Heart failure assisting device, heart failure assisting system, one-way flow control component and kit

Abstract

The invention provides a heart failure assisting device, a heart failure assisting system, a one-way flow control component and a kit. The heart failure auxiliary device comprises a balloon catheter and a balloon catheter, wherein the balloon catheter comprises a catheter body and a balloon arranged on the catheter body; the one-way flow control components are separated from the balloon catheter, each one-way flow control component comprises a supporting structure and at least one one-way membrane arranged on the supporting structure, and the at least one one-way membrane of the one-way flow control component is located on at least one side of the balloon in the state that the one-way membrane is placed in place in the body. According to the heart failure assisting device, the heart failure assisting system and the one-way flow control component, the heart failure assisting effect can be further improved.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular to a heart failure assist device, a heart failure assist system, a one-way flow control component, and a kit. Background Art

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

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

[0004] Intra-aortic balloon pumping (IABP) is a mechanical circulatory support technique currently widely used clinically to assist the failing heart in pumping blood. Existing IABP devices consist of a balloon catheter and a pump. A balloon catheter is placed in the patient's descending aorta. At the onset of diastole (when the aortic valve closes), the pump inflates the intra-aortic balloon, increasing aortic pressure and enhancing coronary perfusion and peripheral vascular flow. Before the onset of systole, the balloon is rapidly deflated, creating a local "vacuum" effect that assists ventricular ejection, reduces cardiac afterload, decreases cardiac work, and reduces myocardial oxygen consumption. Cyclic inflation and deflation of the balloon according to the cardiac cycle lowers systolic pressure, improves left ventricular ejection, increases myocardial oxygen supply, reduces myocardial oxygen demand, and improves cardiac function.

[0005] Given that the intra-aortic balloon pump 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 heart failure assistance device, a heart failure assistance system, a one-way flow control component and a kit that can improve the heart failure assistance effect.

[0008] In a first aspect, an embodiment of the present disclosure provides a heart failure assist device, comprising:

[0009] A balloon catheter comprising a catheter body and a balloon disposed on the catheter body; and

[0010] A one-way flow control member is separate from the balloon catheter, each of the one-way flow control members includes a support structure and at least one one-way membrane arranged on the support structure, wherein the at least one one-way membrane of the one-way flow control member is located on at least one side of the balloon when placed in place in the body.

[0011] In a second 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.

[0012] In a third aspect, an embodiment of the present disclosure provides a one-way flow control member, which includes a support structure and a one-way membrane arranged on the support structure. The one-way flow control member is arranged independently of the balloon catheter and is configured to cooperate with the balloon of the balloon catheter, so as to close or throttle in response to the volume change of the balloon to prevent or reduce the fluid on one side of the one-way membrane from flowing to the other side.

[0013] In a fourth aspect, an embodiment of the present disclosure provides a kit comprising the one-way flow control member according to the third aspect.

[0014] 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

[0015] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. The elements shown are not limited to the scale shown in the drawings. The same or similar reference numerals in the drawings represent the same or similar elements, wherein:

[0016] FIG1( a ) is a schematic diagram of a one-way flow control member for a heart failure assist device according to an embodiment of the present disclosure. Figure 1(b)-Figure 1(c) 1 (a) along the line AA cut, showing the one-way membrane of the balloon catheter of the embodiment shown in FIG 1 (a), wherein FIG 1 (b) shows a closed state, FIG 1 (c) shows an open state;

[0017] Figure 2 is a schematic diagram of a balloon catheter for a heart failure assist device according to an embodiment of the present disclosure;

[0018] Figure 3 The figure shows the state of the heart failure assist device in the body and the direction of blood flow during cardiac contraction;

[0019] Figure 4 Shown during diastole Figure 3 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0020] Figure 5 Shown Figure 3The one-way flow control member and the puncture insertion path of the balloon catheter of the heart failure assist device of the embodiment shown;

[0021] Figure 6 The figure shows a one-way flow control member of a heart failure assist device and a puncture and insertion path of a balloon catheter according to another embodiment of the present disclosure;

[0022] Figure 7 FIG4 shows the state of a heart failure assist device in vivo and the direction of blood flow during cardiac contraction according to another embodiment of the present disclosure;

[0023] Figure 8 Shown during diastole Figure 7 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0024] Figure 9 Shown Figure 7 The one-way flow control member and the puncture insertion path of the balloon catheter of the heart failure assist device of the embodiment shown;

[0025] Figure 10 The figure shows a one-way flow control member of a heart failure assist device and a puncture and insertion path of a balloon catheter according to another embodiment of the present disclosure;

[0026] Figure 11 is an overall schematic diagram of a heart failure assist device according to another embodiment of the present disclosure, wherein a combination of a one-way flow control member and a balloon catheter is positioned in a first orientation;

[0027] Figure 12 Shows the heart contraction according to Figure 11 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0028] Figure 13 Shown during diastole Figure 11 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0029] Figure 14 is an overall schematic diagram of a heart failure assist device according to another embodiment of the present disclosure, wherein the combination of the one-way flow control member and the balloon catheter is positioned in a second orientation;

[0030] Figure 15 Shows the heart contraction according to Figure 14 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0031] Figure 16 Shown during diastole Figure 14 The state of the heart failure assist device in the embodiment shown and the direction of blood flow in the body;

[0032] Figure 17 is a schematic diagram of a component conveyor for conveying a one-way flow control component according to an embodiment of the present disclosure;

[0033] Figure 18 is a schematic diagram of a balloon catheter delivery device according to an embodiment of the present disclosure;

[0034] Figure 19 Schematic diagram of a recoverer for recovering a one-way flow control member according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below in conjunction with specific embodiments and accompanying drawings. Here, the exemplary embodiments of the present invention and their descriptions are used to explain the present invention, but are not intended to limit the present invention.

[0036] 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 particular order, hierarchical relationship, quantitative limitation or importance.

[0037] In addition, unless expressly stated otherwise, words such as “include”, “comprising”, “have”, and “containing” should be understood as open-ended, that is, meaning “including but not limited to”.

[0038] The term "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.

[0039] 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 intended to include the plural form, and vice versa.

[0040] In this specification, the terms "connect," "fix," etc. should be understood broadly. For example, "connection" can refer to mechanical connection, electrical connection, or internal communication between two components; it can be direct connection or indirect connection through an intermediary. Those skilled in the art will understand the specific meanings of these terms based on specific circumstances.

[0041] In this specification, unless the context clearly indicates otherwise, when referring to "proximal," it refers to the end closer to the operator or the side facing the operator during use; when referring to "distal," it refers to the end farther from the operator or the side facing away from the operator during use. In particular, in this specification, since different components, such as a one-way flow control component and a balloon catheter, can be inserted into position from different blood vessels, when describing these different components, such as a one-way flow control component and a balloon catheter, their proximal and distal terms are relative to the operational placement position / orientation of each component. For example, for an independent one-way flow control component, the definitions of its proximal and distal terms are determined based on its actual placement direction, i.e., the direction from its entry point into the blood vessel toward the target location is the distal direction, and the direction from the entry point toward the target location is the proximal direction.

[0042] As previously mentioned, intra-aortic balloon pumping (IABP) plays an important role in assistive treatment of heart failure, and the industry continues to seek further improvements to its effectiveness. The inventors have discovered that during IABP, the pumping action of the intra-aortic balloon causes bidirectional blood flow on both sides of the balloon. This bidirectional flow effect partially offsets the intended directional blood flow effect of the balloon pumping action, potentially affecting the therapeutic effect on heart failure patients.

[0043] Furthermore, as previously mentioned, the balloon is rapidly deflated before the onset of systole, creating a local "vacuum" effect that assists ventricular ejection, reduces the patient's cardiac afterload, decreases cardiac work, and reduces myocardial oxygen consumption. However, after in-depth research, the inventors discovered that when the balloon deflates / empties to create this local "vacuum," the resulting negative pressure simultaneously causes blood to flow back from both the distal and proximal sides of the balloon. This bidirectional flow prevents blood from being pumped solely toward the aortic valve, reducing the pumping effect on cardiac ejection. This results in a minimal increase in cardiac output, which should have significantly improved, and weakens the assistive function of the balloon pump.

[0044] In this regard, the embodiments of the present disclosure provide a heart failure assist device, a heart failure assist system, a one-way flow control component and a kit, which use a one-way flow control component separate from the balloon catheter to control the one-way flow of the fluid, thereby at least partially alleviating or solving the above-mentioned problems. When using intra-aortic balloon counterpulsation, 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 setting a one-way flow control component separate from the balloon catheter and making its one-way membrane able to respond to the volume change of the balloon, effective control of the direction of blood flow can be achieved. This structure not only does not reduce the basic effect of balloon counterpulsation, but can enhance the overall function of balloon counterpulsation by directional guidance of blood flow.

[0045] It should be understood that the above explanation of the principles of the related art is only for the purpose of 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.

[0046] Accordingly, in an embodiment of the present disclosure, a heart failure assist device is provided, which may include: a balloon catheter, the balloon catheter including a catheter body and a balloon arranged on the catheter body; and a one-way flow control member separate from the balloon catheter, each of the one-way flow control members including a support structure and at least one one-way membrane arranged on the support structure, wherein the at least one one-way membrane of the one-way flow control member is located on at least one side of the balloon when placed in place in the body.

[0047] 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 in any combination to obtain new embodiments as needed. It should be understood that each embodiment does not necessarily solve all of the above-mentioned technical problems, and the technical problems that can be solved or the technical effects achieved are not limited to those described above.

[0048] See also Figures 1(a) to 5 , shows a heart failure assist device 1 according to an embodiment of the present disclosure. The heart failure assist device 1 comprises a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10.

[0049] As shown in FIG. 1 , the one-way flow control member 20 includes a support structure 21 and a (first) one-way membrane 23 disposed on the support structure 21 .

[0050] Continue to refer Figure 1(a)-Figure 1(c), the support structure 21 is, for example, in the form of a stent. The support structure 21 includes, for example, a first stent segment 211 located at the distal side and, for example, a second stent segment 212 located at the proximal side. The support structure 21 may further include a recovery connection portion 213, on which a hook-shaped structure 2131 is provided. The support structure (stent), such as the first support structure (stent) 21, may further include a strut 214 connecting the first stent segment 211 and the second stent segment 212. Figure 1(a)-Figure 1(c) As shown, the support structure, for example, in the form of a bracket, can form a grid structure, and the support structure 21 can adjust its support strength and flexibility according to specific needs by changing the density and shape of its grid structure.

[0051] like Figure 1(a)-Figure 1(c) As shown, the first stent segment 211 is a large diameter segment that can be used to prop open a blood vessel at a corresponding position, such as a blood vessel at the descending aorta DA. The first stent segment 211 can have a diameter of 10mm-50mm, for example. As shown in FIG1 , the first stent segment 211 can have a stabilizing arch 1211 for supporting the blood vessel wall so as to stably support the blood vessel. Continuing with reference to FIG1 , the second stent segment 212 is specifically in a generally conical shape and is connected to or integral with the recovery connection 213. As described below, the hook-shaped structure 2131 of the recovery connection 213 can be connected to the snare 53 ( Figure 19 ) are joined. Furthermore, the first support segment 211 and the second support segment 212 are connected by a support rod 214 to form an integral support frame. Preferably, the support rod 214 as a whole can have a tapering cross-section, such as an arcuate or sloped cross-section, thereby transitioning from the larger diameter first support segment 211 to the smaller diameter second support segment 212.

