Left ventricular assist device

Abstract

Provided in the present invention is a left ventricular assist device, comprising: a drive control mechanism, which comprises a twisting-shell drive module and a core-shaft drive module; a transmission shaft, which comprises a twisting shell and a core shaft, the twisting shell being movably sleeved on the core shaft; and a micro pump head, which comprises a pump head impeller and a pump head transmission assembly, wherein the proximal end of the pump head impeller is in transmission connection with 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, and the proximal end of the pump head transmission assembly is in transmission connection with 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, so as to drive the distal end and the proximal end of the pump head impeller to rotate together, thereby enabling the pump head impeller to rotate while maintaining a fixed outer diameter. The twisting-shell drive module drives the twisting shell and the core shaft to rotate relative to each other, so as to drive the proximal end of the pump head impeller to rotate relative to the distal end, thereby enabling the pump head impeller to fold or unfold. The solution provided in the present invention can realize adjustment of the outer diameter of the micro pump head in the left ventricular assist device, thereby improving the operational efficiency and safety of the left ventricular assist device.

Description

Left ventricular assist device Technical Field

[0001] This invention relates to the field of auxiliary device technology, and specifically to a left ventricular assist device. Background Technology

[0002] In the past decade or so, the number of high-risk cardiovascular interventional surgeries both domestically and internationally has been increasing year by year. To reduce the risk of death caused by obstructed or stopped blood circulation during surgery, interventional left ventricular assist devices (LVADs) have been widely used in high-risk cardiovascular interventional procedures. An LVAD is a percutaneous mechanical circulatory support system that provides auxiliary blood flow to high-risk cardiovascular interventional patients during and after the procedure using a mechanical micropump. It can partially or completely assist the function of the left ventricle, helping the heart deliver oxygenated blood to the whole body. Existing LVADs mainly use micropump heads equipped with non-deformable rigid impellers. Due to the size limitations of the device, the auxiliary flow rate they can generate is relatively small. To meet the needs of maintaining blood circulation in high-risk interventional surgeries, the common solution for LVADs with fixed impeller sizes is to increase the impeller speed. However, high-speed impeller rotation inevitably causes excessive shear force within the blood, leading to changes in red blood cell permeability and irreversible cell damage, thus increasing the risk of hemolysis in patients.

[0003] Therefore, there is an urgent need to design an interventional left ventricular assist device equipped with a high-folding-ratio active folding impeller that can simultaneously take into account the small size 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-mentioned technical problems, the present invention provides a left ventricular assist device, comprising:

[0006] Drive control mechanism,

[0007] Includes a twisting shell drive module and a mandrel drive module;

[0008] A drive shaft, comprising a twisting shell and a spindle, wherein the twisting shell is movably fitted over the spindle; and

[0009] Miniature pump head, including pump head impeller and pump head drive assembly, wherein

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

[0011] The mandrel drive module drives the mandrel and the twisting shell to rotate synchronously, thereby causing 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; and the twisting shell drive module drives the twisting shell and the mandrel to rotate relative to each other, thereby causing the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller folds or unfolds.

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

[0013] The flexible section of the twisted shell is fixedly connected to the connecting section of the twisted shell micro-pump head and the connecting section of the twisted shell drive control mechanism by welding; wherein

[0014] The distal end of the twisted 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 twisted shell drive control mechanism connecting section is used for transmission connection with the twisted shell drive module;

[0015] In one embodiment, the drive shaft further includes:

[0016] A protective sleeve is movably fitted over the twisting shell. The proximal end of the protective sleeve is connected to the protective sleeve drive module of the drive control mechanism, and the distal end of the protective sleeve is fixedly connected to the proximal end of the pump head protection assembly of the micro pump head. The drive control mechanism controls the outer diameter of the pump head protection assembly by controlling the sliding of the protective sleeve on the twisting shell.

[0017] Optionally, the left ventricular assist device further includes a pressure sensor, the pressure sensor including an optical fiber, the protective sleeve having an optical fiber hole, and the optical fiber passing through the optical fiber hole;

[0018] Optionally, the pressure sensor further includes 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, wherein the signal transmission optical fiber is integrally formed with the pressure monitoring optical fiber, and the near end of the signal transmission optical fiber is fixed and communicatively connected to the fiber optic demodulator via a threaded connector.

[0020] Optionally, the protective sleeve is made of medical Pebax tubing, the twisted shell is made of multi-strand double-layer synchronous torque spring tubing, and / or the mandrel is made of plastic-coated steel wire rope.

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

[0022] A foldable impeller, the distal end of which is fixedly connected to the spindle via the pump head drive assembly; and

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

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

[0025] An impeller frame, the proximal end of which is fixedly connected to the twisting shell via the twisting connector, and the distal end of which is fixedly connected to the mandrel via the pump head drive assembly; and

[0026] Impeller blade surface, the impeller blade surface covers the outside of the impeller frame;

[0027] Optionally, the impeller frame includes:

[0028] A proximal retaining ring, wherein the proximal retaining ring is fixedly connected to the twisting shell via the twisting connector;

[0029] The distal retaining ring, the proximal end of which is fixedly connected to the spindle via the pump head drive assembly; and

[0030] Impeller skeleton wire, the impeller skeleton wire is spirally disposed between the proximal fixed ring and the distal fixed ring;

[0031] Optionally, the impeller skeleton filaments are made of an elastic material;

[0032] Optionally, the twisted connector is provided with multiple rotation limiting bosses at its distal end, and the proximal outer edge of the proximal fixing ring is provided with multiple limiting grooves accordingly. The twisted connector and the proximal fixing ring are rotated and limited by the insertion and cooperation of the rotation limiting bosses and the limiting grooves.

[0033] Optionally, the distal and proximal ends of the impeller blades are respectively covered by the distal fixing ring and the proximal fixing ring, and are pushed outward by the impeller skeleton wires to form an impeller.

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

[0035] A mandrel sleeve extends through the impeller frame, with its distal end fixedly connected to the distal end fixing ring and its proximal end sleeved within the proximal end fixing ring and fixedly connected to the mandrel.

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

[0037] A top shaft bearing is sleeved on the distal end of the top shaft, and the proximal end face of the top shaft bearing is in contact with the distal end face of the mandrel sleeve.

[0038] A top shaft sleeve, the top shaft sleeve being fixedly fitted onto the distal end of the top shaft, and the inner edge of the top shaft bearing being limited between the distal end face of the mandrel sleeve and the proximal end face of the top shaft sleeve; and

[0039] A top sleeve, the proximal end of which is fitted onto the distal end of the top shaft;

[0040] Optionally, a mandrel collar is fixedly sleeved at the proximal end of the mandrel sleeve, the proximal end face of the mandrel collar is flush with the proximal end face of the mandrel sleeve, and is limited to the proximal end of the proximal fixing ring and the distal end of the twisting connector;

[0041] Optionally, a top sleeve ring is provided on the mandrel sleeve, the top sleeve ring is sleeved on the far end of the mandrel sleeve, and the far end face of the top sleeve ring is fixedly connected to the proximal end face of the top sleeve.

[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 annular groove at the proximal end of the top sleeve, and the outer edge of the top shaft bearing is limited between the annular groove at the proximal end of the top sleeve and the top sleeve ring.

[0043] The above-described solution of the present invention has at least the following beneficial effects:

[0044] The left ventricular assist device provided by the above-described solution of the present invention includes: a drive control mechanism, a transmission shaft, and a miniature pump head; wherein the drive control mechanism includes a twisting shell drive module and a spindle drive module; the transmission shaft includes a spindle and a twisting shell movably sleeved outside the spindle; the miniature pump head includes a pump head impeller and a pump head transmission assembly, the proximal end of the pump head impeller is drivenly 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 drivenly connected to the spindle drive module through the spindle, and the pump head is driven by the spindle drive module. The moving mandrel and the twisting shell rotate synchronously to drive the distal and proximal ends of the pump head impeller to rotate together, so that the pump head impeller rotates with a fixed outer diameter. The twisting shell drive module drives the twisting shell and the mandrel to rotate relative to each other, so that the proximal end of the pump head impeller rotates relative to the distal end, so that the pump head impeller folds or unfolds. Through the cooperation of the drive control mechanism, the transmission shaft and the micro pump head, the unfolding and folding of the pump head impeller in the micro pump head of the left ventricular assist device can be realized, so as to adjust the outer diameter of the pump head impeller in the micro pump head, thereby improving the efficiency and safety of the left ventricular assist device. Attached Figure Description

[0045] Figure 1 is a schematic diagram of the overall structure of the left ventricular assist device provided in an embodiment of the present invention;

[0046] Figure 2 is a three-dimensional structural schematic diagram of the transmission shaft provided in an optional embodiment of the present invention;

[0047] Figure 3 is a front sectional view of Figure 2;

[0048] Figure 4 is a three-dimensional structural schematic diagram of the protective sleeve provided in an optional embodiment of the present invention;

[0049] Figure 5 is a three-dimensional structural schematic diagram of the twisted shell provided in an optional embodiment of the present invention;

[0050] Figure 6 is a three-dimensional structural schematic diagram of the mandrel provided in an optional embodiment of the present invention;

[0051] Figure 7 is a schematic diagram of the overall structure of a pressure sensor provided in an optional embodiment of the present invention;

[0052] Figure 8 is a schematic diagram of the installation of the optical fiber and the housing in a pressure sensor provided by an optional embodiment of the present invention;

[0053] Figure 9 is a cross-sectional schematic diagram of the connection between the miniature pump head and the drive shaft provided in an optional embodiment of the present invention;

[0054] Figure 10 is a three-dimensional structural diagram of the pump head impeller when it is deployed (normal state) according to an optional embodiment of the present invention;

[0055] Figure 11 is an exploded view of Figure 10;

[0056] Figure 12 is a three-dimensional structural diagram of the impeller skeleton when unfolded (normal state) according to an optional embodiment of the present invention;

[0057] Figure 13 is a three-dimensional structural diagram of the impeller blade surface provided in an optional embodiment of the present invention;

[0058] Figure 14 is a three-dimensional structural diagram of the impeller skeleton when folded according to an optional embodiment of the present invention;

[0059] Figure 15 is a schematic diagram of a foldable impeller provided in an optional embodiment of the present invention being rotated and twisted in the direction shown in the figure under normal conditions;

[0060] Figure 16 is a schematic diagram of the foldable impeller in the folded state after rotation and twisting as shown in Figure 15;

[0061] Figure 17 is a three-dimensional structural schematic diagram of a pump head drive assembly provided in an optional embodiment of the present invention;

[0062] Figure 18 is an exploded view of Figure 17;

[0063] Figure 19 is a three-dimensional structural schematic diagram of a pump head protection assembly provided in an optional embodiment of the present invention;

[0064] Figure 20 is an exploded view of Figure 19;

[0065] Figure 21 is a front cross-sectional view of a drive control mechanism provided in an optional embodiment of the present invention;

[0066] Figure 22 is a three-dimensional structural schematic diagram of the housing provided in an optional embodiment of the present invention;

[0067] Figure 23 is a schematic diagram of the assembly of the first housing and the clutch shift fork according to an optional embodiment of the present invention;

[0068] Figure 24 is a schematic diagram of the assembly of the second housing and the clutch shift fork provided in an optional embodiment of the present invention;

[0069] Figure 25 is an exploded view of Figure 22;

