Drug delivery cutting balloon dilation catheter

Abstract

The utility model relates to a kind of medicine delivery cutting balloon dilatation catheter, it includes inner tube, intermediate tube, outer tube, balloon and cutting tool, intermediate tube is sleeved on inner tube, intermediate tube distal end is fixedly closed connection with inner tube;Outer tube is sleeved on intermediate tube;Balloon distal end is fixedly connected with inner tube distal end, proximal end is fixedly connected with outer tube distal end, balloon inside is connected with the balloon filling passage between outer tube and intermediate tube;Cutting tool is fixedly set on the outer surface of balloon, and extend along parallel to balloon axis direction, cutting tool is equipped with medicine injection through-hole and along the medicine drainage groove of cutting tool axial extension, medicine injection through-hole is connected with medicine drainage groove and the medicine channel between inner tube and intermediate tube.The utility model can be higher efficient and more uniform, comprehensive drug delivery while cutting, improve the cutting and drug treatment effect to intravascular plaque, can effectively reduce the occurrence of vascular restenosis, improve the treatment effect and life quality of patient.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a drug delivery cutting balloon dilation catheter. Background Technology

[0002] The cutting balloon dilatation catheter is a medical device used to treat vascular stenosis, combining balloon dilation and cutting techniques. It consists of a balloon and blades attached to its surface. When the balloon is not inflated, the blades are encased in the balloon's folds; when the balloon dilates, the blades protrude from the surface, cutting the plaque in the blood vessel. The cutting balloon dilatation catheter is inserted into the blood vessel, and the balloon cutter dilates the narrowed area, restoring patency. This design confines the damage to the diseased vascular intima caused by balloon dilation to the incision site, reducing irregular tears. The cutting balloon dilatation catheter offers advantages such as ease of operation, minimal trauma, and rapid recovery. Because there is no open incision during the procedure, the risk of infection and bleeding is reduced, and postoperative scarring is avoided.

[0003] To improve treatment efficacy, medication can be applied to the cutting area, leading to the development of drug-eluting cutting balloon dilatation catheters. These catheters have drug coatings on the balloon and blade surfaces, allowing for simultaneous cutting and drug delivery of the vascular lesion plaque during balloon dilation. However, drug detachment is prone to occur during delivery, reducing the drug load, and the drug coating may directly affect the blade's plaque-cutting effectiveness. Another type of cutting balloon dilatation catheter incorporates a drug delivery channel on the balloon surface and a drug delivery port on the blade, connecting the delivery port to the delivery channel. While this solves the drug detachment problem, it still provides localized drug delivery, and the drug cannot fully cover the cutting site, thus the therapeutic effect still needs improvement. Utility Model Content

[0004] The purpose of this invention is to provide a drug delivery cutting balloon dilation catheter that can deliver drugs comprehensively and efficiently while cutting plaques within blood vessels.

[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0006] This utility model provides a drug delivery cutting balloon dilation catheter, comprising an inner tube, a middle tube, an outer tube, a balloon, and a cutting tool. The inner tube has a guidewire channel extending axially and open at both ends; the middle tube is sleeved on the inner tube, with its distal end fixedly connected to the inner tube and in a closed state, and a through hole on its distal sidewall; the outer tube is sleeved on the middle tube; the balloon has a radially expanded state and a radially contracted state, with its distal end fixedly connected to the distal end of the inner tube and / or the middle tube, and its proximal end fixedly connected to the distal end of the outer tube; the interior of the balloon communicates with the balloon inflation channel formed between the outer tube and the middle tube. The balloon has a through hole on its side wall; the cutting tool is fixedly mounted on the outer surface of the balloon and extends in a direction parallel to the axis of the balloon. The cutting tool has a drug injection through hole and a drug drainage groove extending in a direction parallel to the axis of the balloon. The drug injection through hole is connected to the drug drainage groove. The drug injection through hole is also connected to the drug channel formed between the inner tube and the intermediate tube through the through hole on the side wall of the balloon, the drug delivery tubing located inside the balloon, and the through hole on the distal side wall of the intermediate tube.

