CN117244161A

CN117244161A - Medical catheter, preparation method thereof, and medical equipment containing the same

Info

Publication number: CN117244161A
Application number: CN202311472863.4A
Authority: CN
Inventors: 秦思豪; 徐庆桥; 涂明明; 陈卫军
Original assignee: Shanghai Jingjiashan Medical Technology Co ltd
Current assignee: Shanghai Jingjiashan Medical Technology Co ltd
Priority date: 2023-11-07
Filing date: 2023-11-07
Publication date: 2023-12-19

Abstract

The invention provides a medical catheter, a preparation method thereof and medical equipment comprising the same, wherein the medical catheter comprises a catheter body; the pipe body comprises an inner layer, a first braiding layer, a second braiding layer and a high polymer layer; the inner layer, the first braiding layer and the second braiding layer are sequentially arranged from inside to outside; the polymer layer is coated outside the second braiding layer and is embedded in gaps among the inner layer, the first braiding layer and the second braiding layer; the inner layer, the first braiding layer and the second braiding layer are fixedly connected through the high polymer layer; the inner layer comprises a first pipe body and at least one second pipe body arranged on the outer wall of the first pipe body. The medical catheter has a double-layer metal wire weaving structure, so that the overall hardness and torsion control performance of the catheter are improved; the multi-cavity structure of the inner layer increases the functionality of the medical catheter and has wide application range.

Description

Medical catheter, preparation method thereof and medical equipment comprising medical catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical catheter, a preparation method thereof and medical equipment comprising the same.

Background

In vascular intervention operation, the accuracy of the positioning of the intervention operation is extremely important, and because of the complexity of human body construction, in order to accurately send an implant to a target position through blood vessels of different paths, a medical catheter is generally required to move along a guiding structure to reach a lesion position at the distal end of the blood vessel so as to establish a diagnosis and treatment path, and the intervention operation has the characteristics of small trauma, multiple indications, definite curative effect, quick postoperative recovery and the like, so that the structure of the catheter plays a very important role in clinical operation.

The traditional catheter is structurally made of single-cavity single-layer metal woven mesh, the torsion control requirement in operation cannot be met under the condition of larger part resistance (such as continuous bending of 90 degrees), stability in operation is poor, torque cannot be transmitted in real time, operation difficulty of operation is definitely increased, time cost is greatly increased, meanwhile, operation technology and clinical experience of a clinician are relatively dependent, meanwhile, the structural function of a single cavity is relatively single, and functions such as multi-component joint work cannot be achieved.

CN213216813U discloses a multilumen tube and an endoscope assembly, wherein the multilumen tube comprises: a multi-lumen tube having axially formed proximal and distal ends; and the inflatable balloon is arranged at the far end of the multi-cavity tube body, and the interior of the multi-cavity tube body is axially divided into a first inner pipeline which is not communicated with each other and matched with the endoscope, a second inner pipeline which is communicated with the inflatable balloon, and a third inner pipeline and a fourth inner pipeline which limit different liquid flow directions. The endoscope assembly can realize multiple functions under the condition of one-time insertion, so that the operation time is greatly saved, the bleeding of a patient is reduced, the operation difficulty is reduced, and the operation quality is improved.

CN211132644U discloses a multi-cavity tube with holes on a partition wall for flexible transmission, comprising a tube body, and is characterized in that at least 2 channel cavities distributed along the axis of the tube body are arranged in the tube body, the channel cavities are separated from each other by the partition wall, all the channel cavities comprise a transmission cavity and at least one perfusion cavity, and the at least one perfusion cavity is communicated with the transmission cavity by at least one hole on the partition wall; the transmission cavity is internally penetrated with a connecting driving flexible shaft for transmitting torque generated by a power source to the rotating functional piece, the power source is positioned at the proximal end of the connecting driving flexible shaft, and the rotating functional piece is positioned at the distal end of the driving flexible shaft.

However, the overall hardness and torque control properties of the multi-lumen tubing described above remain to be further improved.

