Perfusion method of delivery system of modular in-aorta entrainment pump

Abstract

The invention discloses a perfusion method of a delivery system of a modularized aorta entrainment pump, which comprises the following steps of: (1) in the conveying process and the assembling process of an anchoring support and a micro axial flow blood pump through a conveying sheath tube, closing a return pipeline valve, opening a perfusion pipeline valve, starting a perfusion device, injecting heparin saline water into a perfusion pipeline, and sealing the perfusion pipeline; a plurality of guide matching holes of the anchoring support are poured and scoured; (2) when the miniature axial flow blood pumps are assembled on the anchoring support in parallel and stably run, a return pipeline valve is opened, an inner cavity of the delivery catheter is perfused and scoured, and the delivery catheter is scoured out of the body through a return pipeline; and (3) after the operation of the micro axial flow blood pump is finished, closing the return pipeline valve, and continuing to execute the step (1) until the whole modular assembly is moved out of the body. A plurality of inner cavities of the anchoring support and the delivery catheter can be perfused and scoured through one perfusion port, thrombus is avoided, and safe and long-term use of the modular aorta entrainment pump is facilitated.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical device ventricular assist devices, and in particular to a perfusion method of a delivery system of a modular intra-aortic entrainment pump. Background Art

[0002] Different from classic implantable circulatory assist devices, percutaneous mechanical circulatory assist devices are mainly used in the treatment of cardiogenic shock and high-risk PCI patients. Due to their advantages such as less trauma, fast start-up and simple operation, they are becoming more and more widely used in clinical applications.

[0003] At present, the percutaneous mechanical circulatory assist devices used in clinical practice are mainly micro-axial flow blood pumps, which can provide active forward blood flow, effectively reduce the left ventricular load, reduce myocardial oxygen consumption, increase cardiac output, coronary artery flow and blood perfusion of end organs. However, the high shear stress generated by the high-speed rotation of the blood pump rotor causes great damage to the blood and is prone to cause damage to the aortic valve, which is the main reason limiting its long-term use.

[0004] The modular intra-aortic entrainment pump is a new percutaneous mechanical circulatory assist device. Its technical solution is: multiple micro-axial flow blood pumps and anchoring supports are delivered in series to the aorta via a catheter, the anchoring support is fixed at a specified position, and multiple micro-axial flow blood pumps are assembled in parallel on the anchoring device in sequence. Multiple blood pumps jointly provide hemodynamic support. The rotor speed of a single blood pump is relatively low, which causes less damage to the blood. In addition, this type of device does not cross the valve and causes less damage to the aortic valve.

[0005] The anchoring device of the modular intra-aortic entrainment pump and the pump body of the micro-axial flow pump enter the descending aorta through the delivery cannula. The control line of the axial flow pump passes through the inner cavity of the anchoring device and the proximal catheter and extends to the outside of the body. The surgeon uses the anchor support catheter and the control line to implement the serial implantation, parallel assembly and removal of the axial flow pump and the anchoring device. During the whole process, thrombi are easily formed on the inner cavity of the proximal catheter and the surface of the control line. During the removal process, thrombi are easy to fall off, which will endanger the patient's physiological health, especially for medium- and long-term use.

[0006] To solve the above problems, it is necessary to design a reasonable delivery system and perfusion method to achieve percutaneous delivery of multiple axial flow blood pumps while being able to perfuse and flush the inner cavity of the delivery system and the outer surface of the micro-axial flow blood pump control line to reduce the risk of thrombosis. Summary of the invention

[0007] The purpose of the present invention is to provide a perfusion method for a modular intra-aortic entrainment pump delivery system to avoid thrombus formation and detachment in the system cavity during operation, thereby endangering the health of patients.