[0070] Figure 26 is a three-dimensional structural schematic diagram of the protective sleeve driving module provided in an optional embodiment of the present invention;

[0071] Figure 27 is an exploded view of Figure 26;

[0072] Figure 28 is a three-dimensional structural schematic diagram of the twisting shell drive module provided in an optional embodiment of the present invention;

[0073] Figure 29 is a three-dimensional structural schematic diagram of the second gear set provided in an optional embodiment of the present invention;

[0074] Figure 30 is an exploded view of Figure 29;

[0075] Figure 31 is a front sectional view of Figure 29;

[0076] Figure 32 is an exploded view of some components of the twisted shell drive module in Figure 28;

[0077] Figure 33 is a three-dimensional structural schematic diagram of the spindle drive module provided in an optional embodiment of the present invention;

[0078] Figure 34 is an exploded view of Figure 33;

[0079] Figure 35 is an exploded view of a clutch ring provided in an optional embodiment of the present invention;

[0080] Figure 36 is an exploded view of a braking assembly provided in an optional embodiment of the present invention;

[0081] Figure 37 is a front cross-sectional view of a braking assembly provided in an optional embodiment of the present invention;

[0082] Figure 38 is a cross-sectional schematic diagram of the assembly of the braking component and the first housing provided in an optional embodiment of the present invention;

[0083] Figure 39 is a cross-sectional schematic diagram of the assembly of the braking component and the second housing provided in an optional embodiment of the present invention;

[0084] Figure 40 is an assembly schematic diagram of the clutch and spindle connection provided in an optional embodiment of the present invention;

[0085] Figure 41 is an assembly schematic diagram of the clutch and twisting shell connector provided in an optional embodiment of the present invention;

[0086] Figure 42 is a schematic diagram of the usage process of the left ventricular assist device provided in an optional embodiment of the present invention;

[0087] Figure 43 is a schematic diagram of the connection between the drive control mechanism, the transmission shaft, and the micro pump head in the left ventricular assist device provided in an optional embodiment of the present invention when the pump head impeller is in the deployed state.

[0088] Figure 44 is a schematic diagram of a slider of a remotely sliding brake element provided in an optional embodiment of the present invention;

[0089] Figure 45 is a schematic diagram of rotating the clutch ring in the direction shown in the figure according to an optional embodiment of the present invention;

[0090] Figure 46 is a schematic diagram of a proximal sliding clutch circumference provided in an optional embodiment of the present invention;

[0091] Figure 47 is a schematic diagram of rotating the clutch ring in the direction shown in the figure according to an optional embodiment of the present invention;

[0092] Figure 48 is a schematic diagram of pushing the second gear set to the inside of the drive control mechanism according to an optional embodiment of the present invention;

[0093] Figure 49 is a schematic diagram of rotating the second twisting gear in the direction shown in the figure according to an optional embodiment of the present invention;

[0094] Figure 50 is a schematic diagram of a sliding protective sleeve slider provided in an optional embodiment of the present invention. Detailed Implementation

[0095] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0096] In the following description, certain specific details are set forth for the purpose of illustrating various disclosed embodiments in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the art will recognize that embodiments may be practiced without one or more of these specific details. In other instances, well-known apparatuses, structures, and techniques associated with this application may not have been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0097] Throughout this specification, references to "an embodiment" or "an embodiment" indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Therefore, the appearance of "in an embodiment" or "an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any manner in one or more embodiments.

[0098] In the following description, in order to clearly demonstrate the structure and working method of the present invention, a number of directional terms will be used. However, terms such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and not as limiting terms.

[0099] As shown in Figures 1 to 18, an embodiment of the present invention provides a left ventricular assist device 1, including a drive control mechanism 4, a transmission shaft 3, and a miniature pump head 2. The drive control mechanism 4 is used to provide driving force for the operation of the miniature pump head 2 and includes a twisting shell drive module 42 and a spindle 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 spindle 33. The miniature pump head 2 includes a pump head impeller 22 and a pump head transmission assembly 23. The pump head transmission assembly 23 is disposed through the pump head impeller 22. The proximal end of the pump head impeller 22 is 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. The proximal end of the pump head transmission assembly 23 is connected to the spindle drive module 43 through the spindle 33. The spindle drive module 43 drives the spindle 33 and the twisting shell 32 to rotate synchronously, thereby causing the distal and proximal ends 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 spindle 33 to rotate relative to each other, thereby causing the proximal end of the pump head impeller 22 to rotate relative to the distal end, so that the pump head impeller 22 folds or unfolds.

[0100] In this embodiment, the drive control mechanism 4 serves as the drive control module in the entire left ventricular assist device 1. It is connected to the micro pump head 2 via the drive shaft 3. When the distal end of the spindle drive module 43 is connected to the proximal end of the twisting shell drive module 42, the spindle drive module 43 drives the spindle 33 to rotate and drives the twisting shell drive module 42 to rotate synchronously. The twisting shell drive module 42 further drives the twisting shell 32 to rotate, thereby achieving synchronous rotation of the twisting shell 32 and the spindle 33, which in turn drives the pump head impeller 22 to rotate with a fixed outer diameter (synchronous rotation here refers to rotation at the same angular velocity). When the distal end of the spindle drive module 43 separates 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 spindle 33 (at this time, the spindle drive module 43 stops running and the spindle 33 remains stationary). When the twisting shell 32 rotates relative to the spindle 33, it can drive the proximal end of the pump head impeller 22 to rotate relative to the distal end. The rotation of the proximal end of the pump head impeller 22 relative to the distal end can cause the pump head impeller 22 to unfold or fold, thereby changing the outer diameter of the pump head impeller 22.

[0101] 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 decreases; when the pump head impeller 22 is unfolded, the overall outer diameter is much larger than the outer diameter when folded), it is possible to implant the micro-pump head 2 into a designated location in the human body via minimally invasive interventional surgery in a folded state. Subsequently, the pump head impeller 22 can deform and unfold into a spiral shape with a larger outer diameter inside the human body, enabling the left ventricular assist device 1 to provide sufficient auxiliary blood flow to the patient at low speeds, thereby improving the blood supply efficiency and safety of the left ventricular assist device 1. At the same time, the adjustable outer diameter of the pump head impeller 22 also helps to reduce the resistance when the entire micro-pump head 2 enters and passes through the catheter, which is more conducive to the rapid and safe deployment and retrieval of the left ventricular assist device 1.

[0102] Here, the drive shaft 3 serves as the connecting component between the drive control mechanism 4 and the micro-pump head 2 in the entire left ventricular assist device 1. It enables the drive control of the micro-pump head 2, which is located at the distal end of the assist device and enters the patient's body, through the drive control mechanism 4 at the proximal end of the assist device. This avoids the drive control mechanism 4 from entering the patient's body along with the micro-pump head 2, which not only reduces the size of the interventional incision but also avoids the potential harm to the patient caused by the heat generated by the motor in the drive control mechanism 4. Furthermore, the drive control mechanism 4 can be reused outside the patient's body, thereby reducing the overall cost of using the left ventricular assist device 1.

[0103] Preferably, the distal end of the mandrel 33 is bonded and fixed to the proximal end of the pump head drive assembly 23, and the distal end of the twisted 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 drive assembly 23); more preferably, the bonding and fixing here can be done with biocompatible adhesive to avoid harm to the human body.

[0104] Here, both the mandrel 33 and the twisting shell 32 are cylindrical, and the twisting shell 32 is an annular cylinder with its inner diameter matching the outer diameter of the mandrel 33 so that it can be fitted onto the outside of the mandrel 33; wherein, the length of the mandrel 33 is longer than the length of the twisting shell 32, and the lengths of both can be set according to the actual needs of the application.

[0105] Preferably, the mandrel 33 can be made of plastic-coated steel wire rope, and the twisted shell 32 can be made of multi-strand double-layer synchronous torque spring tube.

[0106] As shown in Figure 5, in an optional embodiment of the present invention, the twisting shell 32 may include 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 connecting section 322 and the twisting shell drive control mechanism connecting section 324 by welding; wherein, the distal end of the twisting shell micro-pump head connecting section 322 is used for fixed connection to 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 to the twisting shell drive module 42. Here, the twisting shell flexible section 323 may be integrally formed from multiple strands of double-layer synchronous torque spring tubes to ensure the flexibility of the entire drive shaft 3 during use.

[0107] Preferably, the distal end of the twisted shell micro pump head connecting section 322 is provided with a twisted connector mounting slot 321 that is adapted to the proximal end of the pump head impeller 22. When assembling the pump head impeller 22 and the twisted shell 32, the twisted connector mounting slot 321 at the distal end of the twisted shell 32 is engaged with the twisted shell connecting slot at the proximal end of the pump head impeller 22 to achieve stable torque transmission between the twisted shell 32 and the pump head impeller 22. More preferably, biocompatible adhesive can be used at the engagement point to bond the parts together, which can improve the stable connection between the two while avoiding harm to the human body.

[0108] As shown in Figures 2 to 4, in an optional embodiment of the present invention, the drive shaft 3 may further include a protective sleeve 31, which is movably fitted over the twisting shell 32. The proximal end of the protective sleeve 31 is 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. The protective sleeve 31 is controlled to slide on the twisting shell 32 by the protective sleeve drive module 41 to control the outer diameter of the pump head protection assembly 21.

[0109] In this embodiment, the protective sleeve 31 serves as a protective layer between the spindle 33 and the twisting shell 32. It is an annular cylinder and is fitted over 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 to facilitate its fit. Lubricant is filled between the protective sleeve 31 and the twisting shell 32 to reduce heat generation of the drive shaft 3 during operation. The twisting shell 32 is slightly longer than the protective sleeve 31; their lengths can be adjusted according to actual application requirements. Preferably, the protective sleeve 31 can be made of medical Pebax tubing, but it is not limited to medical Pebax tubing; other suitable materials 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 with biocompatible adhesive to avoid harm to the human body.

[0110] As shown in Figures 7 and 8, in an optional embodiment of the present invention, the left ventricular assist device 1 may further include a pressure sensor 5, which includes an optical fiber 51 and a fiber optic demodulator 52. The optical fiber 51 and the fiber optic demodulator 52 are communicatively connected via a threaded connector. An optical fiber hole 311 is provided on the protective sleeve 31, and the optical fiber 51 passes through the optical fiber hole 311. When using the left ventricular assist device 1, a portion of the pressure sensor 5 enters the patient's body along with the micro-pump head 2, enabling real-time acquisition of the patient's blood flow pressure data to accurately capture changes in blood flow pressure.

[0111] In an optional embodiment of the present invention, the protective sleeve 31 has a distal slot 312 and a proximal slot 313 respectively provided for assembling and fixing the optical fiber 51. Preferably, the distal slot 312 is disposed on the side wall of the distal end of the protective sleeve 31 and extends axially, and the proximal slot 313 is disposed on the side wall of the proximal end of the protective sleeve and is located in the extending direction of the distal slot 312. The distal end of the optical fiber 51 enters the optical fiber hole 311 through the proximal slot 313 of the protective sleeve 31 and exits through the distal slot 312 of the protective sleeve 31.

