Method for preparing left ventricular assist device

Abstract

The present invention provides a method for preparing a left ventricular assist device, the left ventricular assist device comprising a micropump head, a transmission shaft, and a drive control mechanism, the micropump head comprising a pump head impeller and a pump head transmission assembly, the transmission shaft comprising a core shaft and a twisting shell, the drive control mechanism comprising a twisting shell drive module and a core shaft drive module, the method comprising the following steps: passing the pump head transmission assembly through the pump head impeller, fixing the distal and proximal ends of the pump head impeller to the distal end of the pump head transmission assembly and the distal end of the twisting shell, respectively; inserting the core shaft into the twisting shell and fixing the distal end of the core shaft to the proximal end of the pump head transmission assembly; arranging the twisting shell drive module at the distal end of the core shaft drive module and detachably connecting it to the core shaft drive module, connecting the distal end of the twisting shell drive module to the proximal end of the twisting shell through transmission; and connecting the distal end of the core shaft drive module to the proximal end of the core shaft through transmission. The solution of the present invention can obtain a left ventricular assist device that takes into account both the micro volume of the device and the high blood flow, thereby improving its safety in use and work efficiency.

Description

Technical Field

[0001] The present invention relates to the technical field of assist device preparation, and in particular to a method for preparing a left ventricular assist device. Background Art

[0002] Over the past decade, the number of high-risk cardiovascular interventional procedures has steadily increased both domestically and internationally. To reduce the risk of death from obstructed or stopped blood circulation during surgery, interventional left ventricular assist devices (LVADs) have been widely used in these procedures. LVADs are percutaneous mechanical circulatory assist systems that use a mechanical micropump to provide supplemental blood flow to patients undergoing high-risk cardiovascular interventional procedures during and after surgery. These devices partially or fully assist the left ventricle, helping the heart deliver oxygenated blood to the body. Existing LVADs primarily use micropump heads equipped with non-deformable, rigid impellers. Limited by their size, these devices can generate relatively low flow rates. To maintain patient circulation during high-risk interventional procedures, a common solution for LVADs with a constant impeller size is to increase the impeller speed. However, high-speed impeller rotation inevitably causes excessive shear stress within the blood, leading to changes in red blood cell permeability and irreversible cell damage, thereby increasing the risk of hemolysis.

[0003] Therefore, it is urgent to prepare an interventional left ventricular assist device equipped with a high folding ratio active folding impeller that can simultaneously take into account the micro-volume of the device, high blood flow and low risk of hemolysis. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a method for preparing a left ventricular assist device to obtain a left ventricular assist device that takes into account the micro volume of the device, high blood supply flow and low risk of hemolysis, thereby improving the use efficiency and safety of the left ventricular assist device.

[0005] To solve the above technical problems, the present invention provides a method for preparing a left ventricular assist device, wherein the left ventricular assist device includes a micro pump head, a drive shaft, and a drive control mechanism, wherein the micro pump head includes a pump head impeller and a pump head drive assembly, the drive shaft includes a core shaft and a twisting shell, and the drive control mechanism includes a twisting shell drive module and a core shaft drive module. The method comprises the following steps:

[0006] Pass the pump head transmission assembly through the pump head impeller, and fix the distal end of the pump head impeller to the distal end of the pump head transmission assembly; fix the proximal end of the pump head impeller to the distal end of the twisting shell;

[0007] Inserting the core shaft into the twisting housing, and fixedly connecting the distal end of the core shaft to the proximal end of the pump head transmission assembly;

[0008] Arrange the twisting shell drive module at the distal end of the core shaft drive module, and connect the distal end of the twisting shell drive module to the proximal end of the twisting shell through transmission;

[0009] The distal end of the core shaft driving module is connected to the proximal end of the core shaft by transmission, and the distal end of the core shaft driving module is detachably connected to the proximal end of the twisting shell driving module.

[0010] In one embodiment, the micro pump head further includes a pump head protection assembly, and the transmission shaft further includes a protective sleeve. After the step of "fixedly connecting the distal end of the pump head impeller to the distal end of the pump head transmission assembly", the following steps are further included:

[0011] The pump head protection assembly coaxial cover is arranged outside the pump head impeller, and the distal end of the pump head protection assembly is fixedly connected to the distal end of the pump head transmission assembly, and the proximal end of the pump head protection assembly is fixedly connected to the distal end of the protective sleeve.

[0012] In one embodiment, the drive control mechanism further includes a protective sleeve drive module, and the step of "fixedly connecting the distal end of the core shaft to the proximal end of the pump head transmission assembly" further includes the following steps:

[0013] The twisting shell is inserted into the protective sleeve, and the protective sleeve driving module is sleeved on the proximal end of the protective sleeve, and the protective sleeve driving module is transmission-connected to the proximal end of the protective sleeve.

[0014] In one embodiment, the pump head impeller includes a foldable impeller and a twisting connector, and the step of "fixedly connecting the distal end of the pump head impeller to the distal end of the pump head transmission assembly, and fixedly connecting the proximal end of the pump head impeller to the distal end of the twisting shell" includes the steps of:

[0015] The distal end of the foldable impeller is fixedly connected to the distal end of the pump head transmission assembly, the proximal end of the foldable impeller is clamped to the distal end of the twisting connector, and the proximal end of the twisting connector is fixedly connected to the distal end of the twisting shell;

[0016] Optionally, the foldable impeller includes an impeller frame and an impeller blade surface, and the step of "fixedly connecting the distal end of the foldable impeller to the distal end of the pump head transmission assembly, and clamping the proximal end of the foldable impeller to the distal end of the twisting connector" includes the steps of:

[0017] The distal end of the impeller frame is fixedly connected to the distal end of the pump head transmission assembly, and the proximal end of the impeller frame is clamped to the distal end of the twisting connector;

[0018] Optionally, the method further comprises the steps of:

[0019] Covering the impeller blades on the outside of the impeller frame;

[0020] Optionally, the impeller skeleton includes a proximal fixing ring, a distal fixing ring, and an impeller skeleton wire, and the step of "fixedly connecting the distal end of the impeller skeleton to the distal end of the pump head transmission assembly, and clamping the proximal end of the impeller skeleton to the distal end of the twisting connector" includes the steps of:

[0021] The impeller skeleton wire is spirally arranged between the proximal fixing ring and the distal fixing ring, the distal fixing ring is fixedly connected to the distal end of the pump head transmission assembly, and the proximal end of the proximal fixing ring is clamped to the distal end of the twisting connector.

[0022] In one embodiment, the pump head transmission assembly includes a core sleeve, a top shaft, a top shaft bearing, a top shaft sleeve, and a top sleeve, and the step of "fixedly connecting the distal end of the impeller skeleton to the distal end of the pump head transmission assembly" includes the steps of:

[0023] Pass the core sleeve through the impeller frame, and fix the distal end of the core sleeve to the distal end fixing ring;

[0024] The proximal end of the top shaft is fixedly embedded into the distal end of the core shaft sleeve;

[0025] The top shaft bearing is sleeved on the distal end of the top shaft, and the proximal end surface of the top shaft bearing is in contact with the distal end surface of the core shaft sleeve;

[0026] The top shaft sleeve is fixedly mounted on the distal end of the top shaft, and the inner edge of the top shaft bearing is limited to be located between the distal end surface of the core shaft sleeve and the proximal end surface of the top shaft sleeve;

[0027] Sleeve the proximal end of the top sleeve onto the distal end of the top shaft;

[0028] Optionally, the pump head transmission assembly further includes a core shaft collar and a top collar, and the method further includes the steps of:

[0029] The mandrel sleeve is fixedly mounted on the proximal end of the mandrel sleeve, and the proximal end surface of the mandrel sleeve is aligned with the proximal end surface of the mandrel sleeve, and the mandrel sleeve is limited to be located between the proximal end of the proximal fixing ring and the distal end of the twisting connector;

[0030] The top collar is sleeved on the distal end of the core sleeve, and the distal end surface of the top collar is fixedly connected to the proximal end surface of the top sleeve;

[0031] Optionally, the step of “fixedly connecting the distal end of the core shaft to the proximal end of the pump head transmission assembly” includes the steps of:

[0032] The proximal end of the core shaft sleeve is sleeved in the proximal fixing ring and fixedly connected to the core shaft.

[0033] In one embodiment, the pump head protection assembly includes an anchor bracket and a top sleeve tip, and the step of "fixedly connecting the distal end of the pump head protection assembly to the distal end of the pump head transmission assembly, and fixedly connecting the proximal end of the pump head protection assembly to the distal end of the protective sleeve" includes the steps of:

[0034] The distal end of the anchoring bracket is fixedly sleeved on the distal end of the top sleeve, the tip of the top sleeve is arranged on the distal end of the anchoring bracket, and the proximal end of the top sleeve tip is fixedly connected to the distal end of the top sleeve; the proximal end of the anchoring bracket is fixedly connected to the distal end of the protective sleeve;

[0035] Optionally, the pump head protection assembly further includes a bracket protection sleeve connecting ring, and the step of "fixedly connecting the proximal end of the anchor bracket to the distal end of the protection sleeve" further includes the steps of:

[0036] The distal end of the stent protective sleeve connecting ring is embedded and fixed in the annular proximal end of the anchoring stent, and the distal end surface of the stent protective sleeve connecting ring is aligned with the distal end surface of the annular proximal end of the anchoring stent, and the stent protective sleeve connecting ring is slidably sleeved outside the twisting shell and fixedly connected to the distal end of the protective sleeve;

[0037] Optionally, the anchor stent includes an anchor stent skeleton and an anchor stent membrane, wherein the anchor stent skeleton includes an anchor stent skeleton proximal ring, an anchor stent skeleton distal ring, and a plurality of anchor stent skeleton wires arranged in parallel between the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring, and the method further includes the steps of:

[0038] The distal ring of the anchoring stent frame is fixed on the outside of the distal end of the top sleeve, and the distal end of the stent protection sleeve connecting ring is embedded and fixed in the proximal ring of the anchoring stent frame;

[0039] Optionally, the method further comprises the steps of:

[0040] The anchoring stent membrane is sheathed outside the anchoring stent skeleton.

[0041] In one embodiment, the protective cover drive module includes a protective cover slider, a protective cover slider bearing, and a protective cover slider end cover. The step of "sleeving the protective cover drive module on the proximal end of the protective cover and simultaneously connecting the protective cover drive module to the proximal end of the protective cover" includes the following steps:

[0042] The protective cover slider bearing is embedded in the proximal ring groove of the protective cover slider, and the outer edge of the protective cover slider bearing is limited between the proximal ring groove of the protective cover slider and the protective cover slider end cover, and the protective cover slider end cover is arranged at the proximal end of the protective cover slider and fixedly connected to the protective cover slider;

[0043] The protective cover slider is sleeved on the proximal end of the protective cover and the protective cover slider is fixedly connected to the protective cover when the distal end surface of the protective cover slider bearing is in contact with the proximal end surface of the protective cover.

[0044] In one embodiment, the twisting shell drive module includes a twisting shell connector and a twisting gear set, wherein the twisting gear set includes a first twisting gear shaft, a first twisting gear, a first twisting gear shaft bearing, a twisting shell connector bearing, a second gear set, a twisting shell sleeve, and a twisting shell sleeve bearing. The step of "transmission-connecting the distal end of the twisting shell drive module to the proximal end of the twisting shell" includes the steps of:

[0045] Put the twisting shell shaft sleeve bearings on both ends of the twisting shell shaft sleeve respectively;

[0046] The twisting shell shaft sleeve with the twisting shell shaft sleeve bearings respectively sleeved on both ends is sleeved on the proximal end of the twisting shell;

[0047] Sleeving the first twisting gear on the first twisting gear shaft, arranging the first twisting gear shaft bearing on the distal end of the first twisting gear shaft, and sleeve the first twisting gear shaft onto the proximal end of the twisting shell;

[0048] The twisting shell connector bearing is arranged in the middle section of the twisting shell connector and the twisting shell connector is put onto the proximal end of the twisting shell. When the proximal end surface of the twisting shell connector is aligned with the proximal end surface of the twisting shell, the twisting shell connector is fixedly connected to the twisting shell;

[0049] The proximal end of the first twisting gear shaft is sleeved onto the distal end of the twisting shell connector and fixedly connected to the twisting shell connector.

[0050] In one embodiment, the spindle drive module includes a spindle connector, a coupling, a clutch, a clutch reset elastic member, and a spindle connector bearing, and the step of "transmission-connecting the distal end of the spindle drive module to the proximal end of the spindle" includes the steps of:

[0051] The core shaft connecting member bearing is sleeved on the proximal end of the core shaft connecting member;

[0052] Sleeve the proximal end of the clutch onto the distal end of the core shaft connector, and arrange the clutch reset elastic member between the core shaft connector and the clutch;

[0053] The distal end of the core shaft connector is sleeved onto the exterior of the proximal end of the core shaft and fixedly connected to the core shaft, and the distal end of the clutch is sleeved onto the proximal end of the twisting shell connector;

[0054] Optionally, the spindle drive module further includes a motor flange and a drive motor, and the method further includes the steps of:

[0055] The motor flange is fixedly connected to the driving motor, and the proximal end of the core shaft connector is inserted into the distal end of the coupling, and the rotating shaft of the driving motor is inserted into the proximal end of the coupling;

[0056] Optionally, the drive control mechanism further includes a housing, wherein the housing includes a first housing and a second housing, and the method further includes the steps of:

[0057] The assembly after the protective sleeve driving module is connected to the proximal end of the protective sleeve by transmission, the assembly after the twisting shell driving module is connected to the proximal end of the twisting shell by transmission, and the assembly after the core shaft driving module is connected to the proximal end of the core shaft by transmission are sequentially installed at corresponding positions in the second shell, the first shell is arranged relative to the second shell, and the first shell and the second shell are fixedly connected to form a cavity structure inside;

[0058] Optionally, the housing further comprises a distal cover, a brake assembly cover, a second gear set cover and a proximal cover, and the method further comprises the steps of:

[0059] The distal cover and the proximal cover are respectively arranged at the distal end and the proximal end of the shell, and the distal cover is fixedly connected to the distal end of the shell, and the proximal cover is fixedly connected to the proximal end of the shell.

