Dual-lumen multifunctional catheter

The coaxial design and malleable structure of the dual-lumen multifunctional catheter solve the problems of cumbersome operation and complications associated with single-lumen catheters, enabling efficient and safe interventional surgical procedures.

WO2025241742A1PCT designated stage Publication Date: 2025-11-27SINOVA MEDICAL TECHNOLOGIES CO LTD
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Patent Information

Application Number
PCT/CN2025/087520
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-21
Filing Date
2025-04-07
Publication Date
2025-11-27

AI Technical Summary

Technical Problem

Existing single-lumen angiography catheters are cumbersome to operate in interventional procedures, requiring repeated threading of the guidewire and angiography, and are prone to complications such as embolic agent or drug reflux, affecting the efficiency and safety of the procedure.

Method used

This multifunctional catheter features a coaxial dual-lumen structure, with the inner and outer lumens not completely sealed. The outer lumen is used for angiography and drug injection, while the inner lumen is used for guidewire guidance. Combined with a malleable structural segment, it can adapt to different blood vessel shapes, enabling rapid localization and management of complications.

Benefits of technology

Improve surgical efficiency, reduce the number of guidewire changes, lower the risk of complications, and enhance surgical convenience and safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed in the present application is a dual-lumen multifunctional catheter, comprising a catheter body and a Y-connector, wherein the catheter body comprises an inner-lumen tube and an outer-lumen tube, the outer-lumen tube is sleeved outside the inner-lumen tube, an annular cavity is formed between an outer wall of the inner-lumen tube and an inner wall of the outer-lumen tube, and the inner-lumen tube and the outer-lumen tube are connected at a tip part which is not completely sealed and serves as an outlet of the outer lumen. In conclusion, the present application relates to a dual-lumen multifunctional catheter, which integrates multiple functions of angiography, drug perfusion and access establishment, allows guidewire and microcatheter to pass therethrough, and does not need to repeatedly replace guidewire during angiography, thereby improving the operation convenience, shortening the operation time, and reducing the treatment cost; a shapeable structure section is further provided at one end of the catheter, has a shape that can be adjusted according to different blood vessel requirements, and is highly practical; and the catheter assists in positioning of the microcatheter, and a contrast agent and drugs can be injected through the outer lumen as needed during embolotherapy to reduce complications.
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Description

Dual-lumen multifunctional catheter

[0001] This application is based on and claims priority to Chinese Patent Application No. 202410632707.8, filed on May 21, 2024, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0002] The present application belongs to the technical field of medical devices, and specifically relates to a dual-lumen multifunctional catheter. BACKGROUND

[0003] In clinical practice, when treating tissue and organ lesions through interventional surgery, an interventional treatment channel needs to be established first. Under the guidance of imaging equipment, contrast agent is injected through the lumen of a contrast catheter to observe the blood vessel path, and a secondary blood vessel entrance is found with the help of a curved structure of a distal fixed form under the guidance of a guide wire. The catheter is pushed to the corresponding secondary blood vessel position.

[0004] After the contrast catheter reaches the corresponding secondary blood vessel, a microcatheter and a microguide wire can be advanced along the contrast catheter and further superselectively enter the blood vessel near the lesion. After the microcatheter reaches the lesion, embolic agents or drugs are injected for treatment. If complications occur during the treatment, appropriate measures need to be taken to handle the complications. Through the study of existing surgical methods, the applicant found that the contrast catheter has only one lumen. When positioning the secondary blood vessel, the guide wire needs to be withdrawn from the lumen for contrast observation. The medical staff spends a lot of surgical time on the back-and-forth threading of the guide wire and contrast observation. When the microcatheter is superselectively positioned, the guide wire also needs to be threaded back and forth and contrast observed. The operation is extremely cumbersome, which seriously affects the surgical efficiency.

[0005] In addition, when the microcatheter injects embolic agents or other drugs, it is easy to cause reflux of the embolic agents or drugs and some other complications. Because there is only a single lumen, relevant drugs cannot be injected in time to reduce complications.

[0006] Any prior art mentioned in the specification does not mean that it is recognized or suggested that the prior art constitutes part of the common general knowledge in any jurisdiction, or can be reasonably expected to be understood, considered relevant and / or combined with other prior art by a person skilled in the art.