[0052] In the embodiment of the present disclosure, the support structure (bracket) 21 can be made of superelastic material, such as nickel titanium alloy. Figure 1(a)-Figure 1(c) As shown, for example, a support structure in the form of a stent can form a grid structure, and the support structure 21 can adjust its support strength and flexibility according to specific needs by changing the density and shape of its grid structure. In the embodiment of the present disclosure, the surface of the support structure (stent) 21 may be coated. 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 by any suitable means, including but not limited to sewing with sutures, adhesive bonding, spraying, dipping, electrospinning, etc.

[0053] In the embodiment of the present disclosure, as shown in Figures (a) to 1 (c), the one-way membrane is, for example, in the form of a valve. Preferably, the (first) one-way membrane (valve) 23 may include a plurality of leaflets 230. In some preferred embodiments, the one-way membrane 23 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 may be two or more than three. Figure 3 and Figure 4 As shown, the one-way membrane 23 and its leaflets have a fixed end 231 and a free end 232. The fixed end 231 can be fixedly connected to the inner side of the support structure 21. Depending on the placement position in the body, the free end 232 of the one-way membrane 23 can be located closer to or away from the balloon relative to the fixed end 231. Figure 1(a)-Figure 1(c) to Figure 5 In the illustrated embodiment, the free end 232 of the one-way membrane 23 may be located on a side facing away from the balloon 11 relative to the fixed end 231 .

[0054] In the embodiment of the present disclosure, the connection between the (first) one-way membrane (valve) 23 and the support structure 21 can be carried out in a variety of ways. In some embodiments, the connection can be made by sewing with sutures. In other embodiments, adhesive bonding can 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 embodiment of the present disclosure, the leaflet can be arranged on the inner surface of the support structure (stent) 21, or it can be arranged at other positions of the support structure (stent) 21, such as other stent structures specially provided for fixing the one-way membrane (valve), such as anchor crowns.

[0055] In this embodiment, the material of the (first) one-way membrane (valve) 23 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, they can be treated with alcohol immersion or detergent. In some other embodiments, it can also be made of polymer materials, such as LLDPE, ePTFE, SEBS, TPU, silicone rubber, etc. In the embodiments of the present disclosure, any suitable one-way membrane (valve) material can be selected according to different mechanical properties and biocompatibility requirements.

[0056] In some embodiments, an anticoagulant coating may be applied to the surface of the (first) one-way membrane (valve) 23 to improve blood compatibility. The choice of coating and the process used can be tailored to specific needs, ensuring an anticoagulant effect without compromising the mechanical properties of the leaflets. In some embodiments, the leaflet material itself may also have anticoagulant properties.

[0057] In some embodiments, appropriate leaflet contour designs can be employed to achieve a good seal under blood pressure. For example, the connection area of ​​the fixed end 231 can be reinforced to improve connection reliability and durability. For example, the free end 232 can have an optimized edge shape to reduce the impact of blood on the leaflet and extend its service life.

[0058] like Figure 2 As shown, the balloon catheter 10 includes a catheter body 14 , a balloon 11 disposed on the catheter body 14 , and a connector 15 disposed at the proximal end of the catheter body 14 .

[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 means of heat melting or bonding. 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 present embodiment, the filling gas of the balloon is preferably an inert gas, such as but not limited to helium.

[0060] In the embodiment of the present disclosure, a catheter lumen (not marked) that allows the trachea to pass through can be formed in the catheter body 14. The catheter body 14 may include an inner tube and an outer tube that are connected, so that an overlapping lumen can be provided, thereby allowing one of the lumens to be placed on the basis of the trachea, while 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 silk 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 silk or a multi-layer composite structure can be used. 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 silk or a multi-layer composite structure can be used. 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 silk or a multi-layer composite structure can be used. In some embodiments, the outer tube can adopt a three-layer composite structure, including an inner layer of PTFE, an intermediate layer of metal braided wire layer and an outer layer of Pebax or nylon layer. This structure can provide good pushing performance and torsion control. In the embodiment of the present disclosure, a tip can be provided at the distal end of the catheter body 14, and the tip can adopt a rounded or chamfered structure to avoid damage to the blood vessel wall when entering the blood vessel. In the embodiment of the present disclosure, the tip can be an integral part of the inner tube or outer tube, or fixedly connected to the distal end of the inner tube and / or outer tube. In some embodiments, in order to facilitate positioning under X-rays, a developing structure can be provided on the inner tube, outer tube or tip of the balloon segment. These developing structures can take various forms, such as an extruded tube containing barium sulfate or bismuth, or a platinum-iridium alloy ring, a gold ring or a tantalum ring, etc. These developing marks can be used to accurately indicate the position of the balloon. In a preferred embodiment not shown, radiopaque development marks can be provided on the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1, respectively, that is, the balloon catheter 10 includes a first development mark (such as the development mark described above), and the one-way flow control member 20 includes a second development mark. The first development mark and the second development mark can be used to indicate the relative placement position between the balloon 11 of the balloon catheter 10 and the one-way membrane of the one-way flow control member 20, and can be combined with the ray projection device of the heart failure assist system to obtain an accurate positioning effect, as described below. In some embodiments, a protective outer jacket (outer tube accessory) can also be provided on the outside of the catheter body 14. This outer jacket can protect the outer tube from the influence of the external environment and maintain the cleanliness and sterility of the catheter.

[0061] The connector 15 includes at least one, preferably two or more interfaces, including but 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] In the embodiment of the present disclosure, 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 mentioned above, helium can be used as the working gas in the trachea. Its small molecular weight and low density 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 embodiment of the present disclosure, as mentioned 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. People will understand that, as described below, doctors can select automatic or manual mode as needed and set the appropriate counterpulsation ratio to achieve the best assist effect.

[0063] Below is a combination of Figure 1-2 and Figure 3-4 The working process of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment when they are placed in place in the body is described, wherein: Figure 3 The figure shows the state of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 in the body and the related blood flow direction during cardiac contraction. Figure 4 The diagram shows the in vivo status of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 during diastole and the related blood flow direction.

[0064] like Figure 3 and Figure 4 As shown schematically, the balloon catheter 10 and the one-way flow control member 20 are placed in place in the body, that is, placed in the descending aorta DA, and the one-way flow control member 20 and its (first) one-way membrane 23 are located on the side of the balloon 11 of the balloon catheter 10 away from the aortic valve AV.

[0065] How the (first) one-way membrane 23 controls the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0066] Specifically, if Figure 3As shown, before or during the onset of the cardiac systole, the counterpulsation pump can drive the balloon 11 to empty rapidly. 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 one-way membrane (valve) 23 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 side of the first one-way membrane 23 away from the balloon 11 that is greater than the pressure difference on the side close to the balloon 11. In this embodiment, when placed in place in the body, the free end 232 of the first one-way membrane 23 is located on the side away from the balloon 11 relative to the fixed end 231. That is, when placed in place in the body, the free end 232 is located below the fixed end 231, as shown in FIG. Figure 3 As shown. Thus, the first unidirectional membrane 23 of the unidirectional flow control member 20 forms such a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the bottom to the top, which can also be expressed as a unidirectional flow from the ventral side to the heart side or a unidirectional flow from the abdominal aorta toward the balloon. Figure 3 As shown, under the action of the aforementioned pressure differential, the free end 232 of the first unidirectional membrane 23 closes, and the leaflets fit tightly together to form a reliable seal. This closed state effectively prevents blood from flowing back from the abdominal aorta (blood flow direction 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 utilized (blood flow direction shown by arrow A1), which can better assist the ventricle in ejecting blood into the aorta, significantly increasing cardiac output, while reducing the patient's cardiac afterload, reducing cardiac work, and reducing myocardial oxygen consumption.

[0067] like Figure 4 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 one-way membrane (valve) 23 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 one-way membrane 23 that is greater on the side close to the balloon 11 than on the side away from the balloon 11. As mentioned above, the one-way flow control direction of the first one-way membrane 23 of the one-way flow control component 20 is a one-way flow from top to bottom (a one-way flow from the heart side to the ventral side or a one-way flow from the balloon direction toward the abdominal aorta). Thus, as Figure 4 As shown, under the action of the aforementioned pressure differential, the free end 232 of the first unidirectional membrane 23 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 abdominal aorta. This not only increases blood supply to the kidneys (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 perfusion of the coronary arteries (blood flow direction, see arrow A2).

[0068] Through the above-mentioned structural design and working mechanism, the one-way flow control component 20 of this embodiment cooperates with the volume change of the balloon catheter 10 to alleviate 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 one-way membrane 23 effectively prevents blood backflow 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 expanded, the reasonable opening of the first one-way membrane 23 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 one-way membrane 23 can automatically open and close according to the volume change of the balloon 11, without the need for an additional control mechanism, and the structure is simple and reliable.

[0069] It should be noted that the working mode of the first one-way membrane 23 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 open to allow forward flow. For example, the one-way membrane can also be designed to be normally open. When the balloon deflates and generates negative pressure, the normally open one-way membrane is forced to close or throttle in response to the pressure differential to control backflow. When the balloon is inflated, the one-way membrane (valve) returns to its open state to allow forward 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.

[0070] The following is combined with reference to Figures 1-5 and Figure 17-19 The following describes the operation of placing the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment into the body and the operation of recovering them from the body, as well as related components, devices, etc.

[0071] like Figure 17 As shown, the heart failure assist device 1 may further include a component conveyor 30 for guiding, for example, conveying and placing the one-way flow control component 20. The component conveyor 30 may include an inner tube 31 and an outer tube 33, and may further include an optional inner tube connector 32 and an outer tube connector 34. Figure 17 As shown, the outer tube 33 can be stacked on the inner tube 31 and the inner tube 31 can be slidably arranged relative to the outer tube 33.

[0072] In the disclosed embodiment, the material of the inner tube 31 can be harder than the material of the outer tube 33, for example, but not limited to, made of stainless steel tube, PEEK tube or nylon tube. Preferably, the inner tube 31 may have a connection structure with the one-way flow control member 20, more specifically the support structure 21, at the end, so as to accurately release the one-way flow control member. The inner tube connector 32 can be in the form of a Luer connector (e.g., a female Luer connector) so as to be connected to the matching Luer connector (e.g., a male Luer connector) of the fluid supply unit. The design of the inner tube connector 32 is conducive to flushing the inner tube and injecting heparinized saline. At the same time, the inner tube and the inner tube connector can also provide a channel for the guide wire to pass through.

[0073] In the embodiment of the present disclosure, the outer tube 33 can be used as a sheath for conveying the one-way flow control member 20. The outer tube 33 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 coiled spring, and an outer layer of Pebax or nylon. Preferably, the proximal end of the outer tube 33 can be designed to be a harder structure to provide good pushing performance, while the distal end adopts a softer structure to facilitate passing through complex and curved blood vessels. Preferably, a rounded or chamfered structure is provided at the farthest end of the outer tube. This design can avoid damage to the blood vessel wall when entering the blood vessel.

[0074] The outer tube connector 34 may include a connector body and a sealing structure 343. The connector body may be made of a metal material such as stainless steel, or a polymer material such as PE, ABS, PP, or PC. The sealing structure 343 may be made of an elastomeric material such as silicone or TPE with similar elasticity. This structural design ensures smooth passage of the inner tube 31 while effectively preventing blood leakage.

[0075] The outer tube connector 34 may also include a side branch structure, which may include a connecting tube 341 and a valve, such as a three-way valve 342 or a two-way valve. This design allows heparinized saline to be injected through the valve, such as the three-way valve 342, during operation and transported through the lumen of the inner tube 33, thereby preventing the formation of blood clots in the component transporter 30.

