Shockwave balloon catheter device

Abstract

The present application provides a shock wave balloon catheter device, which comprises a catheter body and a balloon connected with the distal end of the catheter body, the catheter body has a liquid passage cavity extending along the axial direction of the catheter body, and the inner cavity of the balloon is connected with the liquid passage cavity; the balloon is provided with a first shock wave emitting element for releasing axial impact wave along the axial direction of the balloon and a second shock wave emitting element for releasing radial impact wave along the radial direction of the balloon, the first shock wave emitting element and the second shock wave emitting element are electrically connected with a high-voltage generator, and the first shock wave emitting element is located in the distal end of the balloon. The shock wave balloon catheter device can release impact wave along the axial direction and the radial direction of the balloon, so as to cope with various complex calcified lesions when applied to the treatment of calcified lesions in blood vessels.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shockwave balloon catheter device. Background Technology

[0002] Vascular calcification is a narrowing and hardening of blood vessels caused by the accumulation of plaque. These plaques are composed of fibrous tissue, fat, and calcium. The accumulated calcified plaques obstruct normal blood flow, leading to insufficient supply of oxygen and nutrients to the body.

[0003] When it occurs in the peripheral blood vessels, it causes arteriosclerosis of the lower extremities. Mild cases may cause coldness, numbness, and intermittent claudication in the lower extremities, while severe cases can lead to weakened or absent pulses in the lower extremity arteries, especially the dorsalis pedis artery, and may even require amputation. When vascular calcification occurs in the coronary arteries, the clinical manifestations include coronary atherosclerotic heart disease, myocardial ischemia, angina pectoris, and myocardial infarction.

[0004] In recent years, minimally invasive interventional methods have been mainly used to treat vascular calcification lesions. These methods include high-pressure balloons, chocolate balloons, cutting balloons, spinous process balloons, scoring balloons, and plaque rotational excision / rotational atherectomy. However, these instruments have their limitations, with a high complication rate, and can only treat superficial calcifications. They are ineffective for severe calcifications, eccentric calcifications, and other conditions.

[0005] Based on this, a new technology has recently emerged—extending extracorporeal shock wave lithotripsy (ESWL) to the field of vascular intervention. This involves inserting a catheter containing a balloon into the blood vessel. The balloon expands and adheres to the vessel wall at the site of calcified lesions. At this point, electrodes within the balloon, connected to a high-voltage generator, produce a liquid-electric wave source. Upon excitation, this source releases a high-voltage shock wave, generating a shock wave due to cavitation. This shock wave propagates through the liquid medium and impacts and fractures the calcified area within the blood vessel through the balloon wall, pulverizing the calcified material, restoring the vessel's elasticity, and remodeling the diseased vessel. Simultaneously, it avoids damage to the vessel wall / intima.

[0006] Both US-based Shockwave Therapy and domestic medical companies have offered various technical solutions for treating calcified lesions using shockwave technology. However, current technologies for treating calcified lesions with shockwaves utilize non-compliant or semi-compliant balloons containing electrode arrays capable of radially releasing shockwaves. When dealing with severe calcified lesions, the balloon cannot pass through the lesion, rendering radial shockwave release ineffective and hindering treatment. Furthermore, when dealing with asymmetrical and complex-shaped lesions, non-compliant balloons cannot fully adhere to the lesion wall after expansion, preventing shockwave energy from reaching the surface of the calcified material and resulting in poor treatment outcomes. Summary of the Invention

[0007] The purpose of this invention is to provide a shockwave balloon catheter device to solve the problem that radial shock waves alone cannot pass through and treat complex calcified lesions when balloons are used to treat them.

[0008] To address the aforementioned technical problems, this invention provides a shockwave balloon catheter device, comprising a catheter body and a balloon, wherein the balloon is connected to the distal end of the catheter body, the catheter body has a fluid-permeable cavity extending along its own axial direction, and the inner cavity of the balloon is connected to the fluid-permeable cavity; the balloon is provided with a first shockwave emitting element for releasing axial shock waves along the axial direction of the balloon and a second shockwave emitting element for releasing radial shock waves along the radial direction of the balloon, both the first and second shockwave emitting elements being electrically connected to a high-voltage generator, and the first shockwave emitting element being located within the distal end of the balloon.

[0009] Optionally, the angle between the axis of the first shock wave emitting element and the distal end face of the balloon is 0 to 90°.

[0010] Optionally, the first shock wave emitting element does not contact the inner surface of the balloon.

[0011] Optionally, the catheter body includes an outer tube and an inner tube arranged coaxially. The outer tube is sleeved outside the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon. The inner tube penetrates the balloon, and the distal end of the inner tube is connected to the distal end of the balloon.

[0012] Optionally, the first shock wave emitting element includes a plurality of first electrodes disposed on the distal outer surface of the inner tube and spaced apart from each other, each of the first electrodes extending along the axial direction of the inner tube.

