WO2022099829A1

WO2022099829A1 - Hemodialysis catheter and production method therefor

Info

Publication number: WO2022099829A1
Application number: PCT/CN2020/133849
Authority: WO
Inventors: 闻潮声; 林悦凤
Original assignee: 广东百合医疗科技股份有限公司
Priority date: 2020-11-11
Filing date: 2020-12-04
Publication date: 2022-05-19
Also published as: CN112386757A; CN112386757B

Abstract

A hemodialysis catheter and a production method therefor. The hemodialysis catheter comprises a catheter body (100); one end of the catheter body (100) is a head end, and the other end of the catheter body (100) is a tail end; a first guide hole (110) and a second guide hole (120) are provided on the end face of the head end in the length extension direction of the catheter body (100); a separation rib (130) is provided between the first guide hole (110) and the second guide hole (120), and the separation rib (130) equally divides the interior of the catheter body (100) into a first guide cavity and a second guide cavity; a guide channel (140) is provided in the separation rib (130), the guide channel (140) extends in the length direction of the catheter body (100) and penetrates through the catheter body (100), a first opening (150) and a second opening (160) are provided on the outer side wall of the catheter body (100), the first guide hole (110) is in communication with a first extension tube (200), the second guide hole (120) is in communication with a second extension tube (300), and a guide channel (140) is in communication with a guide tube (400). The hemodialysis catheter has diversified functions, is flexible to use, and can effectively improve the practicability in clinical medicine.

Description

A kind of hemodialysis catheter and its production method

technical field

The invention relates to a medical device, in particular to a hemodialysis catheter and a production method thereof.

Background technique

The hemodialysis catheter is an intravascular catheter used for dialysis treatment. It is generally punctured from the subclavian vein, internal jugular vein or femoral vein. During dialysis treatment, it is connected to the extracorporeal blood circuit, hemodialysis machine and hemodialyzer. The blood flows out from the arterial end of the dialysis catheter and enters the dialyzer through the arterial pipeline of the blood circuit. The dialyzer uses molecular diffusion to filter impurities in the blood, adjusts the ion balance, and finally enters the venous end of the dialysis catheter through the venous pipeline of the blood circuit. Return to the human body to form a circulation. In the clinical treatment process, the guide wire is first inserted into the blood vessel through puncture, then the hemodialysis catheter is pushed along the guide wire into the blood vessel, and finally the guide wire is removed from the hemodialysis catheter to complete the process. Intubation. Existing hemodialysis catheters usually have a double-lumen structure, which can only perform simple dialysis treatment, with single function and poor user experience.

technical solutions

The purpose of the present invention is to provide a hemodialysis catheter and a production method thereof, so as to solve one or more technical problems existing in the prior art, and at least provide a beneficial choice or create conditions.

The solution that the present invention solves its technical problem is:

A hemodialysis catheter comprises a tube body, one end of the tube body is a head end, the other end of the tube body is a terminal end, and the end face of the head end is provided with a first guide hole along the length extending direction of the tube body and the second guide hole, a separation rib is arranged between the first guide hole and the second guide hole, and the separation rib divides the inside of the pipe body into a first guide cavity and a second guide cavity. A guide cavity, a guide channel is arranged in the separation rib, the guide channel runs through the length direction of the tube body, and the outer side wall of the tube body is provided with a first opening and a second an opening, the first opening communicates with the first guide hole, the second opening communicates with the second guide hole, the first guide hole communicates with a first extension tube, the The second guide hole communicates with the second extension tube, and the guide channel communicates with the guide tube.

The technical solution has at least the following beneficial effects: three mutually independent spaces are arranged in the pipe body, which are the guide channels located on the separating rib, the first guide hole and the second guide hole on both sides of the separating rib, which guide the Both ends of the guide channel are in a conducting state, and the end of the first guide hole away from the orifice is communicated with the first opening, and the end of the second guide hole away from the orifice is communicated with the second opening. During catheter placement, the guide wire can be inserted into the guide channel and extended out of the guide tube, and the first guide hole and the second guide hole can be used as blood inflow and blood outflow channels, respectively. The tube and the second extension tube are convenient to connect the tube body to the peripheral equipment, so that the blood can flow in and out. During the dialysis process, infusion and blood drawing can also be carried out through the guide tube, which is more convenient to use. , the functions of the invention are more diverse, the use is more flexible, and the practicability in clinical medicine can be effectively improved.

