CN119327031B

CN119327031B - Left ventricular assist device

Info

Publication number: CN119327031B
Application number: CN202411513552.2A
Authority: CN
Inventors: 朱禛彦; 唐一超
Original assignee: Tongji University
Current assignee: Tongji University
Priority date: 2024-10-28
Filing date: 2024-10-28
Publication date: 2025-10-03
Anticipated expiration: 2044-10-28
Also published as: CN119327031A

Abstract

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

Description

Left ventricle auxiliary device

Technical Field

The invention relates to the technical field of auxiliary devices, in particular to a left ventricle auxiliary device.

Background

The number of high-risk cardiovascular intervention operations at home and abroad has increased year by year in recent decades, and in order to reduce the death risk of patients caused by blood circulation blockage or stopping during the operation, interventional left ventricular assist devices have been widely used in high-risk cardiovascular intervention operations. The interventional left ventricle auxiliary device is a percutaneous mechanical circulation auxiliary system which provides auxiliary blood flow for high-risk cardiovascular interventional operation patients in and after operation through a mechanical micropump, can partially or completely assist the function of the left ventricle and helps the heart to convey oxygenated blood to the whole body. The prior interventional left ventricle auxiliary device mainly uses a miniature pump head provided with a non-deformable rigid impeller, is limited by the size of equipment, and can generate small auxiliary flow. In order to meet the requirement of maintaining the blood circulation of a patient in a high-risk interventional operation, an interventional left ventricle auxiliary device with a fixed impeller size is generally adopted, the rotating speed of the impeller is increased, however, the impeller rotating at a high speed inevitably causes the internal shearing force of blood to be too high, so that the permeability of red blood cells is changed and irreversible cells are damaged, and the risk of hemolysis of the patient is increased.

Therefore, there is a need to design an interventional left ventricle auxiliary device with a high-expansion-ratio active expansion impeller, which can simultaneously achieve the functions of instrument micro volume, high blood supply flow and low risk of hemolysis.

Disclosure of Invention

The invention aims to provide a left ventricular assist device to improve the use efficiency and safety of the left ventricular assist device.

In order to solve the above technical problems, the present invention provides a left ventricular assist device, comprising:

The control mechanism is driven to drive the control mechanism,

Comprises a twisting shell driving module and a mandrel driving module;

The transmission shaft comprises a twisting shell and a mandrel, wherein the twisting shell is movably sleeved outside the mandrel, and

A miniature pump head comprising 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 driving module through the twisting shell, the distal end of the pump head driving assembly is fixedly connected with the distal end of the pump head impeller, the proximal end of the pump head driving assembly is in transmission connection with the mandrel driving module through the mandrel,

The mandrel and the twisting shell are driven to synchronously rotate by the mandrel driving module so as to drive the distal end and the proximal end of the pump head impeller to jointly rotate, so that the pump head impeller rotates with a fixed outer diameter, and the twisting shell and the mandrel are driven to relatively rotate by the twisting shell driving module so as to drive the proximal end of the pump head impeller to relatively rotate with the distal end, so that the pump head impeller is folded or unfolded.

In one embodiment, the twisting shell comprises a twisting shell micro pump head connecting section, a twisting shell flexible section and a twisting shell driving control mechanism connecting section;

the twisting shell flexible section is fixedly connected with the twisting shell micro pump head connecting section and the twisting shell driving control mechanism connecting section through welding respectively, wherein

The far end of the twisting shell micro pump head connecting section is fixedly connected with the near end of the pump head impeller, and the near end of the twisting shell driving control mechanism connecting section is in transmission connection with the twisting shell driving module;

in one embodiment, the drive shaft further comprises:

The protective sleeve is movably sleeved outside the twisting shell, the proximal end of the protective sleeve is in transmission connection with a protective sleeve driving module of the driving control mechanism, the distal end of the protective sleeve is fixedly connected with the proximal end of a pump head protection assembly of the miniature pump head, and the driving control mechanism controls the outer diameter of the pump head protection assembly by controlling the protective sleeve to slide on the twisting shell;

Optionally, the left ventricle auxiliary device further comprises a pressure sensor, the pressure sensor comprises an optical fiber, an optical fiber hole is formed in the protective sleeve, and the optical fiber is arranged in the optical fiber hole in a penetrating mode;

Optionally, the pressure sensor further comprises a fiber bragg grating demodulator, and the fiber is in communication connection with the fiber bragg grating demodulator through a threaded connector;

Optionally, the optical fiber comprises a pressure monitoring optical fiber and a signal transmission optical fiber, the signal transmission optical fiber and the pressure monitoring optical fiber are integrally formed, and the proximal end of the signal transmission optical fiber and the fiber grating demodulator are fixed and in communication connection through a threaded connector;

Optionally, the protective sheath is made from a medical Pebax tube, the twist shell is made from a multi-strand double-layer synchronous torque spring tube, and/or the mandrel is made from a plastic-coated wire rope.

In one embodiment, the pump head impeller comprises:

A foldable impeller, the distal end of which is fixedly connected with the mandrel through the pump head transmission component, and

The distal end of the twisting connecting piece is clamped with the proximal end of the foldable impeller, and the proximal end of the twisting connecting piece is fixedly connected with the twisting shell.

In one embodiment, the collapsible impeller comprises:

the impeller skeleton, the proximal end of the impeller skeleton is fixedly connected with the twisting shell through the twisting connecting piece, the distal end of the impeller skeleton is fixedly connected with the mandrel through the pump head transmission assembly, and

Impeller blade surfaces, wherein the impeller blade surfaces are coated outside the impeller framework;

optionally, the impeller skeleton includes:

the proximal end fixing ring is fixedly connected with the twisting shell through the twisting connecting piece;

A distal retaining ring having a proximal end fixedly coupled to the mandrel via the pump head drive assembly, and

The impeller skeleton wire is spirally arranged between the proximal end fixing ring and the distal end fixing ring;

Optionally, the impeller skeleton wire is made of an elastic material;

Optionally, the distal end of the twisting connecting piece is provided with a plurality of rotation limiting bosses, the outer edge of the proximal end fixing ring is correspondingly provided with a plurality of limiting grooves, and the twisting connecting piece and the proximal end fixing ring are in insertion fit with the limiting grooves through the rotation limiting bosses to carry out rotation limiting;

Optionally, the distal end and the proximal end of the impeller blade surface are respectively coated outside the distal end fixing ring and the proximal end fixing ring, and are jacked outwards by the impeller skeleton wires to form the impeller.

In one embodiment, the pump head transmission assembly includes:

The core sleeve penetrates through the impeller framework, the far end of the core sleeve is fixedly connected with the far end fixing ring, and the near end of the core sleeve is sleeved in the near end fixing ring and is fixedly connected with the core shaft;

The proximal end of the top shaft is fixedly embedded into the distal end of the mandrel sleeve;

The top shaft bearing is sleeved at the far end of the top shaft, and the near end face of the top shaft bearing is contacted with the far end face of the mandrel sleeve;

the top shaft sleeve is fixedly sleeved at the far end of the top shaft, the inner edge of the top shaft bearing is limited between the far end face of the mandrel sleeve and the near end face of the top shaft sleeve, and

The proximal end of the top sleeve is sleeved at the distal end of the top shaft;

Optionally, a mandrel collar is fixedly sleeved at the proximal end of the mandrel sleeve, and the proximal end face of the mandrel collar is flush with the proximal end face of the mandrel sleeve and is limited between the proximal end of the proximal fixed ring and the distal end of the twisting connecting piece;

optionally, a top collar is sleeved on the core sleeve, the top collar is sleeved at the far end of the core sleeve, and the far end face of the top collar is fixedly connected with the near end face of the top sleeve;

optionally, the proximal end of the top sleeve is provided with a ring groove adapted to the top shaft bearing, the top shaft bearing is embedded in the ring groove at the proximal end of the top sleeve, and the outer edge of the top shaft bearing is limited between the ring groove at the proximal end of the top sleeve and the top sleeve ring.

In one embodiment, the micropump head further comprises:

The pump head protection assembly is coaxially covered outside the pump head impeller, the proximal end of the pump head protection assembly is in transmission connection with a protective sleeve driving module in the driving control mechanism through the protective sleeve, and the distal end of the pump head protection assembly is fixedly connected with the distal end of the pump head transmission assembly;

Optionally, the pump head protection assembly includes:

The proximal end of the anchoring support is fixedly connected with the distal end of the protective sleeve, the distal end of the anchoring support is sleeved and fixed at the distal end of the pump head transmission assembly, and

The top sleeve tip is arranged at the far end of the anchoring bracket, and the near end of the top sleeve tip is fixedly connected with the far end of the pump head transmission assembly;

Optionally, the pump head protection assembly further comprises a bracket protection sleeve connecting ring, wherein the distal end of the bracket protection sleeve connecting ring is embedded and fixed at the annular proximal end of the anchoring bracket, and the distal end face of the bracket protection sleeve connecting ring is flush with the distal end face of the annular proximal end of the anchoring bracket, and

The support protective sleeve connecting ring is sleeved outside the twisting shell in a sliding manner and is fixedly connected with the distal end of the protective sleeve;

optionally, an anchoring groove is formed at the distal end of the top sleeve, an anchoring rod is arranged at the proximal end of the top sleeve tip, and the anchoring rod is in plug-in fit with the anchoring groove so as to fixedly connect the proximal end of the top sleeve tip with the distal end of the pump head transmission assembly;

optionally, the anchoring stent comprises:

an anchoring bracket framework, the proximal end of which is fixedly connected with the distal end of the protective sleeve, the distal end of which is sleeved and fixed at the distal end of the pump head transmission assembly, and

The anchoring support membrane is sleeved outside the anchoring support framework;

Optionally, the anchoring stent framework comprises an anchoring stent framework proximal ring, an anchoring stent framework distal ring and a plurality of anchoring stent framework wires juxtaposed between the anchoring stent framework proximal ring and the anchoring stent framework distal ring, the anchoring stent framework wires being bent outwards when the anchoring stent framework proximal ring and the anchoring stent framework distal ring are close to each other to expand the structure of the pump head protection assembly, and the anchoring stent framework wires being tightened inwards when the anchoring stent framework proximal ring and the anchoring stent framework distal ring are far away from each other to retract the structure of the pump head protection assembly;

optionally, the anchor stent skeleton wire is made of an elastic material.

In one embodiment, the drive control mechanism further comprises:

The twisting shell driving module is arranged in the shell, the far end of the twisting shell driving module is in transmission connection with the near end of the twisting shell, the mandrel driving module is arranged in the shell and is arranged at the near end of the twisting shell driving module, the far end of the mandrel driving module is in transmission connection with the near end of the mandrel, and the far end of the mandrel driving module is in separable connection with the near end of the twisting shell driving module, wherein

When the mandrel driving module is connected with the twisting shell driving module, the mandrel driving module drives the mandrel to synchronously rotate with the twisting shell, and when the mandrel driving module is separated from the twisting shell driving module, the twisting shell driving module drives the twisting shell to rotate relative to the mandrel.

In one embodiment, the twist shell drive module includes:

A twisting shell connecting piece, wherein the twisting shell connecting piece is fixedly connected with the twisting shell, the proximal end of the twisting shell connecting piece is detachably connected with the distal end of the mandrel driving module, and

The twisting gear set is arranged at the far end of the twisting shell connecting piece and is used for controlling the twisting shell connecting piece to rotate when the far end of the mandrel driving module is separated from the near end of the twisting shell driving module;

optionally, the twisting gearset comprises:

A first twist gear shaft;

the first twisting gear is sleeved on the first twisting gear shaft and fixedly connected with the twisting shell connecting piece through the first twisting gear shaft;

A first twist gear shaft bearing disposed at a distal end of the first twist gear shaft and rotatably supporting the first twist gear shaft within the housing;

a twisting shell connector bearing arranged at the middle section of the twisting shell connector and rotatably supporting the twisting shell connector in the shell, and

A second gear set detachably engaged with the first twist gear and controlling rotation of the first twist gear when the second gear set is engaged with the first twist gear;

Optionally, the first twisting gear shaft is provided with a multistage stepped shaft body, and the proximal end of the first twisting gear shaft is sleeved and fixed at the distal end of the twisting shell connecting piece;

Optionally, the twisting shell driving module further comprises a twisting shell shaft sleeve and a twisting shell shaft sleeve bearing, wherein the twisting shell shaft sleeve bearing is sleeved at two ends of the twisting shell shaft sleeve respectively, and the twisting shell shaft sleeve is sleeved at the proximal end of the twisting shell and is arranged at the proximal end of the first twisting gear shaft;

optionally, the second gear set includes:

A second twist gear shaft;

the second twisting gear is sleeved on the second twisting gear shaft and is detachably meshed with the first twisting gear;

The second twisting gear shaft bearing is arranged between the second twisting gear shaft and the second twisting gear;

The second twisting gear limiting piece is respectively arranged at two ends of the second twisting gear shaft and fixedly connected with the second twisting gear shaft, one side of the second twisting gear limiting piece is inserted into the shell, the other side of the second twisting gear limiting piece extends out of the shell and supports the second twisting gear outside the shell, and

The second twisting gear reset elastic piece is arranged between the second twisting gear limiting piece and the shell and separates the second twisting gear from the first twisting gear.