[0013] Optionally, the first shock wave emitting element further includes a first developing ring and an insulating layer coaxially disposed with the inner tube, the insulating layer being disposed between the first developing ring and the plurality of first electrodes.

[0014] Optionally, the second shock wave emitting element includes a plurality of second electrodes, at least one of which is connected in series with the first electrode. Alternatively, the second electrode is connected in parallel with the first electrode.

[0015] Optionally, the balloon includes a first sub-balloon and a second sub-balloon, and the fluid passage includes a first sub-fluid passage and a second sub-fluid passage spaced apart from each other. The first sub-fluid passage is connected to the inner cavity of the first sub-balloon, and the second sub-fluid passage is connected to the inner cavity of the second sub-balloon. The first sub-balloon and the second sub-balloon are spaced apart along the distal to proximal end of the balloon. The first shock wave emitting element is disposed in the first sub-balloon, and the second shock wave emitting element is disposed in the second sub-balloon; or both the first shock wave emitting element and the second shock wave emitting element are disposed in the first sub-balloon.

[0016] Optionally, the balloon includes a first sub-balloon and a second sub-balloon, and the fluid passage includes a first sub-fluid passage and a second sub-fluid passage separated from each other. The first sub-fluid passage is connected to the inner cavity of the first sub-balloon, and the second sub-fluid passage is connected to the inner cavity of the second sub-balloon. The second sub-balloon is sleeved on the outside of the first sub-balloon, the first shock wave emitting element is disposed inside the first sub-balloon, and the second shock wave emitting element is disposed inside the second sub-balloon. The first sub-balloon is made of a compliant material, and the second sub-balloon is made of a non-compliant material or a semi-compliant material.

[0017] Optionally, the outer diameter of the inner tube located in the first sub-balloon is smaller than the outer diameter of the inner tube located outside the first sub-balloon.

[0018] Optionally, the balloon includes a first conical portion, a straight portion, and a second conical portion connected in sequence from the distal end to the proximal end. The inner and outer diameters of the first conical portion gradually increase from the distal end to the proximal end, and the inner and outer diameters of the second conical portion gradually decrease from the distal end to the proximal end.

[0019] Optionally, both the straight portion and the second tapered portion include connected inner and outer layers. The inner layer is made of a compliant material, and the outer layer is made of a non-compliant or semi-compliant material. The first tapered portion is connected to the inner layer of the straight portion, and the first tapered portion is made of a compliant material.

[0020] Optionally, the balloon is provided with a second imaging ring, which is sleeved on the inner tube.

[0021] Compared with the prior art, the shockwave balloon catheter device provided by the present invention has the following advantages: The shockwave balloon catheter device provided by the present invention includes a catheter body and a balloon, the balloon being connected to the distal end of the catheter body, the catheter body having a fluid passage chamber extending along its own axis, and the inner cavity of the balloon communicating with the fluid passage chamber; the balloon is provided with a first shockwave emitting element for releasing axial shock waves along the axial direction of the balloon and a second shockwave emitting element for releasing radial shock waves along the radial direction of the balloon, both the first shockwave emitting element and the second shockwave emitting element being electrically connected to a high-voltage generator, the first shockwave emitting element being located in the distal end of the balloon. For severely calcified lesions where the shockwave balloon catheter device cannot pass through the lesion, under X-ray guidance, the distal end of the balloon is positioned at the site of the severely calcified lesion, and a conductive medium is injected to inflate the balloon. The distal end of the balloon expands to adhere to the calcified lesion wall, while the side of the balloon adheres to the blood vessel wall. At this point, the high-voltage generator is activated, energizing the first shockwave emitting element, thereby causing the shockwave balloon catheter device to release axial shock waves toward the distal end of the balloon to open the lesion. After the lesion is opened, a portion of the conductive medium is withdrawn to shrink the balloon. The balloon is then pushed through the lesion, and the side of the balloon is positioned at the calcified lesion. The conductive medium is injected again to inflate the balloon, and the high-voltage generator is activated, energizing the second shockwave emitting element, thereby causing the shockwave balloon catheter device to release radial shock waves toward the side of the balloon, breaking up the calcified lesion. Continued injection of the conductive medium to inflate the balloon further thins and compacts the loosened calcifications against the blood vessel wall to restore blood flow. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the shockwave balloon catheter device provided in the first embodiment of the present invention.

[0023] Figure 2 This is a longitudinal cross-sectional view of a balloon provided in an embodiment of the present invention.

[0024] Figure 3 A cross-sectional view of the first shock wave emitting element provided in the first embodiment of the present invention.

[0025] Figure 4 A transverse cross-sectional view of the first shock wave emitting element provided in the second embodiment of the present invention.

[0026] Figure 5 This is a longitudinal cross-sectional view of a second shock wave emitting element provided in an embodiment of the present invention.

[0027] Figure 6 This is a schematic diagram of parallel electrode connection provided in an embodiment of the present invention.

[0028] Figure 7This is a schematic diagram of electrode series connection provided in an embodiment of the present invention.