[0076] The outer tube 33 includes a distal receptacle 35 for accommodating the one-way flow control member 20 in a retracted state. During use, the one-way flow control member 20 is pre-installed in its retracted state within the distal receptacle 35 of the outer tube 33 of the component transporter 30 and manually transported to a target location via the sheath (outer tube 33) of the component transporter 30. Once at the target location, the one-way flow control member 20 is precisely released by the relative sliding movement of the inner tube 31 and outer tube 33.

[0077] Through this structural design, the component conveyor 30 can not only safely and reliably convey the one-way flow control component 20 to the target position, but also achieve precise release, providing reliable protection for clinical applications.

[0078] like Figure 18 As shown, the heart failure assist device 1 further includes a balloon catheter delivery device 40. Figure 18 As shown, the balloon catheter delivery device 40 includes a delivery catheter 41 and a catheter connector 42 .

[0079] The delivery catheter 41 can be used as a tool 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. In some embodiments, a three-layer composite structure can also be used, including an inner layer of PTFE, a middle layer of metal braided wire or coiled spring, and an outer layer of Pebax or nylon. Preferably, the proximal end of the delivery catheter 41 can be designed to have a harder structure to provide good pushing performance, while the distal end adopts a softer structure to facilitate passage through complex and curved blood vessels. A rounded or chamfered structure is provided at the farthest end of the catheter. This design can avoid damage to the blood vessel wall when entering the blood vessel.

[0080] The catheter connector 42 comprises a connector body 421 and a sealing structure 422. The connector body 421 can be made of a metal material such as stainless steel, or a polymer material such as PE, ABS, PP, or PC. The sealing structure 422 is made of an elastomeric material such as silicone or TPE with similar elasticity. This structural design ensures smooth passage of the balloon catheter 10 while effectively preventing blood leakage.

[0081] The catheter connector 42 also includes a side branch structure, which may include a side branch tube 423 and a three-way valve 424 or a two-way valve. This design allows for the injection of heparinized saline solution through the three-way valve 424 during surgery. This saline solution, for example, can be delivered through the lumen of the balloon catheter body, thereby preventing the formation of blood clots within the balloon catheter delivery device 40. Furthermore, the side branch structure can be used to measure blood pressure or monitor blood reflux, helping the physician accurately position the balloon. If the balloon position needs to be adjusted, the side branch structure can also be used for temporary drug administration or other clinical procedures.

[0082] Optionally, sleeves 43 are provided on both sides of the catheter connector 42 of the balloon catheter delivery device 40. Figure 18As shown, the sleeve 43 includes a connection interface 431 and a cuff 432. In some embodiments, the distal sleeve 43 is connected to the sheath of the conveyor catheter 41 through its connection interface 431, thereby protecting the conveyor catheter 41 of the balloon catheter conveyor 40. The proximal sleeve 43 can be connected to the connector 15 of the balloon catheter 10 through its connection interface 431, and is used to protect the catheter body 14 of the balloon catheter 10 outside the body. Optionally, the connection interface 431 can be made of 304 stainless steel, or a polymer material such as PE, PP, PC, ABS, silicone, etc., and its connection with other components can be achieved by means of snap, thread or pin connection. Optionally, the cuff 432 can be designed into a circular or oval shape, and its length can be adjusted according to actual needs. The connection interface 431 and the cuff 432 can be fixedly connected by bonding, welding or crimping.

[0083] During use, the balloon catheter 10 is delivered to the target location in a deflated state along the sheath of the balloon catheter delivery device 40. With this structural design, the heart failure assist device 1 not only achieves effective counterpulsation but also ensures the safety and controllability of the surgical operation, providing reliable protection for clinical application.

[0084] like Figure 19 As shown, the heart failure assist device 1 may further include a recycler 50 for retrieving the one-way flow control member 20. Figure 19 As shown, the retriever 50 includes an inner tube 51 , an outer tube 52 and at least one, preferably a plurality of, snares 53 .

[0085] In the embodiment of the present disclosure, the snare 53 is disposed at the distal end of the inner tube 51 and is adapted to engage the hook structure 2131 of the recovery connection portion 213 of the one-way flow control member 20. Figure 19 As shown, the snare 53 can be made of a filamentous material. More specifically, the filamentous material of the snare 53 can be selected from any one of nickel titanium, stainless steel, nylon wire, ultra-high molecular weight polyethylene wire, PTFE wire, platinum-iridium alloy, and gold wire. Preferably, the filamentous material of the snare 53 can be nickel titanium or stainless steel wire plated with gold / platinum or wrapped with heavy metal wire to improve the visualization effect of the snare wire in the blood vessel. The distal end 531 of the snare has at least one loop similar to a circle or an ellipse to reliably hook the hook-shaped structure 2131 of the recovery connection portion of the one-way flow control member 20. Optionally, the retriever 50 can also include a snare pull wire 54 connected to the snare 53, which is, for example, made of the same material as the snare. The snare pull wire 54 can extend in the lumen of the inner tube 51 to the proximal end of the retriever, so that the operator can pull back the one-way flow control member 20 by operating the snare pull wire, so that the recovery connection part 213 of the one-way flow control member 20 is close to the end of the inner tube 51, thereby facilitating the compression of the one-way flow control member 20 through the relative movement of the outer tube 52 relative to the inner tube 51.

[0086] In the disclosed embodiment, the inner tube 51 can be made of any suitable material, including but not limited to PE, PA, Pebax, PEEK and other polymer materials or a three-layer composite structure (inner layer PTFE, middle layer braided wire or spring, outer layer Pebax or nylon). Figure 19 As shown, the inner tube is provided with a developing mark 511 at the end, such as PtIr, gold or barium sulfate, tungsten powder, etc., which is conducive to radiological identification of the distal end position of the inner tube in the blood vessel.

[0087] In the disclosed embodiment, the outer tube 52 can be made of any suitable material, including but not limited to PE, PA, Pebax, PEEK and other polymer materials or a three-layer composite structure (inner layer PTFE, middle layer braided wire or spring, outer layer pebax or nylon). Preferably, the proximal end of the outer tube is harder (to facilitate pushing) and the distal end of the outer tube is softer (to facilitate entering the curved target blood vessel). Figure 19 As shown, the outer tube is provided with a developing mark 521 at the end, such as built-in PtIr, gold or barium sulfate, tungsten powder, etc., which is conducive to radiological identification of the distal end position of the outer tube in the blood vessel.

[0088] Reference below Figure 5 and Figures 17 to 19 The following describes the placement and recovery processes of the one-way flow control member 20 and the balloon catheter 10 of the heart failure assist device 1 according to an embodiment of the present disclosure.

[0089] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be placed in the body along a first insertion direction D1, such as in the descending aorta DA, and the balloon catheter 10 can be configured to be placed in the body along a different second insertion direction D2, such as in the descending aorta DA. Figure 5 In the specific embodiment shown, the one-way flow control member 20 is placed in position along a first insertion direction D1 from bottom to top. More specifically, the first insertion direction includes the iliac artery or the femoral artery FA ( Figure 5 ) is placed in the descending aorta DA. The balloon catheter 10 is placed in position along the second placement direction D2 from top to bottom. More specifically, the second placement direction includes the placement direction of the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 5 In this embodiment, the aortic arch is accessed via the subclavian artery. In this embodiment, a member delivery device 30 can be used to guide the one-way flow control member 20, thereby placing the one-way flow control member 20 in place. In this embodiment, the balloon catheter 10 can be placed using a sheath, or the balloon catheter 10 can be placed in place by sheathless puncture.

[0090] exist Figure 5In the embodiment shown, due to different insertion directions / orientations / positions, the insertion operation of the one-way flow control member 20 and the insertion operation of the balloon catheter 10 can be performed in any suitable order, such as synchronously or asynchronously. For example, the balloon catheter 10 can be inserted first and then the one-way flow control member 20, or vice versa.

[0091] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be recovered from the body along a first recovery direction D3, such as from the descending aorta DA, and the balloon catheter 10 can be configured to be recovered from the body along a different second recovery direction D4, such as from the descending aorta DA. Figure 5 In the specific embodiment shown, the one-way flow control member 20 is recovered along a first recovery direction D3 from top to bottom, that is, a direction opposite to the first insertion direction D1. More specifically, the first recovery direction includes the first recovery direction from the descending aorta DA through the iliac artery or the femoral artery FA ( Figure 5 The balloon catheter 10 is recovered along the second recovery direction D4 from bottom to top, i.e., the direction opposite to the second insertion direction D2. More specifically, the second recovery direction includes the recovery direction from the descending aorta through the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 5 In the middle, it was retrieved via the aortic arch and subclavian artery approach.

[0092] exist Figure 5 In the embodiment shown, due to different recovery directions / orientations / positions, the recovery operation of the one-way flow control member 20 and the recovery operation of the balloon catheter 10 can be performed in any suitable order, such as synchronously or asynchronously. For example, the balloon catheter 10 can be recovered first and then the one-way flow control member 20, or vice versa.

[0093] In another embodiment, the first insertion direction D1 and the first recovery direction D3 of the one-way flow control member 20 can be set independently, so that the first recovery direction D3 does not have to be the opposite direction of the first insertion direction D1, that is, there is no need to recover the one-way flow control member 20 in the original direction opposite to the insertion direction.

[0094] In some embodiments, the one-way flow control member 20 can be configured to be placed in place in the body along the insertion direction, and the balloon catheter 10 can also be configured to be placed in place in the body along the same insertion direction, for example, along the same insertion direction. Figure 5 The second insertion direction D2 is the same as the second insertion direction D2 shown, for example, the balloon catheter is inserted into the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. More specifically, the balloon catheter is inserted into the aortic arch via the subclavian artery. In these embodiments, the insertion operation of the balloon catheter 10 is performed after the insertion operation of the one-way flow control member 20. In these embodiments, the withdrawal direction of the one-way flow control member 20 can still be the same as that shown in FIG. Figure 5The first recovery direction D3 shown in FIG. 1 is consistent with the first recovery direction D3 shown in FIG. 1 , and the recovery direction of the balloon catheter 10 can also be consistent with the first recovery direction D3 shown in FIG. Figure 5 The second retraction direction D4 shown is consistent, and thus, the retraction operation of the one-way flow control member 20 and the retraction operation of the balloon catheter 10 can still be performed in any appropriate order.

[0095] See also Figure 6 , shows the modified schemes of the heart failure assist device 1 and the one-way flow control member 20 thereof according to other embodiments of the present disclosure. Figure 6 The main difference between the heart failure assist device 1 and the one-way flow control member 20 in the embodiment shown in FIG. 1 to FIG. 5 is the orientation of the recovery connection portion of the support structure (stent) of the one-way flow control member 20 relative to the one-way membrane, thereby Figure 6 The one-way flow control member 20 in the embodiment shown has Figure 5 The different (first) recovery directions of the one-way flow control member 20 in the illustrated embodiment and other features (including the working process of the one-way fluid control) can be referred to the embodiments shown in Figures 1 to 5 and will not be described in detail here.

[0096] In such Figure 6 In the embodiment shown, the heart failure assist device 1 includes a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10. The one-way flow control member 20 includes a support structure 21 and a (first) one-way membrane 23 disposed on the support structure 21. The support structure 21 is also in the form of a stent, and includes a recovery connection portion, on which a hook-shaped structure ( Figure 6 Not explicitly shown). The one-way membrane is, for example, in the form of a valve and comprises a plurality of leaflets, such as Figure 6 As shown, the one-way membrane 23 and its leaflets have a fixed end 231 and a free end 232. Figure 6 In the embodiment shown, the relative orientation of the free end 232 of the one-way membrane 23 and the recovery connection portion and its hook structure is the same as that shown in FIG. Figure 5 In contrast to the embodiment shown, Figure 6 In the embodiment, the free end 232 of the one-way membrane 23 is still located on the side away from the balloon 11 relative to the fixed end 231, but the recovery connection portion faces the balloon. Figure 6 In the embodiment, the free end 232 of the (first) one-way membrane (valve) 23 faces away from the recovery connection portion of the support structure (stent). Accordingly, the fixed position of the fixed end 231 of the one-way membrane 23 can be adjusted accordingly as needed.

