Left ventricular assist device

Abstract

The present invention provides a left ventricular assist device, comprising: a drive control mechanism including a twisting shell drive module and a core shaft drive module; a transmission shaft including a twisting shell and a core shaft, wherein the twisting shell is movably mounted on the core shaft; a micro pump head including a pump head impeller and a pump head transmission assembly, wherein the proximal end of the pump head impeller is transmission-connected to the twisting shell drive module via the twisting shell, the distal end of the pump head transmission assembly is fixedly connected to the distal end of the pump head impeller, the proximal end of the pump head transmission assembly is transmission-connected to the core shaft drive module via the core shaft, the core shaft drive module drives the core shaft and the twisting shell to rotate synchronously, thereby driving 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; the twisting shell drive module drives the twisting shell and the core shaft to rotate relative to each other, thereby driving the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller folds or unfolds. The solution provided by the present invention can adjust the outer diameter of the micro pump head in the left ventricular assist device, thereby improving its efficiency and safety.

Description

Technical Field

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

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

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

[0004] The technical problem to be solved by the present invention is to provide a left ventricular assist device to improve the efficiency and safety of the left ventricular assist device.

[0005] To solve the above technical problems, the present invention provides a left ventricular assist device, comprising:

[0006] Drive control mechanism,

[0007] It includes a twisting shell drive module and a core shaft drive module;

[0008] A transmission shaft, comprising a twisting shell and a core shaft, wherein the twisting shell is movably sleeved on the outside of the core shaft; and

[0009] The micro pump head includes a pump head impeller and a pump head transmission assembly, wherein

[0010] The proximal end of the pump head impeller is connected to the twisting shell drive module through the twisting shell, the distal end of the pump head transmission assembly is fixedly connected to the distal end of the pump head impeller, and the proximal end of the pump head transmission assembly is connected to the core shaft drive module through the core shaft.

[0011] The core shaft driving module drives the core shaft and the twisting shell to rotate synchronously to drive the distal end and the proximal end of the pump head impeller to rotate together, so that the pump head impeller rotates with a fixed outer diameter; and the twisting shell driving module drives the twisting shell and the core shaft to rotate relative to each other 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.

[0012] In one embodiment, the twisting housing includes a twisting housing micro pump head connection section, a twisting housing flexible section, and a twisting housing drive control mechanism connection section;

[0013] The twisting shell flexible section is fixedly connected to the twisting shell micro pump head connecting section and the twisting shell drive control mechanism connecting section respectively by welding;

[0014] The distal end of the twisting shell micro pump head connecting section is used for fixed connection with the proximal end of the pump head impeller, and the proximal end of the twisting shell drive control mechanism connecting section is used for transmission connection with the twisting shell drive module;

[0015] In one embodiment, the transmission shaft further comprises:

[0016] A protective cover, the protective cover can be movably mounted on the twisting shell, the proximal end of the protective cover is drivingly connected to the protective cover drive module of the drive control mechanism, and the distal end of the protective cover is fixedly connected to the proximal end of the pump head protection assembly of the micro pump head, and the drive control mechanism controls the outer diameter of the pump head protection assembly by controlling the protective cover to slide on the twisting shell;

[0017] Optionally, the left ventricular assist device further comprises a pressure sensor, the pressure sensor comprises an optical fiber, the protective cover is provided with an optical fiber hole, and the optical fiber is passed through the optical fiber hole;

[0018] Optionally, the pressure sensor further comprises a fiber Bragg grating demodulator, and the optical fiber is communicatively connected to the fiber Bragg grating demodulator via a threaded connector;

[0019] Optionally, the optical fiber includes a pressure monitoring optical fiber and a signal transmission optical fiber, the signal transmission optical fiber and the pressure monitoring optical fiber are integrally formed, and the proximal end of the signal transmission optical fiber is fixed and communicatively connected to the fiber Bragg grating demodulator via a threaded connector;

[0020] Optionally, the protective sleeve is made of a medical Pebax tube, the twisting shell is made of a multi-strand double-layer synchronous torque spring tube, and / or the core shaft is made of a plastic-coated steel wire rope.

[0021] In one embodiment, the pump head impeller comprises:

[0022] a foldable impeller, the distal end of which is fixedly connected to the core shaft via the pump head transmission assembly; and

[0023] A twisting connector, wherein the distal end of the twisting connector is clamped with the proximal end of the foldable impeller, and the proximal end of the twisting connector is fixedly connected to the twisting shell.

[0024] In one embodiment, the foldable impeller comprises:

[0025] an impeller skeleton, wherein a proximal end of the impeller skeleton is fixedly connected to the twisting shell via the twisting connector, and a distal end of the impeller skeleton is fixedly connected to the core shaft via the pump head transmission assembly; and

[0026] An impeller blade surface, wherein the impeller blade surface covers the outside of the impeller skeleton;

[0027] Optionally, the impeller skeleton comprises:

[0028] a proximal fixing ring, the proximal fixing ring being fixedly connected to the twisting shell via the twisting connector;

[0029] a distal fixing ring, the proximal end of which is fixedly connected to the core shaft via the pump head transmission assembly; and

[0030] An impeller skeleton wire, the impeller skeleton wire being spirally arranged between the proximal fixing ring and the distal fixing ring;

[0031] Optionally, the impeller skeleton wire is made of elastic material;

[0032] Optionally, the distal end of the twisting connector is provided with a plurality of rotation limiting bosses, and the proximal outer edge of the proximal fixing ring is correspondingly provided with a plurality of limiting grooves, and the twisting connector and the proximal fixing ring are rotationally limited by plugging the rotation limiting bosses into the limiting grooves;

[0033] Optionally, the distal end and the proximal end of the impeller blade are respectively covered on the outside of the distal fixing ring and the proximal fixing ring, and are pushed outward by the impeller skeleton wire to form an impeller.

[0034] In one embodiment, the pump head transmission assembly includes:

[0035] A core shaft sleeve, the core shaft sleeve passes through the impeller frame, the distal end of the core shaft sleeve is fixedly connected to the distal fixing ring, and the proximal end of the core shaft sleeve is sleeved in the proximal fixing ring and fixedly connected to the core shaft;

[0036] A top shaft, the proximal end of which is fixedly embedded in the distal end of the core shaft sleeve;

[0037] A top shaft bearing, wherein the top shaft bearing is sleeved at the distal end of the top shaft, and the proximal end surface of the top shaft bearing contacts the distal end surface of the core shaft sleeve;

[0038] A top shaft sleeve, wherein 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; and

[0039] A top sleeve, wherein the proximal end of the top sleeve is sleeved on the distal end of the top shaft;

[0040] Optionally, the proximal fixing sleeve of the mandrel sleeve is provided with a mandrel collar, the proximal end surface of the mandrel collar is flush with the proximal end surface of the mandrel sleeve, and is limited to be located between the proximal end of the proximal fixing ring and the distal end of the twisting connector;

[0041] Optionally, a top collar is sleeved on the core shaft sleeve, the top collar is sleeved on the distal end of the core shaft sleeve, and the distal end surface of the top collar is fixedly connected to the proximal end surface of the top collar;

[0042] Optionally, the proximal end of the top sleeve is provided with an annular groove adapted to the top shaft bearing, the top shaft bearing is embedded in the proximal annular groove of the top sleeve, and the outer edge of the top shaft bearing is limited to be located between the proximal annular groove of the top sleeve and the top sleeve ring.

[0043] In one embodiment, the micro pump head further comprises:

[0044] A pump head protection assembly, wherein the pump head protection assembly coaxial cover is arranged outside the pump head impeller, and the proximal end of the pump head protection assembly is transmission-connected to the protection cover drive module in the drive control mechanism through the protection cover, and the distal end of the pump head protection assembly is fixedly connected to the distal end of the pump head transmission assembly;

[0045] Optionally, the pump head protection assembly includes:

[0046] An anchoring bracket, the proximal end of the anchoring bracket is fixedly connected to the distal end of the protective sleeve, and the distal end of the anchoring bracket is sleeved and fixed to the distal end of the pump head transmission assembly; and

[0047] A top sleeve tip, 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 pump head transmission assembly;

[0048] Optionally, the pump head protection assembly further comprises a bracket protection sleeve connecting ring, the distal end of the bracket protection sleeve connecting ring is embedded and fixed in the annular proximal end of the anchor bracket, and the distal end surface of the bracket protection sleeve connecting ring is flush with the distal end surface of the annular proximal end of the anchor bracket, and

[0049] The stent protective cover connecting ring is slidably sleeved outside the twisting shell and is fixedly connected to the distal end of the protective cover;

[0050] Optionally, an anchoring groove is provided at the distal end of the top sleeve, and an anchoring rod is provided at the proximal end of the top sleeve tip, and the anchoring rod is plugged into and matched with the anchoring groove to fixedly connect the proximal end of the top sleeve tip with the distal end of the pump head transmission assembly;

[0051] Optionally, the anchoring bracket includes:

[0052] An anchoring support frame, wherein the proximal end of the anchoring support frame is fixedly connected to the distal end of the protective sleeve, and the distal end of the anchoring support frame is sleeved and fixed to the distal end of the pump head transmission assembly; and

[0053] Anchoring stent membrane, said anchoring stent membrane being sleeved outside said anchoring stent skeleton;

[0054] Optionally, the anchoring support frame includes a proximal ring of the anchoring support frame, a distal ring of the anchoring support frame, and a plurality of anchoring support frame wires arranged in parallel between the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame, the anchoring support frame wires bend outward when the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame approach each other to expand the structure of the pump head protection assembly outward, and the anchoring support frame wires are tightened inward when the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame move away from each other to retract the structure of the pump head protection assembly inward;

[0055] Optionally, the anchoring stent skeleton wire is made of elastic material.

[0056] In one embodiment, the drive control mechanism further comprises:

[0057] The twisting shell drive module is arranged in the shell, and the distal end of the twisting shell drive module is connected to the proximal end of the twisting shell by transmission; the core shaft drive module is arranged in the shell and arranged at the proximal end of the twisting shell drive module, and the distal end of the core shaft drive module is connected to the proximal end of the core shaft by transmission, and the distal end of the core shaft drive module is detachably connected to the proximal end of the twisting shell drive module, wherein

[0058] When the core shaft driving module is connected to the twisting shell driving module, the core shaft driving module drives the core shaft and the twisting shell to rotate synchronously; and when the core shaft driving module is separated from the twisting shell driving module, the twisting shell driving module drives the twisting shell to rotate relative to the core shaft.

[0059] In one embodiment, the twisting shell driving module includes:

[0060] a twisting shell connector, wherein the twisting shell connector is fixedly connected to the twisting shell, and a proximal end of the twisting shell connector is detachably connected to a distal end of the core shaft drive module; and

[0061] a twisting gear set, the twisting gear set being arranged at the distal end of the twisting housing connector and being used to control the rotation of the twisting housing connector when the distal end of the mandrel drive module is separated from the proximal end of the twisting housing drive module;

[0062] Optionally, the twisting gear set includes:

[0063] First twisting gear shaft;

[0064] a first twisting gear, wherein the first twisting gear is sleeved on the first twisting gear shaft and fixedly connected to the twisting housing connector through the first twisting gear shaft;

[0065] a first twisting gear shaft bearing, the first twisting gear shaft bearing being disposed at a distal end of the first twisting gear shaft and rotatably supporting the first twisting gear shaft within the housing;

[0066] a twisting shell connector bearing, the twisting shell connector bearing being disposed in a middle section of the twisting shell connector and rotatably supporting the twisting shell connector within the housing; and

[0067] a second gear set, the second gear set being detachably meshed with the first twisting gear and controlling the first twisting gear to rotate when the second gear set is meshed with the first twisting gear;

[0068] Optionally, the first twisting gear shaft is configured as a multi-stepped shaft, and the proximal end of the first twisting gear shaft is sleeved and fixed to the distal end of the twisting housing connector;

[0069] Optionally, the twisting shell driving module further includes a twisting shell sleeve and a twisting shell sleeve bearing, the twisting shell sleeve bearings are respectively sleeved on both ends of the twisting shell sleeve, the twisting shell sleeve is sleeved on the proximal end of the twisting shell, and is arranged on the proximal end of the first twisting gear shaft;

[0070] Optionally, the second gear set includes:

[0071] Second twisting gear shaft;

[0072] a second twisting gear, the second twisting gear being sleeved on the second twisting gear shaft and detachably meshing with the first twisting gear;

[0073] a second twisting gear shaft bearing, wherein the second twisting gear shaft bearing is disposed between the second twisting gear shaft and the second twisting gear;

[0074] a second twisting gear limiting member, the second twisting gear limiting member being respectively provided at both ends of the second twisting gear shaft and fixedly connected to the second twisting gear shaft, one side of the second twisting gear limiting member being inserted into the housing, and the other side of the second twisting gear limiting member being extended out of the housing and supporting the second twisting gear on the outside of the housing; and

[0075] The second twisting gear reset elastic member is arranged between the second twisting gear limiting member and the housing and separates the second twisting gear from the first twisting gear.

