Preparation method of left ventricle auxiliary device

Abstract

The invention provides a preparation method of a left ventricular assist device, the left ventricular assist device comprises a micro pump head, a transmission shaft and a driving control mechanism, the micro pump head comprises a pump head impeller and a pump head transmission assembly, the transmission shaft comprises a mandrel and a twisting shell, and the driving control mechanism comprises a twisting shell driving module and a mandrel driving module. The method comprises the following steps that a pump head transmission assembly penetrates through a pump head impeller, and the far end and the near end of the pump head impeller are fixed to the far end of the pump head transmission assembly and the far end of a twisting shell correspondingly; a mandrel is inserted into the twisting shell, and the far end of the mandrel and the near end of the pump head transmission assembly are fixed; the twisting shell driving module is arranged at the far end of the mandrel driving module and is detachably connected with the mandrel driving module, and the far end of the twisting shell driving module is in transmission connection with the near end of the twisting shell; and the far end of the mandrel driving module is in transmission connection with the near end of the mandrel. According to the scheme, the left ventricle auxiliary device with the instrument micro-size and the high blood supply flow can be obtained, and the use safety and the working efficiency of the left ventricle auxiliary device are improved.

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] In the past decade, the number of high-risk cardiovascular interventional surgeries at home and abroad has increased year by year. In order to reduce the risk of death caused by obstruction or cessation of blood circulation during surgery, interventional left ventricular assist devices have been widely used in high-risk cardiovascular interventional surgeries. Interventional left ventricular assist devices are percutaneous mechanical circulatory assist systems that use mechanical micropumps to provide auxiliary blood flow to patients undergoing high-risk cardiovascular interventional surgery during and after surgery. They can partially or completely assist the function of the left ventricle and help the heart deliver oxygenated blood to the whole body. Existing interventional left ventricular assist devices mainly use micropump heads equipped with non-deformable rigid impellers. Due to the size of the device, the auxiliary flow rate they can generate is relatively small. In order to meet the needs of maintaining patient blood circulation during high-risk interventional surgeries, the commonly used solution for interventional left ventricular assist devices with constant impeller size is to increase the impeller speed. However, the high-speed rotation of the impeller will inevitably cause excessive shear force inside the blood, leading to changes in red blood cell permeability and irreversible cell damage, thereby increasing the risk of hemolysis in patients.

[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 supply 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 has a micro-volume, high blood supply flow and low risk of hemolysis, thereby improving the use efficiency and safety of the left ventricular assist device.

[0005] In order 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 comprises a micro pump head, a transmission shaft and a drive control mechanism, wherein the micro pump head comprises a pump head impeller and a pump head transmission assembly, the transmission shaft comprises a core shaft and a twisting shell, the drive control mechanism comprises a twisting shell drive module and a core shaft drive module, and the method comprises the following steps:

[0006] The pump head transmission assembly passes through the pump head impeller, and the distal end of the pump head impeller is fixedly connected to the distal end of the pump head transmission assembly; the proximal end of the pump head impeller is fixedly connected to the distal end of the twisting shell;

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

[0008] Arrange the twisting shell driving module at the distal end of the mandrel driving module, and connect the distal end of the twisting shell driving module with the proximal end of the twisting shell by transmission;

[0009] The distal end of the mandrel driving module is connected to the proximal end of the mandrel by transmission, and the distal end of the mandrel 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, the transmission shaft further includes a protective sleeve, and the step of "fixedly connecting the distal end of the pump head impeller to the distal end of the pump head transmission assembly" further includes the following steps:

[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 mandrel 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 comprises 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 with the distal end of the pump head transmission assembly, and clamping the proximal end of the impeller skeleton with the distal end of the twisting connector" comprises 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] The core sleeve is passed through the impeller frame, and the distal end of the core sleeve is fixedly connected 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 sleeve is arranged 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 sleeved 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 spindle collar and a top collar, and the method further includes the steps of:

[0029] The mandrel sleeve ring is fixedly mounted on the proximal end of the mandrel sleeve, and the proximal end surface of the mandrel sleeve ring is aligned with the proximal end surface of the mandrel sleeve, and the mandrel sleeve ring 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 sleeve ring is sleeved on the distal end of the core shaft sleeve, and the distal end surface of the top sleeve ring is fixedly connected with the proximal end surface of the top sleeve;

[0031] Optionally, the step of “fixedly connecting the distal end of the mandrel to the proximal end of the pump head transmission assembly” comprises 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 anchor bracket is fixedly sleeved on the distal end of the top sleeve, the top sleeve tip is arranged at the distal end of the anchor 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 anchor bracket is fixedly connected to the distal end of the protective sleeve;

[0035] Optionally, the pump head protection assembly further includes a support protection sleeve connecting ring, and the step of "fixedly connecting the proximal end of the anchoring support 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 anchoring stent comprises an anchoring stent skeleton and an anchoring stent membrane, wherein the anchoring stent skeleton 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, and the method further comprises the steps of:

[0038] The distal ring sleeve of the anchoring stent frame is fixed outside 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 support membrane is sleeved outside the anchoring support frame.

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

[0042] The bearing of the protective cover slider is embedded in the proximal annular groove of the protective cover slider, and the outer edge of the bearing of the protective cover slider is limited between the proximal annular groove of the protective cover slider and the end cover of the protective cover slider, and the end cover of the protective cover slider 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 driving module includes a twisting shell connecting member 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 connecting member bearing, a second gear set, a twisting shell sleeve and a twisting shell sleeve bearing, and the step of "transmission connecting the distal end of the twisting shell driving module with the proximal end of the twisting shell" includes the steps of:

[0045] The twisting shell shaft sleeve bearings are respectively sleeved onto the two ends of the twisting shell shaft sleeve;

[0046] The twisting shell shaft sleeve, with the twisting shell shaft sleeve bearings respectively sleeved at 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 on the proximal end of the twisting shell;

[0048] The twisting shell connecting member bearing is arranged in the middle section of the twisting shell connecting member and the twisting shell connecting member is sleeved onto the proximal end of the twisting shell, and the proximal end face of the twisting shell connecting member is aligned with the proximal end face of the twisting shell, and the twisting shell connecting member 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 connecting member and fixedly connected to the twisting shell connecting member.

