CN115192122A

CN115192122A - Shock wave balloon catheter device

Info

Publication number: CN115192122A
Application number: CN202210827191.3A
Authority: CN
Inventors: 闫永岗; 李立夫
Original assignee: Shanghai Jiamuyao Medical Technology Co ltd
Current assignee: Shanghai Jiamuyao Medical Technology Co ltd
Priority date: 2022-07-13
Filing date: 2022-07-13
Publication date: 2022-10-18

Abstract

The invention provides a seismic balloon catheter device, which comprises a catheter body and a balloon, wherein the balloon is connected with the far end of the catheter body, the catheter body is provided with a liquid through cavity extending along the axial direction of the catheter body, and the inner cavity of the balloon is communicated with the liquid through cavity; the balloon is internally provided with a first seismic wave transmitting element for releasing axial shock waves along the axial direction of the balloon and a second seismic wave transmitting element for releasing radial shock waves along the radial direction of the balloon, the first seismic wave transmitting element and the second seismic wave transmitting element are electrically connected with a high-voltage generator, and the first seismic wave transmitting element is positioned in the far end of the balloon. The shock wave balloon catheter device can release shock waves to the axial direction and the radial direction of the balloon, so that the shock wave balloon catheter device can be used for treating various complex calcified lesions when being applied to calcified lesion treatment in blood vessels.

Description

Shock wave balloon catheter device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a shock wave balloon catheter device.

Background

Vascular calcification is a disease of stenosis and sclerosis of blood vessels caused by the accumulation of plaque in the blood vessels of the human body, the so-called plaque consisting of fibrous tissue, fat and calcium. The accumulated calcified plaque prevents the normal flow of blood, resulting in insufficient supply of oxygen and nutrients to the body,

arteriosclerosis of lower limbs caused by peripheral blood vessels, coolness, numbness and intermittent claudication of the lower limbs caused by slight occurrence, and pulsation of lower limb arteries, especially dorsum arteries, caused by serious occurrence, even amputation treatment is required. Vascular calcification occurs in coronary arteries and is clinically manifested as atherosclerotic heart disease, myocardial ischemia, angina pectoris, and myocardial infarction.

In recent years, minimally invasive intervention methods are mainly adopted for treating calcified vascular lesions, mainly including high-pressure balloons, chocolate balloons, cutting balloons, spinous process balloons, nicking balloons and rotary cutting/rotary grinding of plaques, but all the instruments have limitations, high complications, can only treat superficial calcification and are ineffective for severe calcification, eccentric calcification and the like.

Based on the above, a new technology, i.e., an extracorporeal lithotripsy is introduced into the field of vascular intervention recently, a catheter with a balloon at the far end is inserted into a blood vessel, the balloon expands and adheres to the wall at a calcified lesion, at the moment, an electrode in the balloon generates a hydroelectric wave source under the communication of a high-voltage generator, and the wave source releases high-voltage shock waves after being excited to generate shock waves due to a cavitation effect. The shock wave is transmitted through the liquid medium and impacts and fractures the calcified area in the blood vessel through the saccule wall to crush the calcified substance, so that the blood vessel recovers elasticity, the diseased blood vessel is remodeled, and meanwhile, the damage to the inner wall/intima of the blood vessel is avoided.

The shock wave technology is applied by both American shock wave medical companies and domestic medical enterprises to provide various technical schemes for treating calcified lesions. However, the prior art treatment of calcified lesions with shockwave techniques has been performed using non-compliant or semi-compliant balloons with electrodes that radially release shockwaves. When severe calcified lesions are faced, the balloon cannot pass through the lesions and cannot be realized in a mode of radially releasing shock waves, so that the aim of treatment is difficult to achieve; when the non-compliant balloon expands, the balloon cannot be attached to the wall completely after the non-compliant balloon expands, so that the shock wave energy cannot be transmitted to the surface of calcified substances, and the treatment effect is poor.

Disclosure of Invention

The invention aims to provide a shock wave balloon catheter device to solve the problem that when a balloon is used for treating complex calcified lesions, radial shock waves cannot pass through the lesions and treat the lesions by means of the balloon alone.

In order to solve the technical problem, the invention provides a shock wave balloon catheter device which comprises a catheter body and a balloon, wherein the balloon is connected with the far end of the catheter body, the catheter body is provided with a liquid through cavity which extends along the axial direction of the catheter body, and the inner cavity of the balloon is communicated with the liquid through cavity; the balloon is internally provided with a first seismic wave transmitting element for releasing axial shock waves along the axial direction of the balloon and a second seismic wave transmitting element for releasing radial shock waves along the radial direction of the balloon, the first seismic wave transmitting element and the second seismic wave transmitting element are electrically connected with a high-voltage generator, and the first seismic wave transmitting element is positioned in the far end of the balloon.