In one embodiment, the spindle drive module includes:

The mandrel connecting piece is sleeved outside the mandrel and fixedly connected with the mandrel;

The coupler is characterized in that the far end of the coupler is fixedly connected with the mandrel connecting piece, and the near end of the coupler is fixedly connected with the driving motor;

the clutch is arranged at the far end of the mandrel connecting piece and sleeved outside the mandrel, is connected with the mandrel connecting piece in a synchronous rotation way and is detachably connected with the twisting shell connecting piece, and

The clutch reset elastic piece is arranged between the mandrel connecting piece and the clutch;

Optionally, the mandrel driving module further includes a mandrel connector bearing, where the mandrel connector bearing is sleeved on the proximal end of the mandrel connector and rotatably supports the mandrel connector in the housing;

optionally, the mandrel drive module further comprises:

The brake assemblies are arranged on two sides of the coupler in pairs and used for braking the coupler;

optionally, the brake assembly includes:

The brake piece sliding block is arranged outside the shell;

the braking piece is arranged on the inner side of the braking piece sliding block, the large end of the braking piece extends out of the shell and is in sliding connection with the braking piece sliding block, the small end of the braking piece is inserted into the shell and is matched with the outer wall of the coupler, and

The pair of brake piece reset elastic pieces are arranged between the brake piece and the shell, one ends of the pair of brake piece reset elastic pieces are inserted into corresponding mounting holes of the brake piece, and the other ends of the pair of brake piece reset elastic pieces are inserted into corresponding mounting holes of the shell;

optionally, the brake piece sliding block is provided with a wedge-shaped bottom surface, the large end of the brake piece is provided with a limit groove, and the wedge-shaped bottom surface and two side surfaces of the brake piece sliding block are respectively contacted with the arc-shaped top surface and the two side surfaces of the limit groove;

optionally, the mandrel drive module further comprises:

A clutch shifting ring which is arranged outside the shell in a sliding sleeve manner and is provided with a clutch shifting fork mounting hole along the radial direction, and

The clutch shifting fork is arranged in the clutch shifting fork mounting hole and penetrates through the shell to be matched with the clutch, so that the clutch can be driven to move by operating the clutch shifting ring, and the clutch is separated from or connected with the twisting shell connecting piece;

Optionally, the clutch shifting ring comprises a first clutch shifting ring and a second clutch shifting ring, and the first clutch shifting ring and the second clutch shifting ring are oppositely arranged to form the annular clutch shifting ring.

Optionally, the driving control mechanism further includes:

The protective sleeve driving module is sleeved at the proximal end of the protective sleeve and is in transmission connection with the proximal end of the protective sleeve, and the protective sleeve driving module drives the protective sleeve to move;

the protective sleeve driving module comprises a protective sleeve sliding block, a protective sleeve sliding block bearing and a protective sleeve sliding block end cover, wherein the protective sleeve sliding block is sleeved at the proximal end of the protective sleeve and is fixedly connected with the protective sleeve;

optionally, the protective sleeve driving module includes at least two protective sleeve slide bearings, and the at least two protective sleeve slide bearings are embedded in the protective sleeve slide proximal ring groove and make the distal end surface of the protective sleeve slide bearing far away from the protective sleeve slide end cover contact with the proximal end surface of the protective sleeve;

Optionally, the protective sleeve slider is provided with a protective sleeve slider locking member, and the protective sleeve slider locking member cooperates with a corresponding structure at a different position of the housing to lock the protective sleeve slider at a different position of the housing.

The scheme of the invention at least comprises the following beneficial effects:

The left ventricle auxiliary device comprises a driving control mechanism, a transmission shaft and a miniature pump head, wherein the driving control mechanism comprises a twisting shell driving module and a mandrel driving module, the transmission shaft comprises a mandrel and a twisting shell movably sleeved outside the mandrel, the miniature pump head comprises a pump head impeller and a pump head transmission assembly, the proximal end of the pump head impeller is in transmission connection with the twisting shell driving module through the twisting shell, the distal end of the pump head transmission assembly is fixedly connected with the distal end of the pump head impeller, the proximal end of the pump head transmission assembly is in transmission connection with the mandrel driving module through the mandrel, the mandrel and the twisting shell are driven by the mandrel driving module to synchronously rotate so as to drive the distal end and the proximal end of the pump head impeller to rotate together so as to enable the pump head impeller to rotate with a fixed outer diameter, the twisting shell and the mandrel are driven by the twisting shell driving module to relatively rotate so as to drive the proximal end of the pump head impeller to fold or unfold, and fold the pump head impeller in the miniature pump head of the miniature pump head auxiliary device can be achieved through the mutual matching of the driving control mechanism, the transmission shaft and the miniature pump head, so that the outer diameter of the pump head impeller in the miniature pump head can be adjusted, and the auxiliary device can be used more effectively.

Drawings

FIG. 1 is a schematic view of the overall structure of a left ventricular assist device according to an embodiment of the present invention;

FIG. 2 is a schematic perspective view of a drive shaft according to an alternative embodiment of the present invention;

FIG. 3 is a front cross-sectional view of FIG. 2;

Fig. 4 is a schematic perspective view of a protective sleeve according to an alternative embodiment of the present invention;

FIG. 5 is a schematic perspective view of a twist shell according to an alternative embodiment of the present invention;

FIG. 6 is a schematic perspective view of a mandrel according to an alternative embodiment of the present invention;

FIG. 7 is a schematic diagram of the overall structure of a pressure sensor according to an alternative embodiment of the present invention;

FIG. 8 is a schematic view of the installation of an optical fiber and a housing in a pressure sensor according to an alternative embodiment of the present invention;

FIG. 9 is a schematic cross-sectional view of an alternative embodiment of a micropump head coupled to a driving shaft;

FIG. 10 is a schematic perspective view of an alternative embodiment of the pump head impeller according to the present invention when deployed (normal);

FIG. 11 is an exploded view of FIG. 10;

FIG. 12 is a schematic view of a perspective structure of an impeller skeleton according to an alternative embodiment of the present invention when the impeller skeleton is unfolded (normal state);

FIG. 13 is a schematic perspective view of a vane face of an impeller in accordance with an alternative embodiment of the present invention;

FIG. 14 is a schematic perspective view of an alternative embodiment of the impeller skeleton according to the present invention;

FIG. 15 is a schematic view of a foldable impeller provided in an alternative embodiment of the present invention, which is normally rotationally twisted in the direction shown;

FIG. 16 is a schematic view of the collapsible impeller of FIG. 15 in a folded condition after rotational twisting;

FIG. 17 is a schematic perspective view of a pump head drive assembly according to an alternative embodiment of the present invention;

FIG. 18 is an exploded view of FIG. 17;

FIG. 19 is a schematic perspective view of a pump head protection assembly according to an alternative embodiment of the present invention;

FIG. 20 is an exploded view of FIG. 19;

FIG. 21 is a front cross-sectional view of a drive control mechanism provided in an alternative embodiment of the present invention;

FIG. 22 is a schematic perspective view of a housing according to an alternative embodiment of the present invention;

FIG. 23 is a schematic view illustrating the assembly of a first housing with a clutch fork according to an alternative embodiment of the present invention;

FIG. 24 is a schematic view of an alternative embodiment of the present invention for assembling a second housing with a clutch fork;

FIG. 25 is an exploded view of FIG. 22;

Fig. 26 is a schematic perspective view of a protective casing driving module according to an alternative embodiment of the present invention;

FIG. 27 is an exploded view of FIG. 26;

FIG. 28 is a schematic perspective view of a twist shell drive module according to an alternative embodiment of the present invention;

FIG. 29 is a schematic perspective view of a second gear set provided in an alternative embodiment of the invention;

FIG. 30 is an exploded view of FIG. 29;

FIG. 31 is a front cross-sectional view of FIG. 29;

FIG. 32 is an exploded view of a portion of the components of the twist housing drive module of FIG. 28;

FIG. 33 is a schematic perspective view of a spindle drive module according to an alternative embodiment of the present invention;

FIG. 34 is an exploded view of FIG. 33;

FIG. 35 is an exploded view of a clutch collar provided in an alternative embodiment of the present invention;

FIG. 36 is an exploded view of a brake assembly provided in an alternative embodiment of the present invention;

FIG. 37 is a front cross-sectional view of a brake assembly provided in an alternative embodiment of the present invention;

FIG. 38 is a schematic cross-sectional view of a brake assembly assembled with a first housing in accordance with an alternative embodiment of the present invention;

FIG. 39 is a schematic cross-sectional view of an alternative embodiment of the present invention providing a brake assembly assembled with a second housing;

FIG. 40 is a schematic illustration of the assembly of a clutch and spindle connection provided by an alternative embodiment of the present invention;

FIG. 41 is a schematic view of the clutch and twist shell connection provided by an alternative embodiment of the present invention;

FIG. 42 is a schematic diagram illustrating a flow chart of a left ventricular assist device according to an alternative embodiment of the present invention;

FIG. 43 is a schematic view of the connection of the drive control mechanism to the drive shaft and the micropump in an alternative embodiment of the present invention when the pump impeller is in an expanded state;

FIG. 44 is a schematic view of a distally sliding detent slider provided by an alternative embodiment of the present invention;

FIG. 45 is a schematic illustration of a rotating clutch dial in the direction shown in the drawings provided by an alternative embodiment of the present invention;

FIG. 46 is a schematic illustration of a proximally-sliding clutch collar provided in accordance with an alternative embodiment of the present invention;

FIG. 47 is a schematic illustration of a rotating clutch dial in the direction shown in the drawings provided by an alternative embodiment of the present invention;

FIG. 48 is a schematic illustration of a second gear set being pushed inboard of the drive control mechanism provided by an alternative embodiment of the present invention;

FIG. 49 is a schematic view of a second twist gear rotated in the direction shown in the drawings provided by an alternative embodiment of the present invention;

fig. 50 is a schematic view of a proximally sliding sheath slider provided in accordance with an alternative embodiment of the present invention.

Reference numerals illustrate 1, left ventricular assist device;

2. the micro pump head comprises a micro pump head body, a pump head protection assembly, a top sleeve tip, an anchor support, 2121 an anchor support skeleton, 2122 an anchor support membrane, 213 a support protective sleeve connecting ring;

22. Pump head impeller, 221, foldable impeller, 2211, impeller skeleton, 2212, impeller blade surface, 22111, far-end fixing ring, 22112, impeller skeleton wire, 22113, near-end fixing ring, 222, twisting connecting piece;

23. Pump head transmission assembly, 231, top sleeve, 232, top shaft sleeve, 233, top shaft bearing, 234, top sleeve ring, 235, top shaft, 236, mandrel sleeve, 237, mandrel sleeve ring;

3. Transmission shaft, 31, protective sleeve, 311, optical fiber hole, 312, far end notch, 313, near end notch, 32, twisting shell, 321, twisting connector installation notch, 322, twisting shell micropump head connection section, 323, twisting shell flexible section, 324, twisting shell driving control mechanism connection section, 33, mandrel, 34, optical fiber pressure sensor;

4. drive control mechanism, 40, housing, 401, first housing, 4011, first projection, 4012, second projection, 4013, third projection, 4014, first fiber groove, 402, second housing, 4021, fourth projection, 4022, fifth projection, 4023, sixth projection, 4024, second fiber groove, 403, distal end cap, 404, proximal end cap, 405, brake assembly cap, 406, second gear set cap;

41. The device comprises a protective sleeve driving module, 411, a protective sleeve sliding block, 4111, a protective sleeve sliding block locking piece, 412, a protective sleeve sliding block bearing, 413 and a protective sleeve sliding block end cover;

42. Twisting shell driving module 421, second gear group, 4211, second twisting gear limit part, 4212, second twisting gear shaft bearing, 4213, second twisting gear, 4214, second twisting gear shaft, 4215, second twisting gear reset elastic part, 422, twisting shell shaft sleeve bearing, 423, twisting shell shaft sleeve, 424, first twisting gear shaft bearing, 425, first twisting gear, 426, first twisting gear shaft, 427, twisting shell connecting piece bearing, 428, twisting shell connecting piece;

43. The device comprises a mandrel driving module, 431, a clutch shifting fork, 432, a clutch shifting ring, 4321, a first clutch shifting ring, 4322, a second clutch shifting ring, 4323, a clutch shifting fork mounting hole, 433, a clutch, 434, a clutch reset elastic piece, 435, a mandrel connecting piece, 436, a mandrel connecting piece bearing, 437, a coupling, 438, a brake component, 4381, a brake piece sliding block, 43811, a seventh bulge, 43812, a wedge-shaped bottom surface, 4382, a brake piece, 43821, a limiting groove, 4383, a brake piece reset elastic piece, 439, a motor flange plate, 4310 and a driving motor;

5. the pressure sensor, the optical fiber, the 511, the pressure monitoring optical fiber, the 512, the signal transmission optical fiber, the 52, the fiber grating demodulator;

6. A conduit;

A. proximal end, distal end.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below 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 embodied 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.

In the following description, for the purposes of explanation of various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. One skilled in the relevant art will recognize, however, that an embodiment may be practiced without one or more of the specific details. In other instances, well-known devices, structures, and techniques associated with the present application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

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

In the following description, for the purposes of clarity of presentation of the structure and manner of operation of the present invention, the description will be made with the aid of directional terms, but such terms as "forward," "rearward," "left," "right," "outward," "inner," "outward," "inward," "upper," "lower," etc. are to be construed as convenience, and are not to be limiting.

As shown in fig. 1 to 18, an embodiment of the present invention proposes a left ventricle auxiliary device 1, which comprises a driving control mechanism 4, a transmission shaft 3 and a micro pump head 2, wherein the driving control mechanism 4 is used for providing driving force for the operation of the micro pump head 2 and comprises a twisting shell driving module 42 and a mandrel driving module 43, the transmission shaft 3 is used for transmitting the driving force provided by the driving control mechanism 4 and comprises a twisting shell 32 and a mandrel 33, the micro pump head 2 comprises a pump head impeller 22 and a pump head transmission assembly 23, wherein the pump head transmission assembly 23 penetrates through the pump head impeller 22, a proximal end of the pump head impeller 22 is in transmission connection with the twisting shell driving module 42 through the twisting shell 32, a distal end of the pump head transmission assembly 23 is fixedly connected with a distal end of the pump head impeller 22, and a proximal end of the pump head transmission assembly 23 is in transmission connection with the mandrel driving module 43 through the mandrel 33. The mandrel 33 and the twisting shell 32 are driven to rotate synchronously through the mandrel driving module 43 so as to drive the distal end and the proximal end of the pump head impeller 22 to rotate together, so that the pump head impeller 22 rotates with a fixed outer diameter, and the twisting shell 32 and the mandrel 33 are driven to rotate relatively through the twisting shell driving module 42 so as to drive the proximal end and the distal end of the pump head impeller 22 to rotate relatively, so that the pump head impeller 22 is folded or unfolded.

