Shockwave Therapy Catheter System

Abstract

The present application provides a shock wave therapy catheter system, including a first catheter, a shock wave generating device and a valve supporting device, wherein a first cavity is provided in the first catheter; the shock wave generating device includes at least one first balloon that can be inflated with liquid and a plurality of electrodes installed in the first balloon, the first balloon is arranged in the first cavity, and the distal end of the first balloon can be removed from the first cavity; the valve supporting device includes a second catheter and an inflatable supporting structure, the second catheter is arranged in the first cavity, and the supporting structure is connected to the second catheter; when the distal end of the second catheter passes through the valve gap, the supporting structure expands and abuts against one side of the valve, the first balloon is inflated with liquid and abuts against the other side of the valve, and the valve is clamped between the supporting structure and the first balloon. The shock wave therapy catheter system of the present application can fix the valve between the supporting structure and the first balloon, and make the shock wave discharge electrode close to the treatment site, thereby improving the treatment effect.

Description

Technical Field

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

[0002] Calcified aortic valve disease (CAVD) is a type of disease characterized by progressive calcification of aortic valve leaflets, eventual deformation of the leaflets, and abnormal opening and closing function, leading to left ventricular outflow tract stenosis and hemodynamic disturbances. With the global aging population, its incidence rate has increased year by year, becoming one of the most common causes of aortic valve stenosis. In the ranking of cardiovascular diseases in developed countries, CAVD is the third largest disease, second only to coronary atherosclerosis and hypertension. According to a study in my country, the incidence of valve calcification in the elderly population over 50 years old is 12.5%, of which aortic calcification accounts for 94.4%.

[0003] Since there is still a lack of effective drugs for the treatment of CAVD, surgical aortic valve replacement and transcatheter aortic valve replacement are currently the main methods for treating severe calcific aortic valve disease. Artificial aortic valves can be divided into two types: biological valves and mechanical valves, each with its own advantages and disadvantages. For example, biological valves have a limited service life, while mechanical valves have a long life but require lifelong anticoagulant medication and have a low long-term survival rate. With the development of cardiac surgical technology, valvuloplasty has gradually attracted the attention of a large number of cardiac surgeons and has become one of the important means of treating heart valve disease. Compared with artificial valve replacement, valvuloplasty is a surgery that repairs the valve through incision, suturing, repairing, and implanting a shaping ring to preserve the valve's own structure and restore valve function. It has the advantages of not requiring lifelong anticoagulation, rapid recovery of postoperative cardiac function, low mortality, and good quality of life.

[0004] Shock wave therapy provides a feasible treatment method for aortic valvuloplasty. Its mechanism of action is based on the hydrostatic effect generated by the discharge of electrodes in a liquid medium. During the electrode discharge process, the large current passing through the liquid medium can vaporize the surrounding liquid to form bubbles and rapidly expand outward, followed by volume contraction in a very short time, producing a cavitation effect. During the rapid expansion and rupture of the bubbles, since the particle movement speed exceeds the speed of sound in the medium, a powerful shock wave is generated. This phenomenon is also called the hydrostatic effect. The shock wave generated by the hydrostatic effect is used to impact the target calcified area to break or loosen the calcified tissue, thereby opening the calcified valve or expanding the valve opening to achieve a therapeutic effect.

[0005] Due to the damping effect of the liquid medium, the intensity of the shock wave decays exponentially with the distance from the shock wave source. More specifically, the impact intensity of the shock wave in valvuloplasty is inversely proportional to the square of the distance from the shock wave source to the valve. Therefore, when applying shock waves, it is desirable to minimize the distance between the shock wave source and the valve site being treated to maximize the effect of the shock waves.

[0006] Existing shock wave catheter devices generally have the following problems that cannot be effectively solved: (1) The electrodes or arc generators that generate shock waves are located in the middle of the catheter, far away from the site of valve lesions. The shock wave source cannot effectively act on the calcified site at a close distance, weakening the effect of the shock wave. (2) The heart valve is a freely movable entity. When the shock wave passes through the valve, the valve will move and deform, thereby weakening the effect of shock wave therapy. (3) When performing valvuloplasty, loose / detached calcified tissue fragments / detached materials enter the blood, which may cause blood vessel blockage and trigger risks of thrombosis, stroke, myocardial infarction, etc. The above problems limit the effective application of shock wave therapy catheter devices in valvuloplasty. Summary of the invention

[0007] In order to solve the above-mentioned defects existing in the prior art, the shock wave therapy catheter system provided in the present application can fix the valve between the support structure and the first balloon, and make the shock wave discharge electrode close to the treatment site, thereby improving the treatment effect.