Optionally, an included angle between an axis of the first seismic wave transmitting element and the distal end face of the balloon is 0 to 90 °.

Optionally, the first seismic wave emitting element is not in contact with the inner surface of the balloon.

Optionally, the catheter body includes an outer tube and an inner tube that are coaxially arranged, the outer tube is sleeved outside the inner tube, the distal end of the outer tube is connected with the proximal end of the balloon, the inner tube penetrates through the balloon, and the distal end of the inner tube is connected with the distal end of the balloon.

Optionally, the first seismic wave emitting element includes a plurality of first electrodes disposed on the outer surface of the distal end of the inner tube at intervals, and each of the first electrodes extends in the axial direction of the inner tube.

Optionally, the first seismic wave emitting element further includes a first developing ring and an insulating layer coaxially disposed with the inner tube, and the insulating layer is disposed between the first developing ring and the plurality of first electrodes.

Optionally, the second seismic wave emitting element includes a plurality of second electrodes, and 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.

Optionally, the balloon comprises a first sub-balloon and a second sub-balloon, the liquid through cavity comprises a first sub-liquid through cavity and a second sub-liquid through cavity which are separated from each other, the first sub-liquid through cavity is communicated with the inner cavity of the first sub-balloon, and the second sub-liquid through cavity is communicated with the inner cavity of the second sub-balloon; the first sub-balloon and the second sub-balloon are arranged at intervals from the distal end to the proximal end of the balloon; the first seismic wave transmitting element is arranged in the first sub-balloon, and the second seismic wave transmitting element is arranged in the second sub-balloon; or the first seismic wave transmitting element and the second seismic wave transmitting element are both arranged in the first sub-balloon.

Optionally, the balloon comprises a first sub-balloon and a second sub-balloon, the liquid through cavity comprises a first sub-liquid through cavity and a second sub-liquid through cavity which are separated from each other, the first sub-liquid through cavity is communicated with the inner cavity of the first sub-balloon, and the second sub-liquid through cavity is communicated with the inner cavity of the second sub-balloon; the second sub-sacculus is sleeved outside the first sub-sacculus, the first seismic wave transmitting element is arranged in the first sub-sacculus, the second seismic wave transmitting element is arranged in the second sub-sacculus, the first sub-sacculus is made of a compliant material, and the second sub-sacculus is made of a non-compliant material or a semi-compliant material.

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.

Optionally, the balloon comprises a first tapered portion, a straight portion and a second tapered portion connected in sequence from the distal end to the proximal end, wherein the inner diameter and the outer diameter of the first tapered portion are gradually increased from the distal end to the proximal end, and the inner diameter and the outer diameter of the second tapered portion are gradually decreased from the distal end to the proximal end.

Optionally, the flat portion with the second toper portion all includes inlayer and the skin that links to each other, the material of inlayer is compliance material, outer material is non-compliance material or semi-compliance material, first toper portion with the inlayer of flat portion links to each other, just the material of first toper portion is compliance material.

Optionally, a second developing ring is arranged in the balloon, and the second developing ring is sleeved on the inner tube.

Compared with the prior art, the seismic balloon catheter device provided by the invention has the following advantages: the invention provides a seismic wave balloon catheter device which comprises a catheter body and a balloon, wherein the balloon is connected with the far end of the catheter body, the catheter body is provided with a liquid through cavity extending along the axial direction of the catheter body, and the inner cavity of the balloon is communicated with the liquid through cavity; the balloon is internally provided with a first seismic wave transmitting element for releasing axial shock waves along the axial direction of the balloon and a second seismic wave transmitting element for releasing radial shock waves along the radial direction of the balloon, the first seismic wave transmitting element and the second seismic wave transmitting element are electrically connected with a high-voltage generator, and the first seismic wave transmitting element is positioned in the far end of the balloon. For severe calcification lesions, when the shock wave balloon catheter device cannot pass through the lesions, under X-rays, the far end of the balloon is positioned to the severe calcification lesions, a conductive medium is injected to expand the balloon, the far end of the balloon expands and calcified lesions adhere to the wall, the side face of the balloon adheres to the wall of a blood vessel, the high-voltage generator is started at the moment, the first shock wave emitting element is electrified, and then the shock wave balloon catheter device releases axial shock waves towards the far end of the balloon to open the lesions. After the lesion is opened, partial conductive medium is drawn out to shrink the balloon, the balloon is pushed to pass through the lesion and the side face of the balloon is positioned at the calcified lesion, the conductive medium is injected again to expand the balloon and the high-voltage generator is started to electrify the second seismic wave emitting element, so that the seismic wave balloon catheter device releases radial shock waves towards the side face of the balloon to break the calcified lesion, and the conductive medium is continuously injected to expand the balloon to thin and compact the loosened calcified substance on the inner wall of the blood vessel so as to achieve the purpose of recovering blood flow.