[0097] Other features of the support structure and the one-way membrane as well as features of other components of the heart failure assist device are not described here in detail.

[0098] exist Figure 6In the embodiment of the heart failure assist device 1, when the balloon catheter 10 and the one-way flow control member 20 separated from the balloon catheter 10 are placed in place in the body, the working process can be referred to Figures 1 to 2. Figure 5 Example of .

[0099] exist Figure 6 In the embodiment of the heart failure assist device 1, the one-way flow control member 20 and the balloon catheter 10 can be placed in the process of referring to FIG. Figure 5 However, the placement direction of the one-way flow control member 20 and the balloon catheter 10 of the heart failure assist device 1 can be different from the above-mentioned Figure 5 The implantation directions of the illustrated embodiments are different. For example, the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 may have the same implantation direction, ie, the first and second implantation directions D1 and D2 from top to bottom.

[0100] exist Figure 6 In the embodiment of the one-way flow control member 20, the recovery connection portion has Figure 5 Different orientations of the embodiment shown, whereby the (first) retraction direction D3 of the one-way flow control member 20 is different from the Figure 5 The recycling direction is opposite to that shown. Figure 6 In the illustrated embodiment, the retraction operation of the one-way flow control member 20 is performed after the retraction operation of the balloon catheter 10 .

[0101] See also Figures 7 to 9 , shows another embodiment of a heart failure assist device 1 of the present disclosure. The heart failure assist device 1 also includes a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10. The specific structure of the balloon catheter 10 can be referred to the above embodiment and will not be repeated here.

[0102] In this embodiment, the one-way flow control member 20 includes a support structure 21, a first one-way membrane 23 and a second one-way membrane 25 disposed on the support structure 21. The support structure 21 is in the form of a bracket, including a single bracket for supporting the first one-way membrane 23 and the second one-way membrane 25.

[0103] like Figure 7 and Figure 8 As shown, when placed in place within the body, the heart failure assist device 1 is configured such that the balloon 11 is positioned between the first one-way membrane 23 and the second one-way membrane 25 relative to the support structure 21. Specifically, the first one-way membrane 23 is located on the side of the balloon 11 facing away from the aortic valve AV, and the second one-way membrane 25 is located on the side of the balloon 11 closer to the aortic valve AV. The specific structural and material characteristics of the support structure 21 can be found in the corresponding contents of the aforementioned embodiments.

[0104] like Figure 7In the embodiment shown, the specific structural features of the first unidirectional membrane can be referred to Figures 1 to 2. Figure 5 The second one-way membrane 25 can also be in the form of a valve, including multiple leaflets. In some preferred embodiments, the second one-way membrane 25 can adopt a three-leaf structure design. Figure 7 and Figure 8 As shown, the first one-way membrane 23 (valve) and its leaflets may include a fixed end 231 and a free end 232. The second one-way membrane 25 (valve) and its leaflets may have a fixed end 251 and a free end 252. The fixed end 251 of the second one-way membrane 25 (valve) may be fixedly connected to the inner side of the support structure 21. Figure 7 As shown, the free end 252 of the second one-way membrane 25 (valve) can be located on the side away from the aortic valve AV compared to the fixed end 251. As a result, the first one-way membrane 23 and the second one-way membrane 25 can have the same orientation and thus have the same orientation of unidirectional flow control. That is, when placed in place in the body, the free end 232 of the first one-way membrane 23 is located on the side away from the balloon 11 relative to the fixed end 231, and the free end 252 of the second one-way membrane 25 is located on the side closer to the balloon 11 relative to the fixed end 251. The material characteristics of the first one-way membrane 23 and the second one-way membrane 25 and the connection method with the support structure 21 can refer to the corresponding contents in the aforementioned embodiments.

[0105] People will understand, Figures 7 to 9 The structural features, material selection, connection methods and other technical features of the various components of the heart failure assist device in the embodiment shown can be referred to Figures 1 to Figure 5 The corresponding technical features in the illustrated embodiments are not described in detail here.

[0106] The following combination Figure 7 and Figure 8 The working process of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment when they are placed in place in the body is described, wherein: Figure 7 The figure shows the state of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 in the body and the related blood flow direction during cardiac contraction. Figure 8 The diagram shows the in vivo status of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 during diastole and the related blood flow direction.

[0107] like Figure 7 and Figure 8 As shown schematically, the balloon catheter 10 and the one-way flow control member 20 are placed in place in the body, that is, inserted into the descending aorta DA, and the first one-way membrane 23 is located on the side of the balloon 11 of the balloon catheter 10 away from the aortic valve AV, and the second one-way membrane 25 is located on the side of the balloon 11 close to the aortic valve AV.

[0108] How the first one-way membrane 23 and the second one-way membrane 25 control the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0109] Specifically, if Figure 7 As shown, before or at the beginning of the cardiac systole, the counterpulsation pump drives the balloon 11 to be quickly emptied. In this process, the rapid emptying of the balloon 11 forms a local "vacuum" effect around it, generating negative pressure.

[0110] At this time, the blood pressure on the side of the first one-way membrane 23 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 side of the first one-way membrane 23 away from the balloon 11 that is greater than the pressure on the side close to the balloon 11. In this embodiment, when placed in place in the body, the free end 232 of the first one-way membrane 23 is located on the side away from the balloon 11 relative to the fixed end 231. That is, when placed in place in the body, the free end 232 is located below the fixed end 231. Figure 7 As shown. Thus, the first unidirectional membrane 23 of the unidirectional flow control member 20 forms such a unidirectional flow control unit, which can selectively control (block or throttle) the unidirectional flow from the bottom to the top, which can also be expressed as a unidirectional flow from the ventral side to the heart side or a unidirectional flow from the abdominal aorta toward the balloon. Figure 7 As shown, under the influence of the aforementioned pressure differential, the free end 232 of the first one-way membrane 23 closes, and the leaflets tightly fit together to form a reliable seal. This closed state effectively prevents blood from flowing back from the abdominal aorta (blood flow direction is shown by arrow A3), thereby enhancing the directional suction effect on the AV side of the aortic valve.

[0111] At the same time, the blood pressure on the side of the second unidirectional membrane 25 closer to the balloon 11 is lower than the blood pressure on the side away from the balloon, resulting in a pressure differential on the second unidirectional membrane 25 with a greater pressure difference on the side away from the balloon 11 than on the side closer to the balloon 11. In this embodiment, when placed in place in the body, the free end 252 of the second unidirectional membrane 25 is located on the side of the fixed end 251 closer to the balloon 11. That is, when placed in place in the body, the free end 252 is located below the fixed end 251. Thus, the second unidirectional membrane 25 forms a unidirectional flow control unit that can selectively control unidirectional flow from top to bottom, which in this embodiment can also be expressed as unidirectional flow from the cardiac side to the ventral side or unidirectional flow from the aortic valve toward the balloon. Under the action of the above-mentioned pressure differential opposite to the unidirectional flow control, the free end 252 of the second unidirectional membrane 25 is opened, and the leaflets form a good flow channel. This open state allows blood to flow from the aortic valve in the AV direction (blood flow direction is shown by arrow A1). At this time, the aortic valve AV is in an open state. Through the cooperation between the closing of the first one-way membrane 23 and the opening of the second one-way membrane 25 , the negative pressure effect of the balloon 11 is fully exerted.

[0112] The coordination of the closing of the first one-way membrane 23 and the opening of the second one-way membrane 25 can better assist the ventricle in ejecting 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.

[0113] like Figure 8 As shown, after the start of cardiac diastole (when the aortic valve AV is closed), the counterpulsation pump drives the balloon 11 to inflate.

[0114] At this time, due to the pressure generated by the expansion of the balloon 11, the blood pressure on the side of the first one-way membrane (valve) 23 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 one-way membrane 23 where the side close to the balloon 11 is greater than the pressure on the side away from the balloon 11. As mentioned above, the one-way flow control direction of the first one-way membrane 23 of the one-way flow control member 20 is a one-way flow from top to bottom (one-way flow from the heart side to the ventral side or one-way flow from the balloon toward the abdominal aorta). Therefore, as Figure 8 As shown, under the action of the aforementioned pressure difference, the free end 232 of the first unidirectional membrane 23 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 abdominal aorta, thereby increasing the blood supply to the kidney KD (blood flow direction is shown by arrow A5).

[0115] At the same time, the blood pressure on the side of the second one-way membrane 25 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 one-way membrane 25, where the side away from the balloon 11 is smaller than the side close to the balloon 11. As mentioned above, when placed in place in the body, the free end 252 is located below the fixed end 251. Thus, the second one-way membrane 25 forms a one-way flow control unit, which can selectively control (block or throttle) the one-way flow from the bottom to the top, which in this embodiment can also be expressed as a one-way flow from the ventral side to the heart side or a one-way flow from the balloon toward the aortic valve. Under the action of the above-mentioned pressure difference consistent with the one-way flow control direction, the free end 252 of the second one-way membrane 25 is closed, and the leaflets are tightly fitted 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 25 can still fully perfuse the coronary artery (see arrow A2 for blood flow direction). The opening of the first one-way membrane 23 and the closing of the second one-way membrane 25 not only further increase the blood supply to the kidney KD (see arrow A5 for the blood flow direction), but also further improve the perfusion effect of other peripheral blood vessels (see arrow A4 for the blood flow direction).

[0116] like Figure 8As shown, there is a radial gap between the support structure (stent) 21 and the inflated balloon 11. This integrally extended support structure design ensures normal expansion and contraction of the balloon 11 while providing a stable support environment for the balloon catheter by cooperating with the reasonable gap between the balloon and the support structure.

[0117] Through the above-described structural design and working mechanism, the one-way flow control member 20 of this embodiment, in conjunction with the volume change of the balloon catheter 10, solves the problem of bidirectional blood flow caused by balloon pumping in the prior art. As described in the background art, after the onset of diastole (when the aortic valve is closed), the balloon pump drives the inflation of the intra-aortic balloon, increasing aortic pressure, increasing coronary perfusion and peripheral vascular flow. However, in some cases, peripheral vascular blood flow is still insufficient. This may be due to the influence of the bidirectional flow of blood on both sides of the balloon, resulting in some blood not being effectively directed to the peripheral vessels. In particular, when the balloon 11 is deflated, the closing of the first one-way membrane 23 and the opening of the second one-way membrane 25 effectively prevent blood backflow on the abdominal aorta side, significantly enhancing the suction effect on the aortic valve side and improving the auxiliary effect on ventricular ejection. In addition, after the onset of diastole (when the aortic valve is closed), the balloon pump drives the inflation of the intra-aortic balloon, increasing aortic pressure, increasing coronary perfusion and peripheral vascular flow. After research, the inventors discovered that during the balloon inflation phase, peripheral blood flow can still be insufficient under certain conditions. This is likely due to the bidirectional flow of blood on both sides of the balloon, which prevents some blood from being effectively directed to the peripheral vessels. Therefore, by coordinating the opening of the first unidirectional membrane 23 and the closing of the second unidirectional membrane 25, the problem of insufficient peripheral blood flow in the prior art is overcome. Throughout the entire operation, both the first and second unidirectional membranes 23, 25 automatically open and close according to the volume changes of the balloon 11, eliminating the need for additional control mechanisms and resulting in a simple and reliable structure.