In this embodiment, the driving control mechanism 4 is used as a driving control module in the whole left ventricle auxiliary device 1, and is in driving connection with the micro pump head 2 through the transmission shaft 3, when the distal end of the mandrel driving module 43 is connected with the proximal end of the twisting shell driving module 42, the mandrel driving module 43 drives the mandrel 33 to rotate and drives the twisting shell driving module 42 to synchronously rotate, and the twisting shell driving module 42 further drives the twisting shell 32 to rotate, so that synchronous rotation of the twisting shell 32 and the mandrel 33 is realized, and further drives the pump head impeller 22 to integrally rotate at a fixed outer diameter (synchronous rotation herein means rotation at the same angular speed). When the distal end of the mandrel driving module 43 is separated from the proximal end of the twisting shell driving module 42, the twisting shell driving module 42 drives the twisting shell 32 to rotate relative to the mandrel 33 (the mandrel driving module 43 stops running at this time, the mandrel 33 is fixed), and when the twisting shell 32 rotates relative to the mandrel 33, the proximal end of the pump head impeller 22 can be driven to rotate relative to the distal end, and the pump head impeller 22 can be unfolded or folded by rotating the proximal end of the pump head impeller 22 relative to the distal end, so as to change the outer diameter of the pump head impeller 22.

By controlling the folding or unfolding of the pump head impeller 22 in the micro pump head 2 (the overall outer diameter is reduced when the pump head impeller 22 is folded, and the overall outer diameter is far greater than the outer diameter when the pump head impeller 22 is folded) the micro pump head 2 is beneficial to realizing the purpose that the micro pump head 2 is implanted at a designated position in a human body through minimally invasive intervention operation in a folded state, and then the pump head impeller 22 can be deformed and unfolded in the human body into a spiral shape with a larger outer diameter, so that the left ventricle auxiliary device 1 has the capability of providing sufficient auxiliary blood flow for a patient at a low rotating speed, and further the blood supply efficiency and the use safety of the left ventricle auxiliary device 1 are improved. The pump head impeller 22 with adjustable outer diameter also helps to reduce the resistance of the entire micropump head 2 when entering and passing through the catheter, and is more beneficial to achieve rapid and safe deployment and recovery of the left ventricular assist device 1.

Here, the transmission shaft 3 is used as a connecting piece between the driving control mechanism 4 and the micro pump head 2 in the whole left ventricle auxiliary device 1, so that the driving control of the micro pump head 2 entering the far end of the auxiliary device in the patient body by the driving control mechanism 4 at the near end of the auxiliary device can be realized outside the patient body, the driving control mechanism 4 can be prevented from entering the patient body along with the micro pump head 2, the size of an intervention wound is reduced, the damage to the patient possibly caused by heat generated by a motor in the driving control mechanism 4 can be avoided, and meanwhile, the driving control mechanism 4 can be repeatedly used outside the patient body, so that the use cost of the whole left ventricle auxiliary device 1 is reduced.

Preferably, the distal end of the mandrel 33 is adhered to the proximal end of the pump head transmission assembly 23, the distal end of the twisting shell 32 is adhered to the proximal end of the pump head impeller 22 (the distal end of the pump head impeller 22 is adhered to the distal end of the pump head transmission assembly 23), and more preferably, the adhesion is achieved by using biocompatible glue to avoid injury to human body.

The mandrel 33 and the twisting shell 32 are both cylinders, the twisting shell 32 is an annular cylinder, and the inner diameter of the annular cylinder is matched with the outer diameter of the mandrel 33 so as to be sleeved outside the mandrel 33, wherein the length of the mandrel 33 is longer than that of the twisting shell 32, and the length of the mandrel 33 and the length of the twisting shell 32 can be set according to practical requirements in application.

Preferably, the mandrel 33 may be made of plastic-coated steel wire rope and the twist shell 32 may be made of multi-strand double-layer synchronous torque spring tube.

In an alternative embodiment of the present invention, as shown in fig. 5, the twist shell 32 may include a twist shell micro pump head connection section 322, a twist shell flexible section 323, and a twist shell drive control mechanism connection section 324. The twisting shell flexible section 323 is fixedly connected with the twisting shell micro pump head connecting section 322 and the twisting shell driving control mechanism connecting section 324 through welding respectively, wherein the far end of the twisting shell micro pump head connecting section 322 is fixedly connected with the near end of the pump head impeller 22, and the near end of the twisting shell driving control mechanism connecting section 324 is in transmission connection with the twisting shell driving module 42. Here, the twisting shell flexible section 323 may be integrally formed of a multi-strand double-layer synchronous torque spring tube to ensure flexibility of the entire drive shaft 3 during use.

Preferably, the distal end of the twisting shell micro-pump head connecting section 322 is provided with a twisting connector mounting notch 321 adapted to the proximal end of the pump head impeller 22, when the pump head impeller 22 and the twisting shell 32 are assembled, the twisting connector mounting notch 321 at the distal end of the twisting shell 32 is clamped with the twisting shell connecting notch at the proximal end of the pump head impeller 22, so as to realize stable transmission of torque between the twisting shell 32 and the pump head impeller 22, more preferably, the twisting shell micro-pump head connecting section can be bonded by using biocompatible glue at the clamping position, and injury to human body can be avoided while stable connection of the twisting shell micro-pump head impeller and the pump head impeller is improved.

As shown in fig. 2 to 4, in an alternative embodiment of the present invention, the transmission shaft 3 may further include a protective sleeve 31, where the protective sleeve 31 is movably sleeved outside the twisting shell 32, a proximal end of the protective sleeve 31 is in driving connection with the protective sleeve driving module 41, a distal end of the protective sleeve 31 is fixedly connected with a proximal end of the pump head protection assembly 21, and the protective sleeve 31 is controlled by the protective sleeve driving module 41 to slide on the twisting shell 32 so as to control the outer diameter of the pump head protection assembly 21.

In this embodiment, the protective sleeve 31 is used as a protective layer between the mandrel 33 and the twisting shell 32, is an annular cylinder, is sleeved outside the twisting shell 32, and has an inner diameter slightly larger than an outer diameter of the twisting shell 32, so that the protective sleeve 31 is sleeved outside the twisting shell 32, and is filled with a lubricating liquid between the protective sleeve 31 and the twisting shell 32, thereby reducing heat generated by the transmission shaft 3 in the operation process, wherein the twisting shell 32 is slightly longer than the protective sleeve 31, and the lengths of the protective sleeve and the twisting shell can be set according to practical requirements in application. Preferably, the protecting sleeve 31 can be made of medical Pebax tube, but is not limited to medical Pebax tube, and other suitable materials harmless to human body can be selected, and preferably, the distal end of the protecting sleeve 31 and the proximal end of the pump head protecting assembly 21 can be fixedly bonded through biocompatible glue so as to avoid injury to human body.

In an alternative embodiment of the invention, as shown in fig. 7 to 8, the left ventricular assist device 1 may further comprise a pressure sensor 5, the pressure sensor 5 comprising an optical fiber 51 and a fiber grating demodulator 52, the optical fiber 51 being communicatively connected to the fiber grating demodulator 52 by a threaded connector. The protective sleeve 31 is provided with an optical fiber hole 311, and the optical fiber 51 is arranged in the optical fiber hole 311 in a penetrating way. When the left ventricular assist device 1 is used, a part of the pressure sensor 5 enters the patient along with the micropump head 2, so that the blood flow pressure data of the patient can be acquired in real time to accurately capture the blood flow pressure change.

In an alternative embodiment of the present invention, the distal end and the proximal end of the protective sheath 31 are respectively provided with a distal notch 312 and a proximal notch 313 for facilitating assembly and fixing of the optical fiber 51, preferably, the distal notch 312 is provided on a side wall of the distal end of the protective sheath 31 and extends in the axial direction, and the proximal notch 313 is provided on a side wall of the proximal end of the protective sheath and is located in the extending direction of the distal notch 312, and the distal end of the optical fiber 51 is penetrated into the optical fiber hole 311 from the proximal notch 313 of the protective sheath 31 and is penetrated out from the distal notch 312 of the protective sheath 31.

As shown in fig. 7, the fiber grating demodulator 52 is fixed to the drive control mechanism 4 and is communicatively connected to the controller module of the left ventricular assist device 1. The distal end of the optical fiber 51 sequentially passes through the optical fiber groove of the drive control mechanism 4 and the optical fiber hole 311 of the protective sleeve 31, so that the whole optical fiber 51 is laid in the first optical fiber groove 4014, the second optical fiber groove 4024 and the optical fiber hole 311 of the protective sleeve 31 of the drive control mechanism 4, and the proximal end of the optical fiber 51 is in communication connection with the fiber grating demodulator 52 through a threaded connector.

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, where a proximal end of the signal transmission optical fiber 512 is communicatively connected to the fiber grating demodulator 52 through a threaded connector.

In this embodiment, the pressure monitoring fiber 511 is a fiber inscription for monitoring blood flow pressure data in the patient in real time. The signal transmission optical fiber 512 is an optical fiber non-writing section, and the proximal end of the signal transmission optical fiber 512 is in communication connection with the fiber grating demodulator 52 through a threaded connector, so as to transmit the blood flow pressure data monitored by the pressure monitoring optical fiber 511 to the fiber grating demodulator 52 in real time. The pressure monitoring fiber 511 is laid close to the micro pump head 2 and enters the patient body together with the micro pump head 2 when the auxiliary device is used, so that the real-time monitoring is facilitated.

When the optical fiber 51 is laid, the pressure monitoring optical fiber 511 penetrates into the optical fiber hole 311 from the proximal slot 313 of the protective sleeve 31 and penetrates out from the distal slot 312 of the protective sleeve 31, and meanwhile, when the pressure monitoring optical fiber 511 is ensured to completely penetrate out of the optical fiber hole 311 and is just placed in the distal slot 312, the signal transmission optical fiber 512 is bonded and fixed with the optical fiber hole 311 so as to avoid falling off during use, further, the real-time monitoring of blood pressure is realized and the accuracy of monitoring is improved, and preferably, the signal transmission optical fiber 512 and the optical fiber hole 311 can be bonded and fixed by using biocompatible glue so as to avoid injury to human bodies.

As shown in fig. 10 to 11, in an alternative embodiment of the present invention, the pump head impeller 22 includes a foldable impeller 221 and a twisting connection piece 222, wherein a distal end of the foldable impeller 221 is fixedly connected with the mandrel 33 through the pump head transmission assembly 23, a proximal end of the foldable impeller 221 is clamped with a distal end of the twisting connection piece 222, and a proximal end of the twisting connection piece 222 is fixedly connected with the twisting shell 32.

In this embodiment, the proximal end of the foldable impeller 221 is fixedly clamped to the distal end of the twisting connector 222, and is fixedly connected to the distal end of the twisting shell 32 through the proximal end of the twisting connector 222, and the proximal end of the twisting shell 32 is in driving connection with the twisting shell driving module 42 in the driving control mechanism 4. The twisting shell 32 is driven to rotate by the twisting shell driving module 42, the twisting shell 32 rotates to drive the twisting shell connecting piece 222 to rotate, and the proximal end of the foldable impeller 221 is driven to rotate by the twisting shell connecting piece 222. Because the distal end of the foldable impeller 221 is fixedly connected with the distal end of the mandrel 33 through the pump head transmission assembly 23, the proximal end of the mandrel 33 is in transmission connection with the mandrel driving module 43 in the driving control mechanism 4, the mandrel 33 is driven to rotate through the mandrel driving module 43, the mandrel 33 rotates to drive the pump head transmission assembly 23 to rotate, and the pump head transmission assembly 23 drives the distal end of the foldable impeller 221 to rotate.

When the mandrel 33 rotates in synchronization with the twisting housing 32, the distal end and the proximal end of the collapsible impeller 221 rotate in synchronization, so that the pump head impeller 22 as a whole rotates with a fixed outer diameter size. When the twisting housing 32 is rotated relative to the mandrel 33, the proximal end of the collapsible impeller 221 is rotated relative to the distal end, and the collapsible impeller 221 expands or collapses as the proximal end is rotated relative to the distal end to change the outer diameter of the overall pump head impeller 22 (increasing the outer diameter when expanded and decreasing the outer diameter when collapsed).

Optionally, the twisting connector 222 is provided with a spindle hole through which the spindle 33 passes, so that the distal end of the spindle 33 passes through the twisting connector 222 and is fixedly connected with the distal end of the foldable impeller 221 through the pump head transmission assembly 23.

As shown in fig. 12 to 13, in an alternative embodiment of the present invention, the foldable impeller 221 includes an impeller skeleton 2211 and impeller blades 2212, the proximal end of the impeller skeleton 2211 is fixedly connected with the twisting shell 32 through the twisting connecting piece 222, the distal end of the impeller skeleton 2211 is fixedly connected with the mandrel 33 through the pump head transmission assembly 23, and the impeller blades 2212 are coated outside the impeller skeleton 2211.

In this embodiment, the impeller skeleton 2211 can be twisted and folded or twisted and unfolded integrally, the impeller blade surface 2212 is coated outside the impeller skeleton 2211, and the distal end and the proximal end of the impeller blade surface 2212 are respectively adhered and fixed on the distal end and the proximal end of the impeller skeleton 2211, so as to ensure that the impeller blade surface 2212 cannot fall off in the folding and unfolding process and the auxiliary blood supply process.

Preferably, the impeller blade surface 2212 can be prepared by using a super-elastic medical silica gel material with biocompatibility, on one hand, the damage to human body and blood cells caused by the pump head impeller 22 in the using process can be reduced, on the other hand, the pump head impeller 22 has high folding ratio deformability (when the impeller skeleton 2211 is twisted and unfolded, the impeller blade surface 2212 can be jacked outwards by the impeller skeleton 2211 to form a spiral impeller and increase the outer diameter of the integral pump head impeller 22, and when the impeller skeleton 2211 is twisted and folded, the impeller blade surface 2212 can shrink inwards to be cylindrical and reduce the outer diameter of the integral pump head impeller 22), preferably, the medical silica gel material can be prepared by stirring and solidifying the Dragon Skin silicone with the mass ratio of 2:1 and SLIC THINNER thinner at normal temperature, and has good elastic deformability, 100% Young modulus of 21.75kPa, the maximum strain which can be reached is 1328.2% and the maximum stress which can be born is 675.3kPa, so as to meet the requirements of the whole micro pump head 2 in the using process.