Drawings

Fig. 1 is a schematic view of a seismic balloon catheter apparatus according to a first embodiment of the present invention.

Fig. 2 is a longitudinal cross-sectional view of a balloon provided in accordance with an embodiment of the present invention.

FIG. 3 is a transverse cross-sectional view of a first seismic transmitting element according to a first embodiment of the invention.

FIG. 4 is a transverse cross-sectional view of a first seismic transmitting element provided in accordance with a second embodiment of the invention.

FIG. 5 is a longitudinal cross-sectional view of a second seismic transmitting element according to an embodiment of the invention.

Fig. 6 is a schematic diagram of parallel connection of electrodes according to an embodiment of the present invention.

Fig. 7 is a schematic diagram of an electrode series connection according to an embodiment of the invention.

FIG. 8 is a schematic view of a seismic balloon catheter apparatus according to a second embodiment of the present invention.

Fig. 9 is a schematic view of a seismic balloon catheter device according to a third embodiment of the present invention.

Fig. 10 is a schematic view of a seismic balloon catheter device according to a fourth embodiment of the invention.

FIG. 11 is a transverse cross-sectional view of a first access chamber and a second access chamber provided in accordance with a first embodiment of the present invention.

FIG. 12 is a transverse cross-sectional view of a first fluid passing lumen and a second fluid passing lumen provided in accordance with a second embodiment of the present invention.

Wherein the reference numerals are as follows:

01-balloon; 02-a first seismic transmitting element; 03-a second seismic emitting element; 04-a first developing ring; 05-a second developer ring; 06-inner tube; 07-an outer tube; 08-wire; 09-a connecting seat; 10-a high voltage generator;

021-a first electrode; 022-an insulating layer; 023-an insulating material; 031-a second electrode;

011-first sub-balloon; 012-a second sub-balloon;

071-passing liquid cavity; 0711-a first sub-cavity; 0712-a second sub-cavity for fluid communication;

013-inner layer; 014-outer layer.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings are intended to show different emphasis, sometimes in different proportions.

It will be understood that when an element or layer is referred to as being "on …," connected to "another element or layer, it can be directly on, connected to, or include intervening elements or layers. In contrast, when an element is referred to as being "directly on …" or "directly connected to" another element or layer, there are no intervening elements or layers included. Although the terms first, second, third, etc. may be used to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. Spatial relational terms, such as "below … …," "below," "above … …," "above," and the like, may be used herein for ease of description to describe the relationship of one element or feature to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, then elements or features described as "below … …," "beneath," "under" or "on" other elements or features would then be oriented. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatial descriptors used herein interpreted accordingly. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising" are used in an inclusive sense to specify the inclusion of one or more features, steps, operations, elements, components, and/or groups thereof, but do not preclude the inclusion or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of the associated listed items.

The invention aims to provide a shock wave balloon catheter device to solve the problem that when a balloon is used for treating complex calcified lesions, radial shock waves cannot pass through the lesions and treat the lesions by means of the balloon alone. It is noted that, as will be understood by those skilled in the art, reference herein to "proximal" refers to the end closer to the operator (i.e., the end distal to the lesion), and reference herein to "distal" refers to the end further from the operator (i.e., the end closer to the lesion).

In order to solve the above technical problem, the present invention provides a seismic balloon catheter device, please refer to fig. 1, which schematically shows a schematic view of a seismic balloon catheter device according to a first embodiment of the present invention, as shown in fig. 1, the seismic balloon catheter device provided by the present invention includes a catheter body and a balloon 01, the balloon 01 is connected to a distal end of the catheter body, the catheter body has a liquid through cavity 071 axially extending along the catheter body, and an inner cavity of the balloon 01 is communicated with the liquid through cavity 071; the balloon 01 is internally provided with a first seismic wave transmitting element 02 for releasing axial shock waves along the axial direction of the balloon 01 and a second seismic wave transmitting element 03 for releasing radial shock waves along the radial direction of the balloon 01, the first seismic wave transmitting element 02 and the second seismic wave transmitting element 03 are both electrically connected with a high-voltage generator 10, and the first seismic wave transmitting element 02 is positioned in the far end of the balloon 01. It should be noted that, as will be understood by those skilled in the art, the balloon 01 is correspondingly changed in volume and deformed according to the amount of the conductive medium filled in the inner cavity of the balloon 01.