[0118] It should also be noted that the working mode of the second one-way membrane 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) can 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 open to allow forward flow. For example, the one-way membrane can also be designed to be normally open. When the balloon deflates and generates negative pressure, the normally open one-way membrane is forced to close or throttle in response to the pressure differential to control backflow. When the balloon is inflated, the one-way membrane (valve) returns to its open state to allow forward 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.

[0119] The following reference Figure 7-9 and Figure 17-19 The following describes the operation of placing the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment into the body and the operation of recovering them from the body, as well as related components, devices, etc.

[0120] exist Figure 7-9 In the illustrated embodiment, the heart failure assist device 1 may correspondingly include a component conveyor, a retriever, and a balloon catheter conveyor, the features of which can be referred to the description of the embodiments shown in Figures 1-5 and will not be repeated here.

[0121] Reference below Figure 9 and Figures 17 to 19 The following describes the placement and recovery processes of the one-way flow control member 20 and the balloon catheter 10 of the heart failure assist device 1 according to an embodiment of the present disclosure.

[0122] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be placed in the body along a first insertion direction D1, such as in the descending aorta DA, and the balloon catheter 10 can be configured to be placed in the body along a different second insertion direction D2, such as in the descending aorta DA. Figure 9 In the specific embodiment shown, the one-way flow control member 20 is placed in position along a first insertion direction D1 from bottom to top. More specifically, the first insertion direction includes the iliac artery or the femoral artery FA ( Figure 9) is placed in the descending aorta DA. The balloon catheter 10 is placed in position along the second placement direction D2 from top to bottom. More specifically, the second placement direction includes the placement direction of the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 9 In the embodiment, the balloon catheter 10 is inserted into the aortic arch via the right subclavian artery. In this embodiment, a component delivery device 30 can be used to guide the one-way flow control component 20, thereby placing the one-way flow control component 20 in place. In this embodiment, the balloon catheter 10 can be inserted using a sheath or by sheathless puncture.

[0123] exist Figure 9 In the illustrated embodiment, the placement operation of the balloon catheter 10 is performed after the placement operation of the one-way flow control member 20 (ie, after the one-way flow control member 20 is expanded).

[0124] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be recovered from the body along a first recovery direction D3, such as from the descending aorta DA, and the balloon catheter 10 can be configured to be recovered from the body along a different second recovery direction D4, such as from the descending aorta DA. Figure 9 In the specific embodiment shown, the one-way flow control member 20 is recovered along a first recovery direction D3 from top to bottom, that is, a direction opposite to the first insertion direction D1. More specifically, the first recovery direction D3 includes the process from the descending aorta DA through the iliac artery or the femoral artery FA ( Figure 9 The balloon catheter 10 is recovered along the second recovery direction D4 from bottom to top, that is, the direction opposite to the second insertion direction D2. More specifically, the second recovery direction D4 includes the recovery direction from the descending aorta DA through the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 9 In the middle, the vessel was retrieved via the transaortic arch and right subclavian artery approach.

[0125] exist Figure 9 In the illustrated embodiment, the retraction operation of the one-way flow control member 20 is performed after the retraction operation of the balloon catheter 10 (ie, after the balloon 11 is deflated and removed).

[0126] In another embodiment, the first insertion direction D1 and the first recovery direction D3 of the one-way flow control member 20 can be set independently, so that the first recovery direction D3 does not have to be the opposite direction of the first insertion direction D1, that is, there is no need to recover the one-way flow control member 20 in the original direction opposite to the insertion direction.

[0127] In some embodiments, the one-way flow control member 20 can be configured to be placed in place in the body along the insertion direction, and the balloon catheter 10 can also be configured to be placed in place in the body along the same insertion direction, for example, along the same insertion direction. Figure 9The second insertion direction D2 is the same as that shown in FIG. 1 , for example, the balloon is inserted into the descending aorta DA via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. More specifically, the balloon is inserted into the aortic arch via the right subclavian artery. In these embodiments, the insertion operation of the balloon catheter 10 is also performed after the insertion operation of the one-way flow control member 20. In these embodiments, the withdrawal direction of the one-way flow control member 20 can still be the same as that shown in FIG. Figure 9 The first recovery direction D3 shown in FIG. 1 is consistent with the first recovery direction D3 shown in FIG. 1 , and the recovery direction of the balloon catheter 10 can also be consistent with the first recovery direction D3 shown in FIG. Figure 9 Here, the retraction operation of the one-way flow control member 20 is also performed after the retraction operation of the balloon catheter 10 .

[0128] See also Figure 10 , shows the modified schemes of the heart failure assist device 1 and the one-way flow control member 20 thereof according to other embodiments of the present disclosure. Figure 10 The heart failure assist device 1 and the one-way flow control member 20 in the embodiment shown are compared with Figures 7 to 9 The main difference of the embodiment shown is the orientation of the recovery connection portion of the support structure (stent) of the one-way flow control member 20 relative to the one-way membrane, thereby Figure 10 The one-way flow control member 20 in the embodiment shown has Figure 9 The one-way flow control member 20 has different (first) recovery directions in the illustrated embodiment. Other features (including the working process of the one-way fluid control) can be referred to in Figures 7 to 9 The embodiments shown are not described in detail here.

[0129] In such Figure 10 In the embodiment shown, the heart failure assist device 1 includes a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10. The one-way flow control member 20 includes a support structure 21 and a first one-way membrane 23 and a second one-way membrane 25 disposed on the support structure 21. The support structure 21 is also in the form of a stent, for example, and includes a recovery connection portion having a hook-shaped structure ( Figure 10 Not explicitly shown). The first one-way membrane is, for example, in the form of a valve and includes a plurality of leaflets, such as Figure 10 As shown, the first one-way membrane 23 and its leaflets have a fixed end 231 and a free end 232. The second one-way membrane 25 can also be in the form of a valve, including multiple leaflets. The second one-way membrane 25 (valve) and its leaflets can have a fixed end 251 and a free end 252. Figure 10 In the embodiment shown, the relative orientation of the free end 232 of the first unidirectional film 23 and the free end 252 of the second unidirectional film 25 to the recovery connection portion and its hook-shaped structure is opposite to that of the embodiment shown in Figure 9, that is, in Figure 10In the embodiment, the first free end 232 of the first unidirectional membrane 23 is still located on the side away from the balloon 11 relative to the fixed end 231, and the free end 252 of the second unidirectional membrane 25 is still located on the side close to the balloon 11 relative to the fixed end 251, but the recovery connection portion faces the balloon. Figure 10 In the embodiment, the free end 232 of the first one-way membrane (valve) 23 and the free end 252 of the second one-way membrane 25 are both away from the recovery connection portion of the support structure (stent). Accordingly, the fixed positions of the fixed ends 231 of the first one-way membrane 23 and the fixed ends 251 of the second one-way membrane 25 can be adjusted as needed.

[0130] Other features of the support structure and the one-way membrane as well as features of other components of the heart failure assist device are not described here in detail.

[0131] exist Figure 10 In the embodiment of the present invention, when the balloon catheter 10 of the heart failure assist device 1 and the one-way flow control member 20 separated from the balloon catheter 10 are placed in place in the body, the working process can be referred to Figures 7 to 9 Example of .

[0132] exist Figure 10 In the embodiment of the heart failure assist device 1, the one-way flow control member 20 and the balloon catheter 10 are placed in the same direction as Figures 7 to 9 In contrast to the embodiment shown, for example Figure 10 In the embodiment shown, the first insertion direction D1 is from top to bottom, and the second insertion direction D2 is from bottom to top. However, the insertion direction of the one-way flow control member 20 and the balloon catheter 10 of the heart failure assist device 1 can also refer to the above-mentioned Figure 9 Direction of insertion of the illustrated embodiment.

[0133] exist Figure 10 In the embodiment of the one-way flow control member 20, the recovery connection portion has Figure 9 Different orientations of the illustrated embodiments, whereby Figure 10 In the embodiment of the one-way flow control member 20, the (first) recovery direction D3 is the same as Figure 9 The (first) recovery direction D3 shown is opposite, i.e. from bottom to top. Figure 10 In the embodiment of the present invention, the (second) retraction direction D4 of the balloon catheter 10 is the same as that of Figure 9 The (second) recovery direction D4 shown is opposite, where Figure 10 In the illustrated embodiment, the retraction operation of the one-way flow control member 20 is performed after the retraction operation of the balloon catheter 10 .

[0134] See also Figures 11 to 13 , shows a heart failure assist device 1 according to another embodiment of the present disclosure. The heart failure assist device 1 comprises a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10. Figure 11 1 is an overall schematic diagram of the heart failure assist device of this embodiment, wherein the combination of the one-way flow control member and the balloon catheter is positioned in a first orientation.

[0135] In this embodiment, the one-way flow control member 20 includes a support structure 21 and a one-way membrane 23 disposed on the support structure 21 , which may be referred to herein as a first one-way membrane.

[0136] In this embodiment, the support structure 21 is in the form of a bracket. The specific structure and material characteristics of the support structure 21 can be referred to Figures 1 to 2. Figure 5 The corresponding contents in the illustrated embodiment.

[0137] exist Figure 11 、 12 In the embodiment shown, the (first) one-way membrane (valve) 23 may include a plurality of leaflets. The one-way membrane 23 and its leaflets have a fixed end 231 and a free end 232. The fixed end 231 may be fixedly connected to the inner side of the support structure 21. In this embodiment, the free end 232 of the one-way membrane 23 may be located on a side away from the balloon 11 relative to the fixed end 231. The specific structural features of the (first) one-way membrane can be referred to Figures 1 to 2. Figure 5 The corresponding design in the embodiment shown.

[0138] like Figure 11 As shown, the balloon catheter 10 includes a catheter body 14 , a balloon 11 disposed on the catheter body 14 , an integrated one-way membrane 13 disposed on the proximal side of the balloon 11 , and an integrated support structure 12 disposed on the catheter body 14 for supporting the integrated one-way membrane 13 .

[0139] In this embodiment, the integrated support structure 12 can also be in the form of a stent. The integrated support structure (stent) 12 can include a first stent segment located at the distal side and a second stent segment located at the proximal side. The integrated support structure (stent) 12 can also include a strut connecting the first stent segment and the second stent segment. The difference between the integrated support structure (stent) 12 and the support structure 21 is that the integrated support structure (stent) 12, especially its second stent segment, has a connecting portion for fixed connection to the catheter body 14. Other specific structural and material features of the integrated support structure (stent) 12 can refer to the support structure 21 and are not repeated here.

[0140] In this embodiment, the integrated one-way membrane 13 can be in the form of a valve. The integrated one-way membrane (valve) 13 can include a plurality of leaflets. The integrated one-way membrane 13 and its leaflets have a fixed end 131 and a free end 131. The fixed end 131 can be fixedly connected to the inner side of the integrated support structure 12. In this embodiment, the free end 132 of the integrated one-way membrane 13 can be located on a side close to the balloon 11 relative to the fixed end 131. Other specific structural and material features of the integrated one-way membrane can refer to the corresponding design of the one-way membrane 23 and will not be repeated here.

[0141] For other specific structural features of the balloon catheter 10 , reference may be made to the corresponding contents in the aforementioned embodiments, which will not be described in detail here.

[0142] People will understand, Figures 11 to 13 The structural features, material selection, connection methods and other technical features of the various components of the heart failure assist device in the embodiment shown can be referred to Figures 1 to Figure 5 The corresponding technical features in the illustrated embodiments are not described in detail here.

[0143] The following combination Figure 11 and Figure 13 The working process of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment when they are placed in place in the body is described, wherein: Figure 12 The figure shows the state of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 in the body and the related blood flow direction during cardiac contraction. Figure 13 The diagram shows the in vivo status of the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 during diastole and the related blood flow direction.

