Balloon catheter

By setting up a valve structure in the balloon catheter and switching the valve state with the fluid flow, the problem that the current left ventricular auxiliary device does not meet the physiological state is solved, and physiological fluid flow of cardiac systolic aspiration and diastolic discharge is achieved to protect organ health.

CN115177859BActive Publication Date: 2025-08-29BEIJING YELLWIN MEDICAL TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202210901595.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-07-28
Publication Date
2025-08-29
Estimated Expiration
2042-07-28

AI Technical Summary

Technical Problem

The existing left ventricular assist devices will continuously draw out the blood from the left ventricle during the systolic and diastolic periods, resulting in advection flow with fluid dynamic characteristics that do not conform to the physiological state, causing organ damage.

Method used

Design a balloon catheter with a built-in valve structure, which can switch state under the action of fluid flow. The valve opens and blocks the fluid discharge hole during the systolic period, and the valve gathers and blocks the catheter during the diastole to achieve pulsating fluid flow, which conforms to the physiological state.

Benefits of technology

The left ventricle blood is aspirated during the systolic period, and the ascending aorta is discharged into the ascending aorta during the diastolic period to avoid blood flow, achieve advection with the dynamic characteristics of fluid flow in line with physiological states, and protect the organ from harm.

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Abstract

The present invention relates to the field of medical device technology, and provides a balloon catheter comprising: a first end of the catheter having a suction hole, a second end of the catheter being connected to a fluid storage device, and a tube wall between the first and second ends of the catheter having a drainage hole; a first end of a valve being connected to the inner wall of the catheter, the valve being located in the tube section between the drainage hole and the suction hole and being disposed proximal to the drainage hole; when the valve is in a first state, the second end of the valve is in an open state, the second end of the valve blocks the drainage hole, and the suction hole is in communication with the second end of the catheter; when the valve is in a second state, the second end of the valve is in a gathered state, the valve transversely blocks the catheter, and the second end of the catheter is in communication with the drainage hole. The balloon catheter provided by the present invention can block the drainage hole during cardiac systole, thereby drawing blood from the left ventricle into the fluid storage device; and during cardiac diastole, the valve transversely blocks the catheter, preventing blood from the fluid storage device from entering the left ventricle, thereby achieving pulsatile fluid flow.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a balloon catheter. Background Art

[0002] With economic development and changes in people's lifestyles, especially the aging of the population and the acceleration of urbanization, unhealthy lifestyles are becoming increasingly prominent, and the impact of cardiovascular disease risk factors on residents' health is becoming more significant. The incidence of cardiovascular disease continues to rise. Cardiogenic shock is the main cause of various heart diseases such as acute myocardial infarction and acute myocarditis, and is also the most common cause of death in these patients. Interventional left ventricular assist devices are devices that directly drain blood from the left ventricle to the body to reduce cardiac load, replace ventricular work, increase peripheral blood supply, and partially or completely replace left ventricular ejection function. They are of great significance in the treatment of cardiogenic shock.

[0003] The current left ventricular assist device has the following main problems: it continuously pumps blood out of the left ventricle and discharges it into the periphery during both systole and diastole. Its fluid flow dynamics do not conform to the physiological horizontal flow, and will cause chronic damage to the organ during use. Summary of the Invention

[0004] The present invention provides a balloon catheter to solve the defect in the prior art that the catheter continuously draws blood out of the left ventricle during both the systolic and diastolic phases of the heart, resulting in a horizontal flow whose fluid dynamics characteristics do not conform to the physiological state.

[0005] The present invention provides a balloon catheter, comprising: a catheter, wherein the first end of the catheter is provided with a suction hole, the second end of the catheter is used to be connected to a liquid storage device, and the tube wall between the first end and the second end of the catheter is provided with a drainage hole; a valve, the first end of the valve is connected to the inner wall of the catheter, the valve is located in the tube section between the drainage hole and the suction hole, and is arranged close to the drainage hole; under the action of liquid flow, the valve can switch between a first state and a second state, when the valve is in the first state, the second end of the valve is in an open state, the second end of the valve blocks the drainage hole, and the suction hole is communicated with the second end of the catheter; when the valve is in the second state, the second end of the valve is in a gathered state, the valve transversely blocks the catheter, and the second end of the catheter is communicated with the drainage hole.