[0007] In this embodiment of the invention, the inner tube, the intermediate tube, and the outer tube are coaxial, and the cavity between the intermediate tube and the inner tube serves as the drug channel; the cavity between the intermediate tube and the outer tube serves as the balloon inflation channel, used to input inflation medium into the balloon or extract inflation medium from the balloon, so that the balloon switches between the radial expansion state and the radial contraction state.

[0008] In this invention, the drug drainage channel extends along the axial direction of the cutting tool, and the cutting tool extends along the axial direction of the balloon. After the drug enters the drug drainage channel through the drug injection through hole, it is simultaneously, uniformly, and continuously delivered to the cutting point along the axial direction of the cutting tool, resulting in higher drug delivery efficiency and more uniform and comprehensive administration.

[0009] In this embodiment of the invention, the bottom surface of the cutting tool conforms to the outer surface of the balloon, and the cross-section of the cutting tool is approximately an isosceles triangle with the base of the isosceles triangle on the bottom surface. This structure has high cutting efficiency for intravascular plaques.

[0010] Furthermore, the drug drainage groove is recessed both inside and outside the outer surface of the side of the cutting tool.

[0011] Furthermore, the drug drainage channel includes a first drug drainage channel and a second drug drainage channel respectively disposed on both sides of the cutting tool, which further improves the drug delivery efficiency and comprehensive drug delivery at the cutting site, thereby improving the therapeutic effect.

[0012] According to some specific embodiments of this utility model, the drug injection through hole is a Y-shaped through hole that connects the first drug drainage groove and the second drug drainage groove to the through hole on the side wall of the balloon.

[0013] Specifically, the first channel extends upward from the center of the bottom surface of the cutting tool, and the second and third channels extend from the upper end of the first channel to the two sides of the cutting tool, respectively. The first channel, the second channel, and the third channel are connected to form the Y-shaped through hole.

[0014] In this embodiment of the invention, when the balloon is in the radially expanded state, the drug delivery hose extends in a straight line, the proximal end of the drug delivery hose is connected to the drug channel through a through hole on the distal sidewall of the intermediate tube, and the distal end of the drug delivery hose is connected to the Y-shaped through hole through a through hole on the sidewall of the balloon.

[0015] According to some specific embodiments of this utility model, the drug delivery tubing is welded and fixedly connected to the intermediate tube, the drug delivery tubing and the sealing patch are integrally formed, and the sealing patch is adhesively fixedly connected to the inner wall of the balloon. During production, the sealing patch and the inner wall of the balloon are bonded together with adhesive using ultraviolet light curing. The main function of the sealing patch is to prevent leakage and pressure loss of the balloon when perforating the side wall of the balloon, while maintaining the structural strength of the balloon. The perforation of the side wall of the balloon is done after the sealing patch is bonded to the inner wall of the balloon, and the diameter of the hole is smaller than the bottom width of the cutting tool. When perforating, it is necessary to penetrate the side wall of the balloon and the sealing patch. Before perforation, physiological saline is injected into both the balloon and the drug delivery tubing to make the balloon and drug delivery tubing full, which facilitates perforation. Perforation is carried out by puncture and grinding, and ultrasonic cleaning is used after grinding. The balloon needs to be in a pressure-maintaining state during cleaning. The cutting tool is also bonded to the outer wall of the balloon by ultraviolet light curing. When pasting, pay attention to aligning the Y-shaped through hole with the through hole on the side wall of the balloon. In addition, in terms of materials and processes, the outer tube, middle tube and inner tube are all made of high-strength nylon material, which has good biocompatibility and mechanical properties and can meet the needs of intravascular operations; the balloon is made of high-strength, low-compliance polyester material, which can withstand high pressure expansion and has good elasticity and recovery performance; the blade is made of platinum alloy material, which has sharp cutting edges and good corrosion resistance, and also has good visualization effect.