[0029] Figure 8 This is a schematic diagram of a shockwave balloon catheter device provided in a second embodiment of the present invention.

[0030] Figure 9 This is a schematic diagram of a shockwave balloon catheter device provided in the third embodiment of the present invention.

[0031] Figure 10 This is a schematic diagram of a shockwave balloon catheter device provided in the fourth embodiment of the present invention.

[0032] Figure 11 A transverse cross-sectional view of the first liquid passage chamber and the second liquid passage chamber provided in the first embodiment of the present invention.

[0033] Figure 12 A transverse cross-sectional view of the first and second liquid passage chambers provided for a second embodiment of the present invention.

[0034] The labels in the accompanying drawings are explained as follows:

[0035] 01-Balloon; 02-First shock wave emitting element; 03-Second shock wave emitting element; 04-First imaging ring; 05-Second imaging ring; 06-Inner tube; 07-Outer tube; 08-Wire; 09-Connector; 10-High voltage generator;

[0036] 021-First electrode; 022-Insulating layer; 023-Insulating material; 031-Second electrode;

[0037] 011 - First sub-balloon; 012 - Second sub-balloon;

[0038] 071-Liquid passage chamber; 0711-First sub-liquid passage chamber; 0712-Second sub-liquid passage chamber;

[0039] 013 - Inner layer; 014 - Outer layer. Detailed Implementation

[0040] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0041] It should be understood that when an element or layer is referred to as "on" or "connected to" other elements or layers, it may be directly on or connected to other elements or layers, or may include intervening elements or layers. Conversely, when an element is referred to as "directly on" or "directly connected to" other elements or layers, intervening elements or layers are not included. Although the terms first, second, third, etc., may be used to describe various elements, components, areas, layers, and / or portions, these elements, components, areas, layers, and / or portions should not be limited by these terms. These terms are only used to distinguish one element, component, area, layer, or portion from another element, component, area, layer, or portion. Therefore, without departing from the teachings of this invention, the first element, component, area, layer, or portion discussed below may be referred to as a second element, component, area, layer, or portion. Spatial relation terms such as "below," "under," "below," "above," "on top," "above," etc., may be used herein for convenience of description to describe the relationship between one element or feature shown in the figures and other elements or features. It should be understood that, in addition to the orientations shown in the figures, spatial relational terms are intended to also include different orientations of the devices in use and operation. For example, if the devices in the figures are flipped, then elements or features described as “below,” “under,” or “below” will be oriented “on” other elements or features. Devices may be oriented additionally (rotated 90 degrees or otherwise) and the spatial descriptive terms used herein will be interpreted accordingly. The terminology used herein is intended only to describe particular embodiments and is not intended to limit the invention. When used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “comprising” is used to identify the inclusion of features, steps, operations, elements, and / or components, but does not exclude the inclusion or addition of one or more other features, steps, operations, elements, components, and / or groups. When used herein, the terms “and / or” include any and all combinations of the associated listed items.

[0042] The purpose of this invention is to provide a shockwave balloon catheter device to solve the problem that radial shockwaves alone cannot pass through and treat complex calcified lesions when used alone for balloon treatment. It should be noted that, as those skilled in the art will understand, the term "proximal" as used herein refers to the end closer to the operator (i.e., the end furthest from the lesion), and the term "distal" refers to the end furthest from the operator (i.e., the end closer to the lesion).

[0043] To address the aforementioned technical problems, this invention provides a shockwave balloon catheter device, please refer to... Figure 1 The diagram schematically illustrates the shockwave balloon catheter device provided in the first embodiment of the present invention, as shown below. Figure 1As shown, the shockwave balloon catheter device provided by the present invention includes a catheter body and a balloon 01. The balloon 01 is connected to the distal end of the catheter body. The catheter body has a fluid-permeable cavity 071 extending along its own axial direction, and the inner cavity of the balloon 01 is connected to the fluid-permeable cavity 071. The balloon 01 is provided with a first shockwave emitting element 02 for releasing axial shock waves along the axial direction of the balloon 01 and a second shockwave emitting element 03 for releasing radial shock waves along the radial direction of the balloon 01. Both the first shockwave emitting element 02 and the second shockwave emitting element 03 are electrically connected to a high-voltage generator 10. The first shockwave emitting element 02 is located within the distal end of the balloon 01. It should be noted that, as those skilled in the art will understand, the balloon 01 undergoes volume changes and deformations corresponding to the amount of conductive medium filling the inner cavity of the balloon 01.

