Percutaneous circulation auxiliary device

Abstract

The utility model discloses a percutaneous circulation auxiliary device. The percutaneous circulation auxiliary device comprises an intervention catheter and a diaphragm pump. The intervention catheter is provided with at least one blood inlet and at least one blood outlet, the blood inlet and the blood outlet are both one-way valves and are both in one-way conduction, and the diaphragm pump comprises a blood cavity separated by a flexible diaphragm and a driving liquid cavity used for charging and discharging liquid. When in use, the device is communicated with a liquid charging and discharging control device, is mainly used for assisting blood pumping of the right ventricle, can be placed into the right ventricle through femoral veins, assists the heart in doing work, and increases cardiac output; the utility model relates to a pulsating pump which can pump blood according to systole and diastole of the heart. The device is simple in structure and low in manufacturing cost, and has a good application prospect.

Description

Technical Field

[0001] The utility model relates to a percutaneous circulation assist device, belonging to the technical field of medical equipment. Background Art

[0002] With the continued growth of patients with acute heart failure and the ineffectiveness of drug treatment, percutaneous mechanical circulatory support (MCS) has become the fastest-growing field in the diagnosis and treatment of CHIP. Currently, commonly used MCS devices in clinical practice include intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), and percutaneous axial flow pump systems.

[0003] At present, commonly used percutaneous mechanical circulatory assist devices have achieved good results in the treatment of acute heart failure. However, the current percutaneous mechanical circulatory assist devices are mainly used for acute left heart failure. For acute right heart failure, there are currently no relevant percutaneous circulatory assist devices in China. Summary of the Invention

[0004] The purpose of the utility model is: the utility model aims to provide a percutaneous circulatory assist device, which is mainly used to assist the right ventricle in pumping blood. It can be inserted into the right ventricle through the femoral vein to assist the heart in doing work and increase cardiac output. The utility model is a pulsating pump that can pump blood according to the contraction and relaxation of the heart.

[0005] In order to achieve the above-mentioned purpose, the present invention provides a percutaneous circulation assist device, including an interventional catheter and a diaphragm pump; the interventional catheter is provided with a blood inlet and a bleeding port, the blood inlet and the bleeding port are configured as one-way valves and enable the interventional catheter to conduct blood in a unidirectional manner, and the diaphragm pump includes a blood chamber separated by a flexible diaphragm and a driving liquid chamber for filling and discharging liquid.

[0006] Furthermore, the device further comprises a liquid filling and discharging control device in communication with the diaphragm pump, the blood chamber in communication with the proximal end of the interventional catheter, the driving liquid chamber in communication with the liquid filling and discharging control device, the bleeding port in communication with the distal end of the interventional catheter, and the blood inlet in communication with the proximal end of the interventional catheter. In the present invention, the proximal end and the distal end are relative terms, the proximal end being defined as the end closest to the connection between the interventional catheter and the diaphragm pump, and the distal end being defined as the end further from the connection between the interventional catheter and the diaphragm pump.

[0007] Furthermore, the blood inlet and the bleeding port are composed of a support and a valve leaf, the valve leaves of the blood inlet and the bleeding port have opposite opening and closing directions, a hole is provided on the support, and the valve leaf is communicated with the hole provided on the support when it is opened.

[0008] Furthermore, the valve leaf of the bleeding port is a two-leaf valve, a flexible perforated diaphragm or a flexible plastic ball, and the valve leaf of the blood inlet is a flexible perforated diaphragm.

[0009] Furthermore, when the valve leaf of the bleeding port is a flexible perforated diaphragm, the flexible perforated diaphragm of the blood inlet is sleeved inside the support member, and the flexible perforated diaphragm of the bleeding port is sleeved outside the support member, and the openings of the flexible perforated diaphragm and the channels of the support member are staggered.

[0010] Furthermore, when the valve leaf of the bleeding port is a two-leaf valve, the bleeding port is composed of a two-leaf valve and a support member with a pore, one end of the two-leaf valve is fixedly connected to the support member, and the other end is configured to be openable and closable; the material of the two-leaf valve is a flexible material, and the support member is cylindrical and is used to support the two-leaf valve; when the valve leaf of the bleeding port is a flexible plastic ball, the bleeding port is a ball cage valve composed of a flexible plastic ball and a support member with a pore.

[0011] Furthermore, a guide wire hole is provided at the distal end of the bleeding port, and the proximal end is connected to the interventional catheter.

[0012] Furthermore, a supporting bracket is provided on the blood inlet.

