Balloon catheter, heart failure assisting device and heart failure assisting system

Abstract

The invention provides a balloon catheter, a heart failure assisting device and a heart failure assisting system. The balloon catheter comprises a catheter body; the balloon is arranged on the catheter body; at least one unidirectional membrane disposed on at least one side of the balloon; and the at least one supporting structure is arranged on the catheter body and is used for supporting the at least one unidirectional membrane. According to the balloon catheter, the heart failure assisting device and the heart failure assisting system, the heart failure assisting effect can be further improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a balloon catheter, a heart failure assist device and a heart failure assist system. Background Art

[0002] In a normal healthy person, the myocardial oxygen demand and coronary artery oxygen supply maintain a dynamic balance. When the myocardial oxygen demand increases, the oxygen supply can be increased by increasing the blood flow in the coronary arteries.

[0003] When heart failure develops, cardiac output decreases and may result in a decrease in myocardial oxygen supply. In an attempt to compensate, preload, afterload, and heart rate may increase. These may result in an increase in myocardial oxygen demand. As the failure process progresses, this cycle may develop, leading to a further imbalance between myocardial oxygen demand and supply and may lead to failure of the heart's pump function. Myocardial oxygen supply may continue to decrease while myocardial oxygen demand may continue to increase.

[0004] Intra-aortic balloon pump (IABP) is a mechanical circulatory assist technique that is currently widely used in clinical practice to assist the failing heart to pump blood. Existing intra-aortic balloon pump devices include a balloon catheter and a pump. For this purpose, a balloon catheter can be placed in the patient's descending aorta. After the onset of diastole (when the aortic valve is closed), the balloon pump drives the balloon in the aorta to inflate, thereby increasing the pressure in the aorta, increasing coronary perfusion and peripheral vascular flow; before the onset of systole, the balloon is quickly emptied to form a local "vacuum" effect, assisting ventricular ejection, reducing the patient's heart afterload, reducing cardiac work, and reducing myocardial oxygen consumption. The balloon is periodically expanded and contracted according to the cardiac cycle, thereby achieving the purpose of reducing systolic pressure, improving left ventricular ejection, increasing myocardial oxygen supply, reducing myocardial oxygen demand, and improving cardiac function.

[0005] Given that the intra-aortic balloon counterpulsation device plays an important role in clinical practice, the industry hopes to further improve its heart failure assistance effect.

[0006] The content of this background technology description is only for facilitating understanding of the relevant technology in this field and is not regarded as an admission of the prior art. Summary of the invention

[0007] The embodiments of the present disclosure aim to provide a balloon catheter, a heart failure assist device and a heart failure assist system that can improve the heart failure assist effect.

[0008] In a first aspect, an embodiment of the present disclosure provides a balloon catheter, which may include: a catheter body; a balloon disposed on the catheter body; at least one unidirectional membrane disposed on at least one side of the balloon; and at least one support structure disposed on the catheter body for supporting the at least one unidirectional membrane.

[0009] In a second aspect, an embodiment of the present disclosure provides a heart failure assist device, which includes a balloon catheter according to the first aspect.

[0010] In a third aspect, an embodiment of the present disclosure provides a heart failure assistance system, which includes a heart failure assistance device according to the first aspect.

[0011] Other optional features and technical effects of the embodiments of the present disclosure are partially described below, and partially can be understood by reading this document. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. The elements shown are not limited by the proportions shown in the accompanying drawings. The same or similar reference numerals in the accompanying drawings represent the same or similar elements, wherein:

[0013] Figure 1 is an overall schematic diagram of a balloon catheter according to an embodiment of the present disclosure;

[0014] Figure 2 for Figure 1 A schematic diagram of a support structure and a one-way membrane of a balloon catheter of the illustrated embodiment;

[0015] Figure 3 For along Figure 2 The cross-sectional view taken along line AA in Figure 1 The one-way membrane of the balloon catheter of the illustrated embodiment, wherein a represents a closed state and b represents an open state;

[0016] Figure 4 Shows that during heart contraction Figure 1 The state of the balloon catheter in the body and the direction of blood flow of the illustrated embodiment, wherein the balloon catheter is configured to be inserted via femoral artery puncture;

[0017] Figure 5 Shows that during diastole Figure 1 The state of the balloon catheter in the body and the direction of blood flow of the illustrated embodiment, wherein the balloon catheter is configured to be inserted via femoral artery puncture;

[0018] Figure 6 An overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure is shown;

[0019] Figure 7 Shows that during heart contraction Figure 6 The state of the balloon catheter in the illustrated embodiment and the direction of blood flow in the body, wherein the balloon catheter is configured to be placed in place via the right subclavian artery;

[0020] Figure 8 Shows that during diastole Figure 6The state of the balloon catheter in the illustrated embodiment and the direction of blood flow in the body, wherein the balloon catheter is configured to be placed in place via the right subclavian artery;

[0021] Figure 9.1-9.2 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0022] Figure 10.1-10.2 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0023] Figure 11.1-11.2 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0024] Figure 12.1-12.2 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0025] Fig.13 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0026] Fig.14 Shows that during heart contraction Fig.13 The state of the balloon catheter in the body and the direction of blood flow of the illustrated embodiment, wherein the balloon catheter is configured to be inserted via femoral artery puncture;

[0027] Fig.15 Shows that during diastole Fig.13 The state of the balloon catheter in the body and the direction of blood flow of the illustrated embodiment, wherein the balloon catheter is configured to be placed in place via the femoral artery;

[0028] Fig.16 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0029] Fig.17 Shows that during heart contraction Fig.16 The state of the balloon catheter in the illustrated embodiment and the direction of blood flow in the body, wherein the balloon catheter is configured to be placed in place via the right subclavian artery;

[0030] Fig.18 Shows that during diastole Fig.16 The state of the balloon catheter in the illustrated embodiment and the direction of blood flow in the body, wherein the balloon catheter is configured to be placed in place via the right subclavian artery;

[0031] Fig.19 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0032] Fig. 20 is an overall schematic diagram of a balloon catheter according to another embodiment of the present disclosure;

[0033] Fig.21 is an overall schematic diagram of a balloon catheter delivery device according to an embodiment of the present disclosure;

[0034] Fig. 22 A schematic diagram of assembling a balloon catheter delivery device and a balloon catheter according to an embodiment of the present disclosure;

[0035] Figure 23-Figure 24 The state of the balloon catheter in the body and the blood flow direction according to an embodiment of the present disclosure, wherein the balloon catheter is configured to be placed in place via the femoral artery;

[0036] Figure 25-26 The figure shows the state of the balloon catheter in the body and the blood flow direction according to an embodiment of the present disclosure, wherein the balloon catheter is configured to be placed into position via the right subclavian artery. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific implementation methods and drawings. Here, the exemplary implementation methods of the present invention and their descriptions are used to explain the present invention, but are not intended to limit the present invention.

[0038] In this specification, for the convenience of description, words such as "first", "second", etc. may be used to refer to similar or related elements or features, but the use of these words does not imply any specific order, hierarchical relationship, quantitative limitation or importance.

[0039] In addition, unless explicitly stated otherwise, words such as "include", "comprising", "have", "containing", etc. should be understood as open-ended, that is, meaning "including but not limited to".

[0040] The "or" used in this specification should be understood as an inclusive "or" (i.e., "and / or"), unless explicitly stated as an exclusive "or". When "and / or" is used, it means any one or a combination of multiple items listed.

[0041] In addition, the terms "may", "might", "can", etc. used in this specification indicate that the described features, elements, steps, operations, etc. are optional and not required. Unless the context clearly indicates otherwise, the singular form is also intended to include the plural form, and vice versa.

[0042] In this specification, the terms "connection", "fixation" and the like should be understood in a broad sense. For example, "connection" can be a mechanical connection, an electrical connection, or the internal connection between two components; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0043] In this specification, unless the context clearly indicates otherwise, when referring to "proximal" or "proximal end", it means the end closer to the operator or the side facing the operator when in use; when referring to "distal" or "distal end", it means the end away from the operator or the side facing away from the operator when in use.

[0044] As mentioned above, intra-aortic balloon counterpulsation (IABP) plays an important role in the auxiliary treatment of heart failure, and the industry still hopes to further improve its auxiliary effect on heart failure. The inventor found through research that in intra-aortic balloon counterpulsation (IABP), the pumping action of the aortic balloon will cause blood to flow in both directions on both sides of the balloon. This bidirectional flow effect will partially offset the expected directional blood flow effect of the balloon pumping, which may affect the treatment effect on patients with heart failure.

[0045] Furthermore, as mentioned above, the balloon is quickly emptied before the onset of the cardiac systole, forming a local "vacuum" effect, assisting ventricular ejection, reducing the patient's cardiac afterload, reducing cardiac work, and reducing myocardial oxygen consumption. After in-depth research, the inventors found that when the balloon is contracted / emptied to form a local "vacuum" effect, the negative pressure generated will simultaneously cause blood reflux on the distal and proximal sides of the balloon. This two-way reflux makes it impossible to only aspirate blood on the aortic valve side, reduces the suction effect on cardiac ejection, and makes the increase in cardiac output, which should have been significantly increased, not much, weakening the auxiliary function of the balloon counterpulsation.

[0046] In this regard, the embodiments of the present disclosure propose a balloon catheter, a heart failure assist device, and a heart failure assist system, which use a fluid control element that cooperates with the balloon to control the unidirectional flow of fluid, thereby at least partially alleviating or solving the above-mentioned problems. When the volume of the balloon changes to produce the desired hemodynamic effect, the conventional design concept tends to maintain the patency of the blood flow channel and avoid setting any additional structure in the blood flow path. However, after in-depth research, the inventors found that by providing a unidirectional membrane structure on at least one side of the balloon, and enabling the unidirectional membrane to respond to the volume change of the balloon, the direction of blood flow can be effectively controlled. This structure not only does not reduce the basic effect of the balloon counterpulsation, but can enhance the overall function of the balloon counterpulsation by directional guidance of the blood flow.

[0047] It should be understood that the above explanation of the principles of the related art is only for facilitating the understanding of the technical solution of the present invention, and the protection scope of the present invention should not be limited by the above technical principles.

[0048] Accordingly, in an embodiment of the present disclosure, a balloon catheter is provided, comprising: a catheter body; a balloon disposed on the catheter body; at least one unidirectional membrane disposed on at least one side of the balloon; and at least one support structure disposed on the catheter body for supporting the at least one unidirectional membrane.