[0044] Specifically, for severely calcified lesions, when the balloon 01 cannot pass through the lesion, under X-ray, the distal end of the balloon 01 is positioned at the site of the severely calcified lesion, and the conductive medium is injected through the fluid passage 071 to inflate the balloon 01. The distal end of the balloon 01 expands and adheres to the wall of the calcified lesion, while the side of the balloon 01 adheres to the wall of the blood vessel. At this time, the high-voltage generator 10 is activated to energize the first shock wave emitting element 02, thereby causing the shock wave balloon catheter device to release an axial shock wave toward the distal end of the balloon 01 to open the lesion. After the lesion is opened, a portion of the conductive medium is withdrawn through the infusion chamber 071 to shrink the balloon 01. The balloon 01 is then pushed through the lesion and positioned laterally at the calcified lesion. The conductive medium is injected again to expand the balloon 01, and the high-voltage generator 10 is activated, energizing the second shock wave emitting element 03. This causes the shock wave balloon catheter device to release radial shock waves toward the side of the balloon 01, breaking up the calcified lesion. Continued injection of the conductive medium further expands the balloon 01, thinning and compacting the loose calcifications against the inner wall of the blood vessel to restore blood flow. It should be understood that the shock wave balloon catheter device also includes a connecting seat 09, which is sealed to the proximal end of the catheter body to prevent leakage during the injection and extraction of the conductive medium.

[0045] Please continue to refer to this. Figure 1 ,like Figure 1 As shown, preferably, the angle between the axis of the first shock wave emitting element 02 and the distal end face of the balloon 01 is 0° to 90°. Figure 1As shown in the figure, θ is the angle between the axis of the first shock wave emitting element 02 and the distal end face of the balloon 01. The angle θ can be designed at any angle from 0 to 90° according to operational requirements. The inventors of this invention have found through a large number of experiments that when the angle θ is 90 degrees, the shock wave energy transmitted by the first shock wave emitting element 02 to the axial end face of the balloon 01 is the largest, which can achieve the effect of impacting the calcified lesion with greater intensity.

[0046] It should be noted that, preferably, the first shock wave emitting element 02 does not contact the inner surface of the balloon 01. This arrangement can prevent the first shock wave emitting element 02 from causing excessive vibration of the balloon 01, thereby avoiding excessive release of axial shock waves along the axis of the balloon 01 and improving the treatment effect.

[0047] Please continue to refer to this. Figure 1 Preferably, the catheter body includes an outer tube 07 and an inner tube 06 coaxially arranged. The outer tube 07 is sleeved outside the inner tube 06, and the distal end of the outer tube 07 is connected to the proximal end of the balloon 01. The inner tube 06 penetrates the balloon 01, and the distal end of the inner tube 06 is connected to the distal end of the balloon 01. The inner tube 06 is used for guidewire routing to guide the shockwave balloon catheter device into the patient's body. This arrangement forms the fluid passage chamber 071 between the outer tube 07 and the inner tube 06, enabling the filling and extraction of the conductive medium into the balloon 01.

[0048] Please refer to Figure 2 This is a longitudinal cross-sectional view of the balloon 01 provided in an embodiment of the present invention. Figure 2 As shown, the balloon 01 comprises, from distal to proximal, a first conical portion, a straight portion, and a second conical portion connected in sequence. The inner and outer diameters of the first conical portion gradually increase from distal to proximal, while the inner and outer diameters of the second conical portion gradually decrease from distal to proximal. This design allows for a smooth transition of the balloon, reducing damage to the patient.

[0049] Furthermore, such as Figure 2As shown, both the straight portion and the second conical portion include connected inner layers 013 and outer layers 014. The inner layer 013 is made of a compliant material, and the outer layer 014 is made of a non-compliant or semi-compliant material. The first conical portion is connected to the inner layer of the straight portion, and the first conical portion is made of a compliant material. When treating severely calcified or completely calcified lesions, the inner layer 013, after expansion, can adapt to various shape changes and closely adhere to the calcified lesion. Then, the first shock wave emitting element 02 releases shock waves, more effectively opening the lesion. The outer layer 014 is made of a non-compliant or semi-compliant material. Within the preset diameter range of the balloon 01, the inner layer 013 primarily plays a role, allowing the balloon 01 to adhere more closely to the wall in complex asymmetric situations, improving the treatment effect. The outer layer 014 serves to fix the expansion range and prevent the inner layer 013 from over-expanding and damaging blood vessels. In this structure, the conductive medium is first injected, and the compliant material on the axial end face of the balloon 01 is used to completely adhere to the wall of the severely calcified or completely calcified lesion. Then, the first shock wave emitting element 02 releases a shock wave to open the lesion. Next, a portion of the conductive medium is extracted to cause the balloon 01 to contract, and the balloon 01 is pushed forward.

[0050] Preferred, such as Figure 1 As shown, the balloon 01 is provided with a second radiopaque ring 05, which is sleeved on the inner tube 06. Further, as... Figure 1 As shown, in this embodiment, the second imaging ring 05 is located near the proximal end of the second shock wave element 03. The balloon 01 is positioned to the lesion via the second imaging ring 05. At this time, the compliant material properties of the inner layer 013 of the balloon 01 are utilized to expand and achieve complete adhesion to the vascular wall. Then, the second shock wave emitting element 03 releases shock waves to the calcified lesion. After treatment, the conductive medium is injected to expand the balloon 01, causing the balloon 01 to thin and compact the loose calcifications against the vascular wall to restore blood flow. At this time, the non-compliant or semi-compliant material of the outer layer 014 plays a role in preventing the inner layer 013, made of compliant material, from over-expanding and damaging the blood vessel.