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

[0009] A perfusion method for a delivery system of a modular intra-aortic entrainment pump, characterized in that the steps are as follows: (1) during the delivery and assembly process of the anchor support and the micro-axial blood pump through the delivery sheath, the return line valve is closed, the perfusion line valve is opened, the perfusion device is started, heparin saline is injected into the perfusion line, and multiple guide matching holes of the anchor support are perfused and flushed; (2) when the micro-axial blood pump is assembled in parallel on the anchor support and runs stably, the return line valve is opened, the inner cavity of the delivery catheter is perfused and flushed, and flushed out of the body through the return line; (3) after the operation of the micro-axial blood pump is completed, the return line valve is closed, and step (1) is continued until the entire modular assembly is removed from the body;

[0010] The delivery system comprises the anchor support, a delivery catheter, a connector, an infusion line, a return line and an infusion device, wherein:

[0011] The anchoring support is arranged at the distal end of the delivery catheter, has a plurality of docking contact surfaces and associated guide matching holes, is used for parallel assembly of a plurality of micro axial flow blood pumps, and is also provided with an expansion stent;

[0012] The delivery catheter is provided with a perfusion cavity and a plurality of delivery cavities associated with the guide matching holes, and a thin-walled inner cavity is provided at the distal end to connect the delivery cavity and the perfusion cavity of the delivery catheter with the guide matching holes of the anchor support;

[0013] The connector is arranged at the proximal end of the delivery catheter, and the connector includes a plurality of push inlets and side arms correspondingly connected to the delivery cavity and a perfusion interface connected to the perfusion cavity, and the side arm is provided with an inner cavity connected to the push inlet;

[0014] The distal end of the perfusion pipeline is connected to the perfusion interface, and the proximal end is connected to the outlet of the perfusion device, which is used to inject heparin saline into the inner cavity of the system;

[0015] The far end of the reflux pipeline is connected to the side arm of the joint, and the proximal end is connected to the recovery port of the perfusion device for the reflux of the perfusion liquid.

[0016] The system and multiple micro-axial flow blood pumps enter the descending aorta through a delivery sheath, and can realize parallel assembly of multiple micro-axial flow blood pumps to jointly provide hemodynamic support. It can also achieve perfusion and flushing of the guide matching holes and the catheter lumen to avoid thrombus formation, which is conducive to the long-term safe use of the modular intra-aortic entrainment pump.

[0017] Furthermore, the proximal end of the anchoring support is tubular, has the same diameter as the delivery catheter, and is connected by welding or bonding; the guide matching holes of the anchoring support are equidistantly distributed along the circumferential direction.

[0018] Furthermore, the delivery catheter has sufficient bending rigidity and biocompatibility, and the material may be polytetrafluoroethylene.

[0019] Furthermore, the delivery lumens and guide matching holes of the delivery catheter are equal in number, equal in inner diameter, and corresponding in position, allowing the blood pump control line to pass through the delivery lumens and the guide matching holes at the same time.

[0020] Furthermore, the inner diameter of the delivery lumen of the delivery catheter ranges from 1 to 2.5 mm, and the inner diameter of the perfusion lumen ranges from 0.2 to 0.5 mm.

[0021] Furthermore, the depth of the delivery thin-wall inner cavity is 0.5 to 1 mm, the wall thickness is 0.1 to 0.3 mm, and the length of the delivery catheter is 50 to 60 cm.

[0022] Furthermore, the inner diameter of the push inlet of the connector smoothly transitions with the inner diameter of the delivery cavity and gradually increases, the side arm of the connector and the push inlet are vertically distributed or Y-shaped, and a liquid stop valve is arranged inside the push inlet of the connector, which can be a six-petal structure or a cross-cut structure.

[0023] Furthermore, a three-way valve is provided on the perfusion pipeline; the reflux pipeline includes a reflux branch and a reflux main line, the distal ends of the reflux branches are connected with the corresponding side arms respectively, the proximal ends of the reflux branches are connected with the distal ends of the reflux main lines through a multi-way interface, and the proximal ends of the reflux main lines are connected with the perfusion device through a two-way valve.

[0024] Furthermore, the outer diameters of the anchoring support and the delivery catheter are set so as to be delivered to the descending aorta through a 16-21F sheath.

[0025] Beneficial effects of the present invention:

[0026] (1) It can realize the percutaneous delivery of anchoring support and multiple micro-axial blood pumps;

[0027] (2) Multiple lumens of the anchor support and the delivery catheter can be perfused and flushed through a perfusion port to avoid thrombus formation, which is beneficial to the safe and long-term use of the modular intra-aortic entrainment pump. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiment of the present invention, the embodiment will be described below with reference to the accompanying drawings.