[0144] like Figure 12 and Figure 13 Schematically, the balloon catheter 10 and the one-way flow-control member 20 are placed in place within the body, i.e., placed in the descending aorta DA. The one-way membrane 23 and the integrated one-way membrane 13 of the one-way flow-control member 20 are respectively located on either side of the balloon 11. Specifically, the (first) one-way membrane 23 of the one-way flow-control member 20 is located on the side of the balloon 11 facing away from the aortic valve AV, while the integrated one-way membrane 13 is located on the side of the balloon 11 closer to the aortic valve AV.

[0145] How the (first) one-way membrane 23 and the integrated one-way membrane 13 control the flow direction of blood in response to the volume change of the balloon 11 will be described below.

[0146] Specifically, if Figure 12 As shown, before or at the beginning of the cardiac systole, the counterpulsation pump drives the balloon 11 to be quickly emptied. In this process, the rapid emptying of the balloon 11 forms a local "vacuum" effect around it, generating negative pressure.

[0147] At this time, the blood pressure on the side of the one-way membrane 23 close to the balloon 11 is lower than the blood pressure on the side away from the balloon, so that the pressure difference on the side of the one-way membrane 23 away from the balloon 11 is greater than that on the side close to the balloon 11. In this embodiment, when placed in place in the body, the free end 232 of the one-way membrane 23 is located on the side away from the balloon 11 relative to the fixed end 231. That is, when placed in place in the body, the free end 232 is located below the fixed end 231. Figure 12 As shown. Thus, the one-way membrane 23 of the one-way flow control member 20 forms such a one-way flow control unit, which can selectively control (block or throttle) the one-way flow from the bottom to the top, which can also be expressed as a one-way flow from the ventral side to the heart side or a one-way flow from the abdominal aorta toward the balloon. Figure 12 As shown, under the influence of the aforementioned pressure differential, the free end 232 of the one-way membrane 23 closes, and the leaflets tightly fit together to form a reliable seal. This closed state effectively prevents blood from flowing back from the abdominal aorta (blood flow direction shown by arrow A3), thereby enhancing the directional suction effect on the AV side of the aortic valve.

[0148] At the same time, the blood pressure on the side of the integrated one-way 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 side of the integrated one-way membrane 13 away from the balloon 11 (the proximal side of the balloon catheter) that is greater than the pressure on the side close to the balloon 11 (the distal side). In this embodiment, when placed in place in the body, the free end 132 of the integrated one-way membrane 13 is located on the side of the fixed end 131 close to the balloon 11. That is, when placed in place in the body, the free end 132 is located below the fixed end 131. Thus, the integrated one-way membrane 13 forms a one-way flow control unit that can selectively control one-way flow from top to bottom. In this embodiment, it can also be expressed as one-way flow from the proximal side to the distal side of the balloon catheter, one-way flow from the cardiac side to the ventral side, or one-way flow from the aortic valve toward the balloon. Under the action of the above-mentioned pressure difference opposite to the one-way flow control, the free end 132 of the integrated one-way membrane 13 is opened, and the leaflets form a good flow channel. This open state allows blood to flow in the direction of the aortic valve AV (see arrow A1 for blood flow direction). 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 closed (first) one-way membrane 23 and the open integrated one-way membrane 13.

[0149] Through the coordination of the closing of the first one-way membrane 23 and the opening of the integrated one-way membrane 13, the ventricle can be better assisted to eject blood to the aorta, significantly increasing cardiac output, while reducing the patient's cardiac afterload, reducing cardiac work, and reducing myocardial oxygen consumption.

[0150] like Figure 13As shown, after the start of cardiac diastole (when the aortic valve AV is closed), the counterpulsation pump drives the balloon 11 to inflate.

[0151] At this time, due to the pressure generated by the expansion of the balloon 11, the blood pressure on the side of the first one-way membrane (valve) 23 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 one-way membrane 23, where the pressure on the side close to the balloon 11 is greater than the pressure on the side away from the balloon 11. As mentioned above, the one-way flow control direction of the first one-way membrane 23 of the one-way flow control member 20 is a one-way flow from top to bottom (one-way flow from the heart side to the ventral side or one-way flow from the balloon toward the abdominal aorta). Therefore, as Figure 13 As shown, under the action of the aforementioned pressure difference, the free end 232 of the first unidirectional membrane 23 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 abdominal aorta, thereby increasing the blood supply to the kidney KD (blood flow direction is shown by arrow A5).

[0152] At the same time, the blood pressure on the side of the integrated one-way 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 side of the integrated one-way membrane 13 away from the balloon 11 that is smaller than the pressure on the side close to the balloon 11. As mentioned above, when placed in place in the body, the free end 132 is located below the fixed end 131. As a result, the integrated one-way membrane 13 forms a one-way flow control unit, which can selectively control (block or throttle) the one-way flow from the bottom to the top, which in this embodiment can also be expressed as a one-way flow from the ventral side to the heart side or a one-way flow from the balloon toward the aortic valve. Under the action of the above-mentioned pressure difference consistent with the one-way flow control direction, the free end 132 of the integrated one-way membrane 13 is closed, and the leaflets are tightly fitted 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 integrated one-way membrane 13 can still fully perfuse the coronary artery (see arrow A2 for the direction of blood flow). By opening the first one-way membrane 23 and closing the integrated one-way membrane 13, not only the blood supply to the kidney KD is further increased (blood flow direction see arrow A5), but also the perfusion effect of other peripheral blood vessels is further improved (blood flow direction see arrow A4).

[0153] Accordingly, through the above structural design and working mechanism, the one-way flow control member 20 of this embodiment cooperates with the volume change of the balloon catheter 10 with an integrated one-way membrane to solve the problem of bidirectional blood flow caused by balloon pumping in the prior art.

[0154] The following reference Figure 11-13 and Figure 17-19 The following describes the operation of placing the balloon catheter 10 and the one-way flow control member 20 of the heart failure assist device 1 of this embodiment into the body and the operation of recovering them from the body, as well as related components, devices, etc.

[0155] exist Figure 11-13 In the illustrated embodiment, the heart failure assist device 1 may correspondingly include a component conveyor, a retriever, and a balloon catheter conveyor, the features of which can be referred to the description of the embodiments shown in Figures 1-5 and will not be repeated here.

[0156] Reference below Figure 12-13 and Figure 17-19 The following describes the placement and recovery processes of the one-way flow control member 20 and the balloon catheter 10 of the heart failure assist device 1 according to an embodiment of the present disclosure.

[0157] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be placed in the body along a first insertion direction D1, such as in the descending aorta DA, and the balloon catheter 10 can be configured to be placed in the body along a different second insertion direction D2, such as in the descending aorta DA. Figure 12 In the specific embodiment shown, the one-way flow control member 20 is placed in position along a first insertion direction D1 from bottom to top. More specifically, the first insertion direction D1 includes the iliac artery or the femoral artery FA ( Figure 12-13 ) is placed in the descending aorta DA. The balloon catheter 10 is placed in position along the second placement direction D2 from top to bottom. More specifically, the second placement direction D2 includes the placement direction of the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 12-13 In another exemplary embodiment, the one-way flow control member 20 and the balloon catheter 10 can be placed in place along a second insertion direction D2 from top to bottom. More specifically, the second insertion direction D2 includes an insertion direction of the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 12-13 In the embodiment, the aortic arch is accessed via the right subclavian artery. In another exemplary embodiment, the one-way flow control member 20 can be placed in place first, and then the balloon catheter 10 can be placed in place. In this embodiment, the one-way flow control member 20 can be guided by a member conveyor 30 to be placed in place. In this embodiment, the balloon catheter 10 can be placed using a sheath or by sheathless puncture.

[0158] exist Figure 12-13 In the illustrated embodiment, due to different insertion directions / orientations / positions, the insertion of the one-way flow control member 20 and the balloon catheter 10 can be performed in any suitable order, such as synchronously or asynchronously. For example, the balloon catheter 10 can be inserted first, followed by the one-way flow control member 20, or vice versa. Thus, in this embodiment, a bilateral one-way membrane structure can be provided while achieving flexibility in insertion operations.

[0159] In the embodiment of the present disclosure, the one-way flow control member 20 can be configured to be recovered from the body along a first recovery direction D3, such as from the descending aorta DA, and the balloon catheter 10 can be configured to be recovered from the body along a different second recovery direction D4, such as from the descending aorta DA. Figure 5 In the specific embodiment shown, the one-way flow control member 20 is recovered along a first recovery direction D3 from top to bottom, that is, a direction opposite to the first insertion direction D1. More specifically, the first recovery direction D3 includes the process from the descending aorta DA through the iliac artery or the femoral artery FA ( Figure 12-13 The balloon catheter 10 is recovered along the second recovery direction D4 from bottom to top, that is, the direction opposite to the second insertion direction D2. More specifically, the second recovery direction D4 includes the recovery direction from the descending aorta through the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch. Figure 12-13 In the middle, it was retrieved via the aortic arch and subclavian artery approach.

[0160] exist Figure 12-13 In the illustrated embodiment, due to the different retrieval directions / orientations / positions, the retrieval operation of the one-way flow control member 20 and the retrieval operation of the balloon catheter 10 can be performed in any suitable order, such as synchronously or asynchronously. For example, the balloon catheter 10 can be retrieved first and then the one-way flow control member 20, or vice versa. Thus, in this embodiment, a bilateral one-way membrane structure can be provided while achieving flexibility in retrieval operations.

[0161] In another embodiment, the first insertion direction D1 and the first recovery direction D3 of the one-way flow control member 20 can be set independently, so that the first recovery direction D3 does not need to be the opposite direction of the first insertion direction D1, that is, it is not necessary to recover the one-way flow control member 20 in the direction opposite to the insertion direction. The independent setting of the first insertion direction D1 and the first recovery direction D3 can refer to Figure 5 The embodiments of the present invention are not described in detail here.

[0162] See also Figures 14 to 16 , shows a heart failure assist device 1 according to another embodiment of the present disclosure. The heart failure assist device 1 comprises a balloon catheter 10 and a one-way flow control member 20 separate from the balloon catheter 10. Figure 11 The overall schematic diagram of the heart failure assist device of this embodiment, wherein the combination of the one-way flow control component and the balloon catheter is Figures 11 to 13 The second orientation is shown opposite the first orientation.

[0163] exist Figure 14 The balloon catheter 10 of the heart failure assist device 1 of the embodiment shown and the one-way flow control member 20 separated from the balloon catheter 10 may have the same Figure 11The same structural features, material selection and other technical features as the embodiment shown are different in that the balloon catheter 10 and the one-way flow control member 20 separated from the balloon catheter 10 have a second orientation opposite to the first orientation. As a result, the one-way membrane 23 of the one-way flow control member 20 (herein referred to as the first one-way membrane) is located on the side of the balloon 11 close to the aortic valve AV, and the (proximal) integrated one-way membrane 13 of the balloon catheter 10 is located on the side of the balloon 11 of the balloon catheter 10 away from the aortic valve AV. Accordingly, the placement direction and / or retrieval direction of the balloon catheter 10 and the one-way flow control member 20 may be different from the first orientation. Figures 11 to 13 The embodiment shown is the opposite.

[0164] Thus, the unidirectional flow control work of the integrated unidirectional membrane 13 of the balloon catheter 10 and the (first) unidirectional membrane 23 of the unidirectional flow control member 20 in response to the change in balloon volume can be referred to as Figures 11 to 13 The embodiment shown is only Figures 14 to 16 The integrated one-way membrane 13 works similarly to Figures 11 to 13 The (first) unidirectional film in the embodiment shown and vice versa.

