A method of manufacturing a blood pump

Abstract

The application relates to a blood pump manufacturing method, a pump shell is made of non-ceramic material, so that the pump shell is easier to manufacture, thereby reducing the manufacturing cost of the whole blood pump assembly, and meanwhile, a drainage groove is arranged on the outer wall of the pump shell, so that the flushing liquid can flow from the outer wall of the pump shell to take away the heat on the pump shell, the temperature of the pump shell is kept within the set temperature, the temperature of the pump shell is prevented from being too high to affect the operation, and the safety of the operation is improved. The application forms an auxiliary groove and a relay channel by pre- machining the drainage groove on the pump shell, then crimping the wire on the drainage groove, injecting the filling agent, and then extracting the wire, so that the accommodating cavity is communicated with the drainage groove, so that the flushing liquid can flow to the drainage groove, the wire extraction mode is adopted, the processing mode is simplified, and the communication between the drainage groove and the accommodating cavity is ensured.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular 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 of time. 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 works to pump the blood in the left ventricle into the aorta through the cannula, thereby achieving the surgical purpose. Current blood pumps mostly use axial flow pumps, which drive the impeller to rotate through the rotating shaft. There is a gap between the rotating shaft and the end cover at the distal end of the blood pump to ensure that the rotating shaft can rotate freely. The existence of this gap allows the patient's blood to enter the pump casing, causing thrombosis inside the blood pump. In order to prevent this situation, a flushing fluid is input into the proximal side of the blood pump, so that the flushing fluid passes between the rotating shaft and the stator and is sprayed toward the distal end from the gap, thereby achieving liquid sealing and preventing blood from entering the blood pump; when the flushing fluid is sprayed out, it will also bring out the heat generated by the operation of the blood pump.

[0003] When the blood pump is running, both the rotating shaft and the stator will generate heat. In order 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 to dissipate the heat from the blood pump. The existing technology achieves this in two aspects. On the one hand, the heat inside the axial flow pump is taken away by the aforementioned flushing fluid, and at the same time, the pump casing is made of ceramic material to improve the thermal insulation performance of the pump casing; however, since the radial dimension of the blood pump is very small, it is relatively difficult to manufacture such a small-sized ceramic pump casing, which increases the production cost of the entire blood pump, thereby pushing up the cost of the ventricular assist device, which is not conducive to the performance of heart surgery. Summary of the Invention

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

[0005] The technical solution adopted in the present invention is:

[0006] A method for manufacturing a blood pump, comprising the steps of:

[0007] 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;

[0008] S200, fixing the stator in the pump housing, inserting the rotating shaft into the inner side of the stator, sleeve-mounting a first bearing and an end cover at the distal end of the rotating shaft, wherein the end cover is located at the distal side of the first bearing, and sleeve-mounting a second bearing at the proximal end of the rotating shaft;

[0009] S300, sleeve the proximal connecting member onto the outside of the second bearing from the proximal end, so that the first constant diameter section is sleeved onto 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;

[0010] S400. Slide the stopper over the outside of the proximal connector from the proximal end. Insert the plug leg into the annular cavity formed between the first constant diameter section and the pump housing. The radial inner side of the plug leg abuts against the outer wall of the first constant diameter section, the radial outer side of the plug leg abuts against the inner wall of the pump housing, and the outer wall of the variable diameter section abuts against the mating cavity. The second constant diameter section passes through the mating opening. Adjust the angle of the stopper so that the first drainage hole is connected to the second drainage hole.

[0011] S500, crimping and drawing a thread on the drainage groove along the direction of the drainage groove, with the distal end of the thread extending out of the distal end of the drainage groove, and the proximal end of the thread extending out of the proximal end of the drainage groove, and the proximal end of the thread sequentially passing through the second drainage hole and the first drainage hole to at least the accommodating cavity;

[0012] S600: Sleeve a connecting pipe on the outside of the pump housing, with the straight section sleeved on the outside of the pump housing and the receiving section located on the outside of the stopper. The axis of the connecting pipe is aligned 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.

[0013] 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;

[0014] 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;

[0015] S900 , the thread is drawn out to form an auxiliary groove on the inner wall of the outer sheath and a relay channel on the sealing member.

