Counter-pulsation balloon catheter and counter-pulsation balloon catheter system

Abstract

The invention provides a counterpulsation balloon catheter and a counterpulsation balloon catheter system. The counterpulsation balloon catheter comprises a main balloon, an auxiliary balloon and a catheter body. The catheter is provided with a filling cavity formed in the axial direction of the catheter, and the main balloon is communicated with the filling cavity; the main balloon is configured to expand when the filling fluid is filled into the filling cavity and contract when the filling fluid is pumped out of the filling cavity, and expansion and contraction of the main balloon meet counterpulsation requirements; the auxiliary balloon is arranged on the near end side of the main balloon in the axial direction of the catheter; the auxiliary balloon is communicated with the filling cavity; the auxiliary balloon is configured to expand by filling the filling cavity with filling fluid so as to abut against a target tube wall for positioning; when the auxiliary balloon is expanded and abuts against the target tube wall to be positioned, a gap exists between the cross section contour, at the auxiliary balloon, of the counterpulsation balloon catheter and the target tube wall.

Description

Technical Field

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

[0002] In clinical practice, percutaneous coronary intervention (PCI) is still the main means to restore epicardial vascular patency in a timely manner. However, after successful revascularization, even if the microvessels of some patients with acute ST-segment elevation myocardial infarction (STEMI) are perfused in time, the previously blocked microchannels are not effectively opened and the ischemic area of ​​the myocardium may still increase, leading to higher mortality and morbidity.

[0003] The coronary sinus counterpulsation balloon catheter is placed in the coronary sinus (CS) through the venous vascular access. By connecting to the counterpulsation device, the balloon can be expanded and contracted cyclically, intermittently blocking the blood flow in the coronary sinus, thereby controlling the intermittent increase and decrease of blood pressure in the coronary sinus, prompting the reflux of coronary venous blood to be redistributed to the damaged area of ​​the myocardium, thereby improving myocardial perfusion after percutaneous coronary intervention, reducing the area of ​​myocardial infarction, and improving heart function.

[0004] However, in the long-term operation, the rapid inflation and deflation process of the counterpulsation balloon will be disturbed by the impact of blood flow, and the anatomical characteristics of the coronary sinus itself (such as irregular diameter and changes in blood flow direction) can easily cause the counterpulsation balloon catheter to shift or fall off. This will not only affect the treatment effect, but may also lead to a decrease in treatment effect or vascular damage, thus endangering safety.

[0005] In addition, the anatomical structure of the coronary sinus varies from patient to patient, such as differences in diameter, curvature, and wall thickness. The dynamic inflation and deflation process of the counterpulsation balloon during the counterpulsation operation has limited adaptability to different vascular morphologies, making it difficult for the counterpulsation balloon catheter to meet the needs of all patients. Summary of the invention

[0006] The object of the present invention is to provide a counterpulsation balloon catheter and a counterpulsation balloon catheter system to solve at least one of the problems of the existing counterpulsation balloon catheter, namely, easy displacement, poor adaptability and complete blood blockage.

[0007] In order to solve the above technical problems, the present invention provides a counterpulsation balloon catheter, which comprises: a main balloon, an auxiliary balloon and a catheter; The catheter has a filling cavity arranged along its own axis, and the main balloon is connected to the filling cavity; the main balloon is configured to expand by filling the filling cavity with filling fluid, and to contract by withdrawing the filling fluid from the filling cavity, and the expansion and contraction of the main balloon are adapted to counterpulsation requirements; The auxiliary balloon is arranged at the proximal side of the main balloon along the axial direction of the catheter; the auxiliary balloon is communicated with the filling cavity; the auxiliary balloon is configured to expand by filling the filling cavity with filling fluid so as to abut against the target vessel wall; Wherein, when the auxiliary balloon is expanded and positioned against the target vessel wall, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target vessel wall.

[0008] Optionally, the counterpulsation balloon catheter includes a plurality of the auxiliary balloons, and the plurality of the auxiliary balloons are arranged at intervals along the circumference and / or axial direction of the catheter.

[0009] Optionally, when the plurality of auxiliary balloons are expanded and positioned against the target vessel wall, the catheter is detached from the target vessel wall at the auxiliary balloons.

[0010] Optionally, the filling chamber includes a main chamber and an auxiliary chamber, the main chamber is connected to the main balloon, and the auxiliary chamber is connected to the auxiliary balloon; the main chamber and the auxiliary chamber form a main chamber interface and an auxiliary chamber interface that are independent of each other at the proximal end; wherein the auxiliary chamber interface has a control valve.

[0011] Optionally, the filling cavity includes a main cavity and an auxiliary cavity, the main cavity is connected to the main balloon, and the auxiliary cavity is connected to the main balloon and the auxiliary balloon respectively; the main cavity forms a main cavity interface at the proximal end.