[0049] The following describes in detail multiple embodiments of the present disclosure in conjunction with the accompanying drawings. These embodiments can be implemented individually or combined arbitrarily according to actual needs to obtain new embodiments. It should be understood that each embodiment does not have to solve all the above-mentioned technical problems, and the technical problems that can be solved or the technical effects obtained are not limited to those mentioned above.

[0050] See also Figures 1 to 5 , showing a balloon catheter according to an embodiment of the present disclosure. Figure 1 FIG. 1 shows an overall schematic diagram of the balloon catheter 10 of this embodiment. Figure 1 In the illustrated embodiment, the balloon catheter 10 may include a catheter body 14, a balloon 11 disposed on the catheter body 14, a proximal unidirectional membrane disposed on the proximal side of the balloon 11, and a proximal support structure for supporting the proximal unidirectional membrane.

[0051] Combined with reference Figure 1 , Figure 4 and Figure 5 In this embodiment, the balloon catheter 10 can be inserted into place via puncture of the femoral artery FA. As an alternative embodiment, the balloon catheter 10 can also be inserted into place via puncture of the iliac artery. Figure 4 and Figure 5 As shown, when the balloon catheter 10 is placed in place in the patient's body, the proximal unidirectional membrane is located on the side of the balloon 11 away from the aortic valve AV, which can be referred to as the first unidirectional membrane 13. Accordingly, the support structure for supporting the first unidirectional membrane in this embodiment can also be referred to as the first support structure 12.

[0052] Combined with reference Figures 1 to 3 As shown, the support structure is, for example, in the form of a bracket. Figure 2 As shown, the support structure (stent), such as the first support structure (stent) 12, may include a first stent segment 121 located at the distal side and a second stent segment 122 located at the proximal side. The support structure (stent), such as the first support structure (stent) 12, may also include a strut 123 connecting the first stent segment 121 and the second stent segment 122. Figure 2 As shown, the support structure in the form of a bracket, for example, can form a grid structure, and the support structure 12 can adjust its support strength and flexibility according to specific needs by changing the density and shape of its grid structure.

[0053] like Figure 2As shown, the first stent segment 121 is a large diameter segment, which can be used to prop up blood vessels at corresponding positions, such as blood vessels at the descending aorta DA. The first stent segment 121 can have a diameter of 10 mm to 50 mm, for example. Figure 2 As shown, the first stent segment 121 may have a stabilizing arch 1211 for supporting the blood vessel wall, so as to stably support the blood vessel. Figure 2 The second bracket segment 122 is specifically substantially conical in shape and has a connection portion 1221 for fixedly connecting with the catheter body 14. Further, the first bracket segment 121 and the second bracket segment 122 are connected to form an integral support frame via a support rod 123. Preferably, the support rod 123 as a whole may present a reduced cross section, such as an arc-shaped or sloped cross section, so as to transition from the first bracket segment 121 with a large diameter to the second bracket segment 122 with a small diameter.

[0054] In the embodiment of the present disclosure, the support structure (stent), such as the first support structure (stent) 12, can be made of a superelastic material, such as nickel-titanium alloy. In the embodiment of the present disclosure, the support structure (stent), such as the first support structure (stent) 12, can have a coating on its surface. In some embodiments, the coating material includes but is not limited to ePTFE, TPU, polyester, etc., and the coating material can be coated on the surface of the support structure (stent) by any suitable means, including but not limited to suture sewing, adhesive bonding, spraying, dipping, electrospinning, etc.

[0055] Combined with reference Figures 1 to 3 As shown, the one-way membrane is, for example, in the form of a valve. Figure 3 As shown, the one-way membrane (valve), such as the first one-way membrane (valve) 13, may include a plurality of leaflets 130. In some preferred embodiments, the one-way membrane (valve), such as the first one-way membrane (valve) 13, may adopt a three-leaflet structure design, which has structural features similar to biological valves and can provide good fluid control effects. In other embodiments, the number of leaflets 130 may be two or more than three. Figure 4 and Figure 5 As shown, the one-way membrane (valve), such as the first one-way membrane (valve) 13 and its leaflets, may have a fixed end 131 and a free end 132. Figure 2 As shown, the fixed end 131 can be fixedly connected to the inner side and / or the outer side of the first support structure 12, for example, in the form of a stent. In some embodiments, the fixed end of the one-way membrane (valve), such as the first one-way membrane (valve) 13 and its leaflets, can be fixed to the first stent segment 121 and / or the strut 123. In this embodiment, the free end 132 can be located proximal to the fixed end 131, that is, on the side away from the aortic valve AV compared to the fixed end 131, such as Figure 4 and Figure 5As shown. In the disclosed embodiment, the one-way membrane (valve), such as the first one-way membrane (valve) 13, and the support structure (stent), such as the first support structure (stent) 12 can be connected in a variety of ways. In some embodiments, the connection can be made by sewing with sutures. In other embodiments, adhesive bonding can also be used, for example, using a medical-grade adhesive with good biocompatibility. In other embodiments, the connection can also be achieved by spraying, dipping or electrospinning the leaflet material onto the support structure. In the disclosed embodiment, the leaflet can be arranged on the inner surface of the support structure (stent), such as the first support structure (stent) 12, and the support structure (stent), such as the first support structure (stent) 12, can also be arranged at other positions, such as other stent structures specially arranged for fixing the one-way membrane (valve), such as anchor crowns.

[0056] In the embodiment of the present disclosure, the material of the first unidirectional membrane (valve) 13 can be selected according to specific needs. In some embodiments, it can be made of biological tissue materials, such as bovine pericardium, porcine pericardium, etc. Preferably, these biological tissue materials can be specially treated to prevent or slow down calcification, for example, alcohol immersion treatment or descaling agent treatment can be performed. In some other embodiments, it can also be made of polymer materials, such as LLDPE, ePTFE, SEBS, TPU, silicone rubber, etc. In the embodiment of the present disclosure, any suitable unidirectional membrane (valve) material can be selected according to different mechanical properties and biocompatibility requirements.

[0057] In some embodiments, an anticoagulant coating may be applied to the surface of a one-way membrane (valve), such as the first one-way membrane (valve) 13, to improve blood compatibility. The selection and process of the coating may be designed according to specific requirements to ensure the anticoagulant effect without affecting the mechanical properties of the leaflets. In some embodiments, the leaflet material itself may also have anticoagulant properties.

[0058] In some embodiments, a suitable contour design may be adopted for the leaflet to achieve a good sealing effect under the action of blood pressure. For example, the connection area of ​​the fixed end 131 may adopt a reinforced design to improve the reliability and durability of the connection. For example, the free end 132 may adopt an optimized edge shape to reduce the impact of blood on the leaflet and extend the service life.

[0059] In the disclosed embodiment, the balloon 11 can be made of non-compliant, semi-compliant or compliant materials. Optional materials include nylon, Pebax, TPU, PE or silicone. In the disclosed embodiment, the balloon 11 can be fixedly connected to the catheter body 14 by hot melt welding or bonding. In other embodiments, the balloon 11 can be supported and fixed by a supporting structure. In the disclosed embodiment, the balloon 11 can be connected to the trachea and counterpulsation pump of the heart failure assist device, so that under the gas pumping of the counterpulsation pump, the balloon regularly expands (inflates) or contracts (empties). In the disclosed embodiment, the filling gas of the balloon is preferably an inert gas, such as but not limited to helium.

[0060] In the disclosed embodiment, a catheter lumen (not marked) that allows the trachea to pass through can be formed in the catheter body 14. In the disclosed embodiment, the catheter body 14 may include a sleeved inner tube and an outer tube, so that an overlapping lumen can be provided, thereby allowing one lumen to be placed on the basis of the trachea, and the other lumen plays other functional roles. In some embodiments, the inner tube can be made of a variety of materials, such as nylon, PE, Pebax, PTFE, PI, etc., or a PI material containing braided wire can be used. In some embodiments, the outer tube can be made of similar materials, such as nylon, PE, Pebax, PTFE, PI, etc., or a PI material containing braided wire or a multi-layer composite structure can be used. In some embodiments, the outer tube can be made of a three-layer composite structure, including an inner layer of PTFE, an intermediate layer of metal / polymer material braided wire or a spring wire layer, and an outer layer of Pebax or nylon layer, which can provide good push performance and torsion control. In the disclosed embodiment, a tip can be set at the distal end of the catheter body 14, and the tip can be rounded or chamfered to avoid damage to the vascular wall when entering the blood vessel. In the disclosed embodiment, the tip can be an integral part of the inner tube or the outer tube, or fixedly connected to the distal end of the inner tube and / or the outer tube. In some embodiments, in order to facilitate positioning under X-rays, a developing structure can be provided on the inner tube, the outer tube or the tip of the balloon segment. These developing structures can take a variety of forms, such as an extruded tube containing barium sulfate or bismuth, or a platinum-iridium alloy ring, a gold ring or a tantalum ring. These developing marks can be used to accurately indicate the position of the balloon. In some embodiments, a protective coat (outer tube accessory) can also be provided on the outside of the catheter body 14, which can protect the outer tube from the influence of the external environment and maintain the cleanliness and sterility of the catheter.

[0061] Continue to refer Figure 1 The balloon catheter 10 may further include a connector 15 disposed at the proximal end of the catheter body 14. The connector 15 is connected to the catheter body 14 at the proximal end of the balloon catheter 10. The connector 15 may be used to connect to the trachea and the counterpulsation pump of the heart failure assist device, as further described below. Figure 1As shown, the connector 15 may include at least one, preferably two or more interfaces. The interfaces include, for example, but are not limited to, a guidewire lumen for a catheter to enter a target blood vessel along a guidewire, a lumen for connecting to a trachea, or an interface for measuring blood pressure or other clinical uses.

[0062] Combine the following Figure 1-3 and Figure 4-5 The working process of the balloon catheter 10 of this embodiment is described, wherein: Figure 4 The figure shows the state of the balloon catheter 10 in the body and the related blood flow direction during cardiac contraction. Figure 5 The figure shows the state of the balloon catheter 10 in the body during diastole and the related blood flow direction.

[0063] like Figure 4 and Figure 5 As schematically shown, the balloon catheter 10 can be inserted through the femoral artery FA puncture approach. When the balloon 11 reaches a suitable position in the descending aorta DA, the support structure 12 contacts the descending aorta DA and provides support.