[0008] The present application provides a shock wave therapy catheter system, comprising a first catheter, a shock wave generating device and a valve supporting device, wherein a first cavity is arranged in the first catheter; the shock wave generating device comprises at least one first balloon which can be inflated by liquid and a plurality of electrodes installed in the first balloon, the first balloon is arranged in the first cavity, and the distal end of the first balloon can be removed from the first cavity; the valve supporting device comprises at least one inflatable supporting structure, the supporting structure is arranged in the first cavity, and the supporting structure can be removed from the first cavity; when the supporting structure moves out of the first cavity and passes through the valve gap, the supporting structure expands and abuts against one side of the valve, and then the first balloon moves out of the first cavity and is inflated by liquid, abuts against the other side of the valve, so that the valve is clamped between the supporting structure and the first balloon.

[0009] Preferably, the first balloon includes a plurality of sac-shaped sub-parts, and the sac-shaped sub-parts can be expanded by filling with liquid, and the expansion mode of the sac-shaped sub-parts includes any one of the following:

[0010] All the sac-like sub-parts are filled with fluid and expanded simultaneously;

[0011] The cystic sub-sections are expanded separately in sequence;

[0012] The two or more bladder sub-portions expand together in a coordinated manner.

[0013] Optionally, the shock wave generating device further comprises a second catheter, the second catheter is arranged in the first cavity, a second cavity is arranged in the second catheter, and the distal end of the first balloon is connected to the second catheter.

[0014] Preferably, the valve support device further comprises a third catheter, the third catheter is movably disposed in the second cavity, and the support structure is connected to the third catheter.

[0015] Optionally, the support structure includes a folding stent, which includes a first end at the distal end, a second end at the proximal end, and an expansion portion connected between the first end and the second end, and the expansion portion includes a folded state and an expanded state; when the expansion portion is in the folded state, the expansion portion is folded on the third catheter; when the expansion portion is in the expanded state, the expansion portion can be against the valve.

[0016] Optionally, both the first end and the second end are connected to the third catheter; when the folding stent is located in the second cavity, the expansion portion is in a folded state; when the folding stent moves out of the second cavity, the expansion portion expands from the folded state to the expanded state.

[0017] Optionally, the first end is connected to the distal end of the second catheter, and the second end is connected to the distal end of the third catheter; when the second catheter and the third catheter move relative to each other, the expansion portion can expand from the folded state to the expanded state, or the expansion portion can be retracted and folded from the expanded state to the folded state.

[0018] Preferably, each of the first conduit, the second conduit, and the third conduit may be connected to at least one developing ring, and the connection position of the developing ring includes any one of the following:

[0019] The developing rings are respectively fixed to the distal ends of the first conduit, the second conduit and the third conduit;

[0020] The developing rings are respectively fixed to the distal ends of the first conduit, the second conduit and the third conduit, and the proximal end of the supporting structure;

[0021] The developing ring is respectively fixed to the distal ends of the first and third conduits, and the proximal end of the supporting structure.

[0022] Preferably, a third lumen is provided in the third catheter, and the shock wave therapy catheter system further comprises a guide wire, and the guide wire can pass through the third lumen.

[0023] Preferably, the support structure comprises at least one second balloon, the second balloon is disposed in the first lumen, the distal end of the second balloon can be removed from the first lumen, and the second balloon can be inflated by filling with liquid.

[0024] Preferably, the valve support device further comprises a third catheter, the third catheter is movably disposed in the first cavity, and the support structure is connected to the third catheter.

[0025] Preferably, a coating is provided on a part or all of the surface of the first catheter, the shock wave generating device and the valve supporting device, and the coating comprises at least one of the following:

[0026] Anti-thrombotic coating;

[0027] Antimicrobial coating;

[0028] Lubricating coatings;

[0029] Hydrophilic coating.

[0030] Optionally, the electrode is connected to the inner surface of the first balloon.

[0031] Optionally, the shock wave generating device further comprises a flexible support member, wherein the flexible support member is disposed in the first balloon, and the electrode is connected to a side of the flexible support member close to the valve.

[0032] Optionally, the flexible support member includes any one of the following:

[0033] Foldable stand;

[0034] Guidewire;

[0035] catheter;

[0036] Probe;

[0037] Balloon.

[0038] The shock wave generating device further comprises a wire and a power supply device, one end of the wire is electrically connected to the electrode, and the other end of the wire is electrically connected to the power supply device.

[0039] The shock wave generating device also includes a liquid supply device. The opening end of the first balloon passes through the proximal end of the first catheter and docks with the liquid supply device. The liquid supply device is used to fill or drain liquid from the first balloon.

[0040] Preferably, the shock wave generating device further comprises an electromagnetic shielding layer for shielding electromagnetic interference, and the setting position of the electromagnetic shielding layer includes at least one of the following:

[0041] The electromagnetic shielding layer covers the inner surface or the outer surface of the first balloon;

[0042] The electromagnetic shielding layer is embedded in the first balloon;

[0043] The electromagnetic shielding layer is arranged around the circumference of the electrode.