[0165] Similarly, the placement and / or retrieval of the balloon catheter 10 and the one-way flow control member 20 can be referred to Figures 11 to 13 The embodiment shown, for example Figures 14 to 16 The second insertion direction D2 / second retrieval direction D4 of the balloon catheter 10 can be referred to Figures 11 to 13 The first placement direction D1 / first recovery direction D3 of the one-way flow control member 20 in the embodiment.

[0166] 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 to the target blood vessel through the lumen in the catheter body 14 of the balloon catheter 10, and is used to guide the delivery and positioning of the balloon catheter 10. The vascular sheath provides a safe puncture channel, which facilitates 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.

[0167] In a preferred embodiment, the heart failure assistance system also includes a ray projection device, which (such as X-ray) projection device can be configured to cooperate with the first radiopaque development mark of the balloon catheter and the second radiopaque development mark of the one-way flow control member to indicate whether the relative placement position between the balloon of the balloon catheter and the one-way membrane of the one-way flow control member is in a suitable relative placement position.

[0168] The indication can be implemented in a variety of different ways. In some embodiments, the ray projection device can be configured to measure the distance between the first positioning mark and the second positioning mark, and display the distance value on a display interface. When the distance value is within a preset distance range, an indication signal indicating that the position is appropriate can be output; when the distance value exceeds the preset distance range, an indication signal indicating that the position needs to be adjusted can be output. In other embodiments, the ray projection device can be configured to analyze the degree of overlap between the first positioning mark and the second positioning mark in the ray projection image. When the two positioning marks overlap in the ray projection direction, it indicates that the balloon of the balloon catheter and the unidirectional membrane of the unidirectional flow control member are in a suitable relative placement position. At this time, the ray projection device can output an indication signal indicating that the position is appropriate.

[0169] The disclosed embodiments also provide a one-way flow control member and a kit having the one-way flow control member. The one-way flow control member may include a support structure and a one-way membrane disposed on the support structure. The one-way flow control member is disposed independently of the balloon catheter and is configured to cooperate with the balloon of the balloon catheter, thereby closing or throttling in response to volume changes of the balloon to prevent or reduce the flow of fluid from one side of the one-way membrane to the other side. In some embodiments, the kit may have multiple interchangeable one-way flow control members that can be placed on different sides of the balloon as needed. In some preferred embodiments, the balloon catheter itself may have an integrated one-way membrane and support structure.

[0170] To further illustrate the various implementations of the present disclosure and ensure its broad applicability across a variety of operating conditions and design variations, the following multiple specific examples illustrate various implementations. These examples, including but not limited to the technical features detailed below, are intended to demonstrate the adaptability and diversity of the present disclosure in various application scenarios.

[0171] It should be understood that all technical features and specific design forms mentioned in the following embodiments of the present disclosure can be used in combination without conflict. Furthermore, the technical solutions and features of the following embodiments of the present disclosure can also be combined with the descriptions of the preceding embodiments to achieve even better technical results. For example, the unidirectional membrane configuration, support structure arrangement, conduit design, and operation method in any embodiment can be appropriately adjusted and combined with corresponding features in other embodiments to form new technical solutions. This combination can be selected based on actual needs and is not limited by the specific embodiments.

[0172] 1. A heart failure assist device, comprising:

[0173] A balloon catheter comprising a catheter body and a balloon disposed on the catheter body; and

[0174] A one-way flow control member is separate from the balloon catheter, each of the one-way flow control members includes a support structure and at least one one-way membrane arranged on the support structure, wherein the at least one one-way membrane of the one-way flow control member is located on at least one side of the balloon when placed in place in the body.

[0175] 2. According to the heart failure assist device described in Example 1, the one-way membrane of the one-way flow control component is constructed to close or throttle in response to the volume change of the balloon of the balloon catheter when placed in place in the body to prevent or reduce the flow of fluid on one side of the one-way membrane to the other side.

[0176] 3. According to the heart failure assist device of embodiment 2, the one-way membrane of the one-way flow control member includes a first one-way membrane located on the side of the balloon away from the aortic valve when placed in place in the body.

[0177] 4. According to the heart failure assist device described in Example 3, the first unidirectional membrane is configured to be placed in place in the body, to close or throttle when the balloon contracts 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.

[0178] 5. According to the heart failure assist device of embodiment 3, the first unidirectional membrane includes a fixed end and a free end connected to the support structure, wherein the first unidirectional membrane is configured to be placed in place in the body, and the free end is located on the side away from the balloon relative to the fixed end.

[0179] 6. According to the heart failure assist device of Example 3, the one-way membrane of the one-way flow control member includes a second one-way membrane located on a side of the balloon close to the aortic valve when the balloon is placed in place in the body.

[0180] 7. According to the heart failure assist device described in Example 6, the second unidirectional membrane 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 when placed in place in the body, 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.

[0181] 8. According to the heart failure assist device of Example 6, the second unidirectional membrane includes a fixed end and a free end connected to the support structure, wherein the second unidirectional membrane is configured to be placed in place in the body, and the free end is located on a side close to the balloon relative to the fixed end.

[0182] 9. According to the heart failure assist device of Example 6, the support structure includes a single stent for supporting the first unidirectional membrane and the second unidirectional membrane, wherein the heart failure assist device is configured to be placed in place in the body, and the balloon is located between the first unidirectional membrane and the second unidirectional membrane relative to the stent.

[0183] 10. The heart failure assist device according to Example 2, wherein the balloon catheter comprises an integrated one-way membrane disposed on the proximal side of the balloon and an integrated support structure disposed on the catheter body, wherein the integrated support structure is used to support the integrated one-way membrane.

[0184] Wherein, the one-way membrane of the one-way flow control member is located on a side of the balloon facing away from the integrated one-way membrane when placed in place in the body.

[0185] 11. The heart failure assist device according to Example 10, wherein the one-way membrane of the one-way flow control member is located on a side of the balloon facing away from the aortic valve when placed in place in the body, so as to close or throttle when the balloon is deflated to prevent or reduce fluid flow from the abdominal aorta toward the balloon, and to open or expand when the balloon is inflated to allow or increase fluid flow from the balloon toward the abdominal aorta;

[0186] The integrated one-way membrane is located on the side of the balloon close to the aortic valve when placed in place in the body, so that it is opened or expanded when the balloon contracts to allow or increase fluid flow from the aortic valve toward the balloon, and is closed or throttled when the balloon is inflated to prevent or reduce fluid flow from the balloon toward the aortic valve.

[0187] 12. The heart failure assist device according to Example 10, wherein the one-way membrane of the one-way flow control member is located on a side of the balloon close to the aortic valve when placed in place in the body, so as to be opened or expanded when the balloon is deflated to allow or increase fluid flow from the aortic valve toward the balloon, and closed or throttled when the balloon is inflated to prevent or reduce fluid flow from the balloon toward the aortic valve;

[0188] The integrated one-way membrane is located on the side of the balloon away from the aortic valve when placed in place in the body, so that when the balloon is deflated, it is closed or throttled to prevent or reduce the flow of fluid from the abdominal aorta toward the balloon, and when the balloon is inflated, it is opened or expanded to allow or increase the flow of fluid from the balloon toward the abdominal aorta.

[0189] 13. According to any one of embodiments 1 to 12 of the heart failure assist device, the one-way flow control member is configured to be placed in place in the body along an insertion direction, and the balloon catheter is configured to be placed in place in the body along the same insertion direction after the one-way flow control member is placed in place in the body; and / or

[0190] The balloon catheter is configured to be retracted from the body to the outside of the body along a retraction direction, and the one-way flow control member is configured to be retracted from the body to the outside of the body along the same retraction direction after the balloon catheter is retracted from the body to the outside of the body.

[0191] 14. The heart failure assist device according to embodiment 13, wherein the insertion direction includes the insertion direction into the descending aorta via the iliac artery, femoral artery, subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch; and / or

[0192] The recovery direction includes a recovery direction from the descending aorta through the iliac artery, femoral artery, subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch to the outside of the body.

[0193] 15. The heart failure assist device according to any one of Examples 1 to 12, wherein the one-way flow control member is configured to be placed in the body along a first insertion direction, and the balloon catheter is configured to be placed in the body along a second different insertion direction; and / or

[0194] The one-way flow control member is configured to be retracted from the body to the outside of the body along a first retraction direction, and the balloon catheter is configured to be retracted from the body to the outside of the body along a second different retraction direction.

[0195] 16. The heart failure assist device according to embodiment 15, wherein the first insertion direction includes an insertion direction into the descending aorta via the iliac artery or the femoral artery, and the second insertion direction includes an insertion direction into the descending aorta via the subclavian artery, the axillary artery, the radial artery, the brachial artery, the carotid artery, or the aortic arch; or

[0196] The first insertion direction includes an insertion direction into the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch, and the second insertion direction includes an insertion direction into the descending aorta via the iliac artery or femoral artery; and / or

[0197] The first recovery direction includes a recovery direction from the descending aorta via the iliac artery or the femoral artery to the outside of the body, and the second insertion direction includes a recovery direction from the descending aorta via the subclavian artery, the axillary artery, the radial artery, the brachial artery, the carotid artery or the aortic arch to the outside of the body; or

[0198] The first insertion direction includes a recovery direction from the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch to the outside of the body, and the second insertion direction includes a recovery direction from the descending aorta via the iliac artery or femoral artery to the outside of the body.

[0199] 17. The heart failure assist device according to any one of embodiments 1 to 12, further comprising:

[0200] A component conveyor for guiding the one-way flow control component, the component conveyor includes an inner tube and an outer tube, the outer tube includes an end accommodating portion for accommodating the one-way flow control component in a contracted state, the outer tube is overlapped on the inner tube and the inner tube is slidably arranged relative to the outer tube.

[0201] 18. According to any one of embodiments 1 to 12 of the heart failure assist device, the one-way flow control member includes a recovery connection portion with a hook-shaped structure.

[0202] 19. The heart failure assist device according to embodiment 19, further comprising:

[0203] A retriever for retrieving the one-way flow control member comprises a snare for engaging the hook structure, an inner tube and an outer tube, wherein the snare is arranged at the distal end of the inner tube, and the outer tube is sheathed on the inner tube and is slidably arranged relative to the inner tube.

[0204] 20. The heart failure assist device according to any one of embodiments 1 to 12, further comprising:

[0205] A balloon catheter delivery device is used to guide the balloon catheter, wherein the balloon catheter delivery device comprises a sheath, and the balloon catheter is placed in position along the sheath in a collapsed state.

[0206] 21. The heart failure assist device according to any one of embodiments 1 to 12, further comprising:

[0207] a trachea in communication with the balloon; and

[0208] A counterpulsation pump is connected to the trachea.

[0209] 22. According to the heart failure assist device described in any one of Examples 1 to 12, the balloon catheter includes a first radiopaque developing mark, and the one-way flow control member includes a second radiopaque developing mark, and the first developing mark and the second developing mark are used to indicate the relative placement position between the balloon of the balloon catheter and the one-way membrane of the one-way flow control member.

[0210] 23. A heart failure assistance system, comprising the heart failure assistance device according to any one of embodiments 1 to 22.

[0211] 24. According to the heart failure assistance system described in Example 23, the heart failure assistance device is the heart failure assistance device according to Example 22, and the heart failure assistance system also includes a ray projection device, which is configured to indicate whether the relative placement position between the balloon of the balloon catheter and the unidirectional membrane of the unidirectional flow control member is in a suitable relative placement position based on the first development mark and the second development mark.

