Modular aorta internal circulation auxiliary system

Abstract

The invention discloses a modularized aorta internal circulation auxiliary system which comprises a plurality of miniature axial flow blood pumps, an anchoring support, a multi-cavity catheter, a catheter seat, a Y-shaped connector, a controller, a perfusion device and a tearable loader. Each miniature axial flow blood pump comprises a cartridge receiver, a blood pump rotor, a motor and a control line; the near end of the casing is provided with a supporting arc piece and an arc-shaped notch, two spaced supporting rods are arranged at the arc-shaped notch to form three outflow windows, and the casing and the motor are welded and fixed; the blood pump rotor is arranged in the casing and connected with a motor shaft, and the near end of the motor is provided with a contact inclined plane and a diagonal plane; the anchoring support comprises a support body and a self-expansion support, a plurality of guide through holes are formed in the support body, a plurality of abutting slopes are arranged at the far end of the support body, far-end openings of the guide through holes penetrate through the abutting slopes, the abutting slopes of the guide through holes correspond to the contact slopes in a one-to-one mode, and the self-expansion support is used for supporting and positioning in the blood vessel. The folding and expanding states are realized.

Description

Technical Field

[0001] This invention belongs to the technical field of ventricular assist devices for medical devices, and particularly relates to a modular aortic internal circulation assist system. Background Technology

[0002] With the widespread adoption of interventional treatment for complex and high-risk cardiovascular diseases, percutaneous ventricular assist devices are gaining importance in interventional treatment of cardiovascular diseases.

[0003] Currently, transvalvular percutaneous ventricular assist devices such as Impella are widely used. Their working principle involves a high-speed rotating blood pump rotor performing work on the blood, pumping it from the left ventricle through the aortic valve to the ascending aorta via the inlet cannula. These transvalvular ventricular assist devices are prone to causing heart valve damage and aortic regurgitation, and the high shear stress generated by the high-speed rotation of the blood pump rotor poses a high risk of blood damage.

[0004] Modular intra-aortic axial flow pumps are a type of percutaneous ventricular assist device. Multiple miniature axial flow pumps are implanted in series in the aorta via a catheter through the femoral artery. The multiple pumps are assembled in parallel into a modular component to provide hemodynamic support, effectively reducing cardiac afterload, increasing cardiac output, and increasing renal blood perfusion. It is suitable for patients with cardiorenal syndrome.

[0005] Chinese patent application CN106456856A discloses a modular implantable ventricular assist device (VAD). This device includes an expandable frame and multiple pump assemblies. The frame, in a contracted state, is inserted into the body via a catheter and then expands to support the blood vessel wall. The multiple pump assemblies are connected to the frame, forming a modular assembly that collectively provides hemodynamic support. However, the drawback is that the metal wires of the pump unit pose a risk of entanglement, and their spatial positioning is complex and challenging, significantly increasing the difficulty and time required for surgical intervention. Furthermore, the metal wires and frame are prone to thrombosis, increasing the risk of embolic stroke.

[0006] Chinese patent application CN113993576A discloses a modular implantable fluid flow influencing device for mammals, proposes a novel modular assembly, further reduces the risk of thrombosis of such devices, and increases the management of wires / cables, avoiding wire entanglement problems. Specifically, the application includes a plurality of pumping units and a docking unit, after being implanted in the patient's body in series, the plurality of pumping units are assembled in parallel on the docking unit, the pumping unit is closely attached to the docking unit without gap, reducing thrombosis; in addition, the plurality of pumping units are accommodated by the multi-lumen catheter, each wire is pushed through an independent lumen, in some embodiments, the docking unit guide hole and the catheter lumen are provided with a sealing element to prevent blood from entering the lumen, to some extent, to reduce the risk of thrombosis. The application has the disadvantages that the docking surface of the pumping unit and the receiving surface of the docking unit are in direct contact with the blood, and the residual blood between the docking surface and the receiving surface is in a static state after the docking state is formed, which is easy to coagulate after a period of time, forming a thrombus, which is easy to fall off after the docking state is removed, which has the risk of embolism; in addition, the application does not mention the constraint method of the pumping unit, the blood will have a force to the pumping unit to the distal end while the pumping unit is pumping blood and doing work on the blood, without a suitable constraint method, the displacement of the pumping unit may be unstable during the work process; and the application does not mention the perfusion flushing of the lumen, the pumping unit has reciprocating axial movement relative to the docking unit, and only relies on the sealing element, the risk of thrombosis is still relatively large. SUMMARY

[0007] The purpose of the present application is to solve the above technical problems and provide a modular intra-aortic circulation auxiliary system, which can effectively reduce the afterload of the heart, increase the cardiac output, and increase the blood perfusion of peripheral organs such as the kidneys, with little damage to the blood.