[0060] In one embodiment, the spindle drive module further includes a clutch ring and a clutch fork, wherein the clutch ring includes a first clutch ring and a second clutch ring, and the method further includes the steps of:

[0061] The first clutch ring is sleeved on the outside of the first housing, and the second clutch ring is sleeved on the outside of the second housing and fixedly connected to the first clutch ring;

[0062] Optionally, the step of “separably connecting the distal end of the core shaft driving module to the distal end of the twisting shell driving module” includes the steps of:

[0063] The clutch fork is arranged in the clutch fork mounting hole of the clutch ring and passes through the housing to cooperate with the clutch, so that the clutch can be driven to move by operating the clutch ring to separate or connect the clutch and the twisting shell connector;

[0064] Optionally, the second gear set includes a second twisting gear shaft, a second twisting gear, a second twisting gear shaft bearing, a second twisting gear limiter, and a second twisting gear reset elastic member, and the method further includes the steps of:

[0065] Embed the second twisting gear shaft bearings on both sides of the second twisting gear, and align the outer end faces of the second twisting gear shaft bearings with the end faces of the second twisting gear;

[0066] Inserting the second twisting gear shaft into the second twisting gear shaft bearing, and aligning the center of the second twisting gear shaft with the center of the second twisting gear;

[0067] The second twisting gear limiting members are respectively arranged at both ends of the second twisting gear shaft and fixedly connected to the second twisting gear shaft;

[0068] Inserting the second twisting gear reset elastic member into the corresponding mounting hole of the second twisting gear limiting member, inserting one side of the second twisting gear limiting member into the housing, and extending the other side of the second twisting gear limiting member out of the housing, so as to arrange the second twisting gear reset elastic member between the second twisting gear limiting member and the housing, so that the second twisting gear is supported on the outside of the housing and the second twisting gear is detachably engaged with the first twisting gear through the second twisting gear reset elastic member;

[0069] Optionally, the method further comprises the steps of:

[0070] Covering the second gear set cover on the second twisting gear limiter, and fixing the second gear set cover to the housing;

[0071] Optionally, the spindle drive module further includes a brake assembly, and the method further includes the steps of:

[0072] The brake assemblies are arranged in pairs at corresponding positions of the housing, and the brake assemblies are arranged in pairs on both sides of the coupling and are used to brake the coupling;

[0073] Optionally, the brake assembly includes a brake slider, a brake, and a pair of brake reset elastic members, and the method further includes the steps of:

[0074] Insert one end of the pair of brake reset elastic members into the corresponding mounting holes of the brake members, insert the small end of the brake members into the housing and engage with the outer wall of the coupling, and insert the other end of the pair of brake reset elastic members into the corresponding mounting holes of the housing;

[0075] The brake member slider is arranged outside the housing and is slidably connected to the large end of the brake member;

[0076] Optionally, the method further comprises the steps of:

[0077] The brake component cover is covered on the brake member slider, and the brake component cover is fixedly connected to the housing.

[0078] The above solution of the present invention includes at least the following beneficial effects:

[0079] The above-mentioned scheme of the present invention provides a preparation method for a left ventricular assist device, which includes a micro pump head, a transmission shaft and a drive control mechanism, wherein the micro pump head includes a pump head impeller and a pump head transmission assembly, the transmission shaft includes a core shaft and a twisting shell, and the drive control mechanism includes a twisting shell drive module and a core shaft drive module, and the method includes the following steps: passing the pump head transmission assembly through the pump head impeller, and fixing the distal end of the pump head impeller to the distal end of the pump head transmission assembly; fixing the proximal end of the pump head impeller to the distal end of the twisting shell; inserting the core shaft into the twisting shell, and fixing the distal end of the core shaft to the proximal end of the pump head transmission assembly; arranging the twisting shell drive module at the distal end of the core shaft drive module, and transmission connecting the distal end of the twisting shell drive module to the proximal end of the twisting shell; transmission connecting the distal end of the core shaft drive module to the proximal end of the core shaft, and detachably connecting the distal end of the core shaft drive module to the proximal end of the twisting shell drive module. When the proximal end of the core shaft driving module is connected to the distal end of the twisting shell driving module, the core shaft and the twisting shell are driven to rotate synchronously by the core shaft driving module to drive the distal and proximal ends of the pump head impeller to rotate together, so that the pump head impeller rotates with a fixed outer diameter; when the proximal end of the core shaft driving module is separated from the distal end of the twisting shell driving module, the twisting shell and the core shaft are driven to rotate relative to each other by the twisting shell driving module to drive the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller is folded or unfolded; through the mutual cooperation of the drive control mechanism, the transmission shaft and the micro pump head, the unfolding and folding of the pump head impeller in the micro pump head of the auxiliary device can be realized to adjust the outer diameter of the pump head impeller in the micro pump head, thereby improving the use efficiency and safety of the auxiliary device. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Figure 1 is a flow chart of a method for preparing a left ventricular assist device provided by an embodiment of the present invention;

[0081] Figure 2 is a schematic diagram of the three-dimensional structure of a left ventricular assist device provided by an optional embodiment of the present invention;

[0082] Figure 3 is a front cross-sectional view of a left ventricular assist device provided by an optional embodiment of the present invention;

[0083] Figure 4 This is a schematic diagram of the three-dimensional structure of a transmission shaft provided by an optional embodiment of the present invention;

[0084] Figure 5 is a schematic diagram of the three-dimensional structure of a core shaft provided by an optional embodiment of the present invention;

[0085] Figure 6 This is a schematic diagram of the three-dimensional structure of a twisting shell provided by an optional embodiment of the present invention;

[0086] Figure 7 is a half-sectional view of a transmission shaft provided by an optional embodiment of the present invention;

[0087] Figure 8 This is a schematic diagram of the three-dimensional structure of a protective cover provided by an optional embodiment of the present invention;

[0088] Figure 9 is a schematic diagram of the overall structure of a pressure sensor provided by an optional embodiment of the present invention;

[0089] Figure 10 1 is a schematic diagram of the installation of an optical fiber and a housing in a pressure sensor provided by an optional embodiment of the present invention;

[0090] Figure 11 This is an exploded view of the pump head impeller provided by an optional embodiment of the present invention when it is expanded (normal state);

[0091] Figure 12 This is a schematic diagram of the three-dimensional structure of the impeller skeleton when it is unfolded (normal state) provided by an optional embodiment of the present invention;

[0092] Figure 13 This is a schematic diagram of the three-dimensional structure of the impeller skeleton when folded, provided by an optional embodiment of the present invention;

[0093] Figure 14 This is a schematic diagram of the three-dimensional structure of an impeller blade provided by an optional embodiment of the present invention;

[0094] Figure 15 is a schematic diagram of preparing an impeller blade surface provided by an optional embodiment of the present invention;

[0095] Figure 16 is a flow chart of preparing an impeller blade surface provided by an optional embodiment of the present invention;

[0096] Figure 17 is a flow chart of preparing an impeller skeleton by using nickel-titanium alloy wire provided by an optional embodiment of the present invention;

[0097] Figure 18 is a schematic diagram of preparing an impeller skeleton using nickel-titanium alloy wire according to an optional embodiment of the present invention;

[0098] Figure 19 is a flow chart of preparing an impeller skeleton using nickel-titanium powder provided by an optional embodiment of the present invention;

[0099] Figure 20 is a schematic diagram of preparing an impeller skeleton using nickel-titanium powder according to an optional embodiment of the present invention;

[0100] Figure 21 is a flow chart of preparing an impeller skeleton by using a nickel-titanium alloy tube, provided by an optional embodiment of the present invention;

[0101] Figure 22 is a schematic diagram of preparing an impeller skeleton using a nickel-titanium alloy tube, provided by an optional embodiment of the present invention;

[0102] Figure 23 is a schematic diagram of the three-dimensional structure of a pump head impeller in an expanded state provided by an optional embodiment of the present invention;

[0103] Figure 24 is a schematic diagram of the three-dimensional structure of a pump head impeller in a folded state provided by an optional embodiment of the present invention;

[0104] Figure 25 is a schematic diagram of the three-dimensional structure of a pump head transmission assembly provided by an optional embodiment of the present invention;

[0105] Figure 26 is an exploded view of a pump head transmission assembly provided by an optional embodiment of the present invention;

[0106] Figure 27 is a cross-sectional schematic diagram of the connection between a micro pump head and a transmission shaft provided by an optional embodiment of the present invention;

[0107] Figure 28 1 is a schematic diagram of the three-dimensional structure of a pump head protection assembly provided by an optional embodiment of the present invention;

[0108] Figure 29 is an exploded view of a pump head protection assembly provided by an optional embodiment of the present invention;

[0109] Figure 30 is a schematic diagram of the three-dimensional structure of a protective cover driving module provided in an optional embodiment of the present invention;

[0110] Figure 31 is an exploded view of a protective cover driving module provided in an optional embodiment of the present invention;

[0111] Figure 32 1 is a front cross-sectional view of a drive control mechanism provided by an optional embodiment of the present invention;

[0112] Figure 33 This is a flow chart of a twisting housing drive module distal end and a twisting housing proximal end transmission connection provided by an optional embodiment of the present invention;

[0113] Figure 341 is a schematic diagram of the three-dimensional structure of a twisting shell driving module provided in an optional embodiment of the present invention;

[0114] Figure 35 is a schematic diagram of the three-dimensional structure of a second gear set provided by an optional embodiment of the present invention;

[0115] Figure 36 is an exploded view of a second gear set provided by an optional embodiment of the present invention;

[0116] Figure 37 yes Figure 34 Exploded view of some components of the middle twisting shell drive module;

[0117] Figure 38 This is a flow chart of a transmission connection between the distal end of the mandrel drive module and the proximal end of the mandrel provided by an optional embodiment of the present invention;

[0118] Figure 39 1 is a schematic diagram of the three-dimensional structure of a spindle drive module provided in an optional embodiment of the present invention;

[0119] Figure 40 is an exploded view of a spindle drive module provided in an optional embodiment of the present invention;

[0120] Figure 41 This is a schematic diagram of the assembly of a clutch and a core shaft connector provided by an optional embodiment of the present invention;

[0121] Figure 42 This is a schematic diagram of the assembly of a clutch and a twisting housing connector provided by an optional embodiment of the present invention;

[0122] Figure 43 is a schematic diagram of the three-dimensional structure of a housing provided by an optional embodiment of the present invention;

[0123] Figure 44 is an exploded view of a housing provided by an optional embodiment of the present invention;

[0124] Figure 45 1 is a schematic diagram of the assembly of a first housing and a clutch fork provided in an optional embodiment of the present invention;

[0125] Figure 46 1 is a schematic diagram of the assembly of the second housing and the clutch fork provided in an optional embodiment of the present invention;

[0126] Figure 47 is a cross-sectional schematic diagram of the assembly of the brake assembly and the first housing provided by an optional embodiment of the present invention;

[0127] Figure 48 is a schematic cross-sectional view of the assembly of the brake assembly and the second housing provided by an optional embodiment of the present invention;

[0128] Figure 49 is an exploded view of a clutch ring provided in an optional embodiment of the present invention;

[0129] Figure 50 is an exploded view of a brake assembly provided by an optional embodiment of the present invention;

[0130] Figure 51 is a partial cross-sectional view of a brake assembly provided by an optional embodiment of the present invention;

[0131] Figure 52 This is a schematic diagram of the use process of a left ventricular assist device provided by an optional embodiment of the present invention;

[0132] Figures 53 to 60 The diagram shows a process in which a left ventricular assist device provided by an optional embodiment of the present invention is transformed from an expanded state to a folded state.

[0133] Explanation of the accompanying figures: 1. Left ventricular assist device;

[0134] 2. Micro pump head; 21. Pump head protection assembly; 211. Top sleeve tip; 212. Anchor bracket; 2121. Anchor bracket skeleton; 2122. Anchor bracket membrane; 213. Bracket protection sleeve connecting ring;

[0135] 22. Pump head impeller; 221. Foldable impeller; 2211. Impeller frame; 2212. Impeller blade; 22111. Distal fixing ring; 22112. Impeller frame wire; 22113. Proximal fixing ring; 222. Twisted connector;

[0136] 23. Pump head transmission assembly; 231. Top sleeve; 232. Top shaft sleeve; 233. Top shaft bearing; 234. Top sleeve ring; 235. Top shaft; 236. Mandrel sleeve; 237. Mandrel sleeve ring;

[0137] 3. Transmission shaft; 31. Protective cover; 311. Optical fiber hole; 312. Distal notch of protective cover; 313. Proximal notch of protective cover; 32. Twisting housing; 321. Twisting connector mounting notch; 322. Micro-pump head connection section of twisting housing; 323. Flexible section of twisting housing; 324. Twisting housing drive control mechanism connection section; 33. Mandrel;

[0138] 4. Drive control mechanism; 40. Housing; 401. First housing; 4011. First protrusion; 4012. Second protrusion; 4013. Third protrusion; 4014. First optical fiber slot; 402. Second housing; 4021. Fourth protrusion; 4022. Fifth protrusion; 4023. Sixth protrusion; 4024. Second optical fiber slot; 403. Distal cover; 404. Proximal cover; 405. Brake assembly cover; 406. Second gear assembly cover;

[0139] 41. Protective cover drive module; 411. Protective cover slider; 4111. Protective cover slider locking member; 412. Protective cover slider bearing; 413. Protective cover shaft end cap;

[0140] 42. Twisting shell drive module; 421. Second gear set; 4211. Second twisting gear limiter; 4212. Second twisting gear shaft bearing; 4213. Second twisting gear; 4214. Second twisting gear shaft; 4215. Second twisting gear reset elastic member; 422. Twisting shell sleeve bearing; 423. Twisting shell sleeve; 424. First twisting gear shaft bearing; 425. First twisting gear; 426. First twisting gear shaft; 427. Twisting shell connector bearing; 428. Twisting shell connector;

[0141] 43. Spindle drive module; 431. Clutch fork; 432. Clutch ring; 4321. First clutch ring; 4322. Second clutch ring; 4323. Clutch fork mounting hole; 433. Clutch; 434. Clutch return elastic member; 435. Spindle connector; 436. Spindle connector bearing; 437. Coupling; 438. Brake assembly; 4381. Brake member slider; 43811. Seventh protrusion; 43812. Wedge-shaped bottom surface; 4382. Brake member; 43821. Limiting groove; 4383. Brake member return elastic member; 439. Motor flange; 4310. Drive motor;

[0142] 5. Pressure sensor; 51. Optical fiber; 511. Pressure monitoring optical fiber; 512. Signal transmission optical fiber; 52. Fiber Bragg grating demodulator;

[0143] 6. Catheter;

[0144] A. Proximal end; B. Distal end. DETAILED DESCRIPTION

[0145] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0146] In the following description, for the purpose of illustrating the various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other cases, well-known devices, structures, and techniques associated with this application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0147] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0148] In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but words such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and should not be understood as restrictive terms.