[0016] Preferably, the pump housing comprises a cylindrical metal layer and an insulating layer located outside the metal layer;

[0017] In step S100 , a first liquid tank is first formed on the outer wall of the metal layer by laser engraving, an insulating layer is provided on the outer side of the metal layer, the insulating layer covers the first liquid tank, and the drainage tank is formed at the first liquid tank.

[0018] Preferably, 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.

[0019] Preferably, in step S500, the surface of the drawn wire is first lubricated with silicone oil, and then the drawn wire is pressed onto the drainage groove, and the diameter of the drawn wire is consistent with the diameter of the first liquid groove.

[0020] Preferably, in step S500, after the proximal end of the drawn thread extends out of the proximal end of the drainage groove, the proximal end of the drawn thread goes around the outer circumference of the stopper, and then sequentially passes through the second drainage hole and the first drainage hole to at least the accommodating cavity;

[0021] In step S900, the relay channel includes a third drainage hole, a connecting groove and a second liquid groove, wherein the third 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.

[0022] Preferably, 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.

[0023] Preferably, 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, wherein the first liquid groove extends in a wave shape;

[0024] In step S500, the number of the drawn threads is consistent with the number of the first liquid troughs, a corresponding drawn thread is crimped onto each of the drainage troughs, the distal end of each of the drawn threads extends out of the distal end of the drainage trough, and the proximal end of each of the drawn threads extends out of the proximal end of the drainage trough, and 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.

[0025] Preferably, the thread drawn through the second liquid drainage hole is recorded as the first thread drawn, and the other thread drawn is recorded as the second thread drawn.

[0026] In step S500, before the first thread passes through the second drainage hole, it first circles 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.

[0027] Preferably, in step S600, a spacer is inserted between the connecting pipe and the pump housing, the spacer avoids 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.

[0028] Preferably, 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;

[0029] The filler is UV glue or epoxy resin;

[0030] The drawn wire is nickel-titanium wire.

[0031] Beneficial effects of the present invention:

[0032] A blood pump manufactured using the present invention is used in a ventricular assist device. During operation, the shaft rotates relative to the stator, causing the impeller to rotate, pumping blood from the left ventricle into the aorta. During the rotation of the shaft, heat is generated by both the shaft and the stator. Flushing fluid is introduced into the accommodating chamber within the proximal connector through an infusion tube. The flushing fluid passes through the second bearing and enters the space between the shaft and the stator, absorbing heat from the shaft and the stator before ultimately being ejected from the gap in the end cap. Furthermore, heat from the stator is transferred to the pump housing, raising the temperature of the housing. Flushing fluid in the accommodating chamber flows through the first and second drainage holes and the relay channel into the drainage trough and the auxiliary trough. Because the drainage trough is provided on the outer wall of the pump housing and the auxiliary trough is formed by drawing wire, the auxiliary trough and the drainage trough interlock radially. Flushing fluid flowing through the drainage trough removes heat from the pump housing, thereby preventing the housing from overheating. Flushing fluid flowing through the drainage trough is ultimately ejected from the distal end of the drainage trough into the patient's body.

[0033] In the present invention, the pump casing is made of non-ceramic material, making the pump casing easier to manufacture, thereby reducing the manufacturing cost of the entire blood pump assembly. At the same time, by providing a drainage groove on the outer wall of the pump casing, the flushing liquid can flow through the outer wall of the pump casing to take away the heat on the pump casing, so that the temperature of the pump casing is maintained within the set temperature, avoiding the pump casing temperature being too high and affecting the progress of the operation, thereby improving the safety of the operation.

[0034] The present invention forms a drainage groove on the pump casing in advance, and then crimps and draws wire on the drainage groove. After injecting filler, the wire is drawn away to form an auxiliary groove and a relay channel, so that the accommodating chamber is connected to the drainage groove, so that the flushing liquid can flow to the drainage groove. The wire drawing method is used to simplify the processing method and ensure that the drainage groove is connected to the accommodating chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0036] Figure 1 It is a flowchart of a method for making a blood pump;

[0037] Figure 2 is a structural diagram of a pump shell;

[0038] Figure 3 is a schematic diagram of the assembly after step S500;

[0039] Figure 4 is an exploded view of the assembly obtained in step S400;

[0040] Figure 5 is a sectional view of the assembly of Figure 3 ;

