WO2025092027A1 - Valve balloon suction catheter - Google Patents

Abstract

Disclosed is a valve balloon suction catheter, comprising a tip, a balloon, a catheter, and a handle base in sequence from a distal end to a proximal end, the catheter being provided with a fluid passage lumen. The balloon consists of at least four balloon bodies, which are distributed circumferentially around the catheter to form a circular configuration, so as to create a blood flow channel in the center of the balloon, the blood flow channel being arranged in the axial direction of the balloon. A micro axial flow pump is provided in the blood flow channel and is arranged on the catheter, and a guidewire conduit penetrating through the micro axial flow pump is provided in the micro axial flow pump. A distal end of the guidewire conduit passes through the blood flow channel and is fixedly connected to the tip, and a proximal end of the guidewire conduit penetrates through the handle base. A guidewire lumen is provided in the guidewire conduit. The micro axial flow pump is connected to an external impeller drive interface arranged at a proximal end of the handle base. Compared with the prior art, the combination of balloon dilatation and mechanical circulatory assistance establishes a drainage pathway from the left ventricle to the ascending aorta, enabling cardiac blood circulation and improving the safety of the procedure.

Description

Valve Balloon Aspiration Catheter Technical Field

The invention relates to a medical device, in particular to a valve balloon suction catheter.

Background Art

Heart valves are an important part of the human heart. They are located between the four chambers of the heart and the large blood vessels, and play a key role in controlling the direction of blood flow. If there is a problem with the heart valve, such as stenosis, incomplete closure or damage, it will directly affect the normal function of the heart, and may cause blood flow obstruction, blood backflow or excessive heart load. Severe heart valve disease may cause heart failure, arrhythmia and even be life-threatening. Maintaining the health of the heart valves is essential to maintaining normal blood flow in the heart. Among them, the aortic valve is located between the left ventricle and the aorta, in a central position, and the aortic valve is closely related to each heart chamber and valve.

The cardiac balloon, also known as transcatheter percutaneous coronary angioplasty (PTCA), is inserted into the narrowed or blocked coronary artery through a catheter, and then inflated and expanded, thereby compressing the blood vessel wall inside the artery and restoring blood flow.

Valvular balloon dilatation is only used to increase the blood circulation channel, and the incidence of restenosis is high, but it cannot effectively assist in correcting the heart's hemodynamics. Therefore, in order to quickly and surely give the heart a rest, while improving blood circulation, so as to more efficiently improve the treatment effect, has become the direction of our research.

Summary of the invention

The purpose of the present invention is to provide a valve balloon aspiration catheter, and the technical problem to be solved is to assist the blood circulation function of the heart during surgery, prevent ischemia during cardiac surgery, and improve the safety of surgery.

To solve the above problems, the present invention adopts the following technical solutions: a valve balloon aspiration catheter, which includes a tip, a balloon, a catheter, and a handle seat from the distal end to the proximal end, and a liquid passage cavity is provided on the catheter;

The balloon is composed of at least four balloon bodies, which are distributed around the catheter to form a ring, so as to form a blood flow channel in the center of the balloon, the blood flow channel is arranged along the axial direction of the balloon, the proximal end of the balloon body is connected to the distal end of the catheter, the distal end of the balloon body is connected to the proximal end of the tip, and the balloon body is connected to the liquid passage cavity;

A micro axial flow pump is arranged in the blood flow channel, and the micro axial flow pump is arranged on the catheter. A guide wire catheter is arranged in the micro axial flow pump and passes through the inside of the micro axial flow pump. The distal end of the guide wire catheter passes through the blood flow channel and is connected and fixed with the tip. The proximal end of the guidewire catheter penetrates the handle seat, a guidewire cavity is provided in the guidewire catheter, and the micro axial flow pump is connected with an impeller in vitro driving interface arranged on the proximal end of the handle seat.

Furthermore, the proximal and distal ends of the balloon body are respectively provided with support rods, the two ends of the support rod located at the distal end are respectively connected to the distal end of the balloon body and the proximal end of the tip, the two ends of the support rod located at the proximal end are respectively connected to the proximal end of the balloon body and the distal end of the catheter, the support rod located at the proximal end is provided with a support rod through cavity connecting the balloon body and the through cavity, at least two symmetrically arranged balloon bodies are provided with liquid through catheters connected to the support rod through cavity, a shock wave generator is provided on the liquid through catheter, and the emission direction of the shock wave generator is toward the periphery of the balloon.