[0007] SUMMARY

[0008] The purpose of the present application is to provide a dual-lumen multifunctional catheter. The dual-lumen multifunctional catheter adopts a coaxial dual-lumen structure, and the outer lumen and the inner lumen at one end are not completely closed. When the dual-lumen multifunctional catheter is used for positioning and contrast, the doctor does not need to withdraw the guide wire. When the microcatheter is positioned and contrasted, the doctor can inject through the outer lumen of the dual-lumen multifunctional catheter to determine the position of the microcatheter, which facilitates timely adjustment of the position of the catheter. When the microcatheter injects embolic agents or drugs, if reflux or complications occur, the doctor can inject drugs through the outer lumen of the dual-lumen multifunctional catheter to handle the complications.

[0009] To solve the above technical problems, the application adopts the following technical solutions:

[0010] The double-lumen multifunctional catheter comprises a catheter body and a Y-shaped joint, the catheter body comprises an inner lumen tube and an outer lumen tube, the outer lumen tube is sleeved outside the inner lumen tube, an annular cavity is formed between the outer wall of the inner lumen tube and the inner wall of the outer lumen tube, and an annular gap is formed between the distal end of the outer lumen tube and the distal end of the inner lumen tube;

[0011] The Y-shaped joint is connected to the proximal end of the catheter body, the Y-shaped joint is provided with a first connecting port and a second connecting port, the first connecting port is connected to the proximal end of the inner lumen tube, and the second connecting port is connected to the proximal end side wall of the outer lumen tube and communicates with the annular cavity.

[0012] Further, a reinforcing support tube is fixed in the Y-shaped joint and sleeved on the proximal end portion of the inner lumen tube.

[0013] Further, a stress diffusion tube is arranged between the end portion of the Y-shaped joint and the outer wall of the outer lumen tube.

[0014] Further, the distal end of the catheter body has a plastic structure section.

[0015] Further, the first connecting port and the second connecting port are both luer interfaces.

[0016] Compared with the prior art, the application has the beneficial effects that the application relates to a double-lumen multifunctional catheter, which integrates multiple functions of radiography and drug perfusion, uses a conventional guide wire for radiography or drug perfusion, and does not need to replace the guide wire back and forth during radiography, thereby improving the convenience of surgery, shortening the surgery time and reducing the treatment cost; in addition, the plastic structure section is arranged at the distal end, which can adjust the shape according to different blood vessel requirements and has high practicability. The double-lumen multifunctional catheter can assist the microcatheter to quickly superselect to the branch blood vessel near the lesion position without withdrawing the micro guide wire, thereby improving the convenience of surgery and shortening the surgery time. When reflux or other complications occur during the injection of embolic agents or drugs by the microcatheter, the double-lumen multifunctional catheter can be used to inject drugs through the outer lumen to handle the situation in time.

[0017] The terms "comprise" and variations of the term, such as "comprises" and "comprising," will be understood to imply the inclusion of a stated step or integer or group of steps or integers but not the exclusion of any other step or integer or group of steps or integers. BRIEF DESCRIPTION OF DRAWINGS

[0018] The accompanying drawings are used to provide further understanding of the present application, and constitute a part of the specification, which together with the embodiments of the present application, serve to explain the present application, and do not constitute a limitation to the present application. In the drawings:

[0019] Fig. 1 is a structural schematic diagram of a double-lumen multifunctional catheter of the present application;

[0020] Fig. 2 is a structural schematic diagram of a catheter body;

[0021] Fig. 3 is a structural schematic diagram of a Y-shaped joint;

[0022] Fig. 4 is a position schematic diagram of an annular gap;

[0023] Fig. 5 is an external structure diagram of a moldable structure section;

[0024] Fig. 6 is an external structure diagram of a moldable structure section;

[0025] Fig. 7 is an external structure diagram of a moldable structure section. DETAILED DESCRIPTION

[0026] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings of the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0027] The present application will be described in further detail below in conjunction with the embodiments.