[0076] In one embodiment, the spindle drive module includes:

[0077] A core shaft connecting piece, the core shaft connecting piece is sleeved on the outside of the core shaft and fixedly connected to the core shaft;

[0078] A coupling, wherein the distal end of the coupling is fixedly connected to the core shaft connector, and the proximal end of the coupling is fixedly connected to the drive motor;

[0079] A clutch, the clutch being arranged at the distal end of the core shaft connector and sleeved on the outside of the core shaft, the clutch being synchronously rotated with the core shaft connector, and the clutch being detachably connected to the twisting shell connector; and

[0080] A clutch resetting elastic member, the clutch resetting elastic member being arranged between the core shaft connecting member and the clutch;

[0081] Optionally, the spindle drive module further comprises a spindle connector bearing, wherein the spindle connector bearing is sleeved on the proximal end of the spindle connector and rotatably supports the spindle connector in the housing;

[0082] Optionally, the spindle drive module further includes:

[0083] Braking assemblies, which are arranged in pairs on both sides of the coupling and are used to brake the coupling;

[0084] Optionally, the brake assembly includes:

[0085] a brake slider, the brake slider being arranged outside the housing;

[0086] a brake member, wherein the brake member is disposed inside the brake member slider, the large end of the brake member extends out of the housing and is slidably connected to the brake member slider, and the small end of the brake member is inserted into the housing and engaged with the outer wall of the coupling; and

[0087] a pair of brake member reset elastic members, the pair of brake member reset elastic members being arranged between the brake member and the housing, one end of the pair of brake member reset elastic members being inserted into the corresponding mounting holes of the brake member, and the other end of the pair of brake member reset elastic members being inserted into the corresponding mounting holes of the housing;

[0088] Optionally, the brake member slider has a wedge-shaped bottom surface, the large end of the brake member is provided with a limiting groove, and the wedge-shaped bottom surface and two side surfaces of the brake member slider are in contact with the arc-shaped top surface and two side surfaces of the limiting groove respectively;

[0089] Optionally, the spindle drive module further includes:

[0090] A clutch shift ring, which is slidably sleeved outside the housing and has a clutch fork mounting hole radially provided therein; and

[0091] a clutch fork, the clutch fork being disposed in the clutch fork mounting hole and passing 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 housing connector;

[0092] Optionally, the clutch shift ring includes a first clutch shift ring and a second clutch shift ring, and the first clutch shift ring and the second clutch shift ring are arranged opposite to each other to form the annular clutch shift ring.

[0093] Optionally, the drive control mechanism further includes:

[0094] a protective cover driving module, the protective cover driving module being sleeved on the proximal end of the protective cover and being in transmission connection with the proximal end of the protective cover, and driving the protective cover to move;

[0095] Optionally, the protective cover driving module includes a protective cover slider, a protective cover slider bearing, and a protective cover slider end cover, wherein the protective cover slider is sleeved on the proximal end of the protective cover and fixedly connected to the protective cover; the protective cover slider bearing is embedded in the proximal ring groove of the protective cover slider, and the outer edge of the protective cover slider bearing is limited between the proximal ring groove of the protective cover slider and the protective cover slider end cover; the protective cover slider end cover is arranged at the proximal end of the protective cover slider and fixedly connected to the protective cover slider;

[0096] Optionally, the protective cover driving module includes at least two protective cover slider bearings, and the at least two protective cover slider bearings are embedded in the proximal ring groove of the protective cover slider and make the distal end surface of the protective cover slider bearing away from the protective cover slider end cover contact with the proximal end surface of the protective cover;

[0097] Optionally, the protective cover slider is provided with a protective cover slider locking piece, and the protective cover slider locking piece cooperates with corresponding structures at different positions of the shell to lock the protective cover slider at different positions of the shell.

[0098] The above solution of the present invention includes at least the following beneficial effects:

[0099] The left ventricular assist device provided by the above-mentioned solution of the present invention includes: a drive control mechanism, a transmission shaft and a micro pump head; wherein the drive control mechanism includes a twisting shell drive module and a core shaft drive module; the transmission shaft includes a core shaft and a twisting shell movably sleeved on the outside of the core shaft; the micro pump head includes a pump head impeller and a pump head transmission assembly, the proximal end of the pump head impeller is connected to the twisting shell drive module through the twisting shell, the distal end of the pump head transmission assembly is fixedly connected to the distal end of the pump head impeller, the proximal end of the pump head transmission assembly is connected to the core shaft drive module through the core shaft, and the micro pump head is driven by the core shaft drive module. The moving core shaft and the twisting shell rotate synchronously to drive the distal end and the proximal end of the pump head impeller to rotate together, so that the pump head impeller rotates with a fixed outer diameter; the twisting shell drive module drives the twisting shell and the core shaft to rotate relative to each other 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 expansion and folding of the pump head impeller in the micro pump head of the left ventricular assist 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 left ventricular assist device. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] Figure 1 is a schematic diagram of the overall structure of a left ventricular assist device provided by an embodiment of the present invention;

[0101] Figure 2 This is a schematic diagram of the three-dimensional structure of a transmission shaft provided by an optional embodiment of the present invention;

[0102] Figure 3 yes Figure 2 The main cross-sectional view of

[0103] Figure 4 This is a schematic diagram of the three-dimensional structure of a protective cover provided by an optional embodiment of the present invention;

[0104] Figure 5 This is a schematic diagram of the three-dimensional structure of a twisting shell provided by an optional embodiment of the present invention;

[0105] Figure 6 is a schematic diagram of the three-dimensional structure of a core shaft provided by an optional embodiment of the present invention;

[0106] Figure 7 is a schematic diagram of the overall structure of a pressure sensor provided by an optional embodiment of the present invention;

[0107] Figure 8 1 is a schematic diagram of the installation of an optical fiber and a housing in a pressure sensor provided by an optional embodiment of the present invention;

[0108] Figure 9 It is a cross-sectional schematic diagram of the connection between the micro pump head and the transmission shaft provided by an optional embodiment of the present invention;

[0109] Figure 10 This is a schematic diagram of the three-dimensional structure of a pump head impeller provided by an optional embodiment of the present invention when it is expanded (normal state);

[0110] Figure 11 yes Figure 10 Exploded diagram;

[0111] Figure 12 This is a schematic diagram of the three-dimensional structure of the impeller skeleton when it is unfolded (normal state) provided by an optional embodiment of the present invention;

[0112] Figure 13 This is a schematic diagram of the three-dimensional structure of an impeller blade provided by an optional embodiment of the present invention;

[0113] Figure 14 This is a schematic diagram of the three-dimensional structure of the impeller skeleton when folded, provided by an optional embodiment of the present invention;

[0114] Figure 15 This is a schematic diagram of a foldable impeller provided by an optional embodiment of the present invention rotating and twisting in the direction shown in the figure under normal conditions;

[0115] Figure 16 yes Figure 15 Schematic diagram of the foldable impeller in a folded state after rotation and twisting;

[0116] Figure 17 This is a schematic diagram of the three-dimensional structure of a pump head transmission assembly provided by an optional embodiment of the present invention;

[0117] Figure 18 yes Figure 17 Exploded diagram;

[0118] Figure 19 1 is a schematic diagram of the three-dimensional structure of a pump head protection assembly provided by an optional embodiment of the present invention;

[0119] Figure 20 yes Figure 19 Exploded diagram;

[0120] Figure 21 is a front cross-sectional view of a drive control mechanism provided by an optional embodiment of the present invention;

[0121] Figure 22 is a schematic diagram of the three-dimensional structure of a housing provided by an optional embodiment of the present invention;

[0122] Figure 23 1 is a schematic diagram of the assembly of a first housing and a clutch fork provided in an optional embodiment of the present invention;

[0123] Figure 24 1 is a schematic diagram of the assembly of the second housing and the clutch fork provided in an optional embodiment of the present invention;

[0124] Figure 25 yes Figure 22 Exploded diagram;

[0125] Figure 26 is a schematic diagram of the three-dimensional structure of a protective cover driving module provided in an optional embodiment of the present invention;

[0126] Figure 27 yes Figure 26 Exploded diagram;

[0127] Figure 28 1 is a schematic diagram of the three-dimensional structure of a twisting shell driving module provided in an optional embodiment of the present invention;

[0128] Figure 29 is a schematic diagram of the three-dimensional structure of a second gear set provided by an optional embodiment of the present invention;

[0129] Figure 30 yes Figure 29 Exploded diagram;

[0130] Figure 31 yes Figure 29 The main cross-sectional view of

[0131] Figure 32 yes Figure 28 Exploded view of some components of the middle twisting shell drive module;

[0132] Figure 33 1 is a schematic diagram of the three-dimensional structure of a spindle drive module provided in an optional embodiment of the present invention;

[0133] Figure 34 yes Figure 33 Exploded diagram;

[0134] Figure 35 is an exploded view of a clutch ring provided in an optional embodiment of the present invention;

[0135] Figure 36 is an exploded view of a brake assembly provided by an optional embodiment of the present invention;

[0136] Figure 37 is a front cross-sectional view of a brake assembly provided by an optional embodiment of the present invention;

[0137] Figure 38 is a cross-sectional schematic diagram of the assembly of the brake assembly and the first housing provided by an optional embodiment of the present invention;

[0138] Figure 39 is a cross-sectional schematic diagram of the assembly of the brake assembly and the second housing provided by an optional embodiment of the present invention;

[0139] Figure 40 This is a schematic diagram of the assembly of a clutch and a core shaft connector provided by an optional embodiment of the present invention;

[0140] Figure 41 This is a schematic diagram of the assembly of a clutch and a twisting housing connector provided by an optional embodiment of the present invention;

[0141] Figure 42 This is a schematic diagram of the use process of a left ventricular assist device provided by an optional embodiment of the present invention;

[0142] Figure 43 This is a schematic diagram of the connection between the drive control mechanism, the transmission shaft, and the micro pump head when the pump head impeller of the left ventricular assist device provided by an optional embodiment of the present invention is in an expanded state;

[0143] Figure 44 1 is a schematic diagram of a brake member slider sliding toward the distal end provided by an optional embodiment of the present invention;

[0144] Figure 45 is a schematic diagram of rotating a clutch ring in the direction shown in the figure, provided by an optional embodiment of the present invention;

[0145] Figure 46 1 is a schematic diagram of a proximal sliding clutch ring provided by an optional embodiment of the present invention;

[0146] Figure 47 is a schematic diagram of rotating a clutch ring in the direction shown in the figure, provided by an optional embodiment of the present invention;

[0147] Figure 48 is a schematic diagram of pushing the second gear set toward the inside of the drive control mechanism provided by an optional embodiment of the present invention;

[0148] Figure 49 is a schematic diagram of rotating the second twisting gear in the direction shown in the figure, provided by an optional embodiment of the present invention;

[0149] Figure 50 It is a schematic diagram of a proximal sliding protective cover slider provided by an optional embodiment of the present invention.

[0150] Explanation of the accompanying figures: 1. Left ventricular assist device;

[0151] 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;

[0152] 22. Pump head impeller; 221. Foldable impeller; 2211. Impeller frame; 2212. Impeller blade; 22111. Distal fixing ring; 22112. Impeller frame wire; 22113. Proximal fixing ring; 222. Twisted connector;

[0153] 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;

[0154] 3. Drive shaft; 31. Protective sleeve; 311. Optical fiber hole; 312. Distal notch; 313. Proximal notch; 32. Twisting housing; 321. Twisting connector mounting notch; 322. Twisting housing micropump head connection section; 323. Twisting housing flexible section; 324. Twisting housing drive control mechanism connection section; 33. Mandrel; 34. Optical fiber pressure sensor;

[0155] 4. Drive control mechanism; 40. Housing; 401. First housing; 4011. First protrusion; 4012. Second protrusion; 4013. Third protrusion; 4014. First optical fiber slot; 402. Second housing; 4021. Fourth protrusion; 4022. Fifth protrusion; 4023. Sixth protrusion; 4024. Second optical fiber slot; 403. Distal cover; 404. Proximal cover; 405. Brake assembly cover; 406. Second gear assembly cover;

[0156] 41. Protective cover drive module; 411. Protective cover slider; 4111. Protective cover slider locking member; 412. Protective cover slider bearing; 413. Protective cover slider end cap;

[0157] 42. Twisting shell drive module; 421. Second gear set; 4211. Second twisting gear limiter; 4212. Second twisting gear shaft bearing; 4213. Second twisting gear; 4214. Second twisting gear shaft; 4215. Second twisting gear reset elastic member; 422. Twisting shell sleeve bearing; 423. Twisting shell sleeve; 424. First twisting gear shaft bearing; 425. First twisting gear; 426. First twisting gear shaft; 427. Twisting shell connector bearing; 428. Twisting shell connector;

[0158] 43. Spindle drive module; 431. Clutch fork; 432. Clutch ring; 4321. First clutch ring; 4322. Second clutch ring; 4323. Clutch fork mounting hole; 433. Clutch; 434. Clutch return elastic member; 435. Spindle connector; 436. Spindle connector bearing; 437. Coupling; 438. Brake assembly; 4381. Brake member slider; 43811. Seventh protrusion; 43812. Wedge-shaped bottom surface; 4382. Brake member; 43821. Limiting groove; 4383. Brake member return elastic member; 439. Motor flange; 4310. Drive motor;

[0159] 5. Pressure sensor; 51. Optical fiber; 511. Pressure monitoring optical fiber; 512. Signal transmission optical fiber; 52. Fiber Bragg grating demodulator;

[0160] 6. Catheter;

[0161] A. Proximal end; B. Distal end. DETAILED DESCRIPTION

[0162] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0163] In the following description, for the purpose of illustrating the various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other cases, well-known devices, structures, and techniques associated with this application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0164] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0165] In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but words such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and should not be understood as restrictive terms.