Specifically, for severe calcified lesions, when the balloon 01 cannot pass through the lesions, under X-rays, the distal end of the balloon 01 is positioned to the severe calcified lesions, the conductive medium is injected through the liquid passage cavity 071 to expand the balloon 01, the distal end of the balloon 01 is expanded to adhere to the calcified lesions, the side surface of the balloon 01 adheres to the blood vessels, the high-voltage generator 10 is started at this time to electrify the first shock wave emitting element 02, and the shock wave balloon catheter device is further caused to release axial shock waves towards the distal end of the balloon 01 to open the lesions. After the lesion is opened, partial conductive medium is pumped out through the liquid through cavity 071 to shrink the balloon 01, the balloon 01 is pushed to pass through the lesion and the side surface of the balloon 01 is positioned at a calcified lesion, the conductive medium is injected again to expand the balloon 01 and start the high voltage generator 10, so that the second shock wave emitting element 03 is electrified, the shock wave balloon catheter device releases radial shock waves towards the side surface of the balloon 01, the calcified lesion is broken, and the conductive medium is continuously injected to expand the balloon 01 to thin and compact the loosened calcified substance on the inner wall of the blood vessel so as to achieve the purpose of recovering blood flow. It should be understood that the seismic balloon catheter device further comprises a connecting seat 09, and the connecting seat 09 is connected with the proximal end of the catheter body in a sealing manner, so as to avoid liquid leakage in the process of injecting and extracting the conductive medium.

With continuing reference to fig. 1, as shown in fig. 1, preferably, an angle between an axis of the first seismic wave emitting element 02 and the distal end surface of the balloon 01 is 0 to 90 °. As shown in fig. 1, θ in the figure is an included angle between an axis of the first seismic wave emitting element 02 and a distal end surface of the balloon 01, and the included angle θ may be designed according to any one of angles from 0 to 90 degrees according to operation requirements.

It should be noted that, preferably, the first seismic wave emitting element 02 is not in contact with the inner surface of the balloon 01, so that the balloon 01 is prevented from being excessively vibrated by the first seismic wave emitting element 02, and accordingly, excessive axial shock waves released along the axial direction of the balloon 01 are prevented from being released, and the treatment effect is better improved.

With continued reference to fig. 1, preferably, the catheter body includes an outer tube 07 and an inner tube 06 coaxially disposed, the outer tube 07 is sleeved outside the inner tube 06, a distal end of the outer tube 07 is connected to a proximal end of the balloon 01, the inner tube 06 penetrates through the balloon 01, and a distal end of the inner tube 06 is connected to a distal end of the balloon 01. The inner tube 06 is used for guide wire routing to guide the seismic balloon catheter device into the patient. With such an arrangement, the liquid passing cavity 071 is formed between the outer tube 07 and the inner tube 06, so as to fill and extract the conductive medium into and from the balloon 01.

Please refer to fig. 2, which is a longitudinal sectional view of a balloon 01 according to an embodiment of the present invention. As shown in fig. 2, the balloon 01 comprises a first tapered portion, a straight portion and a second tapered portion connected in sequence from the distal end to the proximal end, wherein the inner diameter and the outer diameter of the first tapered portion are gradually increased from the distal end to the proximal end, and the inner diameter and the outer diameter of the second tapered portion are gradually decreased from the distal end to the proximal end. The smooth transition of the saccule can be realized by the arrangement, and the damage to a patient is reduced.

Further, as shown in fig. 2, each of the flat portion and the second tapered portion includes an inner layer 013 and an outer layer 014 connected to each other, the inner layer 013 is made of a compliant material, the outer layer 014 is made of a non-compliant material or a semi-compliant material, the first tapered portion is connected to the inner layer of the flat portion, and the first tapered portion is made of a compliant material. When the inner layer 013 is used for treating severe calcification or full calcification lesions, the inner layer can adapt to various shape changes after expansion, can be tightly attached to the calcified lesions, and then releases shock waves by using the first shock wave emitting element 02 so as to more effectively open the lesions. The outer layer 014 is made of a non-compliant or semi-compliant material. In the preset diameter range of the balloon 01, the inner layer 013 plays a role mainly, so that the balloon 01 adheres to the wall more closely under the complex asymmetric condition, and the treatment effect is improved. The outer layer 014 functions to fix the expansion range and prevent the inner layer 013 from being excessively expanded to damage the blood vessel. Under the structure, the conductive medium is injected, the compliant material on the axial end face of the balloon 01 is utilized to completely adhere to the seriously calcified or completely calcified lesion, and the first seismic wave emitting element 02 is utilized to release the shock wave to open the lesion. Then, a portion of the conductive medium is withdrawn to deflate the balloon 01 and push the balloon 01 forward.

Preferably, as shown in fig. 1, a second developing ring 05 is arranged in the balloon 01, and the second developing ring 05 is sleeved on the inner tube 06. Further, as shown in fig. 1, in the present embodiment, the second developing ring 05 is disposed at the proximal end of the second seismic element 03. The side face of the balloon 01 is positioned to a lesion through the second developing ring 05, the balloon 01 is expanded by utilizing the characteristics of the compliant material of the inner layer 013 and is completely attached to the wall, and then the second shock wave emitting element 03 is utilized to release shock waves for calcified lesions. After treatment, the conductive medium is injected to expand the balloon 01, so that the balloon 01 thins and compacts the loose calcified substances on the inner wall of the blood vessel to restore the blood flow of the blood vessel. At this time, the outer layer 014 functions as a non-compliant or semi-compliant material to prevent the inner layer 013 made of a compliant material from over-expanding and damaging the blood vessel.