[0112] As shown in Figure 7, the fiber Bragg grating demodulator 52 is fixed on the drive control mechanism 4 and communicates with the controller module of the left ventricular assist device 1. The distal end of the optical fiber 51 passes sequentially through the fiber optic slot of the drive control mechanism 4 and the fiber optic hole 311 of the protective sleeve 31, so that the entire optical fiber 51 is laid in the first fiber optic slot 4014, the second fiber optic slot 4024 of the drive control mechanism 4 and the fiber optic hole 311 of the protective sleeve 31; the proximal end of the optical fiber 51 communicates with the fiber Bragg grating demodulator 52 through a threaded connector.

[0113] 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 near end of the signal transmission optical fiber 512 is connected to the fiber optic demodulator 52 via a threaded connector.

[0114] In this embodiment, the pressure monitoring fiber optic cable 511 is a written fiber optic segment used to monitor blood flow pressure data in the patient's body in real time. The signal transmission fiber optic cable 512 is a non-written fiber optic segment, and its proximal end is communicatively connected to the fiber Bragg grating demodulator 52 via a threaded connector, used to transmit the blood flow pressure data monitored by the pressure monitoring fiber optic cable 511 to the fiber Bragg grating demodulator 52 in real time. The pressure monitoring fiber optic cable 511 is laid close to the miniature pump head 2 and, when using the auxiliary device, enters the patient's body along with the miniature pump head 2 for real-time monitoring.

[0115] During the laying of the optical fiber 51, the pressure monitoring optical fiber 511 is inserted into the optical fiber hole 311 through the near end slot 313 of the protective sleeve 31 and exits through the far end slot 312 of the protective sleeve 31. At the same time, while ensuring that the pressure monitoring optical fiber 511 is completely inserted through the optical fiber hole 311 and just placed in the far end slot 312, the signal transmission optical fiber 512 is bonded and fixed to the optical fiber hole 311 to prevent it from falling off during use, thereby realizing real-time monitoring of blood flow pressure and improving the accuracy of monitoring. Preferably, biocompatible adhesive 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.

[0116] As shown in Figures 10 and 11, 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 spindle 33 through the pump head transmission assembly 23, the proximal end of the foldable impeller 221 is engaged 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.

[0117] 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 also fixedly connected to the distal end of the twisting shell 32 via the proximal end of the twisting connector 222. The proximal end of the twisting shell 32 is drive-connected to the twisting shell drive module 42 in the drive control mechanism 4. The twisting shell 32 is driven to rotate by the twisting shell drive module 42, which in turn drives the twisting shell connector 222 to rotate, and in turn drives the proximal end of the foldable impeller 221 to rotate. Since the distal end of the foldable impeller 221 is fixedly connected to the distal end of the spindle 33 via the pump head drive assembly 23, and the proximal end of the spindle 33 is drive-connected to the spindle drive module 43 in the drive control mechanism 4, the spindle drive module 43 drives the spindle 33 to rotate, which in turn drives the pump head drive assembly 23 to rotate, and in turn drives the distal end of the foldable impeller 221 to rotate.

[0118] When the spindle 33 and the twisting shell 32 rotate synchronously, the distal and proximal ends of the expandable impeller 221 rotate synchronously, so that the pump head impeller 22 rotates as a whole with a fixed outer diameter. When the twisting shell 32 rotates relative to the spindle 33, the proximal end of the expandable impeller 221 rotates relative to the distal end. When the proximal end of the expandable impeller 221 rotates relative to the distal end, it will expand or fold to change the outer diameter of the entire pump head impeller 22 (the outer diameter increases when expanded and decreases when folded).

[0119] Optionally, the twisting connector 222 is provided with a mandrel hole through which the mandrel 33 passes, so that the distal end of the mandrel 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.

[0120] As shown in Figures 12 and 13, in an optional embodiment of the present invention, the foldable impeller 221 includes an impeller frame 2211 and an impeller blade surface 2212. The near end of the impeller frame 2211 is fixedly connected to the twisting shell 32 through a twisting connector 222, and the far end of the impeller frame 2211 is fixedly connected to the spindle 33 through a pump head transmission assembly 23. The impeller blade surface 2212 covers the outside of the impeller frame 2211.

[0121] In this embodiment, the impeller frame 2211 can be twisted and folded or twisted and unfolded as a whole. The impeller blade surface 2212 covers the outside of the impeller frame 2211, and the distal end and proximal end of the impeller blade surface 2212 are respectively bonded and fixed to the distal end and proximal end of the impeller frame 2211 to ensure that the impeller blade surface 2212 will not fall off during folding and unfolding and auxiliary blood supply.

[0122] Preferably, the impeller blade surface 2212 can be prepared using a biocompatible, highly elastic medical-grade silicone material. This reduces the risk of damage to the human body and blood cells caused by the pump head impeller 22 during use, while also enabling the pump head impeller 22 to have a large folding-to-unfolding deformation capacity (when the impeller frame 2211 is twisted and unfolded, the impeller blade surface 2212 can be pushed outward by the impeller frame 2211 to form a spiral impeller and increase the overall outer diameter of the pump head impeller 22; when the impeller frame 2211 is twisted and folded, the impeller blade surface 2212 will shrink inward into a cylindrical shape and reduce the overall outer diameter of the pump head impeller 22). Preferably, the medical-grade silicone material can be composed of Dragon Skin silicone and Slice silicone in a mass ratio of 2:1. Thinner diluent is mixed and heated at room temperature to solidify into a film; this 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 meets the requirements of the entire micro pump head 2 during use.

[0123] Optionally, the impeller frame 2211 includes a proximal retaining ring 22113, a distal retaining ring 22111, and impeller frame wires 22112. The proximal end of the proximal retaining ring 22113 is fixedly connected to the twisting shell 32 via a twisting connector 222. The distal retaining ring 22111 is fixedly connected to the spindle 33 via a pump head drive assembly 23. The impeller frame wires 22112 are spirally arranged between the proximal retaining ring 22113 and the distal retaining ring 22111.

[0124] In this embodiment, both the proximal fixation ring 22113 and the distal fixation ring 22111 are annular cylinders, and their outer diameters can be set according to the inner diameter of the medical catheter during use. Preferably, the outer diameters of the proximal fixation ring 22113 and the distal fixation ring 22111 are equal and slightly smaller than the inner diameter of the medical catheter. The arrangement of the proximal fixation ring 22113 and the distal fixation ring 22111 ensures that the foldable impeller 221 is cylindrical in its folded state, and that its outer diameter in the folded state is smaller than the inner diameter of the medical catheter, facilitating the implantation of the foldable impeller 221 into a suitable location via a minimally invasive interventional procedure.

[0125] Here, the distal retaining ring 22111, the proximal retaining ring 22113, and the impeller skeleton wire 22112 can be fabricated in one piece using metal 3D printing to obtain the impeller skeleton 2211. Alternatively, the distal retaining ring 22111, the proximal retaining ring 22113, and the impeller skeleton wire 22112 can also be fabricated by femtosecond laser cutting of nickel-titanium alloy tubes to obtain the impeller skeleton 2211.

[0126] Multiple impeller skeleton wires 22112 are disposed between the proximal fixing ring 22113 and the distal fixing ring 22111, and the multiple impeller skeleton wires 22112 are connected in parallel between the proximal fixing ring 22113 and the distal fixing ring 22111 along the same helical direction. Preferably, the multiple impeller skeleton wires 22112 can be assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 respectively by inserting them into the proximal assembly hole of the distal fixing ring 22111 and the distal assembly hole of the proximal fixing ring 22113 in a form-locking manner. More preferably, biocompatible adhesive can be applied at the assembly point for bonding and fixing.

[0127] In one embodiment, the impeller skeleton wire 22112 is made of a hyperelastic material with a certain stiffness. Preferably, the elastic material is a hyperelastic nickel-titanium metal material with a certain stiffness. The impeller skeleton wire 22112 can be prepared by heat-treating nickel-titanium metal wire using a mold. The impeller skeleton wire 22112 made of this hyperelastic nickel-titanium metal material can provide a certain stiffness to the unfolded foldable impeller 221, ensuring the stability of the foldable impeller 221 during rotation.

[0128] In its unfolded state (normal state), the foldable impeller 221 has a spiral-shaped impeller skeleton wire 22112, preferably a short-period spiral, such as a single-period or double-period spiral, with the outer edge of the spiral extending outwards. When the proximal fixed ring 22113 rotates relative to the distal fixed ring 22111 in the spiral direction, the spiral period of the impeller skeleton wire 22112 increases, and the impeller skeleton wire 22112 is further twisted and folded, causing the outer edge of the spiral to retract inwards, thus reducing the outer diameter of the foldable impeller 221.

[0129] Here, the foldable impeller 221 can be prepared by twisting and pre-tightening the impeller skeleton 2211 in its unfolded state (as shown in Figure 12) to a folded state (as shown in Figure 14), and then fitting the impeller blade surface 2212 onto the surface of the impeller skeleton 2211, resulting in the foldable impeller 221 in its folded state as shown in Figure 16. Releasing the pre-tightening force in the rotation direction shown in Figure 16 causes the impeller skeleton wires 22112 to recover their at least periodic spiral shape under elastic action, with the outer edge of the spiral extending outwards, increasing the outer diameter of the foldable impeller 221, thus obtaining the foldable impeller 221 as shown in Figure 15. Conversely, twisting in the rotation direction shown in Figure 15 yields the foldable impeller 221 in its folded state as shown in Figure 16.

[0130] In one feasible example of the present invention, the distal end of the twisting connector 222 may be provided with multiple rotation limiting bosses, and the proximal outer edge of the proximal fixing ring 22113 is correspondingly provided with multiple limiting grooves. The twisting connector 222 and the proximal fixing ring 22113 are rotated and limited by the insertion and engagement of the rotation limiting bosses and limiting grooves. The assembly connection of the rotation limiting bosses and limiting grooves 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, so as to realize the one-step twisting and folding of the foldable impeller 221.

[0131] In one feasible example of the present invention, the distal and proximal ends 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 wires 22112 to form an impeller. Here, the impeller blade surface 2212 can be bonded to the distal fixing ring 22111 and the proximal fixing ring 22113 respectively using biocompatible adhesive to ensure that the impeller blade surface 2212 will not fall off during folding and blood supply, and at the same time, the biocompatible adhesive can also avoid causing harm to the human body.

[0132] As shown in Figures 17 and 18, in an optional embodiment of the present invention, the pump head drive assembly 23 includes a mandrel sleeve 236, a top shaft 235, a top shaft bearing 233, a top shaft sleeve 232, and a top sleeve 231. The mandrel sleeve 236 penetrates the impeller frame 2211, and its distal end is fixedly connected to a distal fixing ring 22111. The proximal end of the mandrel sleeve 236 is fitted inside the proximal fixing ring 22113 and fixedly connected to the mandrel 33. The proximal end of the top shaft 235 is fixedly embedded in the distal end of the mandrel sleeve 236, and the top shaft bearing 233 is fitted on the distal end of the top shaft 235, with the proximal end face of the top shaft bearing 233 contacting the distal end face of the mandrel sleeve 236. The top shaft sleeve 232 is fixedly fitted on the distal end of the top shaft 235, and the inner edge of the top shaft bearing 233 is limited between the distal end face of the mandrel sleeve 236 and the proximal end face of the top shaft sleeve 232. The proximal end of the top sleeve 231 is sleeved onto the distal end of the top shaft 235, and the proximal end of the top sleeve 231 is provided with an annular groove that is compatible with the top shaft bearing 233.