[0212] 25. A one-way flow control member comprises a support structure and a one-way membrane arranged on the support structure, wherein the one-way flow control member is arranged independently of a balloon catheter and is configured to cooperate with the balloon of the balloon catheter, so as to close or throttle in response to the 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.

[0213] 26. The one-way flow control member according to embodiment 25, wherein the one-way membrane of the one-way flow control member comprises a first one-way membrane and a second one-way membrane, and the support structure comprises a single bracket for supporting the first one-way membrane and the second one-way membrane.

[0214] 27. According to the one-way flow control component of embodiment 26, the first one-way membrane includes a first fixed end and a first free end connected to the support structure; the second one-way membrane includes a second fixed end and a second free end connected to the support structure, wherein the first free end and the second free end have the same orientation.

[0215] 28. The one-way flow control member according to embodiment 25, comprises a recovery connection portion with a hook-shaped structure.

[0216] 29. A kit comprising a balloon catheter and the one-way flow control member according to any one of Examples 25 to 28, wherein the balloon catheter comprises a catheter body and a balloon disposed on the catheter body.

[0217] 30. According to the kit of embodiment 29, the balloon catheter includes an integrated one-way membrane disposed on the proximal side of the balloon and an integrated support structure disposed on the catheter body, wherein the integrated support structure is used to support the integrated one-way membrane.

[0218] In the embodiments of the present disclosure, method features may be incorporated into apparatus to create new embodiments, and vice versa.

[0219] Unless explicitly stated, the actions or steps of the methods, procedures, and methods described in accordance with the 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.

[0220] In this document, 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 document, "one embodiment", "some embodiments", "example", "specific example", or "some examples" are intended to apply 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. Those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, unless they are mutually contradictory.

[0221] It should be understood that the above embodiments are illustrative only and not restrictive. Those skilled in the art may make numerous variations and modifications to the described embodiments without departing from the spirit and scope of the present invention. The scope of the present invention is defined by the appended claims and includes equivalent variations that may be conceived by those skilled in the art based on the present disclosure. Such variations and modifications are intended to fall within the scope of protection of the present invention.

Claims

1. A heart failure assist device, characterized in that: include: A balloon catheter, comprising a catheter body and a balloon arranged on the catheter body; as well as A one-way flow control member is separate from the balloon catheter, each of the one-way flow control members includes a support structure and at least one one-way membrane arranged on the support structure, wherein the at least one one-way membrane of the one-way flow control member is located on at least one side of the balloon when placed in place in the body.

2. The heart failure assist device according to claim 1, characterized in that The one-way membrane of the one-way flow control member is configured to close or throttle in response to volume changes of the balloon of the balloon catheter when placed in place in the body to prevent or reduce the flow of fluid from one side of the one-way membrane to the other side.

3. The heart failure assist device according to claim 2, characterized in that The one-way membrane of the one-way flow control member includes a first one-way membrane located on a side of the balloon facing away from the aortic valve when the balloon is placed in place in the body.

4. The heart failure assist device according to claim 3, characterized in that The first unidirectional membrane is configured to be closed or throttled when the balloon is deflated to prevent or reduce fluid flow from the abdominal aorta toward the balloon when the balloon is placed in place in the body, and to be opened or expanded when the balloon is inflated to allow or increase fluid flow from the balloon toward the abdominal aorta.

5. The heart failure assist device according to claim 3, characterized in that The first unidirectional membrane includes a fixed end connected to the support structure and a free end, wherein the first unidirectional membrane is configured such that when placed in place in vivo, the free end is located on a side away from the balloon relative to the fixed end.

6. The heart failure assist device according to claim 3, characterized in that The one-way membrane of the one-way flow control member includes a second one-way membrane located on a side of the balloon close to the aortic valve when the balloon is placed in place in the body.

7. The heart failure assist device according to claim 6, characterized in that The second unidirectional membrane 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 when placed in place in the body, and to be closed or throttled when the balloon is inflated to prevent or reduce fluid flow from the balloon toward the aortic valve.

8. The heart failure assist device according to claim 6, characterized in that The second unidirectional membrane includes a fixed end connected to the support structure and a free end, wherein the second unidirectional membrane is configured such that when placed in place in vivo, the free end is located on a side closer to the balloon relative to the fixed end.

9. The heart failure assist device according to claim 6, characterized in that The support structure includes a single stent for supporting the first unidirectional membrane and the second unidirectional membrane, wherein the heart failure assist device is configured such that when placed in place in the body, the balloon is located between the first unidirectional membrane and the second unidirectional membrane relative to the stent.

10. The heart failure assist device according to claim 2, characterized in that The balloon catheter comprises an integrated one-way membrane provided on the proximal side of the balloon and an integrated support structure provided on the catheter body, wherein the integrated support structure is used to support the integrated one-way membrane. Wherein, the one-way membrane of the one-way flow control member is located on a side of the balloon facing away from the integrated one-way membrane when placed in place in the body.

11. The heart failure assist device according to claim 10, characterized in that The one-way membrane of the one-way flow control member is located on the side of the balloon facing away from the aortic valve when the balloon is placed in place in the body, so as 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 open or expand when the balloon is inflated to allow or increase the flow of fluid from the balloon toward the abdominal aorta; The integrated one-way membrane is located on the side of the balloon close to the aortic valve when placed in place in the body, so that it is opened or expanded when the balloon contracts to allow or increase fluid flow from the aortic valve toward the balloon, and is closed or throttled when the balloon is inflated to prevent or reduce fluid flow from the balloon toward the aortic valve.

12. The heart failure assist device according to claim 10, characterized in that The one-way membrane of the one-way flow control member is located on a side of the balloon close to the aortic valve when the balloon is placed in place in the body, so that when the balloon is deflated, the one-way membrane is opened or expanded to allow or increase the flow of fluid from the aortic valve toward the balloon, and when the balloon is inflated, the one-way membrane is closed or throttled to prevent or reduce the flow of fluid from the balloon toward the aortic valve; The integrated one-way membrane is located on the side of the balloon away from the aortic valve when placed in place in the body, so that when the balloon is deflated, it is closed or throttled to prevent or reduce the flow of fluid from the abdominal aorta toward the balloon, and when the balloon is inflated, it is opened or expanded to allow or increase the flow of fluid from the balloon toward the abdominal aorta.

13. The heart failure assist device according to any one of claims 1 to 12, characterized in that: The one-way flow control member is configured to be placed in place in the body along an insertion direction, and the balloon catheter is configured to be placed in place in the body along the same insertion direction after the one-way flow control member is placed in place in the body; and / or The balloon catheter is configured to be retracted from the body to the outside of the body along a retraction direction, and the one-way flow control member is configured to be retracted from the body to the outside of the body along the same retraction direction after the balloon catheter is retracted from the body to the outside of the body.

14. The heart failure assist device according to claim 13, characterized in that The placement direction includes placement into the descending aorta via the iliac artery, femoral artery, subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch; and / or The recovery direction includes a recovery direction from the descending aorta through the iliac artery, femoral artery, subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch to the outside of the body.

15. The heart failure assist device according to any one of claims 1 to 12, characterized in that The one-way flow control member is configured to be placed in a body along a first placement direction, and the balloon catheter is configured to be placed in a body along a second different placement direction; and / or The one-way flow control member is configured to be retracted from the body to the outside of the body along a first retraction direction, and the balloon catheter is configured to be retracted from the body to the outside of the body along a second different retraction direction.

16. The heart failure assist device according to claim 15, characterized in that The first insertion direction includes an insertion direction of inserting into the descending aorta via the iliac artery or the femoral artery, and the second insertion direction includes an insertion direction of inserting into the descending aorta via the subclavian artery, the axillary artery, the radial artery, the brachial artery, the carotid artery or the aortic arch; or The first insertion direction includes an insertion direction into the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch, and the second insertion direction includes an insertion direction into the descending aorta via the iliac artery or femoral artery; and / or The first recovery direction includes a recovery direction from the descending aorta via the iliac artery or the femoral artery to the outside of the body, and the second insertion direction includes a recovery direction from the descending aorta via the subclavian artery, the axillary artery, the radial artery, the brachial artery, the carotid artery or the aortic arch to the outside of the body; or The first insertion direction includes a recovery direction from the descending aorta via the subclavian artery, axillary artery, radial artery, brachial artery, carotid artery or aortic arch to the outside of the body, and the second insertion direction includes a recovery direction from the descending aorta via the iliac artery or femoral artery to the outside of the body.

17. The heart failure assist device according to any one of claims 1 to 12, characterized in that Also includes: A component conveyor for guiding the one-way flow control component, the component conveyor includes an inner tube and an outer tube, the outer tube includes an end accommodating portion for accommodating the one-way flow control component in a contracted state, the outer tube is overlapped on the inner tube and the inner tube is slidably arranged relative to the outer tube.

18. The heart failure assist device according to any one of claims 1 to 12, characterized in that The one-way flow control member includes a recovery connection portion with a hook structure.

19. The heart failure assist device according to claim 18, characterized in that Also includes: A retriever for retrieving the one-way flow control member comprises a snare for engaging the hook structure, an inner tube and an outer tube, wherein the snare is arranged at the distal end of the inner tube, and the outer tube is sheathed on the inner tube and is slidably arranged relative to the inner tube.

20. The heart failure assist device according to any one of claims 1 to 12, characterized in that Also includes: A balloon catheter delivery device is used to guide the balloon catheter, wherein the balloon catheter delivery device comprises a sheath, and the balloon catheter is placed in position along the sheath in a collapsed state.

21. The heart failure assist device according to any one of claims 1 to 12, characterized in that Also includes: a trachea in communication with the balloon; as well as A counterpulsation pump is connected to the trachea.

22. The heart failure assist device according to any one of claims 1 to 12, characterized in that The balloon catheter includes a first radiopaque display mark, and the one-way flow control member includes a second radiopaque display mark, wherein the first and second display marks are used to indicate the relative placement positions between the balloon of the balloon catheter and the one-way membrane of the one-way flow control member.

23. A heart failure assistance system, characterized in that: Comprising a heart failure assist device according to any one of claims 1 to 22.

24. The heart failure assist system according to claim 23, characterized in that: The heart failure assist device is a heart failure assist device according to claim 22, and the heart failure assist system also includes a ray projection device, which is configured to indicate whether the relative placement position between the balloon of the balloon catheter and the unidirectional membrane of the unidirectional flow control member is in a suitable relative placement position based on the first development mark and the second development mark.

25. A one-way flow control component, characterized in that: It includes a support structure and a one-way membrane arranged on the support structure. The one-way flow control member is independently arranged from the balloon catheter and is configured to cooperate with the balloon of the balloon catheter, so as to close or throttle in response to the 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.

26. The one-way flow control member according to claim 25, characterized in that: The one-way membrane of the one-way flow control member includes a first one-way membrane and a second one-way membrane, and the support structure includes a single bracket for supporting the first one-way membrane and the second one-way membrane.

27. The one-way flow control member according to claim 26, characterized in that: The first unidirectional membrane includes a first fixed end connected to the support structure and a first free end; the second unidirectional membrane includes a second fixed end connected to the support structure and a second free end, wherein the first free end and the second free end have the same orientation.

28. The one-way flow control member according to claim 25, characterized in that: The one-way flow control member includes a recovery connection portion with a hook structure.

29. A kit, characterized in that The invention comprises a balloon catheter and a one-way flow control member according to any one of claims 25 to 28, wherein the balloon catheter comprises a catheter body and a balloon provided on the catheter body.

30. The kit of claim 29, wherein: The balloon catheter comprises an integrated one-way membrane disposed on the proximal side of the balloon and an integrated support structure disposed on the catheter body, wherein the integrated support structure is used to support the integrated one-way membrane.

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