Blood pump manufacturing method

Abstract

According to the blood pump manufacturing method, a pump shell is made of a non-ceramic material, so that the pump shell is easier to manufacture, the manufacturing cost of a whole blood pump assembly is reduced, meanwhile, a liquid drainage groove is formed in the outer wall of the pump shell, and flushing liquid can flow through the outer wall of the pump shell to take away heat on the pump shell; the temperature of the pump shell is kept within the set temperature, the situation that the temperature of the pump shell is too high, and operation proceeding is affected is avoided, and operation safety is improved. The liquid drainage groove is formed in the pump shell in advance, then the laddered wires are pressed on the liquid drainage groove, the filling agent is injected, and the laddered wires are drawn away, so that the auxiliary groove and the relay channel can be formed, the containing cavity communicates with the liquid drainage groove, flushing liquid can flow to the liquid drainage groove, the laddered wire mode is adopted, the machining mode is simplified, and the machining efficiency is improved. And the liquid discharge groove is ensured to be communicated with the accommodating cavity.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a method for manufacturing a blood pump. Background Art

[0002] Patients with reduced left ventricular function may need to use a left ventricular assist device for a short period. One end of the cannula in the ventricular assist device is inserted into the left ventricle through the aorta, and the other end is located in the aorta. The blood pump assembly in the ventricular assist device operates to pump the blood in the left ventricle into the aorta through the cannula, thereby achieving the surgical purpose. Currently, most blood pumps use axial flow pumps. The rotation of the impeller is driven by a rotating shaft, and there is a clearance fit between the rotating shaft and the end cover at the distal end of the blood pump to ensure the free rotation of the rotating shaft. However, the existence of this clearance allows the patient's blood to enter the pump housing, which may cause thrombosis inside the blood pump. To prevent this situation, a flushing liquid is input to the proximal side of the blood pump, so that the flushing liquid passes between the rotating shaft and the stator and sprays out towards the distal end from the clearance, thereby achieving liquid sealing and preventing blood from entering the blood pump; the heat generated during the operation of the blood pump is also carried out when the flushing liquid sprays out.

[0003] When the blood pump is operating, both the rotating shaft and the stator generate heat. To reduce the impact of the heat of the blood pump on the operation, it is necessary to isolate the heat of the blood pump or conduct the heat on the blood pump. The prior art realizes this through two aspects. On the one hand, the heat inside the axial flow pump is carried away by the aforementioned flushing liquid, and at the same time, the pump housing is made of ceramic material to improve the heat insulation performance of the pump housing; however, due to the very small radial size of the blood pump, it is relatively difficult to manufacture such a small-sized ceramic pump housing, which increases the manufacturing cost of the entire blood pump, thereby increasing the cost of the ventricular assist device and being unfavorable for the performance of cardiac surgery. Summary of the Invention

[0004] In view of this, the present invention provides a method for manufacturing a blood pump. The pump housing is made of non-ceramic material, and a drainage groove is formed on the pump housing, so that the flushing liquid can flow through the first liquid groove, thereby taking away the heat on the pump housing, reducing the manufacturing cost of the blood pump, and avoiding the situation of overheating of the blood pump assembly.

[0005] The technical solution adopted by the present invention is as follows: A method for manufacturing a blood pump, comprising the steps of: S100. Process and form a drainage groove on the outer wall of the pump housing. The distal end of the drainage groove penetrates the distal end of the pump housing, and the proximal end of the drainage groove penetrates the proximal end of the pump housing; S200. Fix and install the stator inside the pump housing, pass the rotating shaft through the inside of the stator, sleeved a first bearing and an end cover on the distal end of the rotating shaft. The end cover is located on the distal side of the first bearing, and a second bearing is sleeved on the proximal end of the rotating shaft; S300. Sleeve the proximal connector on the outside of the second bearing from the proximal end, so that the first equal-diameter section is sleeved on the outside of the second bearing, the reduced-diameter section is located on the proximal side of the rotating shaft, and a receiving cavity is formed in the reduced-diameter section; S400. Sleeve the stopper on the outside of the proximal connector from the proximal end. The insertion leg is inserted into the annular cavity formed between the first equal-diameter section and the pump housing. The radially inner side of the insertion leg is in contact with the outer wall of the first equal-diameter section, and the radially outer side of the insertion leg is in contact with the inner wall of the pump housing. The outer wall of the reduced-diameter section is in contact with the mating cavity. The second equal-diameter section passes out of the mating port, and adjust the angle of the stopper so that the first liquid discharge hole communicates with the second liquid discharge hole; S500. Press and connect a wire along the direction of the liquid discharge groove. The distal end of the wire extends out of the distal end of the liquid discharge groove, the proximal end of the wire extends out of the proximal end of the liquid discharge groove, and the proximal end of the wire sequentially passes through the second liquid discharge hole and the first liquid discharge hole at least into the receiving cavity; S600. Sleeve a connecting pipe on the outside of the pump housing. The straight cylinder section is sleeved on the outside of the pump housing, and the receiving section is located on the outside of the stopper, and make the axis of the connecting pipe coincide with the axis of the rotating shaft. An annular filling cavity is formed between the straight cylinder section and the pump housing, and a special-shaped cavity is formed between the receiving section and the stopper; S700. Inject a filling agent into the filling cavity and the special-shaped cavity so that the filling cavity and the special-shaped cavity are filled with the filling agent; S800. After the filling agent is cured, an outer sheath is formed in the filling cavity, and a seal is formed in the special-shaped cavity; S900. Withdraw the wire, form an auxiliary groove on the inner wall of the outer sheath, and form a relay channel on the seal.

