Modular aorta internal circulation auxiliary system

Abstract

The utility model 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 casing, 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 utility model 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 a device, and increases the management of wires / cables, avoiding the problem of wire entanglement. 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 working 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. Practical new type content

[0007] The utility model discloses a modular aortic internal circulation auxiliary system can effectively reduce the cardiac afterload, increase the cardiac output, increase the blood perfusion of peripheral organs such as kidney and little blood injury.

[0008] In order to realize the above-mentioned purpose, the utility model adopts the following technical scheme:

[0009] A modular aortic internal circulation auxiliary system, including the machine case, blood pump rotor, motor and control line, the proximal end of machine case has a support circular arc spare and an arc notch, is equipped with two interval support rods at this arc notch, to form three outflow windows, and the machine case is welded with the motor fixed;Blood pump rotor sets up in the inside of machine case and is connected with motor shaft, and the proximal end of motor has a contact inclined plane and 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 is provided with a plurality of abutting inclined surfaces. The distal end openings of the guide through holes are arranged on the abutting inclined surfaces. The guide through holes and the abutting inclined surfaces correspond to the contact inclined surfaces one by one. The self-expanding stent is used for supporting and positioning in the blood vessel and has two states of folding and expanding.

[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 comprises a male luer interface, a hemostasis locking valve and a side tube, the male luer interface is communicated 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 hemostasis locking valve of the Y-shaped connector; the hemostasis 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 tearable indentation; the base of the tearable loader is divided into two halves and is symmetrically bonded to the proximal end of the tube body; the hemostasis 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 pump is assembled in parallel 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 an arterial sheath tube with a diameter of 15-21F.

[0027] The beneficial effects of the utility model are as follows:

[0028] (1) The multiple micro axial flow blood pumps in the utility model provide hemodynamic support in the abdominal aorta together, 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 is increased, and the blood perfusion of peripheral organs such as kidneys is increased.

[0029] (2) The utility model establishes a working channel through the Y-shaped connector, the control line extends to the outside of the body, bleeding during the pushing process can be prevented, the control line can be locked, and the stability of the pump body during operation is increased.

[0030] (3) The utility model discloses a perfusion device, which can realize perfusion and flushing of the inner cavity of the system and the control line of the miniature axial flow blood pump, and reduces the risk of thrombosis during use of the system. BRIEF DESCRIPTION OF DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the utility model, the embodiments will be described below with reference to the drawings.

[0032] Figure 1 It is the whole structure schematic diagram of the utility model embodiment.

[0033] Figure 2A It is the whole structure schematic diagram of the utility model embodiment miniature axial flow blood pump.

[0034] Figure 2B It is the pump body structure schematic diagram of the utility model embodiment miniature axial flow blood pump.

[0035] Figure 2C It is the machine case structure schematic diagram of the utility model embodiment miniature axial flow blood pump.

[0036] Figure 2D It is the section view of the utility model embodiment miniature axial flow blood pump control line.

[0037] Figure 3A It is the schematic diagram of the utility model embodiment miniature axial flow blood pump parallel assembly on the anchoring support.

[0038] Figure 3B It is Figure 3A the section view of A-A position.

[0039] Figure 3C It is Figure 3A the section view of B-B position.

[0040] Figure 4 It is the support main body schematic diagram of the utility model embodiment.

[0041] Figure 5 It is the assembly schematic diagram of the utility model embodiment multi-cavity catheter and catheter seat and Y type connector.

[0042] Figure 6 It is the controller schematic diagram of the utility model embodiment.

[0043] Figure 7A , Figure 7B It is the tearable loader schematic diagram of the utility model embodiment.

[0044] Figure 8A It is the catheter delivery process schematic diagram of the utility model embodiment.

[0045] Figure 9AB is a parallel assembly process schematic diagram of the abdominal aorta of the embodiment of the utility model.

[0046] Figure 10A B is a removal process schematic diagram in the abdominal aorta of the embodiment of the utility model.

[0047] Figure 11 It is perfusion fluid flow schematic diagram of the embodiment of the utility model.