Disclosure of Invention

In view of the problems existing in the prior art, the invention provides a medical catheter, a preparation method thereof and medical equipment comprising the same, and the medical catheter is improved in overall hardness and torsion control performance and increased in functionality by sequentially arranging a first braiding layer and a second braiding layer outside an inner layer comprising a first tube body and at least one second tube body arranged on the outer wall of the first tube body.

To achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the present invention provides a medical catheter comprising a body;

the pipe body comprises an inner layer, a first braiding layer, a second braiding layer and a high polymer layer;

the inner layer, the first braiding layer and the second braiding layer are sequentially arranged from inside to outside; the polymer layer is coated outside the second braiding layer and is embedded in gaps among the inner layer, the first braiding layer and the second braiding layer; the inner layer, the first braiding layer and the second braiding layer are fixedly connected through the high polymer layer;

the inner layer comprises a first pipe body and at least one second pipe body arranged on the outer wall of the first pipe body.

The medical catheter provided by the invention is of a double-layer braiding multi-cavity structure, and the inner layer, the first braiding layer and the second braiding layer which are sequentially arranged from inside to outside greatly increase the metal coverage rate inside the medical catheter, improve the overall hardness and the torsion control performance of the medical catheter and are beneficial to reducing the operation difficulty of clinical operations; and the inner layer comprises a first pipe body and at least one second pipe body arranged on the outer wall of the first pipe body, so that the functionality of the medical catheter is increased, the functions of unidirectional or multidirectional bending control of the medical catheter or the simultaneous working of the functional part and the control part of the medical catheter can be realized, and the application range is wide.

The shape of the first pipe body is not particularly limited, and may be circular or other shapes. The invention does not limit the distribution position of the second pipe body on the outer wall of the first pipe body, and the second pipe body position can be distributed according to clinical requirements, so that the multifunctional control can be realized. If the second pipe body is internally penetrated with a metal stay wire, the metal stay wire can freely slide in the second pipe body, so that the bending adjusting function is realized.

Preferably, the inner layer comprises at least two second tubular bodies, which may be, for example, two, three, four, five or six, etc.; at least two second body along the circumference interval setting of first body.

Preferably, the inner diameter of the first pipe body is larger than the inner diameter of the second pipe body.

Preferably, the material of the inner layer comprises polytetrafluoroethylene and/or polyether block amide.

The inner layer is preferably made of polytetrafluoroethylene, so that the surface lubrication of the inner cavity of the catheter can be realized, the conveying resistance of the inner cavity of the catheter and the internal instrument of the catheter can be reduced during operation, and good operation performance is realized.

The wall thickness of the first pipe body is preferably 0.02 to 0.07mm, and may be, for example, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.065mm, or 0.07mm, etc., but the wall thickness is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned value range are equally applicable.

The second pipe body preferably has an inner diameter of 0.2 to 0.6mm, for example, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.55mm, or 0.6mm, but the present invention is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned value range are equally applicable.

Preferably, the first and second braiding layers are composed of flat and/or round filaments.

The thickness of the flat yarn is preferably 0.01 to 0.25mm, and may be, for example, 0.01mm, 0.05mm, 0.1mm, 0.15mm, 0.2mm, 0.23mm, or 0.25mm, etc., but is not limited to the recited values, and other non-recited values within the range of values are equally applicable;

the width is 0.05 to 0.5mm, and may be, for example, 0.05mm, 0.1mm, 0.15mm, 0.2mm, 0.3mm, 0.4mm, or 0.5mm, etc., but is not limited to the recited values, and other values not recited in the range of the recited values are equally applicable.

The diameter of the round wire is preferably 0.05 to 0.3mm, and may be, for example, 0.05mm, 0.08mm, 0.1mm, 0.15mm, 0.2mm, 0.25mm, or 0.3mm, etc., but the round wire is not limited to the recited values, and other non-recited values within the range of the values are equally applicable.

Preferably, the material of the braiding wires used for the first braiding layer and the second braiding layer comprises any one or a combination of at least two of 304 stainless steel, 316 stainless steel, platinum iridium alloy, platinum tungsten alloy or nickel titanium, wherein typical but non-limiting combinations comprise combinations of 304 stainless steel and 316 stainless steel, combinations of platinum iridium alloy and platinum tungsten alloy or combinations of nickel titanium and 304 stainless steel.