[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 "drivingly connecting the distal end of the spindle drive module to the proximal end of the spindle" includes the steps of:

[0051] The spindle connecting member bearing sleeve is arranged on the proximal end of the spindle connecting member;

[0052] Sleeve the proximal end of the clutch onto the distal end of the spindle connector, and arrange the clutch resetting elastic member between the spindle connector and the clutch;

[0053] The distal end of the mandrel connector is sleeved on the outside of the proximal end of the mandrel and fixedly connected to the mandrel, and the distal end of the clutch is sleeved on 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 connecting piece 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 mandrel driving module is connected to the proximal end of the mandrel by transmission are sequentially installed into the corresponding positions in the second shell, the first shell is arranged relative to the second shell, and the first shell is fixedly connected to the second shell 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 outside the first housing, and the second clutch ring is sleeved outside the second housing and fixedly connected to the first clutch ring;

[0062] Optionally, the step of “separably connecting the distal end of the mandrel drive module to the distal end of the twisting shell drive module” comprises 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 into 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 two ends of the second twisting gear shaft and fixedly connected to the second twisting gear shaft;

[0068] Insert the second twisting gear reset elastic member into the corresponding mounting hole of the second twisting gear limiter, insert one side of the second twisting gear limiter into the housing, and extend the other side of the second twisting gear limiter out of the housing, so as to arrange the second twisting gear reset elastic member between the second twisting gear limiter and the housing, so that the second twisting gear is supported on the outside of the housing and the second twisting gear is detachably meshed 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 at both sides of the coupling and are used to brake the coupling;

[0073] Optionally, the brake assembly comprises a brake slider, a brake and a pair of brake resetting elastic members, and the method further comprises 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 match 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 shell.

[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 method for preparing 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 fixedly connecting the distal end of the pump head impeller with the distal end of the pump head transmission assembly; fixingly connecting the proximal end of the pump head impeller with the distal end of the twisting shell; inserting the core shaft into the twisting shell, and fixedly connecting the distal end of the core shaft with 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 with the proximal end of the twisting shell; transmission connecting the distal end of the core shaft drive module with the proximal end of the core shaft, and detachably connecting the distal end of the core shaft drive module with 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 driving module drives the core shaft and the twisting shell to rotate synchronously 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 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 mandrel provided by an optional embodiment of the present invention;

[0085] Figure 6 It 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-section view of a transmission shaft provided by an optional embodiment of the present invention;

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

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

[0089] Fig.10 It 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] Fig.11 is an exploded view of a pump head impeller when it is expanded (normal state) provided by an optional embodiment of the present invention;

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

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

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

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

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

[0096] Fig.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] Fig.18 is a schematic diagram of preparing an impeller skeleton by using nickel-titanium alloy wire provided by an optional embodiment of the present invention;

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

[0099] Fig. 20 is a schematic diagram of preparing an impeller skeleton by using nickel-titanium powder provided by an optional embodiment of the present invention;

[0100] Fig.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] Fig. 22 is a schematic diagram of preparing an impeller skeleton by using a nickel-titanium alloy tube provided by an optional embodiment of the present invention;

[0102] Fig.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] Fig.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] Fig.25 is a three-dimensional structural schematic diagram of a pump head transmission assembly provided by an optional embodiment of the present invention;

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

[0106] Fig. 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] Fig.28 It 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] Fig.29 is an exploded view of a pump head protection assembly provided by an optional embodiment of the present invention;

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

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

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

[0112] Fig.33 It is a flow chart of a twisting shell driving module distal end and a twisting shell proximal end transmission connection provided by an optional embodiment of the present invention;

[0113] Fig.34It is a three-dimensional structural schematic diagram of a twisting shell driving module provided by an optional embodiment of the present invention;

[0114] Fig.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] Fig.36 is an exploded view of a second gear set provided by an optional embodiment of the present invention;

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

[0117] Fig.38 is a flow chart of drivingly connecting the distal end of the mandrel drive module with the proximal end of the mandrel provided by an optional embodiment of the present invention;

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

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

[0120] Fig.41 It is a schematic diagram of the assembly of a clutch and a spindle connecting member provided by an optional embodiment of the present invention;

[0121] Fig.42 It is a schematic diagram of the assembly of a clutch and a twisting housing connecting member provided by an optional embodiment of the present invention;

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

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

[0124] Fig.45 It is a schematic diagram of the assembly of the first housing and the clutch fork provided by an optional embodiment of the present invention;

[0125] Fig.46 It is a schematic diagram of the assembly of the second housing and the clutch fork provided by an optional embodiment of the present invention;

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

[0127] Fig.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] Fig.49 is an exploded view of a clutch ring provided by an optional embodiment of the present invention;

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

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

[0131] Fig.52 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 of a left ventricular assist device provided by an optional embodiment of the present invention changing from an expanded state to a folded state.

[0133] Explanation of the reference numerals: 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 skeleton; 2212. Impeller blade; 22111. Distal end fixing ring; 22112. Impeller skeleton wire; 22113. Proximal end 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 end notch of protective cover; 313. Proximal end notch of protective cover; 32. Twisting shell; 321. Twisting connector mounting notch; 322. Micro pump head connecting section of twisting shell; 323. Flexible section of twisting shell; 324. Driving control mechanism connecting section of twisting shell; 33. Mandrel;

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

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

[0140] 42. Twisting shell driving 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 shaft sleeve bearing; 423. Twisting shell shaft 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 reset elastic member; 435. Spindle connector; 436. Spindle connector bearing; 437. Coupling; 438. Brake assembly; 4381. Brake slider; 43811. Seventh protrusion; 43812. Wedge bottom surface; 4382. Brake; 43821. Limiting groove; 4383. Brake reset 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] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the 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. On the contrary, 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, certain specific details are set forth for the purpose of illustrating the various disclosed embodiments 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 the present application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0147] References throughout the specification to "one embodiment" or "an embodiment" indicate 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 the 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 the words "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", "down", etc. should be understood as convenient terms and should not be understood as restrictive terms.