[0166] like Figures 1 to 18 As shown, an embodiment of the present invention proposes a left ventricular assist device 1, including a drive control mechanism 4, a transmission shaft 3 and a micro pump head 2, wherein the drive control mechanism 4 is used to provide driving force for the operation of the micro pump head 2 and includes a twisting shell drive module 42 and a core shaft drive module 43, the transmission shaft 3 is used to transmit the driving force provided by the drive control mechanism 4 and includes a twisting shell 32 and a core shaft 33, the micro pump head 2 includes a pump head impeller 22 and a pump head transmission assembly 23, wherein the pump head transmission assembly 23 is arranged through the pump head impeller 22, the proximal end of the pump head impeller 22 is transmission-connected to the twisting shell drive module 42 through the twisting shell 32, the distal end of the pump head transmission assembly 23 is fixedly connected to the distal end of the pump head impeller 22, and the proximal end of the pump head transmission assembly 23 is transmission-connected to the core shaft drive module 43 through the core shaft 33. The core shaft driving module 43 drives the core shaft 33 and the twisting shell 32 to rotate synchronously to drive the distal end and the proximal end of the pump head impeller 22 to rotate together, so that the pump head impeller 22 rotates with a fixed outer diameter; and the twisting shell driving module 42 drives the twisting shell 32 and the core shaft 33 to rotate relative to each other to drive the proximal end of the pump head impeller 22 to rotate relative to the distal end, so that the pump head impeller 22 is folded or unfolded.

[0167] In this embodiment, the drive control mechanism 4 serves as the drive control module in the entire left ventricular assist device 1, and is connected to the micro pump head 2 through the transmission shaft 3. When the distal end of the core shaft drive module 43 is connected to the proximal end of the twisting shell drive module 42, the core shaft drive module 43 drives the core shaft 33 to rotate and drives the twisting shell drive module 42 to rotate synchronously. The twisting shell drive module 42 further drives the twisting shell 32 to rotate, thereby realizing the synchronous rotation of the twisting shell 32 and the core shaft 33, and then drives the pump head impeller 22 as a whole to rotate at a fixed outer diameter (the synchronous rotation here refers to rotation at the same angular velocity). When the distal end of the core shaft drive module 43 is separated from the proximal end of the twisting shell drive module 42, the twisting shell drive module 42 drives the twisting shell 32 to rotate relative to the core shaft 33 (at this time, the core shaft drive module 43 stops running and the core shaft 33 is fixed). When the twisting shell 32 rotates relative to the core shaft 33, the proximal end of the pump head impeller 22 can be driven to rotate relative to the distal end. The rotation of the proximal end of the pump head impeller 22 relative to the distal end can make the pump head impeller 22 expand or fold to change the outer diameter of the pump head impeller 22.

[0168] By controlling the folding or unfolding of the pump head impeller 22 in the micro pump head 2 (when the pump head impeller 22 is folded, the overall outer diameter is reduced; when the pump head impeller 22 is unfolded, the overall outer diameter is much larger than the outer diameter when folded), it is helpful to implant the micro pump head 2 in a folded state into a designated location in the human body through minimally invasive interventional surgery. The pump head impeller 22 can then be deformed and unfolded into a spiral shape with a larger outer diameter within the human body, so that the left ventricular assist device 1 has the ability to provide sufficient auxiliary blood flow to the patient at a low rotation speed, thereby improving the blood supply efficiency and use safety of the left ventricular assist device 1. At the same time, the pump head impeller 22 with an adjustable outer diameter also helps to reduce the resistance of the entire micro pump head 2 when entering and passing through the catheter, which is more conducive to the rapid and safe deployment and recovery of the left ventricular assist device 1.

[0169] Here, the drive shaft 3 serves as a connector between the drive control mechanism 4 and the micro pump head 2 in the entire left ventricular assist device 1. It can realize the drive control of the micro pump head 2 at the distal end of the assist device entering the patient's body through the drive control mechanism 4 at the proximal end of the assist device outside the patient's body, thereby preventing the drive control mechanism 4 from entering the patient's body along with the micro pump head 2. This not only reduces the size of the interventional wound, but also avoids the possible harm to the patient caused by the heat generated by the motor in the drive control mechanism 4. At the same time, the drive control mechanism 4 is placed outside the patient's body and can be reused, thereby reducing the use cost of the entire left ventricular assist device 1.

[0170] Preferably, the distal end of the core shaft 33 is bonded and fixed to the proximal end of the pump head transmission assembly 23, and the distal end of the twisting shell 32 is bonded and fixed to the proximal end of the pump head impeller 22 (the distal end of the pump head impeller 22 is bonded and fixed to the distal end of the pump head transmission assembly 23); more preferably, the bonding and fixation here can be done by biocompatible glue to avoid causing harm to the human body.

[0171] 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, and the lengths of the two can be set according to the actual needs of the application.

[0172] Preferably, the core shaft 33 can be made of a plastic-coated steel wire rope, and the twisting shell 32 can be made of a multi-strand double-layer synchronous torque spring tube.

[0173] like Figure 5As shown, in an optional embodiment of the present invention, the twisting housing 32 may include a twisting housing micro pump head connecting section 322, a twisting housing flexible section 323, and a twisting housing drive control mechanism connecting section 324. The twisting housing flexible section 323 is fixedly connected to the twisting housing micro pump head connecting section 322 and the twisting housing drive control mechanism connecting section 324 respectively by welding; wherein, the distal end of the twisting housing micro pump head connecting section 322 is used for fixed connection with the proximal end of the pump head impeller 22, and the proximal end of the twisting housing drive control mechanism connecting section 324 is used for transmission connection with the twisting housing drive module 42. Here, the twisting housing flexible section 323 can be made of multiple strands of double-layer synchronous torque spring tubes in one piece to ensure the flexibility of the entire transmission shaft 3 during use.

[0174] Preferably, a twisting connector mounting slot 321 adapted to the proximal end of the pump head impeller 22 is provided at the distal end of the twisting shell micro pump head connecting section 322. When the pump head impeller 22 and the twisting shell 32 are assembled, the twisting connector mounting slot 321 at the distal end of the twisting shell 32 is snapped into engagement 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-in joint, which can improve the firm connection between the two while avoiding harm to the human body.

[0175] like Figures 2 to 4 As shown, in an optional embodiment of the present invention, the transmission shaft 3 may further include a protective sleeve 31, which is movably mounted on the outside of the twisting shell 32, the proximal end of the protective sleeve 31 is transmission-connected to the protective sleeve drive module 41, and the distal end of the protective sleeve 31 is fixedly connected to the proximal end of the pump head protection assembly 21, and the protective sleeve drive module 41 is used to control the sliding of the protective sleeve 31 on the twisting shell 32 to control the outer diameter of the pump head protection assembly 21.

[0176] In this embodiment, the protective sleeve 31 serves as a protective layer for the core shaft 33 and the twisting shell 32. It is an annular cylindrical body and is mounted 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 mounted on the outside of the twisting shell 32. Lubricating fluid is filled between the protective sleeve 31 and the twisting shell 32, thereby reducing the heat generated by the transmission shaft 3 during operation. The twisting shell 32 is slightly longer than the protective sleeve 31, and the length of the two can be set according to the actual needs of the application. Preferably, the protective sleeve 31 can be made of medical Pebax tubing, but of course it is not limited to medical Pebax tubing. Other suitable materials that are harmless to the human body can also be selected. Preferably, the distal end of the protective sleeve 31 and the proximal end of the pump head protection assembly 21 can be fixedly bonded using biocompatible glue to avoid harm to the human body.

[0177] like Figures 7 and 8As shown, in an optional embodiment of the present invention, the left ventricular assist device 1 may further include a pressure sensor 5. This pressure sensor 5 comprises an optical fiber 51 and a fiber Bragg grating (FBG) interrogator 52, which are communicatively connected via a threaded connector. A fiber hole 311 is defined in the protective cover 31, and the optical fiber 51 is passed through the fiber hole 311. When the left ventricular assist device 1 is in use, a portion of the pressure sensor 5 is inserted into the patient's body along with the micropump head 2, enabling real-time collection of the patient's blood pressure data to accurately capture changes in blood pressure.

[0178] In an optional embodiment of the present invention, a distal notch 312 and a proximal notch 313 are respectively provided at the distal and proximal ends of the protective cover 31 for facilitating the assembly and fixation of the optical fiber 51. Preferably, the distal notch 312 is arranged on the side wall of the distal end of the protective cover 31 and extends axially, and the proximal notch 313 is arranged on the side wall of the proximal end of the protective cover and is located in the extension direction of the distal notch 312. The distal end of the optical fiber 51 passes through the proximal notch 313 of the protective cover 31 into the optical fiber hole 311 and passes through the distal notch 312 of the protective cover 31.

[0179] like Figure 7 As shown, a fiber Bragg grating (FBG) interrogator 52 is secured to the drive control mechanism 4 and communicatively connected to the controller module of the left ventricular assist device 1. The distal end of the optical fiber 51 sequentially passes through the fiber slots 4014 and 4024 of the drive control mechanism 4 and the fiber hole 311 of the protective cover 31, so that the entire optical fiber 51 is routed within the first fiber slot 4014 and the second fiber slot 4024 of the drive control mechanism 4, as well as the fiber hole 311 of the protective cover 31. The proximal end of the optical fiber 51 is communicatively connected to the fiber Bragg grating (FBG) interrogator 52 via a threaded connector.

[0180] 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 . The proximal end of the signal transmission optical fiber 512 is communicatively connected to the fiber Bragg grating demodulator 52 via a threaded connector.

[0181] In this embodiment, the pressure monitoring fiber 511 is a fiber-writing segment, used to monitor blood pressure data in the patient's body in real time. The signal transmission fiber 512 is a non-writing segment of the fiber. The proximal end of the signal transmission fiber 512 is communicatively connected to the fiber Bragg grating demodulator 52 via a threaded connector, which is used to transmit the blood pressure data monitored by the pressure monitoring fiber 511 to the fiber Bragg grating demodulator 52 in real time. The pressure monitoring fiber 511 is laid near the micropump head 2 and, when the auxiliary device is in use, enters the patient's body along with the micropump head 2 to facilitate real-time monitoring.

[0182] When laying the optical fiber 51, the pressure monitoring optical fiber 511 is passed through the proximal notch 313 of the protective cover 31 into the optical fiber hole 311 and out through the distal notch 312 of the protective cover 31. At the same time, when ensuring that the pressure monitoring optical fiber 511 completely passes through the optical fiber hole 311 and is just placed in the distal notch 312, the signal transmission optical fiber 512 is bonded and fixed to the optical fiber hole 311 to avoid falling off during use, thereby realizing real-time monitoring of blood flow pressure and improving the accuracy of monitoring; preferably, biocompatible glue can be used to bond and fix the signal transmission optical fiber 512 to the optical fiber hole 311 to avoid causing harm to the human body.

[0183] like Figures 10 and 11 As shown, in an optional embodiment of the present invention, the pump head impeller 22 includes a foldable impeller 221 and a twisting connector 222; the distal end of the foldable impeller 221 is fixedly connected to the core shaft 33 through the pump head transmission assembly 23, the proximal end of the foldable impeller 221 is clamped with the distal end of the twisting connector 222, and the proximal end of the twisting connector 222 is fixedly connected to the twisting shell 32.

[0184] In this embodiment, the proximal end of the foldable impeller 221 is fixedly engaged with the distal end of the twisting connector 222, and is fixedly connected to the distal end of the twisting housing 32 via the proximal end of the twisting connector 222. The proximal end of the twisting housing 32 is transmission-connected to the twisting housing drive module 42 in the drive control mechanism 4. The twisting housing 32 is driven to rotate by the twisting housing drive module 42, which in turn drives the twisting housing 32 to rotate, and the proximal end of the foldable impeller 221 to rotate via the twisting housing drive module 42. Because the distal end of the foldable impeller 221 is fixedly connected to the distal end of the core shaft 33 via the pump head transmission assembly 23, the proximal end of the core shaft 33 is transmission-connected to the core shaft drive module 43 in the drive control mechanism 4. The core shaft 33 is driven to rotate by the core shaft drive module 43, which in turn drives the pump head transmission assembly 23, and the distal end of the foldable impeller 221 is rotationally driven by the pump head transmission assembly 23.

[0185] When the core shaft 33 and the twisting housing 32 rotate synchronously, the distal and proximal ends of the foldable impeller 221 rotate synchronously, allowing the entire pump head impeller 22 to rotate while maintaining a constant outer diameter. When the twisting housing 32 rotates relative to the core shaft 33, the proximal end of the foldable impeller 221 rotates relative to the distal end. This rotation of the proximal end of the foldable impeller 221 causes the impeller 221 to expand or collapse, changing the outer diameter of the entire pump head impeller 22 (increasing when expanded and decreasing when collapsed).