[0149] See Figures 1 to 5 An embodiment of the present invention provides a method for preparing a left ventricular assist device. The left ventricular assist device 1 includes a micro pump head 2, a drive shaft 3, and a drive control mechanism 4. The micro pump head 2 includes a pump head impeller 22 and a pump head transmission assembly 23. The drive shaft 3 includes a core shaft 33 and a twisting shell 32. The drive control mechanism 4 includes a twisting shell drive module 42 and a core shaft drive module 43. The method for preparing the left ventricular assist device includes the following steps:

[0150] Step 1: Insert the pump head transmission assembly 23 through the pump head impeller 22, and fix the distal end of the pump head impeller 22 to the distal end of the pump head transmission assembly 23, and fix the proximal end of the pump head impeller 22 to the distal end of the twisting shell 32;

[0151] Step 2: insert the core shaft 33 into the twisting housing 32 and fix the distal end of the core shaft 33 to the proximal end of the pump head transmission assembly 23;

[0152] Step 3: Arrange the twisting shell driving module 42 at the distal end of the core shaft driving module 43, and connect the distal end of the twisting shell driving module 42 to the proximal end of the twisting shell 32 through transmission;

[0153] Step 4: The distal end of the core shaft driving module 43 is connected to the proximal end of the core shaft 33 by transmission, and the distal end of the core shaft driving module 43 is detachably connected to the proximal end of the twisting shell driving module 42.

[0154] In this embodiment, after the micro pump head 2 and the transmission shaft 3 are assembled through the above steps 1 to 2, the drive control mechanism 4 and the transmission shaft 3 are assembled through steps 3 to 4; wherein, the drive control mechanism 4 is used to provide driving force for the operation of the micro pump head 2, and the transmission shaft 3 is used to transmit the driving force provided by the drive control mechanism 4; the transmission shaft 3 serves as a connector between the drive control mechanism 4 and the micro pump head 2 in the entire left ventricular assist device 1, and can realize the drive control of the micro pump head 2 at the distal end of the assist device entering the patient's body through the drive control mechanism 4 at the proximal end of the assist device outside the patient's body, thereby avoiding the drive control mechanism 4 from entering the patient's body together with the micro pump head 2, which not only reduces the size of the interventional wound, but also avoids the possible harm to the patient caused by the heat generated by the motor in the drive control mechanism 4. At the same time, the drive control mechanism 4 is placed outside the patient's body and can be reused, thereby reducing the use cost of the entire left ventricular assist device 1.

[0155] Here, the core shaft 33 and the twisting shell 32 are both cylinders, and the twisting shell 32 is an annular cylinder whose inner diameter matches the outer diameter of the core shaft 33 so that it can be sleeved on the outside of the core shaft 33; wherein the length of the core shaft 33 is longer than the length of the twisting shell 32 to facilitate assembly and transmission of driving force; preferably, the core shaft 33 can be made of plastic-coated steel wire rope, and the twisting shell 32 can be made of multiple strands of double-layer synchronous torque spring tube.

[0156] Preferably, the distal end of the pump head impeller 22 and the distal end of the pump head transmission assembly 23, the proximal end of the pump head impeller 22 and the distal end of the twisting shell 32, and the distal end of the core shaft 33 and the proximal end of the pump head transmission assembly 23 can be bonded and fixed; more preferably, they are bonded and fixed by biocompatible glue to avoid causing harm to the human body.

[0157] When the left ventricular assist device 1 is assembled and used, when the distal end of the core shaft drive module 43 is connected to the proximal end of the twisting shell drive module 42, the core shaft drive module 43 drives the core shaft 33 to rotate and drives the twisting shell drive module 42 to rotate synchronously. The twisting shell drive module 42 further drives the twisting shell 32 to rotate, thereby achieving synchronous rotation of the twisting shell 32 and the core shaft 33, and then drives the pump head impeller 22 as a whole to rotate at a fixed outer diameter (synchronous rotation here means rotating at the same angular velocity). When the distal end of the core shaft drive module 43 is separated from the proximal end of the twisting shell drive module 42, the twisting shell drive module 42 drives the twisting shell 32 to rotate relative to the core shaft 33 (at this time, the core shaft drive module 43 stops running and the core shaft 33 is fixed). When the twisting shell 32 rotates relative to the core shaft 33, the proximal end of the pump head impeller 22 can be driven to rotate relative to the distal end. The rotation of the proximal end of the pump head impeller 22 relative to the distal end can cause the pump head impeller 22 to expand or fold, thereby changing the outer diameter of the pump head impeller 22.

[0158] By driving the control mechanism 4 and the transmission shaft 3 to cooperate in controlling the folding or unfolding of the pump head impeller 22 in the micro pump head 2 (when the pump head impeller 22 is folded, the overall outer diameter is reduced; when the pump head impeller 22 is unfolded, the overall outer diameter is much larger than the outer diameter when folded), it helps to implant the micro pump head 2 in a folded state into a designated position in the human body through minimally invasive interventional surgery. Subsequently, the pump head impeller 22 can be deformed and unfolded into a spiral shape with a larger outer diameter in the human body, so that the left ventricular assist device 1 has the ability to provide the patient with sufficient auxiliary blood flow at a low speed, thereby improving the blood supply efficiency and safety of use of the left ventricular assist device 1; at the same time, the pump head impeller 22 with adjustable outer diameter also helps to reduce the resistance of the entire micro pump head 2 when entering and passing through the catheter, which is more conducive to the rapid and safe deployment and recovery of the left ventricular assist device 1.

[0159] like Figure 6 As shown, in an optional embodiment of the present invention, the twisting housing 32 may include a twisting housing micro pump head connecting section 322, a twisting housing flexible section 323, and a twisting housing drive control mechanism connecting section 324. The twisting housing flexible section 323 is fixedly connected to the twisting housing micro pump head connecting section 322 and the twisting housing drive control mechanism connecting section 324 respectively by welding; wherein, the distal end of the twisting housing micro pump head connecting section 322 is used for fixed connection with the proximal end of the pump head impeller 22, and the proximal end of the twisting housing drive control mechanism connecting section 324 is used for transmission connection with the twisting housing drive module 42. Here, the twisting housing flexible section 323 can be made of multiple strands of double-layer synchronous torque spring tubes in one piece to ensure the flexibility of the entire transmission shaft 3 during use.

[0160] Preferably, a twisting connector mounting slot 321 adapted to the proximal end of the pump head impeller 22 is provided at the distal end of the twisting shell micro pump head connecting section 322. When the pump head impeller 22 and the twisting shell 32 are assembled, the twisting connector mounting slot 321 is snap-fitted with the twisting shell connecting slot at the proximal end of the pump head impeller 22 to achieve stable transmission of torque between the twisting shell 32 and the pump head impeller 22; more preferably, biocompatible glue can be used for bonding at the snap-fitting position, which can improve the firm connection between the two while avoiding harm to the human body.

[0161] In an optional embodiment of the present invention, the micro pump head 2 further includes a pump head protection assembly 21, and the transmission shaft 3 further includes a protective sleeve 31. After the above-mentioned step 1 of fixedly connecting the distal end of the pump head impeller 22 to the distal end of the pump head transmission assembly 23, the following steps are further included:

[0162] In step 110 , the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22 , and the distal end of the pump head protection assembly 21 is fixedly connected to the distal end of the pump head transmission assembly 23 , and the proximal end of the pump head protection assembly 21 is fixedly connected to the distal end of the protective sleeve 31 .

[0163] In this embodiment, the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22 to protect the pump head impeller 22; preferably, the distal end of the protective sleeve 31 and the proximal end of the pump head protection assembly 21 can be fixedly bonded by biocompatible glue to avoid causing harm to the human body.

[0164] In an optional embodiment of the present invention, the drive control mechanism 4 further includes a protective cover drive module 41, and after the above step 2, the following steps are further included:

[0165] In step 200 , the twisting shell 32 is inserted into the protective cover 31 , and the protective cover driving module 41 is sleeved on the proximal end of the protective cover 31 , and the protective cover driving module 41 is transmission-connected to the proximal end of the protective cover 31 .

[0166] In this embodiment, since the protective sleeve 31 is sleeved outside the twisting shell 32, and the proximal end of the protective sleeve 31 is transmission-connected to the protective sleeve drive module 41, when the protective sleeve drive module 41 drives the protective sleeve 31 to move on the twisting shell 32, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 can be controlled, thereby controlling the folding or unfolding of the pump head protection assembly 21 to adjust the outer diameter of the pump head protection assembly 21. Specifically, when the protective sleeve drive module 41 drives the protective sleeve 31 to slide toward the distal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 decreases, and the outer diameter of the pump head protection assembly 21 increases; when the protective sleeve drive module 41 drives the protective sleeve 31 to slide toward the proximal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases to match the increase or decrease in the outer diameter of the pump head impeller 22.

[0167] Here, the protective sleeve 31 serves as a protective layer for the core shaft 33 and the twisting shell 32. It is an annular cylindrical body that fits over the twisting shell 32. The inner diameter of the protective sleeve 31 is slightly larger than the outer diameter of the twisting shell 32, allowing for easy fitting of the protective sleeve 31 over the twisting shell 32. Lubricant is filled between the protective sleeve 31 and the twisting shell 32, thereby reducing heat generation during operation of the transmission shaft 3. The twisting shell 32 is slightly longer than the protective sleeve 31, and the lengths of both can be adjusted based on actual application requirements. Preferably, the protective sleeve 31 can be made of medical Pebax tubing, but this is not limited to medical Pebax tubing; other suitable materials that are harmless to the human body can also be selected.

[0168] like Figures 9 and 10 As shown, in an optional embodiment of the present invention, the left ventricular assist device 1 may further include a pressure sensor 5, which includes an optical fiber 51 and a fiber Bragg grating demodulator 52, and the optical fiber 51 and the fiber Bragg grating demodulator 52 are communicatively connected via a threaded connector. Figure 7As shown, the protective cover 31 is provided with an optical fiber hole 311, and the optical fiber 51 is passed through the optical fiber hole 311. When the left ventricular assist device 1 is in use, a portion of the pressure sensor 5 is inserted into the patient's body along with the micro pump head 2, and can collect the patient's blood pressure data in real time to accurately capture blood pressure changes.

[0169] Preferably, if Figure 8 As shown, the distal end and proximal end of the protective cover 31 are respectively provided with a distal notch 312 and a proximal notch 313 for assembling and fixing the optical fiber 51. Preferably, the distal notch 312 is arranged on the side wall of the distal end of the protective cover 31 and extends axially, and the proximal notch 313 is arranged on the side wall of the proximal end of the protective cover and is located in the extension direction of the distal notch 312. The distal end of the optical fiber 51 passes through the proximal notch 313 of the protective cover 31 into the optical fiber hole 311 and passes through the distal notch 312 of the protective cover 31.

[0170] The fiber Bragg grating demodulator 52 is fixed on the drive control mechanism 4 and is in communication connection with the controller module of the left ventricular assist device 1. Figure 10 As shown, the distal end of the optical fiber 51 passes through the optical fiber groove of the drive control mechanism 4 and the optical fiber hole 311 of the protective cover 31 in sequence, so that the entire optical fiber 51 is laid in the first optical fiber groove 4014, the second optical fiber groove 4024 of the drive control mechanism 4 and the optical fiber hole 311 of the protective cover 31; the proximal end of the optical fiber 51 is communicatively connected to the fiber Bragg grating demodulator 52 through a threaded connector.

[0171] Here, the optical fiber 51 may specifically include a pressure monitoring optical fiber 511 and a signal transmission optical fiber 512 integrally formed with the pressure monitoring optical fiber 511, and the proximal end of the signal transmission optical fiber 512 is communicatively connected to the fiber optic Bragg grating demodulator 52 via a threaded connector. Among them, the pressure monitoring optical fiber 511 is an optical fiber writing segment, which is used to monitor the blood flow pressure data in the patient's body in real time. The signal transmission optical fiber 512 is an optical fiber non-writing segment, and the proximal end of the signal transmission optical fiber 512 is communicatively connected to the fiber optic Bragg grating demodulator 52 via a threaded connector, which is used to transmit the blood flow pressure data monitored by the pressure monitoring optical fiber 511 to the fiber optic Bragg grating demodulator 52 in real time. The pressure monitoring optical fiber 511 is laid close to the micro pump head 2, and when the auxiliary device is used, it enters the patient's body together with the micro pump head 2 for real-time monitoring.

[0172] When laying the optical fiber 51, the pressure monitoring optical fiber 511 is passed through the proximal notch 313 of the protective cover 31 into the optical fiber hole 311 and out through the distal notch 312 of the protective cover 31. At the same time, when ensuring that the pressure monitoring optical fiber 511 completely passes through the optical fiber hole 311 and is just placed in the distal notch 312, the signal transmission optical fiber 512 is bonded and fixed to the optical fiber hole 311 to avoid falling off during use, thereby realizing real-time monitoring of blood flow pressure and improving the accuracy of monitoring; preferably, biocompatible glue can be used to bond and fix the signal transmission optical fiber 512 to the optical fiber hole 311 to avoid causing harm to the human body.

[0173] In an optional embodiment of the present invention, Figure 11 As shown, the pump head impeller 22 includes a foldable impeller 221 and a twisting connector 222. The above step 1 may include:

[0174] Step 101: Fixedly connect the distal end of the foldable impeller 221 to the distal end of the pump head transmission assembly 23, clamp the proximal end of the foldable impeller 221 to the distal end of the twisting connector 222, and fixedly connect the proximal end of the twisting connector 222 to the distal end of the twisting housing 32;

[0175] In this embodiment, the proximal end of the foldable impeller 221 is secured to the distal end of the twisting connector 222 by snapping it in place. The proximal end of the foldable impeller 221 is also secured to the distal end of the twisting housing 32 via the twisting connector 222. Because the proximal end of the twisting housing 32 is in transmission connection with the twisting housing drive module 42, when the twisting housing 32 is driven by the twisting housing drive module 42, the twisting housing 32 drives the twisting connector 222 to rotate, which in turn drives the proximal end of the foldable impeller 221 to rotate. The twisting connector 222 can be fabricated from stainless steel using metal 3D printing.

[0176] Alternatively, as Figures 13 and 14 As shown, the foldable impeller 221 includes an impeller frame 2211 and an impeller blade surface 2212. The above step 101 may include:

[0177] Step 1011: The distal end of the impeller frame 2211 is fixedly connected to the distal end of the pump head transmission assembly 23, and the proximal end of the impeller frame 2211 is clamped to the distal end of the twisting connector 222; here, the impeller frame 2211 as a whole can be twisted and folded or twisted and unfolded;

[0178] Optionally, a core shaft hole for the core shaft 33 to pass through is formed on the twisting connector 222, so that the distal end of the core shaft 33 can pass through the twisting connector 222 and be fixedly connected to the proximal end of the pump head transmission assembly 23. Since the proximal end of the core shaft 33 is in transmission connection with the core shaft drive module 43, when the core shaft 33 is driven to rotate by the core shaft drive module 43, the core shaft 33 drives the pump head transmission assembly 23 to rotate, and the distal end of the foldable impeller 221 is driven to rotate by the pump head transmission assembly 23.