Preferably, the number of knitting heads of the first knitting layer and the second knitting layer is 1-32, for example, 1, 5, 10, 15, 20, 25 or 32, but not limited to the listed values, and other non-listed values are equally applicable in the range; the knitting density may be 10 to 120, for example, 10, 20, 50, 80, 100, 110, 120, or the like, but is not limited to the values recited, and other values not recited in the numerical range are equally applicable.

Preferably, the first and second braiding layers are each single-layer braiding.

Preferably, the polymeric layer material comprises any one or a combination of at least two of a thermoplastic polyurethane elastomer, a polyether block amide, or a nylon, wherein typical but non-limiting combinations include a combination of a thermoplastic polyurethane elastomer and a polyether block amide, a combination of a nylon and a thermoplastic polyurethane elastomer, or a combination of a polyether block amide and a nylon.

The hardness of the polymer layer is preferably 25 to 72D, and may be, for example, 25D, 30D, 35D, 40D, 50D, 60D, 72D, or the like, but is not limited to the values listed, and other values not listed in the range are equally applicable.

The hardness of the polymer layer is preferably gradually softened from the proximal end to the distal end, the hardness change is uniform, the medical catheter has no stress concentration, and the damage to human tissues or the functional failure of instruments caused by bending of the medical catheter in the clinical transportation process can be avoided.

In a second aspect, the present invention further provides a medical device, including the medical catheter of the first aspect, further including at least one pull wire, the pull wire is disposed through the second tube, and a distal end of the pull wire is connected to the medical catheter, and by pulling a proximal end of the pull wire, bending of the distal end of the medical catheter can be controlled.

The medical device of the invention further comprises at least one stay wire, which can be one, two, three, four or five, for example.

In a third aspect, the present invention also provides a method for preparing a medical catheter according to the first aspect, the method comprising the steps of:

s1: the outer side of the inner layer is sequentially provided with a first braiding layer, a second braiding layer and a high polymer layer;

s2: and (3) melting the polymer layer by heating, penetrating the melted polymer layer into gaps among the inner layer, the first braiding layer and the second braiding layer, so as to fixedly connect the inner layer, the first braiding layer and the second braiding layer, and cooling to obtain the medical catheter.

The preparation method of the medical catheter is simple to operate, the first braiding layer and the second braiding layer are sequentially arranged on the outer side of the inner layer, the overall hardness and the torsion control performance of the medical catheter are improved, the first braiding layer and the second braiding layer can be sequentially braided on other objects and then transferred to the inner layer, and the first braiding layer and the second braiding layer can also be directly braided on the inner layer in sequence; continuing to set the polymer layer; the high polymer layer is melted in a heating mode by using the heating block, the melted high polymer layer is permeated into the gaps of the inner layer, the first braiding layer and the second braiding layer, so that the inner layer, the first braiding layer and the second braiding layer are fixedly connected, other bonding materials are not required to be added, other operation steps are not required to be added, and the medical catheter can be obtained after cooling.

Compared with the prior art, the invention has at least the following beneficial effects:

(1) The medical catheter provided by the invention has a double-layer metal wire braiding structure, so that the metal coverage rate in the medical catheter is greatly increased, the torsion control performance is better in the use process, a better transmission effect can be realized, the radial dimension of the medical catheter is ensured to meet the use requirement, the overall hardness and the torsion control performance of the medical catheter are improved, and the operation difficulty of clinical operation is reduced;

(2) The medical catheter provided by the invention adopts a multi-cavity structure, the functionality is increased, the functions of unidirectional or multidirectional bending control of the medical catheter or simultaneous working of the catheter functional component and the control component can be realized, and the medical catheter has a large-scale popularization and application range prospect.

Drawings

Fig. 1 is a schematic view of a medical catheter according to an embodiment of the present invention.

Fig. 2 is a front view of a medical catheter according to an embodiment of the present invention.

Fig. 3 is a schematic illustration of an inner layer in a medical catheter according to an embodiment of the present invention.

