Bending-adjustable embolism double-balloon interventional catheter

Abstract

The bending-adjustable embolism double-balloon intervention catheter comprises a catheter body and a first balloon arranged at the far end of the catheter body, the far end of the catheter body can be bent, a second balloon is further arranged at the far end of the catheter body, and a balloon cavity capable of filling the first balloon and the second balloon is formed in the catheter body. A through hole is formed in the portion, located between the first balloon and the second balloon, of a catheter body of the catheter, a medicine cavity channel is formed in the catheter and communicated with the through hole, a guide wire cavity channel is further formed in the catheter, and the far end of the guide wire cavity channel penetrates through the catheter. Compared with the prior art, the medicine is prevented from flowing back and flowing to normal blood vessels, the problem that the medicine flows back in the liver tumor interventional embolism or precise chemotherapy process is solved, the problem that the medicine gathers and converges to normal branch blood vessels for tumor blood supply is solved, the medicine only gathers to the tumor blood supply last branch blood vessels, the accuracy of embolism or chemotherapy is improved, and the treatment effect is improved. And the ability of smoothly passing through the liver blood vessel and quickly reaching the diseased region is achieved.

Description

Technical Field

[0001] The invention relates to a medical device, in particular to an embolization double-balloon interventional catheter with adjustable bend for tumor embolization drugs. Background Art

[0002] Common treatments for liver tumors include surgical resection, chemotherapy, radiotherapy, and interventional therapy. Among interventional therapy, embolization is an important method, which injects embolic substances into the blood vessels supplying the tumor to block the blood supply to the tumor, or delivers chemotherapy drugs to the tumor site, thereby inhibiting tumor growth.

[0003] However, in the existing liver tumor embolization treatment, there is a problem of poor concentration of embolization chemotherapy drugs. This is mainly due to the complexity and diversity of tumor blood vessels and the limitations of existing embolization equipment and technology.

[0004] Existing embolization methods and equipment are often unable to accurately control the distribution of embolic materials in blood vessels, causing embolic drugs to easily flow back into other normal blood vessels, which not only affects the treatment effect but also increases the use of chemotherapy drugs.

[0005] A large amount of chemotherapy drugs diffuse in the body, causing unnecessary damage to other tissues and organs of the patient, increasing the patient's physical burden and treatment side effects. For example, due to the failure of accurate infusion of drugs and embolic agents or the large infusion volume, existing treatment methods may cause adverse reactions of chemotherapy drugs, such as nausea, vomiting, hair loss and other symptoms; it may also have an inhibitory effect on the immune system, making patients more susceptible to infection; the impact on the hematopoietic system may be manifested as a decrease in the number of white blood cells, red blood cells and platelets, causing anemia, bleeding and other problems.

[0006] In addition, the lack of concentration of embolic drugs may also lead to incomplete embolization, and tumor cells can still obtain partial blood supply, continue to grow and spread, and affect the long-term effect of treatment.

[0007] This not only increases the pain and treatment costs of patients, but also brings great challenges to medical work. Therefore, how to effectively solve the problem of liver tumor embolism and chemotherapy drug concentration, as well as accurately reach the terminal blood vessel position of the tumor blood supply, has become an important issue that needs to be solved in the current medical field.

[0008] For example, the embolization microcatheter disclosed in Patent No. ZL201910975862.9 is only a microcatheter for delivering embolization liquid or drugs, and has no anti-reflux device, which can easily cause the embolization drug to flow back into the normal blood vessels and cause the embolization drug to be not concentrated;

[0009] Patent application No. ZL202080052652.3 discloses an embolization catheter for reflux-free delivery of microspheres, wherein the filter section is located near the distal end opening; the filter section includes a large number of openings distributed circumferentially around the wall of the filter section, and the filter section is configured to prevent the embolic microspheres from flowing out while allowing the suspension fluid to flow out to prevent drug backflow. Since the blood supply vessels cannot be completely blocked, the reflux is only prevented by the outflow of the suspension, and the embolic microspheres cannot be completely and effectively gathered in the tumor blood supply vessels, and the phenomenon of embolic microsphere backflow will still occur;

[0010] Patent application number ZL202310683648.2 discloses a balloon microcatheter for proximal drug delivery. As a single-balloon microcatheter, it can only block proximal backflow in one direction. Due to the abundance of liver blood vessels, there may be multiple vascular branches supplying blood to the terminal tumor. It only blocks the proximal backflow but does not block the distal vascular branches, causing the embolic drugs to gather in normal tissues and failing to achieve precise embolization chemotherapy. At the same time, due to the abundance and tortuosity of liver blood vessels, it is difficult for ordinary catheters to reach the lesion site of blood supply at the terminal of the tumor, resulting in a long learning cycle for doctors and low effect of precise embolization. Summary of the invention

[0011] The purpose of the present invention is to provide an adjustable embolization double-balloon interventional catheter, and the technical problem to be solved is to improve the accuracy of embolization or precision chemotherapy and prevent drug backflow during embolization or precision chemotherapy.