[0051] Please refer to Figure 3 This is a cross-sectional view of the first shock wave emitting element 02 provided in the first embodiment of the present invention. Figure 3As shown, the first shock wave emitting element 02 includes a plurality of first electrodes 021 disposed at intervals on the distal outer surface of the inner tube 06, each of the first electrodes 021 extending axially along the inner tube 06. It should be noted that, as those skilled in the art will understand, there may be multiple (including two) first electrodes 021, with insulating material 023 filling the spaces between them. The catheter body injects a conductive medium, such as physiological saline, into the first shock wave emitting element 02 through the fluid passage 071. After the conductive medium fills the interior and surrounding area of ​​the first shock wave emitting element 02, the high-voltage generator 10 is activated. The conductive medium simultaneously contacts the axial direction of multiple first electrodes 021 to achieve electrical connection. At this time, because the insulating material 023 fills the spaces between each first electrode 021, the current cannot be transmitted through the sides of each first electrode 021 and can only be released axially along the first electrode 021, thereby enabling the first shock wave emitting element 02 to release axial shock waves axially toward the distal end face of the balloon 01.

[0052] Please refer to Figure 3 ,like Figure 3 As shown, the first shock wave emitting element 02 further includes a first imaging ring 04 coaxially disposed with the inner tube 06 and an insulating layer 022. The insulating layer 022 is disposed between the first imaging ring 04 and the plurality of first electrodes 021. The first imaging ring 04 is used for positioning marking under X-ray to confirm the position of the first shock wave emitting element 02 in real time for operation. The insulating layer 022 is disposed between the first imaging ring 04 and the plurality of first electrodes 021 to prevent the first electrodes 021 from generating current interference with the first imaging ring 04, so that the first imaging ring 04 can be fixed in the position of the first electrodes 021 without interference.

[0053] Please continue to refer to this. Figure 3 and Figure 4 ,in Figure 4 A schematic cross-sectional view of the first shock wave emitting element 02 provided in the second embodiment of the present invention is shown. Figure 3 and Figure 4 As shown, the difference between the first shock wave emitting element 02 provided in the second embodiment and the first shock wave emitting element 02 provided in the first embodiment is that, in the first embodiment, the transverse cross-section of the first electrode 021 is circular, while in the second embodiment, the transverse cross-section of the first electrode 021 is flat. It should be understood that the cross-section of the first electrode 021 can also be other shapes, which will not be elaborated here.

[0054] Please continue to refer to this. Figure 5 This is a longitudinal cross-sectional view of the second shock wave emitting element 03 provided in an embodiment of the present invention. Figure 5 As shown, the second shock wave emitting element 03 includes several coaxially arranged annular structures sleeved on the outer surface of the inner tube 06. Each annular structure includes an electrode pair and a non-conductive gap, with the non-conductive gap positioned between the two second electrodes 031 of the electrode pair. The catheter body injects a conductive medium, such as physiological saline, into the second shock wave emitting element 03 through the fluid passage. After the conductive medium fills the area around the second shock wave emitting element 03, the high-voltage generator 08 is activated. The conductive medium simultaneously contacts multiple second electrodes 031 to achieve electrical connection, thereby enabling the second shock wave emitting element 03 to release radial shock waves toward the side of the balloon 01.

[0055] It should be noted that the above description is only a preferred embodiment of the method of releasing shock waves by the first shock wave emitting element 02 and the second shock wave emitting element 03, but it is not limited thereto.

[0056] Please refer to Figure 6 and Figure 7 ,in Figure 6 This is a schematic diagram of parallel electrode connection provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of electrode series connection provided in an embodiment of the present invention. Figure 6 As shown, the electrodes of the first shock wave emitting element 02 (i.e., the first electrode 021) and the electrodes of the second shock wave emitting element 03 (i.e., the second electrode 031) are connected in parallel, thus enabling the release of shock waves by controlling the first shock wave emitting element 02 and the second shock wave emitting element 03 respectively. Figure 7 As shown, the second shock wave emitting element 03 includes a plurality of second electrodes 031, at least one of which is connected in series with the first electrode 021. This allows for simultaneous control of the first shock wave emitting element 02 and the second shock wave emitting element 03 to release shock waves, and some of the non-series second electrodes 031 can still be energized at any time to enhance the radial shock wave intensity. It should be understood that different high-voltage generators 09 can also be used to connect the first electrode 021 and the second electrode 031, which will not be elaborated here.