[0186] Optionally, a core shaft hole for the core shaft 33 to pass through is opened on the twisting connector 222, so that the distal end of the core shaft 33 passes through the twisting connector 222 and is fixedly connected to the distal end of the foldable impeller 221 through the pump head transmission assembly 23.

[0187] like Figures 12 to 13As shown, in an optional embodiment of the present invention, the foldable impeller 221 includes an impeller skeleton 2211 and an impeller blade surface 2212. The proximal end of the impeller skeleton 2211 is fixedly connected to the twisting shell 32 through a twisting connector 222, and the distal end of the impeller skeleton 2211 is fixedly connected to the core shaft 33 through a pump head transmission assembly 23. The impeller blade surface 2212 is covered on the outside of the impeller skeleton 2211.

[0188] In this embodiment, the impeller skeleton 2211 as a whole can be twisted and folded or twisted and unfolded, the impeller blade surface 2212 is covered on the outside of the impeller skeleton 2211, and the distal and proximal ends of the impeller blade surface 2212 are respectively bonded and fixed to the distal and proximal ends of the impeller skeleton 2211 to ensure that the impeller blade surface 2212 will not fall off during the folding and auxiliary blood supply process.

[0189] Preferably, the impeller blade surface 2212 can be prepared by a biocompatible superelastic medical silicone material, which can reduce the damage caused by the pump head impeller 22 to the human body and blood cells during use, and on the other hand, can enable the pump head impeller 22 to have a large folding and expansion ratio deformation capability (when the impeller skeleton 2211 is twisted and unfolded, the impeller blade surface 2212 can be pushed outward by the impeller skeleton 2211 to form a spiral impeller and increase the outer diameter of the overall pump head impeller 22. When the impeller skeleton 2211 is twisted and folded, the impeller blade surface 2212 will shrink inward to a cylindrical shape and reduce the outer diameter of the overall pump head impeller 22). Preferably, the medical silicone material here can be made of Dragon Skin silicone and Slice with a mass ratio of 2:1. Thinner diluent is stirred and prepared at room temperature and heated to form a film; the medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75kPa, the maximum strain it can reach is 1328.2%, and the maximum stress it can withstand is 675.3kPa, which can meet the needs of the entire micro pump head 2 during use.

[0190] Optionally, the impeller frame 2211 includes a proximal fixing ring 22113, a distal fixing ring 22111, and an impeller frame wire 22112. The proximal end of the proximal fixing ring 22113 is fixedly connected to the twisting housing 32 via a twisting connector 222. The distal fixing ring 22111 is fixedly connected to the core shaft 33 via the pump head transmission assembly 23. The impeller frame wire 22112 is spirally arranged between the proximal fixing ring 22113 and the distal fixing ring 22111.

[0191] 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 during 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. The arrangement of the proximal fixing ring 22113 and the distal fixing ring 22111 ensures that the foldable impeller 221 maintains an overall cylindrical shape when folded, and that the outer diameter of the foldable impeller 221 is smaller than the inner diameter of the medical catheter when folded, thereby facilitating the implantation of the foldable impeller 221 into a suitable position via a human blood vessel during minimally invasive interventional surgery.

[0192] Here, the distal fixing ring 22111, the proximal fixing ring 22113, and the impeller skeleton wire 22112 can be prepared in an integrated manner by metal 3D printing to obtain the impeller skeleton 2211. The distal fixing ring 22111, the proximal fixing ring 22113, and the impeller skeleton wire 22112 can also be prepared by femtosecond laser cutting a nickel-titanium alloy tube to obtain the impeller skeleton 2211.

[0193] A plurality of impeller skeleton wires 22112 are disposed between the proximal fixing ring 22113 and the distal fixing ring 22111. The plurality of impeller skeleton wires 22112 are connected in parallel along the same spiral direction between the proximal fixing ring 22113 and the distal fixing ring 22111. Preferably, the plurality of impeller skeleton wires 22112 can be assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 in a form-locked manner by being inserted into the proximal assembly holes of the distal fixing ring 22111 and the distal assembly holes of the proximal fixing ring 22113. More preferably, biocompatible glue can be applied at the assembly locations for bonding and fixation.

[0194] In one embodiment, the impeller skeleton wire 22112 is made of a superelastic material having a certain rigidity. Preferably, the elastic material is a superelastic nickel-titanium metal material having a certain rigidity. The impeller skeleton wire 22112 can be prepared by heat-treating the nickel-titanium metal wire through a mold. The impeller skeleton wire 22112 made of the superelastic nickel-titanium metal material provides a certain rigidity for the unfolded foldable impeller 221, ensuring the stability of the foldable impeller 221 during rotation.

[0195] When the foldable impeller 221 is in the expanded state (normal state), the impeller skeleton wire 22112 is helical, preferably a few-cycle helix, such as a single-cycle helix or a double-cycle helix, with the outer edge of the helix extending outward. When the proximal fixing ring 22113 rotates in a helical direction relative to the distal fixing ring 22111 in the expanded state, the helical period of the impeller skeleton wire 22112 increases, and the impeller skeleton wire 22112 further twists and folds, causing the outer edge of the helix to retract inward, thereby reducing the outer diameter of the foldable impeller 221.

[0196] Here, the foldable impeller 221 can be prepared in the following manner: Figure 12 The impeller skeleton 2211 is twisted and pre-tightened to a folded state (as shown in FIG. Figure 14 As shown), and the impeller blade surface 2212 is put onto the surface of the impeller skeleton 2211 to obtain Figure 16 The foldable impeller 221 is shown in the folded state. Figure 16 The pre-tightening force is released in the direction of rotation 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 the outer diameter of the foldable impeller 221 is increased, so as to obtain the following Figure 15 The foldable impeller 221 shown in FIG. Figure 15 By twisting in the direction of rotation shown in FIG. Figure 16 The foldable impeller 221 is shown in a folded state.

[0197] In one embodiment 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 fixing ring 22113 may be provided with a plurality of corresponding limiting grooves. The twisting connector 222 and the proximal fixing ring 22113 are rotationally limited by the rotation-limiting bosses engaging with the limiting grooves. The rotation-limiting bosses and limiting grooves assembled between the twisting connector 222 and the proximal fixing ring 22113 can better transmit the twisting torque to the foldable impeller 221 through the twisting connector 222, thereby achieving one-step twisting and folding of the foldable impeller 221.

[0198] In one embodiment of the present invention, the distal and proximal ends of the impeller blades 2212 are respectively wrapped around the distal fixing ring 22111 and the proximal fixing ring 22113, and are lifted outward by the impeller skeleton wire 22112 to form the impeller. Here, the impeller blades 2212 and the distal fixing ring 22111 and the proximal fixing ring 22113 can be bonded with biocompatible glue to ensure that the impeller blades 2212 do not fall off during folding and blood supply assistance. The biocompatible glue can also prevent harm to the human body.

[0199] like Figures 17 and 18As shown, in an optional embodiment of the present invention, 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 core sleeve 236 extends through the impeller frame 2211. The distal end of the core sleeve 236 is fixedly connected to the distal fixing ring 22111. The proximal end of the core sleeve 236 is sleeved within the proximal fixing ring 22113 and fixedly connected to the core shaft 33. The proximal end of the top shaft 235 is fixedly embedded in the distal end of the core 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 contacts the distal end surface of the core 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 confined between the distal end surface of the core 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 , and an annular groove adapted to the top shaft bearing 233 is formed at the proximal end of the top sleeve 231 .

[0200] In this embodiment, the mandrel sleeve 236 passes through the proximal fixing ring 22113 and the distal fixing ring 22111, and the distal end of the mandrel sleeve 236 is fixedly connected to the distal fixing ring 22111. The proximal end of the mandrel sleeve 236 is sleeved on the outer portion of the distal end of the mandrel 33 in the transmission shaft 3. Preferably, a mandrel collar 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236. The mandrel collar 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236 with its proximal end surface flush 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. Biocompatible glue can be used to bond the mandrel sleeve 236 and the mandrel collar 237 to ensure that the mandrel collar 237 does not fall off the mandrel sleeve 236.

[0201] Preferably, the foldable impeller 221 can be axially positioned by the distal end face of the core shaft ring 237. On this basis, the distal fixing ring 22111 can be bonded to the core shaft sleeve 236 using biocompatible glue. Since the core shaft 33 is inserted and fixed in the core shaft sleeve 236, 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.

[0202] Optionally, a top ring 234 is sleeved on the core shaft sleeve 236 , the top ring 234 is sleeved on the distal end of the core shaft sleeve 236 , and the distal end surface of the top ring 234 is fixedly connected to the proximal end surface of the top sleeve 231 .

[0203] Optionally, the proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235 via a top shaft bearing 233; the top shaft bearing 233 is embedded in an annular groove formed at the proximal end of the top sleeve 231, and the outer edge of the top shaft bearing 233 is confined between the annular groove and the top sleeve ring 234. Here, a biocompatible glue can be used to bond and secure the top shaft sleeve 232 to the top shaft 235 to ensure that the top shaft sleeve 232 does not fall off the top shaft 235. After the top sleeve 231 is sleeved onto the top shaft bearing 233, while ensuring that the distal end faces of the top sleeve 231 and the top shaft bearing 233 are in contact, and the top sleeve ring 234 and the proximal end face of the top shaft bearing 233 are in contact, the top sleeve 231 and the top sleeve ring 234 can be bonded and secured using biocompatible glue.

[0204] By securely connecting the distal end of the mandrel sleeve 236 to the distal fixing ring 22111 of the foldable impeller 221 and securely connecting the proximal end of the mandrel sleeve 236 to the distal end of the mandrel 33 (the proximal end of the mandrel sleeve 236 is sleeved and securely connected to the distal end of the mandrel 33), the mandrel 33 can be driven to rotate via the mandrel drive module 43 in the drive control mechanism 4. As the mandrel 33 rotates, the components of the pump head transmission assembly 23 cooperate to cause the distal end of the foldable impeller 221 to rotate synchronously with the mandrel 33. When the twisting housing 32 is driven to rotate by the twisting housing drive module 42 in the drive control mechanism 4, the twisting housing 32 rotates and, through the twisting connector 222, drives the proximal end of the foldable impeller 221 to rotate synchronously with the twisting housing 32. When the mandrel 33 and twisting housing 32 rotate synchronously, the distal and proximal ends of the foldable impeller 221 rotate synchronously, thereby enabling the entire foldable impeller 221 to rotate in a single direction with a fixed outer diameter. When the core shaft 33 and the twisting shell 32 rotate relative to each other, the distal end and the proximal end of the foldable impeller 221 keep rotating relative to each other, thereby achieving the folding and unfolding of the foldable impeller 221 to adjust the outer diameter of the entire foldable impeller 221 .

[0205] like Figures 19 to 20 As shown, in an optional embodiment of the present invention, the micro pump head 2 may further include a pump head protection assembly 21, the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22, and the proximal end of the pump head protection assembly 21 is transmission-connected to the protective cover drive module 41 through the protective cover 31, 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.

[0206] 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. Here, the proximal end of the pump head protection assembly 21 is fixedly connected to the distal end of the protective sleeve 31, 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. Since the protective sleeve 31 is sleeved outside the twisting shell 32, and the proximal end of the protective sleeve 31 is transmission-connected to the protective sleeve drive module 41, when the protective sleeve drive module 41 drives the protective sleeve 31 to slide on the twisting shell 32, the relative distance between the proximal and distal ends of the pump head protection assembly 21 can be controlled, thereby controlling the folding or unfolding of the pump head protection assembly 21 to adjust the outer diameter of the pump head protection assembly 21. Specifically, when the protective sleeve 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 assembly 21 decreases, and the outer diameter of the pump head protection assembly 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 assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases to match the increase or decrease in the outer diameter of the pump head impeller 22.

[0207] Furthermore, the pump head protection assembly 21 may include an anchor bracket 212 and a top sleeve tip 211. The proximal end of the anchor bracket 212 is fixedly connected to the distal end of the protective sleeve 31. The annular distal end of the anchor bracket 212 is sleeved and fixed to the distal end of the pump head transmission assembly 23. The top sleeve tip 211 is disposed 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 pump head transmission assembly 23.

[0208] In this embodiment, both the proximal and distal ends of the anchoring bracket 212 can be configured as annular, and the proximal end of the top sleeve tip 211 is fixedly connected to the distal end of the top sleeve 231 in the pump head transmission assembly 23. Optionally, the distal end of the top sleeve 231 is provided with an anchoring groove, and the proximal end of the top sleeve tip 211 is provided with an anchoring rod, which engages with the anchoring groove 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 configured as a smooth dome shape to facilitate the entire micro pump head 2 to be introduced into the patient's body through minimally invasive intervention and reduce the resistance encountered by blood flow through the micro pump head 2.

[0209] Optionally, the pump head protection assembly 21 may further include a support protection sleeve connecting ring 213. The distal end of the support protection sleeve connecting ring 213 is embedded and fixed within the annular proximal end of the anchor support 212, and the distal end surface of the support protection sleeve connecting ring 213 is flush with the distal end surface of the annular proximal end of the anchor support 212. In addition, the support protection sleeve connecting ring 213 is slidably mounted outside the twisting shell 32 and fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3, thereby further strengthening the fixed connection between the distal end of the protective sleeve 31 and the proximal end of the anchor support 212.