[0044] Preferably, the shock wave therapy catheter system also includes a collecting device, which includes a fourth catheter and a collecting net. A fourth cavity is provided in the fourth catheter, and the first catheter can be movably arranged in the fourth cavity. The collecting net is connected to the first catheter, or the collecting net is connected between the first catheter and the fourth catheter. The collecting net can be expanded to rest against the inner wall of the blood vessel, or the collecting net can be folded on the first catheter and / or the fourth catheter.

[0045] Optionally, the collecting net is covered on a partial outer wall of the first catheter, and both ends of the collecting net are connected to the first catheter; when the collecting net is located in the fourth cavity, the collecting net is in a folded state; when the collecting net moves out of the fourth cavity, the collecting net expands from a folded state to an expanded state and rests against the inner wall of the blood vessel.

[0046] Optionally, the collecting net is covered on a partial outer wall of the first catheter, one end of the collecting net is connected to the first catheter, and the other end of the collecting net is connected to the fourth catheter; when the first catheter and the fourth catheter move relative to each other, the collecting net can be folded on the first catheter and the fourth catheter, or the collecting net can be expanded to rest against the inner wall of the blood vessel.

[0047] The shock wave therapy catheter system of the present application cooperates with the first balloon through the support structure to fix the valve between the support structure and the first balloon. During the treatment process, the valve can be kept in a stable state and the shock wave discharge electrode can be close to the treatment site, which is beneficial to improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 It is a partial structural schematic diagram of the shock wave therapy catheter system of the first embodiment of the present application in a non-working state.

[0049] Figure 2 yes Figure 1 A partial perspective schematic diagram of the shock wave therapy catheter system is shown in a collapsed state.

[0050] Figure 3 It is a partial structural schematic diagram of the shock wave therapy catheter system of the first embodiment of the present application in a working state.

[0051] Figure 4A and Figure 4BIt is a partial structural schematic diagram of different connection modes of the support structure of the present application.

[0052] Figure 5 yes Figure 2 The schematic diagram of the cross-sectional structure of the shock wave therapy catheter system along AA is shown.

[0053] Figure 6 It is a schematic cross-sectional structural diagram of the shock wave generating device of the present application when the three sac-shaped sub-parts are all filled with liquid.

[0054] Figure 7 It is a schematic cross-sectional structural diagram of a sac-shaped sub-section of the shock wave generating device of the present application when it is filled with liquid alone.

[0055] Figure 8 It is a partial structural schematic diagram of the shock wave therapy catheter system of the second embodiment of the present application in a working state.

[0056] Fig. 9 It is a partial structural schematic diagram of the shock wave therapy catheter system of the third embodiment of the present application in a working state. DETAILED DESCRIPTION

[0057] The following is an explanation of the implementation of the present application by means of specific embodiments. People familiar with the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0058] In the following description, reference is made to the accompanying drawings, which describe several embodiments of the present application. It should be understood that other embodiments may be used and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description should not be considered limiting, and the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application.

[0059] Although the terms first, second, etc. are used herein to describe various elements in some instances, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element.

[0060] Furthermore, as used in this article, the singular forms "one", "an" and "the" are intended to include plural forms as well, unless there is an indication to the contrary in the context. It should be further understood that the terms "comprise", "include" indicate the presence of features, steps, operations, elements, components, projects, kinds, and / or groups, but do not exclude the presence, occurrence or addition of one or more other features, steps, operations, elements, components, projects, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Therefore, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". Only when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way, will there be an exception to this definition.

[0061] First embodiment

[0062] Figure 1 is a partial structural schematic diagram of the shock wave therapy catheter system of the first embodiment of the present application in a non-working state, Figure 2 yes Figure 1 The partial perspective schematic diagram of the shock wave therapy catheter system in a collapsed state is shown. Figure 3 FIG. 1 is a schematic diagram of a partial structure of the shock wave therapy catheter system in the first embodiment of the present application in a working state. Figure 1 , Figure 2 and Figure 3 As shown, the main structure of the shock wave therapy catheter system can be divided into four parts, including a first catheter 11, a shock wave generating device 12, a valve supporting device 13 and a collecting device 14, wherein:

[0063] ① The first conduit 11, in which a first cavity is disposed, and the first cavity can be used for passage of other components and media.

[0064] ② The shock wave generating device 12 includes a first balloon 121 that can be inflated with liquid, a plurality of electrodes 122 installed in the first balloon 121, and a second catheter 123. The second catheter 123 can be movably arranged in the first cavity, the distal end of the first balloon 121 and the distal end of the second catheter 123 are fixed, and the distal end of the first balloon 121 can be removed from the first cavity together with the second catheter 123. When the distal end of the first balloon 121 is removed from the first cavity, the first balloon 121 can be inflated with liquid and abut against the valve 22, and the plurality of electrodes 122 installed on the first balloon 121 are then close to the calcified tissue 23 of the valve 22, so as to implement more effective treatment on the calcified tissue 23.

