A shock wave heart valve interventional therapy delivery system

Abstract

The present application discloses a shock wave heart valve interventional treatment delivery system, the delivery system includes: an outer braided tube, which is a hollow structure; an inner tube, which is a hollow structure, located inside the outer braided tube, and forms a prefabricated channel with the outer braided tube; a conductive electrode cable, which extends in the prefabricated channel and is used to conduct voltage / current pulses. Through the delivery system of the present application, the shock wave device for treating heart valve calcification can transfer and convert energy to the shock wave transmitter, thereby softening the stiff leaflets or rings of valve stenosis and regurgitation, improving the opening and closing state of the leaflets during work, achieving the effect of treatment, and avoiding the risks of implanting artificial valves during and after surgery. It can also be combined with existing surgical treatments to solve the problem of severe valve calcification encountered during surgery and the inability to accurately place the heart valve, that is, effectively avoiding the risks of difficult positioning and fixing of artificial valves, inappropriate release of artificial valves, and difficulty in removing during surgery, and can reduce peripheral leakage.

Description

Technical Field

[0001] The present application belongs to the field of medical technology, and specifically relates to a shock wave heart valve interventional treatment delivery system. Background Art

[0002] Heart valve calcification is the main pathological manifestation of heart valve stenosis and regurgitation, which usually occurs in the elderly; vascular calcification is a common pathological manifestation of atherosclerosis, hypertension, diabetic vascular disease, vascular damage, chronic kidney disease and aging.

[0003] Currently, treatments for heart valve calcification and vascular calcification include: drug therapy, surgical replacement or interventional surgical replacement.

[0004] The inventors of the present application discovered during the long-term research and development process that the effects of existing drug treatments are very limited, while existing surgical or interventional replacement methods have disadvantages such as being highly traumatic to the patient and time-consuming. Summary of the invention

[0005] The present application provides a shock wave heart valve interventional treatment delivery system, which can transmit and convert energy to a shock wave transmitter, and soften the calcified area through shock waves, thereby quickly and effectively completing the treatment of the calcified area.

[0006] In order to solve the above technical problems, a technical solution adopted in the present application is: a shock wave heart valve interventional treatment delivery system, comprising: an outer braided tube, which is a hollow structure; an inner tube, which is a hollow structure, located inside the outer braided tube, forming a prefabricated channel between the outer braided tube; a conductive electrode cable, extending in the prefabricated channel, for conducting voltage / current pulses.

[0007] According to one embodiment of the present application, the outer braided tube comprises an outer tube, a metal braided layer and an inner tube from the outside to the inside, wherein the outer tube is made of segmented polyetheramide resin material, the metal braided layer is woven by metal wire or metal wire, and the inner tube is made of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic elastomer rubber, polyimide or polyamide material.

[0008] According to one embodiment of the present application, the braiding density of the metal braided layer is 30-75ppi.

[0009] According to an embodiment of the present application, a developing ring is fixed to the end of the metal braided layer, and the developing ring is at least arranged at one end of the metal braided layer close to the shock wave emitter.

[0010] According to one embodiment of the present application, a plurality of conductive electrode cables are provided and are arranged in a circular array between the outer braided tube and the inner tube.

[0011] According to an embodiment of the present application, the conductive electrode cable includes a positive conductor and a negative conductor that are spaced apart, an inner insulating layer that wraps the positive conductor and the negative conductor, and an outer insulating layer that wraps the inner insulating layer.

[0012] According to one embodiment of the present application, the positive electrode conductor is a silver-clad copper wire, the negative electrode conductor includes an insulating outer layer and a conductor core, and the conductor core includes a copper wire or a copper-clad steel wire.

[0013] According to one embodiment of the present application, the inner insulating layer is an insulating material, and the transmission system can transmit a voltage of 3-7KV.

[0014] According to one embodiment of the present application, the inner diameter of the inner tube is greater than or equal to 0.035 inches.

[0015] According to one embodiment of the present application, the inner tube is made of polyetheretherketone, polyethylene or polyamide; or, the inner tube is a tube body with a braided structure.

[0016] According to one embodiment of the present application, the prefabricated channel is used to transport electrolyte liquid.