[0008] In order to achieve the above purpose, the present application adopts the following technical solutions:

[0009] A modular intra-aortic circulation auxiliary system, comprising a casing, a blood pump rotor, a motor and a control line, the proximal end of the casing has a support arc member and an arc-shaped notch, the arc-shaped notch is provided with two spaced support rods to form three outflow windows, the casing is welded and fixed with the motor; the blood pump rotor is arranged inside the casing and connected with the motor shaft, the proximal end of the motor has a contact bevel and a bevel surface;

[0010] The anchor support includes a support body and a self-expanding stent, the support body is provided with a plurality of guide through holes, the distal end of the support body has a plurality of abutting bevels, the distal end openings of the guide through holes are arranged on the abutting bevels, the guide through holes and the abutting bevels correspond one by one with the contact bevel, the self-expanding stent is used for supporting and positioning in the blood vessel, and has two states of folding and expansion;

[0011] The multi-lumen catheter is connected with the proximal end of the support body, and has multiple inner cavities in communication with the guide through holes of the support body for accommodating control lines of the micro axial flow blood pump;

[0012] The catheter seat is connected with the proximal end of the multi-lumen catheter and has multiple female luer interfaces in communication with the inner cavities;

[0013] The male luer interface of the Y-shaped connector is connected with the female luer interface of the catheter seat to establish a working channel for the control lines to extend to the outside of the body through the hemostatic lock valve of the Y-shaped connector;

[0014] The controller comprises a host, multiple connection lines and a power line, the connection lines are connected with the control lines correspondingly, and multiple micro axial flow pumps can be driven simultaneously;

[0015] The perfusion device comprises a perfusion pump, a liquid storage bottle and a liquid pipe assembly, the liquid pipe assembly is in communication with the side pipe of the Y-shaped connector to realize perfusion of the inner cavities of the system and the control lines of the blood pump and reduce the risk of blood pump generation; the liquid pipe assembly of the perfusion device comprises an inlet liquid pipe and an outlet liquid pipe, the liquid storage bottle is in communication with the perfusion pump through the inlet liquid pipe, and the outlet liquid pipe connects the perfusion pump with the side pipe of the Y-shaped connector;

[0016] The tearable loader comprises a pipe body, a base and a hemostatic valve, and is used for assisting the anchoring of the support and the multiple micro axial flow blood pumps to enter the blood vessels through the arterial sheath tube;

[0017] The anchoring support and the micro axial flow blood pump are connected in series through the arterial sheath tube and enter the abdominal aorta through the femoral artery puncture, the self-expanding stent is expanded and supported on the blood vessel wall, under the guidance of a medical imaging device, the micro axial flow blood pump is sequentially and parallelly assembled with the anchoring support by pulling the control line, and multiple micro axial flow blood pumps jointly provide hemodynamic support. The system can effectively reduce the cardiac afterload, increase the cardiac output and increase the blood perfusion of peripheral organs such as the kidney, and has little damage to the blood.

[0018] Three outflow windows are formed between the two support rods of the micro axial flow pump casing and between the support arc members and the support rods on the same side, and the positions of the three support arc members are close to each other.

[0019] The control line of the micro axial flow pump comprises a power line, a structural reinforcing wire and an external protective layer; the structural reinforcing wire is a 316L stainless steel wire; the external protective layer comprises a distal smooth section and a proximal rough section; and the overall outer diameter of the control line is 1-2 mm.

[0020] The material of the anchoring support body is polyether ether ketone.

[0021] The self-expanding stent is bonded or welded with the support body, the material of the self-expanding stent is a nickel-titanium alloy with super-elasticity and biocompatibility, and an anticoagulant coating is coated on the inner and outer surfaces of the stent to reduce the risk of thrombosis.

[0022] The material of the multi-lumen catheter is nylon or polytetrafluoroethylene, which meets the axial pushing requirement, and the inner and outer surfaces of the multi-lumen catheter are coated with a smooth coating to ensure the pushing efficiency through the catheter.