[0065] ③ The valve support device 13 includes a third catheter 131 and an expandable support structure. The third catheter 131 is movably arranged in the second cavity of the second catheter 123, and the support structure is connected to the third catheter 131. The support structure includes a folding support 132, and the folding support 132 includes a first end 1321 at the distal end, a second end 1322 at the proximal end, and an expansion portion 1323 connected between the first end 1321 and the second end 1322. The expansion portion 1323 includes a folded state and an expanded state; when the expansion portion 1323 is in the folded state, the expansion portion 1323 is folded and folded on the third catheter 131; when the expansion portion 1323 is in the expanded state, the expansion portion 1323 can be against the valve 22. The folding support 132 can be formed by laser cutting of a metal tube, or it can be made by weaving a plurality of support ribs. In other embodiments, the folding support 132 is an elastic diaphragm, which is tubular, and the middle part of the elastic diaphragm can be elastically expanded or folded.

[0066] Optionally, Figure 4A and Figure 4B 1 is a partial structural diagram of different connection modes of the support structure of the present application. The support structure of the valve support device 13 has two different connection modes. The partial structural diagrams of the different connection modes are as follows: Figure 4A and Figure 4B shown.

[0067] For the first connection method, please refer to Figure 1 and Figure 4AThe first end 1321 and the second end 1322 of the folding bracket 132 are both connected to the third conduit 131, wherein the first end 1321 is connected to the distal end of the third conduit 131, and the second end 1322 is connected to the distal end of the third conduit 131; after the folding bracket 132 is folded, it can be accommodated in the second cavity together with the third conduit 131. When the folding bracket 132 and the third conduit 131 are located in the third cavity, the expansion part 1323 is in a folded state; when the folding bracket 132 is moved out of the third cavity, the expansion part 1323 expands from the folded state to the expanded state. In the present embodiment, the folding stent 132 is a self-expanding stent, which is made of an elastic material (such as nickel-titanium alloy) or a combination of an elastic material and other materials, and has a lantern-like shape after being made; when the expansion portion 1323 of the folding stent 132 is not constrained by space, the expansion portion 1323 is in an expanded state, that is, when the expansion portion 1323 is not constrained by the inner wall of the third lumen, the expansion portion 1323 is in an expanded state; when the folding stent 132 is located in the third lumen, the expansion portion 1323 is constrained by the inner wall of the third lumen and is in a folded state; when in use, the distal end of the second catheter 123 can be first moved to approach the gap of the valve 22 or pass through the gap of the valve 22, and then the third catheter 131 can be pushed out of the third lumen to make the third catheter 131 pass through the gap of the valve 22, at which time the expansion portion 1323 of the folding stent 132 gradually expands from the folded state to the expanded state, and at this time the folding stent 132 supports the valve 22; when use is completed, the third catheter 131 is pulled into the third lumen.

[0068] For the second connection method, please refer to Figure 1 and Figure 4B , the first end 1321 of the folding bracket 132 is connected to the distal end of the third catheter 131, and the second end 1322 is connected to the distal end of the second catheter 123; when the third catheter 131 and the second catheter 123 move relative to each other, the expansion portion 1323 can expand from a folded state to an expanded state, or the expansion portion 1323 can be folded from an expanded state to a folded state. When the third catheter 131 and the second catheter 123 move toward each other, the expansion portion 1323 is gradually squeezed to an expanded state; when the third catheter 131 and the second catheter 123 move in the opposite direction, the expansion portion 1323 is gradually stretched to a folded state. The folding bracket 132 using the second connection method is a manual expansion bracket, which is made of one or more metals (such as nickel-titanium alloys, stainless steel or cobalt-chromium alloys, etc.) or polymer materials.

[0069] ④ The collecting device 14 includes a fourth catheter 141 and a collecting net 142. The fourth catheter 141 is provided with a fourth cavity, and the first catheter 11 is movably arranged in the fourth cavity. The collecting net 142 is connected to the first catheter 11, or the collecting net 142 is connected between the first catheter 11 and the fourth catheter 141. The collecting net 142 can be expanded to abut against the inner wall of the blood vessel 21, or the collecting net 142 can be folded and folded on the first catheter 11 and / or the fourth catheter 141. The outer edge of the expanded collecting net 142 abuts against the inner wall of the blood vessel 21.