[0041] Figure 6 is an enlarged view of part A in Figure 5 ;

[0042] Figure 7 is a sectional view of the assembly after step S600;

[0043] Figure 8 is an enlarged view of part B in Figure 7 ;

[0044] Figure 9 is an enlarged view of part C in Figure 7 ;

[0045] Figure 10 is a structural diagram of a connecting pipe;

[0046] Figure 11 is a sectional view of a pump shell and an outer sheath;

[0047] Figure 12 is a schematic diagram of a seal and a pump shell;

[0048] Figure 13 is a sectional view of a pump shell;

[0049] Figure 14 is an enlarged view of part D in Figure 13 ;

[0050] Figure 15 is a structural diagram of a stopper;

[0051] Figure 16 is a structural diagram of another embodiment of a pump shell.

[0052] In the figure: 1, pump shell; 2, stator; 3, rotating shaft; 4, first bearing; 5, second bearing; 6, proximal end connector; 7, stopper; 8, end cap; 9, filament; 10, connecting pipe; 20, outer sheath; 30, seal;

[0053] 11, metal layer; 12, insulating layer; 13, liquid drainage groove;

[0054] 31. Connecting tank; 32. Second liquid tank;

[0055] 61. First constant diameter section; 62. Variable diameter section; 63. Second constant diameter section; 64. Insertion port; 65. Accommodation cavity; 66. First drainage hole;

[0056] 71. Second drainage hole; 72. Insert leg; 73. Main body;

[0057] 101, straight section; 102, storage section; 103, special-shaped cavity; 104, filling cavity;

[0058] 201. Auxiliary tank; 202. Cooling tank. DETAILED DESCRIPTION

[0059] The present invention is described below based on the following 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.

[0060] Furthermore, persons of ordinary skill in the art will appreciate that the figures provided herein are for illustration purposes only and are not necessarily drawn to scale.

[0061] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include," "comprising," and similar words should be construed in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to."

[0062] In the description of the present invention, it should be understood that the terms "first", "second", etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0063] In the present invention, “distal” refers to the side closer to the patient's body during surgery; and “proximal” refers to the side closer to the operator during surgery.

[0064] See also Figures 1-16 The present invention provides a method for manufacturing a blood pump, which is used in a ventricular assist device as a power source. The ventricular assist device is mainly used in cardiac surgery, such as PCI (Percutaneous coronary intervention) surgery, cardiogenic shock surgery, etc., to pump blood in the left ventricle into the aorta.

[0065] 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 cover 8, and also includes a proximal connecting member 6 and a stop member 7. From far to near, the proximal connecting member 6 includes a first constant diameter section 61, a reducing section 62 and a second constant diameter section 63 connected in sequence. The diameter of the first constant diameter section 61 is larger than the diameter of the second constant diameter section 63. A radially extending first drainage hole 66 is provided on the side wall of the reducing section 62, and an insertion port 64 is formed in the second constant diameter section 63.

[0066] The stopper 7 includes a plug leg 72 and a main body 73. A matching cavity with an opening facing the distal side is formed in the main body 73. A matching port is also provided on the main body 73. The matching port faces the proximal side and is communicated with the matching cavity. A second liquid drainage hole 71 extending radially is provided on the main body 73. There are multiple plug legs 72, and the multiple plug legs 72 are evenly arranged along the circumference of the main body 73. The plug legs 72 are connected to the distal side of the main body 73.

[0067] The connecting tube 10 includes a straight section 101 and a receiving section 102 that are connected to each other. The receiving section 102 is located at the proximal end of the straight section 101 .

[0068] The production method comprises the steps of:

[0069] S100 , forming a drainage groove 13 on the outer wall of the pump housing 1 , wherein the distal end of the drainage groove 13 passes through the distal end of the pump housing 1 , and the proximal end of the drainage groove 13 passes through the proximal end of the pump housing 1 .

[0070] S200. Fix the stator 2 in the pump casing 1, pass the rotating shaft 3 through the inner side of the stator 2, sleeve the first bearing 4 and the end cover 8 at the distal end of the rotating shaft 3, the end cover 8 is located on the distal side of the first bearing 4, and sleeve the second bearing 5 at the proximal end of the rotating shaft 3.