[0133] In this embodiment, the mandrel sleeve 236 passes through the proximal retaining ring 22113 and the distal retaining ring 22111, and the distal end of the mandrel sleeve 236 is fixedly connected to the distal retaining ring 22111. The proximal end of the mandrel sleeve 236 is fitted outside the distal end of the mandrel 33 in the transmission shaft 3. Preferably, a mandrel sleeve ring 237 is fixedly fitted on the proximal end of the mandrel sleeve 236. The mandrel sleeve ring 237 is fixedly fitted on the proximal end of the mandrel sleeve 236 with its proximal end face flush with the proximal end face of the mandrel sleeve 236, and the mandrel sleeve ring 237 is limited to the proximal end of the proximal retaining ring 22113 and the distal end of the twisted connector 222. Here, biocompatible adhesive can be used to bond and fix the mandrel sleeve 236 and the mandrel sleeve ring 237 to ensure that the mandrel sleeve ring 237 will not fall off the mandrel sleeve 236.

[0134] Preferably, the axial positioning of the foldable impeller 221 can be achieved by the distal end face of the mandrel sleeve 237. Based on this, biocompatible adhesive can be used to bond the distal fixing ring 22111 to the mandrel sleeve 236. Since the mandrel 33 is inserted and fixed inside the mandrel sleeve 236, when the mandrel 33 is inserted into the mandrel sleeve 236 until the distal end face of the mandrel 33 contacts the proximal end face of the top shaft 235, biocompatible adhesive can be used to bond and fix the mandrel sleeve 236 and the mandrel 33.

[0135] Optionally, a top sleeve 234 is fitted onto the mandrel sleeve 236. The top sleeve 234 is fitted onto the distal end of the mandrel sleeve 236, and the distal end face of the top sleeve 234 is fixedly connected to the proximal end face of the top sleeve 231.

[0136] Optionally, the proximal end of the top sleeve 231 is fitted onto 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 limited between the annular groove and the top sleeve ring 234. Here, biocompatible adhesive can be used to bond and fix the top shaft sleeve 232 to the top shaft 235 to ensure that the top shaft sleeve 232 will not fall off the top shaft 235. After the top sleeve 231 is fitted onto the top shaft bearing 233, and ensuring that the top sleeve 231 is in contact with the distal end face of the top shaft bearing 233 and that the top sleeve ring 234 is in contact with the proximal end face of the top shaft bearing 233, biocompatible adhesive can be used to bond and fix the top sleeve 231 and the top sleeve ring 234.

[0137] By fixing the distal end of the mandrel sleeve 236 to the distal fixing ring 22111 of the foldable impeller 221, and fixing 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 fitted over and fixedly connected to the distal end of the mandrel 33), the mandrel 33 can be driven to rotate by the mandrel drive module 43 in the drive control mechanism 4. When the mandrel 33 rotates, under the cooperation of the components in the pump head transmission assembly 23, the distal end of the foldable impeller 221 and the mandrel 33 rotate synchronously. When the twisting shell drive module 42 in the drive control mechanism 4 drives the twisting shell 32 to rotate, the twisting shell 32 rotates and drives the proximal end of the foldable impeller 221 to rotate synchronously with the twisting shell 32 through the twisting connector 222. When the mandrel 33 and the twisting shell 32 rotate synchronously, the distal end and the proximal end of the foldable impeller 221 rotate synchronously, thereby realizing that the entire foldable impeller 221 rotates in a single direction with a fixed outer diameter. When the mandrel 33 and the twisting shell 32 rotate relative to each other, the distal and proximal ends of the foldable impeller 221 maintain relative rotation, thereby realizing the folding and unfolding of the foldable impeller 221 to adjust the outer diameter of the entire foldable impeller 221.

[0138] As shown in Figures 19 and 20, in an optional embodiment of the present invention, the micro pump head 2 may further include a pump head protection component 21. The pump head protection component 21 is coaxially covered outside the pump head impeller 22, and the proximal end of the pump head protection component 21 is connected to the protective sleeve drive module 41 through the protective sleeve 31. The distal end of the pump head protection component 21 is fixedly connected to the distal end of the pump head drive component 23.

[0139] In this embodiment, the pump head protection assembly 21 is coaxially mounted on the outside of 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 fitted over the twisting shell 32, and the proximal end of the protective sleeve 31 is 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 drive module 41 drives the protective sleeve 31 to slide to the far end, the relative distance between the proximal and distal ends 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 to the proximal end, the relative distance between the proximal and distal ends of the pump head protection assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases, in order to match the increase or decrease of the outer diameter of the pump head impeller 22.

[0140] 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, and 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.

[0141] 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. The proximal end of the top sleeve tip 211 is installed in the top sleeve 231 by interlocking the anchoring rod with the anchoring groove. 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 enter the patient's body through minimally invasive intervention and reduce the resistance encountered by blood flow when passing through the micro-pump head 2.

[0142] Optionally, the pump head protection assembly 21 may further include a bracket protective sleeve connecting ring 213, the distal end of which is embedded and fixed within the annular proximal end of the anchor bracket 212, and the distal end face of the bracket protective sleeve connecting ring 213 is flush with the distal end face of the annular proximal end of the anchor bracket 212. Furthermore, the bracket 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 of the drive shaft 3, to further strengthen the fixed connection between the distal end of the protective sleeve 31 and the proximal end of the anchor bracket 212.

[0143] Here, after fitting the proximal end of the anchor bracket 212 annularly onto the bracket protective sleeve connecting ring 213, and ensuring 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 anchor bracket 212 annularly, biocompatible adhesive can be used to bond and fix the proximal end of the anchor bracket 212 to the bracket protective sleeve connecting ring 213. Then, fitting the protective sleeve 31 onto the proximal end of the bracket protective sleeve connecting ring 213, and ensuring that the distal end face of the protective sleeve 31 is in contact with the proximal end face of the anchor bracket 212 annularly, biocompatible adhesive can be used to bond and fix the protective sleeve 31 to the bracket protective sleeve connecting ring 213 and the anchor bracket 212 sequentially.

[0144] In an optional embodiment of the present invention, the anchor bracket 212 includes an anchor bracket skeleton 2121 and an anchor bracket membrane 2122. The proximal end of the anchor bracket skeleton 2121 is fixedly connected to the distal end of the protective sleeve 31. The distal end of the anchor bracket skeleton 2121 is sleeved and fixed to the distal end of the pump head transmission assembly 23. The anchor bracket membrane 2122 is sleeved outside the anchor bracket skeleton 2121.

[0145] In this embodiment, the anchoring stent skeleton 2121 provides a certain anchoring support force for the entire pump head protection assembly 21. The anchoring stent membrane 2122 is sleeved on the outside of the anchoring stent skeleton 2121 and can be used to reduce the contact stress between the anchoring stent 212 and the blood vessel. Preferably, the anchoring stent skeleton 2121 and the anchoring stent membrane 2122 can be bonded and fixed with biocompatible adhesive. Here, the anchoring stent skeleton 2121 can be prepared by laser cutting a nickel-titanium alloy tube, and the anchoring stent membrane 2122 can be prepared by molding medical silicone material. Preferably, the medical silicone material can be prepared by stirring and heating Dragon Skin silicone and Slic Thinner diluent in a mass ratio of 2:1 at room temperature and curing into a film. This 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, to meet the needs of the entire micro-pump head 2 during use.

[0146] In an optional embodiment of the present invention, the anchor support frame 2121 includes a proximal ring, a distal ring, and a plurality of anchor support frame wires arranged in parallel between the proximal and distal rings; the anchor support frame wires bend outward when the proximal and distal rings approach each other to expand the structure of the pump head protection assembly 21, and tighten inward when the proximal and distal rings move away from each other to retract the structure of the pump head protection assembly 21.

[0147] In this embodiment, the proximal ring of the anchor bracket skeleton is embedded with the bracket protective sleeve connecting ring 213, and the fixed connection with the protective sleeve 31 is further strengthened by the bracket protective sleeve connecting ring 213. The distal ring of the anchor bracket skeleton is sleeved and fixed to the distal end of the top sleeve 231.

[0148] The anchor support skeleton wires are configured in multiple ways, and the multiple anchor support skeleton wires are arranged side by side between the distal ring and the proximal ring of the anchor support skeleton, forming an anchor support skeleton 2121 with a cage-like structure. When the proximal ring and the distal ring of the anchor support skeleton are close to each other, the anchor support skeleton wires can bend outward to expand the cage-like structure outward; conversely, the anchor support skeleton wires can be stretched at both ends to contract the cage-like structure inward.

[0149] The miniature pump head 2 provided in the embodiments of the present invention needs to be assembled with the distal end of the drive shaft 3 when it is specifically applied to a left ventricular assist device. The assembly process is as follows:

[0150] Step 11: Align and bond the near end faces of the mandrel sleeve 236 and the mandrel sleeve ring 237. Then, fit the foldable impeller 221 onto the mandrel sleeve 236 and axially position the foldable impeller 221 by the far end face of the mandrel sleeve ring 237. Finally, bond and fix the far end fixing ring 22111 to the mandrel sleeve 236.

[0151] Step 12: Insert the top shaft 235 into the mandrel sleeve 236 to a specific position and bond them together. Then, put the top sleeve ring 234 onto the mandrel sleeve 236 and the top shaft bearing 233 onto the top shaft 235, and use the distal end face of the mandrel sleeve 236 to axially position the top shaft bearing 233. Next, put the top shaft sleeve 232 onto the top shaft 235, and bond the top shaft sleeve 232 to the top shaft 235 based on the axial positioning of the top shaft sleeve 232 by the distal end face of the top shaft bearing 233. Finally, put the top sleeve 231 onto the top shaft bearing 233, and bond the top sleeve 231 and the top sleeve ring 234 together, ensuring that the top sleeve 231 and the top sleeve ring 234 are in contact with the distal end face and the proximal end face of the top shaft bearing 233, respectively.

[0152] Step 13: Fit the proximal end of the anchor bracket 212 onto the bracket protective sleeve connecting ring 213, and bond the proximal end of the anchor bracket 212 to the bracket protective sleeve connecting ring 213 while ensuring 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 anchor bracket 212. Then, fit the protective sleeve 31 onto the proximal end of the bracket protective sleeve connecting ring 213, and bond the protective sleeve 31 to the bracket protective sleeve connecting ring 213 and the anchor bracket 212 in sequence, ensuring that the distal end face of the protective sleeve 31 is in contact with the proximal end face of the proximal end of the anchor bracket 212. Assemble the proximal end of the twisted connector 222 onto the distal end of the twisted shell 32, and bond the assembly point. Insert the mandrel 33 into the mandrel sleeve 236 until the distal end face of the mandrel 33 contacts the proximal end face of the top shaft 235, and bond the mandrel sleeve 236 and the mandrel 33.

[0153] Step 14: Insert the mandrel 33 into the twisted shell 32, and attach the distal end of the twisted connector 222 to the proximal end of the proximal fixing ring 22113, and then bond and fix the assembly. Then, while inserting the twisted shell 32 into the protective sleeve 31, slip the annular distal end of the anchor bracket 212 onto the distal end of the top sleeve 231, and bond the anchor bracket 212 to the top sleeve 231. Finally, attach the top sleeve tip 211 to the distal end of the top sleeve 231. At this point, the drive shaft 3 and the micro pump head 2 are assembled.