Optionally, the impeller skeleton 2211 includes a proximal fixation ring 22113, a distal fixation ring 22111, and an impeller skeleton wire 22112. The proximal end of proximal fixation ring 22113 is fixedly coupled to twist housing 32 by twist coupler 222. The distal fixation ring 22111 is fixedly connected to the mandrel 33 by the pump head transmission assembly 23. The impeller skeleton wire 22112 is spirally arranged between the proximal end fixing ring 22113 and the distal end fixing ring 22111.

In this embodiment, the proximal fixation ring 22113 and the distal fixation ring 22111 are both annular cylinders, and the outer diameters of the proximal fixation ring 22113 and the distal fixation ring 22111 may be set according to the inner diameter of the medical catheter in use. Preferably, the outer diameter of the proximal fixation ring 22113 is equal to the outer diameter of the distal fixation ring 22111 and is slightly smaller than the inner diameter of the medical catheter. The proximal end fixing ring 22113 and the distal end fixing ring 22111 can ensure that the foldable impeller 221 is cylindrical in shape in the folded state, and the outer diameter of the foldable impeller 221 in the folded state is smaller than the inner diameter of the medical catheter, so that the foldable impeller 221 can be implanted into a proper position through a human body vessel by minimally invasive interventional operation.

Here, the distal fixation ring 22111, the proximal fixation ring 22113, and the impeller skeleton wire 22112 may be prepared in an integrally formed manner by metal 3D printing, and the impeller skeleton 2211 is obtained. The distal fixation ring 22111, the proximal fixation ring 22113, and the impeller skeleton wire 22112 may also be prepared by femtosecond laser cutting a nickel-titanium alloy tube, and the impeller skeleton 2211 is obtained.

The impeller skeleton wires 22112 arranged between the proximal end fixing ring 22113 and the distal end fixing ring 22111 are multiple, and the impeller skeleton wires 22112 are connected between the proximal end fixing ring 22113 and the distal end fixing ring 22111 in parallel along the same spiral direction. Preferably, the plurality of impeller skeleton wires 22112 can be assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 in a form-locking manner by inserting the proximal assembling hole of the distal fixing ring 22111 and the distal assembling hole of the proximal fixing ring 22113, and more preferably, biocompatible glue can be applied at the assembling place for bonding and fixing.

In one embodiment, the impeller skeleton wire 22112 is made of a super elastic material with a certain rigidity, preferably, the elastic material is a super elastic nickel-titanium metal material with a certain rigidity, and the impeller skeleton wire 22112 can be prepared by heat-treating nickel-titanium metal wires through a die. The impeller skeleton wire 22112 made of the super-elastic nickel-titanium metal material can provide certain rigidity for the unfolded foldable impeller 221, and ensures the stability of the foldable impeller 221 in the rotating process.

In the deployed state (normal state), the impeller skeleton wire 22112 is in a spiral shape, preferably in a less-periodic spiral shape, for example, a single-periodic spiral or a double-periodic spiral, and the outer edge of the spiral extends outwards. When the foldable impeller 221 is in the unfolded state and the proximal end fixing ring 22113 rotates along the spiral direction relative to the distal end fixing ring 22111, the spiral period of the impeller skeleton wire 22112 is increased, the impeller skeleton wire 22112 is further twisted and folded, so that the spiral outer edge is retracted inwards, and the outer diameter of the foldable impeller 221 is reduced.

Here, the foldable impeller 221 may be prepared by twisting and pre-tightening the impeller skeleton 2211 in the unfolded state (as shown in fig. 12) to the folded state (as shown in fig. 14), and sleeving the impeller blade surface 2212 to the surface of the impeller skeleton 2211, to obtain the foldable impeller 221 in the folded state as shown in fig. 16. According to the rotation direction shown in fig. 16, the pretightening force is released, so that the impeller skeleton wire 22112 is recovered to at least a periodical spiral shape under the elastic action, the spiral outer edge extends outwards, the outer diameter of the foldable impeller 221 is increased, and the foldable impeller 221 shown in fig. 15 can be obtained. Conversely, twisting in the direction of rotation as shown in fig. 15 results in the foldable impeller 221 in the folded state as shown in fig. 16.

In an embodiment of the present invention, a plurality of rotation limiting bosses may be disposed at the distal end of the twisting connecting piece 222, and a plurality of limiting grooves are correspondingly disposed at the proximal outer edge of the proximal fixing ring 22113, so that the twisting connecting piece 222 and the proximal fixing ring 22113 perform rotation limiting through the insertion fit of the rotation limiting bosses and the limiting grooves. The rotation limiting boss and limiting groove assembly connection between the twisting connecting piece 222 and the proximal end fixing ring 22113 can better transmit twisting torque to the foldable impeller 221 through the twisting connecting piece 222 so as to realize one-step twisting folding of the foldable impeller 221.

In one example of the present invention, the distal and proximal ends of the impeller blade 2212 are respectively coated outside the distal and proximal fixing rings 22111 and 22113, and are jacked outwards by the impeller skeleton wire 22112 to form an impeller. Here, the impeller blade surface 2212, the distal end fixing ring 22111 and the proximal end fixing ring 22113 can be respectively bonded by biocompatible glue, so that the impeller blade surface 2212 is ensured not to fall off in the folding and unfolding process and the auxiliary blood supply process, and meanwhile, the biocompatible glue can also avoid damaging human bodies.

As shown in fig. 17-18, in an alternative embodiment of the present invention, the pump head transmission assembly 23 includes a core sleeve 236, a top shaft 235, a top shaft bearing 233, a top shaft sleeve 232, and a top sleeve 231. The core sleeve 236 penetrates through the impeller skeleton 2211, the distal end of the core sleeve 236 is fixedly connected with the distal end fixing ring 22111, and the proximal end of the core sleeve 236 is sleeved in the proximal end fixing ring 22113 and is fixedly connected with the core shaft 33. The proximal end of the top shaft 235 is fixedly embedded into the distal end of the core shaft sleeve 236, the top shaft bearing 233 is sleeved on the distal end of the top shaft 235, and the proximal end face of the top shaft bearing 233 is contacted with the distal end face of the core shaft sleeve 236. The top shaft sleeve 232 is fixedly sleeved on the distal end of the top shaft 235, and the inner edge of the top shaft bearing 233 is limited between the distal end face of the core shaft sleeve 236 and the proximal end face of the top shaft sleeve 232. The proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235, and the proximal end of the top sleeve 231 is provided with a ring groove matched with the top shaft bearing 233.

In this embodiment, the core sleeve 236 passes through the proximal fixing ring 22113 and the distal fixing ring 22111, and the distal end of the core sleeve 236 is fixedly connected to the distal fixing ring 22111, and the core sleeve 236 is sleeved on the transmission shaft 3 at the distal end of the core 33. Preferably, the core sleeve 236 is fixedly sleeved with a core shaft collar 237, the core shaft collar 237 is fixedly sleeved on the proximal end of the core sleeve 236 on the premise that the proximal end face of the core shaft collar 237 is flush with the proximal end face of the core sleeve 236, and the core shaft collar 237 is limited between the proximal end of the proximal end fixing ring 22113 and the distal end of the twisting connecting piece 222. The mandrel sleeve 236 may be adhesively secured to the mandrel collar 237 using biocompatible glue to ensure that the mandrel collar 237 does not fall off the mandrel sleeve 236.

Preferably, the axial positioning of the collapsible impeller 221 may be performed by the distal end face of the mandrel collar 237, on the basis of which the distal fixing ring 22111 may be bonded to the mandrel sleeve 236 by means of biocompatible glue, since the mandrel 33 is inserted and fixed into the mandrel sleeve 236, the mandrel sleeve 236 and the mandrel 33 may be bonded and fixed by means of biocompatible glue 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.

Optionally, the mandrel sleeve 236 is sleeved with a top collar 234, the top collar 234 is sleeved at the distal end of the mandrel sleeve 236, and the distal end face of the top collar 234 is fixedly connected with the proximal end face of the top sleeve 231.

Optionally, the proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235 through a top shaft bearing 233, the top shaft bearing 233 is embedded in a ring groove formed on the proximal end of the top sleeve 231, and the outer edge of the top shaft bearing 233 is limited between the ring groove and the top collar 234. Here, the top shaft sleeve 232 and the top shaft 235 may be adhesively fixed by using biocompatible glue, so as to ensure that the top shaft sleeve 232 does not fall off from the top shaft 235. After the top cover 231 is sleeved outside the top shaft bearing 233, the top cover 231 and the top collar 234 may be adhesively fixed using biocompatible glue while ensuring that the top cover 231 is in contact with the distal end face of the top shaft bearing 233 and that the top collar 234 is in contact with the proximal end face of the top shaft bearing 233.

By fixedly connecting the distal end of the core sleeve 236 to the distal end fixing ring 22111 of the foldable impeller 221, the proximal end of the core sleeve 236 is fixedly connected to the distal end of the spindle 33 (the proximal end of the core sleeve 236 is sleeved outside the distal end of the spindle 33 and is fixedly connected), and the spindle 33 can be driven to rotate by the spindle driving module 43 in the driving control mechanism 4. When the mandrel 33 rotates, the distal end of the foldable impeller 221 and the mandrel 33 are kept to rotate synchronously under the cooperation of the components in the pump head transmission assembly 23. When the twisting shell 32 is driven to rotate by the twisting shell driving module 42 in the driving control mechanism 4, the twisting shell 32 rotates and drives the proximal end of the foldable impeller 221 to rotate synchronously with the twisting shell 32 by the twisting connecting piece 222. When the mandrel 33 and the twisting housing 32 rotate synchronously, the distal end and the proximal end of the foldable impeller 221 keep rotating synchronously, thereby realizing that the foldable impeller 221 rotates in a single direction with a fixed outer diameter as a whole. When the mandrel 33 and the twisting shell 32 rotate relatively, the distal end and the proximal end of the foldable impeller 221 keep rotating relatively, so that the foldable impeller 221 is folded and unfolded, and the outer diameter of the whole foldable impeller 221 is adjusted.

As shown in fig. 19 to 20, in an alternative embodiment of the present invention, the micro pump head 2 may further include a pump head protection assembly 21, where the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22, and a proximal end of the pump head protection assembly 21 is in transmission connection with the protection sleeve driving module 41 through the protection sleeve 31, and a distal end of the pump head protection assembly 21 is fixedly connected with a distal end of the pump head transmission assembly 23.

In this embodiment, the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22 to protect the pump head impeller 22. Here, the proximal end of the pump head protection assembly 21 is fixedly connected to the distal end of the protective sleeve 31, and the distal end of the pump head protection assembly 21 is fixedly connected to the distal end of the pump head transmission assembly 23. Because the protective sleeve 31 is sleeved outside the twisting shell 32, and the proximal end of the protective sleeve 31 is in transmission connection with the protective sleeve driving module 41, when the protective sleeve driving module 41 drives the protective sleeve 31 to slide on the twisting shell 32, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 can be controlled, and the pump head protection assembly 21 is further controlled to be folded or unfolded so as to adjust the outer diameter of the pump head protection assembly 21. Specifically, when the protective sleeve driving module 41 drives the protective sleeve 31 to slide distally, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 is reduced, the outer diameter of the pump head protection assembly 21 is increased, and when the protective sleeve driving module 41 drives the protective sleeve 31 to slide proximally, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 is increased, and the outer diameter of the pump head protection assembly 21 is reduced to match the increase or decrease of the outer diameter of the pump head impeller 22.

Further, the pump head protection assembly 21 may include an anchor bracket 212 and a top sleeve tip 211, wherein a proximal end of the anchor bracket 212 is fixedly connected with a distal end of the protective sleeve 31, and a ring-shaped distal end of the anchor bracket 212 is sleeved and fixed on a 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 with the distal end of the pump head transmission assembly 23.

In this embodiment, the proximal end and the distal end of the anchoring bracket 212 may be annular, the proximal end of the top sleeve tip 211 is fixedly connected with 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, and the proximal end of the top sleeve tip 211 is installed in the top sleeve 231 by inserting and matching the anchoring rod with the anchoring groove. Optionally, the distal end of the tip 211 is configured in a smooth dome shape to facilitate minimally invasive access of the entire micropump head 2 into a patient and to reduce resistance to blood flow through the micropump head 2.

Optionally, the pump head protection assembly 21 may further include a bracket protection sleeve connection ring 213, wherein a distal end of the bracket protection sleeve connection ring 213 is embedded and fixed in the annular proximal end of the anchor bracket 212, and a distal end surface of the bracket protection sleeve connection ring 213 is flush with a distal end surface of the annular proximal end of the anchor bracket 212. In addition, the support protective sleeve connecting ring 213 is slidably sleeved outside the twisting shell 32 and is fixedly connected with the distal end of the protective sleeve 31 of the transmission shaft 3, so as to further strengthen the fixed connection between the distal end of the protective sleeve 31 and the proximal end of the anchoring support 212.

Here, the proximal end of the anchor stent 212 and the stent protective sheath connecting ring 213 may be adhesively fixed using biocompatible glue under the condition that the annular proximal end of the anchor stent 212 is sleeved outside the stent protective sheath connecting ring 213 and the distal end face of the stent protective sheath connecting ring 213 is ensured to be flush with the distal end face of the annular proximal end of the anchor stent 212. The protective sheath 31 is then applied to the proximal end of the stent protective sheath attachment ring 213 and the protective sheath 31 can be sequentially adhesively secured to the stent protective sheath attachment ring 213 and the anchor stent 212 using biocompatible glue while ensuring that the distal end face of the protective sheath 31 contacts the proximal end face of the annular proximal end of the anchor stent 212.

In an alternative embodiment of the present invention, the anchor bracket 212 includes an anchor bracket skeleton 2121 and an anchor bracket membrane 2122, wherein a proximal end of the anchor bracket skeleton 2121 is fixedly connected to a distal end of the protective sheath 31, a distal end of the anchor bracket skeleton 2121 is sleeved and fixed to a distal end of the pump head transmission assembly 23, and the anchor bracket membrane 2122 is sleeved and fixed to an outer portion of the anchor bracket skeleton 2121.