[0023] The Y-shaped connector includes a male luer interface, a hemostatic locking valve and a side tube, the male luer interface is in communication with a female luer interface of a catheter seat, the control line extends to the outside of the body through the inner cavity and the hemostatic locking valve of the Y-shaped connector; the hemostatic locking valve is used for hemostasis and locking the control line; the side tube is connected with a perfusion device to perfuse and flush the multiple inner cavities and the control line, thereby reducing the risk of thrombosis.

[0024] The small-diameter tube at the distal end of the tearable loader gradually transitions to a large-diameter tube at the proximal end, the inner wall is coated with a smooth coating, and the outer wall is provided with a tear mark; the base of the tearable loader is divided into two halves and is symmetrically bonded to the proximal end of the tube body; the hemostatic valve is arranged inside the base to prevent bleeding during use.

[0025] The control line of the micro axial flow blood pump passes through the guide through hole of the support, the inner cavity of the multi-lumen catheter and the inner cavity of the catheter seat, and is led out through the Y-shaped connector to form a modular assembly for use, including a catheter in series conveying process, a parallel assembly process and a removal process; the micro axial flow blood pump and the anchoring support have a docking state and a non-docking state, wherein in the docking state, the micro axial flow blood pumps are distributed in parallel assembly on the anchoring support, the contact inclined surface at the proximal end of the micro axial flow pump cooperates with the abutting inclined surface of the anchoring support, and a gap of 0.2-0.5mm is reserved between the contact inclined surface and the abutting inclined surface as a perfusion liquid outlet channel; in the non-docking state, the micro axial flow blood pump is in a separated state from the anchoring support; by pushing or pulling the blood pump control line, the blood pump and the anchoring support can be switched between the docking state and the non-docking state.

[0026] The overall outer diameter of the micro axial flow blood pump is 4-5mm, and the modular assembly is conveyed to the abdominal aorta through a 15-21F arterial sheath tube.

[0027] The beneficial effects of the present application are:

[0028] (1) The multiple micro axial flow blood pumps in the present application jointly provide hemodynamic support in the abdominal aorta, the rotation speed of a single pump is relatively low, the damage to blood is small, the cardiac afterload can be effectively reduced, the cardiac output can be increased, and the blood perfusion of peripheral organs such as the kidney can be increased.

[0029] (2) The working channel of the control line extending to the outside of the body is established through the Y-shaped connector, which can prevent bleeding during the pushing process and can realize the locking of the control line, thereby increasing the stability of the pump body during operation;

[0030] (3) The present invention is equipped with a perfusion device, which can realize the perfusion and flushing of the system cavity and the micro axial flow blood pump control line, reducing the risk of thrombosis during system use. Attached Figure Description

[0031] To more clearly illustrate the embodiments of the present invention, the embodiments will be described below in conjunction with the accompanying drawings.

[0032] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present invention.

[0033] Figure 2A This is a schematic diagram of the overall structure of the miniature axial flow blood pump according to an embodiment of the present invention.

[0034] Figure 2B This is a schematic diagram of the structure of a miniature axial flow blood pump according to an embodiment of the present invention.

[0035] Figure 2C This is a schematic diagram of the casing structure of a miniature axial flow blood pump according to an embodiment of the present invention.

[0036] Figure 2D This is a cross-sectional view of the control line of the miniature axial flow blood pump according to an embodiment of the present invention.

[0037] Figure 3A This is a schematic diagram of a miniature axial flow blood pump assembled in parallel on an anchoring support according to an embodiment of the present invention.

[0038] Figure 3B for Figure 3A Cross-sectional view at position AA.

[0039] Figure 3C for Figure 3A Cross-sectional view at position BB in the middle.

[0040] Figure 4 This is a schematic diagram of the support body according to an embodiment of the present invention.

[0041] Figure 5 This is a schematic diagram of the assembly of the multi-lumen catheter, catheter seat, and Y-type connector according to an embodiment of the present invention.

[0042] Figure 6 This is a schematic diagram of the controller according to an embodiment of the present invention.

[0043] Figure 7A , Figure 7B This is a schematic diagram of a tearable loader according to an embodiment of the present invention.

[0044] Figure 8A -B is a schematic diagram of the catheter delivery process in an embodiment of the present invention.

[0045] Figure 9A -B is a schematic diagram of the parallel assembly process in the abdominal aorta according to an embodiment of the present invention.

[0046] Figure 10A -B is a schematic diagram of the removal process in the abdominal aorta according to an embodiment of the present invention.