[0048] 1 miniature axial flow blood pump;2 anchor support;3 multi-lumen catheter;4 catheter seat;5 Y connector;6 controller;7 perfusion device;8 tearable loader;9 arterial sheath;10 abdominal aorta blood vessel;

[0049] 11 machine case;12 blood pump rotor;13 motor;14 control line;111 support rod;112 support arc piece;131 contact inclined surface;132 inclined surface;141 control line smooth section;142 control line rough section;143 plug;

[0050] 21 support body;22 self-expanding stent;211 abutment surface;212 guide through hole;

[0051] 31 inner cavity;

[0052] 41 female luer interface;

[0053] 51 male luer interface, 52 hemostasis locking valve;53 side tube;

[0054] 61 main machine;62 connecting line;Power cord 63;

[0055] 71 perfusion pump;72 liquid storage bottle;73 liquid pipe assembly;731 liquid inlet pipe;732 liquid storage pipe;

[0056] 81 pipe body;82 base;821 hemostasis valve. DETAILED DESCRIPTION

[0057] Below, the embodiment of the utility model is explained in detail in combination with the drawings. But these embodiments are not limited to the utility model, the conversion of structure, method or function made by the ordinary skill in the art according to these embodiments is included in the protection scope of the utility model.

[0058] In the description of the present application, it needs to be understood that the orientation description such as distal end, proximal end etc. is based on the surgeon, the position close to the surgeon is proximal end, and the position far away from the surgeon is distal end, which is for the convenience of describing the embodiments of the present application and simplifying the description, and is not indicative or suggestive of the device or element indicated must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as the limitation of the embodiments of the present application.

[0059] AsFigures 1-11 The utility model discloses a modularization aortic internal circulation auxiliary system's embodiment, including miniature axial flow blood pump 1, anchor support 2, multi -cavity catheter 3, catheter seat 4, Y type connector 5, controller 6, perfusion device 7 and tearable loader 8.

[0060] The utility model discloses miniature axial flow blood pump 1 of embodiment is by machine case 11, blood pump rotor 12, motor 13 and control line 14 composition. Figure 2B C, the proximal end of machine case 11 has two support rods 111 and a support arc piece 112, three outflow windows are formed between the two support rods and between the support arc piece and the support rod on the same side, and the three support arc pieces are close to each other. The machine case 11 is welded and fixed with the motor 13; the blood pump rotor 12 is arranged inside the machine case 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 and flow out at high speed through the proximal end outflow window; the motor proximal end has a contact inclined surface 131 and an inclined surface 132, wherein the normal line of the contact inclined surface 131 is at an angle of 30° with the motor shaft, which is used for positioning with the abutting inclined surface 211 of the support body, and the inclined surface 132 facilitates the determination and adjustment of the position and angle of the blood pump under the medical imaging equipment; the control line 14 is led out from the contact inclined surface 131 of the motor proximal end, and this biased distribution structure can reduce the outer diameter of the anchor support 2 and reduce the intervention size, as shown in Figure 2D The control line 14 includes three power lines, one structural reinforcing wire and an external protective layer, the structural reinforcing wire has a strong elastic modulus and torsional modulus, can meet the rigidity requirements of the axial pushing and orientation adjustment of the control line 14, and the material is preferably a 316L stainless steel wire. As shown in Figure 2A The external protective layer has an outer diameter of 1.8 mm, includes a distal smooth section 141 and a proximal rough section 142, the smooth section is located in the internal cavity of the system during actual use, so as 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, adjust the orientation of the blood pump, and the proximal end of the control line 14 is provided with a plug 143 for connecting the controller.

[0061] The utility model embodiment has three miniature axial flow blood pumps, as shown in Figure 3A B, when the parallel assembly is distributed, the three outflow windows are directed to the outside of the modular assembly, the support arc piece 112 is directed to the central area of the modular assembly, the support arc piece 112 is not provided with an outflow window, so as to avoid the complex flow field in the central area of the three miniature axial flow blood pumps, and the control line 14 of the miniature axial flow blood pump of the utility model embodiment extends to the outside of the body from the proximal end of the motor 13 through the guide through hole of the anchor support 2, the internal cavities of the multi-cavity catheter 3 and the catheter seat 4 and the Y type connector, and each control line is contained in an independent internal cavity, so as to facilitate the independent operation of the surgeon.

