A balloon catheter and shock wave generating system

Abstract

The present invention relates to a balloon catheter and a shock wave generating system, comprising a catheter body, a balloon connected to the distal end of the catheter body, and an electrode device. The balloon catheter system comprises a movable catheter and a traction guidewire. The movable catheter is movably sleeved on the catheter body located in the balloon. One end of the traction guidewire is connected to the movable catheter and is used to pull the movable catheter to move along the length direction of the catheter body. The electrode device is arranged on the movable catheter. A drug coating is arranged on the outside of the balloon. A protective layer is arranged on the outside of the drug coating. When the electrode device generates shock waves and acts on the protective layer, the protective layer ruptures to allow the drug coating to be released. The present invention achieves the goal of promoting the absorption of drugs by the blood vessel wall while shattering calcified lesions at any position by arranging a movable electrode device and arranging a drug coating and a protective layer on the outside of the balloon, effectively reducing the risk of drugs being destroyed when the balloon enters the blood vessel, and has a simple structure, convenient operation, and low cost.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a balloon catheter and a shock wave generating system. Background Art

[0002] At present, clinical cardiovascular stenosis is complex and diverse, and the main treatments for calcified lesions include: ordinary balloon high-pressure dilatation, cutting balloon dilatation, atherectomy, laser angioplasty, etc. Among them, atherectomy is the most widely used, but atherectomy still has obvious disadvantages such as complex operation, easy to induce spasm, slow blood flow or no reflow, and a high risk of perforation for calcified angled lesions. At the same time, it is expensive and requires high operating skills.

[0003] In recent years, drug-coated balloons have been increasingly used in clinical practice. The main mechanism is to infiltrate paclitaxel into the arterial wall to inhibit intimal hyperplasia. Compared with ordinary balloons, drug-coated balloons significantly reduce the rates of in-stent restenosis and target vessel re-intervention after treatment. However, calcification of the vascular intima or media will interfere with the absorption and distribution of paclitaxel, reducing the effect of drug-coated balloons. Therefore, various volume reduction techniques are usually selected according to the characteristics of the patient's lesions, and then different specifications of drug-coated balloons are selected according to the length of the lesion to deliver drugs, which effectively treats vascular stenosis and maintains long-term patency, but the operation is complicated and the cost is high.

[0004] Refer to the Chinese patent with publication number CN111388086A, which discloses an electrode balloon catheter, including a catheter body, a balloon, a shock wave generating assembly and a transmission assembly, wherein the shock wave generating assembly includes a slide rail, a moving body and an electrode pair, a plurality of moving bodies are arranged on the slide rail, the moving bodies are slidably connected with the slide rail, at least one electrode pair is arranged on each moving body, and the transmission assembly includes a driving shaft, and the driving shaft is sequentially provided with a plurality of external threads along the direction from the proximal end to the distal end of the catheter body end, and the external threads are used to cooperate with the thread groove in the moving body, so that the moving bodies are close to each other or away from each other along the axial direction of the catheter body end. The electrode balloon catheter of the invention can make the shock wave energy emitted when the two electrode pairs are close to each other superimposed, thereby improving the efficiency of calcification lesion pulverization.

[0005] However, the electrode pair of the invention is complicated to operate when moving. During the movement, the driving motor needs to be used to control the rotation of the driving shaft. The driving shaft is provided with a first external thread and a second external thread with opposite rotation directions. The first external thread and the second external thread cooperate with the internal thread grooves of the first moving body and the second moving body respectively to make the first moving body and the second moving body move. The first moving body and the second moving body are supported by the slide rail to avoid circumferential rotation, and make them move closer to or away from each other along the axial direction of the end of the catheter body. The structure is very complicated and it is very troublesome in actual operation. In addition, its technical effect is only to shorten the working time and improve the crushing efficiency, and it is impossible to achieve drug release and promote drug absorption at a specific lesion location. Summary of the invention

[0006] One object of the present invention is to provide a drug-loaded balloon catheter system with movable electrode pairs.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is:

[0008] A balloon catheter system comprises a catheter body, a balloon connected to the distal end of the catheter body, and an electrode device. The balloon catheter system also comprises a movable catheter and a traction guidewire. The movable catheter is movably sleeved on the catheter body located in the balloon. One end of the traction guidewire is connected to the movable catheter and is used to pull the movable catheter to move along the length direction of the catheter body. The electrode device is arranged on the movable catheter. A drug coating is arranged on the outside of the balloon. A protective layer is arranged on the outside of the drug coating. When the electrode device generates a shock wave and acts on the protective layer, the protective layer ruptures and allows the drug coating to be released.

[0009] Preferably, the catheter body includes an inner catheter and an outer catheter sleeved outside the inner catheter, the distal end of the inner catheter extends out of the distal end of the outer catheter, the proximal end of the balloon is connected to the distal end of the outer catheter, the distal end of the balloon is connected to the distal end of the inner catheter, and the movable catheter is sleeved on the inner catheter extending out of the outer catheter.

[0010] Preferably, one end of the traction guidewire is connected to the movable catheter, and the other end of the traction guidewire passes through the gap between the inner catheter and the outer catheter for operation.

[0011] Preferably, the balloon catheter system further comprises a sealing tube, which is arranged between the inner catheter and the outer catheter, one end of which is sealedly connected to the movable catheter, a passage hole is provided at the proximal end of the outer catheter, the other end of which is sealedly connected to the passage hole, the traction guide wire is arranged in the sealing tube, one end of which is connected to the movable catheter, and the other end of which passes through the passage hole for operation. During the balloon inflation process, the sealing tube can achieve sealing and pressure maintenance of the passage hole.

[0012] Preferably, the sealing tube is made of polymer material, and the polymer material is selected from at least one of PET and PTFE.

[0013] Preferably, the two ends of the balloon are connected to the inner catheter and the outer catheter by hot-melt welding and / or laser welding and / or bonding.

[0014] Preferably, the balloon catheter system further comprises a marker ring assembly, the marker ring assembly comprises a first marker ring and a second marker ring, the movable catheter is provided with a plurality of first marker rings, the inner catheter is provided with a plurality of second marker rings, the shapes and / or sizes of the plurality of first marker rings and second marker rings are different, and when the first marker ring and the second marker ring overlap, the position of the movable catheter on the inner catheter is indicated. The marker ring assembly can accurately control the position of the movable catheter in the balloon, realize the uniform release of the drug coating in the blood vessel wall, and avoid duplication or omission of drugs in the same lesion segment.

[0015] Preferably, the balloon catheter system further comprises a handle connected to the proximal end of the catheter body; the handle is provided with an operating portion for pulling the traction guidewire to move along the length direction of the catheter body, and the other end of the traction guidewire is connected to the operating portion.

[0016] Preferably, the handle is provided with a slide groove extending along the distal direction thereof, and the operating part is movably arranged on the slide groove. When the operating part is moved, the traction guide wire pulls the movable catheter to move.

[0017] Preferably, the material of the protective layer is a polymer material with energy response characteristics, and the polymer material includes polyethylene glycol, polylactic acid and dextran. The protective layer is used to prevent the drug coating from being destroyed during the process of entering the blood vessel.

[0018] Preferably, the drug coating uses paclitaxel or rapamycin and their derivatives.

[0019] Preferably, the surface of the balloon is treated with plasma or silicone to increase the adhesion of the drug coating.

[0020] Preferably, one end of the traction guidewire is connected to the movable catheter by welding or bonding.

[0021] Preferably, the material of the traction guidewire includes stainless steel or nickel-titanium alloy, and the outer peripheral surface of the traction guidewire is provided with an insulating layer.

[0022] Another object of the present invention is to provide a shock wave generating system for cardiovascular stenosis lesions.