[0179] In an optional embodiment of the present invention, the method for preparing a left ventricular assist device may further include:

[0180] Step 1012, covering the impeller blade surface 2212 on the impeller frame 2211;

[0181] In this embodiment, the distal end and the proximal end of the impeller blade 2212 can be bonded and fixed to the distal end and the proximal end of the impeller frame 2211 respectively to ensure that the impeller blade 2212 will not fall off during the folding and auxiliary blood supply process.

[0182] Here, the impeller blade surface 2212 can be prepared by a biocompatible super-elastic medical silicone material. On the one hand, it can reduce the damage caused by the pump head impeller 22 to the human body and blood cells during use. On the other hand, it can enable the pump head impeller 22 to have a large folding and expansion ratio deformation capability (when the impeller skeleton 2211 is twisted and unfolded, the impeller blade surface 2212 can be pushed outward by the impeller skeleton 2211 to form a spiral impeller and increase the outer diameter of the overall pump head impeller 22. When the impeller skeleton 2211 is twisted and folded, the impeller blade surface 2212 will shrink inward into a cylindrical shape and reduce the outer diameter of the overall pump head impeller 22).

[0183] like Figures 15 and 16 As shown, in an optional embodiment of the present invention, the impeller blade surface 2212 can be prepared by the following steps:

[0184] Step 161, preparing a material with mechanical properties that meet the requirements, preferably a biocompatible medical silicone material;

[0185] Step 162: pouring the medical silicone raw material into a mold, wherein the shape of the mold is preferably a circular tube;

[0186] Step 163, placing the mold into a heating device for heating;

[0187] Step 164 , after natural cooling, the mold is taken to obtain the impeller blade surface 2212 .

[0188] Optionally, in step 161, an elastic material having mechanical properties that meet the requirements is first prepared. Preferably, the elastic material is a biocompatible medical silicone raw material. Preferably, the medical silicone material can be prepared by mixing DragonSkin silicone and Slic Thinner diluent in a mass ratio of 2:1 at room temperature, stirring, and heating to form a film. The medical silicone material has good elastic deformation ability, with a 100% Young's modulus of 21.75 kPa, a maximum strain of 1328.2%, and a maximum stress of 675.3 kPa, which can meet the needs of the pump head impeller 22 during use.

[0189] Optionally, in step 162, the prepared medical silicone raw material is poured into a cylindrical impeller blade mold;

[0190] Optionally, in step 163, the impeller blade mold cast with the medical silicone raw material is subjected to a heating treatment. The heating treatment is preferably constant temperature heating, more preferably constant temperature heating in a low-temperature oven. The constant temperature heating temperature is preferably 40° C.-80° C., more preferably 60° C., and the constant temperature heating duration is preferably in the range of 15 minutes to 60 minutes, more preferably 30 minutes.

[0191] Optionally, in step 164, after constant temperature heating for a period of time and natural cooling, the following Figure 15 The impeller blades 2212 are shown to be elastic and in a tubular shape.

[0192] In an optional embodiment of the present invention, Figure 12 As shown, the impeller skeleton 2211 includes a proximal fixing ring 22113, a distal fixing ring 22111 and an impeller skeleton wire 22112. The above step 1011 may include:

[0193] In step 10111, the impeller skeleton wire 22112 is spirally arranged between the proximal fixing ring 22113 and the distal fixing ring 22111, the distal fixing ring 22111 is fixedly connected to the distal end of the pump head transmission assembly 23, and the proximal end of the proximal fixing ring 22113 is clamped to the distal end of the twisting connector 222.

[0194] In this embodiment, both the proximal fixing ring 22113 and the distal fixing ring 22111 are annular cylinders, and the outer diameters of the proximal fixing ring 22113 and the distal fixing ring 22111 can be set according to the inner diameter of the medical catheter during use. Preferably, the outer diameters of the proximal fixing ring 22113 and the distal fixing ring 22111 are equal and slightly smaller than the inner diameter of the medical catheter.

[0195] The setting of the proximal fixing ring 22113 and the distal fixing ring 22111 can ensure that the foldable impeller 221 is cylindrical as a whole in the folded state, and the outer diameter of the foldable impeller 221 in the folded state is smaller than the inner diameter of the medical catheter, so that the foldable impeller 221 can be implanted into the appropriate position through the human blood vessels through minimally invasive interventional surgery.

[0196] Here, the distal fixing ring 22111, the proximal fixing ring 22113, and the impeller skeleton wire 22112 can be prepared in an integrated manner by metal 3D printing to obtain the impeller skeleton 2211. The distal fixing ring 22111, the proximal fixing ring 22113, and the impeller skeleton wire 22112 can also be prepared by femtosecond laser cutting a nickel-titanium alloy tube to obtain the impeller skeleton 2211.

[0197] A plurality of impeller skeleton wires 22112 are disposed between the proximal fixing ring 22113 and the distal fixing ring 22111. The plurality of impeller skeleton wires 22112 are connected in parallel along the same spiral direction between the proximal fixing ring 22113 and the distal fixing ring 22111. Preferably, the plurality of impeller skeleton wires 22112 can be assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 in a form-locked manner by being inserted into the proximal assembly holes of the distal fixing ring 22111 and the distal assembly holes of the proximal fixing ring 22113. More preferably, biocompatible glue can be applied at the assembly locations for bonding and fixation.

[0198] In one embodiment of the present invention, the distal end of the twisting connector 222 may be provided with multiple rotation-limiting bosses, and the proximal outer edge of the proximal fixed ring 22113 may be provided with multiple corresponding limiting grooves. During assembly, the rotation-limiting bosses of the twisting connector 222 are plugged into the limiting grooves of the proximal fixed ring 22113 to achieve rotational limiting. The assembled connection of the rotation-limiting bosses and limiting grooves between the twisting connector 222 and the proximal fixed ring 22113 can better transmit the twisting torque to the foldable impeller 221 through the twisting connector 222, thereby achieving one-step twisting and folding of the foldable impeller 221.

[0199] In an optional embodiment of the present invention, Figures 17 and 18 As shown, the impeller skeleton 2211 can be prepared by the following steps:

[0200] Step 171a, selecting a nickel-titanium alloy wire, preferably, the nickel-titanium ratio of the nickel-titanium alloy wire is 53:47-60:40, more preferably 56:44;

[0201] Step 172a, pre-shaping and fixing the nickel-titanium alloy wire using a mold with a spiral groove;

[0202] Step 173a, placing the mold into a heating device for heating;

[0203] Step 174a, after heating, taking out the mold to obtain the impeller skeleton wire 22112;

[0204] In step 175a, the distal and proximal ends of the impeller skeleton wire 22112 are assembled with the distal retaining ring 22111 and the proximal retaining ring 22113, respectively, in a form-locking manner. Biocompatible glue is applied to the assembly points for adhesive fixation. In this embodiment, nickel-titanium alloy wire having a specific nickel-titanium mass fraction ratio is selected and then processed in subsequent steps to obtain an impeller skeleton 2211 that meets the mechanical property and geometric morphology requirements. The impeller skeleton 2211 also provides a certain degree of rigidity for the deployed pump head impeller 22, ensuring the stability of the pump head impeller 22 during use.

[0205] Here, the spiral groove of the mold should match the few-period spiral of the few-period spiral impeller skeleton wire 22112 to obtain the impeller skeleton wire 22112 that meets the size and shape requirements.

[0206] Since the impeller skeleton wire 22112 with a few-period spiral shape is prepared from nickel-titanium alloy wire, the mold with the nickel-titanium alloy wire wrapped inside is subjected to heat treatment to obtain the impeller skeleton wire 22112 with mechanical properties (superelasticity) and geometric morphology (few-period spiral shape) that meet the requirements; here, the heating method is preferably constant temperature heating in a muffle furnace, the constant temperature heating temperature is preferably 450°C-550°C, more preferably 500°C, and the heating time is preferably 10 minutes-30 minutes, more preferably 15 minutes, so as to prepare the impeller skeleton wire 22112 that meets the use requirements.

[0207] Here, both the proximal fixing ring 22113 and the distal fixing ring 22111 can be prepared by metal 3D printing stainless steel; when the distal end and proximal end of the few-period spiral impeller skeleton wire 22112 are fixedly connected to the distal fixing ring 22111 and the proximal fixing ring 22113 respectively, preferably, the distal end and proximal end of the few-period spiral impeller skeleton wire 22112 can be respectively inserted into the proximal corresponding assembly hole of the distal fixing ring 22111 and the distal corresponding assembly hole of the proximal fixing ring 22113, and biocompatible glue can be applied at the assembly point for bonding and fixing, and the biocompatible glue can also avoid causing harm to the human body.

[0208] In another optional embodiment of the present invention, the impeller skeleton 2211 is prepared by metal 3D printing integrally formed. When prepared by metal 3D printing integrally formed, refer to Figures 19 to 20 , the preparation of the impeller skeleton 2211 may include:

[0209] Step 171b, using nickel-titanium powder as raw material, modeling and printing according to the design dimensions, wherein the nickel-titanium ratio in the nickel-titanium powder is preferably 53:47-60:40, more preferably 56:44, and the design dimensions preferably include the pitch, spiral radius, and spiral height;

[0210] Step 172b: fix the impeller skeleton 2211 using a mold that matches the size of the impeller skeleton 2211 to prevent the impeller skeleton 2211 from being deformed by heat during the heat treatment process;

[0211] Step 173b, placing the mold into a heating device for heating;

[0212] Step 174b, after heating, taking a mold to obtain an impeller skeleton 2211 with mechanical properties and geometric morphology that meet the requirements.

[0213] In this embodiment, nickel-titanium powder with a certain nickel-titanium mass fraction ratio is selected and then processed in subsequent steps to obtain an impeller skeleton 2211 that meets the mechanical property and geometric morphology requirements. At the same time, the impeller skeleton 2211 can also provide a certain rigidity for the expanded pump head impeller 22 to ensure the stability of the pump head impeller 22 during use.

[0214] Optionally, in step 171b, nickel-titanium powder is 3D modeled and printed using a pre-designed pitch, spiral radius, and spiral height to obtain an integrally formed impeller skeleton 2211; the pre-designed pitch, spiral radius, and spiral height can all be set based on the specific values ​​of the spiral period corresponding to the few-period spiral impeller skeleton wire 22112;

[0215] Furthermore, in step 173b, the mold to which the impeller skeleton 2211 is fixed is subjected to heat treatment to obtain an impeller skeleton 2211 having mechanical properties (superelasticity) and geometric morphology (few-period spiral) that meet the requirements; here, the heating method is preferably constant temperature heating in a muffle furnace, the constant temperature heating temperature is preferably 450°C-550°C, more preferably 500°C, and the heating time is preferably 10 minutes-30 minutes, more preferably 15 minutes, to prepare an impeller skeleton 2211 that meets the use requirements.

[0216] In another optional embodiment of the present invention, the impeller skeleton 2211 can also be prepared by cutting the nickel-titanium alloy tube by femtosecond laser. When the impeller skeleton 2211 is prepared by cutting the nickel-titanium alloy tube by femtosecond laser, refer to Figure 21 and Figure 22 , the preparation of the impeller skeleton 2211 may include:

[0217] Step 171c: Select a nickel-titanium alloy tube and use a femtosecond laser to process it according to the design drawing to obtain an impeller skeleton 2211 in a folded state. The nickel-titanium ratio of the nickel-titanium alloy tube is preferably 53:47-60:40, more preferably 56:44.

[0218] Step 172c, twisting the impeller skeleton 21 to an unfolded state, and fixing the unfolded impeller skeleton 2211 using a mold that meets the required size;

[0219] Step 173c, placing the mold into a heating device for heating;

[0220] Step 174c: After heating, take out the mold to obtain the impeller skeleton 2211 with mechanical properties and geometric morphology that meet the requirements.

[0221] Optionally, in step 171c, a nickel-titanium alloy tube having a certain nickel-titanium mass fraction ratio is selected and then processed in subsequent steps to obtain an impeller skeleton 2211 that meets the mechanical property and geometric morphology requirements. At the same time, the impeller skeleton 2211 can also provide a certain rigidity for the expanded pump head impeller 22 to ensure the stability of the pump head impeller 22 during use.

[0222] Here, the design drawing includes a cutting pitch, a cutting spiral radius, and a cutting spiral height; preferably, the cutting pitch, the cutting spiral radius, and the cutting spiral height can be set according to the specific values ​​of the spiral period corresponding to the impeller skeleton 2211 in the multi-periodic spiral folded state; further, the multi-periodic spiral folded state impeller skeleton 2211 is twisted into a multi-periodic spiral unfolded state and fixed with a corresponding mold to prevent the impeller skeleton 2211 from being deformed by heat during heat treatment;

[0223] Furthermore, in step 173c, the mold to which the impeller skeleton 2211 is fixed is subjected to heat treatment to obtain an impeller skeleton 2211 having mechanical properties (superelasticity) and geometric morphology (few-period spiral) that meet the requirements; here, the heating method is preferably constant temperature heating in a muffle furnace, the constant temperature heating temperature is preferably 450°C-550°C, more preferably 500°C, and the heating time is preferably 10 minutes-30 minutes, more preferably 15 minutes, to prepare an impeller skeleton 2211 that meets the use requirements.

[0224] Under normal conditions, the pump head impeller 22 is in an expanded state (eg Figure 23 As shown), at this time, the impeller skeleton wire 22112 is spiral, preferably a few-cycle spiral (as shown Figure 12 As shown in FIG. 2 ), for example, it can be a single-cycle spiral or a double-cycle spiral, and the outer edge of the spiral extends outward. When the pump head impeller 22 is in the expanded state, when the proximal fixing ring 22113 rotates in the spiral direction relative to the distal fixing ring 22111, the spiral period of the impeller skeleton wire 22112 increases, and the impeller skeleton wire 22112 is further twisted and pre-tightened to a folded state (as shown in FIG. 2 ). Figure 13 As shown), the outer edge of the spiral is retracted inward, the outer diameter of the pump head impeller 22 is reduced, and the following is obtained: Figure 24 The pump head impeller 22 is shown in the folded state. Figure 24 The pre-tightening force is released in the rotation direction shown, so that the impeller skeleton wire 22112 recovers at least a periodic spiral shape under the action of elasticity, the outer edge of the spiral extends outward, and the impeller blade surface 2212 is pushed outward, so as to obtain the following Figure 23 The pump head impeller 22 shown is in the expanded state. Figure 23 By twisting in the direction of rotation shown in FIG. Figure 24 The pump head impeller 22 is shown in a folded state.