[0013] Furthermore, a pressure sensor is provided near the blood inlet and / or the bleeding outlet, and the pressure sensor is electrically connected to the liquid filling and discharging control device.

[0014] Furthermore, the liquid filling and discharging control device is electrically connected to the electrocardiogram acquisition module and / or the heating module.

[0015] Compared with the prior art, the beneficial effects of the present invention are:

[0016] (1) The present invention can be used to treat acute right heart failure and can be placed into the right ventricle through the femoral vein to produce higher blood assistance.

[0017] (3) The present invention adopts a pulsating pump mode, which is not easy to generate high-speed blood flow to form a large shear stress, thereby greatly reducing the occurrence of hemolysis.

[0018] (4) The blood inlet and bleeding outlet structures designed in the present invention can well realize one-way conduction and matching catheter structure, thereby realizing hydraulically driven blood pumping. The overall structure of the device is simple and the manufacturing cost is low. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a schematic diagram of the overall structure of the percutaneous circulatory assistance device shown in the embodiment;

[0020] Figure 2 A schematic diagram of the device in use;

[0021] Figure 3A This is a schematic diagram of the first control mode of the liquid filling and discharging control device: continuous suction and filling without feedback;

[0022] Figure 3B This is a schematic diagram of the second control mode of the liquid filling and discharging control device: by collecting electrocardiographic signals, the heart beat frequency is determined and the pumping action is performed synchronously with the heart;

[0023] Figure 3C This is a schematic diagram of the third control mode of the liquid filling and discharging control device: by collecting the pressure signal on the catheter, the heart beat frequency is determined and the suction action is performed synchronously with the heart;

[0024] Figure 4 This is a schematic diagram of the structural composition of the interventional catheter;

[0025] Figure 5 This is a schematic diagram of the bleeding port structure shown in Scheme 1 of the embodiment;

[0026] Figure 6 This is a schematic diagram of the bleeding port structure shown in Scheme 2 of the embodiment;

[0027] Figure 7 This is a schematic diagram of the bleeding port structure shown in Scheme 3 of the embodiment;

[0028] Figure 8 Figure 2 is a schematic diagram of the blood inlet structure;

[0029] Figure 9 Schematic diagram of the blood inlet structure with a support bracket;

[0030] Figure 10 A schematic diagram of a device with multiple blood inlets;

[0031] Figure 11 It is a structural diagram of a diaphragm pump;

[0032] Figure markings: 1. interventional catheter; 2. diaphragm pump; 3. blood inlet; 4. bleeding port; 5. liquid filling and discharging control device; 1a. distal catheter segment; 1b. proximal catheter segment; 1c. diaphragm pump connector; 2-1. blood cavity; 2-2. charging and discharging cavity; 2-3. flexible diaphragm; 2-4. first interface; 2-5. second interface; 3a. support member 1; 3b. flexible perforated diaphragm; 3c. support bracket; 4a. bicuspid valve; 4b. support member; 4c. guidewire hole; 4d. flexible perforated diaphragm; 4e. flexible plastic ball. DETAILED DESCRIPTION

[0033] In order to make the present invention more clear and easy to understand, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0034] Example

[0035] A percutaneous circulatory assist device, such as Figure 1As shown, it includes an interventional catheter 1 and a diaphragm pump 2. The interventional catheter 1 is provided with at least one blood inlet 3 and at least one bleeding port 4. Both the blood inlet 3 and bleeding port 4 are one-way valves and are unidirectional. The diaphragm pump 2 includes a blood chamber 2-1 separated by a flexible diaphragm 2-3 and a driving liquid chamber 2-2 for filling and discharging liquid.

[0036] This device can be implanted into the pulmonary artery via the femoral vein. During use, the interventional catheter 1 is implanted in the human body, with its bleeding port 4 placed in the pulmonary artery and its blood inlet 3 placed in the right ventricle. The blood chamber 2-1 of the diaphragm pump 2 is connected to the interventional catheter 1 via an interface, and the drive liquid chamber 2-2 of the diaphragm pump 2 is connected to the liquid filling and discharge control device 5 via an interface. When the liquid filling and discharge control device is pumping, blood enters the diaphragm pump 2 through the blood inlet 3. When the liquid pressure device 5 is filled with liquid, blood is discharged from the bleeding port 4. Figure 2 This is a schematic diagram of the device in use. The device may also include a control device. When the control device is activated and pumping is performed, the right ventricular blood inlet 3 opens, and blood from the right ventricle is pumped from the blood inlet 3 into the blood chamber of the diaphragm pump. When the control device is filled with fluid, the one-way valve at the bleeding port 4 at the pulmonary artery opens, and blood is discharged to the pulmonary artery. This cycle continues. The interventional catheter can transport blood from the right ventricle to the pulmonary artery via the diaphragm pump, thereby relieving pressure on the right ventricle and providing right heart support.