[0057] Please continue to refer to this. Figure 8 This is a schematic diagram of the shockwave balloon catheter device provided in the second embodiment of the present invention. Figure 8As shown, the shockwave balloon catheter device provided in the second embodiment differs from the shockwave balloon catheter device provided in the first embodiment in that the balloon 01 in the shockwave balloon catheter device provided in the second embodiment includes a first sub-balloon 011 and a second sub-balloon 012. The inner cavities of the first sub-balloon 011 and the second sub-balloon 012 are independent of each other and can each generate volume changes and deformations according to the amount of conductive medium filling the inner cavity. The fluid passage chamber 071 includes a first sub-fluid passage chamber 0711 that is spaced apart from each other (see...). Figure 11 and Figure 12 ) and the second sub-fluid passage 0712 (see Figure 11 and Figure 12 The first sub-fluid passage chamber 0711 is connected to the inner cavity of the first sub-balloon 011, and the second sub-fluid passage chamber 0712 is connected to the inner cavity of the second sub-balloon 012. The first sub-balloon 011 and the second sub-balloon 012 are spaced apart from the distal end to the proximal end of the balloon 01. The first shock wave emitting element 02 is disposed inside the first sub-balloon 011, and the second shock wave emitting element 03 is disposed inside the second sub-balloon 012. Thus, before expansion, the first sub-balloon 011 can be completely attached to the inner tube 06. When treating severe calcified lesions, the conductive medium is injected into the first sub-balloon 011 so that it can adhere well to the lesion after expansion. The first shock wave emitting element 02 is used to release shock waves along the axial direction of the balloon to open the lesion. After the lesion is opened, part of the conductive medium is withdrawn to cause the first sub-balloon 011 to contract. Under X-ray, the balloon 01 is pushed distally so that the second sub-balloon 012 passes through the lesion.

[0058] Please continue to refer to this. Figure 8 ,like Figure 8 As shown, in the shockwave balloon catheter device provided in the second embodiment, the second imaging ring 05 is disposed at the proximal and distal ends of the second shockwave element 03. The second sub-balloon 012 is positioned to the lesion location via the second imaging ring 05. The conductive medium is injected into the second sub-balloon 012 to expand it. Radial shock waves are released on the side of the second sub-balloon 012 by the second shockwave emitting element 03 within the second sub-balloon 012 for further treatment of the calcified lesion.

[0059] Please continue to refer to this. Figure 9 This is a schematic diagram of the shockwave balloon catheter device provided in the third embodiment of the present invention. Figure 9As shown, the difference between the shockwave balloon catheter device provided in the third embodiment and the shockwave balloon catheter device provided in the second embodiment is that both the first shockwave emitting element 02 and the second shockwave emitting element 03 in the shockwave balloon catheter device provided in the third embodiment are located inside the first sub-balloon 011. Therefore, when treating severe calcified lesions, the conductive medium is injected into the first sub-balloon 011 to expand it so that it adheres well to the lesion. The first shockwave emitting element 02 releases shock waves along the axial direction of the balloon 01 to open the lesion. After the lesion is opened, part of the conductive medium is withdrawn to contract the first sub-balloon 011. Under X-ray, the balloon 01 is pushed distally so that the first sub-balloon 011 passes through the lesion. The conductive medium is injected into the first sub-balloon 011 again to expand it. The second shockwave emitting element 03 inside the first sub-balloon 011 releases radial shock waves on the side of the first sub-balloon 011 for further treatment of the calcified lesion. Then, a portion of the conductive medium is extracted again to cause the first sub-balloon 011 to contract. Under X-ray, the balloon 01 is pushed distally so that the second sub-balloon 012 passes through the lesion.

[0060] Please continue to refer to this. Figure 9 ,like Figure 9 As shown, in the shockwave balloon catheter device provided in the third embodiment, the second imaging ring 05 is disposed in the second sub-balloon 012. The second sub-balloon 012 is positioned to the lesion location through the second imaging ring 05. The conductive medium is injected into the second sub-balloon 012 to expand it, causing the second sub-balloon 012 to thin and compact the loose calcifications onto the inner wall of the blood vessel, thereby achieving a vascular patency improvement effect.

[0061] Please continue to refer to this. Figure 10 This is a schematic diagram of the shockwave balloon catheter device provided in the fourth embodiment of the present invention. Figure 10As shown, the difference between the shockwave balloon catheter device provided in the fourth embodiment and the shockwave balloon catheter device provided in the second embodiment is that, in the shockwave balloon catheter device provided in the fourth embodiment, the second sub-balloon 012 is sleeved outside the first sub-balloon 011, the first shockwave emitting element 02 is disposed inside the first sub-balloon 011, and the second shockwave emitting element 03 is disposed inside the second sub-balloon 012. The first sub-balloon 011 is made of a compliant material, while the second sub-balloon 012 is made of a non-compliant or semi-compliant material. The compliant material can be made of PVC, TPU, silicone, latex, or other compliant materials. The purpose is to allow it to adapt to various shape changes after expansion and to closely adhere to the calcified lesion when treating severely calcified or completely calcified lesions. In this embodiment, the conductive medium is first injected, and the compliant material on the axial end face of the first sub-balloon 011 is used to completely adhere to the wall of the severely calcified or completely calcified lesion. Then, the first shockwave emitting element 02 is used to release shock waves to open the lesion. Then, a portion of the conductive medium is extracted to cause the balloon 01 to contract, and the balloon 01 is pushed forward.