[0012] Optionally, the cross-section of the main cavity is crescent-shaped; the catheter has a connecting hole opened radially at a position corresponding to the main balloon, and the connecting hole is connected to the crescent-shaped tip portion of the main cavity.

[0013] Optionally, the catheter has a recessed portion opening along the radial direction, and when the auxiliary balloon is in a contracted state, it is accommodated in the recessed portion and does not exceed the circumferential outer contour of the catheter or covers the opening of the recessed portion; when the auxiliary balloon is expanded, it protrudes outward from the recessed portion beyond the circumferential outer contour of the catheter.

[0014] Optionally, the catheter has a guidewire cavity arranged along its own axial direction, and the center of the cross section of the guidewire cavity is offset relative to the center of the cross section of the catheter.

[0015] Optionally, the filling cavity includes a main cavity and an auxiliary cavity, and the catheter has a guidewire cavity; the main cavity forms a main cavity interface at the proximal end of the catheter, the auxiliary cavity forms an auxiliary cavity interface at the proximal end of the catheter, and the guidewire cavity forms a guidewire cavity interface at the proximal end of the catheter; wherein the guidewire cavity interface extends along the axial direction of the catheter, and the main cavity interface and the auxiliary cavity interface extend in a forked manner.

[0016] To solve the above technical problems, the present invention also provides a counterpulsation balloon catheter system, which includes: a counterpulsation device and the counterpulsation balloon catheter as described above; the counterpulsation device is used to fill filling fluid into the filling chamber or extract filling fluid through the filling chamber.

[0017] In summary, in the counterpulsation balloon catheter and counterpulsation balloon catheter system provided by the present invention, the counterpulsation balloon catheter includes: a main balloon, an auxiliary balloon and a catheter; the catheter has a filling cavity arranged along its own axial direction, and the main balloon is connected to the filling cavity; the main balloon is configured to expand by filling the filling cavity with filling fluid, and to contract by withdrawing the filling fluid from the filling cavity, and the expansion and contraction of the main balloon are adapted to the counterpulsation demand; the auxiliary balloon is arranged on the proximal side of the main balloon along the axial direction of the catheter; the auxiliary balloon is connected to the filling cavity; the auxiliary balloon is configured to expand by filling the filling cavity with filling fluid, so as to be positioned against the target vessel wall; wherein, when the auxiliary balloon is expanded and positioned against the target vessel wall, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target vessel wall.

[0018] With such configuration, on the one hand, through the setting of the auxiliary balloon, it can be positioned against the target tube wall, thereby maintaining the stable positioning of the counterpulsation balloon catheter during long-term treatment, avoiding sliding caused by heart pulsation or blood flow impact, and reducing vascular damage. On the other hand, the expansion of the auxiliary balloon can flexibly respond to the differences in vascular anatomy of different patients, and improve the adaptability of the counterpulsation balloon catheter to different patients. On the other hand, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target tube wall, so that even when the counterpulsation balloon catheter is anchored in the blood vessel by the expansion of the auxiliary balloon, the blood flow channel can be retained to prevent the risk of ischemia or thrombosis caused by complete blockage of the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Those skilled in the art will appreciate that the drawings are provided for a better understanding of the present invention, but do not constitute any limitation on the scope of the present invention.

[0020] Figure 1 Schematic diagram of a counterpulsation balloon catheter system according to an embodiment of the present invention.

[0021] Figure 2 is a schematic diagram of the AA section of the counterpulsation balloon catheter, in which the auxiliary balloon is in a deflated state.

[0022] Figure 3 is a schematic diagram of the AA section of the counterpulsation balloon catheter, in which the auxiliary balloon is in the expanded state.

[0023] Figure 4Schematic diagram of the BB section of the counterpulsation balloon catheter, in which the auxiliary lumen is connected to the main balloon.

[0024] Figure 5 It is a schematic diagram of the BB section of the counterpulsation balloon catheter, in which the auxiliary lumen is not connected to the main balloon.

[0025] In the attached figure: 1-main balloon; 2-auxiliary balloon; 3-catheter; 30-filling chamber; 31-main chamber; 32-auxiliary chamber; 33-main chamber interface; 34-auxiliary chamber interface; 35-fluid hole; 36-guidewire chamber; 37-guidewire chamber interface; 38-connecting hole; 39-recessed portion; 4-target tube wall; 5-gap; 6-counterpulsation device; 61-charge and discharge drive unit; 7-pressure sensor; 81-control valve; 82-syringe; 9-developing ring. DETAILED DESCRIPTION