As a further improvement of the above technical solution, the orientation of the first opening is opposite to the orientation of the second opening. The inflow and outflow directions of blood are opposite, which can reduce the occurrence of blood flowing out of the tube body and then flow back into the tube body immediately, which can improve the efficiency of dialysis treatment.

As a further improvement of the above technical solution, the inner wall surface of the first guide hole facing the first opening is a first guide surface, and the first guide surface is in the direction from the head end to the end Inclined in a direction close to the first opening. The inclined design of the first guide surface can guide the inflow of blood, so that the blood deviates from the second opening when it converges from the first opening and flows in, further reducing the occurrence of blood flowing back into the tube body immediately after flowing out of the tube body.

As a further improvement of the above technical solution, the inner wall surface of the second guide hole facing the second opening is a second guide surface, and the second guide surface is in the direction from the head end to the end Inclined in a direction close to the second opening. Similarly, the inclined design of the second guide surface can guide the outflow of blood, so that when the blood flows out of the second opening, the blood is guided along the second guide surface and away from the first opening, further reducing the flow of blood from the tube body. The situation occurs when it flows back into the pipe body immediately after the outflow.

As a further improvement of the above technical solution, the end is connected with a connection seat, and the first extension tube, the second extension tube and the guide tube are respectively connected to the connection seat. The connection seat can make the first extension tube, the second extension tube and the guide tube more conveniently connected to the connection seat.

As a further improvement of the above technical solution, a first pipe clamp is provided on the first extension pipe, a second pipe clamp is provided on the second extension pipe, and a third pipe clamp is provided on the guide pipe. The first extension tube can be opened or closed through the first tube clamp to control the on-off of the first extension tube. Similarly, the second extension tube can be opened or closed through the second tube clamp to control the on-off of the second extension tube. , the guide tube can be opened or closed through the third tube clamp to control the on-off of the guide tube.

As a further improvement of the above technical solution, a first pipe joint is provided at the end of the first extension pipe away from the pipe body, and a second pipe joint is provided at the end of the second extension pipe away from the pipe body. A third pipe joint is provided at one end of the guide pipe away from the pipe body. The first pipe joint can be used to easily connect the peripheral pipeline to the first extended pipe. Similarly, the second pipe joint can be used to easily connect the peripheral pipeline to the second extended pipe. The pipe joint can easily connect the pipeline of the peripheral equipment to the pipe body.

A method for producing a hemodialysis catheter, comprising the following steps: Step S1: inserting a pipe body from a molding cavity opened on one side of a molding die, heating the molding die, and heating the part of the catheter inserted into the molding cavity to a molten state, and Insert the forming core from the forming channel opened on the other side of the forming mold, and the forming core extends into the forming cavity along the center line of the forming cavity; Step S2: Insert the first core needle and the second core needle into the forming cavity. In the forming cavity, the positions of the first core needle and the second core needle in the forming cavity are symmetrical with respect to the forming core; step S3: cooling and forming; step S4: demoulding to obtain a semi-finished product; step S5: in The outer side wall of the semi-finished product is opened with holes to obtain the above-mentioned hemodialysis catheter.

The technical solution has at least the following beneficial effects: first insert the tube body into the molding cavity, and heat the molding die, so that the part of the tube body inserted into the molding cavity is heated to a molten state, and then inserts the molding core, the molding core can be obtained Guide the shape of the channel, and then insert the first core needle and the second core needle into the molding cavity, and the positions of the first core needle and the second core needle respectively form the first guide hole and the second guide hole , a separating rib is formed between the first core needle and the second core needle, and then a semi-finished product is obtained after cooling and molding, and the first opening and the second opening are obtained by opening the holes, so that the hemodialysis catheter can be obtained. There are three independent channels in the dialysis catheter.

As a further improvement of the above technical solution, the first core needle is a semi-annular cylinder, the top side of the first core needle is provided with an arc-shaped cut surface, and the arc-shaped cut surface extends to the end of the first core needle On the side of the bottom edge, in the step S2, when the first core needle is inserted into the molding cavity, the arc-shaped cut surface faces into the molding cavity. The arc-shaped cut surface shape of the first core needle enables the first guide hole to form an inclined first guide surface design during molding, which saves the trouble of post-processing and makes the whole production more convenient.