[0047] Figure 11 This is a schematic diagram of the flow of the perfusion fluid according to an embodiment of the present invention.

[0048] 1. Miniature axial flow blood pump; 2. Anchoring support; 3. Multi-lumen catheter; 4. Catheter hub; 5. Y-type connector; 6. Controller; 7. Irrigation device; 8. Tearable loader; 9. Arterial sheath; 10. Abdominal aorta.

[0049] 11 Casing; 12 Blood pump rotor; 13 Motor; 14 Control line; 111 Support rod; 112 Support arc component; 131 Contact bevel; 132 Beveled surface; 141 Smooth section of control line; 142 Rough section of control line; 143 Plug;

[0050] 21 Support body; 22 Self-expanding bracket; 211 Abutment surface; 212 Guide through hole;

[0051] 31. Inner cavity;

[0052] 41-inch female Luer interface;

[0053] 51. Luer connector; 52. Hemostatic locking valve; 53. Side tube;

[0054] 61 Main unit; 62 Connecting cable; Power cord; 63;

[0055] 71 Filling pump; 72 Storage bottle; 73 Liquid tubing assembly; 731 Inlet pipe; 732 Storage pipe;

[0056] 81 Tube body; 82 Base; 821 Hemostatic valve. Detailed Implementation

[0057] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings. However, these embodiments are not limited to the present invention, and any structural, methodological, or functional modifications made by those skilled in the art based on these embodiments are included within the scope of protection of the present invention.

[0058] In the description of this application, it should be understood that the directional descriptions, such as distal and proximal, are based on the surgeon. The position closer to the surgeon is proximal and the position farther from the surgeon is distal. This is for the convenience of describing the embodiments of this application and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on the embodiments of this application.

[0059] like Figures 1-11As shown, an embodiment of the modular intra-aortic circulation auxiliary system of the present application comprises a micro axial flow blood pump 1, an anchoring support 2, a multi-lumen catheter 3, a catheter seat 4, a Y-shaped connector 5, a controller 6, a perfusion device 7 and a tearable loader 8.

[0060] The micro axial flow blood pump 1 of the embodiment of the present application is composed of a casing 11, a blood pump rotor 12, a motor 13 and a control wire 14. Figure 2B The proximal end of the casing 11 has two support rods 111 and a support arc member 112, three outflow windows are formed between the two support rods and between the support arc member and the support rod on the same side, and the three support arc members are close to each other. The casing 11 is fixedly welded with the motor 13; the blood pump rotor 12 is arranged inside the casing 11 and connected with the motor shaft, the motor drives the blood pump rotor to rotate at high speed to suck the blood at the distal end into the casing and then flow out at high speed through the proximal end outflow window; the motor proximal end has a contact slope 131 and a bevel 132, wherein the normal line of the contact slope 131 is at an angle of 30° with the motor shaft, which is used to cooperate with the abutting slope 211 of the support body to position, and the bevel 132 facilitates the determination and adjustment of the position and angle of the blood pump under the medical imaging equipment; the control wire 14 is led out from the contact slope 131 of the motor proximal end, and this biased distribution structure can reduce the outer diameter of the anchoring support 2 and reduce the intervention size, see Figure 2D The control wire 14 includes 3 power supply wires, 1 structural reinforcing wire and an external protective layer, the structural reinforcing wire has a strong elastic modulus and torsional modulus, which can meet the rigidity requirements of the axial pushing and orientation adjustment of the control wire 14, and the material is preferably a 316L stainless steel wire. See Figure 2A The external protective layer has an outer diameter of 1.8 mm and includes a distal smooth section 141 and a proximal rough section 142, the smooth section is located in the inner cavity of the system during actual use to ensure the axial pushing efficiency, and the rough section is located outside the body to facilitate the manual pushing and rotation of the surgeon to adjust the orientation of the blood pump, and the proximal end of the control wire 14 is provided with a plug 143 for connecting the controller.

[0061] The embodiment of the present application has 3 micro axial flow blood pumps, see Figure 3A When the three micro axial flow blood pumps are assembled in parallel, the three outflow windows are directed to the outer side of the modular assembly, the support arc members 112 are directed to the central area of the modular assembly, and the support arc members 112 are not provided with outflow windows to avoid the complex flow field in the central area of the three micro axial flow blood pumps, and the control wire 14 of the micro axial flow blood pump of the embodiment of the present application extends from the proximal end of the motor 13 through the guide through hole of the anchoring support 2, the inner cavity of the multi-lumen catheter 3 and the catheter seat 4 and the Y-shaped connector to the outside of the body, and each control wire is contained in an independent inner cavity to facilitate the independent operation of the surgeon.