[0012] To solve the above problems, the present invention adopts the following technical solutions: an adjustable embolization double-balloon interventional catheter, comprising a catheter, a first balloon arranged at the distal end of the catheter, the distal end of the catheter is adjustable, a second balloon is also arranged at the distal end of the catheter, a balloon cavity is provided in the catheter for filling the first balloon and the second balloon, a through hole is provided on the catheter body between the first balloon and the second balloon, a drug cavity is provided in the catheter, the drug cavity is connected with the through hole, so that embolism or drug solvent can be injected from the proximal end of the catheter through the drug cavity, and a guidewire cavity is also provided in the catheter, and the distal end of the guidewire cavity passes through the catheter.

[0013] Furthermore, a developing ring is provided on the conduit.

[0014] Furthermore, at least a portion of the catheter body located at the first balloon and the second balloon is provided with a developing ring.

[0015] Furthermore, a bending adjustment core wire for adjusting the bending is provided in the catheter, and the distal end of the bending adjustment core wire is fixed to the distal end of the catheter, so that the distal end of the catheter can be bent and deformed when the bending adjustment core wire is pulled.

[0016] Furthermore, two bending adjustment core wires are provided in the catheter, and the bending adjustment core wires are symmetrically arranged on opposite sides of the catheter.

[0017] Furthermore, a hydrophilic coating is provided on the outer wall of the distal tube body of the catheter.

[0018] Furthermore, the catheter includes an inner tube, a first reinforcement layer arranged outside the inner tube, and a second reinforcement layer arranged outside the first reinforcement layer. The inner tube is tubular and has an axially arranged inner cavity. The guidewire cavity is composed of the inner cavity. The balloon cavity and the drug cavity are arranged in the second reinforcement layer. The proximal end and distal end of the first balloon and the proximal end and distal end of the second balloon are sealed and connected to the second reinforcement layer, and the through hole is arranged on the second reinforcement layer.

[0019] Furthermore, the hardness of the catheter gradually decreases from the proximal end to the distal end.

[0020] Furthermore, the hardness of the second reinforcement layer gradually decreases from the proximal end to the distal end.

[0021] Furthermore, the first reinforcement layer is composed of at least one of a braided structure and a spiral spring structure.

[0022] Compared with the prior art, the present invention provides a second balloon, a through hole is provided on the catheter body between the first balloon and the second balloon, a drug cavity connected to the through hole is provided in the catheter, and the two balloons block the proximal and distal ends of the blood supply vessel where the tumor is located, so that the drug is injected into the blood supply vessel between the two balloons through the through hole, thereby avoiding drug reflux and flow to normal blood vessels, solving the problem of drug backflow during interventional embolization or precise chemotherapy of liver tumors, and solving the problem of drug aggregation and convergence in normal branch blood vessels supplying blood to the tumor, so that the drug is only aggregated in the terminal blood vessels supplying blood to the tumor, thereby improving the accuracy of embolism or chemotherapy, and setting the distal end of the catheter to an adjustable bend structure, thereby solving the problem of smooth passage in the liver blood vessels and the ability to quickly reach the lesion site. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a structural schematic diagram of the present invention.

[0024] Figure 2 yes Figure 1 Cross-sectional view along the DD direction.

[0025] Figure 3 yes Figure 1 Cross-sectional view along the AA direction.

[0026] Figure 4 yes Figure 3 Cross-sectional view along CC direction.

[0027] Figure 5 It is a schematic diagram of the connection between the bending core wire and the catheter of the present invention.

[0028] Figure 6 It is a schematic diagram of the positional relationship between the developing ring and the balloon of the present invention.

[0029] Figure 7 It is a schematic diagram of the positional relationship between the developing ring and the guide tube of the present invention. DETAILED DESCRIPTION

[0030] The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

[0031] In the present invention, the distal end refers to the end away from the surgical operator; the proximal end refers to the end close to the surgical operator. Figure 1 The position of the developing ring is marked in FIG. 1 , but it does not mean that the developing ring is arranged on the outer wall of the conduit 1 . Figure 1 The markings are for schematic purposes only.