[0006] Preferably, the pump housing includes a cylindrical metal layer and an insulating layer located outside the metal layer; In step S100, first laser engrave a first liquid groove on the outer wall of the metal layer, set an insulating layer outside the metal layer, the insulating layer covers the first liquid groove, and form the liquid discharge groove at the position of the first liquid groove.

[0007] Preferably, the cross-section of the first liquid groove is semi-circular, the diameter of the first liquid groove is 0.1-0.2 mm, and the thickness of the insulating layer is 5-50 μm.

[0008] Preferably, in step S500, first lubricate the surface of the wire with silicone oil, and then press the wire to the liquid discharge groove. The diameter of the wire is the same as the diameter of the first liquid groove.

[0009] Preferably, in step S500, after the proximal end of the wire drawing extends out of the proximal end of the drainage groove, the proximal end of the wire drawing winds around the outer periphery of the stopper once, and then sequentially passes through the second drainage hole, the first drainage hole and at least reaches the accommodation cavity; In step S900, the relay channel includes a third drainage hole, a connection groove and a second liquid groove, wherein the third drainage hole radially penetrates through the seal, and both the connection groove and the second liquid groove are located on the outer surface of the seal, the connection groove is an annular structure, one end of the second liquid groove is connected to the connection groove, and the other end of the second liquid groove is connected to the auxiliary groove.

[0010] Preferably, in step S100, the number of the first liquid grooves is one, and the first liquid groove is spirally arranged around the outer wall of the metal layer.

[0011] Preferably, in step S100, the outer wall of the metal layer is divided into a plurality of cooling regions in the circumferential direction, and a first liquid groove is respectively formed by laser engraving on each cooling region, and the first liquid groove extends in a wavy shape; In step S500, the number of the wire drawings is the same as the number of the first liquid grooves, a corresponding wire drawing is crimped on each drainage groove, the distal ends of the wire drawings all extend out of the distal end of the drainage groove, and the proximal ends of the wire drawings all extend out of the proximal end of the drainage groove, wherein the proximal end of one wire drawing sequentially passes through the second drainage hole, the first drainage hole and at least reaches the accommodation cavity.

[0012] Preferably, the wire drawing passing through the second drainage hole is denoted as the first wire drawing, and the other wire drawings are denoted as the second wire drawings. In step S500, before the first wire drawing passes through the second drainage hole, it first winds around the outer periphery of the stopper to form a surrounding structure, and the proximal ends of the second wire drawings are all located on the proximal side of the surrounding structure.

[0013] Preferably, in step S600, a spacer is inserted between the connecting pipe and the pump housing, the spacer avoids the wire drawing, and a part of the spacer exposes the connecting pipe so that the axis of the connecting pipe is consistent with the axis of the rotating shaft.

[0014] Preferably, in step S100, an insulating layer is prepared on the outside of the metal layer by coating or by means of vacuum vapor deposition, and the material of the insulating layer is polytetrafluoroethylene, polyether ether ketone or parylene; The filler is UV glue or epoxy resin; The wire drawing is a nitinol wire.

[0015] Advantages of the present invention: The blood pump manufactured using the present invention is applied to a ventricular assist device. When the blood pump is operating, the rotating shaft rotates relative to the stator, causing the impeller to rotate, so as to pump the blood in the left ventricle into the aorta. During the rotation of the rotating shaft, both the rotating shaft and the stator generate heat. The flushing liquid is input into the accommodating cavity in the proximal connector through the infusion tube. The flushing liquid enters between the rotating shaft and the stator through the second bearing, thereby absorbing the heat of the rotating shaft and the stator, and finally sprays out from the gap of the end cover. In addition, the heat on the stator is also transferred to the pump housing, causing the temperature of the pump housing to rise. The flushing liquid in the accommodating cavity flows through the first drain hole, the second drain hole and the relay channel to the drain groove and the auxiliary groove. Since the drain groove is provided on the outer wall of the pump housing, and the auxiliary groove is formed by wire drawing, the auxiliary groove and the drain groove are radially buckled with each other. When the flushing liquid flows on the drain groove, it will take away the heat on the pump housing, thus preventing the temperature of the pump housing from being too high. The flushing liquid flowing through the drain groove finally sprays out from the distal end of the drain groove and enters the patient's body.

[0016] In the present invention, the pump housing is made of a non-ceramic material, making the pump housing easier to manufacture, thereby reducing the manufacturing cost of the entire blood pump assembly. At the same time, by providing a drain groove on the outer wall of the pump housing, the flushing liquid can flow through the outer wall of the pump housing to take away the heat on the pump housing, keeping the temperature of the pump housing within the set temperature, preventing the temperature of the pump housing from being too high and affecting the operation of the surgery, and improving the safety of the surgery.