Please refer to fig. 3, which is a transverse cross-sectional view of a first seismic wave emitting element 02 according to a first embodiment of the present invention. As shown in fig. 3, the first seismic wave emitting element 02 includes a plurality of first electrodes 021 disposed on the outer surface of the distal end of the inner tube 06 at intervals, and each of the first electrodes 021 extends in the axial direction of the inner tube 06. It should be noted that, as understood by those skilled in the art, the first electrode 021 may have a plurality of (two) electrodes, and insulating material 023 is filled between the electrodes, the catheter body injects the conductive medium, such as saline, into the first seismic wave transmitting element 02 through the liquid through cavity 071, after the conductive medium fills the inside and the periphery of the first seismic wave transmitting element 02, the conductive medium is electrically connected to the axial direction of the first electrodes 021 at the same time, and at this time, because the insulating material 023 is filled between the first electrodes 021, current cannot be transmitted through the side surfaces of the first electrodes 021, so that current can only be released along the axial direction of the first electrodes 021, and thus the first seismic wave transmitting element 02 releases an axial shock wave along the axial direction towards the distal end face of the balloon 01.

Referring to fig. 3, as shown in fig. 3, the first seismic wave emitting element 02 further includes a first developing ring 04 and an insulating layer 022 coaxially disposed on the inner tube 06, wherein the insulating layer 022 is disposed between the first developing ring 04 and the first electrodes 021. The first developing ring 04 is used for positioning and marking under X-ray, and the position of the first seismic wave emitting element 02 is confirmed in real time, so as to facilitate operation. The insulating layer 022 is disposed between the first developing ring 04 and the first electrodes 021, so as to prevent the first electrodes 021 from generating current interference on the first developing ring 04, and the first developing ring 04 can be fixed at the position of the first electrodes 021 without interference.

With continued reference to fig. 3 and 4, fig. 4 schematically shows a transverse cross-sectional view of a first seismic wave emitting element 02 provided in accordance with a second embodiment of the invention. As shown in fig. 3 and 4, the first seismic wave emitting element 02 provided in the second embodiment is different from the first seismic wave emitting element 02 provided in the first embodiment in that the first electrode 021 has a circular transverse cross-section in the first embodiment, and the first electrode 021 has a flat transverse cross-section in the second embodiment. It should be understood that the cross section of the first electrode 021 can be other shapes, and is not described in detail here.

Please refer to fig. 5, which is a longitudinal sectional view of a second seismic wave emitting device 03 according to an embodiment of the present invention. As shown in fig. 5, the second seismic wave transmitting element 03 includes a plurality of coaxially disposed ring structures sleeved on the outer surface of the inner tube 06, each ring structure includes an electrode pair and a non-conductive gap, and the non-conductive gap is disposed between two second electrodes 031 of the electrode pair. The catheter body injects a conductive medium such as physiological saline into the second seismic wave emitting element 03 through the liquid through cavity, after the conductive medium fills the periphery of the second seismic wave emitting element 03, the high voltage generator 08 is started, and the conductive medium simultaneously contacts with the plurality of second electrodes 031 to realize electrical connection, so that the second seismic wave emitting element 03 releases radial shock waves towards the side surface of the balloon 01.

It should be noted that, the above description is only for the preferred embodiment of the way of releasing the shock wave by the first seismic wave emitting element 02 and the second seismic wave emitting element 03, but not limited thereto.

Referring to fig. 6 and 7, fig. 6 is a schematic diagram illustrating parallel connection of electrodes according to an embodiment of the present invention; fig. 7 is a schematic diagram of an electrode series connection according to an embodiment of the invention. As shown in fig. 6, the first electrode 021 of the first seismic emitting element 02 and the second electrode 031 of the second seismic emitting element 03 are connected in parallel, so that the first seismic emitting element 02 and the second seismic emitting element 03 can be controlled to release shock waves respectively. As shown in fig. 7, the second seismic wave transmitting element 03 includes a plurality of second electrodes 031, and at least one of the second electrodes 031 is connected in series with the first electrode 021, so that the first seismic wave transmitting element 02 and the second seismic wave transmitting element 03 can be controlled to release shock waves simultaneously, and part of the second electrodes 031 that are not connected in series can be electrified at any time to enhance the strength of the radial shock waves. It should be understood that the first electrode 021 and the second electrode 031 can be connected by providing different high voltage generators 09, which will not be described herein.