[0210] Here, after the proximal annular end of the anchoring stent 212 is placed over the stent protective sleeve connecting ring 213 and the distal end surface of the stent protective sleeve connecting ring 213 is ensured to be flush with the distal end surface of the proximal annular end of the anchoring stent 212, a biocompatible glue can be used to bond and secure the proximal end of the anchoring stent 212 to the stent protective sleeve connecting ring 213. Subsequently, the protective sleeve 31 is placed over the proximal end of the stent protective sleeve connecting ring 213 and, while ensuring that the distal end surface of the protective sleeve 31 is in contact with the proximal end surface of the proximal annular end of the anchoring stent 212, a biocompatible glue can be used to bond and secure the protective sleeve 31 to the stent protective sleeve connecting ring 213 and then to the anchoring stent 212.

[0211] In an optional embodiment of the present invention, the anchoring bracket 212 includes an anchoring bracket skeleton 2121 and an anchoring bracket membrane 2122. The proximal end of the anchoring bracket skeleton 2121 is fixedly connected to the distal end of the protective sleeve 31. The distal end of the anchoring bracket skeleton 2121 is sleeved and fixed on the distal end of the pump head transmission assembly 23. The anchoring bracket membrane 2122 is sleeved outside the anchoring bracket skeleton 2121.

[0212] In this embodiment, the anchoring support skeleton 2121 provides a certain anchoring support force for the entire pump head protection assembly 21. The anchoring support membrane 2122 is disposed outside the anchoring support skeleton 2121 and can be used 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 using a biocompatible glue. Here, the anchoring support skeleton 2121 can be prepared by laser cutting a nickel-titanium alloy tube, and the anchoring support membrane 2122 can be prepared by molding a medical silicone material. Preferably, the medical silicone material can be prepared by mixing DragonSkin silicone and Slic Thinner diluent in a mass ratio of 2:1 at room temperature, stirring, and then heating to form a film. The medical silicone material has good elastic deformation ability, with a 100% Young's modulus of 21.75 kPa, a maximum strain of 1328.2%, and a maximum stress of 675.3 kPa, which can meet the needs of the entire micro pump head 2 during use.

[0213] In an optional embodiment of the present invention, the anchoring support skeleton 2121 includes a proximal ring of the anchoring support skeleton, a distal ring of the anchoring support skeleton, and a plurality of anchoring support skeleton wires arranged in parallel between the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton; the anchoring support skeleton wire bends outward when the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton approach each other, so that the structure of the pump head protection assembly 21 expands outward, and the anchoring support skeleton wire is tightened inward when the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton move away from each other, so that the structure of the pump head protection assembly 21 retracts.

[0214] In this embodiment, the proximal ring of the anchoring stent skeleton is embedded with the stent protective sleeve connecting ring 213 , and the stent protective sleeve connecting ring 213 further strengthens the fixed connection with the protective sleeve 31 . The distal ring of the anchoring stent skeleton is fixed to the distal end of the top sleeve 231 .

[0215] The anchoring stent skeleton wire is set to be 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 bend outward to make the cage-like structure expand outward; conversely, the anchoring stent skeleton wire can be stretched to both ends to make the cage-like structure shrink inward.

[0216] The micro pump head 2 provided in the embodiment of the present invention, when specifically applied to a left ventricular assist device, needs to be assembled with the distal end of the transmission shaft 3. The assembly process is as follows:

[0217] Step 11: Align the proximal end surfaces of the core shaft sleeve 236 and the core shaft collar 237 and bond them together. Then, insert the foldable impeller 221 onto the core shaft sleeve 236, and axially position the foldable impeller 221 using the distal end surface of the core shaft collar 237. Finally, bond the distal fixing ring 22111 to the core shaft sleeve 236.

[0218] Step 12, insert the top shaft 235 into the core shaft sleeve 236 to a specific position and glue the two together, then successively put the top collar 234 onto the core shaft sleeve 236, and the top shaft bearing 233 onto the top shaft 235, and use the distal end of the core shaft sleeve 236 to axially position the top shaft bearing 233; then put the top shaft sleeve 232 onto the top shaft 235, and glue the top shaft sleeve 232 and the top shaft 235 together on the basis of axially positioning the top shaft sleeve 232 through the distal end of the top shaft bearing 233; finally, put the top sleeve 231 onto the top shaft bearing 233, and glue the top sleeve 231 and the top collar 234 together while ensuring that the top sleeve 231 and the top collar 234 are in contact with the distal end face and the proximal end face of the top shaft bearing 233 respectively;

[0219] In step 13, the proximal end of the anchor bracket 212 is put on the bracket protective sleeve connecting ring 213, and the proximal end of the anchor bracket 212 is bonded and fixed to the bracket protective sleeve connecting ring 213 under the condition that the distal end face of the bracket protective sleeve connecting ring 213 is flush with the distal end face of the proximal end of the annular proximal end of the anchor bracket 212; then the protective sleeve 31 is put on the proximal end of the bracket protective sleeve connecting ring 213, and under the condition that the distal end face of the protective sleeve 31 is in contact with the proximal end face of the annular proximal end of the anchor bracket 212, the protective sleeve 31 is successively bonded to the bracket protective sleeve connecting ring 213 and the anchor bracket 212; the proximal end of the twisting connector 222 is assembled to the distal end of the twisting shell 32, and the assembly is bonded and fixed; 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, and the core shaft sleeve 236 and the core shaft 33 are bonded and fixed;

[0220] Step 14: Insert the core shaft 33 into the twisting shell 32, plug and assemble the distal end of the twisting connector 222 to the proximal end of the proximal fixing ring 22113, and glue and fix the assembly; then, insert the twisting shell 32 into the protective sleeve 31, while inserting the annular distal end of the anchor bracket 212 onto the distal end of the top sleeve 231, and glue the anchor bracket 212 to the top sleeve 231; finally, assemble the top sleeve tip 211 to the distal end of the top sleeve 231; at this point, the transmission shaft 3 and the micro pump head 2 are assembled;

[0221] The twisting housing 32 and the core shaft 33 are driven by the drive control mechanism 4 to rotate synchronously or relatively. When the twisting housing 32 and the core shaft 33 rotate synchronously, the pump head impeller 22 as a whole rotates in a single direction with a fixed outer diameter to achieve the blood pumping function. When the twisting housing 32 and the core shaft 33 rotate relatively, the proximal end of the pump head impeller 22 rotates relative to the distal end, and the foldable impeller 221 is expanded or folded, thereby changing the outer diameter of the entire pump head impeller 22 (increasing the outer diameter when expanded and decreasing the outer diameter when folded).

[0222] When the foldable impeller 221 is folded, the outer diameter of the entire pump head impeller 22 is reduced, and the pump head impeller 22 is in a folded state. At this time, the protective cover driving module 41 drives the protective cover 31 to slide proximally, so that the structure of the pump head protection component 21 is contracted inward, thereby making the entire micro pump head 2 in a folded state. The micro pump head 2 as a whole enters the patient's body through a minimally invasive intervention in a folded state, which can improve the safety and convenience of use; after the folded pump head impeller 22 enters the patient's body, it deforms and expands into an expanded state with a larger outer diameter in the body, and at this time the outer diameter of the pump head impeller 22 is much larger than the outer diameter in the folded state, thereby enabling the left ventricular assist device 1 to provide the patient with sufficient auxiliary blood flow at a low speed, thereby improving the blood supply efficiency of the left ventricular assist device 1 and reducing the risk of hemolysis; at the same time, the pump head impeller 22 with adjustable outer diameter and the pump head protection component 21 can effectively 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.

[0223] like Figures 21 to 24 As shown, in an optional embodiment of the present invention, the drive control mechanism 4 further includes a housing 40 having a cavity structure. A twisting housing drive module 42 is disposed within the housing 40, with the distal end of the twisting housing drive module 42 being in driving connection with the proximal end of the twisting housing 32. A spindle drive module 43 is disposed within the housing 40 and positioned proximal to the twisting housing drive module 42. The distal end of the spindle drive module 43 is in driving connection with the proximal end of the spindle 33, and the distal end of the spindle drive module 43 is detachably connected to the proximal end of the twisting housing drive module 42.

[0224] When the core shaft drive module 43 is connected to the twisting shell drive module 42, the core shaft drive module 43 drives the core shaft 33 and the twisting shell 32 to rotate synchronously, and drives the distal end and the proximal end of the pump head impeller 22 to rotate together, and the pump head impeller 22 as a whole rotates in a single direction with a fixed outer diameter to realize the blood pumping function; and when the core shaft drive module 43 is separated from the twisting shell drive module 42, the twisting shell drive module 42 drives the twisting shell 32 to rotate relative to the core shaft 33, and drives the proximal end of the pump head impeller 22 to rotate relative to the distal end, and the pump head impeller 22 folds or unfolds, so that the outer diameter of the pump head impeller 22 can be adjusted.

[0225] 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 driving module 43 drives the twisting shell 32 to rotate relative to the core shaft 33 (at this time, the core shaft driving module 43 is connected to the proximal end of the twisting shell driving module 42). Block 43 stops running and the core shaft 53 is fixed), when the twisting shell 32 rotates relative to the core shaft 33, the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end. When the proximal end of the pump head impeller 22 rotates relative to the distal end, the pump head impeller 22 can be expanded or folded, which helps to implant the micro pump head 2 in a folded state into a designated position in the human body through minimally invasive interventional surgery. Subsequently, the pump head impeller 22 can be deformed and expanded 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 the assist device; 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.

[0226] like Figures 26 to 27 As shown, in an optional embodiment of the present invention, the drive control mechanism 4 may further include a protective sleeve drive module 41, which is sleeved on the proximal end of the protective sleeve 31 and is transmission-connected to the proximal end of the protective sleeve 31, and the protective sleeve drive module 41 drives the protective sleeve 31 to move. Since the protective sleeve 31 is sleeved outside the twisting shell 32, when the protective sleeve drive module 41 drives the protective sleeve 31 to move on the twisting shell 32, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 can be controlled, thereby controlling the folding or unfolding of the pump head protection assembly 21 to adjust the outer diameter of the pump head protection assembly 21 to match the increase or decrease in the outer diameter of the pump head impeller 22. Specifically, when the protective sleeve drive module 41 drives the protective sleeve 31 to slide toward the distal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 decreases, and the outer diameter of the pump head protection assembly 21 increases. When the protective sleeve drive module 41 drives the protective sleeve 31 to slide toward the proximal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases.

[0227] Preferably, the protective cover drive module 41 may include a protective cover slider 411, a protective cover slider bearing 412, and a protective cover slider end cap 413. The protective cover slider 411 is sleeved over the proximal end of the protective cover 31 and fixedly connected thereto. An annular groove is provided at the proximal end of the protective cover slider 411 to mate with the protective cover slider bearing 412. The protective cover slider bearing 412 is embedded within the annular groove at the proximal end of the protective cover slider 411, with the outer edge of the protective cover slider bearing 412 located between the proximal groove at the proximal end of the protective cover slider 411 and the protective cover slider end cap 413. Glue can be used to secure the protective cover slider 411 to the protective cover 31, ensuring that the proximal end surface of the protective cover 31 is flush with the distal end surface of the annular groove provided at the proximal end of the protective cover slider 411. The protective cover slider end cap 413 is provided at the proximal end of the protective cover slider 411 and fixedly connected thereto. The protective cover slider 411 and the protective cover slider end cover 413 can be prepared by photocuring 3D printing of medical hard resin.

[0228] 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 annular groove of the protective cover slider 411 and make the distal end face of the protective cover slider bearing 412 away from the protective cover slider end cover 413 contact the proximal end face of the protective cover 31; and the outer edges of at least two protective cover slider bearings 412 are limited between the proximal annular groove of the protective cover slider 411 and the protective cover slider end cover 413, and the protective cover slider end cover 413 is sleeved on the proximal end of the transmission shaft 3. While ensuring that the distal end face of the protective cover slider bearing 412 contacts the distal end face of the annular groove of the protective cover slider 411 and the proximal end face of the protective cover slider bearing 412 contacts the distal end face of the protective cover slider end cover 413, glue can preferably be used to bond and fix the protective cover slider 411 and the protective cover slider end cover 413.

[0229] Preferably, the protective cover slider 411 is provided with a protective cover slider locking piece 4111, and the protective cover slider locking piece 4111 cooperates with corresponding structures at different positions on the shell 40 to lock the protective cover slider 411 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.

[0230] Preferably, a sliding groove is opened on the shell 40 along the axial direction, and the two sides of the protective cover slider 411 are slidably arranged in the sliding groove to enable the entire protective cover slider 411 to slide along the axial direction in the shell 40, and the protective cover slider 411 is locked at different positions of the shell 40 through the protective cover slider locking piece 4111.

[0231] like Figures 22 to 25As shown, in an optional embodiment of the present invention, the shell 40 includes a first shell 401 and a second shell 402 installed in conjunction with the first shell 401. The first shell 401 and the second shell 402 are arranged opposite to each other and form a cavity structure inside.