[0006] According to a balloon catheter provided by the present invention, the valve includes: multiple leaflets, the multiple leaflets are evenly distributed along the circumferential direction of the catheter, each leaflet is an arc-shaped leaflet, the first end of each leaflet is connected to the inner wall of the catheter, and under the action of liquid flow, the second ends of the leaflets can move away from or gather together.

[0007] According to a balloon catheter provided by the present invention, when the valve is in the first state, the second ends of the plurality of leaflets are away from each other, the second ends of the leaflets are in contact with the drainage hole, and through holes are formed between the plurality of leaflets.

[0008] According to a balloon catheter provided by the present invention, when the valve is in the second state, the second ends of the plurality of leaflets gather together, and the plurality of leaflets form a closed surface.

[0009] According to a balloon catheter provided by the present invention, each leaflet includes: a first skeleton and a first membrane body, the first skeleton is a hollow frame structure, one end of the first skeleton is connected to the inner wall of the catheter, and the other end of the first skeleton extends obliquely toward the second end and the center of the catheter, the first membrane body covers the side of the first skeleton close to the inner wall of the catheter, and the first membrane body is a flexible membrane body; when the valve is in the first state, the first membrane body is in contact with the drainage hole; when the valve is in the second state, the first membrane body gathers to form the closed surface.

[0010] According to the balloon catheter provided by the present invention, the number of the leaflets matches the number of the drainage holes.

[0011] According to a balloon catheter provided by the present invention, the catheter includes an expansion tube segment, and the catheter has a third state and a fourth state. When the catheter is in the third state, the diameter of the expansion tube segment is equal to the diameter of the other tube segments of the catheter; when the catheter is in the fourth state, the diameter of the expansion tube segment is larger than the diameter of the other tube segments of the catheter; wherein the drainage hole is arranged on the tube wall of the expansion tube segment, and the valve is arranged in the expansion tube segment.

[0012] According to a balloon catheter provided by the present invention, the expansion tube section includes: a second skeleton and a second membrane body, the second membrane body is covered on the outside of the second skeleton, and the second skeleton is elastic; when the catheter is in the third state, the second skeleton is in a contracted state, and when the catheter is in the fourth state, the second skeleton is in an expanded state.

[0013] According to a balloon catheter provided by the present invention, the drainage hole is provided in the middle of the expansion tube section. When the catheter is in the fourth state, the diameter of the expansion tube section gradually decreases from the middle to both ends.

[0014] According to a balloon catheter provided by the present invention, the first end of the catheter is in the form of a frustum, and there are a plurality of suction holes, which are evenly distributed along the circumference of the frustum.

[0015] The balloon catheter provided by the present invention, by arranging a valve inside the catheter, can utilize the impact of the liquid flow on the valve to make the valve be in an open state or a gathered state, so that during the heart's contraction period, the valve opens and blocks the drainage hole, and the blood in the left ventricle can be sucked into the liquid storage device, while the blood in the ascending aorta will not be sucked into the liquid storage device; during the heart's diastole period, the valve gathers to form a closed surface to laterally block the catheter, and the suction hole will not suck blood into the liquid storage device, and the blood in the liquid storage device will not enter the left ventricle, thereby realizing pulsating liquid flow, and the liquid flow dynamics characteristics are consistent with the horizontal liquid flow in the physiological state, avoiding damage to the organs. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction is given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 This is one of the structural diagrams of the balloon catheter provided by the present invention;

[0018] Figure 2 yes Figure 1 Schematic diagram of the skeleton structure of the expansion pipe section shown in;

[0019] Figure 3 yes Figure 1 Schematic diagram of the structure of the valve shown in FIG;

[0020] Figure 4 yes Figure 2 Schematic diagram of the valve skeleton structure shown in FIG;

[0021] Figure 5 yes Figure 1 A top view of the valve is shown in FIG;

[0022] Reference numerals:

[0023] 10: catheter; 11: first tube section; 12: expansion tube section; 13: second tube section; 14: drainage hole; 15: suction hole; 20: valve; 21: slit; 22: leaflet; 101: second skeleton; 201: first skeleton. DETAILED DESCRIPTION

[0024] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0025] The features of the terms "first" and "second" in the description and claims of the present invention may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, the meaning of "plurality" is two or more.

[0026] The following combination Figure 1-Figure 5 The balloon catheter of the present invention is described.