Please refer to fig. 8, which is a schematic view of a seismic balloon catheter device according to a second embodiment of the present invention. As shown in fig. 8, the seismic balloon catheter device provided by the second embodiment is different from the seismic balloon catheter device provided by the first embodiment in that the balloon 01 in the seismic balloon catheter device provided by the second embodiment comprises a first sub-balloon 011 and a second sub-balloon 012, and the lumens of the first sub-balloon 011 and the second sub-balloon 012 are spatially independent from each other and can respectively generate volume change and deformation according to the amount of the conductive medium filled in the lumens. The liquid passing cavity 071 includes a first sub liquid passing cavity 0711 (see fig. 11 and 12) and a second sub liquid passing cavity 0712 (see fig. 11 and 12) that are separated from each other, the first sub liquid passing cavity 0711 communicates with the inner cavity of the first sub balloon 011, the second sub liquid passing cavity 0712 communicates with the inner cavity of the second sub balloon 012, the first sub balloon 011 and the second sub balloon 012 are arranged at intervals from the distal end to the proximal end of the balloon 01, the first seismic wave emitting element 02 is disposed in the first sub balloon 011, and the second seismic wave emitting element 03 is disposed in the second sub balloon 012. Therefore, the first sub-balloon 011 can be completely attached to the inner tube 06 before expansion, when severe calcified lesions are treated, the conductive medium is injected into the first sub-balloon 011 to enable the first sub-balloon to adhere to the lesion well after expansion, the first shock wave emitting element 02 is utilized to release shock waves along the axial direction of the balloon to open the lesion, after the lesion is opened, a part of the conductive medium is extracted to enable the first sub-balloon 011 to contract, and the balloon 01 is pushed to the far end under X-ray to enable the second sub-balloon 012 to penetrate through the lesion.

With continuing reference to fig. 8, as shown in fig. 8, in the seismic balloon catheter device according to the second embodiment, the second visualization ring 05 is disposed at the proximal end and the distal end of the second seismic element 03. The second sub-balloon 012 is positioned to a lesion position by the second developing ring 05, the conductive medium is injected into the second sub-balloon 012 to expand the second sub-balloon 012, and a radial shock wave is released from the side surface of the second sub-balloon 012 by the second shock wave emitting element 03 in the second sub-balloon 012 to further treat calcified lesion.

Please refer to fig. 9, which is a schematic view of a seismic balloon catheter device according to a third embodiment of the present invention. As shown in fig. 9, the difference between the balloon catheter device according to the third embodiment and the balloon catheter device according to the second embodiment is that the first and second seismic emitting

elements

02 and 03 of the balloon catheter device according to the third embodiment are disposed in the first sub-balloon 011. Therefore, when severe calcification lesions are treated, the conductive medium is injected into the first sub-balloon 011 to enable the first sub-balloon 011 to adhere to the lesions well after expansion, the first seismic wave emitting element 02 is used for releasing shock waves along the axial direction of the balloon 01 to open the lesions, after the lesions are opened, a part of the conductive medium is extracted to enable the first sub-balloon 011 to contract, the balloon 01 is pushed to the far end under X-rays, the first sub-balloon 011 penetrates through the lesions, the conductive medium is injected into the first sub-balloon 011 again to expand the first sub-balloon 011, and the second seismic wave emitting element 03 in the first sub-balloon 011 is used for releasing radial shock waves on the side face of the first sub-balloon 011 to further treat the calcification lesions. Then, a part of the conductive medium is withdrawn again to contract the first sub-balloon 011, and the balloon 01 is pushed to the distal end under X-ray, so that the second sub-balloon 012 passes through the lesion.

With continued reference to fig. 9, as shown in fig. 9, in the shock balloon catheter device according to the third embodiment, the second developing ring 05 is disposed in the second sub-balloon 012. The second sub-balloon 012 is positioned to a lesion position through the second developing ring 05, and the conductive medium is injected into the second sub-balloon 012 to expand the second sub-balloon 012, so that the second sub-balloon 012 thins and compacts the loosened calcified substances on the inner wall of the blood vessel, thereby realizing the dredging effect on the blood vessel.

Please refer to fig. 10, which is a schematic view of a balloon catheter device according to a fourth embodiment of the present invention. As shown in fig. 10, the difference between the seismic balloon catheter device provided by the fourth embodiment and the seismic balloon catheter device provided by the second embodiment is that the second sub-balloon 012 of the seismic balloon catheter device provided by the fourth embodiment is sleeved outside the first sub-balloon 011, the first seismic emitting element 02 is disposed in the first sub-balloon 011, and the second seismic emitting element 03 is disposed in the second sub-balloon 012. The first sub-balloon 011 is made of a compliant material, and the second sub-balloon 012 is made of a non-compliant material or a semi-compliant material. The compliant material can be made of compliant materials such as PVC, TPU, silica gel and latex, and aims to adapt to various shape changes after expansion and be tightly attached to calcified lesions when severe calcified or fully calcified lesions are treated. Then, a portion of the conductive medium is withdrawn to deflate the balloon 01 and push the balloon 01 forward.