[0026] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0027] As used in the present invention, the singular forms "one", "an", "one" and "the" include plural objects, the term "or" is generally used in a sense that includes "and / or", the term "several" is generally used in a sense that includes "at least one", and the term "at least two" is generally used in a sense that includes "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, and "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which include not only the endpoints. The terms "proximal end" and "distal end" are defined herein relative to a counterpulsation balloon catheter having an end for intervention in the human body and a control end extending outside the body. The term "proximal end" refers to the position closer to the control end of the counterpulsation balloon catheter extending out of the body, and the term "distal end" refers to the position closer to the end of the counterpulsation balloon catheter that intervenes in the human body and is therefore farther away from the control end of the counterpulsation balloon catheter. Optionally, in the application scenario of manual or hand operation, the terms "proximal end" and "distal end" are defined in this article relative to an operator such as a surgeon or clinician. The term "proximal end" refers to the position closer to the operator, and the term "distal end" refers to the position closer to the counterpulsation balloon catheter and is therefore farther away from the operator. In addition, as used in the present invention, "installed", "connected", "connected", and an element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, matching or transmission relationship between the two elements, and the connection, coupling, matching or transmission between the two elements can be direct or indirectly through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, an element can be in any orientation such as inside, outside, above, below or one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upper direction toward the top of the corresponding figure, and the downward or lower direction toward the bottom of the corresponding figure.

[0028] The purpose of the present invention is to provide a counterpulsation balloon catheter and a counterpulsation balloon catheter system to solve at least one of the problems of the existing counterpulsation balloon catheter, such as easy displacement, poor adaptability, and complete blood blockage.

[0029] Please refer to Figures 1 to 5The embodiment of the present invention provides a counterpulsation balloon catheter, which includes: a main balloon 1, an auxiliary balloon 2 and a catheter 3; the catheter 3 has a filling cavity 30 arranged along its own axial direction, and the main balloon 1 is connected to the filling cavity 30; the main balloon 1 is configured to expand by filling the filling cavity 30 with filling fluid, and to contract by withdrawing the filling fluid from the filling cavity 30, and the expansion and contraction of the main balloon 1 are adapted to the counterpulsation demand; the auxiliary balloon 2 is arranged on the proximal side of the main balloon 1 along the axial direction of the catheter 3 ( Figure 1 the auxiliary balloon 2 is connected to the filling chamber 30; the auxiliary balloon 2 is configured to expand by filling the filling chamber 30 with filling fluid so as to abut against the target vessel wall 4; wherein, when the auxiliary balloon 2 is expanded and abuts against the target vessel wall 4, there is a gap 5 between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon 2 and the target vessel wall 4.

[0030] In one application scenario, the distal end of the counterpulsation balloon catheter is delivered to a predetermined part of the heart, such as the coronary sinus region, through vascular intervention, and the proximal end of the counterpulsation balloon catheter extends out of the body and is used to connect to the counterpulsation device 6. The counterpulsation device 6 is used to fill the filling fluid through the filling chamber 30 or extract the filling fluid through the filling chamber 30, so as to control the expansion or contraction of the main balloon 1 and the auxiliary balloon 2. The filling fluid here is preferably a liquid (such as saline, etc.), and can also be a gas or a gas-liquid mixture, etc., which is not limited to this embodiment. The counterpulsation device 6 can accurately control the expansion and contraction of the main balloon 1 by driving the filling or extraction of the filling fluid. The expansion and contraction of the main balloon 1 is adapted to the counterpulsation demand, that is, according to the rhythm of the heart, the blood flow of the coronary sinus is intermittently blocked, thereby achieving the purpose of controlling the intermittent increase and decrease of the blood pressure of the coronary sinus. Its specific principle can be referred to the prior art, and will not be described in detail here. The diameter of the main balloon 1 matches the size of the coronary sinus, and its outer diameter when expanded can be 4mm~16mm, and the axial length of the main balloon 1 along the catheter 3 can be 10mm~25mm. The cross section of the catheter 3 is preferably circular, and its outer diameter can be 1.67mm~3.33mm. Optionally, in order to facilitate positioning, the catheter 3 is provided with a plurality of developing rings 9 at appropriate positions, for example, the developing rings 9 can be provided near the main balloon 1, which are used to indicate the position of the main balloon 1 under X-ray.

[0031] In some embodiments, the auxiliary balloon 2 can be manually controlled by an additional syringe 82. In other embodiments, the auxiliary balloon 2 can also be automatically controlled by the counterpulsation device 6. Similar to the main balloon 1, the auxiliary balloon 2 expands when filled with filling fluid and contracts when the filling fluid is extracted. Since the auxiliary balloon 2 is arranged on the proximal side of the main balloon 1 in the axial direction of the catheter 3, and is preferably arranged at an interval with the main balloon 1, the main balloon 1 and the auxiliary balloon 2 are at different axial positions of the catheter 3, and the expansion and contraction of the auxiliary balloon 2 will not affect the expansion and contraction of the main balloon 1 to adapt to the counterpulsation demand.