[0037] There are three control modes for the liquid filling and discharging control device: 1. Continuous suction and filling without feedback, such as Figure 3A 2. By collecting ECG signals, the heart beat frequency is determined and the pumping action is synchronized with the heart, as shown in the figure. Figure 3B 3. By collecting the pressure signal on the catheter, the heart beat frequency is determined and the suction action is synchronized with the heart, as shown. Figure 3C The pressure signal is collected by arranging a pressure sensor near the blood inlet and / or bleeding outlet of the interventional catheter.

[0038] The interventional catheter 1 is mainly composed of a distal catheter segment 1a, a proximal catheter segment 1b and a diaphragm pump connector 1c. The bleeding port 4 is located at the end of the distal catheter segment 1a away from the proximal catheter segment 1b (which can be the end of the distal catheter, the most distal end), and the blood inlet 3 is located at the end of the distal catheter segment 1a close to the proximal catheter segment 1b. Figure 4 As shown in the figure, both the bleeding port 4 and the blood inlet 3 are one-way valve structures, and the two one-way valves are not opened at the same time. When the catheter is performing aspiration, the bleeding port 4 is closed and the blood inlet 3 is open. When the catheter is performing a fluid filling operation, the bleeding port 4 is open and the blood inlet 3 is closed. The diaphragm pump connector is used to connect a diaphragm pump.

[0039] Among them, the bleeding port is designed as a one-way valve, which can prevent blood from entering the diaphragm pump from this position during suction. There are multiple implementation plans for the one-way valve design structure.

[0040] Option 1: If Figure 5 As shown, the bleeding outlet includes a two-leaf valve 4a and a support member 4b with a pore. One end of the two-leaf valve 4a is fixedly connected to the support member 4b, and the other end can be opened and closed. The material of the two-leaf valve 4a is a flexible material, which can be made of rubber or polymer material. The support member 3b is cylindrical as a whole, made of plastic or metal material, and is used to support the two-leaf valve. One end (distal end) is provided with a guide wire hole 4c for inserting an interventional catheter, and the other end is connected to the interventional catheter. When the two-leaf valve 4a is aspirated in the catheter, a negative pressure is generated in the catheter, thereby closing the valve. When the catheter is filled with liquid, the pressure in the catheter is greater than the pressure at the pulmonary artery position, and the valve opens under the action of the positive pressure difference.

[0041] Option 2: If Figure 6 As shown, the bleeding port is composed of a flexible perforated diaphragm 4d and a support member 4b with apertures. The flexible perforated diaphragm is sheathed over the support member 4b, with both ends of the flexible perforated diaphragm 4d bonded or welded to the support member 4b. The apertures of the support member and the flexible perforated diaphragm do not overlap but are staggered. When the pressure inside the catheter is lower than the pressure outside the catheter, the diaphragm is pressed against the support member. Since the apertures do not overlap, blood cannot enter the catheter. Conversely, blood can be discharged from the bleeding port. The apertures of the flexible perforated diaphragm and the support member can have various shapes.

[0042] Option 3: If Figure 7 As shown, the bleeding port is composed of a flexible plastic ball 4e and a support member 4b with a pore, forming a ball-and-cage valve. During catheter suction, negative pressure is generated within the catheter, causing the flexible plastic ball 4e to close the ball-and-cage valve. When the catheter is filled with fluid, the pressure within the catheter exceeds the pressure at the pulmonary artery, and the positive pressure differential causes the ball-and-cage valve to open.

[0043] The blood inlet is also designed as a one-way valve, so that blood can be sucked from this position when blood is drawn. There are multiple implementation schemes for the one-way valve design structure.

[0044] like Figure 8 As shown, the blood inlet is composed of a porous support member 3a and a flexible perforated diaphragm 3b. The flexible perforated diaphragm 3a is inserted into the interior of the support member 3b, with both ends bonded or welded to the support member. The holes in the support member and the flexible perforated diaphragm do not overlap but are staggered. When the pressure inside the catheter is lower than the pressure outside the catheter, the flexible perforated diaphragm separates from the support member, allowing blood to enter the diaphragm pump through the holes in the support member and the flexible perforated diaphragm. Otherwise, blood cannot enter through the blood inlet. The holes in the flexible perforated diaphragm and support member can have various shapes.