As a further improvement of the above technical solution, the structure of the second core needle is center-symmetrical with respect to the structures of the forming core and the first core needle. The structure of the first core needle and the second core needle is the same, and the mold manufacturing is more cost-effective and convenient. When in use, only the first core needle needs to be rotated 180 degrees around the forming core to obtain the required amount of the second core needle. Similarly, the arc-shaped section of the second core needle makes the second guide hole form an inclined second guide surface design during molding, which saves the trouble of post-processing and makes the whole production more convenient.

Description of drawings

In order to illustrate the technical solutions in the embodiments of the present invention more clearly, the following briefly describes the accompanying drawings that are used in the description of the embodiments. Obviously, the described drawings are only a part of the embodiments of the present invention, but not all of the embodiments, and those skilled in the art can obtain other design solutions and drawings according to these drawings without creative work.

Fig. 1 is the overall structure schematic diagram of the present invention;

Fig. 2 is the structural schematic diagram of the head end of the pipe body of the present invention;

Fig. 3 is the A-A sectional structure schematic diagram of Fig. 2;

Fig. 4 is the structural schematic diagram of the pipe end of the present invention;

Fig. 5 is the structure schematic diagram of the molding die of the present invention;

FIG. 6 is a schematic structural diagram of the first core needle and the second core needle of the present invention.

In the drawings: 100-pipe body, 110-first guide hole, 120-second guide hole, 130-separation rib, 140-guide channel, 150-first opening, 160-second opening, 170- Second guide surface, 200-first extension tube, 300-second extension tube, 400-guide tube, 510-first tube clip, 520-second tube clip, 530-third tube clip, 610-first tube clip One pipe joint, 620-second pipe joint, 630-third pipe joint, 700-connecting seat, 810-forming mold, 811-forming cavity, 812-forming channel, 820-first core needle, 821-arc cut surface , 830-second core needle.

Embodiments of the present invention

The concept, specific structure and technical effects of the present invention will be clearly and completely described below with reference to the embodiments and accompanying drawings, so as to fully understand the purpose, characteristics and effects of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative efforts are all within the scope of The scope of protection of the present invention. In addition, all connection relationships mentioned in the text do not mean that the components are directly connected, but refer to a better connection structure that can be formed by adding or reducing connection accessories according to specific implementation conditions. Various technical features in the present invention can be combined interactively on the premise of not contradicting each other.

Referring to FIG. 1, a hemodialysis catheter includes a tube body, one end of the tube body is a head end, the other end of the tube body is a terminal end, and the end face of the head end is provided with a first end along the length extending direction of the tube body. A guide hole and a second guide hole, a partition rib is arranged between the first guide hole and the second guide hole, and the partition rib divides the inside of the pipe body into first guide holes. cavity and a second guide cavity, the separating rib is provided with a guiding channel, the guiding channel is along the length direction of the tube body and penetrates the tube body, and the outer side wall of the tube body is provided with a first an opening and a second opening, the first opening and the first guide hole communicate with each other, the second opening and the second guide hole communicate with each other, and the first guide hole communicates with a first extension The second guide hole communicates with a second extension tube, and the guide channel communicates with a guide tube.

It can be seen from the above that there are three mutually independent spaces in the pipe body, which are the guide channels located on the partition ribs, the first guide holes and the second guide holes located on both sides of the partition ribs, and the two ends of the guide channels are: The end of the first guide hole away from the orifice is in communication with the first opening, and the end of the second guide hole away from the orifice is in communication with the second opening. The guide wire can be inserted into the guide channel and extended out of the guide tube, and the first guide hole and the second guide hole can be used as channels for blood inflow and blood outflow, respectively. Then it is convenient to connect the tube body to the peripheral equipment, so that the blood flows in and out. During the dialysis process, operations such as infusion and blood drawing can also be carried out through the guide tube, which is more convenient to use. Therefore, the function of the present invention is more Diversified and more flexible in use, which can effectively improve the practicability in clinical medicine.

When the hemodialysis catheter is undergoing dialysis treatment, after the blood enters the tube body, it goes through the extracorporeal circulation blood circuit for dialysis treatment, and then returns from the tube body to the venous blood vessel. , this phenomenon is called recirculation. The recirculation rate is an evaluation index of the dialysis treatment efficiency. The lower the recirculation rate, the better the dialysis treatment effect. Otherwise, the dialysis efficiency is worse. In order to reduce the recirculation rate, in this embodiment, the direction of the first opening is The orientation of the second opening is opposite. The inflow and outflow directions of blood are opposite, which can reduce the occurrence of blood flowing out of the tube body and then flow back into the tube body immediately, which can improve the efficiency of dialysis treatment.