[0032] For further information, please refer to Figure 3 , after the auxiliary balloon 2 is filled with filling fluid and expanded, it is positioned against the target tube wall 4. The target tube wall 4 here can be, for example, a blood vessel wall (in actual treatment applications) or a sheath wall (in interventional delivery process). The abutment and positioning of the auxiliary balloon 2 against the target tube wall 4 can anchor the position of the entire counterpulsation balloon catheter. In actual treatment applications, the stable positioning of the counterpulsation balloon catheter during long-term treatment can be maintained, and sliding caused by heart pulsation or blood flow impact can be avoided, reducing vascular damage. In the interventional delivery process, the abutment and positioning of the auxiliary balloon 2 against the sheath wall can be used to anchor the counterpulsation balloon catheter and the sheath, which is convenient for delivery and positioning. On the contrary, the auxiliary balloon 2 shrinks when the filling fluid is extracted, and it can be separated from the abutment and positioning with the target tube wall 4, that is, the anchoring is released, which is suitable for scenes such as position adjustment or removal of the counterpulsation balloon catheter.

[0033] Furthermore, the expansion degree of the auxiliary balloon 2 (i.e., the size of its expansion) can be adjusted according to the amount of filling fluid. It can be understood that the cross-sectional shape of the catheter 3 is relatively fixed, and by adjusting the expansion degree of the auxiliary balloon 2, it can adapt to target tube walls 4 of different inner diameters or shapes. This allows the counterpulsation balloon catheter to flexibly cope with the differences in vascular anatomy of different patients, thereby improving the adaptability of the counterpulsation balloon catheter to different patients.

[0034] The inventor has found that under some conditions of counterpulsation, the expansion of the existing counterpulsation balloon catheter is too large, which may completely block the blood vessels and cause ischemia or thrombosis. Based on the setting of the auxiliary balloon 2, it can assist in forming a blocking effect on blood flow after expansion, thereby reducing the expansion demand of the main balloon 1 and reducing the risk of the main balloon 1 completely blocking the blood vessels. In addition, please refer to Figure 3 There is a gap 5 between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon 2 (the cross-sectional outer profile of the combination formed by the guiding tube 3 and the auxiliary balloon 2) and the target tube wall 4, so that even when the counterpulsation balloon catheter is anchored in the blood vessel by the expansion of the auxiliary balloon 2, the blood flow channel (gap 5) can be retained to prevent the risk of ischemia or thrombosis caused by complete blockage of the blood vessel. That is, the existence of the gap 5 can further prevent the blood flow from being blocked.

[0035] The present embodiment does not particularly limit the shape of the auxiliary balloon 2. As a preferred example, the auxiliary balloon 2 after expansion can be in a shape with a soft curved outer contour, such as a sphere or an ellipsoid, to reduce the possibility of damage to the vascular wall when it contacts the vascular wall. In other embodiments, the auxiliary balloon 2 after expansion can also be in a shape such as a crescent attached to the outer wall of the catheter 3, or even an irregular shape. However, since it is necessary to have a gap 5 between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon 2 and the target vessel wall 4, the auxiliary balloon 2 after expansion should not form a complete ring in the circumferential direction, or the combination of the auxiliary balloon 2 and the catheter 3 after expansion should not block the target vessel wall 4 to avoid completely blocking the blood flow.

[0036] Optionally, the material of the main balloon 1 and the auxiliary balloon 2 can be selected to use a polymer with high flexibility and low elastic modulus, such as a flexible polyurethane material (PU), which has high flexibility and durability. Alternatively, a thermoplastic elastomer (TPE) can also be used. These materials can enable the main balloon 1 and the auxiliary balloon 2 to dynamically adapt to the movement of the blood vessel wall, further improving the patient's tolerance. The catheter 3 preferably uses polyether block amide (PEBAX) as the main material to ensure support and delivery flexibility.

[0037] Optionally, the counterpulsation balloon catheter may include only one auxiliary balloon 2. When the counterpulsation balloon catheter includes only one auxiliary balloon 2, when the auxiliary balloon 2 expands and abuts against the target vessel wall 4, the other side of the catheter 3 radially relative to the auxiliary balloon 2 may abut against the target vessel wall 4, thereby forming an anchor through the relative expansion and abutment of the catheter 3 and the auxiliary balloon 2 against the target vessel wall 4.