[0149] See also Figures 1 to 5 The embodiment of the present invention provides a method for preparing a left ventricular assist device, wherein the left ventricular assist device 1 includes a micro pump head 2, a transmission shaft 3 and a drive control mechanism 4, wherein the micro pump head 2 includes a pump head impeller 22 and a pump head transmission assembly 23, the transmission shaft 3 includes a core shaft 33 and a twisting shell 32, and 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, pass 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 shell 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, arranging the twisting shell driving module 42 at the distal end of the core shaft driving module 43, and connecting the distal end of the twisting shell driving module 42 to the proximal end of the twisting shell 32 by transmission;

[0153] Step 4, the distal end of the mandrel drive module 43 is connected to the proximal end of the mandrel 33 by transmission, and the distal end of the mandrel drive module 43 is detachably connected to the proximal end of the twisting shell drive module 42.

[0154] In this embodiment, on the basis of assembling the micro pump head 2 and the transmission shaft 3 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 connecting piece between the drive control mechanism 4 and the micro pump head 2 in the entire left ventricular assist device 1, and the drive control mechanism 4 at the proximal end of the assist device 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 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, and 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, so as 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 tubes.

[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 mandrel drive module 43 is connected to the proximal end of the twisting shell drive module 42, the mandrel drive module 43 drives the mandrel 33 to rotate and drives the twisting shell drive module 42 to rotate synchronously, and the twisting shell drive module 42 further drives the twisting shell 32 to rotate, thereby realizing the synchronous rotation of the twisting shell 32 and the mandrel 33, and then drives the pump head impeller 22 to rotate as a whole with a fixed outer diameter (here, synchronous rotation refers to rotation at the same angular velocity). When the distal end of the mandrel 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 mandrel 33 (at this time, the mandrel drive module 43 stops running and the mandrel 33 is fixed). When the twisting shell 32 rotates relative to the mandrel 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 unfold or fold, so as to change the outer diameter of the pump head impeller 22.

[0158] By driving the control mechanism 4 and the transmission shaft 3 to cooperate and control 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 is helpful 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 an adjustable outer diameter can also help 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 shell 32 may include a twisting shell micro pump head connection section 322, a twisting shell flexible section 323 and a twisting shell drive control mechanism connection section 324. The twisting shell flexible section 323 is fixedly connected to the twisting shell micro pump head connection section 322 and the twisting shell drive control mechanism connection section 324 respectively by welding; wherein, the distal end of the twisting shell micro pump head connection section 322 is used for fixed connection with the proximal end of the pump head impeller 22, and the proximal end of the twisting shell drive control mechanism connection section 324 is used for transmission connection with the twisting shell drive module 42. Here, the twisting shell flexible section 323 can be made of a plurality of double-layer synchronous torque spring tubes integrally formed to ensure the flexibility of the entire transmission shaft 3 during use.

[0160] Preferably, a twisting connector installation 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 installation slot 321 is snap-connected 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-connection, which can improve the stable 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] 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] Step 200 , insert the twisting shell 32 into the protective cover 31 , and sleeve the protective cover driving module 41 on the proximal end of the protective cover 31 , and at the same time, 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 driving module 41, when the protective sleeve driving 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 component 21 can be controlled, thereby controlling the pump head protection component 21 to fold or unfold, so as to adjust the outer diameter of the pump head protection component 21. Specifically, when the protective sleeve driving 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 component 21 decreases, and the outer diameter of the pump head protection component 21 increases; when the protective sleeve driving 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 component 21 increases, and the outer diameter of the pump head protection component 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. The protective sleeve 31 is an annular cylinder and is sleeved on the outside of the twisting shell 32. The inner diameter of the protective sleeve 31 is slightly larger than the outer diameter of the twisting shell 32, so that the protective sleeve 31 can be sleeved on the outside of the twisting shell 32, and lubricating liquid is filled between the protective sleeve 31 and the twisting shell 32, thereby reducing the heat generated by the transmission shaft 3 during operation; wherein the twisting shell 32 is slightly longer than the protective sleeve 31, and the lengths of the two can be set according to the actual needs of the application. Preferably, the protective sleeve 31 can be made of a medical Pebax tube, of course not limited to medical Pebax tubes, and 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, the pressure sensor 5 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 inserted into the optical fiber hole 311. When the left ventricular assist device 1 is used, a part of the pressure sensor 5 enters the patient's body together with the micro pump head 2, and the patient's blood pressure data can be collected in real time to accurately capture the 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 slot 312 and a proximal slot 313 for assembling and fixing the optical fiber 51. Preferably, the distal slot 312 is arranged on the side wall of the distal end of the protective cover 31 and extends axially, and the proximal slot 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 slot 312. The distal end of the optical fiber 51 passes through the proximal slot 313 of the protective cover 31 into the optical fiber hole 311 and passes through the distal slot 312 of the protective cover 31.

[0170] The fiber Bragg grating demodulator 52 is fixed to the drive control mechanism 4 and is in communication connection with the controller module of the left ventricular assist device 1. Fig.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 with the fiber 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 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 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 grating demodulator 52 via a threaded connector, which is used to transmit the blood pressure data monitored by the pressure monitoring optical fiber 511 to the fiber 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 passes 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, Fig.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, 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;

[0175] In this embodiment, the proximal end of the foldable impeller 221 is fixedly connected with the distal end of the twisting connector 222, and the proximal end of the foldable impeller 221 is fixedly connected with the distal end of the twisting shell 32 through the twisting connector 222. Since the proximal end of the twisting shell 32 is transmission-connected with the twisting shell driving module 42, when the twisting shell 32 is driven to rotate by the twisting shell driving module 42, the twisting shell 32 drives the twisting connector 222 to rotate, and the proximal end of the foldable impeller 221 is driven to rotate through the twisting connector 222. Here, the twisting connector 222 can be prepared by metal 3D printing stainless steel.

[0176] Alternatively, if Figure 13 to Figure 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 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; here, the impeller skeleton 2211 as a whole can be twisted and folded or twisted and unfolded;

[0178] Optionally, a mandrel hole for the mandrel 33 to pass through is provided on the twisting connector 222, so that the distal end of the mandrel 33 passes through the twisting connector 222 and is fixedly connected to the proximal end of the pump head transmission assembly 23. Since the proximal end of the mandrel 33 is transmission-connected with the mandrel drive module 43, when the mandrel 33 is driven to rotate by the mandrel drive module 43, the mandrel 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.