[0154] The twisting shell 32 and the spindle 33 are driven to rotate synchronously or relative to each other by the drive control mechanism 4; when the twisting shell 32 and the spindle 33 rotate synchronously, the pump head impeller 22 rotates in one direction with a fixed outer diameter to achieve the blood pumping function; when the twisting shell 32 and the spindle 33 rotate relative to each other, the proximal end of the pump head impeller 22 rotates relative to the distal end, and the foldable impeller 221 will unfold or fold, thereby changing the outer diameter of the entire pump head impeller 22 (increasing the outer diameter when unfolded, and decreasing the outer diameter when folded);

[0155] When the foldable impeller 221 is folded, the outer diameter of the entire pump head impeller 22 decreases, and the pump head impeller 22 is in a folded state. At this time, in conjunction with the protective sleeve drive module 41, the protective sleeve 31 is driven to slide proximally, so that the structure of the pump head protection component 21 contracts inward, thereby allowing the entire micro pump head 2 to be in a folded state. The entire micro pump head 2 is inserted into 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 is inserted into the patient's body, it deforms and unfolds into an unfolded state with a larger outer diameter. 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 sufficient auxiliary blood flow to the patient at 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 adjustable outer diameter of the pump head impeller 22 and the pump head protection component 21 can effectively reduce the resistance when the entire micro pump head 2 enters and passes through the catheter, which is more conducive to the rapid and safe deployment and retrieval of the left ventricular assist device 1.

[0156] As shown in Figures 21 to 24, in an optional embodiment of the present invention, the drive control mechanism 4 further includes a housing 40 with a cavity structure. The twisting shell drive module 42 is disposed within the housing 40, and its distal end is drively connected to the proximal end of the twisting shell 32. The spindle drive module 43 is disposed within the housing 40 and arranged near the proximal end of the twisting shell drive module 42. The distal end of the spindle drive module 43 is drively connected to the proximal end of the spindle 33, and the distal end of the spindle drive module 43 and the proximal end of the twisting shell drive module 42 are detachably connected.

[0157] When the spindle drive module 43 is connected to the twisting shell drive module 42, the spindle drive module 43 drives the spindle 33 and the twisting shell 32 to rotate synchronously, and drives the distal and proximal ends of the pump head impeller 22 to rotate together. The pump head impeller 22 rotates in one direction with a fixed outer diameter to realize the blood pumping function. When the spindle 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 spindle 33, and drives the proximal end of the pump head impeller 22 to rotate relative to the distal end. The pump head impeller 22 folds or unfolds, thereby adjusting the outer diameter of the pump head impeller 22.

[0158] In this embodiment, the twisting shell drive module 42 and the spindle drive module 43 are sequentially disposed within the housing 40, and the distal end of the spindle drive module 43 and the proximal end of the twisting shell drive module 42 are detachably connected. When the distal end of the spindle drive module 43 is connected to the proximal end of the twisting shell drive module 42, the spindle drive module 43 drives the spindle 33 to rotate and drives the twisting shell drive module 42 to rotate synchronously. The twisting shell drive module 42 further drives the twisting shell 32 to rotate, thereby achieving synchronous rotation of the twisting shell 32 and the spindle 33. When the twisting shell 32 and the spindle 33 rotate synchronously, the entire pump head impeller 22 can be driven to rotate with a fixed outer diameter. When the distal end of the spindle 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 spindle 33 (at this time, the spindle drive module 43...). When block 43 stops operating and spindle 53 remains fixed, the rotation of twisting shell 32 relative to spindle 33 will cause the proximal end of pump head impeller 22 to rotate relative to the distal end. When the proximal end of pump head impeller 22 rotates relative to the distal end, it can unfold or fold, which helps to implant the micro pump head 2 into the designated location in the human body in a folded state through minimally invasive interventional surgery. Subsequently, pump head impeller 22 can deform and unfold into a spiral shape with a large outer diameter in the human body, so that the left ventricular assist device 1 can provide sufficient auxiliary blood flow to the patient at low speed, thereby improving the blood supply efficiency and safety of the assist device. At the same time, the adjustable outer diameter of pump head impeller 22 also helps to reduce the resistance when the entire micro pump head 2 enters and passes through the catheter, which is more conducive to the rapid and safe deployment and retrieval of left ventricular assist device 1.

[0159] As shown in Figures 26 and 27, in an optional embodiment of the present invention, the drive control mechanism 4 may further include a protective sleeve drive module 41. The protective sleeve drive module 41 is sleeved on the proximal end of the protective sleeve 31 and is connected to the proximal end of the protective sleeve 31 for transmission. The protective sleeve 31 is driven to move by the protective sleeve drive module 41. 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 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 to match the increase or decrease of the outer diameter of the pump head impeller 22. Specifically, when the protective sleeve drive module 41 drives the protective sleeve 31 to slide to the distal end, the relative distance between the proximal and distal ends of the pump head protection assembly 21 decreases, and the outer diameter of the pump head protection assembly 21 increases.

[0160] Preferably, the protective sleeve driving module 41 may include a protective sleeve slider 411, a protective sleeve slider bearing 412, and a protective sleeve slider end cap 413. The protective sleeve slider 411 is fitted onto the proximal end of the protective sleeve 31 and is fixedly connected to the protective sleeve 31. The proximal end of the protective sleeve slider 411 has an annular groove adapted to the protective sleeve slider bearing 412. The protective sleeve slider bearing 412 is embedded in the annular groove at the proximal end of the protective sleeve slider 411, and its outer edge is limited between the annular groove at the proximal end of the protective sleeve slider 411 and the protective sleeve slider end cap 413. While ensuring that the proximal end face of the protective sleeve 31 is flush with the distal end face of the annular groove at the proximal end of the protective sleeve slider 411, adhesive can be used to bond and fix the protective sleeve slider 411 to the protective sleeve 31. The protective sleeve slider end cap 413 is disposed on the proximal end of the protective sleeve slider 411 and is fixedly connected to the protective sleeve slider 411. Among them, the protective sleeve slider 411 and the protective sleeve slider end cap 413 can be prepared by photopolymerization 3D printing of medical rigid resin.

[0161] Optionally, the protective sleeve drive module 41 includes at least two protective sleeve slider bearings 412. The at least two protective sleeve slider bearings 412 are embedded in the proximal annular groove of the protective sleeve slider 411, such that the distal end face of the protective sleeve slider bearing 412 away from the protective sleeve slider end cap 413 contacts the proximal end face of the protective sleeve 31. The outer edges of the at least two protective sleeve slider bearings 412 are limited between the proximal annular groove of the protective sleeve slider 411 and the protective sleeve slider end cap 413. The protective sleeve slider end cap 413 is sleeved on the proximal end of the drive shaft 3. Under the condition that the distal end face of the protective sleeve slider bearing 412 contacts the distal end face of the annular groove of the protective sleeve slider 411 and the proximal end face of the protective sleeve slider bearing 412 contacts the distal end face of the protective sleeve slider end cap 413, it is preferable to use glue to bond and fix the protective sleeve slider 411 and the protective sleeve slider end cap 413.

[0162] Preferably, the protective cover slider 411 is provided with a protective cover slider locking member 4111. The protective cover slider locking member 4111 cooperates with corresponding structures at different positions on the housing 40 to lock the protective cover slider 411 at different positions on the housing 40. Preferably, the protective cover slider locking member 4111 is a groove provided on the surface of the protective cover slider 411, which will be described in further detail below.

[0163] Preferably, a sliding groove is provided on the housing 40 along the axial direction, and the two sides of the protective sleeve slider 411 are slidably disposed in the sliding groove so as to realize that the entire protective sleeve slider 411 slides in the housing 40 along the axial direction, and the protective sleeve slider 411 is locked in different positions of the housing 40 by the protective sleeve slider locking member 4111.

[0164] As shown in Figures 22 to 25, in an optional embodiment of the present invention, the housing 40 includes a first housing 401 and a second housing 402 that is fitted and installed with the first housing 401. The first housing 401 and the second housing 402 are disposed opposite to each other and form a cavity structure inside.

[0165] Optionally, the housing 40 further includes a distal end cover 403, a second gear set cover 406, a brake assembly cover 405, and a proximal end cover 404. The distal end cover 403 and the proximal end cover 404 are respectively disposed at the distal and proximal ends of the housing 40. The second gear set cover 406 is disposed outside the second gear set in the twisting shell 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 end cover 403, the proximal end cover 404, the brake assembly cover 405, and the second gear set cover 406 can all be manufactured by injection molding.

[0166] Preferably, a boss is provided on the mating surface where the first housing 401 and the second housing 402 meet; a groove is provided on the mating surface where the second housing 402 and the first housing 401 meet, at a position corresponding to the boss. The first housing 401 is assembled onto the second housing 402 with the boss on the mating surface of the first housing 401 aligned with the groove on the mating surface of the second housing 402, and the two are fixed together with screws. As shown in Figure 23, preferably, a first optical fiber groove 4014 is provided on the mating surface of the first housing 401, and a second optical fiber groove 4024 is provided on the mating surface of the second housing 402, as shown in Figure 24. When the first housing 401 and the second housing 402 are arranged opposite each other to form a cavity structure housing 40, the first optical fiber groove 4014 and the second optical fiber groove 4024 also connect to each other to form an optical fiber groove for laying optical fiber 51.

[0167] Preferably, the distal ends of the first housing 401 and the distal ends of the second housing 402, and the proximal ends of the first housing 401 and the proximal ends of the second housing 402 are respectively provided with mutually mating external threads. The distal ends of the first housing 401 and the distal ends of the second housing 402 are screwed and fixed to the distal end cover 403, and the proximal ends of the first housing 401 and the proximal ends of the second housing 402 are screwed and fixed to the proximal end cover 404, so as to further ensure the stability of the connection between the first housing 401 and the second housing 402.

[0168] More preferably, a first protrusion 4011, a second protrusion 4012, and a third protrusion 4013 are provided on the outer wall of the first housing 401, and a fourth protrusion 4021, a fifth protrusion 4022, and a sixth protrusion 4023 are provided on the outer wall of the second housing 402. The first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021, and the fifth protrusion 4022 cooperate with the protective sleeve slider locking member 4111 on the protective sleeve slider 411 in the protective sleeve drive module 41 to lock the protective sleeve slider 411 in different positions of the housing 40. The third protrusion 4013 and the sixth protrusion 4023 cooperate with relevant components in the spindle drive module 43, which will be described in further detail below.

[0169] As shown in Figures 28 to 32, in an optional embodiment of the present invention, the twisting shell drive module 42 includes a twisting shell connector 428 and a twisting gear set. The twisting shell connector 428 is fixedly connected to the twisting shell 32, while the proximal end of the twisting shell connector 428 is detachably connected to the distal end of the mandrel drive module 43. The twisting gear set is disposed at the distal end of the twisting shell connector 428 and is used to control the rotation of the twisting shell connector 428 when the distal end of the mandrel drive module 43 is separated from the proximal end of the twisting shell drive module 42.

[0170] In this embodiment, the twisted shell connector 428 cooperates with the twisted 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, while its axial dimension remains unchanged, so that the deformation process of the pump head impeller 22 has high controllability.

