A conformable and wall-adherent pulse balloon dilatation catheter and its use method

Abstract

The present invention discloses a conformable and wall-adhering pulse balloon dilatation catheter and a method for using the catheter. The catheter comprises an outer tube and an inner tube arranged inside the outer tube. The dilatation balloon is wrapped around the outside of the inner tube. At least one electrode is sleeved on the outside of the dilatation balloon, and the electrode is also sleeved on the outside of the inner tube. Contrast fluid is filled into the dilatation balloon through an opening of the inner tube to expand it. The electrode limits the dilatation balloon to at least two expansion bodies, and the electrode is located in the gap between adjacent expansion bodies. After contrast fluid is injected into the lesion site, the balloon in the device perfectly fits the calcification, and the calcification is treated by the pulse shock wave generated by the electrode outside the balloon, which ensures both the treatment effect and the safety during the treatment process.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a conformable and wall-adherent pulse balloon dilatation catheter. Background Art

[0002] The existing pulse shock wave balloon materials are relatively hard. The balloon remains in a folded state during transportation. After entering the blood vessel, contrast fluid is injected into the balloon to expand the balloon and begin to pressurize. At this time, the outer wall of the balloon is close to the expansion position, but considering the physical properties of the existing pulse shock wave balloon material, when it comes into contact with calcification, there is a certain probability that the balloon will rupture, or it will not fit the blood vessel wall well for treatment. At the same time, the electrode is placed inside the balloon. During the treatment process, the pulse shock wave generated by the electrode discharge will experience a lot of attenuation during the radiation propagation process, causing the calcification close to the generator to be impacted first, and the farthest calcification will only be impacted by a small amount of pulse shock wave, resulting in a very limited treatment effect. In addition, due to the volume limitation of the balloon, the number of electrodes that can be placed is also very limited. At the same time, the electrode and the inner tube need to be fixed to ensure the stability of the electrode during operation. The existing method requires the catheter and the inner tube to be fixed together by welding or gluing, which increases the cost and complexity of the process.

[0003] The explosion-proof stone removal balloon catheter provided by the existing publication number CN206995302U has a catheter body, one end of which is provided with an inflatable balloon, the other end of which is provided with an injection end connected to the balloon, an exhaust ring is provided on the catheter body, a first cavity is provided in the exhaust ring, a slider matching with it is slidably provided in the first cavity, a first spring is provided between the slider and the first cavity, an exhaust hole connected to the first cavity is provided on the outer peripheral surface of the exhaust ring, and a channel connected to the balloon is provided in the exhaust ring. The present invention has a simple structure, can effectively prevent the balloon from exploding, and avoids the problem that the existing balloon catheters have no safety measures, and when the operator performs improper inflation operation on the balloon, it is easy to cause the balloon to explode, resulting in unnecessary trauma to the patient. In this patent, although the balloon explosion can be effectively prevented, since the catheter needs to move in the blood vessel, the diameter of the catheter is small, so it is necessary to set the exhaust ring on the catheter body, which requires a high cost. At the same time, since the structure inside the exhaust ring is small, it is not easy to repair when it is damaged.

[0004] The existing shock wave balloon catheter with multiple shock wave sources provided by the publication number CN104582597A includes an expansion angioplasty balloon catheter, which includes multiple shock wave sources. The catheter includes an elongated carrier and an expansion balloon formed around the carrier in a sealed relationship with the carrier at a seal, the balloon surrounds the carrier to form an annular channel, and the annular channel allows fluid such as saline to enter the balloon to inflate the balloon, the carrier includes a guide wire lumen, and the guide wire lumen is arranged to receive the guide wire. The calcification area can be treated by the shock wave source, but in this invention, the shock wave source is arranged inside the balloon, which will cause the shock wave to be blocked by the balloon during the process of diffusion to the outside, so that the energy of the shock wave is attenuated, reducing the treatment effect of the calcification area. Summary of the invention

[0005] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a pulse balloon dilatation catheter that conforms to the wall.

[0006] In order to achieve the above object, the present invention adopts the following technical solution: a conformable and wall-adherent pulse dilatation balloon dilatation catheter, comprising an outer tube and an inner tube arranged inside the outer tube, wherein the dilatation balloon is wrapped around the outside of the inner tube;

[0007] At least one electrode is sleeved on the outside of the expansion balloon, and the electrode is also sleeved on the outside of the inner tube, and contrast liquid is filled into the expansion balloon through the opening of the inner tube to expand it, and the electrode limits the expansion balloon into at least two expansion bodies;

[0008] The electrodes are located in gaps between adjacent expansion bodies.

[0009] As a further description of the above technical solution, the Young's modulus of the pressure-resistant polymer material used to make the expansion balloon is 30MPA-1.4GPA.

[0010] As a further description of the above technical solution, the number of the electrodes is set to at least one.

[0011] As a further description of the above technical solution, the inner tube is a multi-lumen tube, which includes a wire pipeline and an infusion pipeline for conveying contrast fluid.