[0028] A specific embodiment of a double-lumen multifunctional catheter provided by the present application is as follows:

[0029] As shown in Figs. 1-4, the double-lumen multifunctional catheter comprises a catheter body 100 and a Y-shaped joint 1. The catheter body 100 comprises an inner lumen tube 2 and an outer lumen tube 3. The inner lumen tube 2 is made of a high-molecular elastic material. The surface friction coefficient of the inner lumen tube 2 made of the high-molecular elastic material is small, so that the injection of contrast agent is more smooth. Meanwhile, the inner lumen tube 2 has a certain elasticity. When the inner lumen is injected, the lumen naturally expands to improve the flow rate of the inner lumen. When the outer lumen is injected, the inner lumen tube is squeezed to expand the space of the outer lumen and improve the flow rate of the outer lumen. The outer lumen tube 3 is made of a metal wire and a high-molecular material. The metal wire is a stainless steel wire or a nickel-titanium alloy wire. The high-molecular material comprises polytetrafluoroethylene, polyamide and block polyether amide elastomer. The catheter with this structure has good pushability, supportability and anti-burst strength, which improves the operability and safety of the surgery.

[0030] As shown in FIG. 2, the inner lumen tube 2 and the outer lumen tube 3 are coaxial double lumen structure, that is, the inner lumen tube 2 is inserted into the outer lumen tube 3, and the outer wall of the inner lumen tube 2 and the inner wall of the outer lumen tube 3 form an annular cavity 4, as shown in FIG. 4, the distal end of the outer lumen tube 3 and the distal end of the inner lumen tube 2 have an annular gap 5, which can also be understood as the distal end of the outer lumen tube 3 and the inner lumen tube 2 are not completely sealed, and the annular gap 5 is located at the distal end of the annular cavity 4; the product is not punched at the distal end position, the outer lumen tube and the inner lumen tube are connected at the tip position, and are not completely sealed, which serves as the outer lumen outlet.

[0031] The Y-shaped joint 1 is connected to the proximal end of the catheter body 100, and a stress diffusion tube 6 is arranged between the end of the Y-shaped joint 1 and the outer wall of the outer lumen tube 3, the stress diffusion tube 6 is also made of high molecular elastic material, which can effectively avoid the catheter from being broken at the joint connection position when the tube body is bent, the Y-shaped joint 1 is provided with a first connecting port 7 and a second connecting port 8, both of which are standard luer joints, which can be connected with other devices with standard interfaces for use, and the first connecting port 7 is connected with the proximal end of the inner lumen tube 2;

[0032] The Y-shaped joint 1 is also fixed with a reinforcing support tube 9, the reinforcing support tube 9 is made of polyamide material, and the reinforcing support tube 9 is sleeved on the proximal end of the inner lumen tube 2, which can play a supporting role, and can improve the connection strength and sealing strength of the inner lumen tube 2 and the first connecting port 7, preventing the connection point from being washed off when the inner lumen or the outer lumen injects contrast medium. The inner lumen tube 2 mainly functions to inject contrast, and can also pass through a guide wire or a microcatheter; the second connecting port 8 is connected to the proximal side wall of the outer lumen tube 3, and is in communication with the annular cavity 4, and when injecting through the second connecting port 8, the contrast medium or the medicament can flow out through the annular gap, when the microcatheter or the guide wire is inserted into the inner lumen tube 2, the outer lumen tube 3 can inject contrast medium, which can assist the positioning of the double lumen multifunctional catheter and the microcatheter, and avoid the reflux of embolic agents or drugs and other complications when the microcatheter injects embolic agents.

[0033] When the present application is used in surgery, the contrast medium can be injected into the annular cavity 4 through the second connecting port 8 as the guide wire is advanced, so as to accurately confirm the position in the blood vessel, without the need to replace the guide wire, thereby improving the surgical efficiency and shortening the operation time; secondly, when the microcatheter injects embolic agents, the present application can assist the microcatheter to accurately inject embolic agents, and physiological saline or contrast medium can be injected into the annular cavity 4 through the second connecting port 8, thereby improving the effect of embolization treatment.

[0034] In addition, due to the special material of the outer lumen tube 3 and the inner lumen tube 2, when injecting into the outer lumen tube 3, the inner lumen tube 2 is extruded, so that the annular cavity 4 occupies more space, thereby improving the injection rate; when injecting into the inner lumen tube 2, the pressure of the inner lumen tube 2 increases, the annular cavity 4 is extruded, and the inner lumen tube 2 occupies more space, thereby improving the injection rate.