[0029] Figure 1 Schematic diagram of a delivery system according to an embodiment of the present invention.

[0030] Figure 2 Schematic diagram of the anchor support structure of an embodiment of the present invention.

[0031] Figure 3 Schematic diagram of the delivery catheter structure according to an embodiment of the present invention.

[0032] Figure 4 This is a cross-sectional view of the connection position between the anchor support and the delivery catheter according to an embodiment of the present invention.

[0033] Figure 5 Schematic diagram of the joint structure of an embodiment of the present invention.

[0034] Figure 6 This is a cross-sectional view of the connection position between the connector and the proximal end of the delivery catheter according to an embodiment of the present invention.

[0035] Figure 7 It is a schematic diagram of the docking state of the anchor support and the micro axial flow blood pump according to an embodiment of the present invention.

[0036] Figure 8 It is a schematic diagram of the serial delivery process of the delivery system according to an embodiment of the present invention when used.

[0037] Fig. 9 It is a schematic diagram of the delivery system according to an embodiment of the present invention in a parallel assembly state during application.

[0038] Fig.10 Schematic diagram of the flow direction of the perfusion liquid in the perfusion step (a) of an embodiment of the present invention.

[0039] Fig.11 Schematic diagram of the flow direction of the perfusion liquid in the perfusion step (b) of an embodiment of the present invention.

[0040] In the figure:

[0041] 1 anchoring support; 2 delivery catheter; 3 connector; 4 perfusion line; 5 return line; 6 perfusion device; 7 micro axial blood pump, 8 delivery sheath; 9 aorta;

[0042] 11 support body; 111 docking surface; 112 abutting surface; 113 guide matching hole; 114 bracket mounting hole;

[0043] 12 self-expanding stent; 121 upper stent; 122 lower stent;

[0044] 21 perfusion cavity; 22 delivery cavity; 23 thin-walled cavity;

[0045] 31 push inlet; 311 hemostatic valve; 32 side arm; 33 perfusion interface;

[0046] 41 three-way valve;

[0047] 51 reflux branch; 52 three-dimensional four-way interface; 53 reflux main road; 54 two-way valve;

[0048] 71, 72, 73 micro axial flow blood pumps; 711, 721, 731 micro axial flow blood pump control lines. DETAILED DESCRIPTION

[0049] The following examples are merely used to illustrate possible implementations of the present invention, but are not intended to limit the scope of the present invention, so it is necessary to explain them first.

[0050] like Figures 1 to 11 As shown in the figure, it is a preferred embodiment of the present invention, a method for perfusing a delivery system of a modular intra-aortic entrainment pump, which can achieve perfusion and flushing of three groups of cavities in the delivery system through a perfusion interface, and the specific method is as follows:

[0051] (a) During the delivery and parallel assembly process of the anchor support 1 and the micro-axial blood pump through the delivery sheath, that is, in the undocking state, close the two-way valve 54 of the return line, open the three-way valve 41 of the perfusion line, start the perfusion device, and inject heparin saline into the perfusion line to prevent blood from entering the guide matching hole 113 and the delivery cavity 22, thereby reducing the risk of thrombosis. Fig.10 Schematic diagram of the perfusion fluid flow direction in the undocking state;

[0052] (b) When the micro-axial blood pumps 71, 72, and 73 are assembled in parallel and run stably on the anchor support, i.e., in the docking state, the two-way valve 54 of the return main circuit and the three-way valve 41 of the perfusion line are opened, and heparinized saline is continuously injected into the perfusion line to flush the blood stains or thrombi remaining in the inner cavity out of the body through the return line, see Fig.11 Schematic diagram of the perfusion fluid flow direction in the docking state;

[0053] (c) After the operation of the micro-axial blood pump is completed, the return line valve 54 is closed and step (a) is continued until the entire modular assembly is removed from the body.