[0032] like Figure 1 and Figure 2 As shown, the present invention discloses an adjustable-bend embolization double-balloon interventional catheter, comprising a catheter 1, a first balloon 2 and a second balloon 3 arranged at the distal end of the catheter 1, the first balloon 2 and the second balloon 3 being arranged at intervals to achieve blocking between the proximal end and the distal end of the diseased blood vessel, the distal end of the catheter 1 being adjustable-bend to achieve control of the catheter 1 in pushing in the liver blood vessel, the catheter 1 being provided with a balloon cavity 4 capable of filling the first balloon 2 and the second balloon 3, the balloon cavity 4 not penetrating the distal end of the catheter 1, an injection through hole 15 communicating with the balloon cavity 4 being provided on the tube body of the catheter 1 located at the first balloon 2 and the second balloon 3, the balloon cavity 4 axially extending It extends to the proximal end of the catheter 1 and penetrates the proximal end of the catheter 1. A through hole 5 is provided on the catheter body of the catheter 1 between the first balloon 2 and the second balloon 3. A drug lumen 6 is provided in the catheter 1. The drug lumen 6 is communicated with the through hole 5. The distal end of the drug lumen 6 does not penetrate the distal end of the catheter 1. The drug lumen 6 axially extends to the proximal end of the catheter 1 and penetrates the proximal end of the catheter 1 so as to inject embolism or drug solvent from the proximal end of the catheter 1 through the drug lumen 6. A guidewire lumen 7 is also provided in the catheter 1. The distal end and proximal end of the guidewire lumen 7 penetrate the distal end and proximal end of the catheter 1 respectively. The guidewire lumen 7, the drug lumen 6 and the balloon lumen 4 are not coaxially arranged.

[0033] Two balloons are used and a separate balloon cavity is provided for balloon filling. Filling medium is supplied to fill, block and withdraw the balloon, so that the embolic drug can only accumulate in the area between the two balloons. A separate drug cavity is also provided for drug delivery, and a distal opening is opened between the two balloons to facilitate the delivery of drugs to the blood vessels supplying the tumor.

[0034] In the present invention, three through holes 5 are provided and spaced apart, and one injection through hole 15 is provided in each of the first balloon 2 and the second balloon 3 .

[0035] like Figure 1 As shown, a developing ring 8 is provided on the catheter 1 to achieve accurate positioning of the balloon in the blood vessel. Optionally, at least the portion of the catheter body of the catheter 1 located at the first balloon 2 and the second balloon 3 is provided with a developing ring 8, as shown in FIG. Figure 6 As shown, optionally, the developing ring 8 is respectively arranged at a position opposite to the shoulder of the first balloon 2 and the second balloon 3, and a developing ring 8 is also arranged at the distal end of the catheter 1, 1-2 mm away from the distal end of the catheter 1, as a developing ring at the head end, to further improve the accurate positioning of the balloon in the blood vessel; as an example, the distance between the two developing rings 8 near the through hole 5 is 0.8-1.5 cm. The developing ring 8 is connected and fixed to the catheter 1 by welding or gluing.

[0036] In the present invention, the first balloon 2 and the second balloon 3 are compliant balloons, which can be made of TPU (thermoplastic polyurethane elastomer) or TPE (thermoplastic elastomer) material.

[0037] like Figure 3 and Figure 4 As shown, the catheter 1 includes an inner tube 10, a first reinforcement layer 11 arranged outside the inner tube 10, and a second reinforcement layer 12 arranged outside the first reinforcement layer 11. The inner tube 10 is a tubular structure, having an axially arranged inner cavity, the guide wire cavity 7 is composed of the inner cavity, the balloon cavity 4 and the drug cavity 6 are arranged in the tube wall of the second reinforcement layer 12, the proximal end and the distal end of the first balloon 2 and the proximal end and the distal end of the second balloon 3 are sealed and connected to the second reinforcement layer 12, the through hole 5 is arranged on the second reinforcement layer 12, and the outer wall of the distal end of the second reinforcement layer 12 is provided with a hydrophilic coating, as shown in FIG. Figure 7 As shown, the developing ring 8 is sleeved and fixed outside the first reinforcing layer 11 .