[0023] In order to achieve the above object, the technical solution adopted by the present invention is:

[0024] A shock wave generating system comprises a balloon catheter system and an energy generator. The balloon catheter system is a balloon catheter system described above, and an electrode device of the balloon catheter system is electrically connected to the energy generator.

[0025] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0026] The present invention provides a movable electrode device and a drug coating and a protective layer on the outside of the balloon, so that shock waves can be applied to any lesion location, thereby achieving the goal of promoting the absorption of drugs by the blood vessel wall while shattering the calcified lesions, effectively reducing the risk of the drug being destroyed when the balloon enters the blood vessel, and has a simple structure, easy operation and low cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Attached Figure 1 is a schematic diagram of the shock wave generating system of this embodiment;

[0028] Attached Figure 2 is a schematic structural diagram of the balloon catheter system of this embodiment;

[0029] Attached Figure 3 For attachment Figure 2 Schematic diagram of the cross section of AA;

[0030] Attached Figure 4 For attachment Figure 2 Schematic diagram of the cross section of BB.

[0031] In the above figures: 1. Energy generator; 11. Connecting wire; 2. Balloon catheter system; 21. Catheter body; 211. Inner catheter; 212. Outer catheter; 22. Balloon; 23. Electrode device; 24. Movable catheter; 25. Retraction guidewire; 26. Sealing tube; 261. Channel hole; 27. Handle; 271. Operating part; 272. Slide groove; 28. Drug coating; 29. ​​Protective layer; 30. Marking ring assembly; 301. First marking ring; 302. Second marking ring. DETAILED DESCRIPTION

[0032] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. 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] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0034] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0035] like Figure 1 The shock wave generating system shown includes an energy generator 1 and a balloon catheter system 2 . The balloon catheter system 2 is connected to the energy generator 1 via a connecting wire 11 .

[0036] The balloon catheter system 2 includes a catheter body 21, a balloon 22, an electrode device 23, an active catheter 24, a traction guide wire 25, a sealing tube 26, a handle 27, a drug coating 28, a protective layer 29, and a marker ring assembly 30. Figure 2 As shown, where:

[0037] The balloon 22 is connected to the distal end of the catheter body 21, the handle 27 is connected to the proximal end of the catheter body 21, the movable catheter 24 is movably mounted on the catheter body 21 located in the balloon 22, the electrode device 23 is arranged on the movable catheter 24, the traction guidewire 25 is arranged in the sealing tube 26, one end of the traction guidewire 26 is connected to the movable catheter 24, and the other end of the traction guidewire 26 is connected to the handle 27, the drug coating 28 is arranged on the outside of the balloon 22, the protective layer 29 is arranged on the outside of the drug coating 22, and the marking ring assembly 30 is arranged on the movable catheter 24 and the catheter body 21.

[0038] Specifically:

[0039] The catheter body 21 includes an inner catheter 211 and an outer catheter 212. The outer catheter 212 is sleeved outside the inner catheter 211. The distal end of the inner catheter 211 extends out of the distal end of the outer catheter 212. The proximal end of the balloon 22 is connected to the distal end of the outer catheter 212, and the distal end of the balloon 22 is connected to the distal end of the inner catheter 211. In this embodiment, the two ends of the balloon 22 are connected to the inner catheter 211 and the outer catheter 212 by hot melt welding and / or laser welding and / or bonding.

[0040] The movable conduit 24 is sleeved on the inner conduit 211 extending out of the outer conduit 212. Figure 3 As shown, the electrode device 23 is arranged on the movable catheter 24 and is connected to the energy generator 1 through the connecting wire 11. The energy generator 1 can control the electrode device 23 to generate shock waves.

[0041] The handle 27 is connected to the proximal end of the catheter body 21 . The handle 27 is provided with an operating portion 271 . The operating portion 271 is arranged in a slide groove 272 extending along the distal direction of the handle 27 . The operating portion 271 can move in the slide groove 272 along the distal direction.