Furthermore, the micro axial flow pump includes an impeller shaft and an impeller. A through cavity is provided in the catheter for the impeller shaft to pass through. The distal end of the impeller shaft extends from the distal end of the catheter. The proximal end of the impeller shaft is inserted into the handle seat and connected to the impeller extracorporeal drive interface. The impeller is arranged on the distal end of the impeller shaft. A through cavity is provided in the impeller shaft, and the guide wire catheter passes through the through cavity.

Furthermore, an impeller protective cover is provided outside the impeller, the proximal end of the impeller protective cover is connected and fixed to the distal end of the conduit, and a protective cover through hole is provided on the impeller protective cover.

Furthermore, the impeller protection cover through hole is arranged at the proximal end of the impeller protection cover.

Furthermore, the impeller protective cover comprises an outer ring surrounding the periphery of the impeller and a conical surface arranged at the proximal end of the outer ring, and the protective cover through hole is arranged on the conical surface.

Furthermore, the outer wall of the impeller protection cover is an arc-shaped transition surface or a triangular transition surface.

Furthermore, the handle seat includes a liquid passing interface, and a channel connected to the liquid passing interface is provided in the handle seat; a through hole penetrating the proximal end and the distal end of the handle seat is provided on the axis of the handle seat, the proximal end of the catheter is inserted into the through hole from the distal end of the handle seat, the proximal end of the catheter is sealed and connected to the through hole, the liquid passing cavity is connected to the through cavity of the liquid passing interface, the impeller extracorporeal drive interface is arranged on the proximal end of the through hole, the impeller shaft is connected to the impeller extracorporeal drive interface via the through hole, the proximal end of the guide wire catheter passes through the impeller extracorporeal drive interface and extends from the proximal end of the handle seat, and an electrical connector electrically connected to the shock wave generator is provided on the handle seat.

Furthermore, the conduit is composed of an outer tube and an inner tube, the outer tube is coaxial with the inner tube, the outer diameter of the inner tube is smaller than the inner diameter of the outer tube, a liquid cavity is formed between the outer tube and the inner tube, and the impeller shaft passes through the inner tube.

Furthermore, the shock wave generator is arranged at the center of the balloon body.

Furthermore, the two symmetrically arranged shock wave generators are connected in series.

Compared with the prior art, the present invention combines balloon dilatation with mechanical circulatory assistance. While widening the blood circulation path, the impeller assists in replacing some of the functions of the heart valves, draws the oxygenated blood from the left ventricle through the catheter inlet, and then pumps it directly into the ascending aorta, establishing a drainage pathway from the left ventricle to the ascending aorta, thereby realizing the blood circulation of the heart. Since the heart will not be in a state of ischemia, the safety of the operation is improved. This process puts the heart in a resting state, which is convenient for subsequent recovery and treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of the overall structure of Embodiment 1 of the present invention.

FIG2 is a schematic diagram of the structure of the balloon according to Example 1 of the present invention.

Fig. 3 is a cross-sectional view taken along the direction A-A in Fig. 1 .

Fig. 4 is a cross-sectional view taken along the B-B direction in Fig. 1 .

Fig. 5 is a cross-sectional view taken along the C-C direction in Fig. 1 .

FIG. 6 is a schematic structural diagram of a handle base according to Embodiment 1 of the present invention.

FIG. 7 is a partial enlarged view of the handle base according to Embodiment 1 of the present invention.

FIG8 is a second partial enlarged view of the handle base according to Embodiment 1 of the present invention.

FIG. 9 is a schematic diagram of the overall structure of Embodiment 2 of the present invention.

FIG. 10 is a schematic diagram of the structure of the balloon according to Example 2 of the present invention.

Fig. 11 is a cross-sectional view taken along the A-A direction in Fig. 9 .

Fig. 12 is a cross-sectional view taken along the B-B direction in Fig. 9 .

Fig. 13 is a cross-sectional view taken along the C-C direction in Fig. 9 .

FIG. 14 is a schematic structural diagram of a handle base according to Embodiment 2 of the present invention.

FIG. 15 is a partial enlarged view of the handle base according to Embodiment 2 of the present invention.

FIG. 16 is a second partial enlarged view of the handle base according to Embodiment 2 of the present invention.