[0016] In this embodiment of the invention, a plurality of cutting blades are spaced apart along the circumferential direction of the balloon, a plurality of through holes are respectively opened on the sidewalls of the balloon and the intermediate tube, and a plurality of drug delivery hoses are correspondingly arranged inside the balloon.

[0017] Furthermore, it is preferable to arrange 4 to 8 cutting blades at uniform intervals along the circumferential direction of the balloon.

[0018] More preferably, the drug injection holes on two adjacent cutting blades are staggered in the axial direction of the balloon, and the drug injection holes on two cutting blades spaced apart are located on the same circumference. The multiple holes on the side wall of the intermediate tube and the multiple drug delivery hoses inside the balloon are adjusted according to the position of the drug injection holes.

[0019] In this embodiment of the present invention, the drug delivery cutting balloon dilation catheter further includes a three-lumen catheter seat disposed at the proximal end of the inner tube, the intermediate tube and the outer tube. The three-lumen catheter seat includes a guidewire lumen coaxial with and connected to the guidewire channel, a balloon inflation medium inlet lumen connected to the balloon inflation channel, and a drug inlet lumen (73) connected to the drug channel.

[0020] Furthermore, a stress diffusion tube is provided at the distal end of the three-lumen catheter seat to improve the stability of the device.

[0021] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art:

[0022] This utility model's drug delivery cutting balloon dilation catheter, through the special structural design of the drug drainage groove and drug injection through hole on the cutting blade, enables the drug to be delivered evenly and continuously to the cutting site while cutting, resulting in higher drug delivery efficiency and more uniform and comprehensive drug delivery. This improves the cutting of intravascular plaques and the effect of drug treatment, effectively reduces the occurrence of restenosis, and improves the treatment effect and quality of life of patients. Attached Figure Description

[0023] Figure 1 This is a three-dimensional structural schematic diagram of the drug delivery cutting balloon dilation catheter of Example 1;

[0024] Figure 2 This is a cross-sectional view of the drug delivery cutting balloon dilation catheter of Example 1;

[0025] Figure 3 This is a partial three-dimensional structural diagram of the drug delivery cutting balloon dilation catheter of Example 1 (the three-lumen catheter seat is hidden);

[0026] Figure 4 This is a partial cross-sectional view of the infusion cutting balloon dilation catheter of Example 1 (the three-lumen catheter seat is hidden);

[0027] Figure 5 This is a schematic cross-sectional view of a portion of the drug delivery cutting balloon dilation catheter along the radial direction of the balloon in Example 1.

[0028] In the attached diagrams above, 1 is the inner tube; 2 is the intermediate tube; 3 is the outer tube; 4 is the balloon; 5 is the cutting tool; 51 is the drug injection port; 52 is the drug drainage channel; 6 is the drug delivery tubing; 61 is the sealing patch; 7 is the three-lumen catheter seat; 71 is the guidewire lumen; 72 is the balloon inflation medium inlet lumen; 73 is the drug inlet lumen; and 74 is the stress diffusion tube. Detailed Implementation

[0029] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of the present invention.

[0030] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the present invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0031] In the description of this utility model, it should be understood that "distal end" refers to the end of the instrument or component away from the operator, and "proximal end" refers to the end of the instrument or component closer to the operator; "axial" refers to the direction parallel to the line connecting the centers of the distal and proximal ends of the instrument or component, and "radial" refers to the direction perpendicular to the axial direction; "inner" and "outer" are positions defined by distance relative to the center of the instrument or component, where "inner" is the position closer to the center of the instrument or component, and "outer" is the position away from the center of the instrument or component. The above description of directional terms is only for the convenience of describing the embodiments of the present invention and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of this utility model.

[0032] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this utility model according to the specific circumstances.

[0033] In the description of this utility model, "multiple" refers to two or more.

[0034] Example 1

[0035] like Figures 1-5As shown, this embodiment provides a drug delivery cutting balloon dilation catheter, which includes an inner tube 1, a middle tube 2, an outer tube 3, a balloon 4, a cutting tool 5, and a three-lumen catheter seat 7.