[0038] Preferably, the counterpulsation balloon catheter includes a plurality of auxiliary balloons 2, and the plurality of auxiliary balloons 2 are arranged at intervals along the circumference and / or axial direction of the catheter 3. Although the counterpulsation balloon catheter can also be anchored by the auxiliary balloon 2 when only one auxiliary balloon 2 is included, a greater number of auxiliary balloons 2 in the circumferential direction and / or axial direction helps to improve the anchoring effect. It should be noted that the scheme of arranging a plurality of auxiliary balloons 2 at the same axial position (i.e., the same cross-section) of the catheter 3 and arranging a plurality of auxiliary balloons 2 at intervals in the axial direction of the catheter 3 can be applied independently or in combination. In some embodiments, the plurality of auxiliary balloons 2 can be at the same circumferential position on the catheter 3 but at different positions in the axial direction, that is, the plurality of auxiliary balloons 2 form an axial column on the catheter 3. In some embodiments, the plurality of auxiliary balloons 2 can also be at the same axial position on the catheter 3 but at different circumferential positions to form a ring shape. In other embodiments, the plurality of auxiliary balloons 2 can be arranged at intervals in the circumferential direction and axial direction at the same time, that is, forming a plurality of groups of axially spaced ring shapes.

[0039] Optionally, a plurality of the auxiliary balloons 2 are arranged circumferentially around the catheter 3; when the plurality of the auxiliary balloons 2 are expanded and positioned against the target vessel wall 4, the catheter 3 is separated from the target vessel wall 4 at the auxiliary balloons 2. Figure 2 and Figure 3 In one exemplary embodiment, three auxiliary balloons 2 are arranged at the same axial position (i.e., the same cross section) of the catheter 3, and the three auxiliary balloons 2 are evenly distributed around the catheter 3. It can be understood that when the three auxiliary balloons 2 are expanded, Figure 3 As shown, the catheter 3 will be suspended relative to the target vessel wall 4, thereby reducing the problem of uneven blood flow caused by the eccentricity of the catheter 3 in the target vessel wall 4 and reducing the possibility of thrombosis caused by turbulent flow deceleration.

[0040] In a preferred example, the counterpulsation balloon catheter may include nine auxiliary balloons 2, each of which is a group of three auxiliary balloons 2 arranged circumferentially around the catheter 3 at the same cross-sectional position, and the three groups of auxiliary balloons 2 are arranged at intervals from each other in the axial direction of the catheter 3, such as Figure 1 As shown. In particular, the number of auxiliary balloons 2 in each group that are spaced apart from each other in the axial direction of the catheter 3 may be the same or different. The circumferential position of each group of auxiliary balloons 2 may be the same or different. This embodiment does not limit this. When a plurality of auxiliary balloons 2 are arranged on the same cross section of the catheter 3 and a plurality of auxiliary balloons 2 are spaced apart in the axial direction of the catheter 3, in addition to improving the anchoring stability, it also brings additional beneficial effects, that is, it can limit the extension direction of the distal part of the catheter 3 (referring to the corresponding range of the auxiliary balloon 2 in the axial direction, and the partial area on the distal side of the auxiliary balloon 2), so that the distal part of the catheter 3 can be kept consistent with the extension direction of the axis of the target tube wall 4, so that the main balloon 1 is kept as centered as possible in the blood vessel, and the counterpulsation effect of the main balloon 1 is further improved. More preferably, the number of auxiliary balloons 2 on the same cross section of the catheter 3 is preferably 1 to 4, and the arrangement in the axial direction of the catheter 3 is preferably 1 to 3. In some embodiments, corresponding to curved or complex blood vessel regions, the auxiliary balloon 2 is preferably arranged asymmetrically (such as unevenly distributed in the circumferential direction, etc.) to further enhance the anchoring force.

[0041] Please refer to Figure 5 , and combined with reference Figures 1 to 3 In one embodiment, the filling chamber 30 includes a main chamber 31 and an auxiliary chamber 32, wherein the main chamber 31 is connected to the main balloon 1, and the auxiliary chamber 32 is connected to the auxiliary balloon 2; the main chamber 31 and the auxiliary chamber 32 form a main chamber interface 33 and an auxiliary chamber interface 34 which are independent of each other at the proximal end of the catheter 3; wherein the auxiliary chamber interface 34 has a control valve 81. The main chamber 31 and the auxiliary chamber 32 can be independent cavities, which have no connection with each other, and at the proximal end of the catheter 3 ( Figure 1 On the right side of the counterpulsation device 6, a main cavity interface 33 and an auxiliary cavity interface 34 are formed, which are independent of each other. It can be understood that at this time, the filling of the main balloon 1 and the filling of the auxiliary balloon 2 are independently decoupled. In application, when the counterpulsation balloon catheter is delivered to the predetermined area, the syringe 82 can be connected to the auxiliary cavity interface 34 to inject filling fluid into the auxiliary balloon 2 through the auxiliary cavity 32. After the auxiliary balloon 2 expands to a suitable size (for example, after the auxiliary balloon 2 forms abutment with the target tube wall 4), the control valve 81 is closed, and the shape of the auxiliary balloon 2 is fixed, and the abutment with the target tube wall 4 is maintained, so that the entire counterpulsation balloon catheter is reliably anchored in a predetermined position. The main cavity interface 33 can be connected to the counterpulsation device 6, and based on the control of the counterpulsation device 6, the filling fluid is filled or sucked into the main balloon 1 through the main cavity 31 to achieve the expansion and contraction of the main balloon 1 corresponding to the counterpulsation demand, as described below.