[0054] The delivery system of the modular intra-aortic entrainment pump includes an anchoring support 1, a delivery catheter 2, a connector 3, a perfusion line 4, a return line 5, and a perfusion device 6.

[0055] The anchor support 1 of the embodiment of the present invention is arranged at the distal end of the delivery catheter 2, and the proximal end of the anchor support 1 is tubular and has the same diameter as the delivery catheter 2, and is connected by welding or bonding. Figure 2, including a support body 11 and a self-expanding stent 12. The support body 11 includes three docking contact surfaces 111 and corresponding abutting surfaces 112, a guide matching hole 113, and a stent mounting hole 114. Specifically, the three guide matching holes 113 are through holes, which are arranged at the proximal end of the support body. The docking contact surface 111 is arranged at the distal end of the support body and is formed by cutting along the axial outer wall. The abutting surface 112 is at an angle of 45° with the axis of the support body and is located at the intersection of the guide matching hole and the docking contact surface. The docking contact surface 111, the abutting surface 112 and the guide matching hole 113 are used for parallel assembly with the micro axial blood pump 71, 72, 73; the self-expanding stent 12 is used for fixing the entire modular assembly, including an upper stent 121 and a lower stent 122, which are connected to the support body 11 through the mounting hole 114, and the connection method is welding or bonding. The material of the self-expanding stent is a shape memory alloy, which can be a nickel-titanium alloy.

[0056] See also Figure 3 The delivery catheter 2 of the embodiment of the present invention is provided with a perfusion cavity 21 and three delivery cavities 22 associated with the guide matching holes 113. The inner diameter of the perfusion cavity 21 is 0.5 mm, and the inner diameter of the delivery cavity 22 is 1.5 mm. The number of delivery cavities 22 and the guide matching holes 113 are equal, the inner diameters are equal, and the positions are aligned. The control lines 711, 721, and 731 of the micro-axial blood pump can pass through the delivery cavity and the guide matching holes, allowing the axial pushing movement of the control line; a thin-walled inner cavity 23 with a wall thickness of 0.3 mm and a depth of 0.8 mm is provided at the connection position between the distal end of the delivery catheter 2 and the anchor support, see Figure 4 A cross-sectional view of the connection position of the anchor support and the delivery catheter, wherein the thin-walled inner cavity 23 connects the delivery cavity and the perfusion cavity of the delivery catheter with the guide matching hole of the anchor support. The delivery catheter is preferably 50 to 60 cm long and has sufficient bending rigidity and biocompatibility, and the material may be polytetrafluoroethylene.

[0057] See also Figure 5 and Figure 6 The connector 3 of the embodiment of the present invention is arranged at the proximal end of the delivery catheter 2, including three corresponding push ports 31 and three side arms 32, and has a perfusion interface 33 connected to the perfusion cavity. The three push ports 31 are respectively connected to the delivery cavity 22 of the delivery catheter, and the axis of the push port is at a certain angle to the core axis of the connector, and the inner diameter gradually increases to facilitate the pushing operation of the micro-axial blood pump control line; a cross-shaped hemostatic valve 311 is arranged inside the push port to prevent blood leakage during the pushing process; the inner holes of the three side arms are connected to the push port 311, and are distributed in a Y shape to facilitate the backflow of the perfusion liquid; the perfusion interface 33 is connected to the perfusion cavity 21 of the delivery catheter for perfusing the perfusion pipeline.

[0058] The far end of the perfusion line 4 is connected to the perfusion interface 33, and the near end is connected to the outlet of the perfusion device, which is used to inject heparin saline into the system lumen; a three-way valve 41 is provided on the perfusion line to control the opening and closing of the perfusion line, and other drugs can be injected into the body through the three-way valve; the reflux line 5 includes three branch lines 51 and a main line 53, which are connected and converted through a three-dimensional four-way interface 52. The far end is connected to the side arm 32 of the connector through the three branch lines 51, and the proximal end is connected to the recovery port of the perfusion device for the reflux of the perfusion liquid. A two-way valve 54 is provided on the main line 53 of the reflux line to control the opening and closing of the reflux line. The perfusion device perfuses heparin saline through a perfusion port to achieve perfusion and flushing of the three groups of cavities, which can flush the blood flowing into the inner cavity in time to avoid the formation of thrombus.