[0070] In this embodiment, the collection net 142 is used to intercept and collect the fragments of the calcified tissue 23 or other detached objects; the collection net 142 is composed of an expandable metal net or polymer net, etc., or can be composed of an expandable porous film or filter membrane, etc. The gaps or meshes of the collection net 142 are of a consistent specific size to allow blood components (including plasma, red blood cells, white blood cells, platelets, etc.) to pass through, while preventing all or part of the fragments of the calcified tissue 23 or other surgical detached objects from passing through; or, the gaps or meshes at different parts of the collection net 142 have different sizes, for example: the gaps or meshes at the far end of the collection net 142 are larger, allowing all blood components and detached objects to pass through, while the gaps or meshes at the far end of the collection net 142 are smaller, allowing only blood components (including plasma, red blood cells, white blood cells, platelets, etc.) to pass through, while preventing all or part of the fragments of the calcified tissue 23 or other surgical detached objects from passing through, so as to achieve the effect of collecting the fragments of the calcified tissue 23 or other surgical detached objects inside the collection net 142.

[0071] Optionally, the collecting net 142 is coated on the partial outer wall of the first conduit 11, and both ends of the collecting net 142 are connected to the first conduit 11; when the collecting net 142 is located in the fourth cavity, the collecting net 142 is in a folded state; when the collecting net 142 is moved out of the fourth cavity, the collecting net 142 expands from the folded state to the expanded state. In this embodiment, the collecting net 142 can expand automatically, and when the collecting net 142 is not constrained by space, the collecting net 142 is in an expanded state, that is, when the collecting net 142 is not constrained by the inner wall of the fourth cavity, the collecting net 142 is in an expanded state; when the collecting net 142 is located in the fourth cavity, the collecting net 142 is constrained by the inner wall of the fourth cavity and is in a folded state; when in use, the first conduit 11 can be pushed out of the fourth cavity, and the collecting net 142 gradually expands from the folded state to the expanded state; when use is completed, the first conduit 11 is pulled into the fourth cavity.

[0072] Optionally, the collection net 142 is coated on a partial outer wall of the first catheter 11, one end of the collection net 142 is connected to the first catheter 11, and the other end of the collection net 142 is connected to the fourth catheter 141; when the first catheter 11 and the fourth catheter 141 move relative to each other, the collection net 142 can be folded on the first catheter 11 and the fourth catheter 141, or the collection net 142 can be expanded to abut against the inner wall of the blood vessel 21. When the first catheter 11 and the fourth catheter 141 move toward each other, the collection net 142 is gradually squeezed to an expanded state; when the first catheter 11 and the fourth catheter 141 move in the opposite direction, the collection net 142 is gradually stretched to a folded state.

[0073] In this embodiment, the shock wave generating device 12 further includes a wire 124 and a power supply device (not shown), one end of the wire 124 is electrically connected to the electrode 122, and the other end of the wire 124 is electrically connected to the power supply device.

[0074] In this embodiment, the shock wave generating device 12 also includes a liquid supply device (not shown). The open end of the first balloon 121 passes through the proximal end of the first catheter 11 and docks with the liquid supply device, which is used to fill or drain liquid from the first balloon 121.

[0075] When the distal end of the third catheter 131 passes through the gap of the valve 22, the support structure expands and abuts against one side of the valve 22, and the first balloon 121 is filled with liquid and expands and abuts against the other side of the valve 22, and the valve 22 is clamped between the support structure and the first balloon 121. In this embodiment, the application scenario of the shock wave therapy catheter system is in the field of valvuloplasty 22, and is generally used to impact / loosen / shatter the calcified tissue 23 of the heart valve 22 (for example: the aortic valve and the mitral valve); however, it is expected that the system can also be used in other treatment locations and applications.

[0076] The steps of using the shock wave therapy catheter system of this embodiment to treat the valve 22 include: first extending the shock wave therapy catheter system into the blood vessel 21, and passing the distal end of the third catheter 131 through the gap of the valve 22; then expanding the support structure and abutting against one side of the valve 22, filling the first balloon 121 with liquid, expanding the first balloon 121 and abutting against the other side of the valve 22. At this time, the valve 22 is clamped between the support structure and the first balloon 121, and a high-voltage pulse is applied to the electrode 122. The liquid medium of the electrode 122 quickly vaporizes and expands, and then a cavitation effect occurs and a shock wave is generated. The shock wave acts on the calcified tissue 23 of the valve 22, thereby achieving the effect of treating the calcified tissue 23.

[0077] The shock wave therapy catheter system of the present application cooperates with the first balloon 121 through the support structure to fix the valve 22 between the support structure and the first balloon 121. During the treatment process, the valve 22 can be kept in a stable state and the shock wave discharge electrode 122 can be close to the treatment site, which is beneficial to improving the treatment effect.

[0078] Preferably, the first balloon 121 of the shock wave generating device 12 may further include a plurality of sac-shaped sub-parts. The plurality of sac-shaped sub-parts may share a liquid supply channel so that all the sac-shaped sub-parts are simultaneously filled with liquid and expanded; the plurality of sac-shaped sub-parts may also have separate liquid supply channels so that each sac-shaped sub-part may be expanded separately or the plurality of sac-shaped sub-parts may be expanded in coordination.