[0017] In the present invention, the drain groove is pre-processed on the pump housing, and then wire is crimped on the drain groove. After injecting the filler, the wire is withdrawn, and the auxiliary groove and the relay channel can be formed, enabling the accommodating cavity to communicate with the drain groove, so that the flushing liquid can flow to the drain groove. The wire drawing method simplifies the processing method and ensures the communication between the drain groove and the accommodating cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Through the following description of the embodiments of the present invention with reference to the drawings, the above and other objects, features and advantages of the present invention will become clearer. In the drawings: Figure 1 is a flowchart of the manufacturing method of the blood pump; Figure 2 is a schematic structural diagram of the pump housing; Figure 3 is a schematic diagram of the assembly after step S500; Figure 4 is an exploded view of the assembly obtained in step S400; Figure 5 is Figure 3 a cross-sectional view of the assembly of; Figure 6 is Figure 5 an enlarged view of part A in; Figure 7is a cross-sectional view of the assembled body after step S600; Figure 8 is Figure 7 an enlarged view of part B in Figure 9 is Figure 7 an enlarged view of part C in Figure 10 is a structural schematic diagram of the connecting pipe; Figure 11 is a cross-sectional view of the pump housing and the outer sheath; Figure 12 is a schematic diagram of the seal and the pump housing; Figure 13 is a cross-sectional view of the pump housing; Figure 14 is Figure 13 an enlarged view of part D in Figure 15 is a structural schematic diagram of the stopper; Figure 16 is a structural schematic diagram of another embodiment of the pump housing.

[0019] In the figure: 1, pump housing; 2, stator; 3, rotating shaft; 4, first bearing; 5, second bearing; 6, proximal connector; 7, stopper; 8, end cap; 9, wire drawing; 10, connecting pipe; 20, outer sheath; 30, seal; 11, metal layer; 12, insulating layer; 13, drain groove; 31, connecting groove; 32, second liquid groove; 61, first equal-diameter section; 62, reduced-diameter section; 63, second equal-diameter section; 64, insertion port; 65, accommodation cavity; 66, first drain hole; 71, second drain hole; 72, insertion leg; 73, main body part; 101, straight tube section; 102, storage section; 103, special-shaped cavity; 104, filling cavity; 201, auxiliary groove; 202, cooling groove. Specific embodiments

[0020] The present invention will be described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid obscuring the essence of the present invention, well-known methods, processes, procedures, and components are not described in detail.

[0021] In addition, those of ordinary skill in the art should understand that the drawings provided herein are for illustrative purposes only, and the drawings are not necessarily drawn to scale.

[0022] Unless the context clearly requires otherwise, the words "comprising", "including" and similar words in the whole specification and claims shall be construed in an inclusive sense rather than an exclusive or exhaustive sense; that is, it is the meaning of "including but not limited to".

[0023] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, the meaning of "a plurality" is two or more than two.

[0024] In the present invention, "far" means the side close to the patient's body during the operation; "near" means the side close to the operator during the operation.

[0025] See Figures 1 - 16 , the present invention provides a method for manufacturing a blood pump, which is applied to a ventricular assist device and serves as a power source in the ventricular assist device. The ventricular assist device is mainly applied to cardiac surgery, such as PCI (Percutaneous coronary intervention) surgery, cardiogenic shock and other surgeries, and is used to pump the blood in the left ventricle into the aorta.

[0026] The blood pump includes a pump housing 1, a rotating shaft 3, a stator 2, a first bearing 4, a second bearing 5, a connecting pipe 10 and an end cap 8, and further includes a proximal connector 6 and a stopper 7. From far to near, the proximal connector 6 includes a first equal-diameter section 61, a diameter-changing section 62 and a second equal-diameter section 63 connected in sequence. The diameter of the first equal-diameter section 61 is larger than the diameter of the second equal-diameter section 63. A first drain hole 66 extending radially is provided on the side wall of the diameter-changing section 62, and an insertion port 64 is formed in the second equal-diameter section 63.

[0027] The stopper 7 includes insertion legs 72 and a main body 73. A fitting cavity with an opening facing the far side is formed in the main body 73. A fitting port is further provided on the main body 73. The fitting port faces the proximal side and is communicated with the fitting cavity. A second drain hole 71 extending radially is provided on the main body 73. The number of the insertion legs 72 is multiple, and the multiple insertion legs 72 are uniformly arranged along the circumferential direction of the main body 73. The insertion legs 72 are connected to the distal side of the main body 73.

[0028] The connecting pipe 10 includes a straight tube section 101 and a receiving section 102 connected to each other. The receiving section 102 is located on the proximal side of the straight tube section 101.

[0029] The manufacturing method includes the steps: S100. A drain groove 13 is machined on the outer wall of the pump housing 1. The distal end of the drain groove 13 penetrates the distal end of the pump housing 1, and the proximal end of the drain groove 13 penetrates the proximal end of the pump housing 1.