[0012] As a further description of the above technical solution, the infusion pipeline is connected to the opening on the inner tube, and the opening is located between adjacent electrodes.

[0013] As a further description of the above technical solution, the electrodes are distributed along the axial direction of the expansion balloon.

[0014] As a further description of the above technical solution, the electrode is a ring electrode.

[0015] As a further description of the above technical solution, the expansion balloon is made of medical silicone gel.

[0016] As a further description of the above technical solution, the inner diameter of the electrode is slightly larger than the outer diameter of the inner tube.

[0017] A method for using a conformable and wall-adherent pulse dilatation balloon dilatation catheter, comprising:

[0018] S1, control the outer tube to allow the dilation balloon to pass through the vascular pathway to reach the lesion site;

[0019] S2, injecting contrast fluid into the expansion balloon, causing the expansion balloon to expand and adhere to the calcification, and electrodes to limit the expansion of the expansion balloon;

[0020] S3, in the blood medium, the pulse power source controls the electrode to emit shock waves to the surroundings to break up the surrounding calcifications;

[0021] S4, the contrast solution is discharged, the dilatation balloon is deflated, and the outer tube is controlled to be withdrawn from the lesion site.

[0022] The present invention has the following beneficial effects:

[0023] 1. The Young's modulus of the expansion balloon of the present invention is 30MPA-1.4GPA. During the expansion of the expansion balloon, even if there are external electrodes to restrict it, it will not burst. At the same time, the expansion balloon can fit more fully with the deposits in the blood vessels during the expansion process, ensuring that the expansion balloon is not easy to rupture when it contacts the calcification in the blood vessels, which can effectively protect the patient.

[0024] 2. The present invention arranges electrodes on the outside of the expansion balloon. When the pulse power source controls the electrodes to generate shock waves to the surroundings, there is no external expansion balloon to block it. This can solve the problem of attenuation of the existing pulse shock waves when passing through the expansion balloon. Therefore, the calcification can be broken up more fully, thereby improving the treatment effect.

[0025] 3. In the present invention, the electrode sleeve is arranged on the outside of the expansion balloon and the inner tube, and the inner diameter of the motor tube is slightly larger than the outside of the inner tube. The expansion balloon passes through the gap between the two. When the expansion balloon expands, the pressure on the external electrode increases. Therefore, during the normal operation of the electrode, the stability of the electrode can be maintained. At the same time, there is no need to fix the electrode and the inner tube through welding or gluing, which saves costs and simplifies the process. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A schematic diagram of a conformable and wall-adherent pulse balloon dilatation catheter proposed by the present invention;

[0027] Figure 2 A schematic diagram of balloon expansion of a conformable and wall-adherent pulse balloon dilatation catheter proposed by the present invention;

[0028] Figure 3 This is a schematic diagram of the balloon of the conformable and wall-adherent pulse balloon dilatation catheter proposed by the present invention adhering to the calcification in the blood vessel;

[0029] Figure 4 This is a schematic diagram of a method for using a conformable, wall-adherent pulse balloon dilatation catheter proposed by the present invention.

[0030] Legend:

[0031] 1. Outer tube; 2. Inner tube; 3. Dilatation balloon; 4. Electrode; 5. Blood; 6. Calcification. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] Reference Figure 1 The present invention provides an embodiment of a conformable and wall-adherent pulse balloon dilatation catheter, comprising an outer tube 1 and an inner tube 2 arranged inside the outer tube 1, wherein a dilatation balloon 3 made of a pressure-resistant polymer material is wrapped around the outside of the inner tube 2 and is located between the two sections of the outer tube 1, wherein the distal end of the distal outer tube 1 is a tapered section, which makes it more convenient to pass through the vascular pathway and reach the deep part of the vascular pathway.

[0034] At the same time, the Young's modulus of the pressure-resistant polymer material used to make the expansion balloon 3 is 30MPA-1.4GPA, so that the expansion balloon 3 will not burst due to the structural limitation of the electrode 4 during the process of injecting contrast solution through the infusion line of the inner tube 2. The material of the balloon can be medical organic silicone gel. After the contrast solution is injected into the expansion balloon 3, the expansion balloon 3 expands, and due to the structural limitation of the electrode 4, a Figure 2 as well as Figure 3 The shape shown limits the expansion balloon 3 to three expansion bodies, so that the expansion balloon 3 can fit the position of the expansion more fully, and can ensure that the expansion balloon 3 is not easy to rupture when it contacts the calcification 6 in the blood vessel, which can effectively protect the patient and prevent the expansion balloon 3 from rupturing and causing harm to the patient.