[0171] 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 shell 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 shell connector 428 via the first twisting gear shaft 426. The first twisting gear shaft bearing 424 is located 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 shell connector bearing 427 is located in the middle section of the twisting shell connector 428 and rotatably supports the twisting shell connector 428 within the housing 40. The second gear set 421 can be disengaged from and meshed with the first twisting gear 425, and when the second gear set 421 meshes with the first twisting gear 425, it controls the rotation of 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.

[0172] As shown in Figure 32, the first twisting gear shaft 426 can be configured as a shaft with multiple steps. During assembly, the first twisting gear 425 is assembled to the D-shaped shaft section of the first twisting gear shaft 426, and preferably fixed using a pointed nut; then the first twisting gear shaft bearing 424 is fitted onto the distal end of the first twisting gear shaft 426, and then the first twisting gear shaft 426 is fitted onto the proximal end of the twisting shell 32; the twisting shell connecting bearing 427 is connected from the distal end of the twisting shell connecting member 428 to the twisting... The middle section of the shell connector 428 is then fitted onto the proximal end of the twisting shell 32. While ensuring the proximal end face of the twisting shell connector 428 is aligned with the proximal end face of the twisting shell 32, preferably, a fine-tipped machine tool is used to fix the twisting shell connector 428 and the twisting shell 32. Afterward, the proximal end of the first twisting gear shaft 426 is fitted onto the distal end of the twisting shell connector 428. Preferably, a fine-tipped machine tool can be used to fix the first twisting gear shaft 426 and the twisting shell connector 428. Preferably, the twisting gear set may further include a twisting shell bushing 423 and two sets of twisting shell bushing bearings 422. Two sets of twisting shell bushing bearings 422 are respectively fitted onto both ends of the twisting shell bushing 423. The twisting shell bushing 423 is fitted onto the proximal end of the twisting shell 32 and positioned near the proximal end of the first twisting gear shaft 426. The twisting shell bushing 423 can be manufactured by machining aluminum alloy.

[0173] As shown in Figures 29 to 31, 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 limiting member 4211, and a second twisting gear reset elastic member 4215. The second twisting gear 4213 is sleeved on the second twisting gear shaft 4214 and can be separably meshed with the first twisting gear 425; the second twisting gear shaft bearing 4212 is disposed between the second twisting gear shaft 4214 and the second twisting gear 4213; the second twisting gear limiting member 4211 is respectively disposed 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 is inserted into the housing 40, and the other side of the second twisting gear limiting member 4211 extends out of the housing 40 and supports the second twisting gear 4213 on the outside of the housing 40; the second twisting gear reset elastic member 4215 is disposed between the second twisting gear limiting member 4211 and the housing 40 and is used to separate the second twisting gear 4213 from the first twisting gear 425. Preferably, the second twisting gear reset elastic element 4215 may include two sets of second twisting gear reset springs, wherein each set of second twisting gear reset springs includes two springs.

[0174] When assembling the second gear set 421, firstly, the two second twisting gear shaft bearings 4212 are respectively embedded into both sides of the second twisting gear 4213, and the outer end face of the second twisting gear shaft bearing 4212 is aligned with the end face of the second twisting gear 4213; secondly, the second twisting gear shaft 4214 is sequentially inserted into the two second twisting gear shaft bearings 4212, and the center of the second twisting gear shaft 4214 coincides with the center of the second twisting gear 4213; then, the small ends of the two second twisting gear limiting members 4211 are respectively fitted inward to both ends of the second twisting gear shaft 4214, ensuring that the second twisting gear set 421 is properly positioned. With the large end face of the twisting gear limiting member 4211 aligned with the end face of the second twisting gear shaft 4214, and the top surfaces of the two second twisting gear limiting members 4211 also aligned, it is preferable to use a fine-tipped machine tool to fix the two second twisting gear limiting members 4211 to the second twisting gear shaft 4214 respectively. Finally, the second twisting gear reset elastic member 4215 is inserted into the corresponding mounting hole of the second twisting gear limiting member 4211, and preferably, a biocompatible adhesive is used to bond the end face of the second twisting gear reset elastic member 4215 to the bottom surface of the corresponding mounting hole of the second twisting gear limiting member 4211. The second twisting gear limiting member 4211, the second twisting gear 4213, and the second twisting gear shaft 4214 can be manufactured by machining aluminum alloy.

[0175] Preferably, the upper ends of the two second twisting gear limiting members 4211 can cover the second gear set cover 406 to limit the second gear set 421, prevent the second gear set 421 from falling off the housing 40, and at the same time avoid misoperation of the second gear set 421.

[0176] By setting the second gear set 421, when the distal end of the spindle drive module 43 separates from the proximal end of the twisting shell drive module 42, the second twisting gear 4213 is pressed inward until it meshes with the first twisting gear 425. At this time, by moving the second twisting gear 4213, the operation of the first twisting gear 425 can be realized. The twisting shell connector 428, which is fixedly connected to the first twisting gear 425, is driven to rotate synchronously with the first twisting gear 425. This also drives the twisting shell 32 to rotate synchronously with the first twisting gear 425. The twisting shell 32 drives the proximal end of the pump head impeller 22 to rotate relative to the distal end, thereby controlling the pump head impeller 22 to unfold or fold.

[0177] As shown in Figures 33 and 34, 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 element 434. The spindle connector 435 is sleeved on the outside of the spindle 33 and fixedly connected to it. 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 rotatably connected, and the clutch 433 is detachably connected to the twisting shell connector 428. The clutch reset elastic element 434 is disposed between the spindle connector 435 and the clutch 433. Preferably, the clutch reset elastic element 434 may include three clutch reset springs.

[0178] Preferably, the spindle drive module 43 further 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 within the housing 40. During the assembly of the spindle connector 435, coupling 437, and drive motor 4310, screws can be used to fix the motor flange 439 to the drive motor 4310. Then, the proximal end of the spindle connector 435 is inserted into the distal end of the coupling 437, and the shaft of the drive motor 4310 is inserted into the proximal end of the coupling 437, and secured with screws. The clutch 433, spindle connector 435, coupling 437, and motor flange 439 can be manufactured from machined aluminum alloy.

[0179] Optionally, as shown in Figures 40 and 41, the clutch 433 is engaged with the twisting shell connector 428 and the spindle connector 435 through slots to transmit rotational motion. The clutch 433 and the spindle connector 435 are always connected, while the clutch 433 and the twisting shell connector 428 have both connected and unconnected states. The twisting shell connector 428 has a bevel near its end to facilitate the insertion of the clutch 433 and the twisting shell connector 428.

[0180] Preferably, the spindle connector 435 is provided with a corresponding mounting hole for the clutch reset elastic element 434 to be inserted. During assembly, the proximal end of the clutch reset elastic element 434 is inserted into the corresponding mounting hole of the spindle connector 435. Preferably, glue can be used to bond the proximal end face of the clutch reset elastic element 434 to the bottom surface of the corresponding mounting hole of the spindle connector 435. Since the proximal end of the clutch 433 is sleeved on the distal end of the spindle connector 435 (a corresponding mounting hole is opened on the proximal end face of the clutch 433, and the distal end of the clutch reset elastic element 434 is inserted into the corresponding mounting hole of the clutch 433 during assembly), and the distal end of the clutch 433 is sleeved onto the proximal end of the twisting shell connector 428, the clutch 433 and the twisting shell connector 428 can be connected under the action of the clutch reset elastic element 434.

[0181] As shown in FIG34, in an optional embodiment of the present invention, the spindle drive module 43 may further include a braking component 438, which is arranged in pairs on both sides of the coupling 437 and is used to brake the coupling 37.

[0182] In this embodiment, two braking components 438 are disposed opposite to each other on the first housing 401 and the second housing 402, and the inner sides of the two braking components 438 respectively cooperate with the outer walls of the coupling 437 to brake the coupling 437; preferably, the first housing 401 and the second housing 402 are respectively provided with braking through holes, and one side of the braking component 438 passes through the braking through hole and can be radially translated at the braking through hole.

[0183] Further, as shown in Figures 36 and 37, the braking assembly 438 includes a brake slider 4381, a brake element 4382, and a brake reset elastic element 4383. The brake slider 4381 is disposed outside the housing 40. The large end of the brake element 4382 extends outside the housing 40 and is slidably connected to the brake slider 4381. The small end of the brake element 4382 is inserted into the housing 410 and engages with the outer wall of the coupling 437. The brake reset elastic element 4383 is disposed between the brake element 4382 and the housing 40 and is used to separate the brake element 4382 from the coupling 437. Preferably, the brake reset elastic element 4383 can be a pair of brake reset springs, with one end of the brake reset elastic element 4383 inserted into the corresponding mounting hole of the brake element 4382, and the other end inserted into the corresponding mounting hole of the housing 40.

[0184] In this embodiment, the first housing 401 and the second housing 402 of the housing 40 are respectively provided with brake through holes. The small end of the brake member 4382 passes through the brake through hole and can be translated radially at the brake through hole. The large end of the brake member 4382 is disposed outside the brake through hole and contacts the brake member slider 4381. The first housing 401 and the second housing 402 of the housing 40 are also respectively provided with brake grooves. The brake member slider 4381 is disposed in the brake groove and can be translated axially in the brake groove. Preferably, the brake member slider 4381 has a wedge-shaped bottom surface 43812, and the large end of the brake member 4382 is provided with a limiting groove 43821. The wedge-shaped bottom surface 43812 and the two sides of the brake member slider 4381 contact the arc-shaped top surface and the two sides of the limiting groove 43821, respectively.

[0185] During assembly, after inserting the two ends of the brake reset elastic element 4383 into the corresponding mounting holes of the brake element 4382 and the housing 40 respectively, it is preferable to use glue to bond the end face of the brake reset elastic element 4383 to the bottom surface of the corresponding mounting hole of the brake element 4382; preferably, the brake slider 4381 and the brake element 4382 can both be prepared by injection molding.

[0186] As shown in Figures 38 and 39, preferably, each brake slider 4381 in the two brake assemblies 438 has two seventh protrusions 43811 along the translational direction. The two seventh protrusions 43811 on the brake slider 4381 of one brake assembly 438 respectively engage with two third protrusions 4013 on the first housing 401; the two seventh protrusions 43811 on the brake slider 4381 of the other brake assembly 438 respectively engage with two sixth protrusions 4023 on the second housing 402. When the brake slider 4381 is slid down and the brake reset elastic member 4383 is pressed down or released, the engagement between the seventh protrusions 43811 and the third and sixth protrusions 4013 and 4023 is used to lock the brake slider 4381 in both states: when the brake 4382 in the brake assembly 438 is locked in the coupling 437 and when the coupling 437 is released.

[0187] Preferably, the two braking components 438 are provided with braking component covers 405. The two braking component covers 405 are respectively installed at the corresponding positions of the first housing 401 and the second housing 402 and are fixed by screws to limit the braking components 438 and prevent accidental operation of the braking component slider 4381.

[0188] As shown in Figure 34, in an optional embodiment of the present invention, the spindle drive module 43 further includes a clutch ring 432 and a clutch fork 431. The clutch ring 432 is slidably sleeved on the outside of the housing 40 and has a clutch fork mounting hole 4323 in the radial direction. 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 with the twisting shell connector 428, thereby realizing the separation or connection of the distal end of the spindle drive module 43 and the proximal end of the twisting shell drive module 42.