FIG. 17 is a schematic diagram of the structure of the shock wave generator according to Embodiment 2 of the present invention.

FIG. 18 is a schematic diagram of the internal structure of the shock wave generator of Example 2 of the present invention.

DETAILED DESCRIPTION

The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

In the present invention, the distal end refers to the end away from the surgical operator; the proximal end refers to the end close to the surgical operator.

Example 1

As shown in FIG. 1 , FIG. 2 , and FIG. 4 to FIG. 6 , Embodiment 1 of the present invention discloses a valve balloon aspiration catheter, which includes a tip 1, a balloon 2, a catheter 3, and a handle seat 4 from the distal end to the proximal end, wherein:

The catheter 3 is provided with a liquid passage cavity 31, and the proximal end of the catheter 3 is connected and fixed to the distal end of the handle seat 4;

The balloon 2 is composed of eight balloon bodies 22, which are distributed around the catheter 3 to form a ring to form a blood flow channel 21 in the center of the balloon 2. The overall shape of the balloon 2 is olive-shaped. The blood flow channel 21 is arranged along the axial direction of the balloon 2. The blood flow channel 21 can achieve the treatment of heart valve calcification while retaining a certain amount of cardiac output when the balloon is expanded, avoiding complete blockage of the blood flow channel, thereby reducing the impact of balloon dilatation on hemodynamics and reducing the incidence of blood circulation failure. Support rods 23 are respectively provided at the proximal and distal ends of the balloon body 22. The support rod 23 at the proximal end is connected to the distal end of the catheter 3. A support rod through cavity 231 is provided in the support rod 23 at the proximal end, which is connected to the balloon cavity of the balloon body 22. The proximal end of the support rod through cavity 231 is connected to the distal end of the liquid through cavity 31. When liquid is passed into the liquid through cavity 31, the eight balloon bodies 22 are filled.

A micro axial flow pump 5 is provided in the blood flow channel 21, and the micro axial flow pump 5 is arranged on the catheter 3. A guide wire catheter 7 is provided in the micro axial flow pump 5 and passes through the inside thereof. The distal end of the guide wire catheter 7 passes through the blood flow channel 21 and is connected and fixed with the tip 1. The proximal end of the guide wire catheter 7 passes through the handle seat 4. The guide wire catheter 7 has a guide wire cavity 71. The micro axial flow pump 5 is connected to the impeller extracorporeal drive interface 8 arranged on the proximal end of the handle seat 4. The proximal end of the guide wire catheter 7 passes through the impeller extracorporeal drive interface 8 and forms an entrance with the proximal end of the impeller extracorporeal drive interface 8, so as to guide the blood to flow smoothly into the aorta while the balloon is expanded.

As shown in Figure 2, the micro axial flow pump 5 at least includes an elastic spring-shaped impeller shaft 51 and an impeller 6. A through cavity is provided in the catheter 3 for the impeller shaft 51 to pass through. The distal end of the impeller shaft 51 extends from the distal end of the catheter 3, and the proximal end of the impeller shaft 51 is inserted into the handle seat 4 and connected to the impeller extracorporeal drive interface 8. The impeller 6 is arranged on the distal end of the impeller shaft 51, and a through cavity is provided in the impeller shaft 51, and the guide wire catheter 7 passes through the through cavity.

The outer diameter of the guide wire catheter 7 is smaller than the through cavity diameter of the impeller shaft 5 to ensure that the rotation of the impeller shaft 51 will not drive the guide wire catheter 7 to rotate together.

In the present invention, the impeller drive interface 8 includes a rotating drive component and a non-rotatable fixed component. This is a prior art and will not be described in detail herein. It should be noted that the guide wire catheter 7 passes through the rotating drive component from the center of the impeller body drive 8 and is fixed to the proximal end of the fixed component to ensure that the guide wire catheter 7 will not rotate when the rotating drive component rotates. The proximal end of the impeller shaft 51 is connected to the rotating drive component to achieve rotation.

As shown in FIG2 , the impeller 6 is arranged at the proximal center of the bleeding channel 21, and an impeller protective cover 61 is provided outside the impeller 6 to prevent the impeller 6 from damaging the balloon during operation. The proximal end of the impeller protective cover 61 is connected and fixed to the distal end of the catheter 3, and a protective cover through hole 611 is provided at the proximal end of the impeller protective cover 61 to guide the blood to flow smoothly into the aorta.