[0059] The system and multiple micro-axial flow blood pumps enter the descending aorta through a delivery sheath, and can realize parallel assembly of three micro-axial flow blood pumps to jointly provide hemodynamic support. It can also achieve perfusion and flushing of the support guide matching holes and the catheter lumen to avoid thrombus formation, which is conducive to the long-term safe use of the modular intra-aortic entrainment pump.

[0060] The proximal end of the anchoring support 1 is tubular, with the same diameter as the delivery catheter 2, and is connected by welding or bonding. The guide matching holes 113 of the anchoring support 1 are equidistantly distributed along the circumference. The delivery cavity 22 of the delivery catheter 2 is set to accommodate the micro-axial blood pump control lines 711, 721, 731, and the inner wall is smooth, allowing the axial pushing activity of the control line. The material of the delivery catheter needs to have sufficient bending rigidity and biocompatibility, and can be polytetrafluoroethylene. The delivery cavities 22 and guide matching holes 113 of the delivery catheter 2 are equal in number, equal in diameter, and aligned in position, and the control line can pass through the delivery cavity 22 and the guide matching hole 113 at the same time. The delivery cavity diameter of the delivery catheter ranges from 1 to 2.5 mm, and the perfusion cavity 21 has a diameter of 0.2 to 0.5 mm. A thin-walled inner cavity 23 is provided at the connection position between the distal end of the delivery catheter and the anchoring support, connecting the delivery cavity and the perfusion cavity of the delivery catheter with the guide matching hole of the anchoring support. The depth of the thin-walled inner cavity is 0.5 to 1 mm, and the wall thickness is 0.1 to 0.3 mm. The length of the delivery catheter is 50 to 60 cm. The diameter of the push inlet 31 of the connector 3 smoothly transitions with the inner diameter of the delivery cavity and gradually increases. A liquid stop valve 311 is provided inside the push inlet of the connector, which can be a six-petal structure or a cross-cut structure. The side arm of the connector is provided with an inner cavity and is connected to the push inlet.

[0061] The side arm of the connector and the push inlet can also be distributed vertically. The outer diameter of the delivery device is set to be able to be delivered to the descending aorta through a 16-21F sheath.

[0062] The embodiment of the present invention can realize the serial implantation and parallel assembly with three micro-axial blood pumps through 16-21F delivery sheaths, including docking state and undocking state:

[0063] In the docking state, the three docking contact surfaces 111 of the support body 11 and the corresponding abutment surfaces 112 are tightly fitted with the pump body of the micro axial flow blood pump. Figure 7 This is a schematic diagram of the docking state of the anchor support and the micro axial flow blood pump of this embodiment;

[0064] In the un-docking state, the three docking contact surfaces 111 and the corresponding abutting surfaces 112 of the support body 11 are separated from the pump body of the micro axial flow blood pump.

[0065] See also Figure 8 During the delivery process through the sheath, the anchor support and the three micro-axial blood pumps are distributed in series inside the sheath. The micro-axial blood pump control lines 711, 721, and 731 pass through the guide matching hole 113 of the anchor support and the delivery cavity 22 of the delivery catheter and extend outside the body. The surgeon pushes the delivery catheter 2 and the blood pump control line to push the anchor support and the three micro-axial blood pumps to the descending aorta; after reaching the designated position, the sheath is withdrawn, the delivery catheter is constrained and the control line is pulled, so that the three micro-axial blood pumps are assembled in parallel with the anchor support to form a docking state. The three axial flow pumps jointly provide hemodynamic support. Fig. 9 This is a schematic diagram of stable operation after assembly.

[0066] The embodiment of the present invention can perfuse and flush multiple cavities of the anchor support and the delivery catheter through a perfusion port, thereby avoiding the formation of thrombus, which is beneficial to the safe and long-term use of the modular intra-aortic entrainment pump.