[0030] S200. The stator 2 is fixedly installed in the pump housing 1. The rotating shaft 3 is inserted through the inside of the stator 2. A first bearing 4 and an end cover 8 are sleeved on the distal end of the rotating shaft 3. The end cover 8 is located on the distal side of the first bearing 4. A second bearing 5 is sleeved on the proximal end of the rotating shaft 3.

[0031] S300. The proximal connecting piece 6 is sleeved on the outside of the second bearing 5 from the proximal end, so that the first equal-diameter section 61 is sleeved on the outside of the second bearing 5. The variable-diameter section 62 is located on the proximal side of the rotating shaft 3. An accommodation cavity 65 is formed in the variable-diameter section 62.

[0032] S400. The stop member 7 is sleeved on the outside of the proximal connecting piece 6 from the proximal end. The insertion leg 72 is inserted into the annular cavity formed between the first equal-diameter section 61 and the pump housing 1. The radially inner side of the insertion leg 72 is attached to the outer wall of the first equal-diameter section 61, and the radially outer side of the insertion leg 72 is attached to the inner wall of the pump housing 1. The outer wall of the variable-diameter section 62 is attached to the mating cavity. The second equal-diameter section 63 passes out of the mating opening, and the angle of the stop member 7 is adjusted so that the first drain hole 66 is communicated with the second drain hole 71.

[0033] S500. Along the direction of the drain groove 13, a wire drawing 9 is crimped on the drain groove 13. The distal end of the wire drawing 9 extends out of the distal end of the drain groove 13, and the proximal end of the wire drawing 9 extends out of the proximal end of the drain groove 13. The proximal end of the wire drawing 9 sequentially passes through the second drain hole 71 and the first drain hole 66 at least into the accommodation cavity 65.

[0034] S600. A connecting pipe 10 is sleeved on the outside of the pump housing 1. The straight cylinder section 101 is sleeved on the outside of the pump housing 1. The receiving section 102 is located on the outside of the stop member 7, and the axis of the connecting pipe 10 is aligned with the axis of the rotating shaft 3. An annular filling cavity 104 is formed between the straight cylinder section 101 and the pump housing 1. An irregular cavity 103 is formed between the receiving section 102 and the stop member 7.

[0035] S700. A filling agent is injected into the filling cavity 104 and the irregular cavity 103 so that the filling cavity 104 and the irregular cavity 103 are filled with the filling agent.

[0036] S800. After the filling agent is cured, an outer sheath 20 is formed in the filling cavity 104, and a seal 30 is formed in the irregular cavity 103.

[0037] The S900 withdraws the wire 9, forms an auxiliary groove 201 on the inner wall of the outer sheath 20, and forms a relay channel on the seal 30.

[0038] In the present invention, the pump housing 1 is made of a non-ceramic material (for example, made of stainless steel or copper). On the one hand, it makes the pump housing 1 easier to manufacture, thereby reducing the manufacturing cost of the entire blood pump assembly. In addition, due to the replacement of the material of the pump housing 1, the heat insulation performance of the pump housing 1 is reduced (compared with the pump housing 1 made of ceramic material). That is to say, the heat on the stator 2 can be conducted outward to the pump housing 1, causing the temperature of the pump housing 1 to rise; to solve the problem of the over-high temperature of the pump housing 1. When manufacturing the blood pump in the present invention, a drain groove 13 is first machined on the pump housing 1 so that the flushing liquid can flow in the drain groove 13. Since the temperature of the flushing liquid is relatively low, when the flushing liquid flows in the drain groove 13, the flushing liquid can absorb the heat on the pump housing 1, thereby keeping the temperature of the pump housing 1 within the set temperature range.

[0039] To ensure that the flushing liquid can enter the drain groove 13 during actual application, in the present invention, along the direction of the drain groove 13, the wire 9 is crimped on the drain groove 13. The wire 9 has an interference fit with the drain groove 13. Radially, a part of the wire 9 protrudes from the drain groove 13. The proximal end of the wire 9 passes through the second drain hole 71 and the first drain hole 66. The distal end of the wire 9 protrudes from the distal end of the drain groove 13. A connecting pipe 10 is sleeved outside the pump housing 1, thereby forming a filling cavity 104 and a special-shaped cavity 103. The filling cavity 104 and the special-shaped cavity 103 communicate with each other. The special-shaped cavity 103 is located on the proximal side of the filling cavity 104. The proximal end of the special-shaped cavity 103 is open, and the distal end of the filling cavity 104 is open. Therefore, the filling agent can be filled into the filling wall and the special-shaped cavity 103 from the proximal open end or the distal open end. After the filling agent is cured, the wire 9 is withdrawn. For example, pinch the part of the wire 9 protruding from the distal end. Since the wire 9 is withdrawn, an auxiliary groove 201 and a relay channel can be formed. Due to the original direction of the wire 9, the first drain hole 66, the second drain hole 71, the relay channel, and the auxiliary groove 201 are sequentially connected. Moreover, the distal end of the wire 9 extends out of the distal end of the drain groove 13. Therefore, the distal end of the auxiliary groove 201 communicates with the outside. In this way, the flushing liquid can flow through the first drain hole 66, the second drain hole 71, and the relay channel to the cooling groove 202 formed by the auxiliary groove 201 and the drain groove 13 (the auxiliary groove 201 and the drain groove 13 are mutually buckled in the radial direction), and flow out from the distal end of the cooling groove 202.