[0071] S300, the proximal connecting member 6 is sleeved on the outside of the second bearing 5 from the proximal end, so that the first constant 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, and an accommodating cavity 65 is formed in the variable diameter section 62.

[0072] S400. The stopper 7 is sleeved on the outside of the proximal connector 6 from the proximal end, and the plug leg 72 is inserted into the annular cavity formed between the first equal-diameter section 61 and the pump housing 1. The radial inner side of the plug leg 72 is in contact with the outer wall of the first equal-diameter section 61, and the radial outer side of the plug leg 72 is in contact with the inner wall of the pump housing 1. The outer wall of the variable-diameter section 62 is in contact with the matching cavity, and the second equal-diameter section 63 passes through the matching opening. The angle of the stopper 7 is adjusted so that the first drainage hole 66 is connected to the second drainage hole 71.

[0073] S500. Along the direction of the drainage groove 13, the wire drawing 9 is crimped on the drainage groove 13, the distal end of the wire drawing 9 extends out of the distal end of the drainage groove 13, the proximal end of the wire drawing 9 extends out of the proximal end of the drainage groove 13, and the proximal end of the wire drawing 9 passes through the second drainage hole 71 and the first drainage hole 66 in sequence at least to the accommodating cavity 65.

[0074] S600. A connecting pipe 10 is sleeved on the outside of the pump casing 1, the straight-cylinder section 101 is sleeved on the outside of the pump casing 1, the receiving section 102 is located on the outside of the stopper 7, and the axis of the connecting pipe 10 is consistent with the axis of the rotating shaft 3. An annular filling cavity 104 is formed between the straight-cylinder section 101 and the pump casing 1, and a special-shaped cavity 103 is formed between the receiving section 102 and the stopper 7.

[0075] S700 , injecting a filler into the filling cavity 104 and the special-shaped cavity 103 , so that the filling cavity 104 and the special-shaped cavity 103 are filled with the filler.

[0076] S800 , after the filler is solidified, an outer sheath 20 is formed in the filling cavity 104 , and a sealing member 30 is formed in the special-shaped cavity 103 .

[0077] S900 , the wire drawing 9 is removed, an auxiliary groove 201 is formed on the inner wall of the outer sheath 20 , and a relay channel is formed on the sealing member 30 .

[0078] In the present invention, the pump housing 1 is made of a non-ceramic material (e.g., stainless steel or copper). This makes the pump housing 1 easier to manufacture, thereby reducing the manufacturing cost of the entire blood pump assembly. In addition, due to the change in the material of the pump housing 1, the thermal insulation performance of the pump housing 1 is reduced (compared to a pump housing 1 made of ceramic material). In other words, the heat on the stator 2 can be conducted outward to the pump housing 1, causing the temperature of the pump housing 1 to increase. To solve the problem of excessive temperature of the pump housing 1, the present invention first forms a drainage groove 13 on the pump housing 1 when manufacturing the blood pump, allowing flushing liquid to flow in the drainage groove 13. Since the flushing liquid has a low temperature, when flowing in the drainage groove 13, the flushing liquid can absorb the heat from the pump housing 1, thereby maintaining the temperature of the pump housing 1 within a set temperature range.

[0079] In order to ensure that the flushing liquid can enter the drainage groove 13 in actual application, the present invention presses the wire drawing 9 on the drainage groove 13 along the direction of the drainage groove 13, and the wire drawing 9 and the drainage groove 13 are interference fit. In the radial direction, a part of the wire drawing 9 is exposed from the drainage groove 13, and the proximal end of the wire drawing 9 passes through the second drainage hole 71 and the first drainage hole 66, and the distal end of the wire drawing 9 is exposed from the distal end of the drainage groove 13. A connecting pipe 10 is sleeved on the outer side of the pump housing 1 to form a filling chamber 104 and a special-shaped chamber 103. The filling chamber 104 and the special-shaped chamber 103 are connected to each other. The special-shaped chamber 103 is located on the proximal side of the filling chamber 104, the proximal end of the special-shaped chamber 103 is open, and the distal end of the filling chamber 104 is open, so that the filling wall can be opened from the proximal end or the distal end. The filler is filled in the special-shaped cavity 103. After the filler is solidified, the thread 9 is pulled out, for example, the part of the thread 9 exposed at the distal end is pinched. As the thread 9 is pulled out, an auxiliary groove 201 and a relay channel are formed. Due to the original direction of the thread 9, the first drainage hole 66, the second drainage hole 71, the relay channel and the auxiliary groove 201 are connected in sequence, and the distal end of the thread 9 extends out of the distal end of the drainage groove 13, so that the distal end of the auxiliary groove 201 is connected to the outside world. In this way, the flushing liquid can flow through the first drainage hole 66, the second drainage hole 71, and the relay channel to the cooling groove 202 composed of the auxiliary groove 201 and the drainage groove 13 (the auxiliary groove 201 and the drainage groove 13 are interlocked in the radial direction), and flow out from the distal end of the cooling groove 202.