[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 surface 2212 can be respectively bonded and fixed to the distal end and the proximal end of the impeller frame 2211 to ensure that the impeller blade surface 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, which can reduce the damage caused by the pump head impeller 22 to the human body and blood cells during use on the one hand, and on the other hand, enable the pump head impeller 22 to have a large folding 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 Figure 15 to Figure 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, the material is preferably a biocompatible medical silicone raw material;

[0185] Step 162, pouring the medical silicone raw material into a mold, 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, take out the mold to obtain the impeller blade surface 2212.

[0188] Optionally, in step 161, an elastic material having mechanical properties that meet the requirements is first configured. Preferably, the elastic material is preferably 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, and then heated and cured to form a film; the medical silicone material has good elastic deformation ability, and its 100% Young's modulus is 21.75 kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be tolerated is 675.3 kPa, so as to meet the needs of the pump head impeller 22 when in use;

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

[0190] Optionally, in step 163, the impeller blade surface mold cast with the medical silica gel raw material is subjected to a heating treatment, and the heating treatment is preferably constant temperature heating, more preferably constant temperature heating treatment 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 ranges preferably 15 minutes-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 can be obtained: Fig.15 The impeller blade surface 2212 shown has an elastic tubular shape.

[0192] In an optional embodiment of the present invention, Fig.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] Step 10111, spirally arrange the impeller skeleton wire 22112 between the proximal fixing ring 22113 and the distal fixing ring 22111, fix the distal fixing ring 22111 to the distal end of the pump head transmission assembly 23, and clamp the proximal end of the proximal fixing ring 22113 to the distal end of the twisting connector 222.

[0194] In this embodiment, the proximal fixing ring 22113 and the distal fixing ring 22111 are both 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 when in use. Preferably, the outer diameter of the proximal fixing ring 22113 and the outer diameter of 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 as to facilitate the implantation of the foldable impeller 221 into a suitable 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 cutting a nickel-titanium alloy tube by femtosecond laser to obtain the impeller skeleton 2211.

[0197] There are multiple impeller skeleton wires 22112 disposed between the proximal fixing ring 22113 and the distal fixing ring 22111, and the multiple 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 multiple impeller skeleton wires 22112 can be inserted into the proximal assembly hole of the distal fixing ring 22111 and the distal assembly hole of the proximal fixing ring 22113, and assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 in a form-locked manner, and more preferably, biocompatible glue can be applied at the assembly site for bonding and fixing.

[0198] In an achievable example of the present invention, the distal end of the twisting connector 222 may be provided with a plurality of rotation limiting bosses, and the proximal outer edge of the proximal fixed ring 22113 may be provided with a plurality of limiting grooves. When assembling, the rotation limiting bosses of the twisting connector 222 are plugged into and matched with the limiting grooves of the proximal fixed ring 22113 for rotation limiting. The assembly 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, so as to realize the one-step twisting and folding of the foldable impeller 221.

[0199] In an optional embodiment of the present invention, Figure 17 to Figure 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] Step 175a, assemble the distal end and proximal end of the impeller skeleton wire 22112 with the distal fixing ring 22111 and the proximal fixing ring 22113 respectively in a form-locking manner, and apply biocompatible glue at the assembly site for bonding and fixing. In this embodiment, a nickel-titanium alloy wire 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 requirements of mechanical properties and geometric morphology. At the same time, the impeller skeleton 2211 can also provide a certain rigidity for the pump head impeller 22 in the expanded state to ensure 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 is prepared from nickel-titanium alloy wire, the mold with the nickel-titanium alloy wire wrapped inside is heat-treated to obtain the impeller skeleton wire 22112 with 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, the heating time is preferably 10 minutes-30 minutes, more preferably 15 minutes, 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 and proximal ends 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 and proximal ends of the few-period spiral impeller skeleton wire 22112 can be respectively inserted into the corresponding assembly holes at the proximal end of the distal fixing ring 22111 and the corresponding assembly holes at the distal end 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 integrated molding. When prepared by metal 3D printing integrated molding, refer to Figure 19 to Figure 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 a pitch, a spiral radius, and a 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, take out the mold to obtain the 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 requirements of mechanical properties and geometric morphology. At the same time, the impeller skeleton 2211 can also provide a certain rigidity for the pump head impeller 22 in the expanded state to ensure the stability of the pump head impeller 22 during use;

[0214] Optionally, in step 171b, the nickel-titanium powder is subjected to 3D modeling and printing processing by pre-designing the pitch, spiral radius and spiral height to obtain an integrally formed impeller skeleton 2211; the pre-designed pitch, spiral radius and spiral height can be set according to the specific value 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 (having 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, 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 a nickel-titanium alloy tube by a femtosecond laser. When the impeller skeleton 2211 is prepared by cutting a nickel-titanium alloy tube by a femtosecond laser, refer to Fig.21 and Fig. 22 , the preparation of the impeller skeleton 2211 may include:

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

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

[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 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 requirements of mechanical properties and geometric morphology. At the same time, the impeller skeleton 2211 can also provide a certain rigidity for the pump head impeller 22 in the expanded state 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 value of the spiral period corresponding to the impeller skeleton 2211 in the multi-period spiral folded state; further, the multi-period spiral folded state impeller skeleton 2211 is twisted to a multi-period spiral unfolded state, and fixed with a corresponding mold to prevent the impeller skeleton 2211 from being deformed by heat during the heat treatment process;

[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 (having 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, 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 Fig.23 As shown), the impeller skeleton wire 22112 is in a spiral shape, preferably a few-cycle spiral shape (as shown in FIG. Fig.12 As shown in FIG. 1 ), for example, it may 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 unfolded 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. 1 ). Fig.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: Fig.24 The pump head impeller 22 is in the folded state as shown. Fig.24 The preload 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, and the outer edge of the spiral extends outward and pushes up the impeller blade surface 2212 outward, so as to obtain the following Fig.23 The pump head impeller 22 shown in FIG. Fig.23 By twisting in the direction of rotation shown, the following can be obtained: Fig.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 also include:

[0226] Step 10112, passing the core sleeve 236 through the impeller frame 2211, and fixing the distal end of the core sleeve 236 to the distal end 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 on the distal end of the top shaft 235, and make the proximal end surface of the top shaft bearing 233 contact with the distal end surface of the core shaft sleeve 236;

[0229] Step 10115, 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 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 ring 237 and a top ring 234. The above step 1011 may further include:

[0233] Step 10117, the mandrel collar 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236, and 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 limited between the proximal end of the proximal fixing ring 22113 and the distal end of the twisting connector 222;

[0234] Step 10118, sleeve the top ring 234 on the distal end of the core shaft sleeve 236, and fix the distal end surface of the top ring 234 to the proximal end surface of the top sleeve 231.