[0232] Optionally, the housing 40 further includes a distal cover 403, a second gear set cover 406, a brake assembly cover 405, and a proximal cover 404. The distal cover 403 and the proximal cover 404 are disposed at the distal and proximal ends of the housing 40, respectively. The second gear set cover 406 is disposed outside the second gear set in the twisting housing drive module 42, and the brake assembly cover 405 is disposed outside the brake assembly 438. Here, the first housing 401, the second housing 402, the distal cover 403, the proximal cover 404, the brake assembly cover 405, and the second gear set cover 406 can all be manufactured by open mold injection molding.

[0233] 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. The first shell 401 is assembled to the second shell 402 on the premise that 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 two are fixed with screws; Figure 23 As shown, preferably, a first optical fiber groove 4014 is provided on the mating surface of the first housing 401. Figure 24 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.

[0234] Preferably, the distal end of the first shell 401 and the distal end of the second shell 402, and the proximal end of the first shell 401 and the proximal end of the second shell 402 are respectively provided with external threads that dock with each other, the distal end of the first shell 401 and the distal end of the second shell 402 are screwed and fixed with the distal cover 403, and the proximal end of the first shell 401 and the proximal end of the second shell 402 are screwed and fixed with the proximal cover 404, so as to further ensure the stability of the connection between the first shell 401 and the second shell 402.

[0235] More preferably, 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 piece 4111 on the protective cover slider 411 in the protective cover driving module 41 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 relevant components in the core shaft driving module 43, which will be further described in detail below.

[0236] like Figures 28 to 32 As shown, in an optional embodiment of the present invention, the twisting housing drive module 42 includes a twisting housing connector 428 and a twisting gear set. The twisting housing connector 428 is fixedly connected to the twisting housing 32, and the proximal end of the twisting housing connector 428 is detachably connected to the distal end of the spindle drive module 43. The twisting gear set is disposed at the distal end of the twisting housing connector 428 and is used to control the rotation of the twisting housing connector 428 when the distal end of the spindle drive module 43 is separated from the proximal end of the twisting housing drive module 42.

[0237] In this embodiment, the twisting shell connector 428 cooperates with the twisting shell 32, so that the drive control mechanism 4 can achieve controlled folding or unfolding of the pump head impeller 22 by twisting, so as to facilitate clinical operation; at the same time, during the folding or unfolding process of the pump head impeller 22, only the outer diameter changes, and its axial size remains unchanged, so that the deformation process of the pump head impeller 22 has high controllability.

[0238] In an optional embodiment of the present invention, the twisting gear set may include a first twisting gear shaft 426, a first twisting gear 425, a first twisting gear shaft bearing 424, a twisting housing connector bearing 427, and a second gear set 421. The first twisting gear 425 is sleeved on the first twisting gear shaft 426 and fixedly connected to the twisting housing connector 428 via the first twisting gear shaft 426. The first twisting gear shaft bearing 424 is disposed at the distal end of the first twisting gear shaft 426 and rotatably supports the first twisting gear shaft 426 within the housing 40. The twisting housing connector bearing 427 is disposed at the middle section of the twisting housing connector 428 and rotatably supports the twisting housing connector 428 within the housing 40. The second gear set 421 is detachably meshed with the first twisting gear 425 and controls the rotation of the first twisting gear 425 when the second gear set 421 is meshed with the first twisting gear 425. The first twisting gear 425, the first twisting gear shaft 426 and the twisting shell connector 428 can be manufactured by machining aluminum alloy.

[0239] like Figure 32As shown, the first twisting gear shaft 426 can be set to 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 is preferably fixed with a cutting-edge machine rice; then the first twisting gear shaft bearing 424 is put on the distal end of the first twisting gear shaft 426, and then the first twisting gear shaft 426 is put on the proximal end of the twisting shell 32; the twisting shell connector bearing 427 is put from the distal end of the twisting shell connector 428 to the twisting shell connector. The middle section of the connecting piece 428 is then inserted into the twisting housing connecting piece 428, which is then inserted into the proximal end of the twisting housing 32. While ensuring that the proximal end surface of the twisting housing connecting piece 428 is aligned with the proximal end surface of the twisting housing 32, the twisting housing connecting piece 428 and the twisting housing 32 are preferably secured using a cutting-edge milling machine. The proximal end of the first twisting gear shaft 426 is then inserted into the distal end of the twisting housing connecting piece 428. Preferably, a cutting-edge milling machine can be used to secure the first twisting gear shaft 426 and the twisting housing connecting piece 428. Preferably, the twisting gear assembly further includes a twisting housing sleeve 423 and two sets of twisting housing sleeve bearings 422. Two sets of twisting housing sleeve bearings 422 are respectively sleeved at each end of the twisting housing sleeve 423. The twisting housing sleeve 423 is sleeved onto the proximal end of the twisting housing 32 and positioned proximal to the first twisting gear shaft 426. The twisting housing sleeve 423 can be manufactured by machining aluminum alloy.

[0240] like Figures 29 to 31 As shown, in an optional embodiment of the present invention, 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. Among them, the second twisting gear 4213 is sleeved on the second twisting gear shaft 4214 and is detachably engaged with the first twisting gear 425; the second twisting gear shaft bearing 4212 is arranged between the second twisting gear shaft 4214 and the second twisting gear 4213; the second twisting gear limiters 4211 are respectively arranged at both ends of the second twisting gear shaft 4214 and are fixedly connected to the second twisting gear shaft 4214, one side of the second twisting gear limiter 4211 is inserted into the shell 40, and the other side of the second twisting gear limiter 4211 extends out of the shell 40 and supports the second twisting gear 4213 on the outside of the shell 40, and the second twisting gear reset elastic member 4215 is arranged between the second twisting gear limiter 4211 and the shell 40 and is used to separate the second twisting gear 4213 from the first twisting gear 425. 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.

[0241] When assembling the second gear set 421, first embed the two second twisting gear shaft bearings 4212 on both sides of the second twisting gear 4213 respectively, and align the outer end faces of the second twisting gear shaft bearings 4212 with the end faces of the second twisting gear 4213; secondly, insert the second twisting gear shaft 4214 into the two second twisting gear shaft bearings 4212 in sequence, and make the center of the second twisting gear shaft 4214 coincide with the center of the second twisting gear 4213; then, put the small ends of the two second twisting gear limiters 4211 inwardly onto the two ends of the second twisting gear shaft 4214, and ensure that the second twisting gear After the large end face of the twisting gear stopper 4211 is aligned with the end face of the second twisting gear shaft 4214, and the top surfaces of the two second twisting gear stoppers 4211 are also aligned, the two second twisting gear stoppers 4211 can be fixed to the second twisting gear shaft 4214 using a cutting-edge milling machine. Finally, the second twisting gear reset elastic member 4215 is inserted into the corresponding mounting hole of the second twisting gear stopper 4211, and the end face of the second twisting gear reset elastic member 4215 is preferably bonded to the bottom surface of the corresponding mounting hole of the second twisting gear stopper 4211 using biocompatible glue. The second twisting gear stopper 4211, the second twisting gear 4213, and the second twisting gear shaft 4214 can be made by machining aluminum alloy.

[0242] Preferably, the upper ends of the two second twisting gear limiters 4211 can cover the second gear set cover 406 to limit the second gear set 421 to prevent the second gear set 421 from falling off from the housing 40 and avoid misoperation of the second gear set 421.

[0243] By setting the second gear set 421, when the distal end of the core shaft driving module 43 is separated from the proximal end of the twisting shell driving module 42, the second twisting gear 4213 is pressed inward until the second twisting gear 4213 is engaged with the first twisting gear 425. At this time, the first twisting gear 425 can be operated by toggling the second twisting gear 4213, and the twisting shell connecting piece 428 fixedly connected to the first twisting gear 425 is driven to rotate synchronously with the first twisting gear 425 through the first twisting gear 425, and the twisting shell 32 is driven to rotate synchronously with the first twisting gear 425, and the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end through the twisting shell 32, thereby controlling the pump head impeller 22 to be expanded or folded.

[0244] like Figures 33 to 34As shown, in an optional embodiment of the present invention, the spindle drive module 43 includes a spindle connector 435, a coupling 437, a clutch 433, and a clutch reset elastic member 434. The spindle connector 435 is sleeved on the outside of the spindle 33 and fixedly connected to the spindle 33; the distal end of the coupling 437 is fixedly connected to the spindle connector 435, and the proximal end of the coupling 437 is fixedly connected to the drive motor 4310; the clutch 433 is disposed at the distal end of the spindle connector 435 and sleeved on the outside of the spindle 33. The clutch 433 and the spindle connector 435 are synchronously rotated and connected, and the clutch 433 is detachably connected to the twisting shell connector 428; and the clutch reset elastic member 434 is disposed between the spindle connector 435 and the clutch 433. Preferably, the clutch reset elastic member 434 may include three clutch reset springs.

[0245] Preferably, the spindle drive module 43 also includes a spindle connector bearing 436, which is sleeved on the proximal end of the spindle connector 435 and rotatably supports the spindle connector 435 in the housing 40. When assembling the spindle connector 435, the coupling 437 and the drive motor 4310, screws can be used to fix the motor flange 439 and the drive motor 4310, and then the proximal end of the spindle 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. The clutch 433, the spindle connector 435, the coupling 437 and the motor flange 439 can be made by machining aluminum alloy.

[0246] Alternatively, as Figures 40 to 41 As shown, the clutch 433 is matched with the twisting shell connector 428 and the core shaft connector 435 through slots to realize the transmission of rotational motion, wherein the clutch 433 and the core shaft connector 435 always maintain a connected state, while the clutch 433 and the twisting shell connector 428 have two states of connection and non-connection. The twisting shell connector 428 is provided with a groove at the proximal end to facilitate the connection between the clutch 433 and the twisting shell connector 428.

[0247] Preferably, the core shaft connector 435 is provided with a corresponding mounting hole for inserting the clutch reset elastic member 434. During assembly, the proximal end of the clutch reset elastic member 434 is inserted into the corresponding mounting hole of the core shaft connector 435. Preferably, glue can be used to bond the proximal end surface of the clutch reset elastic member 434 to the bottom surface of the corresponding mounting hole of the core shaft connector 435. Since the proximal end of the clutch 433 is sleeved on the distal end of the core shaft connector 435 (a corresponding mounting hole is provided on the proximal end surface of the clutch 433, and the distal end of the clutch reset elastic member 434 is inserted into the corresponding mounting hole of the clutch 433 during assembly), 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.

[0248] like Figure 34 As shown, in an optional embodiment of the present invention, the spindle drive module 43 may further include a brake assembly 438 , which is arranged in pairs on both sides of the coupling 437 and is used to brake the coupling 437 .

[0249] 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 respectively cooperate with the outer walls opposite to the coupling 437 to brake the coupling 437; preferably, a brake through hole is respectively opened on the first shell 401 and the second shell 402, and one side of the brake assembly 438 passes through the brake through hole and can translate radially at the brake through hole.

[0250] Further, such as Figures 36 to 37 As shown, the brake assembly 438 includes a brake slider 4381, a brake 4382, and a brake reset elastic member 4383. The brake slider 4381 is disposed outside the housing 40, with the large end of the brake 4382 extending out of the housing 40 and slidably connected to the brake slider 4381. The small end of the brake 4382 is inserted into the housing 410 and engages with the outer wall of the coupling 437. The brake reset elastic member 4383 is disposed between the brake 4382 and the housing 40 and is used to separate the brake 4382 from the coupling 437. Preferably, the brake reset elastic member 4383 can be a pair of brake reset springs, with one end of the brake reset elastic member 4383 inserted into the corresponding mounting hole of the brake 4382 and the other end of the brake reset elastic member 4383 inserted into the corresponding mounting hole of the housing 40.

[0251] In this embodiment, a braking through hole is respectively provided on the first shell 401 and the second shell 402 of the shell 40, and the small end of the brake member 4382 passes through the braking through hole and can be radially translated at the braking through hole, and the large end of the brake member 4382 is arranged on the outside of the braking through hole and contacts the brake member slider 4381; a braking groove is also respectively provided on the first shell 401 and the second shell 402 of the shell 40, and the brake member slider 4381 is arranged in the braking groove and can be axially translated in the braking 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, and 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.

[0252] During assembly, after inserting the two ends of the brake member reset elastic member 4383 into the corresponding mounting holes of the brake member 4382 and the shell 40 respectively, it is preferred to use glue to bond the end face of the brake member reset elastic member 4383 to the bottom surface of the corresponding mounting hole of the brake member 4382; preferably, the brake member slider 4381 and the brake member 4382 can be prepared by open mold injection molding.

[0253] like Figures 38 to 39 As shown, preferably, each brake member slider 4381 in the two brake assemblies 438 is provided with two seventh protrusions 43811 along the translation direction. The two seventh protrusions 43811 on the brake 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 achieve locking of the brake member slider 4381 in both states of the brake member 4382 in the brake assembly 438 locking the coupling 437 and releasing the coupling 437.

[0254] Preferably, the two brake assemblies 438 are provided with brake assembly covers 405, which are respectively installed at corresponding positions of the first shell 401 and the second shell 402 and fixed by screwing to limit the brake assembly 438 and avoid misoperation of the brake slider 4381.