[0040] To fully understand the object of the present invention, taking the case of a ventricular assist device during surgery as an example, a cannula is connected to the distal end of a blood pump, a catheter is connected to the proximal end of the blood pump, a liquid inlet pipe is arranged inside the catheter, and the liquid inlet pipe is inserted into an insertion port 64; during surgery, the distal end of the cannula extends into the left ventricle, a blood outlet is arranged at the blood pump (the blood outlet is located on a connecting pipe 10), the blood pump is located in the aorta, the blood pump operates to pump the blood in the left ventricle into the aorta, and at the same time, a flushing liquid (the flushing liquid is a mixed liquid of glucose and heparin) is input into a containing cavity 65 through the liquid inlet pipe. The flushing liquid first fills the containing cavity 65, and then the flushing liquid is divided into two paths. The first path flows through the gap between a second bearing 5 and a rotating shaft 3 to the gap between the rotating shaft 3 and a stator 2. Therefore, this part of the flushing liquid can take away the heat of the rotating shaft 3 and the stator 2, and then this part of the flushing liquid continues to flow towards the distal side, passes through the gap between a first bearing 4 and the rotating shaft 3, and finally sprays out from the gap between the rotating shaft 3 and an end cover 8 (hereinafter referred to as "the first gap"). Since there is a situation where the flushing liquid sprays out towards the distal side at the first gap, blood will not enter the gap between the rotating shaft 3 and the stator 2 from the first gap; the second path flows through a first liquid discharge hole 66, a second liquid discharge hole 71, and a relay channel to a cooling tank 202 jointly formed by an auxiliary tank 201 and a liquid discharge tank 13. Therefore, when the flushing liquid flows in the cooling tank 202, it will take away the heat on the pump housing 1, thereby preventing the temperature of the pump housing 1 from being too high. The flushing liquid flowing through the cooling tank 202 finally sprays out from the distal end of the cooling tank 202 and enters the patient's body.

[0041] In addition, in step S600, by directly sleeving a connecting pipe 10 outside the pump housing 1, due to the structure of the connecting pipe 10, a filling cavity 104 and a special-shaped cavity 103 are naturally formed; thus, in step S700, a filling agent is injected from a proximal open end or a distal open end. Since the filling agent has a certain fluidity, the filling agent can fill the filling cavity 104 and the special-shaped cavity 103; after the filling agent is cured, the connecting pipe 10 is connected to the pump housing 1 through an outer sheath 20 and a seal 30, so that the connecting pipe 10 and the pump housing 1 are connected into a whole, and thus the assembly of the connecting pipe 10 is also realized at the same time.

[0042] A first bearing 4 is sleeved on the distal end of the rotating shaft 3, a second bearing 5 is sleeved on the proximal end of the rotating shaft 3, and both the first bearing 4 and the second bearing 5 are fitted with the inner wall of the pump housing 1 (directly or indirectly), so that the rotating shaft 3 can rotate relative to the pump housing 1; Figure 5In the illustrated embodiment, in step S200, a bushing may also be sleeved on the proximal end of the rotating shaft 3. The bushing is located on the proximal side of the second bearing 5 to axially position the second rotating shaft 3 through the bushing, preventing the second bearing 5 from moving towards the proximal side. From far to near, the proximal connector 6 may include a first equal-diameter section 61, a reduced-diameter section 62, and a second equal-diameter section 63. The proximal connector 6 has a structure with equal wall thickness (the wall thickness is basically the same everywhere). The diameter of the first equal-diameter section 61 is larger than that of the second equal-diameter section 63. From far to near, the diameter of the reduced-diameter section 62 gradually decreases so that the large end of the reduced-diameter section 62 can be connected to the first equal-diameter section 61, and the small end of the reduced-diameter section 62 can be connected to the second equal-diameter section 63. The first equal-diameter section 61 can be sleeved on the outside of the second bearing 5 and the bushing. An insertion port 64 is formed inside the second equal-diameter section 63, and a receiving cavity 65 is formed inside the reduced-diameter section 62. The first drain hole 66 is located in the reduced-diameter section 62. In this way, the proximal connector 6 can cover the proximal end of the rotating shaft 3. The infusion tube is inserted into the insertion port 64 and can be hermetically connected by glue. When the infusion tube injects the flushing liquid into the receiving cavity 65, it is ensured that the flushing liquid will not leak from the insertion port 64.

[0043] In step S200, a end cap 8 is also sleeved on the outside of the rotating shaft 3. The end cap 8 is located on the distal side of the first bearing 4. The end cap 8 is connected to the distal end of the pump housing 1 and substantially closes the distal end of the pump housing 1, forming a relatively small (small radial dimension) gap (the aforementioned first gap) between the rotating shaft 3 and the end cap 8, reducing the possibility of blood entering from the first gap between the rotating shaft 3 and the stator 2. At the same time, it is also convenient to more easily form a high pressure (formed by the accumulation of flushing liquid) on the proximal side of the end cap 8, thereby preventing blood from entering between the stator 2 and the rotating shaft 3.