[0235] In this embodiment, on the premise that the proximal end surface of the mandrel collar 237 is aligned with the proximal end surface of the mandrel sleeve 236, the mandrel collar 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236, and the mandrel collar 237 is limited 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 and fix the sleeve 236 and the mandrel collar 237 to ensure that the mandrel collar 237 will 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 sleeve 237, and on this basis, the distal fixing ring 22111 and the core shaft sleeve 236 can be bonded with biocompatible glue;

[0237] Here, the proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235 through the top shaft bearing 233; the top shaft bearing 233 is embedded in the annular groove opened at the proximal end of the top sleeve 231, and the outer edge of the top shaft bearing 233 is limited between the annular groove and the top sleeve ring 234. Preferably, the top shaft sleeve 232 and the top shaft 235 can be bonded and fixed using biocompatible glue to ensure that the top shaft sleeve 232 will not fall off the top shaft 235. After the top sleeve 231 is sleeved outside the top shaft bearing 233, while ensuring that the top sleeve 231 is in contact with the distal end surface of the top shaft bearing 233 and the top sleeve ring 234 is in contact with the proximal end surface of the top shaft bearing 233, the top sleeve 231 and the top sleeve ring 234 can be bonded and fixed using biocompatible glue.

[0238] Preferably, the top sleeve 231, the top shaft sleeve 232, the top sleeve ring 234, and the mandrel sleeve ring 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 Fig. 27 In an optional embodiment of the present invention, the above step 2 may include:

[0240] Step 201 , sleeve the proximal end of the core shaft sleeve 236 into the proximal fixing ring 22113 and fix the proximal end of the core shaft sleeve 236 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 driving module 43, the core shaft 33 is driven to rotate by the core shaft driving 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, Figure 28 to Figure 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 anchor bracket 212 on the distal end of the top sleeve 231, set the top sleeve tip 211 on the distal end of the anchor 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 anchor bracket 212 to the distal end of the protective sleeve 31.

[0245] In this embodiment, the proximal and distal ends of the anchor bracket 212 can be set to be 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 in the top sleeve 231. Optionally, the distal end of the top sleeve tip 211 is set to be a smooth dome shape, so that the entire micro pump head 2 can enter the patient's body through minimally invasive intervention and reduce the resistance encountered by blood flow when flowing through the micro pump head 2.

[0246] Optionally, the pump head protection assembly 21 further includes a bracket protection sleeve connecting ring 213, and 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, 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 annular proximal end of the anchoring stent 212 is sleeved outside the stent protective sleeve connecting ring 213 and the distal end surface of the stent protective sleeve connecting ring 213 is flush with the distal end surface of the annular proximal end of the anchoring stent 212, the proximal end of the anchoring stent 212 can be bonded and fixed to the stent protective sleeve connecting ring 213 using biocompatible glue. Subsequently, the protective sleeve 31 is sleeved to the proximal end of the stent protective sleeve connecting ring 213, and after the distal end surface of the protective sleeve 31 is in contact with the proximal end surface of the annular proximal end of the anchoring stent 212, the protective sleeve 31 can be bonded and fixed to the stent protective sleeve connecting ring 213 and the anchoring stent 212 using biocompatible glue.

[0249] Optionally, the anchoring stent 212 includes an anchoring stent skeleton 2121 and an anchoring stent membrane 2122, wherein the anchoring stent skeleton 2121 includes 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 above step 11011 may include:

[0250] Step 110111, fix the distal ring sleeve of the anchoring stent framework 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 framework.

[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 tube (the specific process can refer to the specific process of preparing the impeller skeleton 2211 using femtosecond laser cutting of nickel-titanium alloy tube mentioned above, which will not be described in detail here), and the anchoring bracket membrane 2122 can be prepared by inverting medical silicone material; preferably, the medical silicone material can be prepared by stirring and preparing Dragon Skin silicone and Slic Thinner diluent with 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, and its 100% Young's modulus is 21.75 kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be withstood is 675.3 kPa, so as to meet the needs of the entire micro pump head 2 when in use, the top sleeve tip 211 can be prepared by metal 3D printing stainless steel, and the bracket protection 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, and the distal ring of the anchoring stent skeleton is fixed outside the distal end of the top sleeve tip 211. The anchoring stent skeleton wire is set in multiple, 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, and form 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 are close to each other, the anchoring stent skeleton wire can be bent outward to expand the cage-like structure outward; conversely, the anchoring stent skeleton wire can be stretched to both ends to shrink the cage-like structure inward.

[0254] In an optional embodiment of the present invention, Figure 30 to Figure 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. Fig.32 , the above step 200 may include:

[0255] Step 201, embed the protective cover slider bearing 412 in the proximal ring groove of the protective cover slider 411, and limit the outer edge of the protective cover slider bearing 412 between the proximal ring groove of the protective cover slider 411 and the protective cover slider end cover 413, and set the protective cover slider end cover 413 at the proximal end of the protective cover slider 411 and fixedly connect it to the protective cover slider 411;

[0256] Step 2002 , sleeve the protective cover slider 411 on the proximal end of the protective cover 31 and fix the protective cover slider 411 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 .

[0257] In this embodiment, the proximal end of the protective cover slider 411 is provided with an annular groove matched with 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 bonded and fixed using glue. Preferably, the protective cover slider 411 and the protective cover slider end cap 413 can be prepared by photocuring 3D printing medical hard resin.

[0259] Optionally, the protective cover driving module 41 includes at least two protective cover slider bearings 412, 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 411 can be locked at different positions of the shell 40 through the cooperation of 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 arranged 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, Figure 34 to Figure 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. Fig.33 As shown, the above step 3 may include:

[0262] Step 301, respectively sleeve the twisting shell shaft sleeve bearing 422 onto both ends of the twisting shell shaft sleeve 423;

[0263] Step 302, sleeve the twisting shell shaft sleeve 423 with twisting shell shaft sleeve bearings 422 at both ends respectively on the proximal end of the twisting shell 32;

[0264] Step 303, sleeve the first twisting gear 425 on the first twisting gear shaft 426, set 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 to the proximal end of the twisting shell 32;

[0265] Step 304, dispose the twisting shell connector bearing 427 in the middle section of the twisting shell connector 428 and sleeve the twisting shell connector 428 onto the proximal end of the twisting shell 32, and when the proximal end surface of the twisting shell connector 428 is aligned with the proximal end surface of the twisting shell 32, the twisting shell connector 428 is fixedly connected to the twisting shell 32;

[0266] Step 305 , 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 .