[0027] like Figure 1 and Figure 2 As shown, in an embodiment of the present invention, a balloon catheter comprises a catheter 10 and a valve 20. A suction hole 15 is provided at the first end of the catheter 10, and the second end of the catheter 10 is connected to a fluid storage device. A drainage hole 14 is provided in the wall of the catheter 10 between the first and second ends. The first end of the valve 20 is connected to the inner wall of the catheter 10. The valve 20 is located in the section between the drainage hole 14 and the suction hole 15, and is positioned near the drainage hole 14. Under the influence of fluid flow, the valve 20 can switch between a first state and a second state. In the first state, the second end of the valve 20 is in an open state, blocking the drainage hole 14, and the suction hole 15 is in communication with the second end of the catheter 10. In the second state, the second end of the valve 20 is in a closed state, transversely blocking the catheter 10, and the second end of the catheter 10 is in communication with the drainage hole 15.

[0028] Specifically, the balloon catheter is the core component of the interventional left ventricular assist device, and its main functions are: during the cardiac systole, it draws blood from the left ventricle while preventing blood from the ascending aorta from being accidentally drawn into the catheter 10; during the cardiac diastole, it discharges blood into the ascending aorta while preventing blood in the catheter 10 from being accidentally discharged into the left ventricle.

[0029] Specifically, after catheter 10 is implanted in the left ventricle, suction port 15 is located in the left ventricle, and drainage port 14 is located in the ascending aorta. Suction port 15 is used to draw blood from the left ventricle into catheter 10 during systole, ultimately into the fluid reservoir. Drainage port 14 is used to drain blood from the fluid reservoir into the ascending aorta during diastole.

[0030] Specifically, when the valve 20 is in the first state, i.e., during cardiac systole, blood flows from the suction hole 15 to the fluid reservoir. Blood enters the catheter 10 through the suction hole 15. Under the impact of the blood flow, the second end of the valve 20 opens to block the drainage holes 14, thereby preventing blood from flowing into the ascending aorta. At this time, a through hole is formed in the middle of the valve 20, through which blood flows into the fluid reservoir. When the valve 20 is in the second state, i.e., during cardiac diastole, blood enters the catheter 10 from the fluid reservoir. Blood impacts the valve 20 from the opposite direction. The second ends of the valve 20 converge to form a closed surface, laterally blocking the catheter 10 and preventing blood from flowing toward the suction hole 15. Blood is discharged from the drainage holes 14 to the ascending aorta, thereby preventing blood from entering the left ventricle.

[0031] The balloon catheter provided by an embodiment of the present invention, by arranging a valve inside the catheter, can utilize the impact of the liquid flow on the valve to make the valve be in an open state or a gathered state, so that during the heart's contraction period, the valve opens and blocks the drainage hole, and the blood in the left ventricle can be sucked into the liquid storage device, while the blood in the ascending aorta will not be sucked into the liquid storage device; during the heart's diastole period, the valve gathers to form a closed surface to laterally block the catheter, and the suction hole will not suck blood into the liquid storage device, and the blood in the liquid storage device will not enter the left ventricle, thereby realizing pulsating liquid flow, and the liquid flow dynamics characteristics are consistent with the horizontal liquid flow in the physiological state, avoiding damage to the organs.

[0032] like Figure 3 and Figure 4 As shown, in one embodiment of the present invention, the valve 20 includes a plurality of leaflets 22, and the plurality of leaflets 22 are evenly distributed along the circumferential direction of the catheter 10. Each leaflet 22 is an arc-shaped leaflet. The first end of each leaflet 22 is connected to the inner wall of the catheter 10. Under the action of liquid flow, the second ends of the leaflets 22 can move away from or gather together.

[0033] Specifically, if Figure 5As shown, each leaflet 22 is an arc-shaped leaflet, and multiple leaflets 22 are arranged along the circumference of the catheter 10. The first end of each leaflet 22 is a fixed end, and the second end is a free end. When not impacted by the liquid flow, the second end of each leaflet 22 is inclined toward the second end of the catheter 10 and the center of the catheter 10, and there is a gap 21 between the second ends of the multiple leaflets 22. When the liquid flows along the first end to the second end of the catheter 10, the blood impacts the leaflets 22, causing the second ends of the leaflets 22 to move toward the wall of the catheter 10, thereby putting each leaflet 22 in an open state. Each leaflet 22 blocks a drainage hole 14, and a through hole is formed between the multiple leaflets 22. Blood flows through the through hole from the suction hole 15 into the liquid storage device. When the liquid flows along the second end to the first end of the catheter 10, the leaflets 22 gather together under the impact of the liquid flow to form a closed surface to laterally block the catheter 10, so that blood cannot enter the suction hole 15 and can only be discharged into the ascending aorta through the drainage hole 14.