[0035] Two electrodes 4 are arranged on the outside of a complete expansion balloon 3, and the two electrodes 4 are distributed along the axial direction of the expansion balloon 3. The distribution of the electrodes 4 can be equidistant or unequally spaced. The expansion of the expansion balloon 3 can be limited by the electrodes 4, and the electrodes 4 are sleeved on the outside of the inner tube 2. The control wire of the electrode 4 passes through the wire pipeline of the inner tube 2 and is connected to the external pulse power supply. When the expansion balloon 3 is expanded, the electrode 4 is in the gap between the two expansion bodies. The pulse power supply is controlled to make the electrode 4 emit shock waves to the calcification 6 to crush the calcification 6 and other deposits. Since the electrode 4 is outside the expansion balloon 3, when the electrode 4 emits shock waves to the surroundings, the shock waves will not be attenuated by the expansion balloon 3, and the shock waves can be directly conducted through the blood 5, thereby greatly improving the crushing effect of the calcification 6 and other deposits.

[0036] The electrode 4 is sleeved on the outside of the expansion balloon 3 and the inner tube 2, and the inner diameter of the electrode 4 is slightly larger than the outer diameter of the inner tube 2. The expansion balloon 3 is sandwiched between the electrode 4 and the inner tube 2, but there is still a certain gap. When the expansion balloon 3 expands, it will squeeze the external electrode 4, increase the resistance to the inner wall of the electrode 4, improve the stability of the electrode 4, and prevent it from shaking during the normal emission of shock waves, thereby ensuring its working stability.

[0037] In some embodiments, three electrodes 4, four electrodes 4, etc. can be set according to the specific length of the expansion balloon 3 to meet the needs of actual conditions.

[0038] Reference Figure 4 , an embodiment of a method for using a conformable and adherent pulse balloon dilatation catheter provided by the present invention: S1, controlling the outer tube 1 to allow the dilatation balloon 3 to pass through the blood vessel passage to reach the lesion site, wherein the entire balloon dilatation catheter can be moved into the lesion site by hand or by using an instrument, and the lesion site in this patent refers to the location where calcification grows on the inner wall of the blood vessel;

[0039] S2, injecting contrast fluid into the expansion balloon 3, the expansion balloon 3 expands and adheres to the calcification, the contrast fluid is injected into the expansion balloon 3 through the liquid inlet channel opened in the outer tube 1, so that the expansion balloon 3 can expand, and the excessive expansion of the balloon is limited by the electrode;

[0040] S3, in the blood medium, the pulse power source controls the electrode 4 to emit shock waves to the surroundings to break up the surrounding calcifications. The shock waves can also be understood as pulses, which break up the calcifications attached to the inner wall of the blood vessel and make the calcifications fall off from the inner wall of the blood vessel;

[0041] S4, the contrast fluid is discharged, the balloon is deflated, and the outer tube is controlled to be withdrawn from the lesion.

[0042] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A conformable and wall-adherent pulse balloon dilatation catheter, comprising an outer tube (1) and an inner tube (2) arranged inside the outer tube (1), characterized in that: The expansion balloon (3) is wrapped around the outside of the inner tube (2); At least one electrode (4) is sleeved on the outside of the expansion balloon (3), and the electrode (4) is also sleeved on the outside of the inner tube (2). Contrast fluid is filled into the expansion balloon (3) through the opening of the inner tube (2) to expand it. The electrode (4) limits the expansion balloon (3) into at least two expansion bodies; The electrode (4) is located in a gap between adjacent expansion bodies, and the pressure exerted by the expansion balloon (3) on the electrode (4) increases after expansion, so that the electrode (4) and the inner tube (2) do not need to be fixed by welding or gluing, thereby ensuring the stability of the electrode (4).

2. The conformable and wall-adherent pulse balloon dilatation catheter according to claim 1, characterized in that: The Young's modulus of the pressure-resistant polymer material used to make the expansion balloon (3) is 30 MPA-1.4 GPA.

3. The conformable and wall-adherent pulse balloon dilatation catheter according to claim 1, characterized in that: The number of the electrode (4) is set to be at least one.

4. The conformable and wall-adherent pulse balloon dilatation catheter according to claim 1, characterized in that: The inner tube (2) is a multi-lumen tube, which includes a guide wire pipeline and an infusion pipeline for conveying contrast fluid.

5. The conformable and wall-adherent pulse balloon dilatation catheter according to claim 4, characterized in that: The infusion pipeline is in communication with an opening on the inner tube (2), and the opening is located between adjacent electrodes (4).

6. The conformable pulsatile balloon dilatation catheter according to claim 1, characterized in that: The electrodes (4) are distributed along the axial direction of the expansion balloon (3).

7. The conformable pulsatile balloon dilatation catheter according to claim 1, characterized in that: The electrode (4) is a ring electrode.

8. The conformable pulsatile balloon dilatation catheter according to claim 2, characterized in that: The expansion balloon (3) is made of medical organic silicone gel.

9. The conformable pulsatile balloon dilatation catheter according to claim 1, characterized in that: The inner diameter of the electrode (4) is slightly larger than the outer diameter of the inner tube (2).

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