[0062] Please continue to refer to this. Figure 10 ,like Figure 10 As shown, in the shockwave balloon catheter device provided in the fourth embodiment, the second imaging ring 05 is located proximal to the second shockwave element 03. The second sub-balloon 012 is positioned to the lesion via the second imaging ring 05. At this time, the second shockwave emitting element 03 in the second sub-balloon 012 releases shockwaves to the calcified lesion. After treatment, the conductive medium is injected to further expand the second sub-balloon 012, causing the second sub-balloon 012 to thin and compact the loose calcifications against the inner wall of the blood vessel to restore blood flow. Because the second sub-balloon 012 uses a non-compliant or semi-compliant material, it will not expand indefinitely and damage the blood vessel.

[0063] It should be noted that, in cases such as Figure 10 In the shockwave balloon catheter device provided in the fourth embodiment shown, the outer diameter of the inner tube 06 located in the first sub-balloon 011 is smaller than the outer diameter of the inner tube 06 located outside the first sub-balloon 011. Since the second sub-balloon 012 is sleeved outside the first sub-balloon 011, the combined outer diameter of the second sub-balloon 012 and the first sub-balloon 011 is relatively large. Setting the outer diameter of the inner tube 06 located in the first sub-balloon 011 to be smaller than the outer diameter of the inner tube 06 located outside the first sub-balloon 011 reduces the combined outer diameter of the second sub-balloon 012 and the first sub-balloon 011, thereby reducing the volume of the balloon 01 and facilitating interventional treatment with the balloon 01.

[0064] It should be noted that the above is only a description of the preferred arrangement of the first shock wave emitting element 02 and the second shock wave emitting element 03 in the first sub-balloon 011 and the second sub-balloon 012, but it is not limited thereto. The first shock wave emitting element 02 and the second emitting element 03 can also be arranged in the first sub-balloon 011 and the second sub-balloon 012 and play their corresponding roles through other arrangements and combinations, which will not be elaborated here.

[0065] It should be noted that the first sub-liquid passage chamber 0711 and the second sub-liquid passage chamber 0712 can be implemented in various ways. Please refer to [reference needed]. Figure 11 The diagram schematically illustrates the placement of the first sub-liquid passage chamber 0711 and the second sub-liquid passage chamber 0712 provided in the first embodiment of the present invention. Figure 11 As shown, in this embodiment, both the first fluid passage chamber 0711 and the second fluid passage chamber 0712 are separately set up using a delivery pipe in the space between the inner tube 06 and the outer tube 07. The first sub-fluid passage chamber 0711 is connected to the inner cavity of the first sub-balloon 011, and the second sub-fluid passage chamber 0712 is connected to the inner cavity of the second sub-balloon 012, so as to realize the injection and extraction of the conductive medium in the first sub-balloon 011 and the second sub-balloon 012 respectively, so as to realize that the first sub-balloon 011 and the second sub-balloon 012 each generate volume changes and deformations according to the amount of conductive medium filling the inner cavity.

[0066] Please refer to Figure 12 The diagram schematically illustrates the placement of the first sub-liquid passage chamber 0711 and the second sub-liquid passage chamber 0712 according to the second embodiment of the present invention. Figure 12As shown, the difference between the placement of the first sub-fluid passage cavity 0711 and the second sub-fluid passage cavity 0712 in this embodiment and the placement of the first sub-fluid passage cavity 0711 and the second sub-fluid passage cavity 0712 in the first embodiment is that, in this embodiment, the first sub-fluid passage cavity 0711 is separately disposed in the space between the inner tube 06 and the outer tube 07 using a delivery pipe, while the space between the inner tube 06 and the outer tube 07 itself serves as the second sub-fluid passage cavity 0712. The first sub-fluid passage cavity 0711 is connected to the inner cavity of the first sub-balloon 011, and the second sub-fluid passage cavity 0712 is connected to the inner cavity of the second sub-balloon 012, so as to realize the injection and extraction of the conductive medium in the first sub-balloon 011 and the second sub-balloon 012 respectively, so that the first sub-balloon 011 and the second sub-balloon 012 each generate volume changes and deformations according to the amount of conductive medium filling their inner cavities. It should be understood that the first sub-fluid passage chamber 0711 and the second sub-fluid passage chamber 0712 can also be set in other ways, which will not be elaborated here.

[0067] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0068] It should also be noted that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the scope of protection of the present invention.

[0069] It should also be understood that, unless otherwise specified or indicated, the terms “first,” “second,” “third,” etc., in the specification are used only to distinguish the various components, elements, and steps in the specification, and not to indicate the logical or sequential relationships between the various components, elements, and steps.