[0038] In the present invention, the hardness of the catheter 1 gradually decreases from the proximal end to the distal end. Preferably, the hardness of the second reinforcement layer 12 gradually decreases from the proximal end to the distal end. The second reinforcement layer 12 is made of a polymer composite material. According to the hardness, it can be made of at least two composite materials selected from PET, nylon, PEBAX (nylon elastomer), and TPU. Optionally, the tube body material from the proximal end to the distal end uses a composite material composed of nylon, pebax, and TPU in sequence. The hydrophilic coating can be coated with a length of 30-50cm according to the length of the blood vessel curvature. The rigidity is gradually reduced from the proximal end to the distal end. By controlling the bending core wire at the proximal end, the bending of the distal tube body of the catheter can be controlled. A slight twist of the tube body can perform four-way bending in the blood vessel.

[0039] The inner tube 10 is made of PTFE (polytetrafluoroethylene) or polyolefin material, which is convenient for guide wire delivery.

[0040] The first reinforcing layer 11 is composed of at least one of a braided structure or a single-strand spiral spring structure. The braided structure is woven from braided wires. Both the braided structure and the spiral spring structure can be made of stainless steel wire or PET, polyaromatic fiber wire and other materials.

[0041] like Figure 5 As shown, the catheter 1 is adjustable in bendability by providing a bending core wire 9 for bending in the catheter 1, and the distal end of the bending core wire 9 is fixed to the distal end of the catheter 1, so that when the bending core wire 9 is pulled, the distal end of the catheter 1 can be bent and deformed; optionally, two bending core wires 9 are provided in the catheter 1, and the bending core wires 9 are symmetrically arranged on opposite sides of the catheter 1, and a bending core wire cavity 14 is also provided in the second reinforcement layer 12, and the bending core wire cavity 14 extends along the axial direction of the catheter 1 and passes through the proximal end of the second reinforcement layer 12, so that the bending core wire 9 The proximal end of the bending core wire 9 extends out from the proximal end of the second reinforcement layer 12, and the distal end of the bending core wire 9 can be fixed to the first reinforcement layer 11 by welding or by using the head end development also built into the second reinforcement layer 12, and the distal end of the bending core wire 9 is provided with an end portion with a diameter larger than the remaining diameter of the bending core wire 9, so that the end portion is stuck between the head end development ring and the first reinforcement layer 11; the bending core wire 9 can be made of 0.002"-0.006" stainless steel wire or nickel-titanium wire, and is not limited to a single wire form, and can also be a twisted multi-strand wire, such as a double strand or a triple strand.

[0042] The preparation process of the present invention is as follows:

[0043] The inner tube 10 and the first reinforcement layer 11 are made of a PTFE film tube or a polyolefin tube, which can be extruded or dip-coated, and then a stainless steel wire is woven on the inner layer. The material is not limited to stainless steel wire, but can also be nickel-titanium wire, polyaromatic fiber wire, etc. The process is not limited to weaving, and the first reinforcement layer 11 can also be formed by winding a spring;

[0044] Pre-installing the developing ring on the aforementioned semi-finished product;

[0045] The two developing rings inside the balloon are located at the shoulder of the balloon. After positioning, the developing rings are used to pre-tighten and fix the position; the head end developing ring needs to place two PI tubes between the first reinforcing layer 11 and the head end developing ring as the bending core wire cavity 14 of the adjustable bending core wire;

[0046] Install the second reinforcing layer 12, and insert the semi-finished catheter with the developing ring installed into the second reinforcing layer 12; insert the PI tube or PTFE hollow shaft between the second reinforcing layer 12 and the braided tube with the developing ring and the adjustable bend channel installed, as the balloon channel and the drug channel;

[0047] The second reinforcing layer 12 is subjected to hot-melt rheology to form an integral body with the first reinforcing layer 11 and the tube body serving as the balloon cavity, the drug cavity and the bending core wire cavity; the temperature at which the material is melted, such as 180-230 degrees Celsius, is used in a rheometer to form an integral structure;

[0048] If the cavity is made of PTFE material, the tube body needs to be stretched and pulled out after welding to form a cavity;

[0049] Installation of adjustable bending core wire; after the bending core wire 9 is prepared, the end is first plasma welded to make the end larger than the wire diameter, and then inserted into the adjustable bending core wire cavity, stuck in the head end developing ring, and then the catheter body is hot-melted to close the adjustable bending core wire cavity, so that the distal end of the catheter and the adjustable bending core wire become one, and then a pulling force is applied to the proximal core wire to adjust the distal end; in this process, the guide wire cavity, balloon cavity, and drug cavity need to be penetrated with a suitable core shaft as a cushion to prevent cavity collapse;

[0050] The catheter body is perforated. A hole is perforated in the center of the balloon positioning position under a microscope to form an injection through hole 15. A hole is perforated between the two balloons as a through hole 5. The number of holes can be 1-3, evenly distributed in the axial direction, and positioned on the embolic agent cavity. The hole diameter can be selected to be 0.1mm-0.3mm, and cannot exceed 1 / 2 of the tube body diameter to avoid folding of the tube body.