In order to further reduce the recirculation rate, in this embodiment, the inner wall surface of the first guide hole facing the first opening is a first guide surface, and the first guide surface extends from the head end to the first opening. The direction of the tip is inclined in a direction close to the first opening. The inclined design of the first guide surface can guide the inflow of blood, so that the blood deviates from the second opening when it converges from the first opening and flows in, further reducing the occurrence of blood flowing back into the tube body immediately after flowing out of the tube body.

In order to further reduce the recirculation rate, in this embodiment, the inner wall surface of the second guide hole facing the second opening is a second guide surface, and the second guide surface extends from the head end to the second opening. The direction of the tip is inclined in a direction close to the second opening. Similarly, the inclined design of the second guide surface can guide the outflow of blood, so that when the blood flows out of the second opening, the blood is guided along the second guide surface and away from the first opening, further reducing the flow of blood from the tube body. The situation occurs when it flows back into the pipe body immediately after the outflow.

In order to conveniently connect the pipe body to other pipelines, in this embodiment, the end is connected with a connection seat, and the first extension pipe, the second extension pipe and the guide pipe are respectively connected to the connection seat. The connection seat can make the first extension tube, the second extension tube and the guide tube more conveniently connected to the connection seat.

In practical applications, it is necessary to control the on-off of blood in the first extension tube, the second extension tube and the guide tube. Therefore, in this embodiment, the first extension tube is provided with a first tube clamp, so the The second extension tube is provided with a second pipe clamp, and the guide pipe is provided with a third pipe clamp. The first extension tube can be opened or closed through the first tube clamp to control the on-off of the first extension tube. Similarly, the second extension tube can be opened or closed through the second tube clamp to control the on-off of the second extension tube. , the guide tube can be opened or closed through the third tube clamp to control the on-off of the guide tube.

In some embodiments, a first pipe joint is disposed at one end of the first extension pipe away from the pipe body, and a second pipe joint is disposed at one end of the second extension pipe away from the pipe body. The end of the pipe away from the pipe body is provided with a third pipe joint. The first pipe joint can be used to easily connect the peripheral pipeline to the first extended pipe. Similarly, the second pipe joint can be used to easily connect the peripheral pipeline to the second extended pipe. The pipe joint can easily connect the pipeline of the peripheral equipment to the pipe body.

As shown in FIG. 5 , a method for producing a hemodialysis catheter includes the following steps: Step S1 : inserting a tube body from a molding cavity opened on one side of a molding die, heating the molding die, and inserting the catheter into the part of the molding cavity Heating to a molten state, and inserting a molding core from the molding channel opened on the other side of the molding die, and the molding core extends into the molding cavity along the centerline of the molding cavity; Step S2: Connect the first core needle to the molding cavity. The second core needle is inserted into the forming cavity, and the positions of the first core needle and the second core needle in the forming cavity are symmetrical with respect to the forming core; step S3: cooling and forming; step S4: demoulding, obtaining Semi-finished product; Step S5: opening a hole on the outer side wall of the semi-finished product to obtain the above-mentioned hemodialysis catheter.

The tube body inserted into the molding cavity here is a tube with only one channel, such as a single-channel hose, and its end needs to be processed into a three-channel tube body. From this production method, the tube body is first inserted into the molding chamber. inside the cavity, and heating the forming mold, so that the part of the tube body inserted into the forming cavity is heated to a molten state, and then the forming core is inserted, and the forming core can obtain the shape of the guide channel, and then the first core needle and the second core needle are connected. Inserted into the molding cavity, the positions of the first core needle and the second core needle form a first guide hole and a second guide hole respectively, and a separation rib is formed between the first core needle and the second core needle. , and then after cooling and forming, a semi-finished product is obtained, and the first opening and the second opening are obtained by opening the holes, so that the hemodialysis catheter can be obtained, and the hemodialysis catheter has three mutually independent channels.