As shown in FIG. 2 , the impeller protective cover 61 includes an outer ring 612 surrounding the periphery of the impeller 6 and a conical surface 613 arranged at the proximal end of the outer ring 612 , and the protective cover through hole 611 is arranged on the conical surface 613 so that the blood flow can be smoothly guided.

As shown in Figures 2 and 4, the tip 1 has a through cavity, the lumen of the guidewire catheter 7 is connected to the through cavity of the tip 1, the tip 1 is composed of a cone and a cylinder, the cylinder is connected and fixed to the distal end of the catheter 3, and the cone is arranged at the distal end of the cylinder.

As shown in Figures 6 to 8, the handle base 4 includes a liquid interface 41, and a channel connected to the liquid interface 41 is provided in the handle base 4; a through hole 42 penetrating the proximal end and the distal end of the handle base 4 is provided on the axis of the handle base 4, the proximal end of the catheter 3 is inserted into the through hole 42 from the distal end of the handle base 4, the proximal end of the catheter 3 is sealed and connected to the through hole 42, the liquid cavity 31 is connected to the through cavity of the liquid interface 41, the impeller extracorporeal drive interface 8 is arranged on the proximal end of the through hole 42, the impeller shaft 51 is connected to the impeller extracorporeal drive interface 8 via the through hole 42, and the proximal end of the guide wire catheter 7 passes through the impeller extracorporeal drive interface 8 and extends from the proximal end of the handle base 4.

As shown in Figure 6, the through hole 42 is composed of a plurality of holes with different diameters, including, from the distal end to the proximal end, a first through hole 421 adapted to the outer diameter of the catheter 3, a second through hole 422 adapted to the outer diameter of the impeller shaft 51, and a third through hole 423 adapted to the external dimensions of the impeller extracorporeal drive interface 8.

In the present invention, the balloon body 22 and the support rod 23 are an integral structure.

As shown in FIG. 2 , the balloon body 22 includes a cylindrical shape 221 disposed in the middle and a conical shape 222 disposed at the proximal end and the distal end of the cylindrical shape 221 , respectively.

As shown in Figure 3, the distal end of the catheter 3 is sealedly connected to the proximal end of the support rod 23 at the proximal end; specifically, the catheter 3 is composed of an outer tube 32 and an inner tube 33, the outer tube 32 is coaxial with the inner tube 33, the outer diameter of the inner tube 33 is smaller than the inner diameter of the outer tube 32, a liquid passage cavity 31 is formed between the outer tube 32 and the inner tube 33, and the impeller shaft 51 passes through the inner tube 33; of course, it is also possible to set the same number of liquid passage cavities 31 as the balloon body 22 in the tube wall of the catheter 3, the proximal end of the outer tube 32 is bonded and fixed to the distal end of the through hole 42, and the proximal ends of the outer tube 32 and the inner tube 33 are sealedly connected.

When in use, the present invention is placed at the active aortic valve position, and after the liquid is introduced, the balloon is filled, the aortic valve is expanded, and the built-in impeller is driven by an external driver to flow the blood from the left ventricle into the catheter. The blood is extracted from the mouth and pumped into the aorta. Since the heart is not in an ischemic state during the operation, the safety of the operation is improved. Through this process, the heart can rest while maintaining blood circulation, effectively reducing the heart load. It is suitable for the treatment of critical cardiovascular diseases and can also be used as a preliminary treatment for other operations. For example, patients waiting for heart transplantation can use this product to maintain normal heart activity.

Example 2

Example 2 discloses a valve balloon aspiration catheter with a shock wave generator, and its structure is basically the same as that of Example 1. The structure of Example 2 is described in detail below.

As shown in FIG9 , FIG10 , and FIG12 to FIG14 , the present invention discloses a valve expansion shock wave aspiration catheter, which includes a tip 1, a balloon 2, a catheter 3, and a handle seat 4 from the distal end to the proximal end, wherein:

The catheter 3 is provided with a liquid passage cavity 31, and the proximal end of the catheter 3 is connected and fixed to the distal end of the handle seat 4;