In this embodiment, the anchoring stent framework 2121 provides a certain anchoring supporting force for the whole pump head protection assembly 21, the anchoring stent membrane 2122 is sleeved outside the anchoring stent framework 2121 and can be used for reducing the contact stress between the anchoring stent 212 and the blood vessel, and preferably, the anchoring stent framework 2121 and the anchoring stent membrane 2122 can be bonded and fixed through biocompatible glue. The anchoring stent skeleton 2121 can be prepared by cutting a nickel-titanium alloy tube by laser, the anchoring stent film 2122 can be prepared by reverse molding of a medical silica gel material, preferably the medical silica gel material can be prepared by stirring, blending and heating to solidify at normal temperature by using Dragon Skin silicone and SLIC THINNER diluents in a mass ratio of 2:1, and the medical silica gel material has good elastic deformation capability, 100% Young modulus of the medical silica gel material is 21.75kPa, the maximum strain which can be achieved is 1328.2%, and the maximum stress which can be borne is 675.3kPa, so that the requirement of the whole micro pump head 2 in use can be met.

In an alternative embodiment of the invention, the anchor stent skeleton 2121 comprises an anchor stent skeleton proximal ring, an anchor stent skeleton distal ring, and a plurality of anchor stent skeleton wires juxtaposed between the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring, the anchor stent skeleton wires bending outwardly as the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring approach each other to expand the structure of the pump head protection assembly 21, and the anchor stent skeleton wires tensioning inwardly as the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring move away from each other to collapse the structure of the pump head protection assembly 21.

In this embodiment, the proximal end ring of the anchoring stent framework is embedded with a stent protective sleeve connecting ring 213, and the fixed connection with the protective sleeve 31 is further enhanced by the stent protective sleeve connecting ring 213, and the distal end ring of the anchoring stent framework is sleeved and fixed outside the distal end of the top sleeve 231.

The anchoring stent skeleton wires are arranged in a plurality, are arranged between the distal end ring of the anchoring stent skeleton and the proximal end ring of the anchoring stent skeleton in parallel and form an anchoring stent skeleton 2121 with a cage-shaped structure, and can be outwards bent when the proximal end ring of the anchoring stent skeleton and the distal end ring of the anchoring stent skeleton are mutually close to each other so as to outwards expand the cage-shaped structure, and conversely, can be inwards contracted by stretching the two ends.

The micropump head 2 provided in the embodiment of the present invention needs to be assembled with the distal end of the transmission shaft 3 when being specifically applied to the left ventricle auxiliary device, and the assembly process is specifically as follows:

Step 11, aligning and adhesively fixing the proximal end surfaces of the mandrel sleeve 236 and the mandrel collar 237, then sleeving the foldable impeller 221 to the mandrel sleeve 236, axially positioning the foldable impeller 221 through the distal end surface of the mandrel collar 237, and adhesively fixing the distal end fixing ring 22111 and the mandrel sleeve 236;

step 12, inserting the top shaft 235 into the core shaft sleeve 236 to a specific position and bonding and fixing the two, then sleeving the top sleeve ring 234 to the core shaft sleeve 236, sleeving the top shaft bearing 233 to the top shaft 235, and axially positioning the top shaft bearing 233 by using the distal end of the core shaft sleeve 236, sleeving the top shaft sleeve 232 to the top shaft 235, bonding and fixing the top shaft sleeve 232 and the top shaft 235 on the basis of axially positioning the top shaft sleeve 232 by the distal end of the top shaft bearing 233, sleeving the top sleeve 231 to the top shaft bearing 233, and bonding and fixing the top sleeve 231 and the top sleeve ring 234 under the condition that the top sleeve 231 and the top sleeve ring 234 are contacted with the distal end face and the proximal end face of the top shaft bearing 233 respectively;

step 13, sleeving the annular proximal end of the anchoring bracket 212 to the bracket protective sleeve connecting ring 213, and bonding and fixing the proximal end of the anchoring bracket 212 to the bracket protective sleeve connecting ring 213 under the condition that the distal end face of the bracket protective sleeve connecting ring 213 is flush with the distal end face of the annular proximal end of the anchoring bracket 212, sleeving the protective sleeve 31 to the proximal end of the bracket protective sleeve connecting ring 213, bonding the protective sleeve 31 to the bracket protective sleeve connecting ring 213 and the anchoring bracket 212 in sequence under the condition that the distal end face of the protective sleeve 31 is ensured to be contacted with the proximal end face of the annular proximal end of the anchoring bracket 212;

Step 14, inserting the mandrel 33 into the twisting shell 32, inserting and assembling the distal end of the twisting connector 222 to the proximal end of the proximal end fixing ring 22113, and adhering and fixing the assembled part, then inserting the twisting shell 32 into the protective sleeve 31, sleeving the annular distal end of the anchoring bracket 212 to the distal end of the top sleeve 231, adhering the anchoring bracket 212 to the top sleeve 231, and finally assembling the top sleeve tip 211 to the distal end of the top sleeve 231, wherein the assembly of the transmission shaft 3 and the micropump head 2 is completed;

when the twisting shell 32 and the mandrel 33 rotate relatively, the proximal end of the pump head impeller 22 rotates relatively to the distal end, the foldable impeller 221 can be unfolded or folded, and the outer diameter of the whole pump head impeller 22 is changed (the outer diameter is increased when the impeller is unfolded, and the outer diameter is reduced when the impeller is folded);

When the foldable impeller 221 is folded, the outer diameter of the whole pump head impeller 22 is reduced, the pump head impeller 22 is in a folded state, the matched protective sleeve driving module 41 drives the protective sleeve 31 to slide proximally, so that the structure of the pump head protection assembly 21 is contracted inwards, the whole micro pump head 2 is in the folded state, the whole micro pump head 2 enters a patient in a minimally invasive intervention mode in the folded state, the use safety and convenience can be improved, after the pump head impeller 22 in the folded state enters the patient, the pump head impeller 22 is deformed and unfolded in the body to be in an unfolded state with a larger outer diameter, and the outer diameter of the pump head impeller 22 is far larger than the outer diameter in the folded state, so that the left ventricle auxiliary device 1 can provide sufficient auxiliary blood flow capacity for the patient at a low rotating speed, the blood supply efficiency of the left ventricle auxiliary device 1 is improved, the hemolysis risk is reduced, and meanwhile, the pump head impeller 22 with the adjustable outer diameter and the pump head protection assembly 21 can effectively reduce the resistance of the whole micro pump head 2 when entering and passing through a catheter, and the rapid and safe deployment and recovery of the left ventricle auxiliary device 1 are more facilitated.

As shown in fig. 21 to 24, in an alternative embodiment of the present invention, the drive control mechanism 4 further includes a housing 40 having a cavity structure. Wherein, the twisting shell driving module 42 is arranged in the shell 40, and the distal end of the twisting shell driving module 42 is in transmission connection with the proximal end of the twisting shell 32. The mandrel driving module 43 is disposed in the housing 40 and disposed at the proximal end of the twisting shell driving module 42, the distal end of the mandrel driving module 43 is in transmission connection with the proximal end of the mandrel 33, and the distal end of the mandrel driving module 43 is detachably connected with the proximal end of the twisting shell driving module 42.

When the mandrel driving module 43 is connected with the twisting shell driving module 42, the mandrel driving module 43 drives the mandrel 33 to rotate synchronously with the twisting shell 32 and drives the distal end and the proximal end of the pump head impeller 22 to rotate together, the pump head impeller 22 integrally rotates in a single direction with a fixed outer diameter to realize a blood pumping function, and when the mandrel driving module 43 is separated from the twisting shell driving module 42, the twisting shell driving module 42 drives the twisting shell 32 to rotate relative to the mandrel 33 and drives the proximal end and the distal end of the pump head impeller 22 to rotate relative to the distal end, and the pump head impeller 22 is folded or unfolded, so that the outer diameter of the pump head impeller 22 can be adjusted.

In this embodiment, the twisting shell driving module 42 and the mandrel driving module 43 are sequentially disposed in the housing 40, and the distal end of the mandrel driving module 43 is detachably connected to the proximal end of the twisting shell driving module 42; when the distal end of the mandrel driving module 43 is connected with the proximal end of the twisting shell driving module 42, the mandrel driving module 43 drives the mandrel 33 to rotate and drives the twisting shell driving module 42 to synchronously rotate, the twisting shell driving module 42 further drives the twisting shell 32 to rotate, so that synchronous rotation of the twisting shell 32 and the mandrel 33 is realized, when the twisting shell 32 and the mandrel 33 synchronously rotate, the whole pump impeller 22 can be driven to integrally rotate with a fixed outer diameter, when the distal end of the mandrel driving module 43 is separated from the proximal end of the twisting shell driving module 42, the twisting shell driving module 42 drives the twisting shell 32 to rotate relative to the mandrel 33 (at the moment, the mandrel driving module 43 stops running, the mandrel 53 is fixed), when the twisting shell 32 rotates relative to the mandrel 33, the proximal end of the pump impeller 22 can be driven to rotate relative to the distal end, the pump impeller 22 can be unfolded or folded when the proximal end of the pump impeller 22 rotates relative to the distal end, the miniature pump impeller 2 can be conveniently realized to be implanted to a designated position in a human body through a minimally invasive intervention operation, then the pump impeller 22 can be unfolded into a spiral shape with a larger outer diameter in the human body, so that the left auxiliary device 1 has a sufficient rotating speed and can be rapidly deployed with the auxiliary device for assisting the pump impeller 22 and can be conveniently and rapidly deployed with a small outer diameter and can be more convenient for a patient to realize the improvement of the safety device.

As shown in fig. 26 to 27, in an alternative embodiment of the present invention, the driving control mechanism 4 may further include a protective sleeve driving module 41, where the protective sleeve driving module 41 is sleeved on the proximal end of the protective sleeve 31 and is in transmission connection with the proximal end of the protective sleeve 31, and the protective sleeve 31 is driven to move by the protective sleeve driving module 41. Since the protective sleeve 31 is sleeved outside the twisting shell 32, when the protective sleeve driving module 41 drives the protective sleeve 31 to move on the twisting shell 32, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 can be controlled, and the pump head protection assembly 21 is further controlled to be folded or unfolded so as to adjust the outer diameter of the pump head protection assembly 21 to match with the increase or decrease of the outer diameter of the pump head impeller 22. Specifically, when the protective sleeve driving module 41 drives the protective sleeve 31 to slide distally, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 decreases, the outer diameter of the pump head protection assembly 21 increases, and when the protective sleeve driving module 41 drives the protective sleeve 31 to slide proximally, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases.

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 cover 413, wherein the protective sleeve slider 411 is sleeved on the proximal end of the protective sleeve 31 and is fixedly connected with the protective sleeve 31. The proximal end of the protective sleeve slide 411 is provided with an annular groove matched with the protective sleeve slide bearing 412, the protective sleeve slide bearing 412 is embedded in the annular groove at the proximal end of the protective sleeve slide 411, the outer edge of the protective sleeve slide bearing 412 is limited between the annular groove at the proximal end of the protective sleeve slide 411 and the protective sleeve slide end cover 413, and under the condition that the proximal end face of the protective sleeve 31 is flush with the distal end face of the annular groove arranged at the proximal end of the protective sleeve slide 411, the protective sleeve slide 411 and the protective sleeve 31 can be bonded and fixed by using glue. The protective sleeve slider end cover 413 is disposed at the proximal end of the protective sleeve slider 411 and fixedly connected to the protective sleeve slider 411. The protective sleeve slide 411 and the protective sleeve slide end cover 413 can be prepared by photo-curing 3D printing medical hard resin.

Optionally, the protection casing driving module 41 includes at least two protection casing slider bearings 412, where the at least two protection casing slider bearings 412 are embedded in a protection casing slider 411 proximal end ring groove and make a protection casing slider bearing 412 distal end surface far away from the protection casing slider end cover 413 contact with the protection casing 31 proximal end surface, and at least two protection casing slider bearings 412 outer edges are limited between the protection casing slider 411 proximal end ring groove and the protection casing slider end cover 413, and the protection casing slider end cover 413 is sleeved on the proximal end of the transmission shaft 3, so that in the case that the protection casing slider bearing 412 distal end surface contacts with the protection casing slider 411 ring groove distal end surface and the protection casing slider bearing 412 proximal end surface contacts with the protection casing slider end cover 413 distal end surface, glue may be preferably used to bond and fix the protection casing slider 411 and the protection casing slider end cover 413.

Preferably, the protective sleeve slide 411 is provided with a protective sleeve slide locking member 4111, and the protective sleeve slide locking member 4111 cooperates with corresponding structures at different positions on the housing 40 to lock the protective sleeve slide 411 at different positions on the housing 40, preferably, the protective sleeve slide locking member 4111 is a groove provided on a surface of the protective sleeve slide 411, which will be described in further detail below.

Preferably, a sliding through slot is formed on the housing 40 along the axial direction, and two sides of the protective sleeve slide 411 are slidably disposed in the sliding through slot, so as to realize that the integral protective sleeve slide 411 slides in the housing 40 along the axial direction, and the protective sleeve slide 411 is locked at different positions of the housing 40 by the protective sleeve slide locking member 4111.

As shown in fig. 22 to 25, in an alternative embodiment of the present invention, the housing 40 includes a first housing 401 and a second housing 402 mounted in cooperation with the first housing 401, and the first housing 401 is disposed opposite to the second housing 402 and forms a cavity structure therein.

Optionally, the housing 40 further comprises a distal cap 403, a second gear set cap 406, a brake assembly cap 405, and a proximal cap 404. Distal cap 403 and proximal cap 404 are disposed at the distal and proximal ends of housing 40, respectively, a second gear set cover 406 is disposed outside of the second gear set in twist housing drive module 42, and a brake assembly cover 405 is disposed outside of 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 may all be prepared by injection molding.