[0189] Preferably, as shown in FIG35, the clutch ring 432 includes a first clutch ring 4321 and a second clutch ring 4322 that is fitted and installed with the first clutch ring 4321. The second clutch ring 4322 and the first clutch ring 4321 are arranged opposite to each other to form an annular clutch ring 432. More preferably, a boss is provided on the mating surface of the first clutch ring 4321 and the second clutch ring 4322; a groove is provided on the mating surface of the second clutch ring 4322 and the first clutch ring 4321 at a position corresponding to the boss. The first clutch ring 4321 is assembled onto 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 with glue.

[0190] 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 sleeved on the housing 40. Then, two clutch forks 431 are assembled to the clutch ring 432, preferably using glue for bonding. During the assembly process, it is necessary to ensure that the clutch forks 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 located between the two fingers of the clutch fork 431.

[0191] Preferably, as shown in Figures 23 and 24, 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. Rotating the clutch ring 432 in the direction shown in Figure 45 releases the locking state of the clutch fork 431 when the clutch 433 is connected to the twisting shell connector 428 and the spindle connector 435. Then, as shown in Figure 46, the clutch ring 432 slides towards the proximal end, and the clutch ring 432 moves towards the proximal end together with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it will push the clutch 433 towards the proximal end while compressing the clutch reset elastic member 434, until the clutch ring 432 can no longer move further towards the proximal end. Rotating the clutch ring 432 again in the direction shown in Figure 47 causes the clutch fork 431 to enter another locking state. At this time, the clutch 433 and the twisting shell connector 428 are in a non-connected state. Optionally, the clutch fork 431, the first clutch ring 4321, and the second clutch ring 4322 can all be prepared by photopolymerization 3D printing of medical rigid resin.

[0192] The left ventricular assist device 1 provided in the above embodiments of the present invention, as shown in Figure 42, is used in the following process: a folded miniature pump head 2 is implanted through a catheter 6, and then the catheter 6 is withdrawn; after the catheter 6 is removed, the pump head impeller 22 and the pump head protection assembly 21 of the miniature pump head 2 are unfolded in the body in a controlled manner through the cooperation between the transmission shaft 3 and the external drive control mechanism 4; after the pump head impeller 22 is unfolded in a controlled manner, it maintains a fixed outer diameter and rotates in one 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 assembly 21 are folded in the body in a controlled manner through the cooperation between the transmission shaft 3 and the external drive control mechanism 4; after the pump head impeller 22 and the pump head protection assembly 21 are folded in a controlled manner, the miniature pump head 2 is in a folded state, and the folded miniature pump head 2 is taken into the catheter 6; finally, the folded miniature pump head 2 is removed together with the catheter 6.

[0193] As shown in Figure 43, when the left ventricular assist device 1 is in the assisted blood supply state, the pump head impeller 22 and pump head protection assembly 21 in the miniature pump head 2 are in the deployed state due to their own elasticity. At this time, under the action of the second twisting gear reset elastic element 4215, the clutch reset elastic element 434, and the brake reset elastic element 4383, the second twisting gear 4213 and the first twisting gear 425 are in a non-meshing state, the brake 4382 and the coupling 437 are in a non-contact state, and the clutch 433 is in a connected state with the twisting shell connector 428 and the spindle connector 435. The drive motor 4310 drives the coupling 437 to rotate, and the coupling 437 drives the spindle connector 435 to rotate. 435 drives the spindle 33 and clutch 433 to rotate synchronously. Clutch 433 drives the twisting shell connector 428, which in turn drives the twisting shell 32 and spindle 33 to rotate synchronously. When the twisting shell 32 and spindle 33 rotate synchronously, the distal and proximal ends of the pump head impeller 22 unfolded in the micro pump head 2 rotate synchronously, thereby ensuring that the entire pump head impeller 22 rotates synchronously with the twisting shell 32 and spindle 33. At this time, the pump head impeller 22 rotates with a fixed outer diameter, realizing the blood pumping function. In addition, during the auxiliary blood supply process, the twisting shell connector 428 will also drive the first twisting gear shaft 426 and the first twisting gear 425 to rotate, and the twisting shell 32 will drive the twisting shell bushing 423 to rotate.

[0194] Taking the transformation of the micro pump head 2 from the unfolded state to the folded state as an example, the specific transformation between the unfolded and folded states can be achieved through the following steps:

[0195] Step 21, as shown in Figure 44, slide the brake slider 4381 to the far end. While compressing the brake reset elastic element 4383, push the two brake elements 4382 to the locked coupling 437 state. At this time, the coupling 437, the spindle connector 435, and the spindle 33 cannot rotate. At this time, the brake slider 4381 can be locked in the state of the brake assembly 438 locking the coupling 437 by relying on the cooperation between the seventh protrusion 43811 on its own surface and the third protrusion 4013 corresponding to the surface of the first housing 401 and the sixth protrusion 4023 corresponding to the surface of the second housing 402.

[0196] Step 22: Rotate the clutch ring 432 in the direction shown in Figure 45 to release the clutch fork 431 from the locked state when the clutch 433 is connected to the twisting shell connector 428 and the spindle connector 435. Then, slide the clutch ring 432 towards the proximal end in the direction shown in Figure 46. The clutch ring 432 moves towards the proximal end together with the two clutch forks 431. When the distal finger of the clutch fork 431 contacts the clutch 433, it will push the clutch 433 towards the proximal end while compressing the clutch reset elastic element 434, until the clutch ring 432 can no longer move further towards the proximal end. Rotate the clutch ring 432 again in the direction shown in Figure 47 to put the clutch fork 431 into another locked state. At this time, the clutch 433 and the twisting shell connector 428 are in a non-connected state.

[0197] Step 23, as shown in Figure 48, push the second gear set 421 inward until the second twisting gear 4213 is fully engaged with the first twisting gear 425. Then rotate the second twisting gear 4213 in the direction shown in Figure 49. 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. The twisting shell 32 drives the near end of the pump head impeller 22 to rotate, thereby realizing the folding of the pump head impeller 22.

[0198] Step 24, as shown in Figure 50, slide the protective sleeve slider 411 towards the proximal end. The protective sleeve slider 411 drives the protective sleeve 31 to move towards the proximal end, and the protective sleeve 31 drives the pump head protection assembly 21 to move towards the proximal end, thereby realizing the folding of the pump head protection assembly 21. The protective sleeve slider 411 relies on the protective sleeve slider locking piece 4111 on its own surface to cooperate with the first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021 and the fifth protrusion 4022 corresponding to the surfaces of the first housing 401 and the second housing 402 to lock the protective sleeve slider 411 in the folded state.

[0199] This completes the conversion of the miniature pump head 2 in the left ventricular assist device 1 from the unfolded state to the folded state. Reversing the above steps will achieve the conversion of the miniature pump head 2 in the left ventricular assist device 1 from the folded state to the unfolded state.

[0200] Since the deployed state (normal state) is the primary state of the miniature pump head 2 in the left ventricular assist device 1, under the action of the second twisting gear reset elastic element 4215, the clutch reset elastic element 434, and the brake reset elastic element 4383, the second twisting gear 4213 and the first twisting gear 425 are normally in a non-meshing state, the clutch 433 and the twisting shell connector 428 are normally in a connected state, 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 miniature pump head 2, drive shaft 3, protective sleeve drive module 41, clutch shift fork 431, and clutch shift ring 432 can be removed and replaced to achieve the reusability of the drive control mechanism 4.

[0201] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A left ventricular assist device, characterized in that, include: The drive control mechanism (4) includes a twisting shell drive module (42) and a spindle drive module (43); The drive shaft (3) includes a twisting shell (32) and a spindle (33), wherein the twisting shell (32) is movably fitted over the spindle (33); and A miniature pump head (2) includes a pump head impeller (22) and a pump head drive assembly (23), wherein The proximal end of the pump head impeller (22) is connected to the twisting shell drive module (42) via the twisting shell (32), and the distal end of the pump head drive assembly (23) is fixedly connected to the distal end of the pump head impeller (22). The proximal end of the pump head drive assembly (23) is connected to the spindle drive module (43) via the spindle (33). The spindle drive module (43) drives the spindle (33) and the twisting shell (32) to rotate synchronously, thereby causing the distal and proximal ends 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 spindle (33) to rotate relative to each other, thereby causing the proximal end of the pump head impeller (22) to rotate relative to the distal end, so that the pump head impeller (22) folds or unfolds.

2. The left ventricular assist device according to claim 1, characterized in that, The twisting shell (32) includes 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 flexible section (323) of the twisted shell is fixedly connected to the connecting section (322) of the twisted shell micro pump head and the connecting section (324) of the twisted shell drive control mechanism by welding; wherein The distal end of the twisted shell micro pump head connecting section (322) is used to be fixedly connected to the proximal end of the pump head impeller (22), and the proximal end of the twisted shell drive control mechanism connecting section (324) is used to be drivenly connected to the twisted shell drive module (42).

3. The left ventricular assist device according to claim 2, characterized in that, The drive shaft (3) also includes a protective sleeve (31), which is movably fitted over the twisted shell (32). The proximal end of the protective sleeve (31) is connected to the protective sleeve drive module (41) of the drive control mechanism (4), and the distal end of the protective sleeve (31) is fixedly connected to the proximal end of the pump head protection assembly (21) of the micro pump head (2). The drive control mechanism (4) controls the outer diameter of the pump head protection assembly (21) by controlling the protective sleeve (31) to slide on the twisted shell (32). Optionally, the left ventricular assist device (1) further includes a pressure sensor (5), the pressure sensor (5) includes an optical fiber (51), the protective sleeve (31) has an optical fiber hole (311), and the optical fiber (51) passes through the optical fiber hole (311). Optionally, the pressure sensor (5) further includes 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; Optionally, the optical fiber (51) includes a pressure monitoring optical fiber (511) and a signal transmission optical fiber (512). The signal transmission optical fiber (512) is integrally formed with the pressure monitoring optical fiber (511). The near end of the signal transmission optical fiber (512) is fixed and communicatively connected to the fiber optic demodulator (52) through a threaded connector. Optionally, the protective sleeve (31) is made of medical Pebax tubing, the twisted shell (32) is made of multi-strand double-layer synchronous torque spring tubing, and / or the mandrel (33) is made of plastic-coated steel wire rope.

4. The left ventricular assist device according to claim 1, characterized in that, The pump head impeller (22) includes: A foldable impeller (221), the distal end of which is fixedly connected to the spindle (33) via the pump head drive assembly (23); and A twisting connector (222) is provided, the distal end of which is engaged with the proximal end of the foldable impeller (221), and the proximal end of which is fixedly connected to the twisting shell (32).

5. The left ventricular assist device according to claim 4, characterized in that, The foldable impeller (221) includes: An impeller frame (2211), the proximal end of which is fixedly connected to the twisting shell (32) via the twisting connector (222), and the distal end of which is fixedly connected to the mandrel (33) via the pump head drive assembly (23); and Impeller blade surface (2212), the impeller blade surface (2212) covers the outside of the impeller frame (2211); Optionally, the impeller frame (2211) includes: A proximal retaining ring (22113) is fixedly connected to the twisted shell (32) at its proximal end via the twisted connector (222); A distal retaining ring (22111), wherein the distal retaining ring (22111) is fixedly connected to the spindle (33) via the pump head drive assembly (23); and Impeller skeleton wire (22112), the impeller skeleton wire (22112) is spirally disposed between the proximal fixing ring (22113) and the distal fixing ring (22111); Optionally, the impeller skeleton wire (22112) is made of an elastic material; Optionally, the twisted connector (222) is provided with a plurality of rotation limiting bosses at its distal end, and the proximal outer edge of the proximal fixing ring (22113) is provided with a plurality of limiting grooves accordingly. The twisted connector (222) and the proximal fixing ring (22113) are rotated and limited by the insertion and cooperation of the rotation limiting bosses and the limiting grooves. Optionally, the distal and proximal ends 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.