[0042] Please refer to Figure 4 , and combined with reference Figures 1 to 3 In another embodiment, the filling chamber 30 includes a main chamber 31 and an auxiliary chamber 32, wherein the main chamber 31 is connected to the main balloon 1, and the auxiliary chamber 32 is connected to the main balloon 1 and the auxiliary balloon 2 respectively; the main chamber 31 forms a main chamber interface 33 at the proximal end of the catheter 3. Figure 5 The embodiments shown are different. Figure 4 In the illustrated embodiment, the auxiliary cavity 32 and the main cavity 31 are actually interconnected. After the filling fluid flows into the main balloon 1 through the main cavity 31, it will flow into the auxiliary balloon 2 through the auxiliary cavity 32 connected to the main balloon 1, thereby synchronously achieving the filling and expansion of the main balloon 1 and the auxiliary balloon 2. The inventors have found that in actual treatment application scenarios, the moment when the counterpulsation balloon catheter is impacted by blood flow is mainly when the main balloon 1 expands and blocks the blood flow. At this time, the auxiliary balloon 2 expands synchronously and is positioned against the target tube wall 4, which can effectively help the counterpulsation balloon catheter to form an anchor. When the main balloon 1 contracts, the blood flow to the counterpulsation balloon catheter is reduced. At this time, the risk of displacement of the counterpulsation balloon catheter is relatively small, and even if the auxiliary balloon 2 contracts synchronously, it will not be affected. Configuring the main balloon 1 and the auxiliary balloon 2 for linkage control can simplify the surgical process and operation. Optionally, in Figure 4 In the illustrated embodiment, the auxiliary cavity 32 can be arranged only between the main balloon 1 and the auxiliary balloon 2, and the auxiliary cavity 32 can also continue to extend from the auxiliary balloon 2 to the proximal end of the catheter 3 and form an auxiliary cavity interface 34, but at this time the auxiliary cavity interface 34 can be left vacant and the control valve 81 can be kept in a closed state.

[0043] Please refer to Figures 2 to 5Optionally, the catheter 3 has a guidewire cavity 36 arranged along its own axial direction, and the center of the cross section of the guidewire cavity 36 is offset relative to the center of the cross section of the catheter 3. One function of the guidewire cavity 36 is to allow the guidewire to be inserted, and the other function is to be used for hydraulic transmission. The cross section of the guidewire cavity 36 is preferably circular, which is compatible with guidewires with a diameter of 0.018in~0.038in. The center offset of the cross section of the guidewire cavity 36 can reserve space for the main cavity 31 to achieve better fluid mechanics performance under the limited cross-sectional area of ​​the catheter 3, see the description of the main cavity 31 below for details.

[0044] It is understandable that the guidewire cavity 36 preferably passes through both ends of the axial direction of the catheter 3. During the interventional delivery process, the counterpulsation balloon catheter can be pushed to the target position (such as the coronary sinus) through the guidewire cavity 36 along the already installed guidewire. On the other hand, after the interventional delivery is completed, the guidewire is removed to ensure that the guidewire cavity 36 is filled with liquid (such as blood or injected with saline), and then the guidewire cavity interface 37 is connected to the pressure sensor 7. The pressure sensor 7 can detect the blood pressure changes at the coronary sinus based on the principle of hydraulic transmission. Then, according to the blood pressure changes at the coronary sinus, the counterpulsation related parameters of the main balloon 1, such as the filling volume, the pressure holding time, etc., can be adjusted in time, and the control is achieved through the counterpulsation device 6.

[0045] Optionally, the guidewire cavity 36 forms a guidewire cavity interface 37 at the proximal end of the catheter 3, and the guidewire cavity interface 37 extends along the axial direction of the catheter 3 to facilitate the insertion of the guidewire, and the main cavity interface 33 and the auxiliary cavity interface 34 extend in a bifurcated manner relative to the guidewire cavity interface 37, forming a trident shape. Figure 1 The catheter 3 has a plurality of fluid holes 35 on the distal side of the main balloon 1, and the fluid holes 35 are connected to the guidewire cavity 36, so that even at the angle of the tortuous blood vessel, even if the distal opening of the guidewire cavity 36 is blocked, the blood can remain connected to the guidewire cavity 36 through the fluid holes 35, thereby ensuring that the pressure sensor 7 can reliably detect the real-time blood pressure in the distal area of ​​the catheter 3.