[0080] In order to fully understand the purpose of the present invention, taking the ventricular assist device during surgery as an example, the distal end of the blood pump is connected to a cannula, and the proximal end of the blood pump is connected to a catheter. A liquid inlet tube is provided in the catheter, and the liquid inlet tube is plugged into the plug port 64; during surgery, the distal end of the cannula is extended into the left ventricle, and a blood outlet is provided at the blood pump (the blood outlet is located on the connecting tube 10), and the blood pump is located in the aorta. When the blood pump works, the blood in the left ventricle is pumped into the aorta, and at the same time, a flushing liquid (the flushing liquid is a mixture of glucose and heparin) is input into the accommodating chamber 65 through the liquid inlet tube. The flushing liquid first fills the accommodating chamber 65, and then the flushing liquid is divided into two paths. The first path flows through the gap between the second bearing 5 and the rotating shaft 3 to between the rotating shaft 3 and the stator 2, so that this part of the flushing liquid can It takes away the heat from the rotating shaft 3 and the stator 2, and then this part of the flushing fluid continues to flow toward the distal side, passes through the gap between the first bearing 4 and the rotating shaft 3, and is finally ejected from the gap between the rotating shaft 3 and the end cover 8 (hereinafter referred to as the "first gap"). Since the flushing fluid is ejected toward the distal side in the first gap, blood will not enter between the rotating shaft 3 and the stator 2 from the first gap; the second path passes through the first drainage hole 66, the second drainage hole 71, and the relay channel, and flows to the cooling groove 202 composed of the auxiliary groove 201 and the drainage groove 13. Therefore, when the flushing fluid flows in the cooling groove 202, it will take away the heat from the pump housing 1, thereby preventing the temperature of the pump housing 1 from being too high. The flushing fluid flowing through the cooling groove 202 is finally ejected from the distal end of the cooling groove 202 and enters the patient's body.

[0081] In addition, in step S600, by directly sleeved the connecting tube 10 on the outside of the pump casing 1, due to the structure of the connecting tube 10, a filling cavity 104 and a special-shaped cavity 103 are naturally formed; therefore, in step S700, the filler is injected from the proximal opening or the distal opening, and since the filler has a certain fluidity, the filler can fill the filling cavity 104 and the special-shaped cavity 103; and after the filler solidifies, the connecting tube 10 is connected to the pump casing 1 through the outer sheath 20 and the seal 30, so that the connecting tube 10 and the pump casing 1 are connected into a whole, thereby also realizing the assembly of the connecting tube 10 at the same time.

[0082] The distal end of the rotating shaft 3 is provided with a first bearing 4, and the proximal end of the rotating shaft 3 is provided with a second bearing 5. The first bearing 4 and the second bearing 5 are both matched 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 embodiment shown, in step S200, the proximal end of the rotating shaft 3 can also be provided with a sleeve, which is located on the proximal side of the second bearing 5. The second rotating shaft 3 is positioned in the axial direction by the sleeve to prevent the second bearing 5 from moving toward the proximal side. From far to near, the proximal connecting member 6 can include a first equal diameter section 61, a reducing section 62 and a second equal diameter section 63. The proximal connecting member 6 is a structure of equal wall thickness (the wall thickness at each location is basically the same). The diameter of the first equal diameter section 61 is larger than the diameter of the second equal diameter section 63. From far to near, the diameter of the reducing section 62 gradually becomes smaller, so that the reducing section The large end of the segment 62 can be connected to the first equal-diameter segment 61, and the small end of the reducing segment 62 can be connected to the second equal-diameter segment 63. The first equal-diameter segment 61 can be sleeved on the outside of the second bearing 5 and the sleeve. The plug-in port 64 is formed in the second equal-diameter segment 63, and the accommodating cavity 65 is formed in the reducing segment 62. The first drainage hole 66 is located in the reducing segment 62. In this way, the proximal connector 6 can cover the proximal end of the rotating shaft 3, and the infusion tube is plugged into the plug-in port 64 and can be sealed with glue. When the infusion tube injects flushing liquid into the accommodating cavity 65, it is ensured that the flushing liquid will not leak from the plug-in port 64.