[0079] In this case, the first balloon 121 includes three sac-shaped sub-parts, and the three sac-shaped sub-parts of the first balloon 121 are arranged around the axis of the first catheter 11, such as Figures 5 to 7 As shown. Figure 5 Yes Yes Figure 2 The schematic cross-sectional structure diagram of the shock wave therapy catheter system in the collapsed state along the AA is shown. Figure 6 is a schematic cross-sectional view of the shock wave generating device of the present application when the three sac-shaped sub-parts are all filled with liquid, Figure 7 FIG. 1 is a schematic cross-sectional view of a bladder-shaped sub-portion of the shock wave generating device of the present application when filled with liquid. Figure 6 As shown, the three sac-like sub-portions can be inflated with fluid at the same time to achieve simultaneous treatment of each valve 22 leaflet; Figure 7 As shown, the three saccular sub-sections can also be filled with fluid and expanded in sequence to achieve sequential treatment of each leaflet of the valve 22. In this embodiment, there is a sufficient gap between two adjacent saccular sub-sections for blood to pass through, and the outer surface of each saccular sub-section can be coated with an anti-thrombotic coating to prevent blood from clogging between the saccular sub-sections during surgery. In particular, Figure 7 The treatment method shown fixes and treats only one leaflet of the valve 22 at a time, which can effectively avoid blood blockage during the operation.

[0080] Preferably, the shock wave therapy catheter system further comprises a plurality of developing rings, and the positions where the developing rings are fixed may include: the distal ends of the first catheter 11, the second catheter 123 and the third catheter 131, and the proximal end of the supporting structure.

[0081] In this embodiment, the shock wave therapy catheter system includes three developing rings. The first developing ring 15 is disposed near the first end 1321 of the folding support 132, and the second developing ring 16 is disposed near the second end 1322 of the folding support 132; the first developing ring 15 and the second developing ring 16 are used to determine the relative position of the valve 22 and the calcified tissue 23. The third developing ring 17 is disposed at the distal end of the first catheter 11, and is used to determine the relative position of the first catheter 11 and the calcified tissue 23.

[0082] Optionally, a third lumen is provided in the third catheter 131, and the shock wave therapy catheter system further comprises a guide wire 18, which can pass through the third lumen. In this embodiment, the guide wire 18 cooperates with the first developing ring 15 and the second developing ring 16 to assist in locating the position of the valve 22 and assist in delivering the first catheter 11, the third catheter 131, and the second catheter 123 to a predetermined position of the blood vessel 21.

[0083] Optionally, a coating (not shown) is provided on a part or all of the surfaces of the first catheter 11, the shock wave generating device 12 and the valve supporting device 13, and the coating includes at least one of the following:

[0084] Anti-thrombotic coating;

[0085] Antimicrobial coating;

[0086] Lubricating coatings;

[0087] Hydrophilic coating. In this embodiment, the coating can reduce blood adhesion / coagulation on the catheter surface, prevent thrombus formation or lumen blockage, etc.; a lubricating coating is applied to the proximal surface of the first catheter 11 to reduce the friction of the first catheter 11 when it is pushed in the patient's blood vessel 21.

[0088] Optionally, the coating can be provided on the entire outer wall of the first catheter 11, the distal outer wall of the third catheter 131, the distal outer wall of the second catheter 123, and the partial outer surface of the first balloon 121. The setting position of the coating can be freely designed according to actual needs.

[0089] Optionally, the electrode 122 is connected to the inner surface of the first balloon 121. When the first balloon 121 is filled with liquid and expanded to actively approach the valve 22, the electrode 122 can move closer to the valve 22 as the shape of the first balloon 121 changes. At this time, the electrode 122 is close to the calcified tissue 23 of the valve 22, which is conducive to improving the treatment effect.

[0090] Optionally, the shock wave generating device 12 further includes an electromagnetic shielding layer (not shown) for shielding electromagnetic interference, and the electromagnetic shielding layer is arranged at a position including at least one of the following:

[0091] The electromagnetic shielding layer covers the inner surface, the outer surface or the inside of the first balloon 121, or is embedded in the first balloon 121. For example, the electromagnetic shielding layer is conductive silver paint or conductive copper paint, but is not limited thereto.

[0092] The electromagnetic shielding layer is disposed around the electrode 122, such as a dense metal mesh, metal foil, or a polymer film containing a metal grid, but is not limited thereto. In this embodiment, the electromagnetic shielding layer can reduce the electromagnetic interference generated by the electrode 122 during discharge to the human body, equipment, environment, etc., especially the interference to the electrical signal of the patient's heart.