Claims

1. A method for perfusing a delivery system of a modular intra-aortic entrainment pump, characterized in that: The steps are as follows: (1) During the delivery and assembly process of the anchor support and the micro-axial blood pump through the delivery sheath, close the reflux line valve, open the perfusion line valve, start the perfusion device, inject heparin saline into the perfusion line, and perfuse and flush the multiple guide matching holes of the anchor support; (2) When the micro-axial blood pump is assembled in parallel on the anchor support and runs stably, open the reflux line valve, perfuse and flush the inner cavity of the delivery catheter, and flush it out of the body through the reflux line; (3) After the operation of the micro-axial blood pump is completed, close the reflux line valve and continue to perform step (1) until the entire modular assembly is removed from the body; The delivery system comprises the anchor support, a delivery catheter, a connector, an infusion line, a return line and an infusion device, wherein: The anchoring support is arranged at the distal end of the delivery catheter, has a plurality of docking contact surfaces and associated guide matching holes, is used for parallel assembly of a plurality of micro axial flow blood pumps, and is also provided with an expansion stent; The delivery catheter is provided with a perfusion cavity and a plurality of delivery cavities associated with the guide matching holes, and a thin-walled inner cavity is provided at the distal end to connect the delivery cavity and the perfusion cavity of the delivery catheter with the guide matching holes of the anchor support; The connector is arranged at the proximal end of the delivery catheter, and the connector includes a plurality of push inlets and side arms correspondingly connected to the delivery cavity and a perfusion interface connected to the perfusion cavity, and the side arm is provided with an inner cavity connected to the push inlet; The distal end of the perfusion pipeline is connected to the perfusion interface, and the proximal end is connected to the outlet of the perfusion device, which is used to inject heparin saline into the inner cavity of the system; The far end of the reflux pipeline is connected to the side arm of the joint, and the proximal end is connected to the recovery port of the perfusion device for the reflux of the perfusion liquid. The system and multiple micro-axial flow blood pumps enter the descending aorta through a delivery sheath, and can realize parallel assembly of multiple micro-axial flow blood pumps to jointly provide hemodynamic support. It can also achieve perfusion and flushing of the guide matching holes and the catheter lumen to avoid thrombus formation, which is conducive to the long-term safe use of the modular intra-aortic entrainment pump.

2. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 1, characterized in that: The proximal end of the anchoring support is tubular and has the same diameter as the delivery catheter, and is connected by welding or bonding; the guide matching holes of the anchoring support are equidistantly distributed along the circumferential direction.

3. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 1, characterized in that: The delivery catheter has sufficient bending rigidity and biocompatibility, and the material may be polytetrafluoroethylene.

4. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 3, characterized in that: The delivery cavities and guide matching holes of the delivery catheter are equal in number, equal in inner diameter, and corresponding in position, allowing the blood pump control line to pass through the delivery cavity and the guide matching hole at the same time.

5. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 4, characterized in that: The inner diameter of the delivery cavity of the delivery catheter ranges from 1 to 2.5 mm, and the inner diameter of the perfusion cavity ranges from 0.2 to 0.5 mm.

6. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 5, characterized in that: The thin-wall inner cavity of the delivery catheter has a depth of 0.5 to 1 mm, a wall thickness of 0.1 to 0.3 mm, and a length of 50 to 60 cm.

7. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 1, characterized in that: The inner diameter of the push inlet of the connector smoothly transitions with the inner diameter of the delivery cavity and gradually increases. The side arm of the connector is vertically distributed or Y-shaped with the push inlet. A liquid stop valve is arranged inside the push inlet of the connector, which can be a six-petal structure or a cross-cut structure.

8. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 1, characterized in that: A three-way valve is arranged on the perfusion pipeline; the reflux pipeline includes a reflux branch and a reflux main line, the distal ends of the reflux branches are respectively connected with the corresponding side arms, the proximal ends of the reflux branches are connected with the distal ends of the reflux main lines through a multi-way interface, and the proximal ends of the reflux main lines are connected with the perfusion device through a two-way valve.

9. A method for perfusing a modular intra-aortic entrainment pump delivery system according to claim 1, characterized in that: The outer diameters of the anchoring support and the delivery catheter are set so as to be delivered to the descending aorta through a 16-21F sheath.

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