With continued reference to fig. 10, as shown in fig. 10, in the seismic balloon catheter device according to the fourth embodiment, the second developing ring 05 is disposed at the proximal end of the second seismic element 03. The side surface of the second sub-balloon 012 is positioned to the lesion by the second developing ring 05, and at this time, the second shock wave emitting element 03 in the second sub-balloon 012 is used for releasing shock waves to the calcified lesion. After the treatment, the conductive medium is injected to expand the second sub-balloon 012, so that the second sub-balloon 012 thins and compacts the loosened calcified substance on the inner wall of the blood vessel to restore the blood flow of the blood vessel, and because the second sub-balloon 012 uses a non-compliant material or a semi-compliant material, the second sub-balloon 012 cannot expand infinitely to damage the blood vessel.

It should be noted that, in the seismic balloon catheter device according to the fourth embodiment shown in fig. 10, 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. Because the second sub-balloon 012 is sleeved outside the first sub-balloon 011, the outer diameter of the second sub-balloon 012 and the first sub-balloon 011 which are overlapped together is larger. The outer diameter of the inner tube 06 which is arranged in the first sub-balloon 011 is smaller than the outer diameter of the inner tube 06 which is arranged outside the first sub-balloon 011, so that the outer diameter of the second sub-balloon 012 and the first sub-balloon 011 can be reduced, the volume of the balloon 01 is reduced, and the balloon 01 is convenient to intervene in treatment.

It should be noted that, the above description is only about the preferred arrangement of the first seismic wave emitting element 02 and the second seismic wave emitting element 03 in the first sub-balloon 011 and the second sub-balloon 012, but not limited thereto, the first seismic wave emitting element 02 and the second seismic wave emitting element 03 may also be arranged in the first sub-balloon 011 and the second sub-balloon 012 by other arrangement and combination and function correspondingly, and details are not repeated herein.

It should be noted that the arrangement of the first sub liquid through cavity 0711 and the second sub liquid through cavity 0712 can be implemented in various ways. Referring to fig. 11, a schematic diagram of the arrangement positions of the first sub liquid passing cavity 0711 and the second sub liquid passing cavity 0712 according to the first embodiment of the present invention is schematically shown. As shown in fig. 11, in this embodiment, the first liquid through cavity 0711 and the second liquid through cavity 0712 are both separately disposed by using a delivery tube in a space between the inner tube 06 and the outer tube 07, the first sub liquid through cavity 0711 is communicated with an inner cavity of the first sub balloon 011, and the second sub liquid through cavity 0712 is communicated with an inner cavity of the second sub balloon 012, so as to control injection and extraction of the conductive medium in the first sub balloon 011 and the second sub balloon 012, respectively, and realize that the first sub balloon 011 and the second sub balloon 012 respectively generate volume change and deformation according to the amount of the conductive medium filled in the inner cavity.

Referring to fig. 12, a schematic diagram of the arrangement positions of the first sub liquid passing cavity 0711 and the second sub liquid passing cavity 0712 according to the second embodiment of the present invention is schematically shown. As shown in fig. 12, the difference between the positions of the first sub liquid passing cavity 0711 and the second sub liquid passing cavity 0712 provided in the present embodiment and the positions of the first sub liquid passing cavity 0711 and the second sub liquid passing cavity 0712 provided in the first embodiment is that the first sub liquid passing cavity 0711 in the present embodiment is separately provided in the space between the inner tube 06 and the outer tube 07 by using a transfer tube, and the space between the inner tube 06 and the outer tube 07 itself serves as the second liquid passing cavity 0712. The first sub-liquid through cavity 0711 is communicated with the inner cavity of the first sub-balloon 011, and the second sub-liquid through cavity 0712 is communicated with the inner cavity of the second sub-balloon 012, so as to control the injection and extraction of the conductive medium of the first sub-balloon 011 and the second sub-balloon 012 respectively, and realize that the first sub-balloon 011 and the second sub-balloon 012 respectively generate volume change and deformation according to the amount of the conductive medium filled in the inner cavity correspondingly. It should be understood that the first sub-chamber 0711 and the second sub-chamber 0712 can be arranged in other ways, and will not be described herein.

It should be noted that, in the present specification, various embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among various embodiments may be referred to each other. For the system disclosed by the embodiment, the description is relatively simple because the system corresponds to the method disclosed by the embodiment, and the relevant points can be referred to the method part for description.

It should be noted that, although the present invention has been described with reference to the preferred embodiments, the above embodiments are not intended to limit the present invention. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the invention without departing from the scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the protection scope of the technical solution of the present invention, unless the content of the technical solution of the present invention is departed from.