[0064] How the first unidirectional membrane 13 in the balloon catheter 10 controls the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0065] Specifically, Figure 4 As shown, when the heart contracts, the counterpulsation pump can drive the balloon 11 to empty quickly. In this process, due to the rapid emptying of the balloon 11, a local "vacuum" effect is formed around it, generating negative pressure. At this time, the blood pressure on the side of the first unidirectional membrane (valve) 13 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the proximal side than on the distal side. As described above, the free end 132 of the first unidirectional membrane 13 (proximal unidirectional membrane) is located proximal to the fixed end 131. When the balloon catheter 10 is inserted through a position below the descending aorta DA, such as the femoral artery FA or (iliac artery), the free end 132 is located below the fixed end 131, such as Figure 4 As shown. Thus, the first unidirectional membrane 13 (proximal unidirectional membrane) forms such a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the proximal side to the distal side, which can also be expressed as a unidirectional flow from the bottom to the top, and a unidirectional flow from the ventral side to the cardiac side. Thus, as Figure 4 As shown, under the action of the above pressure difference, the free end 132 of the first unidirectional membrane 13 is closed (as shown in FIG. Figure 3(a) shows), the leaflets fit tightly to form a reliable seal. This closed state can effectively prevent blood from flowing back from the abdominal aorta (the direction of blood flow is shown by arrow A3), thereby enhancing the directional suction effect on the aortic valve AV side. At this time, the aortic valve AV is in an open state, and the negative pressure effect of the balloon 11 is fully exerted (the direction of blood flow is shown by arrow A1), which can better assist the ventricle to eject blood to the aorta, significantly increase cardiac output, and at the same time reduce the patient's heart afterload, reduce cardiac work, and reduce myocardial oxygen consumption.

[0066] like Figure 5 As shown, during diastole, the counterpulsation pump drives the balloon 11 to inflate. At this time, due to the pressure generated by the expansion of the balloon 11, the blood pressure on the side of the first unidirectional membrane (valve) 13 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the distal side than on the proximal side. As mentioned above, the unidirectional flow control direction of the first unidirectional membrane 13 (proximal unidirectional membrane) is a unidirectional flow from the distal side to the proximal side (a unidirectional flow from the top to the bottom, a unidirectional flow from the cardiac side to the ventral side). Thus, as Figure 5 As shown, under the action of the above pressure difference, the free end 132 of the first unidirectional membrane 13 is opened (as shown in FIG. Figure 3 (b)). In the open state, the valve leaflets can form a good flow channel, allowing blood to flow smoothly from the balloon 11 to the abdominal aorta, which not only increases the blood supply to the kidney KD (blood flow direction see arrow A5), but also improves the perfusion effect of other peripheral blood vessels (blood flow direction see arrow A4), while maintaining the perfusion of the coronary artery (blood flow direction see arrow A2).

[0067] Through the above-mentioned structural design and working mechanism, the balloon catheter 10 of this embodiment alleviates the problem of bidirectional blood flow caused by balloon pumping in the prior art. In particular, when the balloon 11 contracts, the active response and reliable sealing of the first unidirectional membrane 13 effectively prevents blood reflux on the abdominal aorta side, significantly enhances the suction effect on the aortic valve side, and improves the auxiliary effect on ventricular ejection. At the same time, when the balloon 11 is inflated, the reasonable opening of the first unidirectional membrane 13 also ensures that the blood can fully flow to the peripheral blood vessels, improving the blood supply effect of the peripheral tissues. During the entire working process, the first unidirectional membrane 13 can be automatically opened and closed according to the volume change of the balloon 11, without the need for an additional control mechanism, and the structure is simple and reliable.

[0068] It should be noted that the working mode of the first one-way membrane 13 described in the above embodiment is only exemplary. In different embodiments, the one-way flow control effect of the one-way membrane (valve) may have different degrees. For example, in the illustrated embodiment, the one-way fluid flow can be prevented by closing or substantially closing the one-way membrane (valve). In other embodiments, the one-way fluid flow can also be significantly reduced or throttled by partially closing the one-way membrane (valve). The above-mentioned different one-way flow control effects of the one-way membrane (valve) all fall within the scope of the present invention. In different embodiments, the one-way membrane (valve) may have different initial states and response modes. For example, the one-way membrane (valve) can be designed as a normally closed structure, and when the balloon contracts to generate negative pressure, an additional closing force is generated on the one-way membrane (valve); when the balloon expands, the one-way membrane (valve) is forced to open to allow forward flow. For example, the one-way membrane can also be designed as a normally open structure. When the balloon contracts to generate negative pressure, the normally open one-way membrane is forced to close or throttle in response to the pressure difference to control the backflow; when the balloon expands, the one-way membrane (valve) returns to its open state to allow positive flow. The above-mentioned different initial states and response modes of the one-way membrane (valve) all fall within the scope of the present invention.

[0069] See also Figures 6 to 8 , shows a balloon catheter 10 according to another embodiment of the present disclosure. Figure 6 FIG. 1 shows an overall schematic diagram of the balloon catheter 10 of this embodiment. Figure 6 In the illustrated embodiment, the balloon catheter 10 may include a catheter body 14, a balloon 11 disposed on the catheter body 14, a distal unidirectional membrane disposed at the distal side of the balloon 11, and a distal support structure for supporting the distal unidirectional membrane.

[0070] Combined with reference Figure 6 , Figure 7 and Figure 8 , the balloon catheter 10 in this embodiment can be placed in place via the (right) subclavian artery. As an alternative or supplementary embodiment, the balloon catheter 10 can also be placed in place via the left subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or other locations of the aortic arch. Figure 7 and Figure 8 As shown, when the balloon catheter 10 is placed in place in the patient's body, the distal one-way membrane is located on the side of the balloon 11 away from the aortic valve AV, which can be referred to as the first one-way membrane 13. Accordingly, the support structure for supporting the first one-way membrane in this embodiment can also be referred to as the first support structure 12.

[0071] In this embodiment, the support structure is in the form of a stent. The support structure (stent), such as the first support structure (stent) 12, can be made of a superelastic material, such as nickel-titanium alloy. The surface of the support structure (stent) can be coated, and the coating material can include but is not limited to ePTFE, TPU, polyester, etc. In the embodiment of the present disclosure, the specific structural features of the support structure can refer to Figures 1 to 5 The corresponding design in the embodiment shown.

[0072] In the disclosed embodiment, the one-way membrane is in the form of a valve. The one-way membrane (valve), such as the first one-way membrane (valve) 13, may include a plurality of leaflets. In some preferred embodiments, the one-way membrane (valve) may adopt a three-leaflet structure design. Figure 7 and Figure 8 As shown, the one-way membrane (valve), such as the first one-way membrane (valve) 13 and its leaflets, may have a fixed end 131 and a free end 132. In this embodiment, the free end 132 may be located at the distal end of the fixed end 131, that is, at the side away from the aortic valve AV compared to the fixed end 131, such as Figure 7 and Figure 8 As shown. Accordingly, Figures 6 to 8 In the illustrated embodiment, the fixed end of the one-way membrane (valve), such as the first one-way membrane (valve) and its leaflets, is adjacent to the connecting portion of the second stent segment, while in contrast, Figures 1 to 5 In the embodiment shown, the fixed end of the one-way membrane (valve), such as the first one-way membrane (valve) and its leaflets, is away from the connecting portion of the second stent segment. In the embodiment disclosed herein, other specific structural features of the one-way membrane can be referred to Figures 1 to 5 The corresponding design in the embodiment shown.

[0073] People will understand, Figure 6 The structural features, material selection, connection methods and other technical features of the various components of the balloon catheter in the illustrated embodiment can be referred to Figures 1 to 5 The corresponding technical features in the illustrated embodiment are not described in detail here.

[0074] Combine the following Figures 6 to 8 The working process of the balloon catheter 10 of this embodiment is described, wherein: Figure 7 The figure shows the state of the balloon catheter 10 in the body and the related blood flow direction during cardiac contraction. Figure 8 The figure shows the state of the balloon catheter 10 in the body during diastole and the related blood flow direction.

[0075] like Figure 7 and Figure 8 As schematically shown, the balloon catheter 10 can be placed into position via the (right) subclavian artery. When the balloon 11 reaches a suitable position in the descending aorta DA, the support structure 12 contacts the descending aorta DA and provides support.

[0076] How the first unidirectional membrane 13 in the balloon catheter 10 controls the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0077] Specifically, Figure 7 As shown, before or during the onset of the cardiac systole, the counterpulsation pump can drive the balloon 11 to empty quickly. In this process, due to the rapid emptying of the balloon 11, a local "vacuum" effect is formed around it, generating negative pressure. At this time, the blood pressure on the side of the first unidirectional membrane (valve) 13 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the distal side than on the proximal side. As mentioned above, the free end 132 of the first unidirectional membrane 13 (distal unidirectional membrane) is located distal to the fixed end 131. When the balloon catheter 10 is inserted through the (right) subclavian artery, the free end 132 is located below the fixed end 131, as shown in FIG. Figure 7 As shown. Thus, the first unidirectional membrane 13 (distal unidirectional membrane) forms such a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the distal side to the proximal side, which can also be expressed as a unidirectional flow from the bottom to the top, and a unidirectional flow from the abdominal aorta toward the balloon. Figure 7 As shown, under the action of the above-mentioned pressure difference, the free end 132 of the first unidirectional membrane 13 is closed, and the leaflets are tightly fitted to form a reliable seal. This closed state can effectively prevent the blood from flowing back from the abdominal aorta side (the direction of blood flow is shown by arrow A3), thereby enhancing the directional suction effect on the aortic valve AV side. At this time, the aortic valve AV is in an open state, and the negative pressure effect of the balloon 11 is fully exerted (the direction of blood flow is shown by arrow A1), which can better assist the ventricle to eject blood to the aorta, significantly increase cardiac output, and at the same time reduce the patient's heart afterload, reduce cardiac work, and reduce myocardial oxygen consumption.