The balloon 2 is composed of eight balloon bodies 22, which are distributed around the catheter 3 to form a ring to form a blood flow channel 21 in the center of the balloon 2. The overall shape of the balloon 2 is olive-shaped, and the blood flow channel 21 is arranged along the axial direction of the balloon 2. The blood flow channel 21 can achieve the treatment of heart valve calcification while retaining a certain amount of cardiac output during balloon expansion, avoiding complete blockage of the blood flow channel, thereby reducing the impact of balloon dilatation on hemodynamics and reducing the incidence of blood circulation failure. Support rods 23 are respectively provided at the proximal and distal ends of the balloon body 22. The distal end of the guidewire catheter 7 extends from the distal end of the impeller shaft 5, passes through the blood flow channel 21, and is connected and fixed to the tip 1 and the distal support rod 23. The support rod 23 at the proximal end is connected to the distal end of the catheter 3. The proximal end of the support rod 23 is connected, and a support rod through cavity 231 is provided in the proximal support rod 23. In the balloon body 22, at least one pair of symmetrically arranged sac cavities of the balloon body 22 is provided with an elastic liquid-passing conduit 24. The distal end of the liquid-passing conduit 24 is a closed surface, which is fixedly connected to the distal end of the sac cavity of the balloon body 22. The proximal end of the liquid-passing conduit 24 is communicated with and sealed by the support rod through cavity 241, so that the liquid does not directly enter the balloon body 22 from the support rod through cavity 231. A through hole 241 is provided on the liquid-passing conduit 24, so that the liquid enters the balloon body 22 from the through hole 241 through the support rod through cavity 231 and the liquid-passing conduit 24, so as to fill or contract the balloon body 22; a shock wave generator 9 is provided on the liquid-passing conduit 24, and the emission direction of the shock wave generator 9 is toward the periphery of the balloon 2;

A micro axial flow pump 5 is provided in the blood flow channel 21, and the micro axial flow pump 5 is arranged on the catheter 3. A guide wire catheter 7 is provided in the micro axial flow pump 5 and passes through the inside thereof. The distal end of the guide wire catheter 7 passes through the blood flow channel 21 and is connected and fixed with the tip 1. The proximal end of the guide wire catheter 7 passes through the handle seat 4. The guide wire catheter 7 has a guide wire cavity 71. The micro axial flow pump 5 is connected to the impeller extracorporeal drive interface 8 arranged on the proximal end of the handle seat 4. The proximal end of the guide wire catheter 7 passes through the impeller extracorporeal drive interface 8 and forms an entrance with the proximal end of the impeller extracorporeal drive interface 8, so as to guide the blood to flow smoothly into the aorta while the balloon is expanded.

As shown in Figure 10, the micro axial flow pump 5 at least includes an elastic spring-shaped impeller shaft 51 and an impeller 6. A through cavity is provided in the catheter 3 for the impeller shaft 51 to pass through. The distal end of the impeller shaft 51 extends from the distal end of the catheter 3, and the proximal end of the impeller shaft 51 is inserted into the handle seat 4 and connected to the impeller extracorporeal drive interface 8. The impeller 6 is arranged on the distal end of the impeller shaft 51, and a through cavity is provided in the impeller shaft 51, and the guide wire catheter 7 passes through the through cavity.

The outer diameter of the guidewire catheter 7 is smaller than the through-cavity diameter of the impeller shaft 51 to ensure that the rotation of the impeller shaft 51 will not drive the guidewire catheter 7 to rotate together.

In the present invention, the impeller drive interface 8 includes a rotating drive component and a non-rotatable fixed component. This is a prior art and will not be described in detail herein. It should be noted that the guide wire catheter 7 passes through the rotating drive component from the center of the impeller body drive 8 and is fixed to the proximal end of the fixed component to ensure that the guide wire catheter 7 will not rotate when the rotating drive component rotates. The proximal end of the impeller shaft 51 is connected to the rotating drive component to achieve rotation.

As shown in FIG10 , the impeller 6 is arranged at the proximal center of the bleeding channel 21, and an impeller protective cover 61 is provided outside the impeller 6 to prevent the impeller 6 from damaging the balloon during operation. The impeller protective cover 61 is an olive-shaped structure with diameters at both ends smaller than the middle diameter. The proximal end of the impeller protective cover 61 is connected and fixed to the distal end of the catheter 3, and a protective cover through hole 611 is provided at the proximal end of the impeller protective cover 61 to guide blood to flow smoothly into the aorta.

As shown in FIG. 10 , the impeller protective cover 61 includes an outer wall 612 surrounding the periphery of the impeller 6 and a conical surface 613 arranged at the proximal end of the outer wall 612 , and the protective cover through hole 611 is arranged on the conical surface 613 so that the blood flow can be smoothly guided.