[0062] As Figure 3AAs shown, the anchoring support 2 of the embodiment of the utility model comprises a support main body 21 and a self-expanding support 22. The material of the support main body 21 is high-strength and high-rigidity polyether ether ketone (PEEK) material. Referring to Figure 4 , the support main body 21 has three abutting inclined surfaces 211 and associated guide through holes 212, the normal of the abutting inclined surfaces 211 and the axial direction of the support main body 21 form an angle of 30°, which is used for cooperating with the contact inclined surface of the micro axial flow blood pump 1 to position, the inner diameter of the guide through hole 212 is 2mm, which is used for accommodating the control line of the micro axial flow blood pump; the material of the self-expanding support 22 is super-elastic and biocompatible nickel-titanium alloy, specifically, the self-expanding support 22 is obtained by cutting a large-diameter nickel-titanium alloy pipe, expanding by a mandrel and heat treatment shaping, and coating an anticoagulant coating on the inner and outer surfaces of the support, which can prevent thrombosis, and the self-expanding support 22 is welded and fixed with the support main body 21. The self-expanding support has two states of folding and expanding, and in the folding state, the self-expanding support can be delivered to the abdominal aorta through a sheath, and after reaching the designated position, the support is in the expanded state and is supported on the inner wall of the blood vessel to play a positioning role.

[0063] The proximal end of the multi-lumen catheter 3 is adhesively fixed with the anchoring support main body 21, as shown in Figure 3C , the multi-lumen catheter 3 has three inner cavities 31, and the inner cavities 31 are respectively communicated with the guide through holes 212 of the support main body 21. The control line 14 of the micro axial flow blood pump can enter the inner cavities 31 of the catheter through the guide through holes 212, and the control lines of the three micro axial flow blood pumps are respectively accommodated in the independent inner cavities 31 of the catheter, so that the surgeon can independently operate, the control lines are prevented from being entangled, and thrombosis is reduced. The multi-lumen catheter 3 has high rigidity, meets the catheter delivery requirement of the anchoring support 21, and is preferably made of nylon or polytetrafluoroethylene, and the inner and outer surfaces of the multi-lumen catheter are coated with a smooth coating, the inner diameter of the inner cavities 31 is 2mm, which is slightly larger than the outer diameter of the control line 14, so that a certain radial restraint force can be provided, the control line is prevented from being bent during the pushing process, and the axial pushing efficiency is ensured.

[0064] The proximal end of the catheter seat 4 is connected with the multi-lumen catheter 3, and the material is polycarbonate (PC) and is made by injection molding process. Referring to Figure 5 , the catheter seat 4 has three female luer interfaces 41, which are respectively communicated with the three inner cavities of the multi-lumen catheter, and the three female luer interfaces 41 are respectively connected with the male luer joint ports 51 of the Y-shaped connector 5, so that the working channel of the control line 14 of the micro axial flow blood pump extending to the outside of the body is established.

[0065] As shown in Figure 5As shown, the Y-type connector 5 of the embodiment of the utility model is a Y-type valve with hemostasis and locking functions which is well known in the art, comprising 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, the control line 14 of the micro axial flow blood pump leaves the human body through the hemostasis and locking valve 52 of the Y-type connector 5 for the surgeon to operate. The hemostasis and locking valve 52 prevents blood from seeping out during the pushing process, and can lock the control line, restrict the position of the micro axial flow blood pump, and prevent displacement during operation. The side pipe 53 is in communication with the liquid outlet pipe of the perfusion device, which can realize perfusion of the inner cavity containing the control line 14, avoid thrombosis in the inner cavity during the pushing process, and harm the health of the patient.

[0066] The controller 6 of the embodiment of the utility model comprises a host computer 61, a connecting line 62 and a power line 63, as shown in Figure 6 The connecting line 62 comprises a lead wire 621 and a connector 622, the connector 622 can be connected with the plug 143, and is used for driving the blood pump to rotate according to the control program.

[0067] The perfusion device 7 of the embodiment of the utility model comprises 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 a liquid inlet pipe 731 and a liquid outlet pipe 732, the liquid inlet pipe 731 communicates the liquid storage bottle 72 with the perfusion pump 71, and the liquid outlet 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, the liquid outlet pressure and flow rate of the peristaltic pump are controlled, the perfusion liquid in the liquid storage bottle can be injected into the inner cavity through the side pipe 73, and the perfusion liquid in the liquid storage bottle is heparin saline.

[0068] The tearable loader 8 of the embodiment of the utility model is used for assisting the micro axial flow blood pump 1 and the anchoring support 2 to enter the artery sheath pipe 9, the tearable structure design maintains the conveying efficiency of the blood pump and the anchoring support, and avoids the limitation of the volume of the catheter seat on 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 comprises 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 make the self-expanding stent of the anchoring support gradually recover to a small-diameter state to facilitate entering the artery sheath pipe; the base 82 is internally provided with a hemostasis valve 821, the hemostasis valve is shaped as a cross-shaped notch structure, and blood is prevented from flowing out during the operation process.