[0044] As Figure 15 In the illustrated embodiment, the stopper 7 includes three insertion legs 72 and a main body portion 73. The three insertion legs 72 are connected to the distal end of the main body portion 73. The main body portion 73 forms a mating cavity with an opening facing distally. The three insertion legs 72 are evenly spaced circumferentially. During assembly, the insertion legs 72 are inserted between the first equal-diameter section 61 and the pump housing 1, causing the first equal-diameter section 61 to be radially compressed and limited, ensuring that the flushing liquid in the receiving cavity 65 can only flow along two preset paths. The inner wall of the mating cavity fits against the outer wall of the reduced-diameter section 62, thereby supporting the reduced-diameter section 62 from the outside. The proximal connector 6 can be made of a deformable material such as silicone, etc. Therefore, the first equal-diameter section 61 can be compressed radially to improve the sealing performance. While the stopper 7 is made of a rigid material (such as plastic), so the stopper 7 cannot be compressed and can support the reduced-diameter section 62 from the outside to prevent the reduced-diameter section 62 from deforming outward.

[0045] The distal end of the stopper 7 abuts against the proximal end of the stator 2, so that the stator 2 can position the stopper 7.

[0046] The stopper 7 is provided with a second liquid discharge hole 71, the second liquid discharge hole 71 is located on the main body portion 73, and the radially inner end of the second liquid discharge hole 71 communicates with the radially outer end of the first liquid discharge hole 66. Therefore, the flushing liquid can enter the second liquid discharge hole 71 through the first liquid discharge hole 66, thereby guiding the flushing liquid to the cooling tank 202.

[0047] The pump housing 1 includes a cylindrical metal layer 11 and an insulating layer 12 located outside the metal layer 11.

[0048] In step S100, first, a first liquid groove is formed by laser engraving on the outer wall of the metal layer 11, an insulating layer 12 is provided outside the metal layer 11, the insulating layer 12 covers the first liquid groove, and the liquid discharge groove 13 is formed at the first liquid groove.

[0049] When the blood pump is working, power needs to be supplied to the blood pump, and the pump housing 1 made of pure metal can conduct electricity, thus posing a risk of electrical breakdown. The pump housing 1 of the present invention includes a metal layer 11. First, a first liquid groove is formed by laser engraving on the metal layer 11, and then an insulating layer 12 is provided outside the entire metal layer 11, that is, the insulating layer 12 also covers the first liquid groove and forms a liquid discharge groove 13 along the first liquid groove. The setting of the insulating layer 12 can prevent the phenomenon of electrical breakdown, improve the safety of the blood pump, and ensure the safety of the operation.

[0050] The cross-section of the first liquid groove is semi-circular, the diameter of the first liquid groove is 0.1 - 0.2 mm, and the thickness of the insulating layer 12 is 5 - 50 μm. The diameter of the wire 9 is preferably the same as the diameter of the first liquid groove.

[0051] The thickness of the insulating layer 12 is relatively small, so that the diameter of the liquid discharge groove 13 is slightly smaller than the diameter of the first liquid groove, and the diameter of the wire 9 is the same as the diameter of the first liquid groove. Therefore, the wire 9 and the liquid discharge groove 13 can be in interference fit, so that the wire 9 can be pressed into the liquid discharge groove 13.

[0052] In step S500, first, the surface of the wire 9 is lubricated with silicone oil, and then the wire 9 is pressed to the liquid discharge groove 13. The diameter of the wire 9 is the same as the diameter of the first liquid groove.

[0053] The wire 9 passes through silicone oil, which increases the lubricity of the wire 9 and facilitates the subsequent removal of the wire 9 in step S900.

[0054] In step S500, after the proximal end of the wire 9 extends out of the proximal end of the liquid discharge groove 13, the proximal end of the wire 9 winds around the outer periphery of the stopper 7 once, and then passes through the second liquid discharge hole 71 and the first liquid discharge hole 66 at least to the accommodation cavity 65.

[0055] In step S900, the relay channel includes a third drain hole, a connecting groove 31, and a second liquid tank 32. The third drain hole radially penetrates through the seal 30. The connecting groove 31 and the second liquid tank 32 are both located on the outer surface of the seal 30. The connecting groove 31 is an annular structure. One end of the second liquid tank 32 is connected to the connecting groove 31, and the other end of the second liquid tank 32 is connected to the auxiliary tank 201.

[0056] The proximal end of the wire drawing 9 reaches at least the accommodation cavity 65, which means that the proximal end of the wire drawing 9 is located in the accommodation cavity 65, or in the insertion interface 64, or extends out of the insertion interface 64.