[0267] In this embodiment, during assembly, the twisting shell connector 428 is fixedly connected to the proximal end of the twisting shell 32, and 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 group 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 can be controlled to rotate through the twisting gear group.

[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 to the proximal end of the twisting shell 32;

[0269] The first twisting gear shaft 426 can be configured as a shaft body with multiple steps. When assembling, the first twisting gear 425 is assembled to the D-shaped shaft section of the first twisting gear shaft 426, and preferably fixed with a tip machine. Further, the first twisting gear shaft bearing 424 is sleeved to the distal end of the first twisting gear shaft 426, and the first twisting gear shaft 426 is rotatably supported in 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 tip 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 it is preferred to use a tip 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 prepared by machining aluminum alloy.

[0272] In an optional embodiment of the present invention, Figure 39 to Figure 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. Fig.38 As shown, the above step 4 may include:

[0273] Step 401, sleeve the spindle connector bearing 436 on the proximal end of the spindle connector 435;

[0274] Step 402, sleeve 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] Step 403 , sleeve the distal end of the mandrel connector 435 onto the proximal end of the mandrel 33 and fix it to the mandrel 33 , and sleeve the distal end of the clutch 433 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 spindle connector bearing 436 and the clutch 433 are respectively sleeved onto the proximal and distal ends of the spindle connector 435, the two ends of the clutch reset elastic member 434 are respectively inserted into the corresponding mounting holes of the spindle 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 spindle connector 435; preferably, the clutch reset elastic member 434 may include three clutch reset springs; since the proximal end of the clutch 433 is sleeved on the distal end of the spindle connector 435, and the distal end of the clutch 433 is sleeved onto 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 grooves to realize the transmission of rotational motion, wherein the clutch 433 and the core shaft connector 435 always maintain a connected state, while there are two states of connection and non-connection between the clutch 433 and the twisting shell connector 428. A groove is provided at the proximal end of the twisting shell connector 428 to facilitate the insertion of the clutch 433 and the twisting shell connector 428.

[0279] Further, 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 and the drive motor 4310 can be fixed with screws, and then the proximal end of the mandrel 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 by machining aluminum alloy.

[0283] Alternatively, if Figure 43 to Figure 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 proximal transmission connection between the protective cover drive module 41 and the protective cover 31, the assembly after the proximal transmission connection between the twisting shell drive module 42 and the twisting shell 32, and the assembly after the proximal transmission connection between the core shaft drive module 43 and the proximal transmission connection between 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 preparation method of the left ventricular assist device may further include:

[0286] Step 6, respectively set the distal cover 403 and the proximal cover 404 at the distal end and the proximal end of the shell 40, and fix the distal cover 403 to the distal end of the shell 40, and fix the proximal cover 404 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 matched to form a cavity structure for installing each assembly inside;

[0288] Preferably, a boss is provided on the mating surface of the first shell 401 and the second shell 402; a groove is provided on the mating surface of the second shell 402 and the first shell 401 at a position corresponding to the boss. After each 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 Fig.45As shown, the first housing 401 has a first optical fiber groove 4014 formed on its mating surface. Fig.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, as well as 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 with 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 with 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 shell 401, and a fourth protrusion 4021, a fifth protrusion 4022, and a sixth protrusion 4023 are provided on the outer wall of the second shell 402; wherein the first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021, and the fifth protrusion 4022 cooperate with the protective cover slider locking member 4111 on the protective cover slider 411 to lock the protective cover slider 411 at different positions of the shell 40. The third protrusion 4013 and the sixth protrusion 4023 cooperate with the relevant components in the spindle drive module 43, which will be further described in 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 overall 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 Fig.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 with the first clutch ring 4321 .

[0295] In this embodiment, the first clutch ring 4321 and the second clutch ring 4322 are assembled to the housing 40 from two opposite directions to form an annular clutch ring 432 that is sleeved on the housing 40. Preferably, a boss is provided on the mating surface of the first clutch ring 4321 and the second clutch ring 4322; a groove is provided on the mating surface of the second clutch ring 4322 and the first clutch ring 4321 at a position corresponding to the boss, and the first clutch ring 4321 is assembled to the second clutch ring 4322 on the premise that the boss of the mating surface of the first clutch ring 4321 is aligned with the groove of the mating surface of the second clutch ring 4322, and the two are fixed with glue. Here, the clutch fork 431, the first clutch ring 4321 and the second clutch ring 4322 can all be prepared by photocuring 3D printing medical hard resin.

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

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

[0298] In this embodiment, a clutch fork mounting hole 4323 is radially provided on the clutch ring 432, and the clutch fork 431 is arranged in the clutch fork mounting hole 4323 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 to separate or connect the clutch 433 from the twisting shell connecting member 428, thereby realizing the separation or connection of 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 to the housing 40 from two opposite directions, and then the two clutch forks 431 are assembled to the clutch ring 432, and preferably glue is used for bonding. During the assembly process, it is necessary to ensure that the clutch fork 431 can be inserted into the first housing 401 and the second housing 402, and the proximal shaft section of the clutch 433 must be between the two fingers of the clutch fork 431.

[0300] Preferably, if Figure 45 to Figure 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. Fig.55The clutch ring 432 is rotated in the direction shown to release the locking state of the clutch fork 431 when the clutch 433 is connected to the twisting shell connecting member 428 and the spindle connecting member 435, and then Fig.56 As shown in the figure, 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, the clutch 433 is pushed toward the proximal end while the clutch reset elastic member 434 is compressed, until the clutch ring 432 can no longer move toward the proximal end. Fig.57 The clutch ring 432 is rotated again in the direction shown, so that the clutch fork 431 enters another locking state, and the clutch 433 and the twisting shell connecting member 428 are in a non-connected state.