[0255] like Figure 34As shown, in an optional embodiment of the present invention, the core shaft drive module 43 further includes a clutch ring 432 and a clutch fork 431. The clutch ring 432 is slidably mounted on the outside of the housing 40 and is radially provided with a clutch fork mounting hole 4323. The clutch fork 431 is disposed in the clutch fork mounting hole 4323 and passes through the housing 40 to cooperate with the clutch 433, so that by operating the clutch ring 432, the clutch 433 can be driven to move, thereby separating or connecting the clutch 433 and the twisting shell connecting member 428, thereby achieving separation or connection between the distal end of the core shaft drive module 43 and the proximal end of the twisting shell drive module 42.

[0256] Preferably, if Figure 35 As shown, the clutch ring 432 includes a first clutch ring 4321 and a second clutch ring 4322 mounted in conjunction with the first clutch ring 4321. The second clutch ring 4322 is arranged opposite the first clutch ring 4321 to form an annular clutch ring 432. More preferably, a boss is provided on the mating surfaces of the first clutch ring 4321 and the second clutch ring 4322; a groove is provided on the mating surfaces of the second clutch ring 4322 and the first clutch ring 4321 at a position corresponding to the boss. The first clutch ring 4321 is assembled to the second clutch ring 4322 with the boss on the mating surface of the first clutch ring 4321 aligned with the groove on the mating surface of the second clutch ring 4322, and the two are fixed using glue.

[0257] 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 a clutch ring 432 that is sleeved on the housing 40. 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.

[0258] Preferably, if Figures 23 to 24 As shown, the first housing 401 and the second housing 402 are respectively provided with Z-shaped grooves for limiting the movement trajectory of the clutch ring 432 and locking the clutch fork 431. Figure 45 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 core shaft connector 435, and then Figure 46As shown, the clutch ring 432 is slid toward the proximal end, and the clutch ring 432 moves toward the proximal end with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it compresses the clutch reset elastic member 434 while pushing the clutch 433 toward the proximal end until the clutch ring 432 can no longer move toward the proximal end. Figure 47 The clutch ring 432 is rotated again in the direction shown, causing the clutch fork 431 to enter another locked state. At this time, the clutch 433 and the twisting shell connector 428 are no longer connected. Optionally, the clutch fork 431, the first clutch ring 4321, and the second clutch ring 4322 can all be manufactured by light-curing 3D printing of medical hard resin.

[0259] The left ventricular assist device 1 provided by the above embodiment of the present invention is used in a specific application, such as Figure 42 As shown, the specific use process mainly includes: implanting the micro pump head 2 in a folded state through the catheter 6, and then withdrawing the catheter 6; after removing the catheter 6, the pump head impeller 22 and the pump head protection component 21 of the micro pump head 2 are controlled to expand in the body through the cooperation between the transmission shaft 3 and the drive control mechanism 4 outside the body; after the pump head impeller 22 is controlled to expand, it keeps a fixed outer diameter and rotates in a single direction to achieve auxiliary blood supply; after the auxiliary blood supply is completed, the pump head impeller 22 stops rotating, and then the catheter 6 is inserted; at this time, the pump head impeller 22 and the pump head protection component 21 are controlled to fold in the body through the cooperation between the transmission shaft 3 and the drive control mechanism 4 outside the body; after the pump head impeller 22 and the pump head protection component 21 are controlled to fold, the micro pump head 2 is in a folded state, and the folded micro pump head 2 is stored in the catheter 6; finally, the folded micro pump head 2 is removed together with the catheter 6;

[0260] like Figure 43As shown, when the left ventricular assist device 1 is in the auxiliary blood supply state, the pump head impeller 22 and the pump head protection component 21 in the micro pump head 2 are in the expanded state due to their own elastic action. At this time, under the action of the second twisting gear reset elastic member 4215, the clutch reset elastic member 434 and the brake reset elastic member 4383, the second twisting gear 4213 and the first twisting gear 425 are in a non-meshing state, the brake member 4382 and the coupling 437 are in a non-contact state, and the clutch 433 and the twisting shell connector 428 and the core shaft connector 435 are all in a connected state; the driving motor 4310 drives the coupling 437 to rotate, the coupling 437 drives the core shaft connector 435 to rotate, and the core shaft connector 4383 drives the second twisting gear 4213 and the first twisting gear 425 to rotate. 5 drives the core shaft 33 and the clutch 433 to rotate synchronously, the clutch 433 drives the twisting shell connector 428 and drives the twisting shell 32 and the core shaft 33 to rotate synchronously through the twisting shell connector 428. 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 as a whole rotates synchronously with the twisting shell 32 and the core shaft 33. At this time, the pump head impeller 22 as a whole rotates with the outer diameter fixed, thereby realizing the blood pumping function; in addition, during 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.

[0261] Taking the micro pump head 2 being converted from the expanded state to the folded state as an example, the conversion between the expanded state and the folded state can be achieved by the following steps:

[0262] Step 21, as Figure 44 As shown, the brake member slider 4381 is slid toward the distal end, and the two brake members 4382 are pushed to the locked coupling 437 state while compressing the brake member reset elastic member 4383. At this time, the coupling 437, the core shaft connector 435, and the core shaft 33 are all unable to rotate; at this time, the brake member slider 4381 relies on the seventh protrusion 43811 on its own surface and the third protrusion 4013 corresponding to the surface of the first shell 401 and the sixth protrusion 4023 corresponding to the surface of the second shell 402 to achieve the locking of the brake member slider 4381 when the brake assembly 438 is in the locked coupling 437 state.

[0263] Step 22, press Figure 45 Rotate the clutch ring 432 in the direction shown to release the locked state of the clutch fork 431 when the clutch 433 is connected to the twisting shell connector 428 and the core shaft connector 435; then press Figure 46As shown in the direction, the clutch ring 432 is slid toward the proximal end, and the clutch ring 432 moves toward the proximal end with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it compresses the clutch reset elastic member 434 while pushing the clutch 433 toward the proximal end until the clutch ring 432 can no longer move toward the proximal end. Figure 47 The clutch ring 432 is rotated again in the direction shown, so that the clutch fork 431 enters another locking state, at which time the clutch 433 and the twisting shell connecting member 428 are in a non-connected state.

[0264] Step 23, such as Figure 48 As shown, push the second gear set 421 inward until the second twisting gear 4213 is fully engaged with the first twisting gear 425, and then press Figure 49 The second twisting gear 4213 rotates in the direction shown, the second twisting gear 4213 drives the first twisting gear 425 to rotate in the opposite direction, the first twisting gear 425 drives the first twisting gear shaft 426 to rotate, the first twisting gear shaft 426 drives the twisting shell connector 428 to rotate, the twisting shell connector 428 drives the twisting shell 32 to rotate, and the twisting shell 32 drives the proximal end of the pump head impeller 22 to rotate, thereby realizing the folding of the pump head impeller 22.

[0265] Step 24, such as Figure 50 As shown, the protective cover slider 411 slides toward the proximal end, the protective cover slider 411 drives the protective cover 31 to move toward the proximal end, and the protective cover 31 drives the proximal end of the pump head protection assembly 21 to move toward the proximal end, thereby realizing the folding of the pump head protection assembly 21; the protective cover slider 411 relies on the protective cover slider locking piece 4111 on its own surface and cooperates with the first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021 and the fifth protrusion 4022 corresponding to the surfaces of the first shell 401 and the second shell 402 to realize the locking of the protective cover slider 411 when the pump head protection assembly 21 is in the folded state.

[0266] 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. 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.

[0267] Since the deployed state (normal state) is the primary state of the micropump head 2 in the left ventricular assist device 1, the second twisting gear 4213 and the first twisting gear 425 are normally in a non-meshed state, 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 clutch 433 and the twisting housing connector 428 are normally connected, and the brake 4382 and the coupling 437 are normally in a non-contact state. After use and removal of the left ventricular assist device 1, the micropump head 2, transmission shaft 3, protective sleeve drive module 41, clutch fork 431, and clutch ring 432 can be removed and replaced to achieve reusability of the drive control mechanism 4.

[0268] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A left ventricular assist device, characterized in that: include: A drive control mechanism (4), comprising a twisting shell drive module (42) and a core shaft drive module (43); A transmission shaft (3) comprising a twisting shell (32) and a core shaft (33), wherein the twisting shell (32) is movably sleeved outside the core shaft (33); and A micro pump head (2) comprises a pump head impeller (22) and a pump head transmission assembly (23), wherein the proximal end of the pump head impeller (22) is transmission-connected to the twisting shell drive module (42) via the twisting shell (32), the distal end of the pump head transmission assembly (23) is fixedly connected to the distal end of the pump head impeller (22), the proximal end of the pump head transmission assembly (23) is transmission-connected to the core shaft drive module (43) via the core shaft (33), the pump head impeller (22) comprises: a foldable impeller (221) and a twisting connector (222), the foldable impeller (221) comprises an impeller skeleton (2211), the impeller skeleton (2211) comprises a proximal fixing ring (22113), a distal fixing ring (22111), and a spirally arranged proximal fixing ring (22113) and distal fixing ring (221 11), the distal fixing ring (22111) is fixedly connected to the core shaft (33) through the pump head transmission assembly (23), and the proximal fixing ring (22113) is fixedly connected to the twisting shell (32) through the twisting connector (222); when the foldable impeller (221) is in the unfolded state, the impeller skeleton wire (22112) is in a spiral shape with a small period, and the outer edge of the spiral extends outward, 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, the impeller skeleton wire (22112) is twisted and pre-tightened to a folded state, the foldable impeller (221) in the folded state has a pre-tightening force, and the axial size of the foldable impeller (221) of the pump head impeller (22) remains unchanged during the folding process; The core shaft drive module (43) drives the core shaft (33) and the twisting shell (32) to rotate synchronously to drive the distal end and the proximal end of the pump head impeller (22) to rotate together, so that the pump head impeller (22) rotates with a fixed outer diameter; and the twisting shell drive module (42) drives the twisting shell (32) and the core shaft (33) to rotate relative to each other to drive the proximal end of the pump head impeller (22) to rotate relative to the distal end, so that the pump head impeller (22) is folded or unfolded.

2. The left ventricular assist device according to claim 1, wherein: The twisting shell (32) comprises a twisting shell micro pump head connecting section (322), a twisting shell flexible section (323), and a twisting shell drive control mechanism connecting 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) by welding; wherein The distal end of the twisting shell micro pump head connecting section (322) is used for fixed connection with the proximal end of the pump head impeller (22), and the proximal end of the twisting shell drive control mechanism connecting section (324) is used for transmission connection with the twisting shell drive module (42).

3. The left ventricular assist device according to claim 1, wherein: The transmission shaft (3) further comprises a protective sleeve (31), the protective sleeve (31) being movably sleeved outside the twisting shell (32), the proximal end of the protective sleeve (31) being transmission-connected to the protective sleeve driving module (41) of the driving control mechanism (4), and the distal end of the protective sleeve (31) being fixedly connected to the proximal end of the pump head protection component (21) of the micro pump head (2), and the driving control mechanism (4) controlling the protective sleeve (31) to slide on the twisting shell (32) to control the outer diameter of the pump head protection component (21).

4. The left ventricular assist device according to claim 3, wherein: The left ventricular assist device (1) further comprises a pressure sensor (5), the pressure sensor (5) comprising an optical fiber (51), an optical fiber hole (311) is provided on the protective cover (31), and the optical fiber (51) is passed through the optical fiber hole (311).

5. The left ventricular assist device according to claim 4, wherein: The pressure sensor (5) further comprises a fiber Bragg grating demodulator (52), and the optical fiber (51) is communicatively connected to the fiber Bragg grating demodulator (52) via a threaded connector.

6. The left ventricular assist device according to claim 5, wherein: The optical fiber (51) comprises a pressure monitoring optical fiber (511) and a signal transmission optical fiber (512), wherein the signal transmission optical fiber (512) and the pressure monitoring optical fiber (511) are integrally formed, and the proximal end of the signal transmission optical fiber (512) is fixed and communicatively connected to the fiber optic Bragg grating demodulator (52) via a threaded connector.

7. The left ventricular assist device according to claim 3, wherein: The protective sleeve (31) is prepared from a medical Pebax tube, the twisting shell (32) is prepared from a multi-strand double-layer synchronous torque spring tube, and / or the core shaft (33) is prepared from a plastic-coated steel wire rope.

8. The left ventricular assist device according to claim 1, wherein: The foldable impeller (221) further includes: An impeller blade surface (2212), wherein the impeller blade surface (2212) is coated on the outside of the impeller skeleton (2211).

9. The left ventricular assist device according to claim 1, wherein: The impeller skeleton wire (22112) is made of elastic material.

10. The left ventricular assist device according to claim 1, wherein The twisting connector (222) is provided with a plurality of rotation limiting bosses at the distal end, and a plurality of limiting grooves are correspondingly provided at the proximal outer edge of the proximal fixing ring (22113). The twisting connector (222) and the proximal fixing ring (22113) are rotationally limited by plugging the rotation limiting bosses into the limiting grooves.