[0093] Second embodiment

[0094] Figure 8 FIG. 1 is a partial structural diagram of the shock wave therapy catheter system of the second embodiment of the present application in a working state. Figure 8 As shown, the shock wave therapy catheter system of this embodiment is substantially the same in structure and function as the shock wave therapy catheter system of the above-mentioned embodiment, except that the valve support device 13 is different.

[0095] like Figure 8 As shown, in this embodiment, the valve support device 13 includes a third catheter 131 and a second balloon 133, that is, the support structure of this embodiment is the second balloon 133, the third catheter 131 can be movably arranged in the second cavity of the second catheter 123, the distal end of the second balloon 133 is connected to the distal end of the third catheter 131, the distal end of the second balloon 133 can be removed from the second cavity together with the distal end of the third catheter 131, and the second balloon 133 can be filled with liquid or drained by a liquid supply device.

[0096] When the distal end of the second balloon 133 moves out of the second cavity along with the distal end of the third catheter 131 and passes through the gap of the valve 22, the second balloon 133 is inflated by the liquid supply device, and the inflated second balloon 133 abuts against one side of the valve 22. Then, the first balloon 121 is inflated by the liquid supply device and abuts against the other side of the valve 22, and the valve 22 is clamped between the second balloon 133 and the first balloon 121. Thus, the valve 22 can be kept in a stable state during the treatment process, which is conducive to improving the treatment effect.

[0097] In other embodiments, the third catheter 131 is movably disposed in the first lumen of the first catheter 11, and the support structure is connected to the third catheter 131, that is, the shock wave generating device 12 does not include the second catheter 123. In this embodiment, the second balloon 133 is disposed in the first lumen, the distal end of the second balloon 133 can be removed from the first lumen, and the second balloon 133 can be filled with liquid and expanded.

[0098] Third embodiment

[0099] Fig. 9 FIG. 1 is a partial structural diagram of the shock wave therapy catheter system of the third embodiment of the present application in a working state. Fig. 9 As shown, the shock wave therapy catheter system of this embodiment is substantially the same in structure and function as the shock wave therapy catheter system of the above-mentioned embodiment, except that the shock wave generating device 12 is different.

[0100] Optionally, the shock wave generating device 12 further includes a flexible support 125, which is disposed in the first balloon 121, and the electrode 122 is connected to a side of the flexible support 125 close to the valve 22. In this embodiment, the electrode 122 is flexibly mounted / printed / deposited on the surface of the flexible support 125, and the electrode 122 is connected to the power supply device through a wire 124. The flexible support 125 may include any one or more of a foldable stent, a guide wire, a catheter, a probe, and a balloon.

[0101] In this embodiment, if Fig. 9 As shown, the flexible support member 125 in the first balloon 121 is a foldable stent, the first balloon 121 and the flexible support member 125 can be movably accommodated in the first lumen of the first catheter 11, and a plurality of electrodes 122 are mounted on the surface of the flexible support member 125. When the distal end of the valve support device 13 passes through the valve 22 and expands and opens to abut against one side of the valve 22, the distal ends of the first balloon 121 and the flexible support member 125 move out of the first lumen and abut against the other side of the valve 22, and the valve 22 is clamped between the valve support device 13 and the first balloon 121. At the same time, the electrode 122 is close to the valve 22 with the flexible support member 125 to improve the shock wave treatment effect.

[0102] In particular, if Fig. 9 As shown, in this embodiment, the first balloon 121 can move axially in the first cavity, and can also move circumferentially around the third catheter 131. Thus, the first balloon 121 reaches different leaflet positions of the valve 22, and treats different positions of the valve 22 in multiple times. During the treatment process, since only one leaflet of the valve 22 is fixed and treated each time, blood blockage during the operation can be effectively avoided.

[0103] The above embodiments are merely illustrative of the principles and effects of the present application and are not intended to limit the present application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed in the present application shall still be covered by the claims of the present application.

Claims

1. A shock wave therapy catheter system for treating heart valve calcification, characterized in that: It comprises a first catheter, a shock wave generating device and a valve supporting device; wherein, The first conduit is provided with a first lumen; The shock wave generating device comprises at least one first balloon that can be inflated with liquid, a plurality of electrodes installed in the first balloon, and a second catheter; the second catheter is movably arranged in a first cavity, the distal end of the first balloon is fixed to the distal end of the second catheter, and the distal end of the first balloon is moved out of the first cavity together with the second catheter; after the distal end of the first balloon is moved out of the first cavity, the first balloon can be inflated with liquid and abut against the valve, and the plurality of electrodes installed on the first balloon are close to the calcified tissue of the valve; A valve support device, comprising a third catheter and at least one expandable support structure, the third catheter being movably disposed in the second lumen of the second catheter, the support structure being connected to the third catheter; The support structure includes a foldable stent, the foldable stent includes a first end at a distal end, a second end at a proximal end, and an expansion portion connected between the first end and the second end, the expansion portion includes a folded state and an expanded state; when the expansion portion is in the folded state, the expansion portion is folded on the third catheter; when the expansion portion is in the expanded state, the expansion portion abuts against the valve; The shock wave therapy catheter system fixes the valve between the support structure and the first balloon, keeps the valve in a stable state, and places the shock wave discharge electrode close to the treatment site.