It should be further understood that the terms "first," "second," "third," and the like in the description are used for distinguishing between various components, elements, steps, and the like, and are not intended to imply a logical or sequential relationship between various components, elements, steps, or the like, unless otherwise indicated or indicated.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses and may include sub-steps as well as sub-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 the definition of logical "exclusive or" unless the context clearly dictates otherwise. Further, implementation of embodiments of the present invention may include performing the selected task manually, automatically, or in combination.

Claims

1. The shock wave balloon catheter device is characterized by comprising a catheter body and a balloon, wherein the balloon is connected with the far end of the catheter body, the catheter body is provided with a liquid through cavity extending along the axial direction of the catheter body, and the inner cavity of the balloon is communicated with the liquid through cavity;

the balloon is internally provided with a first seismic wave transmitting element for releasing axial shock waves along the axial direction of the balloon and a second seismic wave transmitting element for releasing radial shock waves along the radial direction of the balloon, the first seismic wave transmitting element and the second seismic wave transmitting element are electrically connected with a high-voltage generator, and the first seismic wave transmitting element is positioned in the far end of the balloon.

2. The seismic balloon catheter device of claim 1, wherein an angle between an axis of the first seismic emitting element and a distal end face of the balloon is 0-90 °.

3. The seismic balloon catheter device of claim 1, wherein the first seismic emitting element is not in contact with the balloon inner surface.

4. The shock balloon catheter device according to claim 1, wherein the catheter body comprises an outer tube and an inner tube coaxially arranged, the outer tube is sleeved outside the inner tube, a distal end of the outer tube is connected with a proximal end of the balloon, the inner tube penetrates through the balloon, and a distal end of the inner tube is connected with a distal end of the balloon.

5. The seismic balloon catheter device of claim 4, wherein the first seismic emitting element comprises a plurality of first electrodes spaced apart from one another disposed on the outer surface of the distal end of the inner tube, each of the first electrodes being disposed along an axial extension of the inner tube.

6. The seismic balloon catheter device of claim 5, wherein the first seismic emitting element further comprises a first visualization ring disposed coaxially with the inner tube and an insulating layer disposed between the first visualization ring and the first plurality of electrodes.

7. The seismic balloon catheter device of claim 5, wherein the second seismic emitting element comprises a plurality of second electrodes;

at least one of the second electrodes is in series with the first electrode; or the second electrode is connected in parallel with the first electrode.

8. The shock balloon catheter device according to claim 1, wherein the balloon includes a first sub-balloon and a second sub-balloon, the liquid passage chamber includes a first sub-liquid passage chamber and a second sub-liquid passage chamber which are separated from each other, the first sub-liquid passage chamber communicates with the inner chamber of the first sub-balloon, and the second sub-liquid passage chamber communicates with the inner chamber of the second sub-balloon; the first and second sub-balloons are spaced apart from a distal end to a proximal end of the balloon;

the first seismic wave transmitting element is arranged in the first sub-balloon, and the second seismic wave transmitting element is arranged in the second sub-balloon; or the first seismic wave transmitting element and the second seismic wave transmitting element are both arranged in the first sub-balloon.

9. The shock balloon catheter device according to claim 4, wherein the balloon includes a first sub-balloon and a second sub-balloon, the liquid passage cavity includes a first sub-liquid passage cavity and a second sub-liquid passage cavity which are separated from each other, the first sub-liquid passage cavity is communicated with the inner cavity of the first sub-balloon, and the second sub-liquid passage cavity is communicated with the inner cavity of the second sub-balloon;

the second sub-sacculus is sleeved outside the first sub-sacculus, the first seismic wave transmitting element is arranged in the first sub-sacculus, the second seismic wave transmitting element is arranged in the second sub-sacculus, the first sub-sacculus is made of a compliant material, and the second sub-sacculus is made of a non-compliant material or a semi-compliant material.

10. The shock balloon catheter device of claim 9, wherein an outer diameter of the inner tube located in the first sub-balloon is smaller than an outer diameter of the inner tube located outside the first sub-balloon.

11. The balloon catheter device according to claim 1, wherein the balloon comprises a first tapered portion, a straight portion and a second tapered portion connected in sequence from a distal end to a proximal end, wherein the first tapered portion has an inner diameter and an outer diameter that both increase gradually from the distal end to the proximal end, and wherein the second tapered portion has an inner diameter and an outer diameter that both decrease gradually from the distal end to the proximal end.

12. The shock balloon catheter device according to claim 11, wherein the straight portion and the second tapered portion each comprise an inner layer and an outer layer connected, the inner layer being made of a compliant material, the outer layer being made of a non-compliant material or a semi-compliant material, the first tapered portion being connected to the inner layer of the straight portion, and the first tapered portion being made of a compliant material.

13. The seismic balloon catheter device of claim 4, wherein a second visualization ring is provided in the balloon, the second visualization ring being sleeved on the inner tube.