[0046] Optional, please refer to Figure 1 The catheter 3 has a bend between the main balloon 1 and the auxiliary balloon 2, and the bend angle can be selected from 45° to 180°, preferably from 135° to 180°. It should be noted that when the bend angle is 180°, that is, the bend of the catheter 3 between the main balloon 1 and the auxiliary balloon 2 tends to be straight, and the catheter 3 is roughly in a straight line. Optionally, the axial length of the catheter 3 from the bend to the distal end is 15mm to 50mm.

[0047] refer to Figures 2 to 5Optionally, the cross section of the main cavity 31 is crescent-shaped; the catheter 3 has a connecting hole 38 radially opened at a position corresponding to the main balloon 1, and the connecting hole 38 is connected to the crescent-shaped tip of the main cavity 31. The cross section of the main cavity 31 is set to be crescent-shaped, which helps to reduce turbulence and eddy currents, and has a higher flow rate than the annular cross section with the same cross-sectional area, which is beneficial to improving the filling and discharge efficiency of the filling fluid. The connecting hole 38 is set at the tip of the crescent, which can reduce the turbulence formed by the filling fluid in the main cavity 31, and is also beneficial to improving the filling and discharge efficiency of the filling fluid. The crescent-shaped cross section of the main cavity 31, combined with the eccentrically arranged guidewire cavity 36, can achieve a better arrangement combination.

[0048] As mentioned above, the auxiliary balloon 2 can shrink and expand, and the state when it is not filled with filling fluid is called the shrink state. The shrink state of the auxiliary balloon 2 is preferably attached to or stored near the outer wall of the catheter 3 as much as possible to reduce the resistance during the interventional delivery process or the movement process. Please continue to refer to Figures 2 to 5 In a preferred embodiment, the catheter 3 has a recessed portion 39 opening in the radial direction. When the auxiliary balloon 2 is in a contracted state, it is accommodated in the recessed portion 39 and does not exceed the circumferential outer contour of the catheter 3 or covers the opening of the recessed portion 39; when the auxiliary balloon 2 is expanded, it protrudes outward from the recessed portion 39 and exceeds the circumferential outer contour of the catheter 3. When the auxiliary balloon 2 is in a contracted state, it can be accommodated in the recessed portion 39 or cover the opening of the recessed portion 39. Figure 2 When the auxiliary balloon 2 expands, it protrudes outward from the recessed portion 39, so that it can contact and abut against the target tube wall 4 before the outer peripheral wall of the catheter 3, as shown in FIG. Figure 3 shown.

[0049] In some embodiments, the recessed portion 39 can be formed by precisely opening a hole on the outer wall of the catheter 3 using laser micro-hole processing technology, and the hole diameter can be, for example, about 0.2 mm, so as to ensure smooth flow of the filling fluid without affecting the mechanical properties of the catheter 3. Then, the auxiliary balloon 2 can be welded to the outer wall of the catheter 3 near the recessed portion 39 by a hot melt process, and the welded portion is sealed.

[0050] The embodiment of the present invention also provides a counterpulsation balloon catheter system, which includes a counterpulsation device 6 and a counterpulsation balloon catheter as described above. The counterpulsation device 6 is used to fill the filling fluid through the filling chamber 30 or extract the filling fluid through the filling chamber. Optionally, the counterpulsation device 6 has a charging and discharging drive unit 61, and the power source of the charging and discharging drive unit 61 can be selected from compressed air, oil pressure, electricity, etc. The specific driving structure of the charging and discharging drive unit 61 can use an air pump, an engine, a motor, etc. to achieve the filling or suction of the filling fluid. The filling chamber 30 (such as its main chamber 31) can be connected to the charging and discharging drive unit 61 through the main chamber interface 33. In an exemplary embodiment, the pressure sensor 7 can be arranged on the counterpulsation device 6, and after the interventional delivery process is completed, the guide wire chamber interface 37 can be connected to the pressure sensor 7. In some embodiments, the counterpulsation device 6 can also have an auxiliary charging and discharging drive unit (not shown), which can replace the syringe 82 to connect to the auxiliary chamber interface 34 to achieve control of the auxiliary balloon 2. The specific structure and principle of the counterpulsation device 6 can be referred to the prior art and will not be described in detail here.

[0051] According to simulations in a virtual coronary sinus model and animal experiments, the counterpulsation balloon catheter and counterpulsation balloon catheter system provided in this embodiment significantly improved positioning stability, and no vascular damage or complete blockage was observed.