Fig. 4 is a schematic illustration of an inner layer and a first braid in a medical catheter in accordance with an embodiment of the present invention.

Fig. 5 is a schematic illustration of an inner layer, a first braid and a second braid in a medical catheter in accordance with an embodiment of the present invention.

Fig. 6 is an axial view of an inner layer, a first braid and a second braid in a medical catheter in accordance with an embodiment of the present invention.

In the figure: 1-an inner layer; 2-a first braid; 3-a second braid; 4-polymer layer.

Detailed Description

The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.

The present invention will be described in further detail below. The following examples are merely illustrative of the present invention and are not intended to represent or limit the scope of the invention as defined in the claims.

It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus are not to be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.

It should be noted that, in the description of the present invention, unless explicitly specified and limited otherwise, the terms "disposed," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art in a specific case.

As an embodiment of the present invention, a medical catheter is provided, a schematic view of which is shown in fig. 1, and a front view of which is shown in fig. 2.

The medical catheter comprises a catheter body, the total length of the medical catheter is 1000mm, and the pipe diameter of the medical catheter is 10F.

The pipe body comprises an inner layer 1, a first braiding layer 2, a second braiding layer 3 and a high polymer layer 4;

the inner layer 1, the first braiding layer 2 and the second braiding layer 3 are sequentially arranged from inside to outside; the polymer layer 4 is coated outside the second braiding layer 3 and is embedded in gaps among the inner layer 1, the first braiding layer 2 and the second braiding layer 3; the inner layer 1, the first braiding layer 2 and the second braiding layer 3 are fixedly connected through the polymer layer 4;

the inner layer 1 comprises a first pipe body and 4 second pipe bodies arranged on the outer wall of the first pipe body.

The 4 second pipes are uniformly distributed at intervals of 90 degrees, and the schematic diagram is shown in fig. 3.

The inner diameter of the first pipe body is larger than that of the second pipe body.

The material of the inner layer 1 is polytetrafluoroethylene.

The wall thickness of the first pipe body is 0.02-0.07 mm, and the inner diameter is 1.8mm.

The inner diameter of the second pipe body is 0.5mm.

The first braid 2 and the second braid 3 are each composed of flat filaments.

A schematic view of the inner layer 1 and the first braid 2 is shown in fig. 4, a schematic view of the inner layer 1, the first braid 2 and the second braid 3 is shown in fig. 5, and an axial view is shown in fig. 6.

The thickness of the flat wire is 0.05mm, the width of the flat wire is 0.15mm, and the length of the flat wire is 1000mm.

The material of the braiding wires used for the first braiding layer 2 and the second braiding layer 3 is 304 stainless steel,

the number of knitting heads of the first knitting layer 2 and the second knitting layer 3 is 16, and the knitting density PPI is 60.

The first braiding layer 2 and the second braiding layer 3 are both single-layer braiding.

The polymer layer 4 is made of Pebax 3533SA01 MED, pebax4533SA01 MED, pebax 55333SA01 MED and Pebax 3533SA01 MED from proximal end to distal endCare ML21 composition. The material of the 1 st section polymer layer is Pebax 3533SA01 MED with the length of 200mm, the material of the 2 nd section polymer layer is Pebax4533SA01 MED with the length of 200mm, the material of the 3 rd section polymer layer is Pebax 55333 SA01 MED with the length of 200mm, and the material of the 4 th section polymer layer is>Care ML21, 600mm in length. The hardness of the polymer layer 4 is 25 to 72D.

As a specific embodiment of the present invention, there is further provided a medical apparatus including the above medical catheter, the medical apparatus further including a pull wire, the pull wire is disposed through the second tube, and a distal end of the pull wire is connected to the medical catheter, and by pulling a proximal end of the pull wire, bending of the distal end of the medical catheter can be controlled. As a specific embodiment of the present invention, there is also provided a method for preparing the medical catheter described above, the method comprising the steps of:

s1: after a first braiding layer 2 and a second braiding layer 3 are braided on the outer side of an inner layer 1 in sequence, a polymer layer 4 is arranged on the second braiding layer 3;

s2: and (3) melting the polymer layer 4 by heating, penetrating the melted polymer layer 4 into gaps among the inner layer 1, the first braiding layer 2 and the second braiding layer 3, thereby fixedly connecting the first braiding layer 2 and the second braiding layer 3 of the inner layer 1, and cooling to obtain the medical catheter.