2. The shock wave therapy catheter system according to claim 1, characterized in that: The first balloon includes a plurality of sac-shaped sub-parts, which can be inflated by filling with liquid. The inflating method of the sac-shaped sub-parts includes any one of the following: All cystic subdivisions are filled with fluid and expanded simultaneously; The cystic subdivisions expand individually in sequence; The two or more bladder subsections expand together in coordination.

3. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The first end and the second end of the foldable stent are both connected to the third catheter; when the foldable stent is located in the second cavity, the expansion portion is in a folded state; when the foldable stent is moved out of the second cavity, the expansion portion expands from the folded state to the expanded state.

4. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The first end of the foldable support is connected to the distal end of the third catheter, and the second end is connected to the distal end of the second catheter; when the second catheter and the third catheter move relative to each other, the expansion part expands from the folded state to the expanded state, or the expansion part is folded from the expanded state to the folded state.

5. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The first conduit, the second conduit, and the third conduit are each connected to at least one developing ring, and the connection position of the developing ring includes any one of the following: The developing rings are respectively fixed at the distal ends of the first catheter, the second catheter and the third catheter; The developing rings are respectively fixed to the distal ends of the first catheter, the second catheter and the third catheter, and the proximal end of the supporting structure; The developing rings are respectively fixed to the distal ends of the first catheter and the third catheter, and the proximal end of the supporting structure.

6. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: A third lumen is arranged in the third catheter, and the shock wave therapy catheter system further comprises a guide wire which can pass through the third lumen.

7. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The support structure includes at least one second balloon, the distal end of the second balloon is connected to the distal end of the third catheter, the distal end of the second balloon can be removed from the second cavity together with the distal end of the third catheter, and the second balloon can be inflated by filling with liquid.

8. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: A coating is provided on a partial or entire surface of the first catheter, the shock wave generating device, and the valve supporting device, and the coating includes at least one of the following: Anti-thrombotic coating; Antimicrobial coating; Lubricating coatings; Hydrophilic coating.

9. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The electrodes are attached to the inner surface of the first balloon.

10. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The shock wave generating device also includes a flexible support member, which is arranged in the first balloon, and the electrode is connected to a side of the flexible support member close to the valve.

11. The shock wave therapy catheter system of claim 10, wherein: The flexible support member includes any of the following: Foldable stand; Guidewire; catheter; Probe; Balloon.

12. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The shock wave generating device also includes a wire and a power supply device. One end of the wire is electrically connected to the electrode, and the other end of the wire is electrically connected to the power supply device.

13. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The shock wave generating device also includes a liquid supply device. The opening end of the first balloon passes through the proximal end of the first catheter and docks with the liquid supply device. The liquid supply device is used to fill or extract liquid from the first balloon.

14. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The shock wave generating device further includes an electromagnetic shielding layer for shielding electromagnetic interference, and the electromagnetic shielding layer is arranged at a position including at least one of the following: The electromagnetic shielding layer covers the inner surface or the outer surface of the first balloon; The electromagnetic shielding layer is embedded in the first balloon; The electromagnetic shielding layer is arranged around the circumference of the electrode.

15. The shock wave therapy catheter system according to claim 1 or 2, characterized in that: The shock wave therapy catheter system also includes a collecting device, which includes a fourth catheter and a collecting net. A fourth cavity is provided in the fourth catheter, and the first catheter can be movably arranged in the fourth cavity. The collecting net is connected to the first catheter, or the collecting net is connected between the first catheter and the fourth catheter. The collecting net can be expanded to rest against the inner wall of the blood vessel, or the collecting net can be folded on the first catheter and / or the fourth catheter.

16. The shock wave therapy catheter system of claim 15, wherein: The collecting net is coated on a partial outer wall of the first catheter, and both ends of the collecting net are connected to the first catheter; when the collecting net is located in the fourth cavity, the collecting net is in a folded state; when the collecting net moves out of the fourth cavity, the collecting net expands from the folded state to the expanded state and rests against the inner wall of the blood vessel.

17. The shock wave therapy catheter system of claim 16, wherein: The collecting net is coated on a partial outer wall of the first catheter, one end of the collecting net is connected to the first catheter, and the other end of the collecting net is connected to the fourth catheter; when the first catheter and the fourth catheter move relative to each other, the collecting net can be folded on the first catheter and the fourth catheter, or the collecting net can be expanded to rest against the inner wall of the blood vessel.

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