[0057] The wire drawing 9 forms a surrounding structure around the outer periphery of the stopper 7. Therefore, in step S700, when filling the filler, the filler can push the surrounding structure to fit against the inner wall of the receiving section 102. Thus, after finally drawing the wire 9, an annular connecting groove 31 is formed at the surrounding structure, so that in actual application, the flushing liquid can flow to the cooling tank 202 only through the first drain hole 66, the second drain hole 71, the third drain hole, the connecting groove 31, and the second liquid tank 32.

[0058] In step S100, the number of the first liquid tanks is one, and the first liquid tank is spirally arranged around the outer wall of the metal layer 11. The first liquid tank (corresponding to the drain tank 13 or the cooling tank 202) winds around the circumferential direction of the pump housing 1 and extends in the axial direction of the pump housing 1, increasing the length of the first liquid tank (calculated by the path), increasing the contact area between the outer wall of the pump housing 1 and the flushing liquid, so that the flushing liquid can fully cool the pump housing 1.

[0059] In step S100, the outer wall of the metal layer 11 is divided into a plurality of cooling regions in the circumferential direction, and a first liquid tank is respectively formed by laser engraving on each of the cooling regions. The first liquid tank extends in a wavy shape.

[0060] In step S500, the number of the wire drawings 9 is the same as the number of the first liquid tanks. A corresponding wire drawing 9 is crimped on each of the drain tanks 13. The distal ends of the wire drawings 9 all extend out of the distal ends of the drain tanks 13, and the proximal ends of the wire drawings 9 all extend out of the proximal ends of the drain tanks 13. The proximal end of one of the wire drawings 9 sequentially passes through the second drain hole 71 and the first drain hole 66 at least to the accommodation cavity 65.

[0061] The wire drawing 9 passing through the second drain hole 71 is denoted as the first wire drawing 9, and the other wire drawings 9 are denoted as the second wire drawings 9. In step S500, before the first wire drawing 9 passes through the second drain hole 71, it first forms a surrounding structure around the outer periphery of the stopper 7, and the proximal ends of the second wire drawings 9 are all located on the proximal side of the surrounding structure.

[0062] The cross-section of each cooling area is fan-shaped, and the length of the cooling area is the same as the length of the pump housing 1. For example, the number of cooling areas is three, and the radian of each cooling area is approximately 120°. The three first liquid tanks (which also correspond to the drain tank 13) are independent of each other, that is, the three first liquid tanks are not directly connected. Therefore, the flow rate of the flushing liquid on the pump housing 1 can be increased, so as to better cool the pump housing 1. Moreover, the first liquid tank extends in a wavy shape, increasing the path length of each first liquid tank and enhancing the cooling effect on the pump housing 1.

[0063] The setting of the first wire drawing 9 enables an annular connection groove 31 to be formed on the seal 30, and the proximal ends of the second wire drawings 9 are all located on the proximal side of the surrounding structure, so that the second wire drawings 9 intersect with the first wire drawing 9, that is, the connection groove 31 communicates with each drain tank 13 (corresponding to the cooling tank 202), so that the flushing liquid is provided for all the cooling tanks 202 through the unique first drain hole 66 and the second drain hole 71.

[0064] In step S600, a spacer is inserted between the connecting pipe 10 and the pump housing 1. The spacer avoids the wire drawing 9, and a part of the spacer protrudes from the connecting pipe 10 so that the axis of the connecting pipe 10 is aligned with the axis of the rotating shaft 3.

[0065] The setting of the spacer is to make the connecting pipe 10 and the rotating shaft 3 coaxial. For example, a plurality of spacers are inserted at the distal end of the connecting pipe 10, and the thickness of the spacer is the same as the thickness of the filling cavity 104.

[0066] Of course, due to the setting of the spacer, in step S800, after the filler is cured, the spacer is first taken out to expose the spacer cavity (the cavity formed by the original position of the spacer), and the filler is filled into the spacer cavity, and then wait for the filler to cure. At this time, an outer sheath 20 is formed in the filling cavity 104.

[0067] In step S100, an insulating layer 12 is prepared on the outside of the metal layer 11 by means of coating or vacuum vapor deposition. The material of the insulating layer 12 is polytetrafluoroethylene, polyether ether ketone or parylene.

[0068] The filler is UV glue or epoxy resin.

[0069] The wire drawing 9 is a nitinol wire.

[0070] The wire drawing 9 is made of nitinol wire, so that the wire drawing 9 has a certain toughness to prevent the wire drawing 9 from being broken in step S900. Moreover, in the present invention, the wire drawing 9 can be reused, reducing the manufacturing cost of the blood pump.

[0071] It should be understood that the above-described embodiments are merely exemplary and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that those skilled in the art can make to the above details will all be included within the scope of the claims of the present invention.

