72 in the inner layer tube 6 are welded by a heat-fusion process to form intermittent weld marks 91. Similar to the medical catheter in example 5, the use of the weld mark helps to balance the flexibility and stress conductivity of the catheter, prevent the member placed inside the medical catheter from catching the slit on the inner tube 6 when moving, and prevent the inner tube 6 and the catheter body from peeling off in some cases.

Example 7

As shown in fig. 12, the medical catheter of the present example is different from the medical catheter of example 4 in that sine-wave-shaped slits 73 in the inner layer tube 6 are welded by a heat-melting process to form sine-wave-shaped weld marks 92. Similar to the medical catheter in example 5, the use of the weld mark helps to balance the flexibility and stress conductivity of the catheter, prevent the member placed inside the medical catheter from catching the slit on the inner tube 6 when moving, and prevent the inner tube 6 and the catheter body from peeling off in some cases.

Example 8

As shown in fig. 13, the medical catheter of the present embodiment is different from the medical catheter of embodiment 1 in that the outer tube 4 is similarly provided with a plurality of parallel slits 7, and the slits 7 extend in the axial direction in the outer tube 4. The medical catheter of the present embodiment is advantageous in that the flexibility of the catheter can be further improved by adding parallel slits to the outer tube 4.

Example 9

As shown in fig. 14, the medical catheter of the present example is different from the medical catheter of example 8 in that the slits 7 of the outer layer tube 4 and the inner layer tube 6 are fused by a heat fusion process to form weld marks 9. Similar to the medical catheter in example 5, the use of the weld mark helps to balance the flexibility and stress conductivity of the catheter, prevent the member placed inside the medical catheter from catching the slit on the inner tube 6 when moving, and prevent the inner tube 6 and the catheter body from peeling off in some cases.

The above description is only for the specific embodiments of the present disclosure, but the scope of the present disclosure is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present disclosure, and all the changes or substitutions should be covered within the scope of the present disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.

Claims

1. The utility model provides a medical catheter, body (2) of medical catheter include outer pipe (4) and inlayer pipe (6), the pipe inner chamber is injectd to the inner wall of inlayer pipe (6), its characterized in that, establish enhancement layer (5) in outer pipe (4), inlayer pipe (6) distal end is equipped with along at least one slit (7) of axial extension, and wherein, at least one slit (7) form weld mark (9) through hot melt processing, weld mark (9) are arranged along the circumference equidistance of inlayer pipe (6).

2. The medical catheter as claimed in claim 1, wherein the slits (7) are arranged equidistantly in the circumferential direction of the inner tube (6).

3. The medical catheter as claimed in claim 1, wherein the two ends of adjacent slits (7) are aligned or offset back and forth.

4. The medical catheter as claimed in claim 1, wherein the two ends of adjacent weld marks (9) are aligned or offset back and forth.

5. The medical catheter according to claim 1, wherein one or more of the slits (7) are interrupted slits (72); alternatively, one or more of the weld marks (9) are intermittent weld marks (91).

6. The medical catheter as claimed in claim 1, wherein the slit (7) is a linear slit or an undulating linear slit; or the welding marks (9) are linear welding marks or wavy linear welding marks.

7. The medical catheter as claimed in claim 6, wherein the wavy line shaped slit is a sine wave shaped slit (73); or the wavy linear weld mark is a sine wave-shaped weld mark (92).

8. The medical catheter according to claim 1, wherein the distance L1 between the distal end of the slit (7) and the end of the inner tube (6) is more than 2 times the inner diameter of the catheter at the position of the distal end of the slit (7); or the distance L1 between the far end of the weld mark (9) and the tail end of the inner layer pipe (6) is more than 2 times of the inner diameter of the conduit at the far end position of the weld mark (9).

9. The medical catheter according to claim 8, wherein the length L2 of the slit (7) or the weld mark (9) is 5mm or more and 1500mm or less.

10. The medical catheter as claimed in claim 9, the slit (7) or the weld mark (9) having a width of 0.05-0.2 mm.

11. Medical tube according to any of claims 1-10, wherein the outer tube (4) is provided with at least one slit (7) and/or at least one weld mark (9) extending in axial direction.

12. Medical tube according to claim 11, wherein the slits (7) and/or weld marks (9) on the outer tube (4) are arranged equidistantly in the circumferential direction of the outer tube (4).

13. The medical tube according to claim 11, wherein the slits (7) in the outer tube (4) are interrupted slits (72) and the weld marks (9) in the outer tube (4) are interrupted weld marks (91).

14. The medical tube according to claim 11, wherein the slits (7) on the outer tube (4) are linear slits or wavy linear slits and the weld marks (9) on the outer tube (4) are linear weld marks or wavy linear weld marks.

15. The medical catheter according to any one of claims 1-10, wherein the reinforcement layer (5) is located at the outer wall of the inner tube (6).

16. The medical catheter according to claim 15, wherein the reinforcement layer (5) is a spring coil or a mesh braided tube.

17. The medical catheter according to any one of claims 1-10, wherein the medical catheter further comprises a visualization section (1) at the distal end and a hub (3) at the proximal end.

18. The medical catheter according to claim 17, wherein the proximal end of the visualization section (1) is connected to the distal end of the outer tube (4).

19. The medical catheter according to any one of claims 1-10, wherein the medical catheter further comprises a hydrophilic coating (8), the hydrophilic coating (8) being provided on the outer wall of the outer tube (4).

20. A medical tube according to any one of claims 1-10, wherein the inner tube is a single or multi-layer tube and the outer tube is a single or multi-layer tube.

21. The medical tube of any one of claims 1-10, wherein the inner tube is an integrally formed tube or a multi-segment fused tube and the outer tube is an integrally formed tube or a multi-segment fused tube.

22. A method of making a medical catheter according to any of claims 1-21, comprising the steps of: making a slit on the inner-layer pipe; and performing hot melting treatment on the slits to form welding marks.

23. The method of making a medical catheter as claimed in claim 22, further comprising the steps of: the developing stage and the outer tube are connected together.

24. The method of making a medical catheter as claimed in claim 23, further comprising the steps of: the medical catheter and the hub are connected together.

25. The method of making a medical catheter as claimed in claim 24, further comprising the steps of: and coating a hydrophilic coating on the outermost layer of the medical catheter.

26. A method of making a medical catheter according to any of claims 1-21, comprising the steps of:

making a slit on the inner-layer pipe;

assembling a reinforcing layer outside the inner layer pipe with the slit;

an outer pipe is sleeved outside the reinforcing layer;

27. The method of making a medical catheter as claimed in claim 26, further comprising the steps of:

and making a slit on the outer layer pipe.

28. The method of making a medical catheter according to claim 27, wherein the slit is scored by a blade or cut by a laser.