As shown in Figure 10, the outer wall 612 of the impeller protective cover 61 is an arc-shaped transition surface or a triangular transition surface, so that when the balloon is not expanded, this part will not scrape the blood vessel or catheter when entering because the distal edge of the impeller protective cover 61 causes the proximal support rod 23 to fold too much, thereby ensuring smooth passage.

However, the present invention is not limited thereto, and the impeller 6 may also be disposed in the middle of the balloon 2 , with the outer wall of the impeller protective cover 61 connected to the balloon body 21 , and the distal end of the impeller shaft 51 extending out of the catheter 3 .

As shown in Figures 10 and 12, the tip 1 has a through cavity, the lumen of the guidewire catheter 7 is connected to the through cavity of the tip 1, the tip 1 is composed of a cone and a cylinder, the cylinder is connected and fixed to the distal end of the catheter 3, and the cone is arranged at the distal end of the cylinder.

As shown in Figures 14 to 16, the handle base 4 includes a liquid interface 41, and a channel connected to the liquid interface 41 is provided in the handle base 4; a through hole 42 penetrating the proximal end and the distal end of the handle base 4 is provided on the axis of the handle base 4, the proximal end of the catheter 3 is inserted into the through hole 42 from the distal end of the handle base 4, the proximal end of the catheter 3 is sealed and connected to the through hole 42, the liquid cavity 31 is connected to the through cavity of the liquid interface 41, and the impeller extracorporeal drive interface 8 is provided. It is arranged on the proximal end of the through hole 42, and the impeller shaft 51 is connected to the impeller extracorporeal drive interface 8 through the through hole 42. The proximal end of the guide wire catheter 7 passes through the impeller extracorporeal drive interface 8 and extends from the proximal end of the handle seat 4. The handle seat 4 is provided with a power connector 43 electrically connected to the shock wave generator 9.

As shown in Figure 14, the through hole 42 is composed of a plurality of holes with different diameters, including, from the distal end to the proximal end, a first through hole 421 adapted to the outer diameter of the catheter 3, a second through hole 422 adapted to the outer diameter of the spring impeller shaft 5, and a third through hole 423 adapted to the external dimensions of the impeller extracorporeal drive interface 8.

In the present invention, the balloon body 22 and the support rod are an integral structure.

As shown in FIG. 10 , the balloon body 22 includes a cylindrical shape 221 disposed in the middle and a conical shape 222 disposed at the proximal end and the distal end of the cylindrical shape 221 , respectively.

As shown in Figures 9 and 18, the shock wave generator 9 includes an electrode ring 91, an insulating sleeve 92, and a metal sleeve 93. The electrode ring 91 is sleeved outside the liquid-passing catheter 24, and the insulating sleeve 92 is arranged between the electrode ring 91 and the liquid-passing catheter 24. The shock wave generator 9 is electrically connected to the power-on connector 43 through a wire 10. The wire 10 is coated with an insulating layer. The wire 10 can extend along the wall of the catheter 3 toward the proximal end of the handle seat 4 and extend to be electrically connected to the power-on connector 43. A copper-exposed area is provided on the wire 10. The metal sleeve 93 is sleeved on the wire. The electrode ring 91 is provided with at least one shock wave emitting hole 911, the shock wave emitting hole 911 faces the outer periphery of the balloon 2, the copper exposed area of the wire is opposite to the shock wave emitting hole 911, and the insulating sleeve 92 is provided with an exposed hole 921 for partially exposing the metal sleeve 93 at the position where the shock wave emitting hole 911 is located. The electrode ring 91, the insulating sleeve 92, and the metal sleeve 93 are filled with gaps with insulating glue 94 and are glued and fixed to the outside of the liquid conduit 24, thereby strengthening the outward emission of this part of the structure and the shock wave generator.

As shown in FIG. 11 , the shock wave generator 9 is disposed at the center of the balloon body 22 .

As shown in Figures 17 and 18, the electrode ring 91 of each shock wave generator 9 is composed of two symmetrically arranged ring bodies 912, a connecting portion 913 is provided between the two ring bodies 912, the connecting portion 913 connects the two ring bodies 912, and shock wave emitting holes 911 are respectively provided on the two ring bodies 912, so that each shock wave generator 9 can release shock wave energy twice, and the two shock wave emitting holes 911 are in the same position.