[0083] In step S200, an end cover 8 is further sleeved on the outer side of the rotating shaft 3. The end cover 8 is located on the distal side of the first bearing 4. The end cover 8 is connected to the distal end of the pump housing 1 and basically closes the distal end of the pump housing 1, so that a smaller (small radial dimension) gap (the aforementioned first gap) is formed between the rotating shaft 3 and the end cover 8, reducing the possibility of blood entering the space between the rotating shaft 3 and the stator 2 through the first gap. At the same time, it also makes it easier to form high pressure (formed by the accumulation of flushing fluid) on the proximal side of the end cover 8, thereby preventing blood from entering the space between the stator 2 and the rotating shaft 3.

[0084] like Figure 15 In the illustrated embodiment, the stopper 7 includes three legs 72 and a main body 73. The three legs 72 are connected to the distal end of the main body 73. The main body 73 forms a matching cavity with an opening facing the distal side. The three legs 72 are evenly spaced in the circumferential direction. During assembly, the legs 72 are inserted between the first equal-diameter section 61 and the pump housing 1, so that the first equal-diameter section 61 is compressed and limited in the radial direction, ensuring that the flushing liquid in the accommodating cavity 65 can only flow along the two preset paths. The inner wall of the matching cavity fits the outer wall of the variable-diameter section 62, thereby supporting the variable-diameter section 62 from the outside. The proximal connector 6 can be made of a deformable material such as silicone, so that the first equal-diameter section 61 can be compressed in the radial direction to improve the sealing performance. The stopper 7 is made of a hard material (such as plastic), so the stopper 7 cannot be compressed and can support the variable-diameter section 62 from the outside to prevent the variable-diameter section 62 from deforming outward.

[0085] The distal end of the stopper 7 abuts against the proximal end of the stator 2 , so that the stopper 7 can be positioned by the stator 2 .

[0086] A second drainage hole 71 is provided on the stopper 7, and the second drainage hole 71 is located on the main body 73. The radial inner end of the second drainage hole 71 is connected to the radial outer end of the first drainage hole 66, so that the flushing liquid can enter the second drainage hole 71 through the first drainage hole 66, thereby guiding the flushing liquid to reach the cooling groove 202.

[0087] The pump housing 1 includes a cylindrical metal layer 11 and an insulating layer 12 located outside the metal layer 11 .

[0088] In step S100 , a first liquid tank is first formed on the outer wall of the metal layer 11 by laser engraving, an insulating layer 12 is provided on the outer side of the metal layer 11 , the insulating layer 12 covers the first liquid tank, and the drain tank 13 is formed at the first liquid tank.

[0089] When the blood pump is working, power needs to be supplied to the blood pump, and the pump housing 1 made of pure metal is conductive, which may create a risk of electrical breakdown. The pump housing 1 of the present invention includes a metal layer 11, and a first liquid tank is first formed by laser engraving on the metal layer 11, and then an insulating layer 12 is arranged on the outside of the entire metal layer 11, that is, the insulating layer 12 also covers the first liquid tank, and a drainage tank 13 is formed along the first liquid tank. The setting of the insulating layer 12 can prevent electrical breakdown, improve the safety of the blood pump, and ensure the safety of the operation.

[0090] The cross section of the first liquid tank is semicircular, the diameter of the first liquid tank is 0.1-0.2 mm, the thickness of the insulating layer 12 is 5-50 μm. The diameter of the wire drawing 9 is preferably consistent with the diameter of the first liquid tank.

[0091] The thickness of the insulating layer 12 is relatively small, so that the diameter of the drainage groove 13 is slightly smaller than the diameter of the first liquid groove, and the diameter of the wire drawing 9 is consistent with the diameter of the first liquid groove, so the wire drawing 9 and the drainage groove 13 can be interference fit, so that the wire drawing 9 can be pressed into the drainage groove 13.