[0070] Furthermore, it should be recognized that the terminology described herein is used only to describe particular embodiments and not to limit the scope of the invention. It must be noted that the singular forms “a” and “an” used herein and in the appended claims include plural bases unless the context clearly indicates otherwise. For example, a reference to “a step” or “an apparatus” means a reference to one or more steps or apparatuses, and may include secondary steps and secondary apparatuses. All conjunctions used should be understood in the broadest sense. And the word “or” should be understood to have the definition of logical “or” rather than logical “exclusive OR”, unless the context clearly indicates otherwise. Furthermore, implementation of embodiments of the invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. A shockwave balloon catheter device, characterized in that, It includes a catheter body and a balloon, the balloon being connected to the distal end of the catheter body, the catheter body having a fluid passage chamber extending along its own axis, and the inner cavity of the balloon communicating with the fluid passage chamber; The balloon is provided with a first shock wave emitting element for releasing axial shock waves along the axial direction of the balloon and a second shock wave emitting element for releasing radial shock waves along the radial direction of the balloon. Both the first shock wave emitting element and the second shock wave emitting element are electrically connected to a high voltage generator. The first shock wave emitting element is located in the distal end of the balloon. The catheter body includes an outer tube and an inner tube arranged coaxially. The outer tube is sleeved outside the inner tube. The distal end of the outer tube is connected to the proximal end of the balloon. The inner tube penetrates the balloon, and the distal end of the inner tube is connected to the distal end of the balloon. The first shock wave emitting element includes a plurality of first electrodes disposed at intervals on the distal outer surface of the inner tube. Each first electrode extends along the axial direction of the inner tube, and insulating material is filled between each first electrode. The conduit body injects a conductive medium into the first shock wave emitting element through the liquid passage. After the conductive medium fills the interior and surrounding area of ​​the first shock wave emitting element, the conductive medium simultaneously contacts the axial direction of the plurality of first electrodes to achieve electrical connection, so that the current can only be released along the axial direction of the first electrodes. The balloon comprises, from distal to proximal, a first conical portion, a straight portion, and a second conical portion connected in sequence. The inner and outer diameters of the first conical portion gradually increase from distal to proximal, while the inner and outer diameters of the second conical portion gradually decrease from distal to proximal. Both the straight portion and the second conical portion include connected inner and outer layers. The inner layer is made of a compliant material, and the outer layer is made of a non-compliant or semi-compliant material. The first conical portion includes only the inner layer and is connected to the inner layer of the straight portion. The first conical portion is made of a compliant material.

2. The shockwave balloon catheter device as described in claim 1, characterized in that, The angle between the axis of the first shock wave emitting element and the distal end face of the balloon is 0~90°.

3. The shockwave balloon catheter device as described in claim 1, characterized in that, The first shock wave emitting element does not contact the inner surface of the balloon.

4. The shockwave balloon catheter device as described in claim 1, characterized in that, The first shock wave emitting element further includes a first developing ring and an insulating layer coaxially disposed with the inner tube, the insulating layer being disposed between the first developing ring and the plurality of first electrodes.

5. The shockwave balloon catheter device as described in claim 1, characterized in that, The second shock wave emitting element includes a plurality of second electrodes; At least one of the second electrodes is connected in series with the first electrode; or the second electrode is connected in parallel with the first electrode.

6. The shockwave balloon catheter device as described in claim 1, characterized in that, The balloon includes a first sub-balloon and a second sub-balloon, and the fluid passage includes a first sub-fluid passage and a second sub-fluid passage spaced apart from each other. The first sub-fluid passage is connected to the inner cavity of the first sub-balloon, and the second sub-fluid passage is connected to the inner cavity of the second sub-balloon. The first sub-balloon and the second sub-balloon are spaced apart along the distal to proximal end of the balloon. The first shock wave emitting element is disposed inside the first sub-balloon, and the second shock wave emitting element is disposed inside the second sub-balloon; or both the first shock wave emitting element and the second shock wave emitting element are disposed inside the first sub-balloon.

7. The shockwave balloon catheter device as described in claim 1, characterized in that, The balloon includes a first sub-balloon and a second sub-balloon, and the fluid passage includes a first sub-fluid passage and a second sub-fluid passage separated from each other. The first sub-fluid passage is connected to the inner cavity of the first sub-balloon, and the second sub-fluid passage is connected to the inner cavity of the second sub-balloon. The second sub-balloon is fitted outside the first sub-balloon, the first shock wave emitting element is located inside the first sub-balloon, the second shock wave emitting element is located inside the second sub-balloon, the first sub-balloon is made of a compliant material, and the second sub-balloon is made of a non-compliant or semi-compliant material.

8. The shockwave balloon catheter device as described in claim 7, characterized in that, The outer diameter of the inner tube located in the first sub-balloon is smaller than the outer diameter of the inner tube located outside the first sub-balloon.

9. The shockwave balloon catheter device as described in claim 1, characterized in that, The balloon is provided with a second imaging ring, which is sleeved on the inner tube.

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