[0078] like Figure 8 As shown, after the start of the cardiac diastole (when the aortic valve AV is closed), the counterpulsation pump drives the balloon 11 to inflate. At this time, due to the pressure generated by the expansion of the balloon 11, the blood pressure on the side of the first unidirectional membrane (valve) 13 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the proximal side than on the distal side. As mentioned above, the unidirectional flow control direction of the first unidirectional membrane 13 (distal unidirectional membrane) is a unidirectional flow from the proximal side to the distal side (a unidirectional flow from the top to the bottom, a unidirectional flow from the balloon toward the abdominal aorta). Thus, as Figure 8As shown, under the action of the above pressure difference, the free end 132 of the first unidirectional membrane 13 is opened. In the open state, the leaflets can form a good flow channel, so that blood can flow smoothly from the direction of the balloon 11 to the direction of the abdominal aorta, which not only increases the blood supply to the kidney KD (blood flow direction see arrow A5), but also improves the perfusion effect of other peripheral blood vessels (blood flow direction see arrow A4); at the same time, the inflation of the balloon 11 increases the diastolic pressure, and the blood at the proximal end of the balloon accelerates the return to the coronary artery, thereby enhancing the coronary perfusion (blood flow direction see arrow A2).

[0079] Through the above-mentioned structural design and working mechanism, the balloon catheter 10 of this embodiment alleviates the problem of bidirectional blood flow caused by balloon pumping in the prior art. In particular, when the balloon 11 contracts, the active response and reliable sealing of the first unidirectional membrane 13 effectively prevents blood reflux on the abdominal aorta side, significantly enhances the suction effect on the aortic valve side, and improves the auxiliary effect on ventricular ejection. At the same time, when the balloon 11 is inflated, the reasonable opening of the first unidirectional membrane 13 also ensures that the blood can fully flow to the peripheral blood vessels, improving the blood supply effect of the peripheral tissues. During the entire working process, the first unidirectional membrane 13 can be automatically opened and closed according to the volume change of the balloon 11, without the need for an additional control mechanism, and the structure is simple and reliable.

[0080] See also Figure 9.1 , Figure 10.1 , Figure 11.1 , Figure 12.1 , showing the deformation schemes of the balloon catheters of other embodiments of the present disclosure. Figure 10.1 , Figure 11.1 , Figure 12.1 The balloon catheter in the embodiment shown is compared to Figure 1 The embodiment shown or Figure 6 The main difference of the embodiment shown is the supporting structure (bracket), and the specific features of other components can be referred to Figure 1 The embodiment shown or Figure 6 The embodiments shown are not described in detail here.

[0081] like Figure 9.1 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a proximal support structure disposed at the proximal end of the balloon 11, and a proximal unidirectional membrane disposed on the proximal support structure. Figure 9.1 When the balloon catheter 10 in the illustrated embodiment is inserted into place from a position below the body (such as through the femoral artery), the proximal unidirectional membrane can be referred to as the first unidirectional membrane 13, and the proximal support structure can be referred to as the first support structure 12 accordingly. Figure 1The difference from the embodiment shown is that the balloon catheter 10 of this embodiment also includes a distal (second) support structure, which can be used to open the blood vessel without supporting the one-way membrane (valve). The provision of the additional distal support extension further improves the axial stability of the balloon catheter in the blood vessel.

[0082] like Figure 10.1 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a distal support structure disposed at the distal end of the balloon 11, and a distal unidirectional membrane disposed on the distal support structure. Figure 10.1 When the balloon catheter 10 in the illustrated embodiment is placed in place via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or other locations of the aortic arch, the distal unidirectional membrane can be referred to as the first unidirectional membrane 13, and the distal support structure can be referred to as the first support structure 12 accordingly. Figure 6 The difference from the embodiment shown is that the balloon catheter 10 of this embodiment also includes a proximal (second) support structure, which can be used to prop open the blood vessel without supporting the one-way membrane (valve). The provision of the additional proximal support extension further improves the axial stability of the balloon catheter in the blood vessel.

[0083] like Figure 11.1 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a proximal support structure disposed at the proximal end of the balloon 11, and a proximal unidirectional membrane disposed on the proximal support structure. Figure 11.1 When the balloon catheter 10 in the illustrated embodiment is inserted into place from a position below the body (such as through the femoral artery), the proximal unidirectional membrane can be referred to as the first unidirectional membrane 13, and the proximal support structure can be referred to as the first support structure 12 accordingly. Figure 1 The difference from the illustrated embodiment is that the support structure is in the form of a stent, extending from one side (proximal side) of the balloon 11 across the balloon to the other side (distal side), completely covering the length of the balloon 11. In particular, there is a radial gap between the support structure (stent) 12 and the balloon 11 in the expanded state. This integrally extended support structure design, while ensuring the normal expansion and contraction of the balloon 11, provides a stable support environment for the balloon catheter by cooperating with the reasonable gap of the balloon.

[0084] like Figure 12.1 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a distal support structure disposed at the distal end of the balloon 11, and a distal unidirectional membrane disposed on the distal support structure. Figure 12.1When the balloon catheter 10 in the illustrated embodiment is placed in place via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or other locations of the aortic arch, the distal unidirectional membrane can be referred to as the first unidirectional membrane 13, and the distal support structure can be referred to as the first support structure 12 accordingly. Figure 6 The difference from the illustrated embodiment is that the support structure is in the form of a stent, extending from one side (proximal side) of the balloon 11 across the balloon to the other side (distal side), completely covering the length of the balloon 11. In particular, there is a radial gap between the support structure (stent) 12 and the balloon 11 in the expanded state. This integrally extended support structure design, while ensuring the normal expansion and contraction of the balloon 11, provides a stable support environment for the balloon catheter by cooperating with the reasonable gap of the balloon.

[0085] Figure 9.1 , Figure 10.1 , Figure 11.1 , Figure 12.1 The opening and closing mechanism of the first one-way membrane 13 in the above-mentioned embodiments is basically the same as that of the above-mentioned embodiments. When the balloon 11 contracts to generate negative pressure, the one-way membrane 13 closes to prevent blood from flowing back from the abdominal aorta; when the balloon 11 expands, the one-way membrane 13 opens to allow blood to flow to the periphery.

[0086] like Figure 9.2 and Fig.23 , Fig.24 As shown, Figure 9.2 The balloon catheter 10 in the illustrated embodiment is inserted into position from a lower body position (eg, via the femoral artery FA). Fig.23 According to the cardiac cycle, when the heart contracts, the counterpulsation pump discharges the helium in the balloon to make it contract. The balloon 11 is quickly emptied, and the blood pressure on the side of the valve 13 close to the balloon decreases. The blood pressure on the side close to the balloon is lower than the pressure on the side away from the balloon. The valve 13 opens, and the aortic valve AV opens at this time, so that the balloon 11 is emptied to create a "vacuum", which better assists the ventricle to eject blood to the aorta (the direction of blood flow is shown by arrow A1), increases cardiac output, and reduces the patient's heart afterload, reduces cardiac work, and reduces myocardial oxygen consumption. Fig.24 As shown, during the diastole of the heart (when the aortic valve AV is closed), the balloon is inflated with helium driven by the intra-aortic balloon counterpulsation pump to expand it. The balloon is inflated by the intra-aortic balloon counterpulsation pump, and the blood pressure on the side of the valve 13 close to the balloon increases. The blood pressure on the side close to the balloon is greater than the pressure on the side away from the balloon. The valve 13 is closed, and the blood in the descending aorta can only flow to the kidneys and lower limbs, increasing the renal KD (the direction of blood flow is shown by arrow A5) and the peripheral vascular blood flow (the direction of blood flow is shown by arrow A4); at the same time, the blood in the aortic arch flows to the coronary artery under the action of diastolic pressure to maintain coronary perfusion (as shown by arrow A2).

[0087] like Figure 10.2 and Fig.25 , Fig.26 As shown, Figure 10.2 The balloon catheter 10 in the illustrated embodiment is inserted into position from an upper position of the body (eg, via the right clavicular artery). Fig.25 According to the cardiac cycle, when the heart contracts, the counterpulsation pump discharges the helium in the balloon to make it contract. The balloon 11 is quickly emptied, and the blood pressure on the side of the valve 13 close to the balloon decreases. The blood pressure on the side close to the balloon is lower than the pressure on the side away from the balloon. The valve 13 opens, and the aortic valve AV opens at this time, so that the balloon 11 is emptied to create a "vacuum", which better assists the ventricle to eject blood to the aorta (the direction of blood flow is shown by arrow A1), increases cardiac output, and reduces the patient's heart afterload, reduces cardiac work, and reduces myocardial oxygen consumption. Fig.26 As shown, during the diastole of the heart (when the aortic valve AV is closed), the balloon is inflated with helium driven by the intra-aortic balloon counterpulsation pump to expand it. The balloon is inflated by the intra-aortic balloon counterpulsation pump, and the blood pressure on the side of the valve 13 close to the balloon increases. The blood pressure on the side close to the balloon is greater than the pressure on the side away from the balloon. The valve 13 is closed, and the blood in the descending aorta can only flow to the kidneys and lower limbs, increasing the renal KD (the direction of blood flow is shown by arrow A5) and the peripheral vascular blood flow (the direction of blood flow is shown by arrow A4); at the same time, the blood in the aortic arch flows to the coronary artery under the action of diastolic pressure to maintain coronary perfusion (as shown by arrow A2).

[0088] Figure 11.2 The balloon catheter approach and working principle are the same Figure 9.2 .

[0089] Figure 12.2 The balloon catheter approach and working principle are the same Figure 10.2 .

[0090] See also Figures 13 to 15 , showing a balloon catheter according to yet another embodiment of the present disclosure. Fig.13 FIG. 1 shows an overall schematic diagram of the balloon catheter 10 of this embodiment. Fig.13 In the illustrated embodiment, the balloon catheter 10 may include a catheter body 14 and a balloon 11 disposed on the catheter body 14. A proximal unidirectional membrane and a proximal support structure for supporting the proximal unidirectional membrane are disposed on the proximal side of the balloon 11, and a distal unidirectional membrane and a distal support structure for supporting the distal unidirectional membrane are disposed on the distal side of the balloon 11.

[0091] Combined with reference Fig.13 , Fig.14 and Fig.15 In this embodiment, the balloon catheter 10 can be inserted into place via puncture of the femoral artery FA. As an alternative embodiment, the balloon catheter 10 can also be inserted into place via puncture of the iliac artery. Fig.14 and Fig.15As shown, when the balloon catheter 10 is placed in place in the patient's body, the proximal unidirectional membrane is located on the side of the balloon 11 away from the aortic valve AV, which can be referred to as the first unidirectional membrane 13, and the distal unidirectional membrane is located on the side of the balloon 11 close to the aortic valve AV, which can be referred to as the second unidirectional membrane 17. Accordingly, the support structure for supporting the first unidirectional membrane in this embodiment can also be referred to as the first support structure 12, and the support structure for supporting the second unidirectional membrane can be referred to as the second support structure 16.