[0062] As Figure 3AAs shown, the anchoring support 2 in this embodiment of the invention includes a support body 21 and a self-expanding bracket 22. The support body 21 is made of high-strength and high-rigidity polyetheretherketone (PEEK) material. See also... Figure 4 The support body 21 has three abutment inclined surfaces 211 and associated guide holes 212. The normal of the abutment inclined surface 211 forms a 30° angle with the axial direction of the support body 21, which is used to cooperate with the contact inclined surface of the miniature axial flow blood pump 1 for positioning. The guide hole 212 has an inner diameter of 2mm and is used to accommodate the control line of the miniature axial flow blood pump. The self-expanding stent 22 is made of a nickel-titanium alloy with superelasticity and biocompatibility. Specifically, it is made by cutting a large-diameter nickel-titanium alloy tube, expanding it with a mandrel, and heat-treating it for shaping. An anticoagulant coating is applied to the inner and outer surfaces of the stent to prevent thrombus formation. The self-expanding stent 22 is welded and fixed to the support body 21. The self-expanding stent has two states: folded and expanded. In the folded state, it can be delivered to the abdominal aorta through a sheath. After reaching the designated position, the stent is in the expanded state, supporting the inner wall of the blood vessel and playing a positioning role.

[0063] In this embodiment of the invention, the multi-lumen catheter 3 is bonded and fixed to the proximal end of the anchoring support body 21, such as... Figure 3C The multi-lumen catheter 3 has three lumens 31, each corresponding to a guide hole 212 on the support body 21. The control line 14 of the miniature axial flow pump enters the catheter lumen 31 through the guide hole 212. The control lines of the three miniature axial flow pumps are housed in independent catheter lumens 31, allowing for independent operation by the surgeon, preventing control line tangling and reducing thrombus formation. The multi-lumen catheter 3 has high rigidity to meet the transcatheter delivery requirements of the anchor support 21. The preferred material is nylon or polytetrafluoroethylene. The inner and outer surfaces of the multi-lumen catheter are coated with a smooth coating. The inner diameter of the lumen 31 is 2mm, slightly larger than the outer diameter of the control line 14, providing a certain radial constraint force to prevent the control line from bending during delivery and ensuring axial delivery efficiency.

[0064] In this embodiment of the invention, the catheter seat 4 is connected to the proximal end of the multi-lumen catheter 3, and is made of polycarbonate (PC) using an injection molding process. See also Figure 5 The catheter hub 4 has three female Luer interfaces 41 that are connected to the three lumens of the multi-lumen catheter, and the three female Luer interfaces 41 are connected to the male Luer connector 51 of the Y-type connector 5, establishing a working channel for the micro axial flow blood pump control line 14 to extend outside the body.

[0065] like Figure 5As shown, the Y-type connector 5 of the embodiment of the present application is a Y-type valve with hemostasis and locking functions, which is well known in the art, and includes a male luer joint port 51, a hemostasis and locking valve 52, and a side pipe 53. The three luer joint ports 51 are connected with the three female luer interfaces of the catheter seat 4, and the control line 14 of the micro axial flow blood pump exits the human body through the hemostasis and locking valve 52 of the Y-type connector 5 for operation by the surgeon. The hemostasis and locking valve 52 prevents blood from leaking out during the pushing process, and can lock the control line to constrain the position of the micro axial flow blood pump to prevent displacement during operation.

[0066] The controller 6 of the embodiment of the present application includes a host 61, a connection line 62, and a power line 63, as shown in Figure 6 The connection line 62 includes a lead 621 and a connector 622, which can be connected with the plug 143 for driving the blood pump to rotate according to a control program.

[0067] The perfusion device 7 of the embodiment of the present application includes a perfusion pump 71, a liquid storage bottle 72, and a liquid pipe assembly 73, as shown in Figure 1 The liquid pipe assembly 73 is divided into an inlet liquid pipe 731 and an outlet liquid pipe 732. The inlet liquid pipe 731 communicates the liquid storage bottle 72 with the perfusion pump 71, and the outlet liquid pipe 732 communicates the perfusion pump 71 with the side pipe 53 of the Y-type connector. The perfusion pump 71 is preferably a peristaltic pump. By controlling the outlet liquid pressure and flow rate of the peristaltic pump, the perfusion liquid in the liquid storage bottle can be injected into the inner cavity through the side pipe 73. The perfusion liquid in the liquid storage bottle is heparin saline.