Preferably, a boss is arranged on a matching surface of the first shell 401 and the second shell 402, a groove is arranged on a matching surface of the second shell 402 and the first shell 401, and the corresponding position of the boss is provided with a groove, the first shell 401 is assembled on the second shell 402 on the premise that the boss of the matching surface of the first shell 401 is aligned with the groove of the matching surface of the second shell 402, and the first shell 401 and the second shell 402 are fixed by using screws, preferably, the matching surface of the first shell 401 is provided with a first optical fiber groove 4014, the matching surface of the second shell 402 is provided with a second optical fiber groove 4024, as shown in fig. 24, and when the first shell 401 and the second shell 402 are oppositely arranged to form the shell 40 with a cavity structure, the first optical fiber groove 4014 and the second optical fiber groove 4024 are mutually butted to form an optical fiber groove for laying an optical fiber 51.

Preferably, the distal end of the first housing 401 and the distal end of the second housing 402, and the proximal end of the first housing 401 and the proximal end of the second housing 402 are respectively provided with external threads in butt joint with each other, the distal end of the first housing 401 and the distal end of the second housing 402 are screwed and fixed with the distal end cover 403, and the proximal end of the first housing 401 and the proximal end of the second housing 402 are screwed and fixed with the proximal end cover 404, so as to further ensure the connection stability of the first housing 401 and the second housing 402.

More preferably, a first boss 4011, a second boss 4012, a third boss 4013 are provided on an outer wall of the first housing 401, and a fourth boss 4021, a fifth boss 4022, a sixth boss 4023 are provided on an outer wall of the second housing 402, wherein the first boss 4011, the second boss 4012, the fourth boss 4021, the fifth boss 4022 cooperate with a protective sleeve slider lock 4111 on a protective sleeve slider 411 in the protective sleeve drive module 41 to lock the protective sleeve slider 411 in a different position of the housing 40, and the third boss 4013 and the sixth boss 4023 cooperate with related components in the spindle drive module 43, as described in further detail below.

28-32, In an alternative embodiment of the present invention, the twist shell drive module 42 includes a twist shell connection 428 and a twist gear set. Twist housing coupler 428 is fixedly coupled to twist housing 32, with the proximal end of twist housing coupler 428 being detachably coupled to the distal end of spindle drive module 43. The twist gear set is disposed at the distal end of the twist shell connection 428 and is used to control rotation of the twist shell connection 428 when the distal end of the mandrel drive module 43 is separated from the proximal end of the twist shell drive module 42.

In this embodiment, twisting housing connector 428 cooperates with twisting housing 32 such that drive control mechanism 4 can effect controlled folding or unfolding of pump head impeller 22 by twisting for clinical operation, while only the outer diameter changes during folding or unfolding of pump head impeller 22, its axial dimension is unchanged, resulting in higher controllability of the deformation process of pump head impeller 22.

In an alternative embodiment of the present invention, the twist gear set may include a first twist gear shaft 426, a first twist gear 425, a first twist gear shaft bearing 424, a twist 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 is fixedly connected with the twisting shell connecting piece 428 through the first twisting gear shaft 426, the first twisting gear shaft bearing 424 is arranged at the far end of the first twisting gear shaft 426 and rotatably supports the first twisting gear shaft 426 in the shell 40, the twisting shell connecting piece bearing 427 is arranged at the middle section of the twisting shell connecting piece 428 and rotatably supports the twisting shell connecting piece 428 in the shell 40, the second gear set 421 is detachably meshed with the first twisting gear 425 and controls the first twisting gear 425 to rotate when the second gear set 421 is meshed with the first twisting gear 425. Wherein the first twist gear 425, the first twist gear shaft 426, and the twist shell connection 428 may be prepared by machining an aluminum alloy.

As shown in fig. 32, the first twisting gear shaft 426 may be provided as a shaft body having a stepped shape of a plurality of stages, and when assembling, the first twisting gear 425 is assembled to the D-type shaft section of the first twisting gear shaft 426 and is preferably fixed using a sharp machine, then the first twisting gear shaft bearing 424 is sleeved to the distal end of the first twisting gear shaft 426, and then the first twisting gear shaft 426 is sleeved to the proximal end of the twisting case 32, the twisting case connector bearing 427 is sleeved from the distal end of the twisting case connector 428 to the middle section of the twisting case connector 428, and then the twisting case connector 428 is sleeved to the proximal end of the twisting case 32, and in the case that the proximal end face of the twisting case connector 428 is aligned with the proximal end of the twisting case 32, the twisting case connector 428 is preferably fixed using a sharp machine, and thereafter the first twisting gear shaft 426 and the twisting case connector 428 are preferably fixed using a sharp machine. Preferably, the twist gearset may further include a twist housing boss 423 and two sets of twist housing boss bearings 422. Two sets of twisting shell shaft sleeve bearings 422 are respectively sleeved at two ends of the twisting shell shaft sleeve 423, and the twisting shell shaft sleeve 423 is sleeved at the near end of the twisting shell 32 and is arranged at the near end of the first twisting gear shaft 426. Wherein the twist shell boss 423 may be prepared by machining an aluminum alloy.

As shown in fig. 29 to 31, in an alternative embodiment of the present invention, the second gear set 421 includes a second twist gear shaft 4214, a second twist gear 4213, a second twist gear shaft bearing 4212, a second twist gear stopper 4211, and a second twist gear return elastic member 4215. The second twisting gear 4213 is sleeved on the second twisting gear shaft 4214 and is detachably engaged with the first twisting gear 425, the second twisting gear shaft bearing 4212 is arranged between the second twisting gear shaft 4214 and the second twisting gear 4213, the second twisting gear limiting members 4211 are respectively arranged at two ends of the second twisting gear shaft 4214 and are fixedly connected with the second twisting gear shaft 4214, one side of each second twisting gear limiting member 4211 is inserted into the shell 40, the other side of each second twisting gear limiting member 4211 extends out of the shell 40 and supports the second twisting gear 4213 outside the shell 40, and the second twisting gear resetting elastic member 4215 is arranged between the second twisting gear limiting members 4211 and the shell 40 and is used for separating the second twisting gear 4213 from the first twisting gear 425. Preferably, the second twist gear restoring elastic member 4215 may include two sets of second twist gear restoring springs, wherein each set of second twist gear restoring springs includes two springs.

When the second gear set 421 is assembled, firstly, two second twisting gear shaft bearings 4212 are respectively embedded into two sides of a second twisting gear 4213, the outer end faces of the second twisting gear shaft bearings 4212 are aligned with the end faces 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, the center of the second twisting gear shaft 4214 is overlapped with the center of the second twisting gear 4213, then small ends of the two second twisting gear limiting members 4211 are respectively sleeved inwards to two ends of the second twisting gear shaft 4214, and on the premise that the end faces of the large ends of the second twisting gear limiting members 4211 are aligned with the end faces of the second twisting gear shaft 4214, and meanwhile, on the premise that the top faces of the two second twisting gear limiting members 4211 are also aligned, the two second twisting gear limiting members 4211 and the second twisting gear shaft 4214 are respectively fixed by using sharp machine rice, finally, the second twisting gear reset elastic members 4215 are inserted into corresponding mounting holes of the second twisting gear limiting members 4211, and the corresponding mounting holes of the second twisting gear reset elastic members 4215 are preferably bonded with the corresponding end faces of the second twisting gear limiting members 4215 by using biocompatible glue. Wherein the second twist gear stopper 4211, the second twist gear 4213, and the second twist gear shaft 4214 may be prepared by machining an aluminum alloy.

Preferably, the upper ends of the two second twisting gear limiting members 4211 may cover the second gear set cover 406 for limiting the second gear set 421, preventing the second gear set 421 from falling off from the housing 40, and avoiding misoperation of the second gear set 421.

By providing the second gear set 421, when the distal end of the mandrel driving module 43 is separated from the proximal end of the twisting shell driving module 42, the second twisting gear 4213 is pressed inwards to be meshed with the first twisting gear 425, at this time, the second twisting gear 4213 is shifted, so that the operation of the first twisting gear 425 can be realized, the twisting shell connecting piece 428 fixedly connected with the first twisting gear 425 is driven to synchronously rotate with the first twisting gear 425 through the first twisting gear 425, the twisting shell 32 is driven to synchronously rotate with the first twisting gear 425, and the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end through the twisting shell 32, so that the expansion or folding of the pump head impeller 22 can be controlled.

As shown in fig. 33 to 34, in an alternative embodiment of the present invention, the spindle driving module 43 includes a spindle connector 435, a coupling 437, a clutch 433 and a clutch reset elastic member 434, wherein the spindle connector 435 is sleeved outside the spindle 33 and is fixedly connected with the spindle 33, the distal end of the coupling 437 is fixedly connected with the spindle connector 435, the proximal end of the coupling 437 is fixedly connected with the driving motor 4310, the clutch 433 is disposed at the distal end of the spindle connector 435 and is sleeved outside the spindle 33, the clutch 433 is synchronously and rotatably connected with the spindle connector 435, the clutch 433 is detachably connected with the twisting shell connector 428, and the clutch reset elastic member 434 is disposed between the spindle connector 435 and the clutch 433. Preferably, the clutch return spring 434 may include three clutch return springs.

Preferably, the spindle drive module 43 further includes a spindle connector bearing 436, the spindle connector bearing 436 being sleeved on the proximal end of the spindle connector 435 and rotatably supporting the spindle connector 435 within the housing 40. In assembling the spindle connector 435, the shaft coupling 437 and the drive motor 4310, the motor flange 439 and the drive motor 4310 may be fixed using screws, and then the proximal end of the spindle connector 435 is inserted into the distal end of the shaft coupling 437, and the rotary shaft of the drive motor 4310 is inserted into the proximal end of the shaft coupling 437, and fixed using screws. Wherein the clutch 433, the spindle connection 435, the coupling 437 and the motor flange 439 can be prepared by machining an aluminum alloy

Alternatively, as shown in fig. 40 to 41, the clutch 433 is matched with the twisting shell connecting piece 428 and the mandrel connecting piece 435 through slots so as to realize transmission of rotary motion, wherein a connection state is always kept between the clutch 433 and the mandrel connecting piece 435, and two states of connection and non-connection exist between the clutch 433 and the twisting shell connecting piece 428, and a groove is arranged at the proximal end of the twisting shell connecting piece 428, so that insertion connection of the clutch 433 and the twisting shell connecting piece 428 can be conveniently realized.

Preferably, the mandrel connector 435 is provided with a corresponding mounting hole into which the clutch reset elastic member 434 is inserted, and when the clutch reset elastic member 434 is assembled, the proximal end of the clutch reset elastic member 434 is inserted into the corresponding mounting hole of the mandrel connector 435, preferably, the proximal end surface of the clutch reset elastic member 434 and the bottom surface of the corresponding mounting hole of the mandrel connector 435 can be bonded by using glue. Because the proximal end of the clutch 433 is sleeved at the distal end of the spindle connecting piece 435 (the proximal end surface of the clutch 433 is provided with a corresponding mounting hole, and the distal end of the clutch return elastic piece 434 is inserted into the corresponding mounting hole of the clutch 433 during assembly), the distal end of the clutch 433 is sleeved at the proximal end of the twisting shell connecting piece 428, and the clutch 433 and the twisting shell connecting piece 428 can be spliced under the action of the clutch return elastic piece 434;

in an alternative embodiment of the invention, as shown in fig. 34, spindle drive module 43 may further include a brake assembly 438, with brake assemblies 438 being disposed in pairs on either side of coupling 437 for braking coupling 37.

In this embodiment, two brake assemblies 438 are disposed on the first housing 401 and the second housing 402 opposite to each other, and inner sides of the two brake assemblies 438 are respectively engaged with opposite outer walls of the coupling 437 to brake the coupling 437, preferably, brake through holes are formed on the first housing 401 and the second housing 402, and one side of the brake assembly 438 passes through the brake through holes and can translate along the radial direction at the brake through holes.

Further, as shown in fig. 36 to 37, the brake assembly 438 includes a brake slider 4381, a brake 4382, and a brake return spring 4383. The brake sliding block 4381 is arranged outside the shell 40, the large end of the brake 4382 extends out of the shell 40 and is slidably connected with the brake sliding block 4381, the small end of the brake 4382 is inserted into the shell 410 and is matched with the outer wall of the coupler 437, the brake resetting elastic member 4383 is arranged between the brake 4382 and the shell 40 and is used for separating the brake 4382 from the coupler 437, preferably, the brake resetting elastic member 4383 can be a pair of brake resetting springs, one end of the brake resetting elastic member 4383 is inserted into a corresponding mounting hole of the brake 4382, and the other end of the brake resetting elastic member 4383 is inserted into a corresponding mounting hole of the shell 40.

In this embodiment, the first housing 401 and the second housing 402 of the housing 40 are respectively provided with a braking through hole, the small end of the braking member 4382 passes through the braking through hole and can translate along the radial direction at the braking through hole, the large end of the braking member 4382 is arranged outside the braking through hole and contacts with the braking member sliding block 4381, the first housing 401 and the second housing 402 of the housing 40 are respectively provided with a braking sliding groove, the braking member sliding block 4381 is arranged in the braking sliding groove and can translate along the axial direction, preferably, the braking member sliding block 4381 is provided with a wedge-shaped bottom surface 43812, the large end of the braking member 4382 is provided with a limit groove 43821, and the wedge-shaped bottom surface 43812 and two side surfaces of the braking member sliding block 4381 are respectively contacted with the arc-shaped top surface and two side surfaces of the limit groove 43821.

During assembly, after the two ends of the brake member resetting elastic member 4383 are respectively inserted into the corresponding mounting holes of the brake member 4382 and the housing 40, the end surface of the brake member resetting elastic member 4383 is preferably bonded with the bottom surface of the corresponding mounting hole of the brake member 4382 by using glue, and preferably, the brake member sliding block 4381 and the brake member 4382 can be prepared by die-opening injection molding.