6. The left ventricular assist device according to claim 5, characterized in that, The pump head drive assembly (23) includes: A mandrel sleeve (236) passes through the impeller frame (2211). The distal end of the mandrel sleeve (236) is fixedly connected to the distal fixing ring (22111), and the proximal end of the mandrel sleeve (236) is sleeved inside the proximal fixing ring (22111) and fixedly connected to the mandrel (33). A top shaft (235) is fixedly embedded at the proximal end of the mandrel sleeve (236); A top shaft bearing (233) is sleeved on the far end of the top shaft (235), and the proximal end face of the top shaft bearing (233) contacts the far end face of the mandrel sleeve (236); A top shaft sleeve (232) is fixedly sleeved on the distal end of the top shaft (235), and the inner edge of the top shaft bearing (233) is limited between the distal end face of the mandrel sleeve (236) and the proximal end face of the top shaft sleeve (232); and A top sleeve (231) is fitted onto the far end of the top shaft (235) at its proximal end; Optionally, the mandrel sleeve (236) is fixedly sleeved with a mandrel collar (237) at its proximal end. The proximal end face of the mandrel collar (237) is flush with the proximal end face of the mandrel sleeve (236) and is limited to the proximal end of the proximal end fixing ring (22113) and the distal end of the twisted connector (222). Optionally, a top sleeve (234) is provided on the mandrel sleeve (236), the top sleeve (234) is sleeved on the far end of the mandrel sleeve (236), and the far end face of the top sleeve (234) is fixedly connected to the proximal end face of the top sleeve (231); Optionally, the proximal end of the top sleeve (231) is provided with an annular groove that is 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 limited between the annular groove at the proximal end of the top sleeve (231) and the top sleeve ring (234).

7. The left ventricular assist device according to claim 3, characterized in that, The micro pump head (2) also includes: Pump head protection assembly (21) is coaxially mounted on the outside of the pump head impeller (22), and the near end of the pump head protection assembly (21) is connected to the protective sleeve drive module (41) in the drive control mechanism (4) through the protective sleeve (31), and the far end of the pump head protection assembly (21) is fixedly connected to the far end of the pump head drive assembly (23); Optionally, the pump head protection assembly (21) includes: An anchor bracket (212), the proximal end of which is fixedly connected to the distal end of the protective sleeve (31), and the distal end of which is sleeved and fixed to the distal end of the pump head transmission assembly (23); and Top sleeve tip (211), the top sleeve tip (211) is disposed at the far end of the anchor bracket (212), and the proximal end of the top sleeve tip (211) is fixedly connected to the far end of the pump head transmission assembly (23); Optionally, the pump head protection assembly (21) further includes a bracket protective sleeve connecting ring (213), the distal end of which is embedded and fixed to the annular proximal end of the anchor bracket (212), and the distal end face of the bracket protective sleeve connecting ring (213) is flush with the distal end face of the annular proximal end of the anchor bracket (212). The bracket protective sleeve connecting ring (213) is slidably sleeved on the outside of the twisted shell (32) and fixedly connected to the far end of the protective sleeve (31); Optionally, the top sleeve (231) is provided with an anchoring groove at its far end, and the top sleeve tip (211) is provided with an anchoring rod at its near end. The anchoring rod is inserted into the anchoring groove to fix the near end of the top sleeve tip (211) to the far end of the pump head transmission assembly (23). Optionally, the anchoring bracket (212) includes: An anchor bracket frame (2121), the proximal end of which is fixedly connected to the distal end of the protective sleeve (31), and the distal end of which is sleeved and fixed to the distal end of the pump head transmission assembly (23); and An anchoring support membrane (2122), which is sleeved over the anchoring support frame (2121); Optionally, the anchor support frame (2121) includes a proximal ring, a distal ring, and a plurality of anchor support frame wires arranged in parallel between the proximal ring and the distal ring. The anchor support frame wires bend outward when the proximal ring and the distal ring approach each other to expand the structure of the pump head protection assembly (21), and tighten inward when the proximal ring and the distal ring move away from each other to retract the structure of the pump head protection assembly (21). Optionally, the anchorage support skeleton wire is made of an elastic material.

8. The left ventricular assist device according to claim 1, characterized in that, The drive control mechanism (4) further includes a housing (40); the twisting shell drive module (42) is disposed within the housing (40), and the distal end of the twisting shell drive module (42) is connected to the proximal end of the twisting shell (32); the spindle drive module (43) is disposed within the housing (40) and arranged near the twisting shell drive module (42), the distal end of the spindle drive module (43) is connected to the proximal end of the spindle (33), and the distal end of the spindle drive module (43) and the proximal end of the twisting shell drive module (42) are detachably connected, wherein... When the mandrel drive module (43) is connected to the twisting shell drive module (42), the mandrel drive module (43) drives the mandrel (33) and the twisting shell (32) to rotate synchronously; and when the mandrel 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 mandrel (33).

9. The left ventricular assist device according to claim 8, characterized in that, The twisted shell drive module (42) includes: A twisted shell connector (428) is fixedly connected to the twisted shell (32), and the proximal end of the twisted shell connector (428) is detachably connected to the distal end of the spindle drive module (43); and A twisting gear set is disposed at the distal end of the twisting shell connector (428) and is used to control the rotation of the twisting shell connector (428) when the distal end of the spindle drive module (43) is separated from the proximal end of the twisting shell drive module (42); Optionally, the twisting gear set includes: First twisting gear shaft (426); The first twisting gear (425) is sleeved on the first twisting gear shaft (426) and fixedly connected to the twisting shell connector (428) through the first twisting gear shaft (426); A first twisted gear shaft bearing (424) is disposed at the distal end of the first twisted gear shaft (426) and rotatably supports the first twisted gear shaft (426) within the housing (40); A twisted shell connector bearing (427) is disposed in the middle section of the twisted shell connector (428) and rotatably supports the twisted shell connector (428) within the housing (40); and The second gear set (421) is separable from and meshes with the first twisting gear (425). When the second gear set (421) meshes with the first twisting gear (425), it controls the rotation of the first twisting gear (425). Optionally, the first twisting gear shaft (426) is configured as a shaft with a multi-stage stepped shape, and the proximal end of the first twisting gear shaft (426) is sleeved and fixed to the distal end of the twisting shell connector (428); Optionally, the twisting shell drive module (42) further includes a twisting shell bushing (423) and a twisting shell bushing bearing (422). The twisting shell bushing (423) is fitted with the twisting shell bushing bearing (422) at both ends. The twisting shell bushing (423) is fitted near the end of the twisting shell (32) and is located near the end of the first twisting gear shaft (426). Optionally, the second gear set (421) includes: Second twisting gear shaft (4214); The second twisting gear (4213) is sleeved on the second twisting gear shaft (4214) and can be disengaged from and meshed with the first twisting gear (425); The second twisting gear shaft bearing (4212) is disposed between the second twisting gear shaft (4214) and the second twisting gear (4213); The second twisting gear limiting member (4211) is respectively disposed 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) is inserted into the housing (40), and the other side of the second twisting gear limiting member (4211) extends out of the housing (40) and supports the second twisting gear (4213) on the outside of the housing (40); and The second twisting gear reset elastic element (4215) is disposed between the second twisting gear limiting element (4211) and the housing (40) and separates the second twisting gear (4213) from the first twisting gear (425).

10. The left ventricular assist device according to claim 8, characterized in that, The spindle drive module (43) includes: A spindle connector (435) is sleeved on the outside of the spindle (33) and fixedly connected to the spindle (33); A coupling (437) is provided, the distal end of which is fixedly connected to the spindle connector (435), and the proximal end of which is fixedly connected to the drive motor (4310). A clutch (433), wherein 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) is synchronously rotatably connected to the spindle connector (435), and the clutch (433) is detachably connected to the twisting shell connector (428); and A clutch reset elastic element (434) is disposed between the spindle connector (435) and the clutch (433); Optionally, the spindle drive module (43) further 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) within the housing (40); Optionally, the spindle drive module (43) further includes: Braking assembly (438), the braking assembly (438) is arranged in pairs on both sides of the coupling (437) and is used to brake the coupling (437); Optionally, the braking assembly (438) includes: Brake slider (4381), the brake slider (4381) is disposed outside the housing (40); A brake element (4382) is disposed inside the brake element slider (4381). The large end of the brake element (4382) extends out of the housing (40) and is slidably connected to the brake element slider (4381). The small end of the brake element (4382) is inserted into the housing (40) and engages with the outer wall of the coupling (437). A pair of brake reset elastic elements (4383) are provided between the brake (4382) and the housing (40). One end of the pair of brake reset elastic elements (4383) is inserted into the corresponding mounting hole of the brake (4382), and the other end of the pair of brake reset elastic elements (4383) is inserted into the corresponding mounting hole of the housing (40). Optionally, the brake slider (4381) has a wedge-shaped bottom surface (43812), and the brake (4382) has a limiting groove (43821) at its large end. The wedge-shaped bottom surface (43812) and the two sides of the brake slider (4381) respectively contact the arc-shaped top surface and the two sides of the limiting groove (43821). Optionally, the spindle drive module (43) further includes: A clutch ring (432), which is slidably sleeved on the outside of the housing (40) and has a clutch fork mounting hole (4323) radially provided; and 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) from the twisting shell connector (428); Optionally, the clutch ring (432) includes a first clutch ring (4321) and a second clutch ring (4322), wherein the first clutch ring (4321) and the second clutch ring (4322) are disposed opposite to each other to form a ring-shaped clutch ring (432). Optionally, the drive control mechanism (4) further includes: A protective sleeve drive module (41) is sleeved on the proximal end of the protective sleeve (31) and connected to the proximal end of the protective sleeve (31) for transmission. The protective sleeve (31) is driven to move through the protective sleeve drive module (41). Optionally, the protective sleeve drive module (41) includes a protective sleeve slider (411), a protective sleeve slider bearing (412), and a protective sleeve slider end cap (413). The protective sleeve slider (411) is sleeved on the proximal end of the protective sleeve (31) and fixedly connected to the protective sleeve (31). The protective sleeve slider bearing (412) is embedded in the proximal annular groove of the protective sleeve slider (411), and the outer edge of the protective sleeve slider bearing (412) is limited between the proximal annular groove of the protective sleeve slider (411) and the protective sleeve slider end cap (413). The protective sleeve slider end cap (413) is disposed on the proximal end of the protective sleeve slider (411) and fixedly connected to the protective sleeve slider (411). Optionally, the protective sleeve drive module (41) includes at least two protective sleeve slider bearings (412), the at least two protective sleeve slider bearings (412) being embedded in the proximal annular groove of the protective sleeve slider (411) such that the distal end face of the protective sleeve slider bearing (412) away from the protective sleeve slider end cap (413) contacts the proximal end face of the protective sleeve (31); Optionally, the protective cover slider (411) is provided with a protective cover slider locking member (4111), which 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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