[0036] In this embodiment, the inner tube 1, the intermediate tube 2, and the outer tube 3 are coaxial. The inner tube 1 is provided with a guide wire channel extending along its axial direction and open at both ends. The intermediate tube 2 is sleeved on the inner tube 1, and the distal end of the intermediate tube 2 is fixedly connected to the inner tube 1 and is in a closed state. The distal sidewall of the intermediate tube 2 is provided with a through hole. The outer tube 3 is sleeved on the intermediate tube 2. The balloon 4 is sleeved outside the distal ends of the inner tube 1 and the intermediate tube 2. It has a radially expanded state and a radially contracted state. The distal end of the balloon 4 is fixedly connected to the distal end of the inner tube 1, and the proximal end is fixedly connected to the distal end of the outer tube 3. The sidewall of the balloon 4 is provided with a through hole. The cutting tool 5 is fixedly disposed on the outer surface of the balloon 4. The cutting tool 5 extends in a direction parallel to the axis of the balloon 4. The cutting tool 5 is provided with a drug injection through hole 51 and a drug drainage groove 52 extending in a direction parallel to the axis of the balloon 4. The drug injection through hole 51 and the drug drainage groove 52 are connected. The cavity between the intermediate tube 2 and the inner tube 1 serves as a drug channel. The drug injection port 51 is also connected to the drug channel through a through-hole on the side wall of the balloon 4, the drug delivery tubing 6 located inside the balloon 4, and a through-hole on the distal side wall of the intermediate tube 2. The interior of the balloon 4 is connected to the balloon inflation channel formed between the outer tube 3 and the intermediate tube 2. The cavity between the intermediate tube 2 and the outer tube 3 serves as the balloon inflation channel, used to introduce inflation media into the balloon 4 or to extract inflation media from the balloon 4, allowing the balloon 4 to switch between a radially expanded state and a radially contracted state.

[0037] In this embodiment, the drug drainage channel 52 extends along the axial direction of the cutting blade 5, and the cutting blade 5 extends along the axial direction of the balloon 4. After entering the drug drainage channel 52 through the drug injection port 51, the drug is simultaneously, uniformly, and continuously delivered to the cutting site along the axial direction of the cutting blade 5, resulting in higher and more uniform drug delivery efficiency. The bottom surface of the cutting blade 5 conforms to the outer surface of the balloon 4, and the cross-section of the cutting blade 5 is approximately an isosceles triangle with the base of the isosceles triangle on the bottom surface. This structure provides high cutting efficiency for intravascular plaques. The drug drainage channel 52 is recessed from the outer surface of the side of the cutting blade 5. The drug drainage channel 52 includes a first drug drainage channel and a second drug drainage channel respectively disposed on both sides of the cutting blade 5, further improving the drug delivery efficiency and comprehensive drug delivery to the cutting site, thereby enhancing the therapeutic effect. In this embodiment, the drug injection through-hole 51 is a Y-shaped through-hole connecting the first drug drainage channel and the second drug drainage channel to through-holes on the sidewall of the balloon 4. The Y-shaped through-hole includes a first channel extending upward from the center of the bottom surface of the cutting blade 5, and a second channel and a third channel extending from the upper end of the first channel to the two sides of the cutting blade 5. When the balloon 4 is in a radially expanded state, the drug delivery hose 6 extends in a straight line. A through-hole is provided on the distal sidewall of the intermediate tube 2. The proximal end of the drug delivery hose 6 communicates with the drug channel through the through-hole on the sidewall of the intermediate tube 2, and the distal end of the drug delivery hose 6 communicates with the Y-shaped through-hole through the through-hole on the sidewall of the balloon 4. In this embodiment, eight cutting blades 5 are evenly spaced along the circumferential direction of the balloon 4, eight through-holes are respectively opened on the sidewalls of the balloon 4 and the intermediate tube 2, and eight drug delivery hoses 6 are correspondingly arranged inside the balloon 4. The drug injection holes 51 on two adjacent cutting blades 5 are staggered in the axial direction of the balloon 4. The drug injection holes 51 on two cutting blades 5 are located on the same circumference. The through holes on the side wall of the intermediate tube 2 and the drug delivery hose 6 inside the balloon 4 are arranged in accordance with the position of the drug injection holes 51.