[0069] The control line 14 of the three micro axial flow blood pumps of the modular aortic internal circulation auxiliary system is led out through the guide through hole 212 of the anchoring support, the multi-cavity catheter 3, the inner cavity of the catheter seat 4 and the Y-shaped connector 5, and forms a modular assembly for use. The embodiment of the utility model includes a catheter series conveying process, a parallel assembly process and a device moving-out process in actual use, and has two states of docking and undocking. In the docking state, the proximal end contact slope of the micro axial flow blood pump is attached to the abutment slope of the support with a 0.5mm gap reserved. In the undocking state, the proximal end of the micro axial flow blood pump is separated from the abutment slope 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 series conveying process of the embodiment of the utility model, and the steps are as follows:

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

[0072] (2) The three micro axial flow blood pumps 1 and the 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-cavity catheter;

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

[0074] (4) Continue to push the multi-cavity 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 communicated 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-cavity 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 tube is withdrawn until the blood pump and the anchoring support are separated from the sheath tube, 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) see Figure 9A , the position of the multi-lumen catheter is constrained, the control line is pulled in sequence to make the micro axial flow blood pump gradually close to the anchor support, the direction is adjusted under the image device, the proximal end of the micro axial flow blood pump contacts the gap between the inclined surface and the inclined surface of the support body, the gap is about 0.2-0.5mm, and the butt joint state is formed, see Figure 9B ;

[0080] (4) the micro axial flow blood pump control line is locked, the control line is connected with the controller, and the controller is started to provide blood flow dynamics support.

[0081] When the modular assembly completes the work, the micro axial flow blood pump and the anchor support are disconnected, see Figure 10A -B, and the steps are as follows:

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

[0083] (2) the position of the catheter is constrained to be stationary, the blood pump control line is pushed, and the blood pump is separated from the anchor support;

[0084] (3) the artery sheath tube is pushed, the anchor support self-expanding stent is gradually recovered into the sheath tube under the action of external force, the blood pump control line is pulled, and the blood pump is gradually recovered into the artery sheath tube, see Figure 10B ;

[0085] (4) the micro axial flow blood pump control line is locked, the multi-lumen catheter is pulled, and the whole device is moved out of the sheath tube;

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

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

[0088] The utility model embodiment modularization aortic inner circulation auxiliary system actually uses, through 15 ~ 21F's arterial sheath pipe delivery to abdominal aorta. Three micro axial flow blood pump parallelly distributed in abdominal aorta, single pump rotation speed 15000rpm, cumulative flow can reach 3.5L / min, can significantly reduce the heart after load, increase the blood perfusion of kidney and other peripheral organs, and the blood injury is less. The Y type connector of the utility model embodiment establishes the extracorporeal working channel of micro axial flow blood pump control line, has hemostatic function, and can realize the axial locking of control line, increases the stability of device in the running process. The perfusion device of the utility model embodiment can realize the perfusion and flushing of the inner cavity of the system, reduces the risk of inner cavity thrombosis in the use process.

Claims

1. A modular aortic internal circulation support system, characterized in that: It includes multiple miniature axial flow blood pumps, anchoring supports, multi-lumen catheters, catheter hubs, Y-connectors, controllers, perfusion devices, and tearable loaders, among which, The miniature axial flow blood pump includes a casing, a blood pump rotor, a motor, and control lines. The near end of the casing has a supporting arc member and an arc-shaped slot. The arc-shaped slot is provided with two spaced support rods to form three outflow windows. The casing is welded and fixed to the motor. The blood pump rotor is located inside the casing and connected to the motor shaft. The near end of the motor has a contact slope and a beveled surface. The anchoring support includes a support body and a self-expanding stent. The support body has several guide holes and several abutment slopes at the distal end of the support body. The distal openings of the guide holes pass through the abutment slopes. The guide holes and the abutment slopes correspond one-to-one with the contact slopes. The self-expanding stent is used for support and positioning in blood vessels and has two states: folded and expanded. The multi-lumen catheter is connected to the proximal end of the support body. The multi-lumen catheter has multiple lumens that correspond to and communicate with the guide holes of the support body, and is used to accommodate the control line of the miniature axial flow blood pump. The catheter hub is connected to the proximal end of the multi-lumen catheter and has multiple female Luer interfaces that communicate with the inner lumen. The male Luer interface of the Y-type connector is connected to the female Luer interface of the catheter hub to establish a working channel for the control line to extend to the outside of the body via the hemostasis locking valve of the Y-type connector. The controller includes a host, multiple connecting lines and a power line. The connecting lines are connected to the control lines, and it can drive multiple micro axial flow pumps to work simultaneously. The perfusion device includes a perfusion pump, a reservoir, and a tubing assembly. The tubing assembly is connected to the side tube of the Y-type connector to achieve perfusion of the system cavity and the blood pump control line, reducing the risk of blood pump formation. The tubing assembly of the perfusion device includes an inlet tube and an outlet tube. The reservoir is connected to the perfusion pump via the inlet tube, and the outlet tube connects the perfusion pump to the side tube of the Y-type connector. The tearable loader includes a tube, a base, and a hemostatic valve, used to assist the anchoring support and multiple miniature axial flow blood pumps in entering the blood vessel through the arterial sheath; The anchoring support and the miniature axial flow blood pump are connected in series through an arterial sheath via femoral artery puncture into the abdominal aorta. The expansion stent expands and supports the vessel wall. Under the guidance of medical imaging equipment, the blood pump control line is pulled to connect the miniature axial flow blood pump and the anchoring support in parallel. Multiple miniature axial flow blood pumps work together to provide hemodynamic support.