[0068] The tearable loader 8 of the embodiment of the present application is used to assist the micro axial flow blood pump 1 and the anchoring support 2 to enter the arterial sheath 9. The tearable structure design maintains the delivery efficiency of the blood pump and the anchoring support, and avoids the limitation of the volume of the catheter seat at the proximal end of the multi-lumen catheter on the withdrawal of the loader. The tearable loader 8 is made of medical-grade polyethylene (PE), polypropylene (PP), or polytetrafluoroethylene (PTFE), and includes a pipe body 81 and a base 82. As shown in Figures 7A-7B The pipe body 81 is shaped as a proximal end large-diameter pipe gradually transitioning to a distal end small-diameter pipe. This structure can gradually recover the self-expanding stent of the anchoring support to a small-diameter state to facilitate the entry into the arterial sheath. The base 82 is internally provided with a hemostasis valve 821 shaped as a cross-shaped notch structure to prevent blood from flowing out during the operation.

[0069] The control lines 14 of the three micro axial flow blood pumps of the modular aortic internal circulation auxiliary system of the embodiment of the application pass through the guide through hole 212 of the anchoring support, the multi-lumen catheter 3, the inner cavity of the catheter seat 4 and the Y-shaped connector 5 to form a modular assembly for use. The embodiment of the application actually includes a catheter in-line delivery process, a parallel assembly process and a device removal process, and has two states of docking and undocking. In the docking state, the proximal end of the micro axial flow blood pump contacts the abutment inclined surface of the support to fit, leaving a 0.5mm gap. In the undocking state, the proximal end of the micro axial flow blood pump is separated from the abutment inclined surface of the support. By restraining the anchoring support catheter and pushing or pulling the blood pump control line, the blood pump and the anchoring support can be switched between the docking and undocking states.

[0070] Figure 8A -B is a schematic diagram of the catheter in-line delivery process of the embodiment of the application, and the steps are as follows:

[0071] (1) The arterial sheath is placed in the abdominal aorta through femoral artery puncture;

[0072] (2) The three micro axial flow blood pumps 1 and one anchoring support 2 are connected in series in the tearable loader 8, the locking valve of the Y-shaped connector is closed, and the micro axial flow blood pump control line is locked with the multi-lumen catheter;

[0073] (3) The small diameter end of the tube body 81 of the tearable loader is inserted into the arterial sheath inlet, and the multi-lumen catheter is slowly pushed to push the anchoring support and the micro axial flow blood pump suite as a whole into the arterial sheath, see Figure 8B When the anchoring support and the micro axial flow blood pump are completely inserted into the arterial sheath, the base is gradually retracted and the two flaps are torn, and the tearable loader is completely removed;

[0074] (4) Continue to push the multi-lumen catheter until the anchoring support reaches the abdominal aorta above the renal artery, and stop pushing;

[0075] (5) The liquid outlet pipe of the perfusion device is connected with the side pipe of the Y-shaped connector, and the perfusion device is started to perfuse and flush the inner cavity.

[0076] When the micro axial flow blood pump 1 and the anchoring support 2 reach the designated position of the abdominal aorta, they are assembled in parallel to form a docking state, and the steps of parallel assembly are as follows:

[0077] (1) Restrict the multi-lumen catheter and the control line to ensure that the position of the anchoring support and the micro axial flow blood pump does not change, and the arterial sheath is retracted until the blood pump and the anchoring support are separated from the sheath, and the self-expanding stent of the anchoring support is expanded and supported on the inner wall of the abdominal aorta blood vessel;

[0078] (2) Open the locking valve of the Y-shaped connector to unlock the micro axial flow blood pump control line;

[0079] (3) seeFigure 9A , constraint multi-lumen catheter position, in turn pull the control line to make the micro axial flow blood pump gradually close to the anchor support, adjust the direction under the image device, make the micro axial flow blood pump near end contact the slope and the support body abutment slope gap cooperation, the gap is about 0.2-0.5mm, form the docking state, see Figure 9B ;

[0080] (4) lock the micro axial flow blood pump control line, connect the control line to the controller, start the controller three axial flow blood pump common operation to provide blood flow dynamics support.