[0038] In this embodiment, the drug delivery tubing 6 is welded and fixedly connected to the intermediate tube 2. The drug delivery tubing 6 is integrally formed with the sealing patch 61, and the sealing patch 61 is adhesively fixedly connected to the inner wall of the balloon 4. During production, the sealing patch 61 and the inner wall of the balloon 4 are bonded together with adhesive using ultraviolet light. The hole in the side wall of the balloon 4 is made after the sealing patch 61 is bonded to the inner wall of the balloon 4, and the diameter of the hole is smaller than the bottom width of the cutting tool 5. Before drilling, physiological saline is injected into both the balloon 4 and the drug delivery tubing 6 to fill the tubing and facilitate drilling. The drilling is done by puncture and grinding, followed by ultrasonic cleaning. During cleaning, the balloon 4 needs to be under pressure. The cutting tool 5 is also bonded to the outer wall of the balloon 4 by ultraviolet light curing. When bonding, care should be taken to align the Y-shaped through hole with the through hole on the side wall of the balloon 4.

[0039] In this embodiment, the outer tube 3, the intermediate tube 2, and the inner tube 1 are all made of high-strength nylon material, which has good biocompatibility and mechanical properties, and can meet the requirements of intravascular operations; the balloon 4 is made of high-strength, low-compliance polyester material, which can withstand high-pressure expansion, and also has good elasticity and recovery properties; the blade is made of platinum alloy material, which has a sharp cutting edge and good corrosion resistance, and also has good visualization effect.

[0040] In this embodiment, the three-lumen catheter seat 7 is disposed at the proximal end of the inner tube 1, the intermediate tube 2, and the outer tube 3. The three-lumen catheter seat 7 includes a guidewire lumen 71 coaxial with and communicating with the guidewire channel, a balloon inflation medium inlet lumen 72 communicating with the balloon inflation channel, and a drug inlet lumen 73 communicating with the drug channel. A stress diffusion tube 74 is also provided at the distal end of the three-lumen catheter seat 7 to improve the stability of the device.

[0041] The working principle of the drug delivery cutting balloon dilation catheter in this embodiment is as follows:

[0042] 1) The balloon 4 is delivered to the target site of the blood vessel, and the drug is delivered to the balloon 4 site through the drug infusion chamber 73 and the drug channel.

[0043] 2) A mixture of contrast agent and saline is injected into balloon 4 through balloon inflation medium inlet chamber 72 and balloon inflation channel, causing balloon 4 to change from a radially contracted state to a radially expanded state. During this process, cutting tool 5 contacts and cuts plaque in blood vessels under the expansion pressure of balloon 4.

[0044] 3) While cutting the plaque inside the blood vessel, the drug is continuously and accurately delivered to the cutting site through the drug drainage channel 52 for drug ablation.

[0045] Clinical application examples of the drug delivery cutting balloon dilation catheter in this embodiment include:

[0046] Atherosclerotic disease: Using the drug-eluting balloon dilatation catheter of this embodiment for intravascular plaque cutting and drug ablation can effectively reduce restenosis in atherosclerotic diseases and improve treatment outcomes.

[0047] Treatment of restenosis: For patients with restenosis, treatment using the infusion cutting balloon dilation catheter of this embodiment can effectively improve vascular patency and reduce the occurrence of restenosis.

[0048] Applicable medications include paclitaxel for preventing restenosis and everolimus for reducing neointimal hyperplasia.