[0092] In step S500 , the surface of the wire drawing 9 is first lubricated with silicone oil, and then the wire drawing 9 is pressed onto the drainage groove 13 . The diameter of the wire drawing 9 is consistent with the diameter of the first drainage groove.

[0093] The drawn wire 9 is passed through silicone oil to increase the lubricity of the drawn wire 9 and facilitate the subsequent removal of the drawn wire 9 in step S900.

[0094] In step S500, after the proximal end of the wire drawing 9 extends out of the proximal end of the drainage groove 13, the proximal end of the wire drawing 9 wraps around the outer circumference of the stopper 7, and then passes through the second drainage hole 71 and the first drainage hole 66 in sequence to at least the accommodating cavity 65.

[0095] In step S900, the relay channel includes a third liquid drainage hole, a connecting groove 31 and a second liquid groove 32, wherein the third liquid drainage hole passes through the seal 30 in the radial direction, the connecting groove 31 and the second liquid groove 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 groove 32 is connected to the connecting groove 31, and the other end of the second liquid groove 32 is connected to the auxiliary groove 201.

[0096] The proximal end of the drawn thread 9 at least reaches the accommodating cavity 65 , which means that the proximal end of the drawn thread 9 is located in the accommodating cavity 65 , or is located in the insertion port 64 , or extends out of the insertion port 64 .

[0097] The wire drawing 9 is wrapped around the outer circumference of the stopper 7 to form a surrounding structure. Therefore, in step S700, when filling the filler, the filler can push the surrounding structure to fit the inner wall of the storage section 102. Therefore, after the wire drawing 9 is finally completed, an annular connecting groove 31 is formed at the surrounding structure, so that in actual application, the flushing liquid can flow into the cooling groove 202 through the first drainage hole 66, the second drainage hole 71, the third drainage hole, the connecting groove 31 and the second liquid groove 32.

[0098] In step S100, one first liquid tank is provided, spirally arranged around the outer wall of the metal layer 11. The first liquid tank (corresponding to the drainage tank 13 or the cooling tank 202) winds circumferentially around the pump housing 1 and extends axially therewith. This increases the length of the first liquid tank (in terms of path) and the contact area between the outer wall of the pump housing 1 and the flushing liquid, allowing the flushing liquid to fully cool the pump housing 1.

[0099] In step S100 , the outer wall of the metal layer 11 is divided into a plurality of cooling areas in the circumferential direction, and a first liquid tank is formed by laser engraving on each cooling area. The first liquid tank extends in a wave shape.

[0100] In step S500, the number of the drawn threads 9 is consistent with the number of the first liquid troughs, and a corresponding drawn thread 9 is crimped onto each of the drainage grooves 13. The distal end of each of the drawn threads 9 extends out of the distal end of the drainage groove 13, and the proximal end of each of the drawn threads 9 extends out of the proximal end of the drainage groove 13. The proximal end of one of the drawn threads 9 passes through the second drainage hole 71 and the first drainage hole 66 in sequence to at least the accommodating cavity 65.

[0101] The thread 9 passing through the second liquid drainage hole 71 is recorded as the first thread 9, and the other thread 9 is recorded as the second thread 9.

[0102] In step S500 , before the first thread 9 passes through the second drainage hole 71 , it first circles around the outer circumference of the stopper 7 to form a surrounding structure, and the proximal end of each second thread 9 is located at the proximal end side of the surrounding structure.

[0103] The cross-section of each cooling area is fan-shaped, and the length of the cooling area is consistent with the length of the pump casing 1. For example, there are three cooling areas, and the arc of each cooling area is approximately 120°. The three first liquid grooves (also corresponding to the drainage grooves 13) are independent of each other, that is, the three first liquid grooves are not directly connected to each other, so the flow rate of the flushing liquid on the pump casing 1 can be increased, thereby better cooling the pump casing 1. Moreover, the first liquid grooves extend along a wave shape, increasing the path length of each first liquid groove, thereby improving the cooling effect on the pump casing 1.