In summary, the medical catheter provided by the invention has a double-layer metal wire braiding structure, so that the metal coverage rate in the medical catheter is greatly increased, the torsion control performance is better in the use process, a better transmission effect can be realized, the radial dimension of the medical catheter is ensured to meet the use requirement, the overall hardness and the torsion control performance of the medical catheter are improved, and the operation difficulty of clinical operation is reduced; the multi-cavity structure increases the functionality of the multi-cavity structure, and can realize the functions of unidirectional or multidirectional bending control of the medical catheter or the simultaneous working of the catheter functional component and the control component, and the like.

The applicant states that the detailed structural features of the present invention are described by the above embodiments, but the present invention is not limited to the above detailed structural features, i.e. it does not mean that the present invention must be implemented depending on the above detailed structural features. It should be apparent to those skilled in the art that any modifications of the present invention, equivalent substitutions of selected components of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope of the present invention and the scope of the disclosure.

The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solution of the present invention within the scope of the technical concept of the present invention, and all the simple modifications belong to the protection scope of the present invention.

Claims

1. A medical catheter, wherein the medical catheter comprises a body;

the pipe body comprises an inner layer (1), a first braiding layer (2), a second braiding layer (3) and a high polymer layer (4);

the inner layer (1), the first braiding layer (2) and the second braiding layer (3) are sequentially arranged from inside to outside; the polymer layer (4) is coated outside the second braiding layer (3) and is embedded in gaps among the inner layer (1), the first braiding layer (2) and the second braiding layer (3); the inner layer (1), the first braiding layer (2) and the second braiding layer (3) are fixedly connected through the high polymer layer (4);

the inner layer (1) comprises a first pipe body and at least one second pipe body arranged on the outer wall of the first pipe body.

2. Medical catheter according to claim 1, characterized in that the inner layer (1) comprises at least two second tubes, which are arranged at intervals along the circumference of the first tube.

3. The medical catheter of claim 1 or 2, wherein an inner diameter of the first tube is greater than an inner diameter of the second tube.

4. A medical catheter according to any of claims 1-3, characterized in that the material of the inner layer (1) comprises polytetrafluoroethylene and/or polyether block amide.

5. The medical catheter of any one of claims 1-4, wherein the first tube has a wall thickness of 0.02-0.07 mm and/or the second tube has an inner diameter of 0.2-0.6 mm.

6. Medical catheter according to any one of claims 1 to 5, characterized in that the first braid (2) and the second braid (3) consist of flat and/or round filaments.

7. Medical catheter according to any one of claims 1-6, characterized in that the number of braiding heads of the first braiding layer (2) and the second braiding layer (3) is 1-32 strands, the braiding density is 10-120, and/or the first braiding layer (2) and the second braiding layer (3) are single-layer braiding.

8. The medical catheter according to any one of claims 1 to 7, wherein the material of the polymer layer (4) comprises any one or a combination of at least two of thermoplastic polyurethane elastomer, polyether block amide or nylon,

and/or the hardness of the polymer layer (4) is 25-72D.

9. A medical device comprising the medical catheter of any one of claims 1-8, further comprising at least one pull wire, said pull wire being threaded through said second tube, and a distal end of said pull wire being connected to said medical catheter, the distal end of said medical catheter being controllable to bend by pulling on a proximal end of said pull wire.

10. A method of preparing a medical catheter according to any one of claims 1 to 8, comprising the steps of:

s1: a first braiding layer (2), a second braiding layer (3) and a polymer layer (4) are sequentially arranged on the outer side of the inner layer (1);

s2: and (3) melting the polymer layer (4) by heating, penetrating the melted polymer layer (4) into gaps of the inner layer (1), the first braiding layer (2) and the second braiding layer (3), thereby fixedly connecting the inner layer (1), the first braiding layer (2) and the second braiding layer (3), and cooling to obtain the medical catheter.