As shown in FIG. 6 , in order to make the whole production method more efficient, in this embodiment, the first core needle is a semi-annular cylinder, the top side of the first core needle is provided with an arc-shaped cut surface, and the arc The arc-shaped cut surface extends to the bottom side of the end of the first core pin. In the step S2, when the first core pin is inserted into the molding cavity, the arc-shaped cut surface faces into the molding cavity. The arc-shaped cut surface shape of the first core needle enables the first guide hole to form an inclined first guide surface design during molding, which saves the trouble of post-processing and makes the whole production more convenient.

Likewise, in order to make the entire production method more efficient, in this embodiment, the structures of the second core needles are center-symmetrical with respect to the structures of the forming core and the first core needles. The structure of the first core needle and the second core needle is the same, and the mold manufacturing is more cost-effective and convenient. When in use, only the first core needle needs to be rotated 180 degrees around the forming core to obtain the required amount of the second core needle. Similarly, the arc-shaped section of the second core needle makes the second guide hole form an inclined second guide surface design during molding, which saves the trouble of post-processing and makes the whole production more convenient.

The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments, and those skilled in the art can also make various equivalent modifications or substitutions without departing from the spirit of the present invention, These equivalent modifications or substitutions are all included within the scope defined by the claims of the present application.

Claims

A hemodialysis catheter is characterized by comprising a tube body, one end of the tube body is a head end, the other end of the tube body is a terminal end, and the end face of the head end is provided with a first end along the extending direction of the length of the tube body. A guide hole and a second guide hole, a partition rib is arranged between the first guide hole and the second guide hole, and the partition rib divides the inside of the pipe body into first guide holes. cavity and a second guide cavity, the separating rib is provided with a guiding channel, the guiding channel is along the length direction of the tube body and penetrates the tube body, and the outer side wall of the tube body is provided with a first an opening and a second opening, the first opening and the first guide hole communicate with each other, the second opening and the second guide hole communicate with each other, and the first guide hole communicates with a first extension The second guide hole communicates with a second extension tube, and the guide channel communicates with a guide tube.
The hemodialysis catheter according to claim 1, wherein the orientation of the first opening is opposite to the orientation of the second opening.
The hemodialysis catheter according to claim 2, wherein the inner wall surface of the first guide hole facing the first opening is a first guide surface, and the first guide surface is formed by the The direction from the head end to the end end is inclined in a direction close to the first opening.
The hemodialysis catheter according to claim 2, wherein the inner wall surface of the second guide hole facing the second opening is a second guide surface, and the second guide surface is formed by the The direction from the head end to the end end is inclined in a direction close to the second opening.
The hemodialysis catheter according to claim 2, wherein the end is connected with a connection seat, and the first extension tube, the second extension tube and the guide tube are respectively connected to the connection seat.
The hemodialysis catheter according to claim 2, wherein a first pipe clamp is provided on the first extension pipe, a second pipe clamp is provided on the second extension pipe, and the guide pipe is provided with a first pipe clamp. A third pipe clamp is arranged on it.
The hemodialysis catheter according to claim 2, wherein a first pipe joint is provided at one end of the first extension tube away from the tube body, and an end of the second extension tube away from the tube body is provided A second pipe joint is provided, and a third pipe joint is provided at one end of the guide pipe away from the pipe body.
A method for producing a hemodialysis catheter, comprising the steps of:

Step S1: insert the tube body from the molding cavity opened on one side of the molding die, heat the molding die to make the part of the catheter inserted into the molding cavity heated to a molten state, and insert molding from the molding channel opened on the other side of the molding die a core, the forming core extends into the forming cavity along the centerline of the forming cavity;

Step S2: inserting the first core needle and the second core needle into the forming cavity, and the positions of the first core needle and the second core needle in the forming cavity are symmetrical with respect to the forming core;

Step S3: cooling and forming;

Step S4: demoulding to obtain a semi-finished product;

Step S5 : opening a hole on the outer side wall of the semi-finished product to obtain the hemodialysis catheter according to any one of claims 1 to 7 .
The method for producing a hemodialysis catheter according to claim 8, wherein the first core needle is a semi-annular cylinder, the top side of the first core needle is provided with an arc-shaped cut surface, and the arc The arc-shaped cut surface extends to the bottom side of the end of the first core pin. In the step S2, when the first core pin is inserted into the molding cavity, the arc-shaped cut surface faces into the molding cavity.
The method for producing a hemodialysis catheter according to claim 9, wherein the structure of the second core needle is center-symmetrical with respect to the structures of the forming core and the first core needle.