[0225] In an optional embodiment of the present invention, Figures 25 to 26 As shown, the pump head transmission assembly 23 includes a core sleeve 236, a top shaft 235, a top shaft bearing 233, a top shaft sleeve 232 and a top sleeve 231. The above step 1011 may further include:

[0226] Step 10112: insert the core sleeve 236 through the impeller frame 2211 and securely connect the distal end of the core sleeve 236 to the distal fixing ring 22111;

[0227] Step 10113, fix the proximal end of the top shaft 235 into the distal end of the core shaft sleeve 236;

[0228] Step 10114: sleeve the top shaft bearing 233 onto the distal end of the top shaft 235 , and make the proximal end surface of the top shaft bearing 233 contact the distal end surface of the core shaft sleeve 236 ;

[0229] Step 10115: Fix the top shaft sleeve 232 on the distal end of the top shaft 235 and limit the inner edge of the top shaft bearing 233 between the distal end surface of the core shaft sleeve 236 and the proximal end surface of the top shaft sleeve 232;

[0230] Step 10116: Sleeve the proximal end of the top sleeve 231 onto the distal end of the top shaft 235.

[0231] In this embodiment, the core sleeve 236 is passed through the proximal fixing ring 22113 and the distal fixing ring 22111 , and the distal end of the core sleeve 236 is fixedly connected to the distal fixing ring 22111 .

[0232] Furthermore, the pump head transmission assembly 23 further includes a core shaft collar 237 and a top collar 234. The above step 1011 may further include:

[0233] Step 10117: securely sleeve the mandrel collar 237 onto the proximal end of the mandrel sleeve 236, align the proximal end surface of the mandrel collar 237 with the proximal end surface of the mandrel sleeve 236, and position the mandrel collar 237 between the proximal end of the proximal fixing ring 22113 and the distal end of the twisting connector 222.

[0234] In step 10118 , the top collar 234 is sleeved on the distal end of the core sleeve 236 , and the distal end surface of the top collar 234 is fixedly connected to the proximal end surface of the top sleeve 231 .

[0235] In this embodiment, the proximal end surface of the mandrel collar 237 is aligned with the proximal end surface of the mandrel sleeve 236, and the mandrel collar 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236, and the mandrel collar 237 is confined between the proximal end of the proximal fixing ring 22113 and the distal end of the twisting connector 222. Biocompatible glue can be used to bond the sleeve 236 and the mandrel collar 237 to ensure that the mandrel collar 237 does not fall off the mandrel sleeve 236.

[0236] Preferably, the foldable impeller 221 can be axially positioned by the distal end surface of the core shaft ring 237, and on this basis, the distal fixing ring 22111 and the core shaft sleeve 236 can be bonded using biocompatible glue;

[0237] Here, the proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235 via the top shaft bearing 233; the top shaft bearing 233 is embedded in the annular groove formed at the proximal end of the top sleeve 231, and the outer edge of the top shaft bearing 233 is confined between the annular groove and the top sleeve ring 234. Preferably, a biocompatible glue can be used to bond the top shaft sleeve 232 to the top shaft 235 to ensure that the top shaft sleeve 232 does not fall off the top shaft 235. After the top sleeve 231 is sleeved onto the top shaft bearing 233, while ensuring that the top sleeve 231 and the distal end surface of the top shaft bearing 233 are in contact, and the top sleeve ring 234 and the proximal end surface of the top shaft bearing 233 are in contact, the top sleeve 231 and the top sleeve ring 234 can be bonded and fixed using biocompatible glue.

[0238] Preferably, the top sleeve 231, top shaft sleeve 232, top collar 234, and mandrel collar 237 can be prepared by metal 3D printing of stainless steel, the top shaft 235 can be prepared by cutting a super-hard high-speed steel round bar, and the mandrel sleeve 236 can be prepared by cutting a stainless steel capillary. Here, the top shaft bearing 233 can be customized and purchased according to the specifications of the prepared other components.

[0239] Reference Figure 27 In an optional embodiment of the present invention, the above step 2 may include:

[0240] In step 201 , the proximal end of the core shaft sleeve 236 is sleeved in the proximal fixing ring 22113 and the proximal end of the core shaft sleeve 236 is fixedly connected to the core shaft 33 .

[0241] In this embodiment, when the core shaft 33 is inserted into the core shaft sleeve 236 until the distal end face of the core shaft 33 contacts the proximal end face of the top shaft 235, the core shaft sleeve 236 and the core shaft 33 can be bonded and fixed using biocompatible glue; since the proximal end of the core shaft 33 is transmission-connected to the core shaft drive module 43, when the core shaft 33 is driven to rotate by the core shaft drive module 43, the core shaft 33 drives the pump head transmission assembly 23 to rotate, and drives the distal end of the foldable impeller 221 to rotate through the pump head transmission assembly 23.

[0242] The distal end of the core shaft sleeve 236 is fixedly connected to the distal fixing ring 22111 of the pump head impeller 22, and the proximal end of the core shaft sleeve 236 is fixedly connected to the distal end of the core shaft 33. Since the proximal end of the core shaft 33 is connected to the core shaft drive module 43, the core shaft 33 is driven to rotate by the core shaft drive module 43. When the core shaft 33 rotates, the core shaft sleeve 236 drives the distal fixing ring 22111 of the pump head impeller 22 to rotate, so that the distal end of the foldable impeller 221 keeps rotating synchronously with the core shaft 33.

[0243] In an optional embodiment of the present invention, Figures 28 to 29 As shown, the pump head protection assembly 21 includes an anchor bracket 212 and a top sleeve tip 211. The above step 110 may include:

[0244] Step 1101, fix the distal end of the anchoring bracket 212 on the distal end of the top sleeve 231, set the top sleeve tip 211 on the distal end of the anchoring bracket 212, and fix the proximal end of the top sleeve tip 211 to the distal end of the top sleeve 231; fix the proximal end of the anchoring bracket 212 to the distal end of the protective sleeve 31.

[0245] In this embodiment, both the proximal and distal ends of the anchoring bracket 212 can be configured as annular; optionally, an anchoring groove is provided at the distal end of the top sleeve 231, and an anchoring rod is provided at the proximal end of the top sleeve tip 211. During assembly, the anchoring rod at the proximal end of the top sleeve tip 211 is plugged into the anchoring groove at the distal end of the top sleeve 231 to install the proximal end of the top sleeve tip 211 within the top sleeve 231. Optionally, the distal end of the top sleeve tip 211 is configured as a smooth dome shape to facilitate the entire micropump head 2 to be introduced into the patient's body through minimally invasive intervention and to reduce the resistance encountered by blood flow through the micropump head 2.

[0246] Optionally, the pump head protection assembly 21 further includes a bracket protection sleeve connecting ring 213. The above step 1101 may further include:

[0247] Step 11011, embed and fix the distal end of the stent protective sleeve connecting ring 213 into the annular proximal end of the anchoring stent 212, and align the distal end face of the stent protective sleeve connecting ring 213 with the distal end face of the annular proximal end of the anchoring stent 212, and slide the stent protective sleeve connecting ring 213 outside the twisting shell 32 and fix it to the distal end of the protective sleeve 31.

[0248] Here, after the proximal annular end of the anchoring stent 212 is placed over the stent protective sleeve connecting ring 213 and the distal end surface of the stent protective sleeve connecting ring 213 is ensured to be flush with the distal end surface of the proximal annular end of the anchoring stent 212, a biocompatible glue can be used to bond and secure the proximal end of the anchoring stent 212 to the stent protective sleeve connecting ring 213. Subsequently, the protective sleeve 31 is placed over the proximal end of the stent protective sleeve connecting ring 213 and, while ensuring that the distal end surface of the protective sleeve 31 is in contact with the proximal end surface of the proximal annular end of the anchoring stent 212, a biocompatible glue can be used to bond and secure the protective sleeve 31 to the stent protective sleeve connecting ring 213 and then to the anchoring stent 212.

[0249] Optionally, the anchor stent 212 includes an anchor stent skeleton 2121 and an anchor stent membrane 2122, wherein the anchor stent skeleton 2121 includes an anchor stent skeleton proximal ring, an anchor stent skeleton distal ring, and a plurality of anchor stent skeleton wires arranged in parallel between the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring. The above step 11011 may include:

[0250] Step 110111, fix the distal ring of the anchoring stent frame to the distal end of the top sleeve 231, and embed and fix the distal end of the stent protection sleeve connecting ring 213 into the proximal ring of the anchoring stent frame.

[0251] In this embodiment, the anchoring support skeleton 2121 provides a certain anchoring support force for the entire pump head protection assembly 21; optionally, during assembly, the anchoring support membrane 2122 is sleeved outside the anchoring support skeleton 2121 to reduce the contact stress between the anchoring support 212 and the blood vessel; preferably, the anchoring support skeleton 2121 and the anchoring support membrane 2122 can be bonded and fixed by biocompatible glue.

[0252] Here, the anchoring bracket skeleton 2121 can be prepared by femtosecond laser cutting of nickel-titanium alloy tubes (the specific process can refer to the specific process of preparing the impeller skeleton 2211 using femtosecond laser cutting of nickel-titanium alloy tubes, which will not be described in detail here), and the anchoring bracket membrane 2122 can be prepared by molding medical silicone material; preferably, the medical silicone material can be prepared by stirring and mixing Dragon Skin silicone and Slic Thinner diluent in a mass ratio of 2:1 at room temperature, and heating and curing to form a film; the medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be withstood is 675.3kPa, to meet the needs of the entire micro pump head 2 during use, the top sleeve tip 211 can be prepared by metal 3D printing stainless steel, and the bracket protective sleeve connecting ring 213 can be prepared by cutting the copper sleeve.

[0253] Here, the proximal ring of the anchoring stent skeleton is embedded in the stent protective sleeve connecting ring 213, and the fixed connection with the protective sleeve 31 is further strengthened by the stent protective sleeve connecting ring 213. The distal ring of the anchoring stent skeleton is fixed to the distal end of the top sleeve tip 211. The anchoring stent skeleton wire is provided in multiple pieces, and the multiple anchoring stent skeleton wires are arranged in parallel between the distal ring of the anchoring stent skeleton and the proximal ring of the anchoring stent skeleton, forming an anchoring stent skeleton 2121 with a cage-like structure; when the proximal ring of the anchoring stent skeleton and the distal ring of the anchoring stent skeleton approach each other, the anchoring stent skeleton wire can bend outward to expand the cage-like structure outward; conversely, the anchoring stent skeleton wire can be stretched at both ends to shrink the cage-like structure inward.

[0254] In an optional embodiment of the present invention, Figures 30 to 31 As shown, the protective cover driving module 41 includes a protective cover slider 411, a protective cover slider bearing 412 and a protective cover slider end cover 413. Figure 32 , the above step 200 may include:

[0255] Step 2001: insert the protective cover slider bearing 412 into the proximal annular groove of the protective cover slider 411. At the same time, the outer edge of the protective cover slider bearing 412 is confined between the proximal annular groove of the protective cover slider 411 and the protective cover slider end cover 413. The protective cover slider end cover 413 is disposed at the proximal end of the protective cover slider 411 and fixedly connected to the protective cover slider 411.

[0256] In step 2002 , the protective cover slider 411 is sleeved on the proximal end of the protective cover 31 and the distal end surface of the protective cover slider bearing 412 is brought into contact with the proximal end surface of the protective cover 31 , and the protective cover slider 411 is fixedly connected to the protective cover 31 .

[0257] In this embodiment, the proximal end of the protective cover slider 411 is provided with an annular groove adapted to the protective cover slider bearing 412. During assembly, the protective cover slider bearing 412 is first installed in the annular groove at the proximal end of the protective cover slider 411, and then the protective cover slider end cover 413 is installed to the proximal end of the protective cover slider 411. Finally, the protective cover slider 411 with the protective cover slider bearing 412 and the protective cover slider end cover 413 installed is sleeved on the proximal end of the protective cover 31 and fixedly connected to the protective cover 31.

[0258] Here, the fixing of the protective cover slider end cap 413 to the protective cover slider 411 and the fixing of the protective cover slider 411 to the protective cover 31 can be performed by gluing. Preferably, the protective cover slider 411 and the protective cover slider end cap 413 can be prepared by light-curing 3D printing medical hard resin.

[0259] Optionally, the protective cover driving module 41 includes at least two protective cover slider bearings 412, and at least two protective cover slider bearings 412 are embedded in the proximal ring groove of the protective cover slider 411, and the outer edges of at least two protective cover slider bearings 412 are limited between the proximal ring groove of the protective cover slider 411 and the protective cover slider end cover 413; during assembly, the distal end faces of the two protective cover slider bearings 412 away from the protective cover slider end cover 413 are brought into contact with the proximal end face of the protective cover 31; the protective cover slider end cover 413 is sleeved on the proximal end of the protective cover 31, and when the distal end face of the protective cover slider bearing 412 is in contact with the distal end face of the ring groove of the protective cover slider 411 and the proximal end face of the protective cover slider bearing 412 is in contact with the distal end face of the protective cover slider end cover 413, glue is used to bond and fix the protective cover slider 411 and the protective cover slider end cover 413.

[0260] Preferably, the protective cover slider 411 is provided with a protective cover slider locking piece 4111, so that during subsequent installation, the protective cover slider 4111 can be locked at different positions of the shell 40 through the cooperation between the protective cover slider locking piece 4111 and the corresponding structure at different positions of the shell 40. Preferably, the protective cover slider locking piece 4111 is a groove set on the surface of the protective cover slider 411, which will be further described in detail below.

[0261] In an optional embodiment of the present invention, Figures 34 to 37 As shown, the twisting shell driving module 42 includes a twisting shell connector 428 and a twisting gear set, wherein the twisting gear set includes a first twisting gear shaft 426, a first twisting gear 425, a first twisting gear shaft bearing 424, a twisting shell connector bearing 427, a second gear set 421, a twisting shell sleeve 423 and a twisting shell sleeve bearing 422, as shown in FIG. Figure 33 As shown, the above step 3 may include:

[0262] Step 301: Put the twisting shell shaft sleeve bearings 422 onto both ends of the twisting shell shaft sleeve 423 respectively;

[0263] Step 302: Sleeve the twisting housing shaft sleeve 423 with twisting housing shaft sleeve bearings 422 at both ends onto the proximal end of the twisting housing 32;

[0264] Step 303: sleeve the first twisting gear 425 onto the first twisting gear shaft 426, dispose the first twisting gear shaft bearing 424 at the distal end of the first twisting gear shaft 426, and sleeve the first twisting gear shaft 426 onto the proximal end of the twisting housing 32;

[0265] Step 304: Dispose the twisting housing connector bearing 427 in the middle of the twisting housing connector 428 and insert the twisting housing connector 428 onto the proximal end of the twisting housing 32. When the proximal end surface of the twisting housing connector 428 is aligned with the proximal end surface of the twisting housing 32, the twisting housing connector 428 is fixedly connected to the twisting housing 32.