2. The modular aortic internal circulation support system according to claim 1, characterized in that, The micro axial flow pump has three outflow windows formed between the two support rods of the casing and between the support arc component and the support rod on the same side, with the three support arc components positioned close to each other.

3. The modular aortic internal circulation support system according to claim 1, characterized in that, The control line of the micro axial flow pump includes a power line, a structural reinforcing wire, and an external protective layer; the structural reinforcing wire is 316L stainless steel wire; the external protective layer includes a smooth section at the distal end and a rough section at the proximal end; the overall outer diameter of the control line is 1~2mm.

4. The modular aortic internal circulation support system according to claim 1, characterized in that, The material of the anchor support body is polyetheretherketone.

5. A modular aortic internal circulation support system according to claim 1, characterized in that, The self-expanding stent is bonded or welded to the support body. The self-expanding stent is made of a nickel-titanium alloy with superelasticity and biocompatibility. The inner and outer surfaces of the stent are coated with an anticoagulant coating to reduce the risk of thrombosis.

6. The modular aortic internal circulation support system according to claim 1, characterized in that, The multi-lumen catheter is made of nylon or polytetrafluoroethylene to meet the axial pushing requirements; the inner and outer surfaces of the multi-lumen catheter are coated with a smooth coating to ensure the pushing efficiency through the catheter.

7. A modular aortic internal circulation support system according to claim 1, characterized in that, The Y-type connector includes a male Luer interface, a hemostatic locking valve, and a side tube. The male Luer interface is connected to the female Luer interface of the catheter hub. The control line extends to the outside of the body through the lumen and the hemostatic locking valve of the Y-type connector. The hemostatic locking valve is used for hemostasis and locking the control line. The side tube is connected to an infusion device to infuse and flush multiple lumens and control lines, reducing the risk of thrombosis.

8. A modular aortic internal circulation support system according to claim 1, characterized in that, The tearable loader tube gradually transitions from a small-diameter tube at the distal end to a large-diameter tube at the proximal end. The inner wall is coated with a smooth coating, and the outer wall has tear indentations. The base of the tearable loader is divided into two halves and symmetrically bonded to the proximal end of the tube. The hemostatic valve is located inside the base to prevent bleeding during use.

9. A modular aortic internal circulation support system according to claim 1, characterized in that, The control line of the miniature axial flow blood pump passes through the guide hole of the support, the inner lumen of the multi-lumen catheter, and the inner lumen of the catheter seat, and exits through a Y-type connector to form a modular component for use, including a series delivery process via catheter, a parallel assembly process, and a removal process. The miniature axial flow blood pump and the anchor support have a docked state and an un docked state. In the docked state, the miniature axial flow blood pump is assembled and distributed in parallel on the anchor support, and the contact slope of the proximal end of the miniature axial flow pump mates with the abutment slope of the anchor support, with a 0.2-0.5mm gap between the contact slope and the abutment slope as a perfusion fluid outflow channel. In the un docked state, the miniature axial flow blood pump and the anchor support are in a separated state. By pushing or pulling the blood pump control line, the blood pump and the anchor support can be switched between the docked and un docked states.

10. A modular aortic internal circulation support system according to claim 9, characterized in that, The overall outer diameter of the miniature axial flow blood pump is 4-5 mm, and the modular components are delivered to the abdominal aorta through a 15-21F arterial sheath.

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