[0301] Alternatively, if Fig.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 also 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, insert one side of the second twisting gear limiter 4211 into the shell 40, and extend the other side of the second twisting gear limiter 4211 out of the shell 40, so as to set the second twisting gear reset elastic member 4215 between the second twisting gear limiter 4211 and the shell 40, so that the second twisting gear 4213 is supported on the outside of the shell 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 limiters 4211 are respectively arranged at the two ends of the second twisting gear shaft 4214, the small ends of the two second twisting gear limiters 4211 can be respectively sleeved 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 limiters 4211 are aligned with the end faces of the second twisting gear shaft 4214 and the top faces of the two second twisting gear limiters 4211 are also aligned, it is preferred to use a cutting-edge machine to fix the two second twisting gear limiters 4211 and the second twisting gear shaft 4214 respectively;

[0307] Preferably, the second twisting gear reset elastic member 4215 may include two groups of second twisting gear reset springs, wherein each group of second twisting gear reset springs includes two springs. Here, the end surface of the second twisting gear reset elastic member 4215 may be bonded to the bottom surface of the corresponding mounting hole of the second twisting gear limiter 4211 using glue.

[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 turning the second twisting gear 4213, and the twisting shell connecting piece 428 fixedly connected to the first twisting gear 425 is driven by the first twisting gear 425 to rotate synchronously with 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 unfolded 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 shell 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 shell 40, and at the same time, it can avoid misoperation of the second gear set 421.

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

[0311] Step 13: Dispose the brake assemblies 438 in pairs at corresponding positions of the housing 40 , and dispose the brake assemblies 438 in pairs at both sides of the coupling 437 to brake the coupling 437 .

[0312] In this embodiment, the two brake assemblies 438 are relatively arranged 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 the coupling 437 to brake the coupling 437 through 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, if Figure 50 to Figure 51 As shown, the brake assembly 438 includes a brake slider 4381, a brake 4382 and a pair of brake reset elastic members 4383. The above step 13 may include:

[0314] Step 131, insert one end of a pair of brake member 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 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 holes of the housing 40;

[0315] Step 132 , dispose the brake member slider 4381 outside the housing 40 and slide it to the large end of the brake member 4382 .

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

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

[0318] The brake member reset elastic member 4383 is arranged 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 reset elastic member 4383 can be a pair of brake member reset springs; after one end of the brake member reset elastic member 4383 is inserted into the corresponding mounting hole of the brake member 4382, preferably, glue is used to bond the end surface of the brake member reset elastic member 4383 to the bottom surface of the corresponding mounting hole of the brake member 4382;

[0319] Preferably, brake grooves are 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 Figure 47 to Figure 48 As shown, two seventh protrusions 43811 are arranged on each brake member slider 4381 in the two brake assemblies 438 along the translation direction, wherein the two seventh protrusions 43811 on the brake member slider 4381 in one brake assembly 438 are respectively engaged with the two third protrusions 4013 on the first housing 401; and the two seventh protrusions 43811 on the brake member slider 4381 in the other brake assembly 438 are respectively engaged with the two sixth protrusions 4023 on the second housing 402. When the brake member slider 4381 is slid and the brake member reset elastic member 4383 is pressed down or released, the engagement between the seventh protrusion 43811 and the third protrusion 4013 and the sixth protrusion 4023 is used to realize the locking of the brake member slider 4381 in the brake assembly 438 in two states: the brake member 4382 in the brake assembly 438 locks the coupling 437 and releases the coupling 437.

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

[0322] The method for preparing the left ventricular assist device provided in the above embodiment of the present invention comprises the following steps: Fig.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 unfold 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 unfold, it keeps the 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 Fig.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 spindle connector 435 are all in a connected state; the driving motor 4310 drives the coupling 437 to rotate, the coupling 437 drives the spindle connector 435 to rotate, and the spindle connector 43 5 drives the core shaft 33 and the clutch 433 to rotate synchronously, the clutch 433 drives the twisting shell connector 428 and drives the twisting shell 32 and the core shaft 33 to rotate synchronously through the twisting shell connector 428, and when the twisting shell 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 shell 32 and the core shaft 33 as a whole. At this time, the pump head impeller 22 rotates as a whole with the outer diameter fixed, realizing the blood pumping function; in addition, in the auxiliary blood supply process, the twisting shell connector 428 also drives the first twisting gear shaft 426 and the first twisting gear 425 to rotate, and the twisting shell 32 drives the twisting shell shaft sleeve 423 to rotate;

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

[0325] Step 151, as Fig.54 As shown, the brake member slider 4381 is slid toward the distal end, and the two brake members 4382 are pushed into the locked coupling 437 state while the brake member reset elastic member 4383 is compressed. At this time, the coupling 437, the spindle connector 435, and the spindle 33 are all non-rotatable; 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. The mutual cooperation between the brake member slider 4381 can 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 Fig.55 Rotate 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 spindle connector 435; then press Fig.56The clutch ring 432 is slid toward the proximal end in the direction shown, 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, the clutch 433 is pushed toward the proximal end while the clutch reset elastic member 434 is compressed until the clutch ring 432 can no longer move toward the proximal end. Fig.57 The clutch ring 432 is rotated again in the direction shown, so that the clutch fork 431 enters another locking state, and the clutch 433 and the twisting shell connecting member 428 are in a non-connected state.

[0327] Step 153, as Fig.58 As shown, push the second gear set 421 inward until the second twisting gear 4213 is fully meshed with the first twisting gear 425, and then press Fig.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 connecting piece 428 to rotate, the twisting shell connecting piece 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, such as Fig.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 to cooperate 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 unfolded state (normal state) is the main state of the micro pump head 2 in the left ventricular assist device 1, 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-engaged state under normal conditions, the clutch 433 and the twisting shell connecting member 428 are in a connected state under normal conditions, and the brake member 4382 and the coupling 437 are in a non-contact state under normal conditions. After using and removing the left ventricular assist device 1, the micro pump head 2, the transmission shaft 3, the protective cover driving module 41, the clutch fork 431 and the clutch ring 432 can be dismantled and replaced to achieve the reusability of the drive control mechanism 4, thereby reducing the use 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 the scope of protection of the present invention.