[0081] Modular assembly complete work, micro axial flow blood pump and anchor support between the docking configuration, see Figure 10A -B, the steps are as follows:

[0082] (1) unlock the micro axial flow blood pump control line;

[0083] (2) constraint catheter position, push the blood pump control line, separate the blood pump and anchor support;

[0084] (3) push the artery sheath tube, under the action of external force, make the anchor support self-expanding stent gradually recover to the sheath tube, pull the blood pump control line, the blood pump gradually string back to the artery sheath tube, see Figure 10B ;

[0085] (4) lock the micro axial flow blood pump control line, pull the multi-lumen catheter, move the whole device out of the sheath tube;

[0086] (5) finally, the artery sheath tube is moved out of the body.

[0087] The embodiment of the application flushes three groups of inner cavities through the side pipes of the Y-shaped connectors, see Figure 1 , the perfusion pump divides the heparin saline in the liquid storage bottle into three paths through the liquid outlet pipe into the side pipes of the three Y-shaped connectors into the inner cavities, as shown in Figure 11 , when the three micro axial flow blood pumps in the embodiment of the application are distributed in parallel, the perfusion liquid flows out from the anchor support guide through hole, flows out through the gap between the micro axial flow blood pump and the support body, and enters the abdominal aorta blood vessel 10, so as to realize perfusion and flushing of the inner cavities and the micro axial flow blood pump control line of the system, greatly reducing the risk of thrombosis.

[0088] The modular intra-aortic circulation auxiliary system in the embodiment of the application is actually used by being delivered to the abdominal aorta through an arterial sheath tube with a size of 15-21F. Three miniature axial flow blood pumps are distributed in parallel in the abdominal aorta, and when the rotating speed of a single pump is 15000 rpm, the cumulative flow can reach 3.5 L / min, which can significantly reduce the afterload of the heart, increase the blood perfusion of peripheral organs such as the kidney, and cause less damage to the blood. The Y-shaped connector in the embodiment of the application establishes an extracorporeal working channel of the control line of the miniature axial flow blood pump, has a hemostatic function, and can realize axial locking of the control line, thereby increasing the stability of the device during operation. The perfusion device in the embodiment of the application can realize perfusion and flushing of the inner cavity of the system, thereby reducing the risk of thrombosis in the inner cavity during use.

Claims

1. A modular intra-aortic circulatory assistance system, comprising a plurality of micro axial flow blood pumps, an anchoring support, a multi-lumen catheter, a catheter hub, a Y-connector, a controller, a perfusion device and a tearable loader, wherein the micro axial flow blood pump comprises a casing, a blood pump rotor, a motor and a control line, the proximal end of the casing is provided with a support arc member and an arc-shaped notch, the arc-shaped notch is provided with two spaced support rods to form three outflow windows, and the casing is fixedly connected with the motor; the blood pump rotor is arranged in the casing and connected with the motor shaft, and the proximal end of the motor is provided with a contact bevel and a bevel surface; the anchoring support comprises a support body and a self-expanding stent, the support body is provided with a plurality of guide through holes, the distal end of the support body is provided with a plurality of abutting bevels, the distal end openings of the guide through holes are arranged on the abutting bevels, the guide through holes and the abutting bevels correspond to the contact bevels one by one, and the self-expanding stent is used for supporting and positioning in the blood vessel and has two states of folding and expansion; the multi-lumen catheter is connected with the proximal end of the support body, the multi-lumen catheter is provided with a plurality of inner cavities corresponding to the guide through holes of the support body and in communication with the guide through holes, and the inner cavities are used for accommodating the control line of the micro axial flow blood pump; the catheter hub is connected with the proximal end of the multi-lumen catheter and is provided with a plurality of female luer interfaces corresponding to the inner cavities and in communication with the inner cavities; the male luer interface of the Y-connector is connected with the female luer interface of the catheter hub to establish a working channel of the control line extending to the outside of the body through a hemostasis locking valve of the Y-connector; the controller comprises a main machine, a plurality of connection lines and a power line, the connection lines are connected with the control line in correspondence, and a plurality of micro axial flow pumps can be driven to work simultaneously; the perfusion device comprises a perfusion pump, a liquid storage bottle and a liquid pipe assembly, the liquid pipe assembly is connected with a side pipe of the Y-connector to realize perfusion of the inner cavities of the system and the control line of the blood pump and reduce the risk of blood pump generation; the liquid pipe assembly of the perfusion device comprises an inlet pipe and an outlet pipe, the liquid storage bottle is connected with the perfusion pump through the inlet pipe, and the outlet pipe connects the perfusion pump with the side pipe of the Y-connector; the tearable loader comprises a pipe body, a base and a hemostasis valve and is used for assisting the anchoring support and the plurality of micro axial flow blood pumps to enter the blood vessel through an arterial sheath tube; the anchoring support and the micro axial flow blood pump are connected in series through the arterial sheath tube and enter the abdominal aorta through femoral artery puncture, the expanded stent is expanded and supported on the blood vessel wall, under the guidance of a medical imaging device, the micro axial flow blood pump and the anchoring support are sequentially and parallelly assembled by pulling the control line, a plurality of micro axial flow blood pumps jointly provide hemodynamic support; the system can effectively reduce the cardiac afterload, increase the cardiac output and increase the blood perfusion of peripheral organs such as the kidney, and has little blood damage. The two support rods of the casing of the micro axial flow pump, the support arc member and the support rod on the same side form three outflow windows, and the three support arc members are located close to each other. The control line of the micro axial flow pump comprises a power line, a structural reinforcing wire and an external protective layer; the structural reinforcing wire is a 316L stainless steel wire; the external protective layer comprises a distal end smooth section and a proximal end rough section; and the overall outer diameter of the control line is 1-2 mm. The material of the anchoring support body is polyether ether ketone. ​ ​ ​ ​ ​ ​ ​ 2. The modular intra-aortic circulatory assistance system of claim 1, wherein, ​ 3. The modular intra-aortic circulatory assist system of claim 1, wherein, ​ 4. The modular intra-aortic circulatory assistance system of claim 1, wherein, ​ 5. The modular intra-aortic circulatory assist system of claim 1, wherein, The self-expanding stent is bonded or welded to the support body, the self-expanding stent is made of a super-elastic and biocompatible nickel-titanium alloy, and the inner and outer surfaces of the stent are coated with an anticoagulant coating to reduce the risk of thrombosis.