In the present invention, two symmetrically arranged shock wave generators 9 are connected in series, as shown in Figure 10, the wire 10 includes a positive wire 101, a negative wire 102, and a connecting wire 103, the positive wire 101 is opposite to the ring body 912 at the proximal end of one of the shock wave generators 9, the negative wire 102 is opposite to the ring body 912 at the proximal end of the other shock wave generator 9, the connecting wire 103 is used to connect the two shock wave generators 9 in series, and the proximal end of the negative wire 102 is electrically connected to the negative pole of the power connector 43.

The positive lead 101 and the negative lead 102 are connected to the support rods 23 at the proximal ends of the respective support rods. The cavity 241 penetrates into the balloon body 22, and the connecting wire 103 can be set against the outer wall of the guide wire catheter 7 and fixed by glue.

As shown in FIG. 17 and FIG. 18 , each liquid conduit 24 is provided with two through holes 241 .

As shown in Figure 11, the distal end of the catheter 3 is sealed and connected to the proximal end of the support rod 23 at the proximal end; specifically, the catheter 3 is composed of an outer tube 32 and an inner tube 33, the outer tube 32 is coaxial with the inner tube 33, the outer diameter of the inner tube 33 is smaller than the inner diameter of the outer tube 32, and a liquid passage cavity 31 is formed between the outer tube 32 and the inner tube 33, and the impeller shaft 51 passes through the inner tube 33; of course, it is also possible to set liquid passage cavities 31 in the tube wall of the catheter 3 with the same number as the balloon body 22, the proximal end of the outer tube 32 is bonded and fixed to the distal end of the through hole 42, and the proximal ends of the outer tube 32 and the inner tube 33 are sealed and connected.

When in use, the present invention is placed at the position of the active aortic valve, and after the liquid is introduced, the balloon body is filled, and after the aortic valve is expanded, the blood in the left ventricle is extracted through the catheter inlet and pumped into the aorta by driving the built-in impeller through the external driver. At this time, the shock wave energy at the working section of the balloon acts on the tricuspid valve close to the balloon wall, and the treatment is completed after the pulse is released for multiple cycles. Since the heart is not in an ischemic state during the operation, the safety of the operation is improved. Through this process, the heart can rest while maintaining the blood circulation of the heart, and the heart load is effectively reduced. It is suitable for the treatment of critical cardiovascular diseases, and can also be used as a preliminary treatment for other operations. For example, patients waiting for heart transplantation can first use this product to maintain the normal activity of the heart; and the shock wave treatment can effectively alleviate the patient's calcified tricuspid valve biomorphology, rather than using an artificial valve to replace the original biological valve.

In Example 2, balloon dilatation is combined with mechanical circulatory assistance. While the balloon widens the blood circulation path, the impeller assists in replacing part of the heart valve function, and the oxygenated blood in the left ventricle is drawn out through the catheter inlet and then directly pumped into the ascending aorta, thereby establishing a drainage pathway from the left ventricle to the ascending aorta and achieving blood circulation in the heart. Since the heart will not be in an ischemic state, the safety of the operation is improved. This process allows the heart to be in a resting state, which is convenient for subsequent recovery and treatment. At the same time, the shock wave energy shatters the calcification of the tricuspid valve, thereby achieving the restoration of the tricuspid valve's biological morphology and solving the problem of valve leakage pressure without the need to use an artificial valve to replace the patient's original biological valve.

Claims (11)