[0049] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A drug delivery cutting balloon dilation catheter, characterized in that: It includes: The inner tube (1) is provided with a guide wire channel that extends along its axial direction and is open at both ends; An intermediate tube (2) is sleeved on the inner tube (1). The distal end of the intermediate tube (2) is fixedly connected to the distal end of the inner tube (1) and is in a closed state. A through hole is provided on the distal side wall of the intermediate tube (2). The outer tube (3) is sleeved on the intermediate tube (2); A balloon (4) having a radially expanded state and a radially contracted state, the distal end of the balloon (4) being fixedly connected to the distal end of the inner tube (1) and / or the intermediate tube (2), the proximal end of the balloon (4) being fixedly connected to the distal end of the outer tube (3), the interior of the balloon (4) being connected to the balloon inflation channel formed between the outer tube (3) and the intermediate tube (2), and the sidewall of the balloon (4) having a through hole; A cutting tool (5) is fixedly disposed on the outer surface of the balloon (4). The cutting tool (5) extends in a direction parallel to the axis of the balloon (4). The cutting tool (5) is provided with a drug injection through hole (51) and a drug drainage groove (52) extending in a direction parallel to the axis of the balloon (4). The drug injection through hole (51) is connected to the drug drainage groove (52). The drug injection through hole (51) is also connected to the drug channel formed between the inner tube (1) and the intermediate tube (2) through a through hole on the side wall of the balloon (4), a drug delivery hose (6) located inside the balloon (4), and a through hole on the distal side wall of the intermediate tube (2).

2. The drug delivery cutting balloon dilation catheter according to claim 1, characterized in that: The bottom surface of the cutting tool (5) conforms to the outer surface of the balloon (4), and the cross-section of the cutting tool (5) is approximately an isosceles triangle, with the base of the isosceles triangle on the bottom surface of the cutting tool (5).

3. The drug delivery cutting balloon dilation catheter according to claim 2, characterized in that: The drug drainage groove (52) is recessed inside and outside the outer surface of the side of the cutting tool (5).

4. The drug delivery cutting balloon dilation catheter according to claim 3, characterized in that: The drug drainage channel (52) includes a first drug drainage channel and a second drug drainage channel respectively disposed on both sides of the cutting tool (5).

5. The drug delivery cutting balloon dilation catheter according to claim 4, characterized in that: The drug injection through-hole (51) is a Y-shaped through-hole that connects the first drug drainage groove and the second drug drainage groove to the through-hole on the side wall of the balloon (4).

6. The drug delivery cutting balloon dilation catheter according to claim 5, characterized in that: When the balloon (4) is in the radially expanded state, the drug delivery hose (6) extends in a straight line, the proximal end of the drug delivery hose (6) is connected to the drug channel through the through hole on the distal side wall of the intermediate tube (2), and the distal end of the drug delivery hose (6) is connected to the Y-shaped through hole through the through hole on the side wall of the balloon (4).

7. The drug delivery cutting balloon dilation catheter according to claim 6, characterized in that: The drug delivery hose (6) is welded and fixedly connected to the intermediate tube (2). The drug delivery hose (6) is integrally formed with the sealing patch (61). The sealing patch (61) is glued and fixedly connected to the inner wall of the balloon (4).

8. The drug delivery cutting balloon dilation catheter according to any one of claims 1 to 7, characterized in that: Multiple cutting blades (5) are spaced apart along the circumferential direction of the balloon (4), and multiple through holes are respectively opened on the sidewalls of the balloon (4) and the intermediate tube (2). Multiple drug delivery hoses (6) are correspondingly arranged inside the balloon (4).

9. The drug delivery cutting balloon dilation catheter according to claim 8, characterized in that: The drug injection holes (51) on two adjacent cutting tools (5) are staggered in the axial direction of the balloon (4), and the drug injection holes (51) on two cutting tools (5) are located on the same circumference.

10. The drug delivery cutting balloon dilation catheter according to claim 1, characterized in that: The drug delivery cutting balloon dilation catheter also includes a three-lumen catheter seat (7) disposed at the proximal end of the inner tube (1), the intermediate tube (2) and the outer tube (3). The three-lumen catheter seat (7) includes a guidewire lumen (71) coaxial with and connected to the guidewire channel, a balloon inflation medium inlet lumen (72) connected to the balloon inflation channel, and a drug inlet lumen (73) connected to the drug channel.

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