[0034] Specifically, when the valve 20 is in the first state, i.e., during systole, blood flows against the leaflets 22, causing them to expand toward the wall of the catheter 10. The leaflets 22 block the drainage holes 14, forming through-holes between the leaflets 22, allowing blood to flow through the valve 20 and into the fluid reservoir. When the valve is in the second state, i.e., during diastole, the fluid reservoir discharges blood into the catheter 10. The blood flows against the second ends of the leaflets 22, causing them to converge toward each other. Under the pressure of the blood, the leaflets 22 converge to form a closed surface, transversely blocking the catheter 10, and blood is discharged through the drainage holes 14 into the ascending aorta.

[0035] Furthermore, in this embodiment, the number of leaflets 22 matches the number of drainage holes 14. In this embodiment, there are three drainage holes 14, which are evenly distributed along the circumference of the catheter 10. The number of leaflets 22 is also three, and the area of ​​each leaflet 22 is larger than the area of ​​the drainage hole 14, so that when the leaflets 22 are in the open state, they can block the drainage hole 14.

[0036] Furthermore, if Figure 4 As shown, each leaflet 22 comprises a first frame 201 and a first membrane. The first frame 201 is a hollow frame structure, with one end connected to the inner wall of the catheter 10 and the other end extending obliquely toward the second end and center of the catheter 10. The first membrane covers the side of the first frame 201 close to the inner wall of the catheter 10. The first membrane is flexible. When the valve 20 is in the first state, the first membrane is in contact with the drainage hole 14. When the valve 20 is in the second state, the first membrane gathers to form the closed surface.

[0037] Specifically, the first skeleton 201 is used to support the first membrane body. The first membrane body is a flexible membrane body that can fit with the drainage hole 14 under the impact of blood, or gather together to form a closed surface.

[0038] like Figure 1 As shown, in one embodiment of the present invention, a catheter 10 includes an expansion segment 12. The catheter 10 has a third state and a fourth state. When the catheter 10 is in the third state, the diameter of the expansion segment 12 is equal to the diameters of the other segments of the catheter 10; when the catheter 10 is in the fourth state, the diameter of the expansion segment 12 is greater than the diameters of the other segments of the catheter 10. A drainage hole 14 is provided in the wall of the expansion segment 10, and a valve 20 is provided within the expansion segment 12.

[0039] Specifically, when the catheter 10 is not implanted in the left ventricle, the catheter 10 is in a third state, in which the expansion segment 12 is not inflated and the diameter of the expansion segment 12 is equal to the diameter of the other segments of the catheter 10, facilitating implantation of the catheter 10 in the left ventricle. After the catheter 10 is implanted in the left ventricle, the catheter 10 is in a fourth state, in which the expansion segment 12 is inflated and the diameter of the expansion segment 12 is larger than the diameter of the other segments of the catheter 10, thereby increasing the amount of blood pumped during systole to meet clinical needs.

[0040] like Figure 2 As shown, in an embodiment of the present invention, the expansion pipe section 12 includes a second skeleton 101 and a second membrane body, the second membrane body is covered on the outside of the second skeleton 101, and the second skeleton 101 is elastic; when the catheter 10 is in the third state, the second skeleton 101 is in a contracted state, and when the catheter 10 is in the fourth state, the second skeleton 101 is in an expanded state.

[0041] Specifically, in this embodiment, a conveying device is used to implant the catheter 10 into the left ventricle. When the catheter 10 is not implanted into the left ventricle, the conveying device applies an external force to the second skeleton 101, and the second skeleton 101 is in a contracted state to reduce the diameter of the catheter 10, thereby facilitating the implantation of the catheter 10 into the left ventricle. After the catheter 10 is implanted into the left ventricle, the force exerted by the conveying device on the second skeleton 101 disappears, and the second skeleton 101 is reset under the action of its own elastic force and is in an expanded state, thereby causing the expansion tube section 12 to expand.