[0092] like Fig.13 As shown, the first support structure 12 and the second support structure 16 may have the same orientation, for example, the connection parts (not marked) of the first support structure 12 and the second support structure 16 are both located on the proximal side. Fig.13 As shown, the first support structure 12 and the second support structure 16 can have different lengths, but the present invention is not limited thereto. Other specific structural features of the proximal and distal (first and second) support structures (stents) can be referred to Figures 1 to 5 The corresponding design in the embodiment shown.

[0093] like Fig.13 In the embodiment shown, the specific structural features of the first (proximal) unidirectional film can be referred to Figures 1 to 5 The corresponding design in the embodiment shown. Fig.13 As shown, the second one-way membrane 17 may also be in the form of a valve, including a plurality of leaflets. In some preferred embodiments, the second one-way membrane 17 may be designed with a three-leaf structure. The second one-way membrane 17 (valve) and its leaflets may have a fixed end 171 and a free end 172. Fig.13 As shown, the fixed end 171 of the second one-way membrane 17 (valve) can be fixedly connected to the inner side of the second support structure 16. Fig.14 As shown, the free end 172 of the second one-way membrane 17 (valve) can be located proximal to the fixed end 171, that is, located on the side away from the aortic valve AV compared to the fixed end 171. Fig.13 In the embodiment shown, the first (proximal) one-way membrane 13 and the second (distal) one-way membrane 17 can have the same orientation, and thus have the same orientation of one-way flow control. In the embodiment of the present disclosure, other specific structural features of the proximal and distal (first and second) one-way membranes (valves) can refer to Figures 1 to 5 The corresponding design in the embodiment shown.

[0094] People will understand, Fig.13 The structural features, material selection, connection methods and other technical features of the various components of the balloon catheter in the illustrated embodiment can be referred to Figures 1 to 5 The corresponding technical features in the illustrated embodiment are not described in detail here.

[0095] Combine the following Figures 13 to 15 The working process of the balloon catheter 10 of this embodiment is described, wherein: Fig.14 The figure shows the state of the balloon catheter 10 in the body and the related blood flow direction during cardiac contraction. Fig.15 The figure shows the state of the balloon catheter 10 in the body during diastole and the related blood flow direction.

[0096] like Fig.14 and Fig.15 As schematically shown, the balloon catheter 10 can be inserted through the femoral artery FA puncture access. When the balloon 11 reaches a suitable position in the descending aorta DA, the first support structure 12 and the second support structure 16 contact the descending aorta DA and provide support.

[0097] How the first one-way film 13 and the second one-way film 17 in the balloon catheter 10 control the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0098] Specifically, Fig.14 As shown, during the cardiac systole, the counterpulsation pump can drive the balloon 11 to be emptied quickly. In this process, the rapid emptying of the balloon 11 forms a local "vacuum" effect around it, generating negative pressure.

[0099] On the proximal side of the balloon 11, the blood pressure on the side of the first unidirectional membrane 13 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the proximal side than on the distal side. The free end 132 of the first unidirectional membrane 13 is located proximal to the fixed end 131. When the balloon catheter 10 is inserted through a position below the descending aorta DA, such as the femoral artery FA or (iliac artery), the free end 132 is located below the fixed end 131. Thus, the first unidirectional membrane 13 forms a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the proximal side to the distal side, which can also be expressed as a unidirectional flow from the bottom to the top, and a unidirectional flow from the ventral side to the cardiac side in this embodiment. Under the action of the above-mentioned pressure difference, the free end 132 of the first unidirectional membrane 13 is closed, and the leaflets are tightly fitted to form a reliable seal. This closed state can effectively prevent blood reflux from the abdominal aorta side (the direction of blood flow is shown by arrow A3).

[0100] At the same time, at the distal side of the balloon 11, the blood pressure on the side of the second unidirectional membrane 17 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the second unidirectional membrane 17 that is greater on the distal side than on the proximal side. Similarly, the free end 172 of the second unidirectional membrane 17 is located proximal to the fixed end 171. When the balloon catheter 10 is inserted through a position below the descending aorta DA, such as the femoral artery FA or (iliac artery), the free end 172 is located below the fixed end 171. Thus, the second unidirectional membrane 17 forms a unidirectional flow control unit, which can selectively control the unidirectional flow from the distal side to the proximal side, which can also be expressed as a unidirectional flow from the top to the bottom, and a unidirectional flow from the heart side to the ventral side in this embodiment. Under the action of the above-mentioned pressure difference opposite to the unidirectional flow control, the free end 172 of the second unidirectional membrane 17 is opened, and the leaflet forms a good flow channel. This open state allows blood to flow from the aortic valve AV direction (the direction of blood flow is shown by arrow A1). At this time, the aortic valve AV is in an open state, and the negative pressure effect of the balloon 11 is fully exerted through the cooperation of the closing of the first one-way membrane 13 and the opening of the second one-way membrane 17 .

[0101] The coordination of the closing of the first one-way membrane 13 and the opening of the second one-way membrane 17 can better assist the ventricle to eject blood to the aorta, significantly increase cardiac output, and at the same time reduce the patient's cardiac afterload, reduce cardiac work, and reduce myocardial oxygen consumption.

[0102] like Fig.15 As shown, after the start of the cardiac diastole (when the aortic valve AV is closed), the counterpulsation pump drives the balloon 11 to inflate.

[0103] At this time, due to the pressure generated by the expansion of the balloon 11, on the proximal side of the balloon 11, the blood pressure on the side of the first unidirectional membrane 13 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the distal side than on the proximal side. The free end 132 of the first unidirectional membrane 13 is located proximal to the fixed end 131. When the balloon catheter 10 is inserted through a position below the descending aorta DA, such as the femoral artery FA or (iliac artery), the free end 132 is located below the fixed end 131. Therefore, under the action of the above-mentioned pressure difference, the free end 132 of the first unidirectional membrane 13 is opened. In the open state, the leaflets can form a good flow channel, so that blood can flow smoothly from the direction of the balloon 11 to the direction of the abdominal aorta (the direction of blood flow is shown by arrows A4 and A5).

[0104] At the same time, on the distal side of the balloon 11, the blood pressure on the side of the second unidirectional membrane 17 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the second unidirectional membrane 17 that is greater on the proximal side than on the distal side. As mentioned above, the free end 172 of the second unidirectional membrane 17 is located proximal to the fixed end 171. When the balloon catheter 10 is inserted through a position below the descending aorta DA, such as the femoral artery FA or (iliac artery), the free end 172 is located below the fixed end 171. As a result, the second unidirectional membrane 17 forms a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the distal side to the proximal side, which can also be expressed in this embodiment as a unidirectional flow from the top to the bottom, and a unidirectional flow from the heart side to the ventral side. Under the action of the above-mentioned pressure difference consistent with the unidirectional flow control direction, the free end 172 of the second unidirectional membrane 17 is closed, and the leaflets fit tightly to form a reliable seal. This closed state can effectively prevent blood from flowing back toward the aortic valve AV, and the blood above the second one-way membrane 17 can still fully perfuse the coronary artery (the direction of blood flow is shown by arrow A2). The opening of the first one-way membrane 13 and the closing of the second one-way membrane 17 not only further increase the blood supply to the kidney KD (the direction of blood flow is shown by arrow A5), but also further improve the perfusion effect of other peripheral blood vessels (the direction of blood flow is shown by arrow A4).

[0105] Through the above structural design and working mechanism, the balloon catheter 10 of this embodiment solves the problem of bidirectional blood flow caused by balloon pumping in the prior art. As described in the background technology, after the start of the diastole (when the aortic valve is closed), the balloon counterpulsation pump drives the aortic balloon to inflate, so that the pressure of the aorta increases, and the coronary perfusion and peripheral blood flow are increased. However, under certain conditions, the peripheral blood flow is still insufficient, which may be due to the influence of the bidirectional flow of blood on both sides of the balloon, resulting in part of the blood being unable to be effectively guided to the peripheral blood vessels. In particular, when the balloon 11 contracts, the blood reflux on the abdominal aorta side is effectively prevented by the closing of the first unidirectional membrane 13 and the opening of the second unidirectional membrane 17, which significantly enhances the suction effect on the aortic valve side and improves the auxiliary effect on ventricular ejection. In addition, after the start of the diastole (when the aortic valve is closed), the balloon counterpulsation pump drives the aortic balloon to inflate, so that the pressure of the aorta increases, and the coronary perfusion and peripheral blood flow are increased. After research, the inventors found that in the balloon expansion stage, the blood flow of the peripheral blood vessels is still insufficient under certain conditions. This may be due to the influence of the two-way flow of blood on both sides of the balloon, resulting in part of the blood being unable to be effectively guided to the peripheral blood vessels. Therefore, through the opening of the first unidirectional membrane 13 and the closing of the second unidirectional membrane 17, the problem of insufficient blood flow of the peripheral blood vessels in the prior art is overcome. During the entire working process, the first unidirectional membrane 13 and the second unidirectional membrane 17 can be automatically opened and closed according to the volume change of the balloon 11, without the need for an additional control mechanism, and the structure is simple and reliable.

[0106] It should also be noted that the working mode of the second unidirectional membrane described in the above embodiment is only exemplary. In different embodiments, the unidirectional flow control effect of the unidirectional membrane (valve) can have different degrees. For example, in the illustrated embodiment, the unidirectional fluid flow can be prevented by closing or substantially closing the unidirectional membrane (valve). In other embodiments, the unidirectional fluid flow can also be significantly reduced or throttled by partially closing the unidirectional membrane (valve). The above-mentioned different unidirectional flow control effects of the unidirectional membrane (valve) all fall within the scope of the present invention. In different embodiments, the unidirectional membrane (valve) can have different initial states and response modes. For example, the unidirectional membrane (valve) can be designed as a normally closed structure, and when the balloon contracts to generate negative pressure, an additional closing force is generated on the unidirectional membrane (valve); when the balloon expands, the unidirectional membrane (valve) is forced to open to allow forward flow. For example, the one-way membrane can also be designed as a normally open structure. When the balloon contracts to generate negative pressure, the normally open one-way membrane is forced to close or throttle in response to the pressure difference to control the backflow; when the balloon expands, the one-way membrane (valve) returns to its open state to allow positive flow. The above-mentioned different initial states and response modes of the one-way membrane (valve) all fall within the scope of the present invention.