Claims

1. A method for manufacturing a blood pump, characterized in that: Includes steps: S100, forming a drainage groove on the outer wall of the pump housing, wherein the distal end of the drainage groove passes through the distal end of the pump housing, and the proximal end of the drainage groove passes through the proximal end of the pump housing; S200, the stator is fixedly installed in the pump housing, the rotating shaft is inserted into the inner side of the stator, a first bearing and an end cover are sleeved on the distal end of the rotating shaft, the end cover is located on the distal side of the first bearing, and a second bearing is sleeved on the proximal end of the rotating shaft; S300, sleeve the proximal connecting member on the outside of the second bearing from the proximal end, so that the first constant diameter section is sleeved on the outside of the second bearing, the reduced diameter section is located on the proximal side of the rotating shaft, and an accommodating cavity is formed in the reduced diameter section; S400, sleeve the stopper from the proximal end onto the outer side of the proximal connector, insert the plug leg into the annular cavity formed between the first equal-diameter section and the pump housing, the radial inner side of the plug leg fits with the outer wall of the first equal-diameter section, the radial outer side of the plug leg fits with the inner wall of the pump housing, the outer wall of the variable-diameter section fits with the matching cavity, the second equal-diameter section passes through the matching opening, and adjust the angle of the stopper so that the first drainage hole is connected with the second drainage hole; S500, crimping and drawing a wire on the drainage groove along the direction of the drainage groove, the distal end of the wire drawing extends out of the distal end of the drainage groove, the proximal end of the wire drawing extends out of the proximal end of the drainage groove, and the proximal end of the wire drawing sequentially passes through the second drainage hole and the first drainage hole at least to the accommodating cavity; S600, sleeve a connecting pipe on the outside of the pump housing, sleeve the straight section on the outside of the pump housing, and place the receiving section on the outside of the stopper, so that the axis of the connecting pipe is consistent with the axis of the rotating shaft, an annular filling cavity is formed between the straight section and the pump housing, and a special-shaped cavity is formed between the receiving section and the stopper; S700, injecting a filler into the filling cavity and the special-shaped cavity, so that the filling cavity and the special-shaped cavity are filled with the filler; S800, after the filler is solidified, an outer sheath is formed in the filling cavity, and a sealing member is formed in the special-shaped cavity; S900, the wire is drawn away to form an auxiliary groove on the inner wall of the outer sheath and a relay channel on the sealing member.

2. The method according to claim 1, characterized in that: The pump housing includes a cylindrical metal layer and an insulating layer located outside the metal layer; In step S100, a first liquid tank is firstly formed on the outer wall of the metal layer by laser engraving, an insulating layer is arranged on the outer side of the metal layer, the insulating layer covers the first liquid tank, and a liquid drain tank is formed at the first liquid tank.

3. The method according to claim 2, characterized in that: The cross section of the first liquid tank is semicircular, the diameter of the first liquid tank is 0.1-0.2 mm, and the thickness of the insulating layer is 5-50 μm.

4. The method according to claim 3, characterized in that: In step S500, the surface of the drawn wire is first lubricated with silicone oil, and then the drawn wire is pressed to the drainage groove, and the diameter of the drawn wire is consistent with the diameter of the first liquid groove.

5. The method according to claim 4, characterized in that: In step S500, after the proximal end of the drawn wire extends out of the proximal end of the drainage groove, the proximal end of the drawn wire goes around the outer circumference of the stopper, and then passes through the second drainage hole and the first drainage hole in sequence to at least the accommodating cavity; In step S900, the relay channel includes a third liquid drainage hole, a connecting groove and a second liquid groove, wherein the third liquid drainage hole passes through the seal in the radial direction, the connecting groove and the second liquid groove are both located on the outer surface of the seal, the connecting groove is an annular structure, one end of the second liquid groove is connected to the connecting groove, and the other end of the second liquid groove is connected to the auxiliary groove.

6. The method according to any one of claims 2 to 5, characterized in that: In step S100, the number of the first liquid tank is one, and the first liquid tank is spirally arranged around the outer wall of the metal layer.

7. The method according to any one of claims 2 to 5, characterized in that: In step S100, the outer wall of the metal layer is divided into a plurality of cooling areas in the circumferential direction, and a first liquid groove is formed by laser engraving on each cooling area, and the first liquid groove extends in a wave shape; In step S500, the number of drawn threads is consistent with the number of first liquid grooves, and a corresponding drawn thread is crimped on each drainage groove. The distal end of each drawn thread extends out of the distal end of the drainage groove, and the proximal end of each drawn thread extends out of the proximal end of the drainage groove. The proximal end of one of the drawn threads passes through the second drainage hole and the first drainage hole in sequence to at least the accommodating cavity.

8. The method according to claim 7, characterized in that: The thread that passes through the second drainage hole is recorded as the first thread, and the other threads are recorded as the second thread. In step S500, before the first thread is drawn through the second drainage hole, it is first wound around the outer circumference of the stopper to form a surrounding structure, and the proximal end of each second thread is located at the proximal end side of the surrounding structure.

9. The method according to claim 1, characterized in that: In step S600, a spacer is inserted between the connecting pipe and the pump housing, the spacer is away from the wire drawing, and a portion of the spacer is exposed from the connecting pipe, so that the axis of the connecting pipe is consistent with the axis of the rotating shaft.

10. The method according to claim 2, characterized in that: In step S100, an insulating layer is prepared on the outer side of the metal layer by coating or vacuum vapor deposition, and the material of the insulating layer is polytetrafluoroethylene, polyetheretherketone or parylene; The filler is UV glue or epoxy resin; The wire used for drawing is nickel-titanium wire.

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