A valve balloon aspiration catheter comprises, from the distal end to the proximal end, a tip (1), a balloon (2), a catheter (3), and a handle seat (4), characterized in that: a liquid passage cavity (31) is provided on the catheter (3); The balloon (2) is composed of at least four balloon bodies (22), which are distributed around the catheter (3) to form a ring, so as to form a blood flow channel (21) in the center of the balloon (2), and the blood flow channel (21) is arranged along the axial direction of the balloon (2), the proximal end of the balloon body (22) is connected to the distal end of the catheter (3), the distal end of the balloon body (22) is connected to the proximal end of the tip (1), and the balloon body (22) is connected to the liquid passage cavity (31); A micro axial flow pump (5) is provided in the blood flow channel (21), the micro axial flow pump (5) is arranged on the catheter (3), a guide wire catheter (7) is provided in the micro axial flow pump (5) and passes through the inside thereof, the distal end of the guide wire catheter (7) passes through the blood flow channel (21) and is connected and fixed to the tip (1), the proximal end of the guide wire catheter (7) passes through the handle seat (4), the guide wire catheter (7) has a guide wire cavity (71), and the micro axial flow pump (5) is connected to an impeller extracorporeal drive interface (8) arranged on the proximal end of the handle seat (4). The valve balloon aspiration catheter according to claim 1 is characterized in that: the proximal and distal ends of the balloon body (22) are respectively provided with support rods (23), the two ends of the support rod (23) located at the distal end are respectively connected to the distal end of the balloon body (22) and the proximal end of the tip (1), the two ends of the support rod (23) located at the proximal end are respectively connected to the proximal end of the balloon body (22) and the distal end of the catheter (3), the support rod (23) located at the proximal end is provided with a support rod through cavity (231) connecting the balloon body (22) and the through cavity (31), at least two symmetrically arranged balloon bodies (22) are provided with a liquid passage catheter (24) connected to the support rod through cavity (231), a shock wave generator (9) is provided on the liquid passage catheter (24), and the emission direction of the shock wave generator (9) is toward the periphery of the balloon (2). The valve balloon aspiration catheter according to claim 1 or 2 is characterized in that: the micro axial flow pump (5) includes an impeller shaft (51) and an impeller (6), a through cavity is provided in the catheter (3) for the impeller shaft (51) to pass through, the distal end of the impeller shaft (51) extends from the distal end of the catheter (3), the proximal end of the impeller shaft (51) is inserted into the handle seat (4) and connected to the impeller extracorporeal drive interface (8), the impeller (6) is arranged on the distal end of the impeller shaft (51), a through cavity is provided in the impeller shaft (51), and the guide wire catheter (7) passes through the through cavity. The valve balloon aspiration catheter according to claim 3 is characterized in that: an impeller protective cover (61) is provided outside the impeller (6), the proximal end of the impeller protective cover (61) is connected and fixed to the distal end of the catheter (3), and a protective cover through hole (611) is provided on the impeller protective cover (61). The valve balloon aspiration catheter according to claim 4 is characterized in that the impeller protection cover through hole (611) is arranged at the proximal end of the impeller protection cover (61). The valve balloon aspiration catheter according to claim 5 is characterized in that: the impeller protector The cover (61) comprises an outer ring (612) surrounding the periphery of the impeller (6) and a conical surface (613) arranged at the proximal end of the outer ring (612), and the protective cover through hole (611) is arranged on the conical surface (613). The valve balloon aspiration catheter according to claim 6 is characterized in that the outer wall (612) of the impeller protection cover (61) is an arc-shaped transition surface or a triangular transition surface. The valve balloon aspiration catheter according to claim 1 or 2 is characterized in that: the handle seat (4) includes a liquid interface (41), and a channel connected to the liquid interface (41) is provided in the handle seat (4); a through hole (42) penetrating the proximal end and the distal end of the handle seat (4) is provided on the axis of the handle seat (4), the proximal end of the catheter (3) is inserted into the through hole (42) from the distal end of the handle seat (4), the proximal end of the catheter (3) is sealed and connected to the through hole (42), the liquid cavity (31) is connected to the through cavity of the liquid interface (41), the impeller extracorporeal drive interface (8) is arranged on the proximal end of the through hole (42), the impeller shaft (5) is connected to the impeller extracorporeal drive interface (8) through the through hole (42), the proximal end of the guide wire catheter (7) passes through the impeller extracorporeal drive interface (8) and extends from the proximal end of the handle seat (4), and an electrical connector (43) electrically connected to the shock wave generator (9) is provided on the handle seat (4). The valve balloon aspiration catheter according to claim 8 is characterized in that: the catheter (3) is composed of an outer tube (32) and an inner tube (33), the outer tube (32) and the inner tube (33) are coaxial, the outer diameter of the inner tube (33) is smaller than the inner diameter of the outer tube (32), the liquid cavity (31) is formed between the outer tube (32) and the inner tube (33), and the impeller shaft (51) passes through the inner tube (33). The valve balloon aspiration catheter according to claim 2 is characterized in that the shock wave generator (9) is arranged at the center of the balloon body (22). The valve balloon aspiration catheter according to claim 10 is characterized in that the two symmetrically arranged shock wave generators (9) are connected in series.