As shown in fig. 38 to 39, preferably, two seventh protrusions 43811 are provided on each of the two stopper sliders 4381 in the translational direction, wherein two seventh protrusions 43811 on the stopper slider 4381 in one stopper assembly 438 are respectively engaged with two third protrusions 4013 on the first housing 401, and two seventh protrusions 43811 on the stopper slider 4381 in the other stopper assembly 438 are respectively engaged with two sixth protrusions 4023 on the second housing 402. When the brake slider 4381 is slid and the brake return elastic member 4383 is pressed down or released, the engagement between the seventh protrusion 43811 and the third protrusion 4013, and the sixth protrusion 4023 is used to lock the brake slider 4381 in two states of the brake 4382 locking coupling 437 and the release coupling 437 in the brake assembly 438;

preferably, the brake assembly cover 405 is disposed outside the two brake assemblies 438, and the two brake assembly covers 405 are respectively installed at corresponding positions of the first housing 401 and the second housing 402 and are fixed by using screw connection to limit the brake assemblies 438 and avoid misoperation of the brake slide 4381.

As shown in fig. 34, in an alternative embodiment of the present invention, the spindle driving module 43 further includes a clutch collar 432 and a clutch fork 431. The clutch collar 432 is slidably sleeved outside the housing 40 and is provided with a clutch fork mounting hole 4323 in a radial direction, and the clutch fork 431 is arranged in the clutch fork mounting hole 4323 and passes through the housing 40 to be matched with the clutch 433, so that the clutch 433 can be driven to move by operating the clutch collar 432 so as to separate or connect the clutch 433 from or with the twisting shell connecting piece 428, and further separation or connection between the distal end of the spindle driving module 43 and the proximal end of the twisting shell driving module 42 is realized.

Preferably, as shown in fig. 35, the clutch collar 432 includes a first clutch collar 4321 and a second clutch collar 4322 mounted in cooperation with the first clutch collar 4321, and the second clutch collar 4322 is disposed opposite to the first clutch collar 4321 to form an annular clutch collar 432. More preferably, a boss is provided on a mating surface of the first clutch collar 4321 and the second clutch collar 4322, a groove is provided on a mating surface of the second clutch collar 4322 and the first clutch collar 4321, and a groove is provided on a position corresponding to the boss, and the first clutch collar 4321 is assembled to the second clutch collar 4322 on the premise that the boss of the mating surface of the first clutch collar 4321 is aligned with the groove of the mating surface of the second clutch collar 4322, and the two are fixed by glue.

In this embodiment, the first clutch collar 4321 and the second clutch collar 4322 are assembled to the housing 40 from two opposite directions and form a clutch collar 432 that is sleeved on the housing 40, and then the two clutch forks 431 are assembled to the clutch collar 432, and preferably bonded by glue, so that the clutch forks 431 can be inserted into the first housing 401 and the second housing 402 during the assembly process, and the proximal shaft section of the clutch 433 needs to be located between the two fingers of the clutch forks 431.

Preferably, as shown in fig. 23 to 24, the first housing 401 and the second housing 402 are respectively provided with a Z-shaped groove for limiting the movement track of the clutch collar 432 and locking the clutch collar 431, the clutch collar 432 is rotated in the direction shown in fig. 45, the clutch collar 432 is released from the locking state of the clutch collar 431 when the clutch 433 is connected to the twisting case connecting member 428 and the spindle connecting member 435, then the clutch collar 432 is slid proximally as shown in fig. 46, the clutch collar 432 moves proximally together with the two clutch collars 431, when the distal fingers of the clutch collar 431 are in contact with the clutch 433, the clutch collar 433 is pushed to move proximally while compressing the clutch return elastic member 434 until the clutch collar 432 cannot move further proximally, and the clutch collar 432 is rotated again in the direction shown in fig. 47, so that the clutch collar 431 enters another locking state, and at this time the clutch collar 433 and the twisting case connecting member 428 are already in the non-connected state. Alternatively, the clutch fork 431, the first clutch collar 4321 and the second clutch collar 4322 may all be prepared by photo-curing 3D printing of medical hard resin.

In the specific application, as shown in fig. 42, the left ventricular assist device 1 provided by the embodiment of the invention is specifically used, which mainly comprises the steps of implanting the folded micro pump head 2 through the catheter 6, then withdrawing the catheter 6, after withdrawing the catheter 6, controlling the pump head impeller 22 and the pump head protection assembly 21 of the micro pump head 2 to be unfolded in a controlled manner through the cooperation between the transmission shaft 3 and the external driving control mechanism 4 in the body, maintaining the fixed outer diameter to rotate in a single direction after the controlled unfolding of the pump head impeller 22, realizing auxiliary blood supply, stopping the rotation of the pump head impeller 22 after the auxiliary blood supply, inserting the catheter 6, controlling the folding of the pump head impeller 22 and the pump head protection assembly 21 in the controlled manner through the cooperation between the transmission shaft 3 and the external driving control mechanism 4 in the body, after the controlled folding of the pump head impeller 22 and the pump head protection assembly 21, enabling the micro pump head 2 to be folded, storing the folded micro pump head 2 into the catheter 6, and finally withdrawing the folded micro pump head 2 together with the catheter 6;

As shown in fig. 43, when the left ventricle auxiliary device 1 is in an auxiliary blood supply state, the pump head impeller 22 and the pump head protection component 21 in the micro pump head 2 are in an unfolding state under the self elastic action, at this time, under the action of the second twisting gear resetting elastic piece 4215, the clutch resetting elastic piece 434 and the brake member resetting elastic piece 4383, the second twisting gear 4213 and the first twisting gear 425 are in a non-engagement state, the brake member 4382 and the coupling 437 are in a non-contact state, the clutch 433 and the twisting shell connecting piece 428 and the mandrel connecting piece 435 are in a connection state, the driving motor 4310 drives the coupling 437 to rotate, the coupling 437 drives the mandrel connecting piece 435 to rotate, the mandrel 33 and the clutch 433 to synchronously rotate, the clutch 433 drives the twisting shell connecting piece 428 and the twisting shell 32 and the mandrel 33 to synchronously rotate through the twisting shell connecting piece 428, and when the twisting shell 32 and the mandrel 33 synchronously rotate, the distal end and the proximal end of the pump head impeller 22 unfolded in the micro pump head impeller 22 and the proximal end shaft are synchronously rotated, and further the whole pump head impeller 22 and the mandrel 33 are guaranteed to synchronously rotate, and the whole pump impeller 22 and the mandrel 33 are further driven to rotate under the condition of fixing the twisting shell 426 and the external diameter of the twisting shell and the twisting shell is also driven to rotate under the condition of the rotation of the spindle shaft sleeve 32 and the integral twisting shell.

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

In step 21, as shown in fig. 44, the brake slider 4381 is slid distally, and the brake return elastic member 4383 is compressed, and simultaneously, the two brake members 4382 are pushed to lock the coupling 437, and at this time, the coupling 437, the mandrel connection member 435 and the mandrel 33 are not rotatable, and at this time, the brake slider 4381 can lock the brake slider 4381 in the state of locking the coupling 437 by means of the interaction between the seventh protrusion 43811 on the surface of the brake slider 4381 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.

Step 22, rotating the clutch collar 432 in the direction shown in fig. 45, releasing the locking state of the clutch collar 431 when the clutch 433 is connected to the twisting case connecting member 428 and the spindle connecting member 435, then sliding the clutch collar 432 proximally in the direction shown in fig. 46, and moving the clutch collar 432 together with the two clutch collars 431 proximally, when the distal fingers of the clutch collar 431 are in contact with the clutch 433, pushing the clutch 433 to move proximally while compressing the clutch return elastic member 434 until the clutch collar 432 cannot move further proximally, and rotating the clutch collar 432 again in the direction shown in fig. 47, bringing the clutch collar 431 into another locking state, wherein the clutch 433 and the twisting case connecting member 428 are in the non-connected state.

Step 23, as shown in fig. 48, pushes the second gear set 421 to the inside until the second twisting gear 4213 is completely engaged with the first twisting gear 425, then rotates the second twisting gear 4213 in the direction shown in fig. 49, the second twisting gear 4213 drives the first twisting gear 425 to reversely rotate, the first twisting gear 425 drives the first twisting gear shaft 426 to rotate, the first twisting gear shaft 426 drives the twisting shell connecting member 428 to rotate, the twisting shell connecting member 428 drives the twisting shell 32 to rotate, and the twisting shell 32 drives the proximal end of the pump head impeller 22 to rotate, thereby realizing the folding of the pump head impeller 22.

Step 24, as shown in fig. 50, the protective sleeve slider 411 is slid proximally, the protective sleeve slider 411 drives the protective sleeve 31 to move proximally, the protective sleeve 31 drives the proximal end of the pump head protection assembly 21 to move proximally, so as to fold the pump head protection assembly 21, and the protective sleeve slider 411 cooperates with the first protrusion 4011, the second protrusion 4012, the fourth protrusion 4021 and the fifth protrusion 4022 corresponding to the surfaces of the first housing 401 and the second housing 402 by means of the protective sleeve slider locking member 4111 on the surface of the protective sleeve slider 411, so as to lock the protective sleeve slider 411 in the folded state of the pump head protection assembly 21.

The conversion from the unfolded state to the folded state of the micro pump head 2 in the left ventricular assist device 1 is completed, and the conversion from the folded state to the unfolded state of the micro pump head 2 in the left ventricular assist device 1 can be realized by reversing the above steps;

Since the unfolded state (normal state) is the main state of the micropump head 2 in the left ventricle auxiliary device 1, the second twisting gear 4213 and the first twisting gear 425 are in a non-engaged state in a normal state, the clutch 433 and the twisting shell connecting member 428 are in a connected state in a normal state, and the brake 4382 and the coupling 437 are in a non-contact state in a normal state under the action of the second twisting gear resetting elastic member 4215, the clutch resetting elastic member 434 and the brake resetting elastic member 4383. After the left ventricular assist device 1 is used and removed, the micropump head 2, the transmission shaft 3, the protective sleeve driving module 41, the clutch fork 431 and the clutch collar 432 are removed and replaced, so that the drive control mechanism 4 can be reused.

While the foregoing is directed to the preferred embodiments of the present invention, it will be appreciated by those skilled in the art that various modifications and adaptations can be made without departing from the principles of the present invention, and such modifications and adaptations are intended to be comprehended within the scope of the present invention.

Claims

1. A left ventricular assist device, comprising:

a drive control mechanism (4) comprising a twisting shell drive module (42) and a mandrel drive module (43);

a transmission shaft (3) comprising a twisting shell (32) and a mandrel (33), wherein the twisting shell (32) is movably sleeved outside the mandrel (33), and

The miniature pump head (2) comprises a pump head impeller (22) and a pump head transmission assembly (23), wherein the proximal end of the pump head impeller (22) is in transmission connection with the twisting shell driving module (42) through the twisting shell (32), the distal end of the pump head transmission assembly (23) is fixedly connected with the distal end of the pump head impeller (22), the proximal end of the pump head transmission assembly (23) is in transmission connection with the mandrel driving module (43) through the mandrel (33), the pump head impeller (22) comprises a foldable impeller (221) and a twisting connecting piece (222), the foldable impeller (221) comprises an impeller skeleton (2211), the impeller skeleton (2211) comprises a proximal end fixing ring (22113), a distal end fixing ring (22111) and impeller skeleton wires (22112) which are spirally arranged between the proximal end fixing ring (22113) and the distal end fixing ring (22111), the distal end fixing ring (22111) is fixedly connected with the mandrel (33) through the pump head transmission assembly (33), the impeller skeleton (2211) is spirally arranged in a spiral shape, when the impeller skeleton (2211) is spirally arranged in a spiral shape, the impeller skeleton (22111) is spirally arranged along the outer edge (22132) in a spiral shape, and the impeller skeleton (22111) is spirally arranged along the spiral shape, and the spiral shell (22132) in a relative rotation direction, the spiral shell (221) is spirally arranged along the spiral shell (22111), the spiral period of the impeller skeleton wire (22112) is increased, the impeller skeleton wire (22112) is twisted and pre-tensioned to a folded state, a foldable impeller (221) in the folded state has a pre-tensioning force, and the axial size of the foldable impeller (221) of the pump head impeller (22) is unchanged in the folding process;

The mandrel (33) and the twisting shell (32) are driven to synchronously rotate through the mandrel driving module (43) so as to drive the distal end and the proximal end of the pump head impeller (22) to jointly rotate, so that the pump head impeller (22) rotates with a fixed outer diameter, and the twisting shell (32) and the mandrel (33) are driven to relatively rotate through the twisting shell driving module (42) so as to drive the proximal end and the distal end of the pump head impeller (22) to rotate relatively, so that the pump head impeller (22) is folded or unfolded.

2. The left ventricular assist device of claim 1, wherein the twist shell (32) comprises a twist shell micropump head coupling section (322), a twist shell flexible section (323), and a twist shell drive control mechanism coupling section (324),

The twisting shell flexible section (323) is fixedly connected with the twisting shell micro pump head connecting section (322) and the twisting shell driving control mechanism connecting section (324) through welding respectively, wherein

The far end of the twisting shell micro pump head connecting section (322) is fixedly connected with the near end of the pump head impeller (22), and the near end of the twisting shell driving control mechanism connecting section (324) is in transmission connection with the twisting shell driving module (42).

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

4. A left ventricular assist device according to claim 3, characterized in that the left ventricular assist device (1) further comprises a pressure sensor (5), the pressure sensor (5) comprises an optical fiber (51), the protective sleeve (31) is provided with an optical fiber hole (311), and the optical fiber (51) is arranged in the optical fiber hole (311) in a penetrating way.

5. The left ventricular assist device of claim 4, wherein the pressure sensor (5) further comprises a fiber-optic grating demodulator (52), the optical fiber (51) being communicatively connected to the fiber-optic grating demodulator (52) by a threaded connector.

6. The left ventricular assist device of claim 5, wherein the optical fiber (51) comprises a pressure monitoring fiber (511) and a signal transmission fiber (512), the signal transmission fiber (512) being integrally formed with the pressure monitoring fiber (511), the signal transmission fiber (512) being secured and communicatively coupled to the fiber grating demodulator (52) at a proximal end thereof by a threaded connector.

7. A left ventricular assist device according to claim 3, characterized in that the protective sheath (31) is made of medical Pebax tubing, the twist 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.

8. The left ventricular assist device of claim 1, wherein the collapsible impeller (221) further comprises:

impeller blade surfaces (2212), wherein the impeller blade surfaces (2212) are coated outside the impeller framework (2211).