[0017] The beneficial effect of the present application is that through the delivery system of the present application, the shock wave device for treating heart valve calcification can transmit and convert energy to the shock wave transmitter, thereby softening the stiff leaflets or rings of valve stenosis and regurgitation, improving the opening and closing state of the leaflets during operation, achieving the effect of treatment, and avoiding the risks during and after implantation of artificial valves. It can also be combined with existing surgical treatments to solve the problem of severe valve calcification and inability to accurately place heart valves during surgery, that is, effectively avoiding the risks of difficult positioning and fixing of artificial valves, inappropriate release of artificial valves, and difficulty in removing during surgery, and can reduce peripheral leakage, shorten the operation time, and greatly improve the operation and prognosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0019] Figure 1 It is a three-dimensional structural schematic diagram of an embodiment of a shock wave heart valve interventional treatment delivery system of the present application;

[0020] Figure 2 It is a schematic cross-sectional structure diagram of an embodiment of the shock wave heart valve interventional treatment delivery system of the present application. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0022] See also Figure 1 to Figure 2 , Figure 1 It is a three-dimensional structural schematic diagram of an embodiment of a shock wave heart valve interventional treatment delivery system of the present application; Figure 2 It is a schematic cross-sectional structure diagram of an embodiment of the shock wave heart valve interventional treatment delivery system of the present application.

[0023] An embodiment of the present application provides a shock wave heart valve interventional treatment delivery system 100, such as Figure 1 As shown, it includes an outer braided tube 10, an inner tube 20 and a conductive electrode cable 30. The outer braided tube 10 is a hollow structure, and the inner tube 20 is located inside the outer braided tube 10, and a prefabricated channel 40 is formed between the inner tube 20 and the outer braided tube 10. The conductive electrode cable 30 extends in the prefabricated channel 40 for conducting voltage / current pulses. The outer braided tube 10 plays the role of establishing the access of the interventional instrument; the conductive electrode cable 30 conducts the voltage / current pulse to the shock wave transmitter; the inner tube 20 has the function of isolating the conductive electrode cable 30 and forming a passage for the internal guide wire (external instrument) to pass through. Through the delivery system 100 of the present application, the shock wave device for treating heart valve calcification can transmit and convert energy to the shock wave transmitter, thereby softening the stiff leaflets or rings of valve stenosis and regurgitation, improving the opening and closing state of the leaflets during operation, achieving the treatment effect, and avoiding the risks during and after the implantation of artificial valves. It can also be combined with existing surgical treatments to solve the problem of severe valve calcification and inability to accurately place the heart valve during surgery. It can effectively avoid the risks of difficulty in positioning and fixing the artificial valve during surgery, inappropriate release of the artificial valve, and difficulty in removing it. It can also reduce peripheral leaks and shorten the operation time, greatly improving surgical operations and prognosis.

[0024] In one embodiment, if Figure 1As shown, the outer braided tube 10 includes an outer tube 11, a metal braided layer 12 and an inner tube 13 from the outside to the inside. The outer tube 11 is made of PEBAX material (block polyetheramide resin material), which has certain softness and deformability. The PEBAX material selected for the outer tube 11 can be of different hardness according to actual needs. The metal braided layer 12 is cross-woven by metal wires or metal wires, which has certain support performance and passing performance. The metal braided layer 12 has a variable braiding density, which can be adjusted according to actual needs. Specifically, the braiding density of the metal braided layer 12 is 30-75ppi, such as 30ppi, 40ppi, 45ppi, 50ppi, 60ppi or 75ppi. The inner tube 13 can be made of polymer materials such as PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene copolymer), TPE (thermoplastic elastomer rubber), PI (polyimide) or PA (polyamide), which has certain ductility and lubricity. Specifically, the metal braided layer 12 is braided outside the inner tube 20 .

[0025] Furthermore, if Figure 1 As shown, a developing ring 14 is fixed at the end of the metal braided layer 12. Since the metal braided layer 12 is woven from metal wires or metal threads, there are messy wire ends at its end. The developing ring 14 plays a role in fixing the wires at the end of the metal braided layer 12 to prevent the scattered wire ends from causing damage to other structures. The developing ring 14 is at least located at one end of the metal braided layer 12 close to the shock wave emitter, or the developing ring 14 can be located at both ends of the metal braided layer 12, which is not limited here. The developing ring 14 can be developed under X-rays and plays a certain positioning role.

[0026] In one embodiment, if Figure 2 As shown, a plurality of conductive electrode cables 30 may be provided, and they are arranged in a circumferential array between the outer braided tube 10 and the inner tube 20. Since the conductive electrode cables 30 need to conduct high voltage / current, the conductive electrode cables 30 arranged in the array maintain a certain distance to avoid mutual interference, transmit electrical energy to the distal electrode generator, ensure that the generator can discharge normally, and convert energy into sound waves to transmit to the valve calcification position. In this embodiment, three conductive electrode cables 30 are provided. In other embodiments, one, two, four or more conductive electrode cables 30 may be provided, so that the delivery system 100 of the present application can be installed with one or more groups of electrodes.