[0035] As another embodiment of the present application, the distal end of the catheter body 100 is a plastic structure section 10, which can be deformed into various shapes to meet the clinical needs to adapt to different blood vessels, for example, as shown in Figure 5, the plastic structure section 10 is shaped as an Amplatz guide catheter, as shown in Figure 6, the plastic structure section 10 is shaped as a Judkins catheter, and as shown in Figure 7, the plastic structure section 10 is shaped as an Internal Mammary catheter.

[0036] The plastic structure section 10 is in a straight line state when the guide wire is supported in the inner lumen tube 2 during surgery, which facilitates the smooth entry of the double-lumen multifunctional catheter into the primary blood vessel, and then the guide wire is withdrawn, and the plastic structure section 10 immediately recovers to the corresponding shape without the support of the guide wire, which is beneficial to quickly positioning to the secondary blood vessel entrance, and at the same time, the annular lumen is used to inject contrast medium to confirm the accuracy of positioning.

[0037] According to the above design scheme, the inner lumen tube 2 and the outer lumen tube 3 of the double-lumen multifunctional catheter of the present application are coaxial double-lumen tubes, the walls of the inner lumen tube 2 and the outer lumen tube 3 form an annular lumen, the first connecting port 7 leads to the inner lumen tube 2, and the second connecting port 8 leads to the annular lumen, both the first connecting port and the second connecting port are standard luer connectors, which can be connected with other devices with standard interfaces for use. The inner lumen tube 2 can be used for high-pressure injection and can pass through the guide wire and the microcatheter, the annular lumen 4 is used for contrast medium injection, which helps the double-lumen multifunctional catheter to quickly position to the corresponding secondary blood vessel entrance, assists the microcatheter to enter the target blood vessel, and the annular lumen 4 is used for drug injection to reduce the complications caused by the microcatheter during embolization therapy.

[0038] Compared with the existing contrast catheter in the market, the double-lumen multifunctional catheter of the present application does not need to withdraw the inner lumen guide wire to quickly position by using the outer lumen to inject contrast medium, and at the same time, the outer lumen is used to assist the microcatheter to quickly position, in addition, when the microcatheter injection embolization agent reflux or causes related complications, the outer lumen of the double-lumen multifunctional catheter can be used for injection treatment to reduce the complications; the double-lumen multifunctional catheter is easy to operate, does not need to withdraw the guide wire or the microcatheter back and forth for contrast operation, improves the operation efficiency, and improves the operation safety.

[0039] It should be noted that in this text, terms such as "including", "containing" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or device.

[0040] While embodiments of the present application have been shown and described, it is to be understood that the embodiments can be varied, modified, substituted and otherwise changed by those skilled in the art without departing from the principles and spirit of the application, the scope of which is to be determined by the following claims and their equivalents.

Claims

1. A dual lumen multi-functional catheter, characterized by: The catheter body comprises an inner lumen tube and an outer lumen tube, the outer lumen tube is sleeved outside the inner lumen tube, an annular cavity is formed between the outer wall of the inner lumen tube and the inner wall of the outer lumen tube, and an annular gap is formed between the distal end of the outer lumen tube and the distal end of the inner lumen tube; The Y-shaped joint is connected to the proximal end of the catheter body, the Y-shaped joint is provided with a first connecting port and a second connecting port, the first connecting port is connected to the proximal end of the inner lumen tube, and the second connecting port is connected to the proximal end side wall of the outer lumen tube and communicates with the annular cavity.

2. The dual lumen multifunctional catheter of claim 1, wherein: A reinforcing support tube is fixed in the Y-shaped joint and sleeved on the proximal end portion of the inner lumen tube.

3. The dual lumen multi-functional catheter of claim 2, wherein: A stress diffusion tube is arranged between the end portion of the Y-shaped joint and the outer wall of the outer lumen tube.

4. The dual lumen multifunctional catheter of claim 1, wherein: The distal end of the catheter body has a plastic type structure section.

5. The dual lumen multi-functional catheter of claim 4, wherein: The first connecting port and the second connecting port are both luer interfaces.

Citation Information

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