11. The left ventricular assist device according to claim 8, wherein The distal end and the proximal end of the impeller blade surface (2212) are respectively covered by the distal fixing ring (22111) and the proximal fixing ring (22113), and are pushed outward by the impeller skeleton wire (22112) to form an impeller.

12. The left ventricular assist device according to claim 3, wherein: The pump head transmission assembly (23) comprises: A core shaft sleeve (236), the core shaft sleeve (236) passes through the impeller frame (2211), the distal end of the core shaft sleeve (236) is fixedly connected to the distal fixing ring (22111), and the proximal end of the core shaft sleeve (236) is sleeved in the proximal fixing ring (22111) and fixedly connected to the core shaft (33); A top shaft (235), wherein the proximal end of the top shaft (235) is fixedly embedded in the distal end of the core shaft sleeve (236); A top shaft bearing (233), wherein the top shaft bearing (233) is sleeved on the distal end of the top shaft (235), and a proximal end surface of the top shaft bearing (233) contacts a distal end surface of the core shaft sleeve (236); A top shaft sleeve (232), wherein 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); and A top sleeve (231), wherein the proximal end of the top sleeve (231) is sleeved on the distal end of the top shaft (235).

13. The left ventricular assist device according to claim 12, wherein: The proximal fixing sleeve of the core shaft sleeve (236) is provided with a core shaft ring (237), the proximal end surface of the core shaft ring (237) is flush with the proximal end surface of the core shaft sleeve (236), and is limited to be located between the proximal end of the proximal fixing ring (22113) and the distal end of the twisting connector (222).

14. The left ventricular assist device according to claim 12, wherein: A top ring (234) is sleeved on the core shaft sleeve (236), the top ring (234) is sleeved on the distal end of the core shaft sleeve (236), and the distal end surface of the top ring (234) is fixedly connected to the proximal end surface of the top sleeve (231).

15. The left ventricular assist device according to claim 14, wherein: The proximal end of the top sleeve (231) is provided with an annular groove adapted to the top shaft bearing (233), the top shaft bearing (233) is embedded in the annular groove at the proximal end of the top sleeve (231), and the outer edge of the top shaft bearing (233) is located between the annular groove at the proximal end of the top sleeve (231) and the top sleeve ring (234).

16. The left ventricular assist device according to claim 12, wherein: The micro pump head (2) further comprises: A pump head protection assembly (21), wherein the pump head protection assembly (21) is coaxially covered outside the pump head impeller (22), and the proximal end of the pump head protection assembly (21) is transmission-connected to the protection cover drive module (41) in the drive control mechanism (4) through the protection cover (31), 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).

17. The left ventricular assist device according to claim 16, wherein: The pump head protection assembly (21) comprises: An anchoring bracket (212), the proximal end of the anchoring bracket (212) is fixedly connected to the distal end of the protective sleeve (31), and the distal end of the anchoring bracket (212) is sleeved and fixed to the distal end of the pump head transmission assembly (23); and A top sleeve tip (211), 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 pump head transmission assembly (23).

18. The left ventricular assist device according to claim 17, wherein: The pump head protection assembly (21) further comprises a support protection sleeve connecting ring (213), wherein the distal end of the support protection sleeve connecting ring (213) is embedded and fixed in the annular proximal end of the anchor support (212), and the distal end surface of the support protection sleeve connecting ring (213) is flush with the distal end surface of the annular proximal end of the anchor support (212), and The support 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).

19. The left ventricular assist device according to claim 17, wherein: 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). The anchoring rod is plugged into and matched with the anchoring groove to fixedly connect the proximal end of the top sleeve tip (211) to the distal end of the pump head transmission assembly (23).

20. The left ventricular assist device according to claim 17, wherein The anchoring bracket (212) comprises: An anchoring support frame (2121), the proximal end of the anchoring support frame (2121) is fixedly connected to the distal end of the protective sleeve (31), and the distal end of the anchoring support frame (2121) is sleeved and fixed to the distal end of the pump head transmission assembly (23); and An anchoring support membrane (2122), wherein the anchoring support membrane (2122) is sleeved outside the anchoring support skeleton (2121).

21. The left ventricular assist device according to claim 20, wherein: The anchoring support frame (2121) includes a proximal ring of the anchoring support frame, a distal ring of the anchoring support frame, and a plurality of anchoring support frame wires arranged in parallel between the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame. When the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame approach each other, the anchoring support frame wires bend outward to expand the structure of the pump head protection component (21), and when the proximal ring of the anchoring support frame and the distal ring of the anchoring support frame move away from each other, the anchoring support frame wires are tightened inward to retract the structure of the pump head protection component (21).

22. The left ventricular assist device according to claim 21, wherein: The anchoring stent skeleton wire is made of elastic material.

23. The left ventricular assist device according to claim 3, wherein: The drive control mechanism (4) further includes a housing (40); the twisting shell drive module (42) is arranged in the housing (40), and the distal end of the twisting shell drive module (42) is transmission-connected to the proximal end of the twisting shell (32); the core shaft drive module (43) is arranged in the housing (40) and disposed at the proximal end of the twisting shell drive module (42), and the distal end of the core shaft drive module (43) is transmission-connected to the proximal end of the core shaft (33), and the distal end of the core shaft drive module (43) is detachably connected to the proximal end of the twisting shell drive module (42), wherein When the core shaft driving module (43) is connected to the twisting shell driving module (42), the core shaft driving module (43) drives the core shaft (33) and the twisting shell (32) to rotate synchronously; and when the core shaft driving module (43) is separated from the twisting shell driving module (42), the twisting shell driving module (42) drives the twisting shell (32) to rotate relative to the core shaft (33).

24. The left ventricular assist device according to claim 23, wherein: The twisting shell driving module (42) comprises: a twisting shell connector (428), wherein the twisting shell connector (428) is fixedly connected to 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 drive module (43); and A twisting gear set is provided at the distal end of the twisting shell connecting member (428) and is used to control the rotation of the twisting shell connecting member (428) when the distal end of the core shaft driving module (43) is separated from the proximal end of the twisting shell driving module (42).

25. The left ventricular assist device according to claim 24, wherein: The twisting gear set comprises: a first twisting gear shaft (426); a first twisting gear (425), wherein the first twisting gear (425) is sleeved on the first twisting gear shaft (426) and fixedly connected to the twisting shell connecting member (428) via the first twisting gear shaft (426); a first twisting gear shaft bearing (424), the first twisting gear shaft bearing (424) being disposed at a distal end of the first twisting gear shaft (426) and rotatably supporting the first twisting gear shaft (426) within the housing (40); a twisting shell connector bearing (427), wherein the twisting shell connector bearing (427) is disposed in the middle section of the twisting shell connector (428) and rotatably supports the twisting shell connector (428) within the housing (40); and A second gear set (421) is configured to be detachably engaged with the first twisting gear (425) and to control the rotation of the first twisting gear (425) when the second gear set (421) is engaged with the first twisting gear (425).

26. The left ventricular assist device according to claim 25, wherein: The first twisting gear shaft (426) is configured as a shaft body having a multi-step shape, and the proximal end of the first twisting gear shaft (426) is sleeved on and fixed to the distal end of the twisting shell connector (428).

27. The left ventricular assist device according to claim 25, wherein: The twisting shell drive module (42) further includes a twisting shell shaft sleeve (423) and a twisting shell shaft sleeve bearing (422), wherein the twisting shell shaft sleeve bearings (422) are respectively sleeved on both ends of the twisting shell shaft sleeve (423), and the twisting shell shaft sleeve (423) is sleeved on the proximal end of the twisting shell (32) and is arranged on the distal end of the first twisting gear shaft (426).

28. The left ventricular assist device according to claim 25, wherein: The second gear set (421) includes: Second twisting gear shaft (4214); a second twisting gear (4213), the second twisting gear (4213) being sleeved on the second twisting gear shaft (4214) and being detachably meshed with the first twisting gear (425); a second twisting gear shaft bearing (4212), the second twisting gear shaft bearing (4212) being arranged between the second twisting gear shaft (4214) and the second twisting gear (4213); a second twisting gear limiting member (4211), the second twisting gear limiting member (4211) being respectively arranged at both ends of the second twisting gear shaft (4214) and fixedly connected to the second twisting gear shaft (4214), one side of the second twisting gear limiting member (4211) being inserted into the housing (40), and the other side of the second twisting gear limiting member (4211) being extended out of the housing (40) and supporting the second twisting gear (4213) on the outside of the housing (40); and A second twisting gear reset elastic member (4215) is provided between the second twisting gear limit member (4211) and the housing (40) and separates the second twisting gear (4213) from the first twisting gear (425).

29. The left ventricular assist device according to claim 24, wherein: The spindle drive module (43) comprises: a core shaft connecting piece (435), the core shaft connecting piece (435) being sleeved on the outside of the core shaft (33) and fixedly connected to the core shaft (33); A coupling (437), wherein the distal end of the coupling (437) is fixedly connected to the core shaft connector (435), and the proximal end of the coupling (437) is fixedly connected to the drive motor (4310); A clutch (433), the clutch (433) being arranged at the distal end of the core shaft connector (435) and sleeved on the outside of the core shaft (33), the clutch (433) being synchronously rotated and connected to the core shaft connector (435), and the clutch (433) being detachably connected to the twisting shell connector (428); and A clutch reset elastic member (434), wherein the clutch reset elastic member (434) is arranged between the core shaft connecting member (435) and the clutch (433).

30. The left ventricular assist device according to claim 29, wherein The spindle drive module (43) further includes a spindle connector bearing (436), wherein the spindle connector bearing (436) is sleeved on the proximal end of the spindle connector (435) and rotatably supports the spindle connector (435) in the housing (40).

31. The left ventricular assist device according to claim 29, wherein The spindle drive module (43) further includes: A brake assembly (438), the brake assembly (438) is arranged in pairs on both sides of the coupling (437) and is used to brake the coupling (437).

32. The left ventricular assist device according to claim 31, wherein The brake assembly (438) includes: A brake member slider (4381), the brake member slider (4381) being arranged outside the housing (40); a brake member (4382), the brake member (4382) being arranged on the inner side of the brake member slider (4381), the large end of the brake member (4382) extending out of the housing (40) and being slidably connected to the brake member slider (4381), and the small end of the brake member (4382) being inserted into the housing (40) and cooperating with the outer wall of the coupling (437); and A pair of brake member reset elastic members (4383), wherein the pair of brake member reset elastic members (4383) are arranged between the brake member (4382) and the shell (40), one end of the pair of brake member reset elastic members (4383) is inserted into the corresponding mounting hole of the brake member (4382), and the other end of the pair of brake member reset elastic members (4383) is inserted into the corresponding mounting hole of the shell (40).

33. The left ventricular assist device according to claim 32, wherein: The brake member slider (4381) has a wedge-shaped bottom surface (43812), and a limiting groove (43821) is provided at the large end of the brake member (4382). The wedge-shaped bottom surface (43812) and two side surfaces of the brake member slider (4381) are in contact with the arc-shaped top surface and two side surfaces of the limiting groove (43821) respectively.

34. The left ventricular assist device according to claim 29, wherein The spindle drive module (43) further includes: A clutch shift ring (432), wherein the clutch shift ring (432) is slidably sleeved outside the housing (40) and is provided with a clutch shift fork mounting hole (4323) in the radial direction; and A clutch fork (431) is disposed 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), thereby separating or connecting the clutch (433) and the twisting shell connector (428).

35. The left ventricular assist device according to claim 34, wherein: The clutch ring (432) comprises a first clutch ring (4321) and a second clutch ring (4322), wherein the first clutch ring (4321) and the second clutch ring (4322) are arranged relative to each other to form the annular clutch ring (432).

36. The left ventricular assist device according to claim 23, wherein The driving control mechanism (4) further includes: A protective sleeve driving module (41) is sleeved on the proximal end of the protective sleeve (31) and is transmission-connected to the proximal end of the protective sleeve (31), and the protective sleeve (31) is driven to move by the protective sleeve driving module (41).

37. The left ventricular assist device according to claim 36, wherein: 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), wherein the protective cover slider (411) is sleeved on the proximal end of the protective cover (31) and fixedly connected to the protective cover (31); the protective cover slider bearing (412) is embedded in the proximal annular groove of the protective cover slider (411), and the outer edge of the protective cover slider bearing (412) is limited between the proximal annular groove of the protective cover slider (411) and the protective cover slider end cover (413); the protective cover slider end cover (413) is arranged at the proximal end of the protective cover slider (411) and fixedly connected to the protective cover slider (411).

38. The left ventricular assist device according to claim 37, wherein: The protective sleeve drive module (41) includes at least two protective sleeve slider bearings (412), and the at least two protective sleeve slider bearings (412) are embedded in the proximal ring groove of the protective sleeve slider (411) so that the distal end surface of the protective sleeve slider bearing (412) away from the protective sleeve slider end cover (413) contacts the proximal end surface of the protective sleeve (31).

39. The left ventricular assist device according to claim 37, wherein The protective cover slider (411) is provided with a protective cover slider locking piece (4111), and the protective cover slider locking piece (4111) cooperates with corresponding structures at different positions of the housing (40) to lock the protective cover slider (411) at different positions of the housing (40).

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