[0042] Furthermore, the catheter 10 includes a first pipe section 11 and a second pipe section 13. The first pipe section 11 and the second pipe section 13 are respectively disposed at both ends of the expansion pipe section 12. One end of the first pipe section 11 is connected to the liquid storage device, and the end of the second pipe section 13 not connected to the expansion pipe section 12 is provided with a plurality of suction holes 15.

[0043] Furthermore, a plurality of drainage holes 14 are provided in the middle of the expansion pipe section 12. When the catheter 10 is in the fourth state, ie, after the expansion pipe section 12 is expanded, the diameter of the expansion pipe section 12 gradually decreases from the middle to both ends.

[0044] Further, if Figure 1 and Figure 2 As shown, in an embodiment of the present invention, the end of the second tube section 13 where the suction holes 15 are located is truncated cone-shaped, with the plurality of suction holes 15 evenly distributed along the circumference of the cone-shaped body. Specifically, the truncated cone-shaped end of the second tube section 13 where the suction holes 15 are located can reduce resistance when the suction holes 15 are used to draw blood.

[0045] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A balloon catheter, characterized in that: include: A catheter, wherein a first end of the catheter is provided with a suction hole, a second end of the catheter is used to connect to a liquid storage device, and a tube wall between the first end and the second end of the catheter is provided with a liquid drainage hole; A valve, wherein the first end of the valve is connected to the inner wall of the catheter, the valve is located in the tube section between the drainage hole and the suction hole, and is arranged near the drainage hole, the valve comprising: a plurality of leaflets, the plurality of leaflets are evenly distributed along the circumference of the catheter, each of the leaflets is an arc-shaped leaflet, the first end of each leaflet is connected to the inner wall of the catheter, and when not impacted by the liquid flow, the second end of each leaflet is inclined toward the second end of the catheter and the center of the catheter, and there are gaps between the second ends of the plurality of leaflets. Under the action of the liquid flow, the second ends of the leaflets can move away from or gather together; Under the action of liquid flow, the valve can switch between a first state and a second state. When the valve is in the first state, the second ends of the plurality of leaflets are away from each other, the second ends of the leaflets are in contact with the drainage hole, a through hole is formed between the plurality of leaflets, and the suction hole is in communication with the second end of the catheter. When the valve is in the second state, the second ends of the plurality of leaflets gather together to form a sealing surface, the sealing surface laterally blocks the catheter, and the second end of the catheter is in communication with the drainage hole; Each of the leaflets comprises: a first frame and a first membrane, wherein the first frame is a hollow frame structure, one end of the first frame is connected to the inner wall of the catheter, and the other end of the first frame extends obliquely toward the second end and the center of the catheter, and the first membrane covers a side of the first frame close to the inner wall of the catheter, and the first membrane is a flexible membrane; The catheter includes an expansion tube section, and the catheter has a third state and a fourth state. When the catheter is in the third state, the diameter of the expansion tube section is equal to the diameter of the other tube sections of the catheter; when the catheter is in the fourth state, the diameter of the expansion tube section is larger than the diameter of the other tube sections of the catheter; wherein the drainage hole is arranged on the tube wall of the expansion tube section, and the valve is arranged in the expansion tube section.

2. The balloon catheter according to claim 1, characterized in that When the valve is in the first state, the first membrane body is in contact with the drainage hole; when the valve is in the second state, the first membrane body is gathered to form the closed surface.

3. The balloon catheter according to claim 1, characterized in that The number of the leaflets matches the number of the drainage holes.

4. The balloon catheter according to claim 1, characterized in that The expansion pipe section comprises: A second skeleton and a second membrane, wherein the second membrane is coated on the outside of the second skeleton, and the second skeleton is elastic; When the catheter is in the third state, the second skeleton is in a contracted state, and when the catheter is in the fourth state, the second skeleton is in an expanded state. The balloon catheter according to claim 1 , wherein: The drainage hole is provided in the middle of the expansion pipe section. When the conduit is in the fourth state, the diameter of the expansion pipe section gradually decreases from the middle to both ends. The balloon catheter according to claim 1 , wherein: The first end of the conduit is in the form of a truncated cone, and the number of the suction holes is multiple, and the multiple suction holes are evenly distributed along the circumference of the truncated cone.

Citation Information

Patent Citations

  • Heart valve

    CN208725961U

  • Balloon catheter

    CN219185601U

  • Heart valve prosthesis

    EP0275535A1

  • Valved self-perfusing catheter guide

    US5180364A