6. The modular intra-aortic circulatory assistance system of claim 1, wherein, The material of the multi-lumen catheter is nylon or polytetrafluoroethylene, which meets the axial pushing requirements; the inner and outer surfaces of the multi-lumen catheter are coated with a smooth coating to ensure the efficiency of catheter pushing.

7. The modular intra-aortic circulatory assist system of claim 1, wherein, The Y-shaped connector includes a male luer interface, a hemostatic locking valve, and a side tube, the male luer interface communicates with the female luer interface of the catheter seat, the control line extends to the outside of the body through the inner lumen and the hemostatic locking valve of the Y-shaped connector; the hemostatic locking valve is used to stop bleeding and lock the control line; the side tube is connected to a perfusion device to perfuse and flush the multiple lumens and control lines, thereby reducing the risk of thrombosis.

8. The modular intra-aortic circulatory assistance system of claim 1, wherein, The small-diameter tube at the distal end of the tearable loader gradually transitions to a large-diameter tube at the proximal end, the inner wall is coated with a smooth coating, and the outer wall is provided with a tearable indentation; the base of the tearable loader is divided into two halves and symmetrically bonded to the proximal end of the tube body; the hemostatic valve is arranged inside the base to prevent bleeding during use.

9. The modular intra-aortic circulatory assist system of claim 1, wherein, The control line of the micro axial flow blood pump passes through the guide through hole of the support, the inner lumen of the multi-lumen catheter, and the inner lumen of the catheter seat, and is pulled out through the Y-shaped connector to form a modular assembly for use, including a catheter series delivery process, a parallel assembly process, and a removal process; the micro axial flow blood pump and the anchoring support have a docked state and an undocked state, wherein in the docked state, the micro axial flow blood pump is parallelly assembled and distributed on the anchoring support, the contact slope at the proximal end of the micro axial flow pump cooperates with the abutting slope of the anchoring support, and a gap of 0.2-0.5mm is reserved between the contact slope and the abutting slope as a perfusion liquid outlet channel; in the undocked state, the micro axial flow blood pump is in a separated state from the anchoring support; by pushing or pulling the blood pump control line, the blood pump and the anchoring support can be switched between the docked and undocked states.

10. The modular intra-aortic circulatory assistance system of claim 1, wherein, The overall outer diameter of the micro axial flow blood pump is 4-5mm, and the modular assembly is delivered to the abdominal aorta through a 15-21F arterial sheath tube.

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