[0027] Furthermore, if Figure 2As shown, the conducting electrode cable 30 includes a positive conductor 31 and a negative conductor 32 arranged at intervals, an inner insulating layer 33 wrapping the positive conductor 31 and the negative conductor 32, and an outer insulating layer 34 wrapping the inner insulating layer 33. The positive conductor 31 is a silver-clad copper wire, and the negative conductor 32 is an enameled wire with an insulating outer layer. Specifically, the negative conductor 32 includes an insulating outer layer and a conductor core. The conductor core is a copper wire or a copper-clad steel wire. The insulating outer layer is polyimide or other insulating materials. The color of the insulating outer layer can be red, yellow or black, etc. Through the multi-layer insulation design, the conveying system 100 of the present application can withstand higher voltages. Specifically, the conveying system 100 of the present application can withstand a voltage of 3-7KV.

[0028] In one embodiment, if Figure 2 As shown, the inner tube 20 can be made of polymer materials such as PEEK (polyetheretherketone), PE (polyethylene), PA (polyamide), etc., which have certain ductility and lubricity. In other embodiments, the inner tube 20 can also be a tube body with a braided structure, which is similar to the outer braided tube 10 and will not be described here.

[0029] In one embodiment, if Figure 2 As shown, the inner diameter of the inner tube 20 is greater than or equal to 0.035 inches, so that it can pass a guide wire with a maximum diameter of 0.035 inches.

[0030] In one embodiment, if Figure 1 and Figure 2 As shown, the prefabricated channel 40 between the outer braided tube 10 and the inner tube 20 is connected to the balloon (wrapped outside the shock wave transmitter) for transporting electrolyte liquid, so that the electrolyte liquid in the balloon can flow in through the prefabricated channel 40.

[0031] In summary, different from the prior art, the shock wave device for treating heart valve calcification relies on the delivery system 100 of the present application to transmit the pulse signal generated by the shock wave generator to the shock wave transmitter, and then the electrode discharges to soften the calcified position of the heart valve or loosen the adhesion position, thereby improving and treating patients with heart valve stenosis and regurgitation. The device can be used for treatment through interventional methods, or combined with the "surgical method of replacing the autologous valve surgical method", effectively improving the success rate of the operation.

[0032] The delivery system 100 of the present application can output high-frequency voltage / current pulses in its working state, and can withstand different current / voltage pulse strengths and repetition frequencies, ensuring that there is no attenuation after multiple discharges. The delivery system 100 of the present application can be accessed through the femoral artery, and has good support and passability, and has a strong ability to pass the arch.

[0033] The above description is only an embodiment of the present application and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A shock wave heart valve interventional therapy delivery system, characterized in that: include: The outer braided tube is a hollow structure used to establish a pathway for interventional devices; An inner tube is located inside the outer braided tube and forms a prefabricated channel with the outer braided tube. The prefabricated channel is used to communicate with the balloon and transport electrolyte liquid. The inner tube is used to form a passage for external instruments to pass through. a conductive electrode cable extending in the prefabricated channel for conducting voltage / current pulses; The conductive electrode cables are provided in a plurality and are arranged in a circumferential array between the outer braided tube and the inner tube; The conductive electrode cable comprises a positive conductor and a negative conductor arranged at intervals, an inner insulating layer wrapping the positive conductor and the negative conductor, and an outer insulating layer wrapping the inner insulating layer; The outer braided tube includes an outer tube, a metal braided layer and an inner tube from the outside to the inside, wherein the outer tube is made of block polyetheramide resin material, the metal braided layer is woven by metal wires or metal lines, and the metal braided layer is woven outside the inner tube, and the inner tube is made of fluorinated ethylene propylene copolymer, thermoplastic elastomer rubber, polyimide or polyamide material.

2. The conveying system according to claim 1, characterized in that The braiding density of the metal braided layer is 30-75ppi.

3. The conveying system according to claim 1, characterized in that A developing ring is fixed at the end of the metal braided layer, and the developing ring is at least arranged at one end of the metal braided layer close to the shock wave transmitter.

4. The conveying system according to claim 1, characterized in that The positive electrode conductor is a silver-clad copper wire, and the negative electrode conductor includes an insulating outer layer and a conductor core, and the conductor core includes a copper wire or a copper-clad steel wire.

5. The conveying system according to claim 1, characterized in that The inner insulating layer is made of insulating material, and the transmission system can transmit a voltage of 3-7KV.

6. The conveying system according to claim 1, characterized in that The inner tube has an inner diameter greater than or equal to 0.035 inches.

7. The conveying system according to claim 1, characterized in that The inner tube is made of polyetheretherketone, polyethylene or polyamide; or, the inner tube is a tube body with a braided structure.

8. The conveying system according to claim 1, characterized in that The inner tube is a hollow structure.

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