[0266] Step 305 , the proximal end of the first twisting gear shaft 426 is sleeved onto the distal end of the twisting housing connector 428 and fixedly connected to the twisting housing connector 428 .

[0267] In this embodiment, during assembly, the twisting shell connector 428 is fixedly connected to the proximal end of the twisting shell 32, and at the same time, the proximal end of the twisting shell connector 428 is detachably connected to the distal end of the core shaft driving module 43, and the twisting gear set is arranged at the distal end of the twisting shell connector 428, so that when the distal end of the core shaft driving module 43 is separated from the proximal end of the twisting shell driving module 42, the twisting shell connector 428 is controlled to rotate by the twisting gear set.

[0268] Here, two sets of twisting shell shaft sleeve bearings 422 are provided and are respectively sleeved on both ends of the twisting shell shaft sleeve 423, and then the twisting shell shaft sleeve 423 is sleeved onto the proximal end of the twisting shell 32;

[0269] The first twisting gear shaft 426 can be configured as a multi-stepped shaft. During assembly, the first twisting gear 425 is assembled to the D-shaped shaft section of the first twisting gear shaft 426 and preferably fixed using a cutting-edge machine. Further, the first twisting gear shaft bearing 424 is sleeved onto the distal end of the first twisting gear shaft 426, and the first twisting gear shaft 426 is rotatably supported within the housing 40.

[0270] Insert the twisting shell connector bearing 427 from the distal end of the twisting shell connector 428 and put it into the middle section of the twisting shell connector 428, and then put the twisting shell connector 428 into the proximal end of the twisting shell 32. At the same time, when the proximal end face of the twisting shell connector 428 is aligned with the proximal end face of the twisting shell 32, it is preferred to use a cutting-edge machine rice to fix the twisting shell connector 428 and the twisting shell 32; thereafter, put the proximal end of the first twisting gear shaft 426 into the distal end of the twisting shell connector 428, and preferably use a cutting-edge machine rice to fix the first twisting gear shaft 426 and the twisting shell connector 428.

[0271] Here, the first twisting gear 425, the first twisting gear shaft 426, the twisting housing connector 428, and the twisting housing sleeve 423 may all be manufactured by machining aluminum alloy.

[0272] In an optional embodiment of the present invention, Figures 39 to 40 As shown, the spindle drive module 43 includes a spindle connector 435, a coupling 437, a clutch 433, a clutch reset elastic member 434 and a spindle connector bearing 436. Figure 38 As shown, the above step 4 may include:

[0273] Step 401: Sleeve the spindle connector bearing 436 onto the proximal end of the spindle connector 435;

[0274] Step 402: Slide the proximal end of the clutch 433 onto the distal end of the spindle connector 435, and dispose the clutch reset elastic member 434 between the spindle connector 435 and the clutch 433;

[0275] In step 403 , the distal end of the core shaft connector 435 is sleeved onto the proximal end of the core shaft 33 and fixedly connected to the core shaft 33 , and the distal end of the clutch 433 is sleeved onto the proximal end of the twisting shell connector 428 .

[0276] In this embodiment, the clutch 433, the spindle connector 435, and the coupling 437 can all be made by machining aluminum alloy.

[0277] Here, after the core shaft connector bearing 436 and the clutch 433 are respectively put on the proximal end and distal end of the core shaft connector 435, the two ends of the clutch reset elastic member 434 are respectively inserted into the corresponding mounting holes of the core shaft connector 435 and the corresponding mounting holes of the clutch 433, and preferably, glue is used to bond and fix the proximal end face of the clutch reset elastic member 434 to the bottom surface of the corresponding mounting hole of the core shaft connector 435; preferably, the clutch reset elastic member 434 can include three clutch reset springs; since the proximal end of the clutch 433 is put on the distal end of the core shaft connector 435, the distal end of the clutch 433 is put on the proximal end of the twisting shell connector 428, under the action of the clutch reset elastic member 434, the clutch 433 and the twisting shell connector 428 can be plugged in.

[0278] Preferably, if Figures 41 to 42 As shown, the clutch 433 is matched with the twisting shell connector 428 and the core shaft connector 435 through slots to realize the transmission of rotational motion, wherein the clutch 433 and the core shaft connector 435 always maintain a connected state, while the clutch 433 and the twisting shell connector 428 have two states of connection and non-connection. The twisting shell connector 428 is provided with a groove at the proximal end to facilitate the connection between the clutch 433 and the twisting shell connector 428.

[0279] Furthermore, the proximal end of the core shaft 33 is inserted into the distal hole of the core shaft connector 435, and the core shaft connector 435 and the core shaft 33 are preferably fixed using a cutting-edge tool.

[0280] Optionally, the spindle drive module 43 further includes a motor flange 439 and a drive motor 4310. The above step 4 may further include:

[0281] Step 404 , fixedly connect the motor flange 439 to the drive motor 4310 , insert the proximal end of the core shaft connector 435 into the distal end of the coupling 437 , and insert the rotating shaft of the drive motor 4310 into the proximal end of the coupling 437 .

[0282] In this embodiment, the motor flange 439 can be fixed to the drive motor 4310 using screws, and then the proximal end of the core shaft connector 435 is inserted into the distal end of the coupling 437, and the rotating shaft of the drive motor 4310 is inserted into the proximal end of the coupling 437 and fixed with screws. Preferably, the motor flange 439 can be made of machined aluminum alloy.

[0283] Alternatively, as Figures 43 to 46 As shown, the drive control mechanism 4 further includes a housing 40, wherein the housing 40 includes a first housing 401 and a second housing 402. The preparation method of the left ventricular assist device may further include:

[0284] Step 5, install the assembly after the protective cover drive module 41 is proximally connected to the protective cover 31, the assembly after the twisting shell drive module 42 is proximally connected to the twisting shell 32, and the assembly after the core shaft drive module 43 is proximally connected to the core shaft 33 into the corresponding positions in the second shell 402 in sequence, set the first shell 401 relative to the second shell 402, and fix the first shell 401 to the second shell 402 to form a cavity structure inside.

[0285] Optionally, the housing 40 further includes a distal cover 403, a brake assembly cover 405, a second gear set cover 406, and a proximal cover 404. The method for preparing the left ventricular assist device may further include:

[0286] Step 6: Distal cover 403 and proximal cover 404 are respectively arranged at the distal end and proximal end of the shell 40 , and distal cover 403 is fixedly connected to the distal end of the shell 40 , and proximal cover 404 is fixedly connected to the proximal end of the shell 40 .

[0287] In this embodiment, the first housing 401 and the second housing 402 are arranged opposite to each other and are assembled together to form a cavity structure for mounting each assembly.

[0288] Preferably, a boss is provided on the mating surface between the first shell 401 and the second shell 402; and a groove is provided on the mating surface between the second shell 402 and the first shell 401 at a position corresponding to the boss. After the assembly is installed in the second shell 402, the boss on the mating surface of the first shell 401 is aligned with the groove on the mating surface of the second shell 402, and the first shell 401 is assembled to the second shell 402, and the two are fixed with screws.

[0289] Preferably, if Figure 45As shown, the first housing 401 has a first optical fiber groove 4014 formed on its mating surface. Figure 46 As shown, a second optical fiber groove 4024 is provided on the mating surface of the second shell 402; when the first shell 401 and the second shell 402 are arranged relative to each other to form a shell 40 with a cavity structure, the first optical fiber groove 4014 and the second optical fiber groove 4024 are also connected to each other to form an optical fiber groove for laying the optical fiber 51.

[0290] Preferably, the distal end of the first shell 401 and the distal end of the second shell 402, and the proximal end of the first shell 401 and the proximal end of the second shell 402 are respectively provided with external threads that dock with each other, so as to facilitate screwing and fixing the distal end of the first shell 401 and the distal end of the second shell 402 to the distal cover 403 and screwing and fixing the proximal end of the first shell 401 and the proximal end of the second shell 402 to the proximal cover 404, so as to ensure the stability of the connection between the first shell 401 and the second shell 402.

[0291] Preferably, if Figures 45 to 48 As shown, a first protrusion 4011, a second protrusion 4012, and a third protrusion 4013 are provided on the outer wall of the first housing 401, and a fourth protrusion 4021, a fifth protrusion 4022, and a sixth protrusion 4023 are provided on the outer wall of the second housing 402. The first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021, and the fifth protrusion 4022 cooperate with a protective cover slider locking member 4111 on the protective cover slider 411 to lock the protective cover slider 411 in different positions of the housing 40. The third protrusion 4013 and the sixth protrusion 4023 cooperate with relevant components of the spindle drive module 43, which will be described in further detail below.

[0292] Preferably, a sliding groove is opened on the shell 40 along the axial direction, and the two sides of the protective cover slider 411 are slidably arranged in the sliding groove to enable the entire protective cover slider 411 to slide along the axial direction in the shell 40, and the protective cover slider 411 is locked at different positions on the shell 40 through the protective cover slider locking piece 4111.

[0293] In an optional embodiment of the present invention, the spindle drive module 43 further includes a clutch ring 432 and a clutch fork 431, wherein, as shown in FIG. Figure 49 As shown, the clutch ring 432 includes a first clutch ring 4321 and a second clutch ring 4322. The preparation method of the left ventricular assist device may further include:

[0294] Step 7: sleeve the first clutch ring 4321 outside the first housing 401 , and sleeve the second clutch ring 4322 outside the second housing 402 and fixedly connect it to the first clutch ring 4321 .

[0295] In this embodiment, a first clutch ring 4321 and a second clutch ring 4322 are assembled into the housing 40 from opposite directions, forming an annular clutch ring 432 that is sleeved onto the housing 40. Preferably, a boss is provided on the mating surfaces of the first clutch ring 4321 and the second clutch ring 4322; a groove is provided on the mating surfaces of the second clutch ring 4322 and the first clutch ring 4321, corresponding to the boss. The first clutch ring 4321 is assembled onto the second clutch ring 4322, with the boss aligned with the groove, and the two are secured together using glue. Here, the clutch fork 431, the first clutch ring 4321, and the second clutch ring 4322 can all be fabricated using a photocurable 3D printing method using medical hard resin.

[0296] In an optional embodiment of the present invention, the above step 4 may include:

[0297] In step 405, the clutch fork 431 is set in the clutch fork mounting hole 4323 of the clutch ring 432 and passes through the housing 40 to cooperate with the clutch 433, so that the clutch 433 can be driven to move by operating the clutch ring 432, thereby separating or connecting the clutch 433 and the twisting shell connector 428.

[0298] In this embodiment, a clutch fork mounting hole 4323 is provided radially on the clutch ring 432. The clutch fork 431 is disposed in the clutch fork mounting hole 4323 and passes through the housing 40 to cooperate with the clutch 433. By operating the clutch ring 432, the clutch 433 can be driven to move, thereby separating or connecting the clutch 433 and the twisting shell connector 428, thereby separating or connecting the distal end of the spindle drive module 43 and the proximal end of the twisting shell drive module 42.

[0299] Here, the first clutch ring 4321 and the second clutch ring 4322 are assembled into the housing 40 from opposite directions. Then, the two clutch forks 431 are assembled into the clutch rings 432, preferably using glue. During the assembly process, ensure that the clutch forks 431 can be inserted into the first housing 401 and the second housing 402, and that the proximal end of the clutch 433 is positioned between the two fingers of the clutch forks 431.

[0300] Preferably, if Figures 45 to 46 As shown, the first housing 401 and the second housing 402 are respectively provided with Z-shaped grooves for limiting the movement trajectory of the clutch ring 432 and locking the clutch fork 431. Figure 55Rotate the clutch ring 432 in the direction shown to release the locking state of the clutch fork 431 when the clutch 433 is connected to the twisting shell connector 428 and the core shaft connector 435, and then Figure 56 As shown, the clutch ring 432 is slid toward the proximal end, and the clutch ring 432 moves toward the proximal end with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it compresses the clutch reset elastic member 434 while pushing the clutch 433 toward the proximal end until the clutch ring 432 can no longer move toward the proximal end. Figure 57 The clutch ring 432 is rotated again in the direction shown, so that the clutch fork 431 enters another locking state. At this time, the clutch 433 and the twisting shell connecting member 428 are in a disconnected state.

[0301] Alternatively, as Figure 36 As shown, the second gear set 421 includes a second twisting gear shaft 4214, a second twisting gear 4213, a second twisting gear shaft bearing 4212, a second twisting gear limiter 4211, and a second twisting gear reset elastic member 4215. The preparation method of the left ventricular assist device may further include:

[0302] Step 8: embed the second twisting gear shaft bearing 4212 into both sides of the second twisting gear 4213, and align the outer end surface of the second twisting gear shaft bearing 4212 with the end surface of the second twisting gear 4213;

[0303] Step 9, insert the second twisting gear shaft 4214 into the second twisting gear shaft bearing 4212, and make the center of the second twisting gear shaft 4214 coincide with the center of the second twisting gear 4213;

[0304] Step 10: The second twisting gear limiters 4211 are respectively arranged at both ends of the second twisting gear shaft 4214 and fixedly connected to the second twisting gear shaft 4214;

[0305] Step 11, insert the second twisting gear reset elastic member 4215 into the corresponding mounting hole of the second twisting gear limiter 4211, and insert one side of the second twisting gear limiter 4211 into the housing 40, and extend the other side of the second twisting gear limiter 4211 out of the housing 40, so as to set the second twisting gear reset elastic member 4215 between the second twisting gear limiter 4211 and the housing 40, so that the second twisting gear 4213 is supported on the outside of the housing 40 and the second twisting gear 4213 and the first twisting gear 425 are detachably engaged through the second twisting gear reset elastic member 4215.

[0306] In this embodiment, when the second twisting gear limiting members 4211 are respectively arranged at both ends of the second twisting gear shaft 4214, the small ends of the two second twisting gear limiting members 4211 can be respectively put on the two ends of the second twisting gear shaft 4214 with the small ends facing inward, and on the premise that the end faces of the large ends of the second twisting gear limiting members 4211 are aligned with the end faces of the second twisting gear shaft 4214 and the top surfaces of the two second twisting gear limiting members 4211 are also aligned, it is preferred to use a cutting-edge machine to fix the two second twisting gear limiting members 4211 and the second twisting gear shaft 4214 respectively;

[0307] Preferably, the second twisting gear reset elastic member 4215 may include two sets of second twisting gear reset springs, wherein each set of second twisting gear reset springs includes two springs. Here, preferably, glue may be used to bond the end surface of the second twisting gear reset elastic member 4215 to the bottom surface of the corresponding mounting hole of the second twisting gear stopper 4211.