[0042] One end of the traction guide wire 25 is connected to the movable catheter 24, and the other end of the traction guide wire 25 passes through the gap between the inner catheter 211 and the outer catheter 212 for operation. In this embodiment, the other end of the traction guide wire 25 passes through the gap between the inner catheter 211 and the outer catheter 212 and is connected to the operating part 271 in the handle 27. When the operating part 271 is moved, the traction guide wire 25 pulls the movable catheter 24 to move along the length direction of the inner catheter 211. One end of the traction guide wire 25 is connected to the movable catheter 24 by welding or bonding. The material of the traction guide wire 25 is a metal material such as stainless steel or nickel-titanium alloy, and an insulating layer is provided on the outer peripheral surface of the traction guide wire 25.

[0043] The sealing tube 26 is sleeved on the outside of the traction guide wire 25, and the sealing tube 26 is arranged between the inner catheter 211 and the outer catheter 212. Figure 4 As shown, one end of the sealing tube 26 is sealed and connected to the movable catheter 24, a channel hole 261 is provided at the proximal end of the outer catheter 212, the other end of the sealing tube 26 is sealed and connected to the channel hole 261, one end of the traction guide wire 25 is connected to the movable catheter 24, and the other end of the traction guide wire 25 passes through the channel hole 261 for operation. During the inflation process of the balloon 22, the sealing tube 26 can achieve sealing and pressure maintenance of the channel hole 261. The material of the sealing tube 26 is a polymer material, such as PET, PTFE, etc. The connecting wire 11 connecting the electrode device 23 and the energy generator 1 is also arranged in the sealing tube 26.

[0044] The marker ring assembly 30 includes a first marker ring 301 and a second marker ring 302. The first marker ring 301 is disposed at both ends of the movable catheter 24, and a plurality of second marker rings 302 are disposed on the inner catheter 211. The shapes and / or sizes of the plurality of first marker rings 301 and second marker rings 302 are different. The marker ring assembly 30 can accurately control the position of the movable catheter 24 in the balloon 22, so as to achieve uniform release of the drug coating 28 in the blood vessel wall, and avoid duplication or omission of drugs in the same lesion segment. When the first marker ring 301 and the second marker ring 302 overlap, the position of the movable catheter 24 on the inner catheter 211 is indicated.

[0045] The drug coating 28 is disposed outside the balloon 22 , and the drug coating 28 uses paclitaxel or rapamycin and its derivatives. The surface of the balloon 22 is treated with plasma or silicone to increase the adhesion of the drug coating 28 .

[0046] The protective layer 29 is arranged outside the drug coating 28 to prevent the drug coating 28 from being damaged during the process of entering the blood vessel. The protective layer 29 has a shock wave response characteristic. When the energy generator 1 controls the electrode device 23 to generate a shock wave and acts on the protective layer 29, the protective layer 29 ruptures and allows the drug coating 28 to be released. The material of the protective layer 29 is a polymer material film such as polyethylene glycol (PEG), polylactic acid (PLA) and dextran.

[0047] During the working process of this embodiment:

[0048] After the balloon catheter system 2 enters the lesion location, it is filled with a mixture of physiological saline and contrast agent and is pressed against the blood vessel wall. At this time, the movable catheter 24 is located at the distal end of the balloon 22. The operating part 271 on the handle 27 is adjusted, and the guide wire 25 is pulled to drive the movable catheter 24 to move so that the movable catheter 24 is located at the first lesion location. At this time, the first marking rings 301 at both ends of the movable catheter 24 overlap with the two second marking rings 302 at the first lesion location on the inner catheter 211.

[0049] The energy generator 1 is turned on to make the electrode device 23 generate shock waves. While the shock waves shatter the calcified lesions, the protective layer 29 located at the first lesion position is ruptured under the action of the shock waves, and the drug coating 28 is fully released to the blood vessel wall.

[0050] After completing the treatment of the first lesion position, adjust the operating part 271 on the handle 27 to move the movable catheter 24 to the second lesion position. At this time, the first marking ring 301 and the second marking ring 302 of the second lesion position overlap, and the electrode device 23 generates shock waves to shatter the calcified lesions while the drug coating 28 is fully released to the blood vessel wall.