Claims

1. A method for preparing a left ventricular assist device, the left ventricular assist device (1) comprising 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 fixing the distal end of the core shaft (33) to the proximal end of the pump head transmission assembly (23); The twisting shell driving module (42) is arranged at the distal end of the core shaft driving module (43), and the distal end of the twisting shell driving module (42) is transmission-connected to the proximal end of the twisting shell (32); The distal end of the mandrel drive module (43) is transmission-connected to the proximal end of the mandrel (33), and the distal end of the mandrel drive module (43) is detachably connected to the proximal end of the twisting shell drive module (42).

2. The method for preparing a left ventricular assist device according to claim 1, characterized in that: The micro pump head (2) further comprises a pump head protection assembly (21), the transmission shaft (3) further comprises a protection sleeve (31), 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)" comprises the following steps: The pump head protection component (21) is coaxially covered outside the pump head impeller (22), and the distal end of the pump head protection component (21) is fixedly connected to the distal end of the pump head transmission component (23), and the proximal end of the pump head protection component (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, characterized in that: The pump head impeller (22) comprises 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)" comprises 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); Optionally, the foldable impeller (221) comprises an impeller skeleton (2211) and an impeller blade surface (2212), and 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)" comprises the steps of: 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); Optionally, the method further comprises the steps of: Wrapping the impeller blade surface (2212) outside the impeller frame (2211); Optionally, the impeller skeleton (2211) comprises a proximal fixing ring (22113), a distal fixing ring (22111) and an impeller skeleton wire (22112), 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), and clamping the proximal end of the impeller skeleton (2211) to the distal end of the twisting connector (222)" comprises the steps of: 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).

5. The method for preparing a left ventricular assist device according to claim 4, characterized in that: The pump head transmission assembly (23) comprises 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)" comprises 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 in 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); Optionally, 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 mandrel sleeve (237) is fixedly sleeved on the proximal end of the mandrel sleeve (236), and the proximal end surface of the mandrel sleeve (237) is aligned with the proximal end surface of the mandrel sleeve (236), and the mandrel sleeve (237) is limited between the proximal end of the proximal fixing ring (22113) and the distal end of the twisting connector (222); The top sleeve ring (234) is sleeved on the distal end of the core shaft sleeve (236), and the distal end surface of the top sleeve ring (234) is fixedly connected to the proximal end surface of the top sleeve (231); Optionally, 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 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).

6. The method for preparing a left ventricular assist device according to claim 5, characterized in that: The pump head protection component (21) comprises an anchor bracket (212) and a top sleeve tip (211), and the step of "fixedly connecting the distal end of the pump head protection component (21) to the distal end of the pump head transmission component (23), and fixedly connecting the proximal end of the pump head protection component (21) to the distal end of the protective sleeve (31)" comprises the steps of: The distal end of the anchor bracket (212) is sleeved and fixed on the distal end of the top sleeve (231), the top sleeve tip (211) is arranged at the distal end of the anchor 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 anchor bracket (212) is fixedly connected to the distal end of the protective sleeve (31); Optionally, 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 anchor 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 surface of the stent protective sleeve connecting ring (213) is aligned with the distal end surface 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); Optionally, 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, and the method further comprises the steps of: The distal ring sleeve of the anchoring stent frame is fixedly mounted 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 mounted inside the proximal ring of the anchoring stent frame; Optionally, the method further comprises the steps of: The anchor support membrane (2122) is sleeved outside the anchor support frame (2121).

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

8. The method for preparing a left ventricular assist device according to claim 3, characterized in that: The twisting shell driving module (42) comprises a twisting shell connecting member (428) and a twisting gear set, wherein the twisting gear set comprises 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)" comprises the steps of: The twisting shell shaft sleeve bearings (422) are respectively sleeved onto the two ends of the twisting shell shaft sleeve (423); The twisting shell shaft sleeve (423) having 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 at 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 sleeved onto the proximal end of the twisting shell (32), and the proximal end surface of the twisting shell connecting member (428) is aligned with the proximal end surface of the twisting shell (32), and the twisting shell connecting member (428) is fixedly connected to 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).

9. The method for preparing a left ventricular assist device according to claim 8, characterized in that: The spindle drive module (43) comprises a spindle connector (435), a coupling (437), a clutch (433), a clutch reset elastic member (434) and a spindle connector bearing (436), and the step of "transmission-connecting the distal end of the spindle drive module (43) to the proximal end of the spindle (33)" comprises the following steps: The spindle connecting member bearing (436) is sleeved on the proximal end of the spindle connecting member (435); The proximal end of the clutch (433) is sleeved onto the distal end of the spindle connecting member (435), and the clutch resetting elastic member (434) is arranged between the spindle connecting member (435) and the clutch (433); The distal end of the mandrel connector (435) is sleeved on the outside of the proximal end of the mandrel (33) and fixedly connected to the mandrel (33), and the distal end of the clutch (433) is sleeved on the proximal end of the twisting shell connector (428); Optionally, the spindle drive module (43) further comprises a motor flange (439) and a drive motor (4310), and the method further comprises the steps of: The motor flange (439) is fixedly connected to the driving motor (4310), and the proximal end of the core shaft connecting member (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); Optionally, 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 proximal end transmission connection between the protective sleeve drive module (41) and the protective sleeve (31), the assembly after the proximal end transmission connection between the twisting shell drive module (42) and the proximal end transmission connection between the twisting shell (32), and the assembly after the proximal end transmission connection between the core shaft drive module (43) and the proximal end transmission connection between the core shaft (33) are sequentially installed into the 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; Optionally, 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).

10. The method for preparing a left ventricular assist device according to claim 9, characterized in that: 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 sleeved outside the second housing (402) and fixedly connected to the first clutch ring (4321); Optionally, the step of "separably connecting the distal end of the mandrel drive module (43) to the distal 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 connecting member (428); Optionally, 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), and the method further includes 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 two ends of the second twisting gear shaft (4214) and are fixedly connected to the second twisting gear shaft (4214); Insert the second twisting gear reset elastic member (4215) into the corresponding mounting hole of the second twisting gear limiter (4211), 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 arrange 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); Optionally, the method further comprises the steps of: Covering the second gear set cover (406) on the second twisting gear stopper (4211), and fixing the second gear set cover (406) to the housing (40); Optionally, the spindle drive module (43) further comprises a brake assembly (438), and the method further comprises 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); Optionally, the brake assembly (438) comprises a brake member slider (4381), a brake member (4382) and a pair of brake member reset elastic members (4383), and the method further comprises 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 cooperate 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); Optionally, 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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