[0308] By setting the second gear set 421, when the distal end of the core shaft driving module 43 is separated from the proximal end of the twisting shell driving module 42, the second twisting gear 4213 is pressed inward until the second twisting gear 4213 is engaged with the first twisting gear 425. At this time, the first twisting gear 425 can be operated by toggling the second twisting gear 4213, and the twisting shell connecting piece 428 fixedly connected to the first twisting gear 425 is driven to rotate synchronously with the first twisting gear 425 through the first twisting gear 425, and the twisting shell 32 is driven to rotate synchronously with the first twisting gear 425, and the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end through the twisting shell 32, thereby controlling the pump head impeller 22 to be expanded or folded.

[0309] Furthermore, in step 12, the second gear set cover 406 is covered on the second twisting gear limiter 4211, and the second gear set cover 406 is fixedly connected to the housing 40; the second gear set cover 406 is used to limit the second gear set 421 to prevent the second gear set 421 from falling off from the housing 40, and at the same time avoid misoperation of the second gear set 421.

[0310] Optionally, the spindle drive module 43 further includes a brake assembly 438. The method for preparing the left ventricular assist device may further include:

[0311] In step 13 , the brake assemblies 438 are arranged in pairs at corresponding positions of the housing 40 , and the brake assemblies 438 are arranged in pairs at both sides of the coupling 437 to brake the coupling 437 .

[0312] In this embodiment, two brake assemblies 438 are arranged relative to each other on the first shell 401 and the second shell 402, and the inner sides of the two brake assemblies 438 are respectively matched with the outer walls opposite to each other of the coupling 437, so that the coupling 437 is braked by the brake assemblies 438; preferably, brake through holes are respectively opened on the first shell 401 and the second shell 402, so that one side of the brake assembly 438 can pass through the brake through hole and translate radially at the brake through hole.

[0313] Alternatively, as Figures 50 to 51 As shown, the brake assembly 438 includes a brake slider 4381, a brake member 4382, and a pair of brake member reset elastic members 4383. The above step 13 may include:

[0314] Step 131: Insert one end of the pair of brake reset elastic members 4383 into the corresponding mounting holes of the brake member 4382, insert the small end of the brake member 4382 into the housing 40 and engage with the outer wall of the coupling 437, and insert the other end of the pair of brake reset elastic members 4383 into the corresponding mounting holes of the housing 40;

[0315] In step 132 , the brake member slider 4381 is disposed outside the housing 40 and is slidably connected to the large end of the brake member 4382 .

[0316] In this embodiment, the brake slider 4381 and the brake member 4382 can both be manufactured by open mold injection molding.

[0317] Here, the brake slider 4381 is disposed outside the housing 40, and the large end of the brake member 4382 extends out of the housing 40 and is slidably connected to the brake slider 4381, and the small end of the brake member 4382 is inserted into the housing 40 and engaged with the outer wall of the coupling 437;

[0318] The brake member return elastic member 4383 is disposed between the brake member 4382 and the housing 40 and is used to separate the brake member 4382 from the coupling 437. Preferably, the brake member return elastic member 4383 may be a pair of brake member return springs. After one end of the brake member return elastic member 4383 is inserted into the corresponding mounting hole of the brake member 4382, the end surface of the brake member return elastic member 4383 is preferably bonded to the bottom surface of the corresponding mounting hole of the brake member 4382 using glue.

[0319] Preferably, a brake groove is respectively provided on the first shell 401 and the second shell 402, and the brake member slider 4381 is arranged in the brake groove and can translate axially in the brake groove; preferably, the brake member slider 4381 has a wedge-shaped bottom surface 43812, and the large end of the brake member 4382 is provided with a limiting groove 43821; during assembly, the wedge-shaped bottom surface 43812 and the two side surfaces of the brake member slider 4381 are respectively in contact with the arc-shaped top surface and the two side surfaces of the limiting groove 43821.

[0320] Preferably, if Figures 47 and 48 As shown, each brake slider 4381 in the two brake assemblies 438 is provided with two seventh protrusions 43811 along the translation direction. The two seventh protrusions 43811 on the brake slider 4381 in one brake assembly 438 respectively engage with the two third protrusions 4013 on the first housing 401, while the two seventh protrusions 43811 on the brake slider 4381 in the other brake assembly 438 respectively engage with the two sixth protrusions 4023 on the second housing 402. When the brake slider 4381 is slid and the brake resetting elastic member 4383 is pressed downward or released, the engagement between the seventh protrusions 43811 and the third and sixth protrusions 4013, 4023 locks the brake slider 4381 in both states: the brake 4382 in the brake assembly 438 is locked to the coupling 437, and the coupling 437 is released.

[0321] Furthermore, in step 14, the brake assembly cover 405 is positioned outside the brake slider 4381 and fixedly connected to the housing 40. Here, the two brake assembly covers 405 are respectively assembled to corresponding positions of the first housing 401 and the second housing 402 and fixed with screws to limit the brake assembly 438 and prevent accidental operation of the brake slider 4381.

[0322] The above embodiment of the present invention provides a method for preparing a left ventricular assist device. After the components are prepared and assembled, Figure 51 As shown, the specific use process mainly includes: implanting the micro pump head 2 in a folded state through the catheter 6, and then withdrawing the catheter 6; after removing the catheter 6, the pump head impeller 22 and the pump head protection component 21 of the micro pump head 2 are controlled to expand in the body through the cooperation between the transmission shaft 3 and the drive control mechanism 4 outside the body; after the pump head impeller 22 is controlled to expand, it keeps a fixed outer diameter and rotates in a single direction to achieve auxiliary blood supply; after the auxiliary blood supply is completed, the pump head impeller 22 stops rotating, and then the catheter 6 is inserted; at this time, the pump head impeller 22 and the pump head protection component 21 are controlled to fold in the body through the cooperation between the transmission shaft 3 and the drive control mechanism 4 outside the body; after the pump head impeller 22 and the pump head protection component 21 are controlled to fold, the micro pump head 2 is in a folded state, and the folded micro pump head 2 is stored in the catheter 6; finally, the folded micro pump head 2 is removed together with the catheter 6;

[0323] like Figure 53As shown, when the left ventricular assist device 1 is in the auxiliary blood supply state, the pump head impeller 22 and the pump head protection component 21 in the micro pump head 2 are in the expanded state due to their own elastic action. At this time, under the action of the second twisting gear reset elastic member 4215, the clutch reset elastic member 434 and the brake reset elastic member 4383, the second twisting gear 4213 and the first twisting gear 425 are in a non-meshing state, the brake member 4382 and the coupling 437 are in a non-contact state, and the clutch 433 and the twisting shell connector 428 and the core shaft connector 435 are all in a connected state; the driving motor 4310 drives the coupling 437 to rotate, the coupling 437 drives the core shaft connector 435 to rotate, and the core shaft connector 4383 drives the second twisting gear 4213 and the first twisting gear 425 to rotate. 5 drives the core shaft 33 and the clutch 433 to rotate synchronously, the clutch 433 drives the twisting housing connector 428 and drives the twisting housing 32 and the core shaft 33 to rotate synchronously through the twisting housing connector 428. When the twisting housing 32 and the core shaft 33 rotate synchronously, the distal end and the proximal end of the pump head impeller 22 deployed in the micro pump head 2 are driven to rotate synchronously, thereby ensuring that the entire pump head impeller 22 rotates synchronously with the twisting housing 32 and the core shaft 33. At this time, the pump head impeller 22 rotates as a whole with the outer diameter fixed, thereby realizing the blood pumping function; in addition, during the auxiliary blood supply process, the twisting housing connector 428 also drives the first twisting gear shaft 426 and the first twisting gear 425 to rotate, and the twisting housing 32 drives the twisting housing shaft sleeve 423 to rotate;

[0324] Taking the micro pump head 2 being converted from the expanded state to the folded state as an example, the conversion between the expanded state and the folded state can be achieved by the following steps:

[0325] Step 151, as Figure 54 As shown, the brake member slider 4381 is slid toward the far end, and the two brake members 4382 are pushed into the locked coupling 437 state while compressing the brake member reset elastic member 4383. At this time, the coupling 437, the core shaft connector 435, and the core shaft 33 are all unable to rotate; at this time, the brake member slider 4381 relies on the seventh protrusion 43811 on its own surface and the third protrusion 4013 corresponding to the surface of the first shell 401 and the sixth protrusion 4023 corresponding to the surface of the second shell 402 to achieve the locking of the brake member slider 4381 when the brake assembly 438 is in the locked coupling 437 state.

[0326] Step 152, press Figure 55 Rotate the clutch ring 432 in the direction shown to release the locked state of the clutch fork 431 when the clutch 433 is connected to the twisting shell connector 428 and the core shaft connector 435; then press Figure 56As shown in the direction, the clutch ring 432 is slid toward the proximal end, and the clutch ring 432 moves toward the proximal end with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it compresses the clutch reset elastic member 434 while pushing the clutch 433 toward the proximal end until the clutch ring 432 can no longer move toward the proximal end. Figure 57 The clutch ring 432 is rotated again in the direction shown, so that the clutch fork 431 enters another locking state, at which time the clutch 433 and the twisting shell connecting member 428 are in a non-connected state.

[0327] Step 153, as Figure 58 As shown, push the second gear set 421 inward until the second twisting gear 4213 is fully engaged with the first twisting gear 425, and then press Figure 59 The second twisting gear 4213 rotates in the direction shown, the second twisting gear 4213 drives the first twisting gear 425 to rotate in the opposite direction, the first twisting gear 425 drives the first twisting gear shaft 426 to rotate, the first twisting gear shaft 426 drives the twisting shell connector 428 to rotate, the twisting shell connector 428 drives the twisting shell 32 to rotate, and the twisting shell 32 drives the proximal end of the pump head impeller 22 to rotate, thereby realizing the folding of the pump head impeller 22.

[0328] Step 154, as Figure 60 As shown, the protective cover slider 411 slides toward the proximal end, the protective cover slider 411 drives the protective cover 31 to move toward the proximal end, and the protective cover 31 drives the proximal end of the pump head protection assembly 21 to move toward the proximal end, thereby realizing the folding of the pump head protection assembly 21; the protective cover slider 411 relies on the protective cover slider locking piece 4111 on its own surface and cooperates with the first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021 and the fifth protrusion 4022 corresponding to the surfaces of the first shell 401 and the second shell 402 to realize the locking of the protective cover slider 411 when the pump head protection assembly 21 is in the folded state.

[0329] At this point, the conversion of the micro pump head 2 in the left ventricular assist device 1 from the expanded state to the folded state is completed, and the conversion of the micro pump head 2 in the left ventricular assist device 1 from the folded state to the expanded state can be achieved by reversing the above steps.

[0330] Since the deployed state (normal state) is the primary state of the micropump head 2 in the left ventricular assist device 1, the second twisting gear 4213 and the first twisting gear 425 are normally in a non-meshed state, the clutch 433 and the twisting housing connector 428 are normally connected, and the brake 4382 and the coupling 437 are normally in a non-contact state. After use and removal of the left ventricular assist device 1, the micropump head 2, transmission shaft 3, protective sleeve drive module 41, clutch fork 431, and clutch ring 432 can be removed and replaced to achieve reusability of the drive control mechanism 4, thereby reducing the cost of the entire left ventricular assist device 1.

[0331] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A method for preparing a left ventricular assist device, wherein the left ventricular assist device (1) comprises a micro pump head (2), a transmission shaft (3) and a drive control mechanism (4), wherein: The micro pump head (2) comprises a pump head impeller (22) and a pump head transmission assembly (23); the transmission shaft (3) comprises a core shaft (33) and a twisting shell (32); the drive control mechanism (4) comprises a twisting shell drive module (42) and a core shaft drive module (43); and the method comprises the following steps: The pump head transmission assembly (23) is passed through the pump head impeller (22), and the distal end of the pump head impeller (22) is fixedly connected to the distal end of the pump head transmission assembly (23); the proximal end of the pump head impeller (22) is fixedly connected to the distal end of the twisting shell (32); Inserting the core shaft (33) into the twisting shell (32), and fixedly connecting the distal end of the core shaft (33) to the proximal end of the pump head transmission assembly (23); The twisting shell drive module (42) is arranged at the distal end of the core shaft drive module (43), and the distal end of the twisting shell drive module (42) is connected to the proximal end of the twisting shell (32) by transmission; The distal end of the core shaft drive module (43) is connected to the proximal end of the core shaft (33) by transmission, and the distal end of the core shaft drive module (43) is detachably connected to the proximal end of the twisting shell drive module (42); When the distal end of the core shaft driving module (43) is connected to the proximal end of the twisting shell driving module (42), the core shaft driving module (43) drives the core shaft (33) and the twisting shell (32) to rotate synchronously; and when the core shaft driving module (43) is separated from the twisting shell driving module (42), the core shaft driving module (43) stops running, the core shaft (33) is fixed, and the twisting shell driving module (42) drives the twisting shell (32) to rotate relative to the core shaft (33).

2. The method for preparing a left ventricular assist device according to claim 1, wherein: The micro pump head (2) further includes a pump head protection assembly (21), and the transmission shaft (3) further includes a protection sleeve (31). The step of "fixedly connecting the distal end of the pump head impeller (22) to the distal end of the pump head transmission assembly (23)" includes the following steps: The pump head protection assembly (21) is coaxially covered outside the pump head impeller (22), and the distal end of the pump head protection assembly (21) is fixedly connected to the distal end of the pump head transmission assembly (23), and the proximal end of the pump head protection assembly (21) is fixedly connected to the distal end of the protective sleeve (31).

3. The method for preparing a left ventricular assist device according to claim 2, characterized in that: The drive control mechanism (4) further comprises a protective sleeve drive module (41), and the step of "fixedly connecting the distal end of the core shaft (33) to the proximal end of the pump head transmission assembly (23)" comprises the following steps: The twisting shell (32) is inserted into the protective sleeve (31), and the protective sleeve driving module (41) is sleeved on the proximal end of the protective sleeve (31), and the protective sleeve driving module (41) is transmission-connected to the proximal end of the protective sleeve (31).

4. The method for preparing a left ventricular assist device according to claim 2, wherein: The pump head impeller (22) includes a foldable impeller (221) and a twisting connector (222), and the step of "fixedly connecting the distal end of the pump head impeller (22) to the distal end of the pump head transmission assembly (23), and fixedly connecting the proximal end of the pump head impeller (22) to the distal end of the twisting shell (32)" includes the steps of: The distal end of the foldable impeller (221) is fixedly connected to the distal end of the pump head transmission assembly (23), the proximal end of the foldable impeller (221) is clamped to the distal end of the twisting connector (222), and the proximal end of the twisting connector (222) is fixedly connected to the distal end of the twisting shell (32).