[0051] Continue to adjust the operating portion 271 on the handle 27 to move the movable catheter 24, and repeat the above steps until all lesion locations are treated.

[0052] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A balloon catheter system, comprising a catheter body, a balloon connected to the distal end of the catheter body, and an electrode device, wherein the catheter body comprises an inner catheter and an outer catheter sleeved outside the inner catheter, the distal end of the inner catheter extends out of the distal end of the outer catheter, and is characterized in that: The balloon catheter system also includes a movable catheter and a traction guidewire. The movable catheter is movably mounted on an inner catheter located in the balloon and extending out of the outer catheter. One end of the traction guidewire is connected to the movable catheter, and the other end of the traction guidewire passes through the gap between the inner catheter and the outer catheter for operation, and is used to pull the movable catheter to move along the length direction of the catheter body. The electrode device is arranged on the movable catheter. In the initial state of the balloon catheter system, the movable catheter is located at the distal end of the balloon; a drug coating is arranged on the outside of the balloon, and a protective layer is arranged on the outside of the drug coating. When the electrode device generates shock waves and acts on the protective layer, the protective layer ruptures and allows the drug coating to be released.

2. The balloon catheter system according to claim 1, characterized in that: The proximal end of the balloon is connected to the distal end of the outer catheter, and the distal end of the balloon is connected to the distal end of the inner catheter.

3. The balloon catheter system according to claim 2, characterized in that: The balloon catheter system also includes a sealing tube, which is arranged between the inner catheter and the outer catheter, one end of the sealing tube is sealed and connected to the movable catheter, a channel hole is provided at the proximal end of the outer catheter, and the other end of the sealing tube is sealed and connected to the channel hole, the traction guidewire is arranged in the sealing tube, one end of the traction guidewire is connected to the movable catheter, and the other end of the traction guidewire passes through the channel hole for operation.

4. The balloon catheter system according to claim 3, characterized in that: The sealing tube is made of polymer material, and the polymer material is selected from at least one of PET and PTFE.

5. The balloon catheter system according to claim 2, characterized in that: The two ends of the balloon are connected to the inner catheter and the outer catheter by hot-melt welding and / or laser welding and / or bonding.

6. The balloon catheter system according to claim 2, characterized in that: The balloon catheter system also includes a marking ring assembly, which includes a first marking ring and a second marking ring. The movable catheter is provided with multiple first marking rings, and the inner catheter is provided with multiple second marking rings. The multiple first marking rings and second marking rings have different shapes and / or sizes. When the first marking rings and the second marking rings overlap, they indicate the position of the movable catheter on the inner catheter.

7. The balloon catheter system according to claim 1, characterized in that: The balloon catheter system also includes a handle connected to the proximal end of the catheter body; the handle is provided with an operating part for pulling the traction guidewire to move along the length direction of the catheter body, and the other end of the traction guidewire is connected to the operating part.

8. The balloon catheter system according to claim 7, characterized in that: The handle is provided with a slide groove extending along the distal direction thereof, and the operating part is movably arranged on the slide groove. When the operating part is moved, the traction guide wire pulls the movable catheter to move.

9. The balloon catheter system according to claim 1, characterized in that: The material of the protective layer is a polymer material with energy response characteristics, and the polymer material includes polyethylene glycol, polylactic acid and dextran.

10. The balloon catheter system according to claim 1, characterized in that: One end of the traction guide wire is connected to the movable catheter by welding or bonding.

11. The balloon catheter system according to claim 1, characterized in that: The material of the traction guide wire includes stainless steel and nickel-titanium alloy, and the outer peripheral surface of the traction guide wire is provided with an insulating layer.

12. A shock wave generating system, comprising a balloon catheter system and an energy generator, characterized in that: The balloon catheter system is the balloon catheter system according to any one of claims 1 to 11, and the electrode device of the balloon catheter system is electrically connected to the energy generator.

Images