[0052] In summary, in the counterpulsation balloon catheter and counterpulsation balloon catheter system provided by the present invention, the counterpulsation balloon catheter includes: a main balloon, an auxiliary balloon and a catheter; the catheter has a filling cavity arranged along its own axial direction, and the main balloon is connected to the filling cavity; the main balloon is configured to expand by filling the filling cavity with filling fluid, and to contract by withdrawing the filling fluid from the filling cavity, and the expansion and contraction of the main balloon are adapted to the counterpulsation demand; the auxiliary balloon is arranged on the proximal side of the main balloon along the axial direction of the catheter; the auxiliary balloon is connected to the filling cavity; the auxiliary balloon is configured to expand by filling the filling cavity with filling fluid, so as to be positioned against the target vessel wall; wherein, when the auxiliary balloon is expanded and positioned against the target vessel wall, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target vessel wall. With such configuration, on the one hand, through the setting of the auxiliary balloon, it can be positioned against the target tube wall, thereby maintaining the stable positioning of the counterpulsation balloon catheter during long-term treatment, avoiding sliding caused by heart pulsation or blood flow impact, and reducing vascular damage. On the other hand, the expansion of the auxiliary balloon can flexibly respond to the differences in vascular anatomy of different patients, and improve the adaptability of the counterpulsation balloon catheter to different patients. On the other hand, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target tube wall, so that even when the counterpulsation balloon catheter is anchored in the blood vessel by the expansion of the auxiliary balloon, the blood flow channel can be retained to prevent the risk of ischemia or thrombosis caused by complete blockage of the blood vessel.

[0053] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the protection scope of the present invention.

Claims

1. A counterpulsation balloon catheter, characterized in that: include: Main balloon, auxiliary balloon and catheter; The catheter has a filling cavity arranged along its own axis, and the main balloon is connected to the filling cavity; the main balloon is configured to expand by filling the filling cavity with filling fluid, and to contract by withdrawing the filling fluid from the filling cavity, and the expansion and contraction of the main balloon are adapted to counterpulsation requirements; The auxiliary balloon is arranged at the proximal side of the main balloon along the axial direction of the catheter; the auxiliary balloon is communicated with the filling cavity; the auxiliary balloon is configured to expand by filling the filling cavity with filling fluid so as to abut against the target vessel wall; Wherein, when the auxiliary balloon is expanded and positioned against the target vessel wall, there is a gap between the cross-sectional profile of the counterpulsation balloon catheter at the auxiliary balloon and the target vessel wall.

2. The counterpulsation balloon catheter according to claim 1, characterized in that: The counterpulsation balloon catheter comprises a plurality of the auxiliary balloons, which are arranged at intervals along the circumference and / or axial direction of the catheter.

3. The counterpulsation balloon catheter according to claim 2, characterized in that: When the plurality of auxiliary balloons are expanded and positioned against the target vessel wall, the catheter is separated from the target vessel wall at the auxiliary balloons.

4. The counterpulsation balloon catheter according to claim 1, characterized in that: The filling chamber includes a main chamber and an auxiliary chamber, wherein the main chamber is connected to the main balloon, and the auxiliary chamber is connected to the auxiliary balloon; the main chamber and the auxiliary chamber form a main chamber interface and an auxiliary chamber interface which are independent of each other at the proximal end; wherein the auxiliary chamber interface has a control valve.

5. The counterpulsation balloon catheter according to claim 1, characterized in that: The filling cavity includes a main cavity and an auxiliary cavity, wherein the main cavity is communicated with the main balloon, and the auxiliary cavity is communicated with the main balloon and the auxiliary balloon respectively; the main cavity forms a main cavity interface at the proximal end.

6. The counterpulsation balloon catheter according to claim 4 or 5, characterized in that: The cross section of the main cavity is crescent-shaped; the catheter has a communicating hole opened in the radial direction at a position corresponding to the main balloon, and the communicating hole is connected with the crescent-shaped tip of the main cavity.

7. The counterpulsation balloon catheter according to claim 1, characterized in that: The catheter has a recessed portion opening along the radial direction. When the auxiliary balloon is in a contracted state, it is accommodated in the recessed portion and does not exceed the circumferential outer contour of the catheter or covers the opening of the recessed portion; when the auxiliary balloon is expanded, it protrudes outward from the recessed portion beyond the circumferential outer contour of the catheter.

8. The counterpulsation balloon catheter according to claim 1, characterized in that: The catheter has a guidewire lumen arranged along the catheter's axial direction, and the center of the cross section of the guidewire lumen is offset relative to the center of the cross section of the catheter.

9. The counterpulsation balloon catheter according to claim 1, characterized in that: The filling cavity includes a main cavity and an auxiliary cavity, and the catheter has a guidewire cavity; the main cavity forms a main cavity interface at the proximal end of the catheter, the auxiliary cavity forms an auxiliary cavity interface at the proximal end of the catheter, and the guidewire cavity forms a guidewire cavity interface at the proximal end of the catheter; wherein the guidewire cavity interface extends along the axial direction of the catheter, and the main cavity interface and the auxiliary cavity interface extend in a forked manner.

10. A counterpulsation balloon catheter system, characterized in that: include: A counterpulsation device and a counterpulsation balloon catheter according to any one of claims 1 to 9; The counterpulsation device is used to fill the filling fluid through the filling chamber or to extract the filling fluid through the filling chamber.

Images