5. The method for preparing a left ventricular assist device according to claim 4, characterized in that: The foldable impeller (221) includes an impeller skeleton (2211) and an impeller blade (2212). The step of "fixedly connecting the distal end of the foldable impeller (221) to the distal end of the pump head transmission assembly (23), and clamping the proximal end of the foldable impeller (221) to the distal end of the twisting connector (222)" includes the following steps: The distal end of the impeller skeleton (2211) is fixedly connected to the distal end of the pump head transmission assembly (23), and the proximal end of the impeller skeleton (2211) is clamped to the distal end of the twisting connector (222).

6. The method for preparing a left ventricular assist device according to claim 5, characterized in that: Also includes the steps: The impeller blade surface (2212) is wrapped around the impeller skeleton (2211).

7. The method for preparing a left ventricular assist device according to claim 5, characterized in that: The impeller skeleton (2211) comprises a proximal fixing ring (22113), a distal fixing ring (22111) and an impeller skeleton wire (22112). The step of "fixedly connecting the distal end of the impeller skeleton (2211) to the distal end of the pump head transmission assembly (23), and clamping the proximal end of the impeller skeleton (2211) to the distal end of the twisting connector (222)" comprises the following steps: The impeller skeleton wire (22112) is spirally arranged between the proximal fixing ring (22113) and the distal fixing ring (22111), the distal fixing ring (22111) is fixedly connected to the distal end of the pump head transmission assembly (23), and the proximal end of the proximal fixing ring (22113) is clamped to the distal end of the twisting connector (222).

8. The method for preparing a left ventricular assist device according to claim 7, characterized in that: The pump head transmission assembly (23) includes a core shaft sleeve (236), a top shaft (235), a top shaft bearing (233), a top shaft sleeve (232) and a top sleeve (231), and the step of "fixedly connecting the distal end of the impeller skeleton (2211) to the distal end of the pump head transmission assembly (23)" includes the steps of: The core shaft sleeve (236) is passed through the impeller frame (2211), and the distal end of the core shaft sleeve (236) is fixedly connected to the distal end fixing ring (22111); The proximal end of the top shaft (235) is fixedly embedded in the distal end of the core shaft sleeve (236); The top shaft bearing (233) is sleeved on the distal end of the top shaft (235), and the proximal end surface of the top shaft bearing (233) is brought into contact with the distal end surface of the core shaft sleeve (236); The top shaft sleeve (232) is fixedly sleeved on the distal end of the top shaft (235), and the inner edge of the top shaft bearing (233) is limited to be located between the distal end surface of the core shaft sleeve (236) and the proximal end surface of the top shaft sleeve (232); The proximal end of the top sleeve (231) is sleeved on the distal end of the top shaft (235).

9. The method for preparing a left ventricular assist device according to claim 8, characterized in that: The pump head transmission assembly (23) further comprises a core shaft collar (237) and a top collar (234), and the method further comprises the steps of: The core shaft ring (237) is fixedly sleeved on the proximal end of the core shaft sleeve (236), and the proximal end surface of the core shaft ring (237) is aligned with the proximal end surface of the core shaft sleeve (236), and the core shaft ring (237) is limited between the proximal end of the proximal fixing ring (22113) and the distal end of the twisting connector (222); The top collar (234) is sleeved on the distal end of the core shaft sleeve (236), and the distal end surface of the top collar (234) is fixedly connected to the proximal end surface of the top sleeve (231).

10. The method for preparing a left ventricular assist device according to claim 8, characterized in that: The step of "fixedly connecting the distal end of the core shaft (33) to the proximal end of the pump head transmission assembly (23)" includes the steps of: The proximal end of the core shaft sleeve (236) is sleeved in the proximal fixing ring (22113) and the proximal end of the core shaft sleeve (236) is fixedly connected to the core shaft (33).

11. The method for preparing a left ventricular assist device according to claim 8, characterized in that: The pump head protection assembly (21) includes an anchor bracket (212) and a top sleeve tip (211), and the step of "fixedly connecting the distal end of the pump head protection assembly (21) to the distal end of the pump head transmission assembly (23), and fixedly connecting the proximal end of the pump head protection assembly (21) to the distal end of the protective sleeve (31)" includes the steps of: The distal end of the anchoring bracket (212) is sleeved and fixed on the distal end of the top sleeve (231), the top sleeve tip (211) is arranged on the distal end of the anchoring bracket (212), and the proximal end of the top sleeve tip (211) is fixedly connected to the distal end of the top sleeve (231); the proximal end of the anchoring bracket (212) is fixedly connected to the distal end of the protective sleeve (31).

12. The method for preparing a left ventricular assist device according to claim 11, characterized in that: The pump head protection assembly (21) further comprises a support protection sleeve connecting ring (213), and the step of "fixedly connecting the proximal end of the anchoring support (212) to the distal end of the protection sleeve (31)" further comprises the steps of: The distal end of the stent protective sleeve connecting ring (213) is embedded and fixed in the annular proximal end of the anchoring stent (212), and the distal end face of the stent protective sleeve connecting ring (213) is aligned with the distal end face of the annular proximal end of the anchoring stent (212), and the stent protective sleeve connecting ring (213) is slidably sleeved outside the twisting shell (32) and fixedly connected to the distal end of the protective sleeve (31).

13. The method for preparing a left ventricular assist device according to claim 12, characterized in that: The anchoring stent (212) comprises an anchoring stent skeleton (2121) and an anchoring stent membrane (2122), wherein the anchoring stent skeleton (2121) comprises an anchoring stent skeleton proximal ring, an anchoring stent skeleton distal ring, and a plurality of anchoring stent skeleton wires arranged in parallel between the anchoring stent skeleton proximal ring and the anchoring stent skeleton distal ring. The method further comprises the steps of: The distal ring of the anchoring stent frame is fixedly sleeved outside the distal end of the top sleeve (231), and the distal end of the stent protection sleeve connecting ring (213) is embedded and fixedly placed inside the proximal ring of the anchoring stent frame.

14. The method for preparing a left ventricular assist device according to claim 13, wherein: The method further comprises the steps of: The anchoring support membrane (2122) is sleeved outside the anchoring support frame (2121).

15. The method for preparing a left ventricular assist device according to claim 3, characterized in that: The protective cover driving module (41) includes a protective cover slider (411), a protective cover slider bearing (412), and a protective cover slider end cover (413). The step of "sleeving the protective cover driving module (41) on the proximal end of the protective cover (31) and simultaneously connecting the protective cover driving module (41) to the proximal end of the protective cover (31)" includes the following steps: The protective cover slider bearing (412) is embedded in the proximal annular groove of the protective cover slider (411), and the outer edge of the protective cover slider bearing (412) is limited between the proximal annular groove of the protective cover slider (411) and the protective cover slider end cover (413), and the protective cover slider end cover (413) is arranged at the proximal end of the protective cover slider (411) and fixedly connected to the protective cover slider (411); The protective cover slider (411) is sleeved on the proximal end of the protective cover (31) and the protective cover slider (411) is fixedly connected to the protective cover (31) when the distal end surface of the protective cover slider bearing (412) is in contact with the proximal end surface of the protective cover (31).

16. The method for preparing a left ventricular assist device according to claim 3, characterized in that: The twisting shell driving module (42) includes a twisting shell connecting member (428) and a twisting gear set, wherein the twisting gear set includes a first twisting gear shaft (426), a first twisting gear (425), a first twisting gear shaft bearing (424), a twisting shell connecting member bearing (427), a second gear set (421), a twisting shell shaft sleeve (423) and a twisting shell shaft sleeve bearing (422), and the step of "transmission-connecting the distal end of the twisting shell driving module (42) to the proximal end of the twisting shell (32)" includes the steps of: The twisting shell shaft sleeve bearings (422) are respectively mounted on both ends of the twisting shell shaft sleeve (423); The twisting shell shaft sleeve (423) with the twisting shell shaft sleeve bearings (422) respectively sleeved on both ends is sleeved on the proximal end of the twisting shell (32); The first twisting gear (425) is sleeved on the first twisting gear shaft (426), the first twisting gear shaft bearing (424) is arranged on the distal end of the first twisting gear shaft (426), and the first twisting gear shaft (426) is sleeved on the proximal end of the twisting shell (32); The twisting shell connecting member bearing (427) is arranged in the middle section of the twisting shell connecting member (428) and the twisting shell connecting member (428) is put on the proximal end of the twisting shell (32), and the twisting shell connecting member (428) is fixedly connected to the twisting shell (32) when the proximal end face of the twisting shell connecting member (428) is aligned with the proximal end face of the twisting shell (32); The proximal end of the first twisting gear shaft (426) is sleeved onto the distal end of the twisting shell connecting member (428) and fixedly connected to the twisting shell connecting member (428).

17. The method for preparing a left ventricular assist device according to claim 16, characterized in that: The spindle drive module (43) includes a spindle connector (435), a coupling (437), a clutch (433), a clutch reset elastic member (434), and a spindle connector bearing (436). The step of "transmission-connecting the distal end of the spindle drive module (43) to the proximal end of the spindle (33)" includes the following steps: The core shaft connecting member bearing (436) is sleeved on the proximal end of the core shaft connecting member (435); The proximal end of the clutch (433) is sleeved onto the distal end of the core shaft connector (435), and the clutch reset elastic member (434) is arranged between the core shaft connector (435) and the clutch (433); The distal end of the core shaft connector (435) is sleeved onto the exterior of the proximal end of the core shaft (33) and fixedly connected to the core shaft (33), and the distal end of the clutch (433) is sleeved onto the proximal end of the twisting shell connector (428).

18. The method for preparing a left ventricular assist device according to claim 17, wherein: The spindle drive module (43) further includes a motor flange (439) and a drive motor (4310), and the method further includes the steps of: The motor flange (439) is fixedly connected to the driving motor (4310), and the proximal end of the core shaft connector (435) is inserted into the distal end of the coupling (437), and the rotating shaft of the driving motor (4310) is inserted into the proximal end of the coupling (437).

19. The method for preparing a left ventricular assist device according to claim 17, wherein: The drive control mechanism (4) further comprises a housing (40), wherein the housing (40) comprises a first housing (401) and a second housing (402), and the method further comprises the steps of: The assembly after the protective sleeve drive module (41) is connected to the proximal end of the protective sleeve (31) through transmission, the assembly after the twisting shell drive module (42) is connected to the proximal end of the twisting shell (32) through transmission, and the assembly after the core shaft drive module (43) is connected to the proximal end of the core shaft (33) through transmission are sequentially installed at corresponding positions in the second shell (402), the first shell (401) is arranged relative to the second shell (402), and the first shell (401) and the second shell (402) are fixedly connected to form a cavity structure inside.

20. The method for preparing a left ventricular assist device according to claim 19, wherein: The housing (40) further comprises a distal cover (403), a brake assembly cover (405), a second gear set cover (406) and a proximal cover (404), and the method further comprises the steps of: The distal cover (403) and the proximal cover (404) are respectively arranged at the distal end and the proximal end of the shell (40), and the distal cover (403) is fixedly connected to the distal end of the shell (40), and the proximal cover (404) is fixedly connected to the proximal end of the shell (40).

21. The method for preparing a left ventricular assist device according to claim 19, wherein: The spindle drive module (43) further comprises a clutch ring (432) and a clutch fork (431), wherein the clutch ring (432) comprises a first clutch ring (4321) and a second clutch ring (4322), and the method further comprises the steps of: The first clutch ring (4321) is sleeved outside the first housing (401), and the second clutch ring (4322) is relatively sleeved outside the second housing (402) and fixedly connected to the first clutch ring (4321).

22. The method for preparing a left ventricular assist device according to claim 21, characterized in that: The step of "separably connecting the distal end of the core shaft drive module (43) to the proximal end of the twisting shell drive module (42)" comprises the steps of: The clutch fork (431) is arranged in the clutch fork mounting hole (4323) of the clutch ring (432) and passes through the housing (40) to cooperate with the clutch (433), so that the clutch (433) can be driven to move by operating the clutch ring (432), thereby separating or connecting the clutch (433) and the twisting shell connector (428).

23. The method for preparing a left ventricular assist device according to claim 20, wherein: The second gear set (421) comprises a second twisting gear shaft (4214), a second twisting gear (4213), a second twisting gear shaft bearing (4212), a second twisting gear limiter (4211) and a second twisting gear reset elastic member (4215), and the method further comprises the steps of: Embed the second twisting gear shaft bearing (4212) on both sides of the second twisting gear (4213), and align the outer end surface of the second twisting gear shaft bearing (4212) with the end surface of the second twisting gear (4213); Inserting the second twisting gear shaft (4214) into the second twisting gear shaft bearing (4212), and aligning the center of the second twisting gear shaft (4214) with the center of the second twisting gear (4213); The second twisting gear limiters (4211) are respectively arranged at both ends of the second twisting gear shaft (4214) and fixedly connected to the second twisting gear shaft (4214); The second twisting gear reset elastic member (4215) is inserted into the corresponding mounting hole of the second twisting gear limiter (4211), and one side of the second twisting gear limiter (4211) is inserted into the housing (40), and the other side of the second twisting gear limiter (4211) is extended out of the housing (40), so that the second twisting gear reset elastic member (4215) is arranged between the second twisting gear limiter (4211) and the housing (40), so that the second twisting gear (4213) is supported on the outside of the housing (40) and the second twisting gear (4213) and the first twisting gear (425) are detachably engaged through the second twisting gear reset elastic member (4215).

24. The method for preparing a left ventricular assist device according to claim 23, wherein: The method further comprises the steps of: The second gear set cover (406) is covered on the second twisting gear limiter (4211), and the second gear set cover (406) is fixedly connected to the housing (40).

25. The method for preparing a left ventricular assist device according to claim 20, characterized in that: The spindle drive module (43) further includes a brake assembly (438), and the method further includes the steps of: The brake assemblies (438) are arranged in pairs at corresponding positions of the housing (40), and the brake assemblies (438) are arranged in pairs at both sides of the coupling (437) and are used to brake the coupling (437).

26. The method for preparing a left ventricular assist device according to claim 25, characterized in that: The brake assembly (438) includes a brake slider (4381), a brake (4382) and a pair of brake reset elastic members (4383). The method further includes the steps of: Insert one end of the pair of brake member reset elastic members (4383) into the corresponding mounting hole of the brake member (4382), insert the small end of the brake member (4382) into the housing (40) and match it with the outer wall of the coupling (437), and insert the other end of the pair of brake member reset elastic members (4383) into the corresponding mounting hole of the housing (40); The brake member slider (4381) is arranged outside the housing (40) and is slidably connected to the large end of the brake member (4382).

27. The method for preparing a left ventricular assist device according to claim 26, characterized in that: The method further comprises the steps of: The brake component cover (405) is covered on the brake component slider (4381), and the brake component cover (405) is fixedly connected to the housing (40).

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