[0051] The balloon is installed above the positioning position of the balloon developing ring, and the production can be completed by welding or gluing.

[0052] The present invention has the following benefits:

[0053] Improve the accuracy of treatment. Through the double balloon design and the position control of the drug flow opening, drugs such as embolic agents or chemotherapy drugs, microspheres, etc. can be accurately delivered to the blood vessels supplying liver tumors, reducing the damage of drugs to healthy liver tissue, improving the accuracy and effectiveness of treatment, and achieving precise embolization and precise chemotherapy.

[0054] Compared with some complex interventional treatment devices, the structure of the present invention is relatively simple, and the operation is more convenient. With the adjustable bending performance, the lesion can be reached farther, and the operation is relatively simple: compared with some complex interventional treatment devices, it helps to shorten the operation time and reduce the risk of surgery. It also reduces the risk of doctors being exposed to radiation.

[0055] Reduce medical costs: To a certain extent, it can reduce dependence on more expensive devices such as microcatheters and reduce patients' medical expenses.

Claims

1. An adjustable-bend embolization double-balloon interventional catheter, comprising a catheter (1) and a first balloon (2) disposed at the distal end of the catheter (1), characterized in that: The distal end of the catheter (1) is adjustable, and a second balloon (3) is also provided at the distal end of the catheter (1). A balloon cavity (4) capable of filling the first balloon (2) and the second balloon (3) is provided in the catheter (1). A through hole (5) is provided on the catheter body of the catheter (1) between the first balloon (2) and the second balloon (3). A drug cavity (6) is provided in the catheter (1), and the drug cavity (6) is connected to the through hole (5) so that an embolism or a drug solvent can be injected from the proximal end of the catheter (1) through the drug cavity (6). A guide wire cavity (7) is also provided in the catheter (1), and the distal end of the guide wire cavity (7) passes through the catheter (1).

2. The adjustable-bend embolization double-balloon interventional catheter according to claim 1, characterized in that: The guide tube (1) is provided with a developing ring (8).

3. The adjustable-bend embolization double-balloon interventional catheter according to claim 2, characterized in that: At least the portion of the catheter body of the catheter (1) located between the first balloon (2) and the second balloon (3) is provided with a developing ring (8).

4. The adjustable-bend embolization double-balloon interventional catheter according to claim 1, characterized in that: The catheter (1) is provided with a bending core wire (9) for adjusting the bend, and the distal end of the bending core wire (9) is fixed to the distal end of the catheter (1), so that when the bending core wire (9) is pulled, the distal end of the catheter (1) can be bent and deformed.

5. The adjustable-bend embolization double-balloon interventional catheter according to claim 4, characterized in that: The catheter (1) is provided with two bending core wires (9), which are symmetrically arranged on opposite sides of the catheter (1).

6. The adjustable-bend embolization double-balloon interventional catheter according to claim 1, characterized in that: A hydrophilic coating is provided on the outer wall of the distal tube body of the catheter (1).

7. The embolization double-balloon interventional catheter with adjustable bend according to any one of claims 1 to 6, characterized in that: The catheter (1) comprises an inner tube (10), a first reinforcement layer (11) arranged outside the inner tube (10), and a second reinforcement layer (12) arranged outside the first reinforcement layer (11); the inner tube (10) is tubular and has an axially arranged inner cavity; the guidewire cavity (7) is composed of the inner cavity; the balloon cavity (4) and the drug cavity (6) are arranged in the second reinforcement layer (12); the proximal end and the distal end of the first balloon (2) and the proximal end and the distal end of the second balloon (3) are sealed and connected to the second reinforcement layer (12); and the through hole (5) is arranged on the second reinforcement layer (12).

8. The adjustable-bend embolization double-balloon interventional catheter according to claim 7, characterized in that: The hardness of the catheter (1) gradually decreases from the proximal end to the distal end.

9. The adjustable-bend embolization double-balloon interventional catheter according to claim 8, characterized in that: The hardness of the second reinforcement layer (12) gradually decreases from the proximal end to the distal end.

10. The adjustable-bend embolization double-balloon interventional catheter according to claim 9, characterized in that: The first reinforcement layer (11) is composed of at least one of a braided structure and a spiral spring structure.

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