[0107] See also Figures 16 to 18 , showing a balloon catheter according to yet another embodiment of the present disclosure. Fig.16 FIG. 1 shows an overall schematic diagram of the balloon catheter 10 of this embodiment. Fig.16 In the illustrated embodiment, the balloon catheter 10 may include a catheter body 14 and a balloon 11 disposed on the catheter body 14. A proximal unidirectional membrane and a proximal support structure for supporting the proximal unidirectional membrane are disposed on the proximal side of the balloon 11, and a distal unidirectional membrane and a distal support structure for supporting the distal unidirectional membrane are disposed on the distal side of the balloon 11.

[0108] Combined with reference Fig.16 , Fig.17 and Fig.18 , the balloon catheter 10 in this embodiment can be placed in place via the (right) subclavian artery. Fig.17 and Fig.18 As shown, when the balloon catheter 10 is placed in place in the patient's body, the distal one-way membrane is located on the side of the balloon 11 away from the aortic valve AV, which can be referred to as the first one-way membrane 13, and the proximal one-way membrane is located on the side of the balloon 11 close to the aortic valve AV, which can be referred to as the second one-way membrane 17. Accordingly, the support structure for supporting the first one-way membrane in this embodiment can also be referred to as the first support structure 12, and the support structure for supporting the second one-way membrane can be referred to as the second support structure 16.

[0109] like Fig.16As shown, the first (distal) support structure 12 and the second (proximal) support structure 16 may have the same orientation, for example, the connection portions (not labeled) of the first support structure 12 and the second support structure 16 are both located proximally. Fig.16 As shown, the first support structure 12 and the second support structure 16 can have different lengths, but the present invention is not limited thereto. Other specific structural features of the proximal and distal (first and second) support structures (stents) can be referred to Figures 6 to 8 The corresponding design in the embodiment shown.

[0110] like Fig.16 In the embodiment shown, the specific structural features of the first (distal) unidirectional membrane can be referred to Figures 6 to 8 The corresponding design in the embodiment shown. Fig.16 As shown, the second (proximal) one-way membrane 17 may also be in the form of a valve, including a plurality of leaflets. In some preferred embodiments, the second one-way membrane 17 may be designed with a three-leaflet structure. The second one-way membrane 17 (valve) and its leaflets may have a fixed end 171 and a free end 172. Fig.16 As shown, the fixed end 171 of the second one-way membrane 17 (valve) can be fixedly connected to the inner side of the second support structure 16. Fig.17 As shown, the free end 172 of the second one-way membrane 17 (valve) can be located at the distal end of the fixed end 171, that is, at the side away from the aortic valve AV compared to the fixed end 171. Fig.16 In the embodiment shown, the first (distal) one-way membrane 13 and the second (proximal) one-way membrane 17 can have the same orientation, and thus have the same orientation of one-way flow control. In the embodiment of the present disclosure, other specific structural features of the distal and proximal (first and second) one-way membranes (valve) can refer to Figures 1 to 5 The corresponding design in the embodiment shown.

[0111] People will understand, Fig.16 The structural features, material selection, connection methods and other technical features of the various components of the balloon catheter in the illustrated embodiment can be referred to Figures 1 to 5 The corresponding technical features in the illustrated embodiment are not described in detail here.

[0112] Combine the following Figures 16 to 18 The working process of the balloon catheter 10 of this embodiment is described, wherein: Fig.17 The figure shows the state of the balloon catheter 10 in the body and the related blood flow direction during cardiac contraction. Fig.18 The figure shows the state of the balloon catheter 10 in the body during diastole and the related blood flow direction.

[0113] like Fig.17 and Fig.18As schematically shown, the balloon catheter 10 can be placed into position via the (right) subclavian artery. When the balloon 11 reaches a suitable position in the descending aorta DA, the first support structure 12 and the second support structure 16 contact the descending aorta DA and provide support.

[0114] How the first one-way film 13 and the second one-way film 17 in the balloon catheter 10 control the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0115] Specifically, Fig.17 As shown, before or at the beginning of the cardiac systole, the counterpulsation pump can drive the balloon 11 to be quickly emptied. In this process, due to the rapid emptying of the balloon 11, a local "vacuum" effect is formed around it, generating negative pressure.

[0116] On the proximal side of the balloon 11, the blood pressure on the side of the first unidirectional membrane 13 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the distal side than on the proximal side. The free end 132 of the first unidirectional membrane 13 is located on the distal side of the fixed end 131. When the balloon catheter 10 is placed in place through the (right) subclavian artery, the free end 132 is located below the fixed end 131. As a result, the first unidirectional membrane 13 forms a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the distal side to the proximal side, which can also be expressed as a unidirectional flow from the bottom to the top, and a unidirectional flow from the ventral side to the heart side in this embodiment. Under the action of the above-mentioned pressure difference, the free end 132 of the first unidirectional membrane 13 is closed, and the leaflets are tightly fitted to form a reliable seal. This closed state can effectively prevent blood reflux from the abdominal aorta side (the direction of blood flow is shown by arrow A3).

[0117] At the same time, on the proximal side of the balloon 11, the blood pressure on the side of the second unidirectional membrane 17 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the second unidirectional membrane 17 that is greater on the distal side than on the proximal side. Similarly, the free end 172 of the second unidirectional membrane 17 is located on the distal side of the fixed end 171. When the balloon catheter 10 is placed in place through the (right) subclavian artery, the free end 172 is located below the fixed end 171. Thus, the second unidirectional membrane 17 forms a unidirectional flow control unit, which can selectively control the unidirectional flow from the proximal side to the distal side, which can also be expressed as a unidirectional flow from the top to the bottom, and a unidirectional flow from the heart side to the ventral side in this embodiment. Under the action of the above-mentioned pressure difference opposite to the unidirectional flow control, the free end 172 of the second unidirectional membrane 17 is opened, and the leaflet forms a good flow channel. This open state allows blood to flow from the AV direction of the aortic valve (the direction of blood flow is shown by arrow A1). At this time, the aortic valve AV is in an open state, and the negative pressure effect of the balloon 11 is fully exerted through the cooperation of the closing of the first one-way membrane 13 and the opening of the second one-way membrane 17 .

[0118] The coordination of the closing of the first one-way membrane 13 and the opening of the second one-way membrane 17 can better assist the ventricle to eject blood to the aorta, significantly increase cardiac output, and at the same time reduce the patient's cardiac afterload, reduce cardiac work, and reduce myocardial oxygen consumption.

[0119] like Fig.18 As shown, after the start of the cardiac diastole (when the aortic valve AV is closed), the counterpulsation pump drives the balloon 11 to inflate.

[0120] At this time, due to the pressure generated by the expansion of the balloon 11, on the distal side of the balloon 11, the blood pressure on the side of the first unidirectional membrane 13 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the first unidirectional membrane 13 that is greater on the proximal side than on the distal side. The free end 132 of the first unidirectional membrane 13 is located on the distal side of the fixed end 131. When the balloon catheter 10 is inserted into place through the (right) subclavian artery, the free end 132 is located below the fixed end 131. Therefore, under the action of the above-mentioned pressure difference opposite to the unidirectional flow control, the free end 132 of the first unidirectional membrane 13 is opened. In the open state, the leaflets can form a good flow channel, allowing blood to flow smoothly from the direction of the balloon 11 to the direction of the abdominal aorta (the direction of blood flow is shown by arrows A4 and A5).

[0121] At the same time, on the proximal side of the balloon 11, the blood pressure on the side of the second unidirectional membrane 17 close to the balloon 11 is higher than the blood pressure on the side away from the balloon, thereby forming a pressure difference on the second unidirectional membrane 17 that is greater on the distal side than on the proximal side. As mentioned above, the free end 172 of the second unidirectional membrane 17 is located on the distal side of the fixed end 171. When the balloon catheter 10 is inserted into place through the (right) subclavian artery, the free end 172 is located below the fixed end 171. As a result, the second unidirectional membrane 17 forms a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the distal side to the proximal side, which can also be expressed in this embodiment as a unidirectional flow from the bottom to the top, and a unidirectional flow from the ventral side to the cardiac side. Under the action of the above-mentioned pressure difference consistent with the unidirectional flow control direction, the free end 172 of the second unidirectional membrane 17 is closed, and the leaflets fit tightly to form a reliable seal. This closed state can effectively prevent blood from flowing back toward the aortic valve AV, and the blood above the second one-way membrane 17 can still fully perfuse the coronary artery (the direction of blood flow is shown by arrow A2). The opening of the first one-way membrane 13 and the closing of the second one-way membrane 17 not only further increase the blood supply to the kidney KD (the direction of blood flow is shown by arrow A5), but also further improve the perfusion effect of other peripheral blood vessels (the direction of blood flow is shown by arrow A4).

[0122] Through the above structural design and working mechanism, the balloon catheter 10 of this embodiment solves the problem of bidirectional blood flow caused by balloon pumping in the prior art. As described in the background technology, during the diastole period, the balloon counterpulsation pump drives the aortic balloon to inflate, so that the pressure of the aorta increases, and the coronary perfusion and peripheral blood flow are increased. However, under certain conditions, the peripheral blood flow is still insufficient, which may be due to the influence of the bidirectional flow of blood on both sides of the balloon, resulting in that part of the blood cannot be effectively guided to the peripheral blood vessels. In particular, when the balloon 11 contracts, the blood reflux on the abdominal aorta side is effectively prevented by the closing of the first unidirectional membrane 13 and the opening of the second unidirectional membrane 17, which significantly enhances the suction effect on the aortic valve side and improves the auxiliary effect on ventricular ejection. In addition, after the start of the diastole period (when the aortic valve is closed), the balloon counterpulsation pump drives the aortic balloon to inflate, so that the pressure of the aorta increases, and the coronary perfusion and peripheral blood flow are increased. After research, the inventors found that in the balloon expansion stage, the blood flow of the peripheral blood vessels is still insufficient under certain conditions. This may be due to the influence of the two-way flow of blood on both sides of the balloon, resulting in part of the blood being unable to be effectively guided to the peripheral blood vessels. Therefore, through the opening of the first unidirectional membrane 13 and the closing of the second unidirectional membrane 17, the problem of insufficient blood flow of the peripheral blood vessels in the prior art is overcome. During the entire working process, the first unidirectional membrane 13 and the second unidirectional membrane 17 can be automatically opened and closed according to the volume change of the balloon 11, without the need for an additional control mechanism, and the structure is simple and reliable.