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

10. The left ventricular assist device of claim 1, wherein a plurality of rotation limiting bosses are provided at a distal end of the twisted connecting member (222), a plurality of limiting grooves are provided at a proximal outer edge of the proximal fixing ring (22113), and the twisted connecting member (222) and the proximal fixing ring (22113) are in insertion connection with the limiting grooves for rotation limitation through the rotation limiting bosses.

11. The left ventricular assist device of claim 8 wherein the distal and proximal ends of the impeller blade (2212) are wrapped around the distal and proximal fixation rings (22111, 22113), respectively, and are lifted outward by the impeller skeleton wire (22112) to form an impeller.

12. A left ventricular assist device according to claim 3, characterized in that the pump head transmission assembly (23) comprises:

The core shaft sleeve (236), the core shaft sleeve (236) penetrates through the impeller skeleton (2211), the far end of the core shaft sleeve (236) is fixedly connected with the far end fixing ring (22111), and the near end of the core shaft sleeve (236) is sleeved in the near end fixing ring (22111) and is fixedly connected with the core shaft (33);

A top shaft (235), wherein the proximal end of the top shaft (235) is fixedly embedded into the distal end of the mandrel sleeve (236);

The top shaft bearing (233), the top shaft bearing (233) is sleeved at the far end of the top shaft (235), and the near end face of the top shaft bearing (233) is contacted with the far end face of the core shaft sleeve (236);

a top shaft sleeve (232), wherein the top shaft sleeve (232) is fixedly sleeved at the far end of the top shaft (235), the inner edge of the top shaft bearing (233) is limited between the far end surface of the core shaft sleeve (236) and the near end surface of the top shaft sleeve (232), and

And the top sleeve (231) is sleeved at the far end of the top shaft (235) at the near end of the top sleeve (231).

13. The left ventricular assist device of claim 12, wherein the mandrel sleeve (236) is fixedly sleeved with a mandrel collar (237), the mandrel collar (237) proximal end face being flush with the mandrel sleeve (236) proximal end face and being defined between the proximal end of the proximal fixation ring (22113) and the distal end of the twist connector (222).

14. The left ventricular assist device according to claim 12, wherein a top collar (234) is sleeved on the mandrel sleeve (236), the top collar (234) is sleeved on the distal end of the mandrel sleeve (236), and a distal end face of the top collar (234) is fixedly connected with a proximal end face of the top sleeve (231).

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

16. The left ventricular assist device according to claim 12, wherein the micropump head (2) further comprises:

The pump head protection assembly (21), the coaxial cover of pump head protection assembly (21) is located outside pump head impeller (22), just pump head protection assembly (21) near-end pass through protective sheath (31) with protective sheath drive module (41) transmission in drive control mechanism (4) are connected, pump head protection assembly (21) distal end with pump head drive assembly (23) distal end fixed connection.

17. The left ventricular assist device of claim 16, wherein the pump head protection assembly (21) comprises:

An anchor bracket (212), wherein the proximal end of the anchor bracket (212) is fixedly connected with the distal end of the protective sleeve (31), the distal end of the anchor bracket (212) is sleeved and fixed at the distal end of the pump head transmission assembly (23), and

The top sleeve tip (211), the top sleeve tip (211) set up in anchor support (212) distal end, top sleeve tip (211) proximal end with pump head drive assembly (23) distal end fixed connection.

18. The left ventricular assist device of claim 17, wherein the pump head protection assembly (21) further comprises a stent protective sheath attachment ring (213), the stent protective sheath attachment ring (213) having a distal end that is secured in-line to the annular proximal end of the anchor stent (212), and a distal end face of the stent protective sheath attachment ring (213) being flush with a distal end face of the annular proximal end of the anchor stent (212), and

The support protective sleeve connecting ring (213) is sleeved outside the twisting shell (32) in a sliding manner and is fixedly connected with the distal end of the protective sleeve (31).

19. The left ventricular assist device of claim 17, wherein an anchoring slot is formed at a distal end of the top sleeve (231), an anchoring rod is provided at a proximal end of the top sleeve tip (211), and the anchoring rod is in plug-fit with the anchoring slot to fixedly connect the proximal end of the top sleeve tip (211) with the distal end of the pump head transmission assembly (23).

20. The left ventricular assist device of claim 17, wherein the anchor stent (212) comprises:

An anchor bracket framework (2121), wherein the proximal end of the anchor bracket framework (2121) is fixedly connected with the distal end of the protective sleeve (31), the distal end of the anchor bracket framework (2121) is sleeved and fixed at the distal end of the pump head transmission assembly (23), and

And the anchoring support membrane (2122), wherein the anchoring support membrane (2122) is sleeved outside the anchoring support framework (2121).

21. The left ventricular assist device of claim 20, wherein the anchor stent scaffold (2121) comprises an anchor stent scaffold proximal ring, an anchor stent scaffold distal ring, and a plurality of anchor stent scaffold filaments juxtaposed between the anchor stent scaffold proximal ring and the anchor stent scaffold distal ring, the anchor stent scaffold filaments bending outwardly to expand the structure of the pump head protection assembly (21) when the anchor stent scaffold proximal ring and the anchor stent scaffold distal ring are in proximity to each other, and the anchor stent scaffold filaments tensioning inwardly to collapse the structure of the pump head protection assembly (21) when the anchor stent scaffold proximal ring and the anchor stent scaffold distal ring are away from each other.

22. The left ventricular assist device of claim 21, wherein the anchor stent skeleton wire is made of an elastic material.

23. A left ventricular assist device according to claim 3, characterized in that the drive control mechanism (4) further comprises a housing (40), the twist shell drive module (42) is arranged in the housing (40), the twist shell drive module (42) distal end is in driving connection with the twist shell (32) proximal end, the mandrel drive module (43) is arranged in the housing (40) and is arranged at the twist shell drive module (42) proximal end, the mandrel drive module (43) distal end is in driving connection with the mandrel (33) proximal end, and the mandrel drive module (43) distal end is in detachable connection with the twist shell drive module (42) proximal end, wherein

The spindle drive module (43) drives the spindle (33) to rotate synchronously with the twisting shell (32) when the spindle drive module (43) is connected with the twisting shell drive module (42), and the twisting shell drive module (42) drives the twisting shell (32) to rotate relative to the spindle (33) when the spindle drive module (43) is separated from the twisting shell drive module (42).

24. The left ventricular assist device of claim 23, wherein the twist shell drive module (42) comprises:

a twisting shell connecting piece (428), wherein the twisting shell connecting piece (428) is fixedly connected with the twisting shell (32), the proximal end of the twisting shell connecting piece (428) is detachably connected with the distal end of the mandrel driving module (43), and

And the twisting gear set is arranged at the far end of the twisting shell connecting piece (428) and is used for controlling the twisting shell connecting piece (428) to rotate when the far end of the mandrel driving module (43) is separated from the near end of the twisting shell driving module (42).

25. The left ventricular assist device of claim 24, wherein the twist gearset comprises:

A first twist gear shaft (426);

The first twisting gear (425), the first twisting gear (425) is sleeved on the first twisting gear shaft (426) and fixedly connected with the twisting shell connecting piece (428) through the first twisting gear shaft (426);

a first twist gear shaft bearing (424), the first twist gear shaft bearing (424) disposed distally of the first twist gear shaft (426) and rotatably supporting the first twist gear shaft (426) within the housing (40);

A twisting case connecting member bearing (427), the twisting case connecting member bearing (427) being provided in a middle section of the twisting case connecting member (428) and rotatably supporting the twisting case connecting member (428) in the housing (40), and

A second gear set (421), the second gear set (421) being detachably engaged with the first twist gear (425) and controlling the rotation of the first twist gear (425) when the second gear set (421) is engaged with the first twist gear (425).

26. The left ventricular assist device of claim 25, wherein the first twist gear shaft (426) is configured as a multi-stage stepped shaft, the first twist gear shaft (426) being sleeved and secured at a proximal end to a distal end of the twist shell connector (428).

27. The left ventricle auxiliary device according to claim 25, wherein the twisting shell driving module (42) further comprises a twisting shell shaft sleeve (423) and a twisting shell shaft sleeve bearing (422), the twisting shell shaft sleeve bearing (422) is respectively sleeved at two ends of the twisting shell shaft sleeve (423), and the twisting shell shaft sleeve (423) is sleeved at the proximal end of the twisting shell (32) and is arranged at the distal end of the first twisting gear shaft (426).

28. The left ventricular assist device of claim 25, wherein the second gear set (421) comprises:

A second twist gear shaft (4214);

the second twisting gear (4213) is sleeved on the second twisting gear shaft (4214) and is detachably meshed with the first twisting gear (425);

A second twist gear shaft bearing (4212), the second twist gear shaft bearing (4212) being disposed between the second twist gear shaft (4214) and the second twist gear (4213);

A second twisting gear limiting piece (4211), wherein the second twisting gear limiting piece (4211) is respectively arranged at two ends of the second twisting gear shaft (4214) and fixedly connected with the second twisting gear shaft (4214), one side of the second twisting gear limiting piece (4211) is inserted into the shell (40), the other side of the second twisting gear limiting piece (4211) extends out of the shell (40) and supports the second twisting gear (4213) at the outer side of the shell (40), and

A second twisting gear return elastic member (4215), wherein the second twisting gear return elastic member (4215) is disposed between the second twisting gear limiting member (4211) and the housing (40) and separates the second twisting gear (4213) from the first twisting gear (425).

29. The left ventricular assist device of claim 24, wherein the mandrel drive module (43) comprises:

The mandrel connecting piece (435), the mandrel connecting piece (435) is sleeved outside the mandrel (33) and fixedly connected with the mandrel (33);

The shaft coupler (437), the far end of the shaft coupler (437) is fixedly connected with the mandrel connecting piece (435), and the near end of the shaft coupler (437) is fixedly connected with the driving motor (4310);

the clutch (433) is arranged at the far end of the mandrel connecting piece (435) and sleeved outside the mandrel (33), the clutch (433) is synchronously and rotationally connected with the mandrel connecting piece (435), the clutch (433) is detachably connected with the twisting shell connecting piece (428), and

And a clutch return elastic member (434), wherein the clutch return elastic member (434) is arranged between the mandrel connecting member (435) and the clutch (433).

30. The left ventricular assist device of claim 29, wherein the mandrel drive module (43) further comprises a mandrel connector bearing (436), the mandrel connector bearing (436) being nested about the proximal end of the mandrel connector (435) and rotatably supporting the mandrel connector (435) within the housing (40).

31. The left ventricular assist device of claim 29, wherein the mandrel drive module (43) further comprises:

and the brake assemblies (438) are arranged on two sides of the coupler (437) in pairs and used for braking the coupler (437).

32. The left ventricular assist device of claim 31, wherein the brake assembly (438) comprises:

A stopper slider (4381), the stopper slider (4381) being provided outside the housing (40);

a brake part (4382), wherein the brake part (4382) is arranged at the inner side of the brake part sliding block (4381), the large end of the brake part (4382) extends out of the shell (40) and is slidably connected with the brake part sliding block (4381), the small end of the brake part (4382) is inserted into the shell (40) and is matched with the outer wall of the coupler (437), and

The pair of brake return elastic pieces (4383), the pair of brake return elastic pieces (4383) are arranged between the brake pieces (4382) and the shell (40), one ends of the pair of brake return elastic pieces (4383) are inserted into corresponding mounting holes of the brake pieces (4382), and the other ends of the pair of brake return elastic pieces (4383) are inserted into corresponding mounting holes of the shell (40).

33. The left ventricular assist device of claim 32, wherein the stopper slider (4381) has a wedge-shaped bottom surface (43812), the stopper (4382) has a stopper groove (43821) at a large end thereof, and the wedge-shaped bottom surface (43812) and both side surfaces of the stopper slider (4381) are respectively in contact with the arc-shaped top surface and both side surfaces of the stopper groove (43821).

34. The left ventricular assist device of claim 29, wherein the mandrel drive module (43) further comprises:

A clutch shifting ring (432), wherein the clutch shifting ring (432) is sleeved outside the shell (40) in a sliding way and is provided with a clutch shifting fork mounting hole (4323) along the radial direction, and

A clutch fork (431), the clutch fork (431) is disposed in the clutch fork mounting hole (4323) and passes through the housing (40) to be matched with the clutch (433), so that the clutch (433) can be driven to move by operating the clutch poking ring (432) to separate or connect the clutch (433) with the twisting shell connecting piece (428).

35. The left ventricular assist device of claim 34, wherein the clutch collar (432) comprises a first clutch collar (4321) and a second clutch collar (4322), the first clutch collar (4321) being disposed opposite the second clutch collar (4322) to form the annular clutch collar (432).

36. The left ventricular assist device according to claim 23, wherein the drive control mechanism (4) further comprises:

The protective sleeve driving module (41), the protective sleeve driving module (41) is sleeved at the proximal end of the protective sleeve (31) and is in transmission connection with the proximal end of the protective sleeve (31), and the protective sleeve (31) is driven to move through the protective sleeve driving module (41).

37. The left ventricular assist device of claim 36, wherein the protective sleeve driving module (41) comprises a protective sleeve slider (411), a protective sleeve slider bearing (412) and a protective sleeve slider end cover (413), wherein the protective sleeve slider (411) is sleeved at the proximal end of the protective sleeve (31) and fixedly connected with the protective sleeve (31), the protective sleeve slider bearing (412) is embedded in a proximal ring groove of the protective sleeve slider (411), the outer edge of the protective sleeve slider bearing (412) is limited between the proximal ring groove of the protective sleeve slider (411) and the protective sleeve slider end cover (413), and the protective sleeve slider end cover (413) is arranged at the proximal end of the protective sleeve slider (411) and fixedly connected with the protective sleeve slider (411).

38. The left ventricular assist device of claim 37, wherein the protective sheath drive module (41) comprises at least two protective sheath slider bearings (412), the at least two protective sheath slider bearings (412) being embedded in the protective sheath slider (411) proximal ring groove and such that a distal end face of the protective sheath slider bearings (412) distal from the protective sheath slider end cap (413) is in contact with the protective sheath (31) proximal end face.

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