[0045] Furthermore, in order to prevent myocardial tissue from being damaged during suction at the proximal blood inlet, a support bracket 3c is provided at the blood inlet. Figure 9 shown.

[0046] Furthermore, the proximal end of the catheter can be provided with multiple blood inlets, which can be provided at the inferior vena cava, right atrium, etc. Figure 10 Similarly, in order to control the blood flow at different positions, the opening area of ​​the valve at different positions can be controlled.

[0047] Figure 11 Figure 2 is a schematic diagram of the diaphragm pump structure. The diaphragm pump includes a blood chamber 2-1 and a driving liquid chamber 2-2, separated by a flexible diaphragm 2-3. The blood chamber 2-1 is connected to the diaphragm pump connector 1c of the interventional catheter via a first interface 2-4, and the driving liquid chamber 2-2 is connected to the liquid filling and discharging control device 5 via a second interface 2-5. The flexible diaphragm 2-3 can be made of a polymer material. When the liquid driving device draws suction, negative pressure is formed in the catheter, and blood enters through the blood inlet. When the liquid is filled, the blood in the blood chamber is discharged, at which time the distal bleeding port is opened and the proximal blood inlet is closed.

[0048] The liquid filling and discharging control device 5 is electrically connected to the constant temperature control module to heat the internal liquid and keep the circulating blood under constant temperature control.

[0049] The above-mentioned implementation cases are only preferred implementation cases of the present utility model and are not any formal or substantial limitations of the present utility model. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present utility model, and these improvements and supplements should also be regarded as the scope of protection of the present utility model.

Claims

1. A transcutaneous circulatory assist device, characterized in that: It includes an interventional catheter and a diaphragm pump; the interventional catheter is provided with a blood inlet and a bleeding port, the blood inlet and bleeding port are configured as one-way valves and enable the interventional catheter to conduct blood in a unidirectional manner, and the diaphragm pump includes a blood chamber separated by a flexible diaphragm and a driving liquid chamber for filling and discharging liquid.

2. The percutaneous circulatory assistance device according to claim 1, wherein It also includes a liquid filling and discharging control device connected to the diaphragm pump, the blood chamber is connected to the proximal end of the interventional catheter, the driving liquid chamber is connected to the liquid filling and discharging control device, the bleeding port is located at the distal end of the interventional catheter, and the blood inlet is located at the proximal end of the interventional catheter.

3. The percutaneous circulatory assistance device according to claim 1, wherein The blood inlet and the bleeding port are composed of a support and a valve leaf. The valve leaves of the blood inlet and the bleeding port have opposite opening and closing directions. A hole is provided on the support. When the valve leaf is opened, it communicates with the hole provided on the support.

4. The percutaneous circulatory assistance device according to claim 3, wherein: The valve leaf of the bleeding port is a two-leaf valve, a flexible perforated diaphragm or a flexible plastic ball, and the valve leaf of the blood inlet is a flexible perforated diaphragm.

5. The percutaneous circulatory assistance device according to claim 4, wherein: When the valve leaf of the bleeding port is a flexible perforated diaphragm, the flexible perforated diaphragm of the blood inlet is sleeved inside the support member, and the flexible perforated diaphragm of the bleeding port is sleeved outside the support member, and the openings of the flexible perforated diaphragm and the channels of the support member are staggered.

6. The percutaneous circulatory assistance device according to claim 4, wherein: When the valve leaf of the bleeding port is a two-leaf valve, the bleeding port is composed of the two-leaf valve and a support member with a pore, one end of the two-leaf valve is fixedly connected to the support member, and the other end is configured to be openable and closable; the material of the two-leaf valve is a flexible material, and the support member is cylindrical and is used to support the two-leaf valve; When the valve leaf of the bleeding port is a flexible plastic ball, the bleeding port is a ball cage valve composed of the flexible plastic ball and a support member with pores.

7. The percutaneous circulatory assistance device according to claim 4, wherein: A guide wire hole is provided at the distal end of the bleeding port, and the proximal end is communicated with the interventional catheter.

8. The percutaneous circulatory assistance device according to any one of claims 1 to 7, wherein: A supporting bracket is provided on the blood inlet.

9. The percutaneous circulatory assistance device according to claim 8, wherein: A pressure sensor is provided near the blood inlet and / or the bleeding outlet, and the pressure sensor is electrically connected to the liquid filling and discharging control device.

10. The percutaneous circulatory assistance device according to claim 9, wherein: The liquid filling and discharging control device is electrically connected to the electrocardiogram acquisition module and / or the heating module.

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