[0123] See also Fig.19 and Fig. 20 , showing the deformation schemes of the balloon catheters of other embodiments of the present disclosure. Figure 19 to Figure 20 The balloon catheter in the embodiment shown is compared to Fig.13 The embodiment shown or Fig.16 The main difference of the embodiment shown is the supporting structure (bracket), and the specific features of other components can be referred to Fig.13 The embodiment shown or Fig.16 The embodiments shown are not described in detail here.

[0124] like Fig.19 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a proximal support structure disposed at the proximal end of the balloon 11, a proximal unidirectional membrane disposed on the support structure (proximal side), and a distal unidirectional membrane disposed on the support structure (distal side). Fig.19 When the balloon catheter 10 in the illustrated embodiment is inserted into position from a lower body position (such as through the femoral artery FA), the proximal unidirectional membrane may be referred to as a first unidirectional membrane 13, and the distal unidirectional membrane may be referred to as a second unidirectional membrane 17. Fig.13The difference from the illustrated embodiment is that the support structure is in the form of a stent, extending from one side (proximal side) of the balloon 11 across the balloon to the other side (distal side), completely covering the length of the balloon 11. At this time, the balloon catheter 10 includes a single support structure, namely a first support structure 12, which supports a first (proximal) unidirectional membrane 13 and a second (distal) unidirectional membrane 17 at the proximal and distal sides, respectively. In particular, there is a radial gap between the support structure (stent) 12 and the balloon 11 in the expanded state. This integrally extended support structure design, while ensuring the normal expansion and contraction of the balloon 11, provides a stable support environment for the balloon catheter by cooperating with a reasonable gap with the balloon.

[0125] like Fig. 20 In the illustrated embodiment, the balloon catheter 10 comprises a catheter body 14, a balloon 11 disposed on the catheter body 14, a proximal support structure disposed at the proximal end of the balloon 11, a proximal unidirectional membrane disposed on the support structure (proximal side), and a distal unidirectional membrane disposed on the support structure (distal side). Fig. 20 When the balloon catheter 10 in the illustrated embodiment is placed in place via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or other locations of the aortic arch, the distal unidirectional membrane may be referred to as the first unidirectional membrane 13, and the proximal unidirectional membrane may be referred to as the second unidirectional membrane 17. Fig.16 The difference from the illustrated embodiment is that the support structure is in the form of a stent, extending from one side (proximal side) of the balloon 11 across the balloon to the other side (distal side), completely covering the length of the balloon 11. At this time, the balloon catheter 10 includes a single support structure, namely a first support structure 12, which supports a first (distal) unidirectional membrane 13 and a second (proximal) unidirectional membrane 17 at the distal and proximal sides, respectively. In particular, there is a radial gap between the support structure (stent) 12 and the balloon 11 in the expanded state. This integrally extended support structure design, while ensuring the normal expansion and contraction of the balloon 11, provides a stable support environment for the balloon catheter by cooperating with a reasonable gap with the balloon.

[0126] like Fig.19 and Fig. 20 As shown, the support structure 12 can also adopt an integral covering design to completely cover the length of the balloon 11. This design can provide a more stable working environment for the double unidirectional membrane and further optimize the overall performance of the device.

[0127] This embodiment provides a heart failure assist device 1. The heart failure assist device 1 comprises the balloon catheter 10 described in the above embodiment, a trachea connected to the balloon 11, and a counterpulsation pump connected to the trachea.

[0128] The trachea is made of flexible material, such as a polyurethane tube with a braided reinforcement layer, or a TPU tube, a PE tube, a PC tube, a PVC tube, a PP tube, etc., with sufficient compressive strength and torsional strength. One end of the trachea is connected to the catheter 14 of the balloon catheter 10 through a joint 15, and the other end is connected to the counterpulsation pump. The trachea is sealed with the joint 15 and with the counterpulsation pump to ensure the reliability of gas transmission.

[0129] The counterpulsation pump controls the inflation and deflation of the balloon 11 according to the cardiac cycle. Before the onset of the cardiac systole, the counterpulsation pump quickly extracts gas from the balloon 11 to quickly empty the balloon 11, and cooperates with the control of the one-way membrane to assist ventricular ejection. After the onset of the cardiac diastole, the counterpulsation pump fills the balloon 11 with gas to expand it, and also cooperates with the one-way membrane to increase peripheral blood supply.

[0130] Through the cooperative work of the counterpulsation pump, the balloon 11 and its one-way membrane, the heart failure assist device 1 of this embodiment can effectively assist the heart function, increase cardiac output, and improve the clinical symptoms of heart failure patients. The device has a simple and reliable structure, is easy to operate clinically, and can meet the treatment needs of different patients.

[0131] refer to Fig.21 and Fig. 22 The embodiment of the present disclosure provides a heart failure assist device 1. The heart failure assist device 1 includes a balloon catheter 10 as described in any of the above embodiments.

[0132] In the disclosed embodiment, the heart failure assist device 1 may also include any suitable component or device for controlling and delivering the balloon catheter 10. In the disclosed embodiment, the heart failure assist device 1 includes a trachea (not shown) and a counterpulsation pump (not shown) connected to the balloon 11. In some embodiments, one end of the trachea is connected to the inner cavity of the balloon 11, and the other end is connected to the counterpulsation pump. Preferably, as described above, helium can be used as the working gas in the trachea, which has a small molecular weight and low density, and can make the inflation and emptying speed of the balloon 11 faster, which is conducive to better matching the contraction and relaxation rhythm of the heart. In other embodiments, other inert gases can also be selected as the working medium. In the disclosed embodiment, as described above, the counterpulsation pump works according to the cardiac cycle. Before the start of the cardiac systole, the counterpulsation pump drives the balloon 11 to empty quickly; after the start of the cardiac diastole, the counterpulsation pump drives the balloon 11 to inflate. It will be understood that as described below, doctors can select automatic or manual mode as needed and set a suitable counterpulsation ratio to achieve the best assisting effect.

[0133] like Fig.21 and Fig. 22 As shown, the heart failure assist device 1 also includes a balloon catheter delivery device 20. Fig.21As shown, the balloon catheter delivery device 20 includes a delivery device catheter 201 and a catheter connector 202 .

[0134] The delivery catheter 201 can be used as a sheath for delivering the balloon catheter 10. It can be made of a single-layer structure, and the material can be selected from PE, nylon or Pebax, etc. In some embodiments, a three-layer composite structure can also be used, including an inner layer of PTFE, an intermediate layer of metal braided wire or spring, and an outer layer of pebax or nylon. Preferably, the proximal end of the delivery catheter 201 can be designed as a harder structure to provide good pushing performance, and the distal end adopts a softer structure to facilitate passing through complex and curved blood vessels. A rounded or chamfered structure is set at the farthest end of the catheter, and this design can avoid damage to the blood vessel wall when entering the blood vessel.

[0135] The catheter connector 202 includes a connector body 2021 and a sealing structure 2022. The connector body 2021 can be made of metal materials such as stainless steel, or polymer materials such as PE, ABS, PP, PC, etc. The sealing structure 2022 is made of an elastomeric material such as silicone or TPE with similar elasticity. This structural design can ensure smooth passage of the balloon catheter 10 and effectively prevent blood leakage.

[0136] The catheter connector 202 also includes a side branch structure, which may include a connecting side branch tube 2023 and a three-way valve 2024. This design allows heparinized saline to be injected through the three-way valve 2024 during surgery, which can be delivered through the lumen of the catheter body of the balloon catheter, thereby preventing thrombosis in the balloon catheter delivery device 20. In addition, the side branch structure can also be used to measure blood pressure or observe blood reflux, helping doctors to accurately locate the balloon position. When the balloon position needs to be adjusted, the side branch structure can also be used for temporary drug administration or other clinical operations.

[0137] Optionally, sleeves 203 are provided on both sides of the catheter connector 202 of the balloon catheter delivery device 20. Fig.21As shown, the sleeve 203 includes a connection interface 2031 and a cuff 2032. In some embodiments, the distal sleeve 203 is connected to the sheath of the conveyor catheter 201 through its connection interface 2031, thereby protecting the conveyor catheter 201 of the balloon catheter conveyor 20. The proximal sleeve 203 can be connected to the connector 15 of the balloon catheter 10 through its connection interface 2031, and is used to protect the catheter body 14 of the balloon catheter 10 in the extracorporeal part. Optionally, the connection interface 2031 can be made of 304 stainless steel, or PE, PP, PC, ABS, silicone and other polymer materials can be selected, and its connection with other components can be connected by snap, thread or pin connection. Optionally, the cuff 2032 can be designed into a circular or elliptical shape, and its length can be adjusted according to actual needs. The connection interface 2031 and the cuff 2032 can be fixedly connected by bonding, welding or crimping.

[0138] When in use, the balloon catheter 10 is delivered to the target position in a contracted state along the sheath of the balloon catheter delivery device 20. Through this structural design, the heart failure assist device 1 can not only achieve an effective counterpulsation function, but also ensure the safety and controllability of the surgical operation, providing a reliable guarantee for clinical application.

[0139] This embodiment also provides a heart failure assist system. The heart failure assist system includes the above-mentioned heart failure assist device 1, which may also include a guide wire and a sheath. When in use, a percutaneous puncture channel is first established through the guide wire and the sheath, and then the balloon catheter 10 of the heart failure assist device 1 is delivered to the target position through the balloon catheter delivery device 20. The guide wire can be delivered through the lumen in the catheter body 14 of the balloon catheter 10 to reach the target blood vessel, and is used to guide the delivery and positioning of the balloon catheter 10. The vascular sheath provides a safe puncture channel, which is convenient for the placement and adjustment of the balloon catheter 10. Through the cooperation of the guide wire and the vascular sheath, the heart failure assist system can achieve precise positioning and safe delivery of the balloon catheter.

[0140] In order to further explain the different implementation modes of the present invention in detail and ensure that the embodiments of the present invention have wide applicability in various operating conditions and design changes, the different implementation modes are now described through the following multiple specific examples. These examples include but are not limited to the technical features listed in detail below, and are intended to demonstrate the adaptability and diversity of the present invention in different application scenarios.