[0104] The setting of the first thread drawing 9 enables an annular connecting groove 31 to be formed on the sealing member 30, and the proximal ends of the second thread drawing 9 are located on the proximal side of the surrounding structure, so that the second thread drawing 9 and the first thread drawing 9 intersect with each other, that is, the connecting groove 31 is connected to each drainage groove 13 (corresponding to the cooling groove 202), so that flushing liquid is provided to all the cooling grooves 202 through the only first drainage hole 66 and the second drainage hole 71.

[0105] 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 portion of the spacer is exposed from the connecting pipe 10 , so that the axis of the connecting pipe 10 is consistent with the axis of the rotating shaft 3 .

[0106] The spacers are provided to ensure that the connecting tube 10 is coaxial with the rotating shaft 3 . For example, a plurality of spacers are inserted at the distal end of the connecting tube 10 , and the thickness of the spacers is consistent with the thickness of the filling cavity 104 .

[0107] Of course, due to the setting of the spacer, in step S800, after the filler is solidified, the spacer is first removed to expose the spacer cavity (the cavity formed by the original position of the spacer), the filler is filled into the spacer cavity, and then the filler is waited for to solidify. At this time, an outer sheath 20 is formed in the filling cavity 104.

[0108] In the step S100 , an insulating layer 12 is prepared on the outer side of the metal layer 11 by coating or vacuum vapor deposition. The material of the insulating layer 12 is polytetrafluoroethylene, polyetheretherketone or parylene.

[0109] The filler is UV glue or epoxy resin.

[0110] The wire drawing 9 is nickel-titanium wire.

[0111] The wire drawing 9 is made of nickel-titanium wire, so that the wire drawing 9 has a certain toughness, which prevents the wire drawing 9 from being torn in step S900. In addition, in the present invention, the wire drawing 9 can be reused, reducing the production cost of the blood pump.

[0112] It should be understood that the above-described implementations are merely exemplary, and are not limiting, and that various obvious or equivalent modifications or substitutions for the above-described details can be made by those skilled in the art without departing from the spirit of the present application, and all such modifications or substitutions are intended to be included within the scope of the claims of the present application.

Claims

1. A method for manufacturing a blood pump, characterized in that: Including 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, fixing the stator in the pump housing, inserting the rotating shaft into the inner side of the stator, sleeve-mounting a first bearing and an end cover at the distal end of the rotating shaft, with the end cover located at the distal end of the first bearing, and sleeve-mounting a second bearing at the proximal end of the rotating shaft; S300, sleeve the proximal connector onto the outside of the second bearing from the proximal end, so that the first constant diameter section is sleeved onto 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. Slide the stopper over the outside of the proximal connector from the proximal end. Insert the plug leg into the annular cavity formed between the first constant diameter section and the pump housing. The radial inner side of the plug leg abuts against the outer wall of the first constant diameter section, the radial outer side of the plug leg abuts against the inner wall of the pump housing, the outer wall of the variable diameter section abuts against the mating cavity, and the second constant diameter section passes through the mating opening. Adjust the angle of the stopper so that the first drainage hole is connected to the second drainage hole. S500, crimping and drawing a thread on the drainage groove along the direction of the drainage groove, with the distal end of the thread extending out of the distal end of the drainage groove, and the proximal end of the thread extending out of the proximal end of the drainage groove, and the proximal end of the thread sequentially passing through the second drainage hole and the first drainage hole to at least the accommodating cavity; S600. Sleeve a connecting pipe on the outside of the pump housing, with the straight section sleeved on the outside of the pump housing and the receiving section located on the outside of the stopper. The axis of the connecting pipe is aligned 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 seal is formed in the special-shaped cavity; S900, the wire is drawn out 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, wherein: 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 first formed on the outer wall of the metal layer by laser engraving, an insulating layer is provided on the outer side of the metal layer, the insulating layer covers the first liquid tank, and a liquid drain groove 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 onto 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 thread extends out of the proximal end of the drainage groove, the proximal end of the drawn thread wraps 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 4, 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 troughs, and a corresponding drawn thread is crimped onto each drainage trough. The distal end of each drawn thread extends out of the distal end of the drainage trough, and the proximal end of each drawn thread extends out of the proximal end of the drainage trough. The proximal end of one of the drawn threads passes through the second drainage hole and the first drainage hole in sequence at least to 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 passes through the second drainage hole, it first circles 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, wherein: 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 manufacturing 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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