[0141] It should be understood that all technical features and specific design forms mentioned in the following embodiments of the present invention can be used in combination without conflicting with each other. In addition, the technical solutions and features of the following embodiments of the present invention can also be combined with the description of the aforementioned embodiments to achieve better technical effects. For example, the one-way membrane configuration, support structure arrangement, catheter design and operation method in any embodiment can be combined with the corresponding features in other embodiments through appropriate adjustments to form a new technical solution. This combination can be selected according to actual needs without being limited by the specific embodiments.

[0142] 1. A balloon catheter, comprising:

[0143] The catheter body;

[0144] a balloon disposed on the catheter body;

[0145] at least one unidirectional membrane disposed on at least one side of the balloon; and

[0146] At least one supporting structure is disposed on the catheter body, and is used to support the at least one unidirectional membrane.

[0147] 2. According to the balloon catheter of Example 1, the one-way membrane is configured to close or throttle in response to a volume change of the balloon to prevent or reduce the flow of fluid on one side of the one-way membrane to the other side.

[0148] 3. According to the balloon catheter described in Example 2, the at least one unidirectional membrane includes a first unidirectional membrane arranged on a side of the balloon away from the aortic valve.

[0149] 4. According to the balloon catheter described in Example 3, the first unidirectional membrane structure is configured to close or throttle when the balloon is deflated to prevent or reduce the flow of fluid from the abdominal aorta toward the balloon, and to be opened or expanded when the balloon is inflated to allow or increase the flow of fluid from the balloon toward the abdominal aorta.

[0150] 5. According to the balloon catheter according to any one of Examples 2 to 4, the at least one unidirectional membrane includes a second unidirectional membrane arranged on a side of the balloon close to the aortic valve.

[0151] 6. According to the balloon catheter described in Example 5, the second unidirectional membrane structure is configured to be opened or expanded when the balloon contracts to allow or increase the flow of fluid from the aortic valve toward the balloon, and to be closed or throttled when the balloon is inflated to prevent or reduce the flow of fluid from the balloon toward the aortic valve.

[0152] 7. According to the balloon catheter of Example 1, the at least one unidirectional membrane includes a proximal unidirectional membrane located proximal to the balloon, and the proximal unidirectional membrane includes a fixed end connected to the support structure and a free end located proximal to the fixed end.

[0153] 8. According to the balloon catheter described in Example 1, the at least one unidirectional membrane includes a proximal unidirectional membrane located proximal to the balloon and a distal unidirectional membrane located distal to the balloon, the proximal unidirectional membrane includes a fixed end connected to the support structure and a free end located proximal to the fixed end of the proximal unidirectional membrane, and the distal unidirectional membrane includes a fixed end connected to the support structure and a free end located proximal to the fixed end of the distal unidirectional membrane.

[0154] 9. The balloon catheter according to Example 7 or 8 is configured to be placed into position via the iliac artery or the femoral artery.

[0155] 10. According to the balloon catheter of Example 1, the at least one unidirectional membrane includes a distal unidirectional membrane, and the distal unidirectional membrane includes a fixed end connected to the support structure and a free end located distal to the fixed end.

[0156] 11. According to the balloon catheter described in Example 1, the at least one unidirectional membrane includes a distal unidirectional membrane and a proximal unidirectional membrane, the distal unidirectional membrane includes a fixed end connected to the support structure and a free end located distal to the fixed end of the distal unidirectional membrane, and the proximal unidirectional membrane includes a fixed end connected to the support structure and a free end located distal to the fixed end of the proximal unidirectional membrane.

[0157] 12. The balloon catheter according to Example 10 or 11 is configured to be placed into position via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch.

[0158] 13. According to the balloon catheter according to any one of Examples 1, 3, 5, 7, 8, 10 and 11, the at least one support structure includes a single stent extending from one side of the balloon across the balloon to the other side.

[0159] 14. According to the balloon catheter described in Example 13, there is a radial gap between the stent and the balloon in the expanded state.

[0160] 15. In the balloon catheter according to embodiment 7, 8 or 11, the at least one supporting structure comprises a proximal stent for supporting the proximal unidirectional membrane.

[0161] 16. In the balloon catheter according to Example 8, 10 or 11, the at least one supporting structure comprises a distal stent for supporting the distal unidirectional membrane.

[0162] 18. According to the balloon catheter described in Example 1, the catheter body includes an inner tube and an outer tube that are connected together.

[0163] 19. A heart failure assist device, comprising: a balloon catheter according to any one of Examples 1 to 18.

[0164] 20. The heart failure assist device according to embodiment 19, further comprising:

[0165] a trachea in communication with the balloon; and

[0166] A counterpulsation pump is connected to the trachea.

[0167] 21. The heart failure assist device according to Example 19 or 20 is characterized in that it also includes a balloon catheter delivery device for guiding the balloon catheter, the balloon catheter delivery device includes a sheath, and the balloon catheter is placed in place along the sheath in a contracted state.

[0168] 22. A heart failure assistance system, characterized in that it comprises a heart failure assistance device according to any one of Examples 19 to 21.

[0169] Unless explicitly stated, the actions or steps of the methods, programs, and embodiments of the present invention do not have to be performed in a specific order and can still achieve the desired results. In some implementations, multitasking and parallel processing are also possible or may be advantageous.

[0170] In this article, multiple embodiments of the present invention are described, but for the sake of brevity, the description of each embodiment is not exhaustive, and the same or similar features or parts between the embodiments may be omitted. In this article, "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" are meant to be applicable to at least one embodiment or example according to the present invention, but not all embodiments. The above terms do not necessarily mean to refer to the same embodiment or example. In the absence of contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples.

[0171] It should be understood that the above embodiments are exemplary only and not restrictive. Without departing from the spirit and scope of the present invention, those skilled in the art may make many variations and modifications to the described embodiments. The scope of the present invention is determined by the appended claims and includes equivalent variations that can be imagined by those skilled in the art based on the disclosure of the present invention. These variations and modifications should all fall within the scope of protection of the present invention.

Claims

1. A balloon catheter, characterized in that: include: The catheter body; a balloon disposed on the catheter body; at least one unidirectional membrane disposed on at least one side of the balloon; as well as At least one supporting structure is disposed on the catheter body, and is used to support the at least one unidirectional membrane.

2. The balloon catheter according to claim 1, characterized in that: The one-way membrane is configured to close or throttle in response to a volume change of the balloon to prevent or reduce the flow of fluid from one side of the one-way membrane to the other side.

3. The balloon catheter according to claim 2, characterized in that: The at least one one-way membrane includes a first one-way membrane disposed on a side of the balloon facing away from the aortic valve.

4. The balloon catheter according to claim 3, characterized in that: The first unidirectional membrane structure is configured to close or throttle when the balloon contracts to prevent or reduce fluid flow from the abdominal aorta toward the balloon, thereby increasing blood ejection from the left ventricle, and to open or expand when the balloon is inflated to allow or increase fluid flow from the balloon toward the abdominal aorta and toward the coronary arteries and upper limb and brain blood supply vessels.

5. The balloon catheter according to any one of claims 2 to 4, characterized in that: The at least one one-way membrane includes a second one-way membrane disposed on a side of the balloon close to the aortic valve.

6. The balloon catheter according to claim 5, characterized in that: The second unidirectional membrane structure is configured to be opened or expanded when the balloon is deflated to allow or increase fluid flow from the aortic valve toward the balloon, and to be closed or throttled when the balloon is inflated to prevent or reduce fluid flow from the balloon toward the aortic valve.

7. The balloon catheter according to claim 1, characterized in that: The at least one unidirectional film includes a proximal unidirectional film located proximal to the balloon, the proximal unidirectional film including a fixed end connected to the support structure and a free end located proximal to the fixed end.

8. The balloon catheter according to claim 1, characterized in that: The at least one unidirectional membrane includes a proximal unidirectional membrane located proximal to the balloon and a distal unidirectional membrane located distal to the balloon, the proximal unidirectional membrane includes a fixed end connected to the support structure and a free end located proximal to the fixed end of the proximal unidirectional membrane, and the distal unidirectional membrane includes a fixed end connected to the support structure and a free end located proximal to the fixed end of the distal unidirectional membrane.

9. The balloon catheter according to claim 7 or 8, characterized in that: The balloon catheter is configured to be placed via the iliac artery or the femoral artery.

10. The balloon catheter according to claim 1, characterized in that: The at least one unidirectional membrane includes a distal unidirectional membrane including a fixed end connected to the support structure and a free end located distal to the fixed end.

11. The balloon catheter according to claim 1, characterized in that: The at least one unidirectional membrane includes a distal unidirectional membrane and a proximal unidirectional membrane, the distal unidirectional membrane includes a fixed end connected to the support structure and a free end located distal to the fixed end of the distal unidirectional membrane, and the proximal unidirectional membrane includes a fixed end connected to the support structure and a free end located distal to the fixed end of the proximal unidirectional membrane.

12. The balloon catheter according to claim 10 or 11, characterized in that: The balloon catheter is configured to be placed via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch.

13. The balloon catheter according to any one of claims 1, 3, 5, 7, 8, 10 and 11, characterized in that The at least one support structure includes a single stent extending across the balloon from one side of the balloon to the other side.

14. The balloon catheter according to claim 13, characterized in that: The stent has a radial gap with the balloon in an expanded state.

15. The balloon catheter according to claim 7, 8 or 11, characterized in that: The at least one support structure includes a proximal stent for supporting the proximal unidirectional membrane.

16. The balloon catheter according to claim 8, 10 or 11, characterized in that: The at least one support structure includes a distal stent for supporting the distal unidirectional membrane.

17. The balloon catheter according to claim 1, characterized in that: The catheter body comprises an inner tube and an outer tube which are sleeved together.

18. A heart failure assist device, characterized in that: include: A balloon catheter according to any one of claims 1 to 17.

19. The heart failure assist device according to claim 18, characterized in that: Also includes: a trachea in communication with the balloon; as well as A counterpulsation pump is connected to the trachea.

20. The heart failure assist device according to claim 18 or 19, characterized in that: Also included is a balloon catheter delivery device for guiding the balloon catheter, wherein the balloon catheter delivery device includes a sheath, and the balloon catheter is placed in place along the sheath in a collapsed state.

21. A heart failure assist system, characterized in that: Comprising a heart failure assist device according to any one of claims 18 to 20.

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