CN119327028B

CN119327028B - Micro pump head

Info

Publication number: CN119327028B
Application number: CN202411513547.1A
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: 2025-08-01
Anticipated expiration: 2044-10-28
Also published as: CN119327028A

Abstract

The invention provides a micro pump head, which relates to the technical field of micro pumps, and is applied to a left ventricle auxiliary device, wherein the left ventricle auxiliary device also comprises a transmission shaft and a driving control mechanism, and the micro 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 a twisting shell driving module of the driving control mechanism through a twisting shell of the transmission shaft, and the proximal end of the pump head transmission assembly is in transmission connection with a mandrel driving module of the driving control mechanism through a mandrel of the transmission shaft. The mandrel and the twisting shell are driven to synchronously rotate through the mandrel driving module so as to drive the distal end and the proximal end of the pump head impeller to jointly rotate, and the twisting shell and the mandrel are driven to relatively rotate through the twisting shell driving module so as to drive the proximal end of the pump head impeller to relatively rotate distally. The miniature pump head can be unfolded or folded to change the outer diameter of the miniature pump head in a human body, so that the blood supply efficiency and the use safety of the auxiliary device are improved.

Description

Micro pump head

Technical Field

The invention relates to the technical field of micropumps, in particular to a micropump head.

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 constant 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.

Disclosure of Invention

The invention aims to solve the technical problem of providing the miniature pump head which can be folded and unfolded in a human body, so that the outer diameter of the whole miniature pump head in the human body is changed, and the auxiliary blood supply efficiency and the use safety of an auxiliary device are improved.

In order to solve the above technical problems, the present invention provides a micro pump head, which is applied to a left ventricular assist device, the left ventricular assist device further includes a transmission shaft and a drive control mechanism, the micro pump head includes:

the proximal end of the pump head impeller is in transmission connection with a twisting shell driving module of the driving control mechanism through a twisting shell of the transmission shaft, and

The pump head transmission assembly is characterized in that the distal end of the pump head transmission assembly is fixedly connected with the pump head impeller, the proximal end of the pump head transmission assembly is in transmission connection with a mandrel driving module of the driving control mechanism through a mandrel of the transmission shaft, the mandrel is driven by the mandrel driving module to synchronously rotate with the twisting shell so as to drive the distal end and the proximal end of the pump head impeller to jointly rotate, and the twisting shell is driven by the twisting shell driving module to relatively rotate with the mandrel so as to drive the proximal end and the relatively distal end of the pump head impeller to rotate.

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.

In one embodiment, the impeller skeleton comprises:

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

A distal fixing ring fixedly connected with the mandrel through the pump head transmission 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 twisting connecting piece distal end is equipped with a plurality of spacing bosss that rotate, a plurality of spacing grooves have been seted up correspondingly to near-end solid fixed ring proximal end outer fringe, the twisting connecting piece with near-end solid fixed ring passes through rotate spacing boss with spacing groove grafting cooperation rotates spacingly.

In one embodiment, 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 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 protection sleeve driving module in the driving control mechanism through a protection sleeve of the transmission shaft, and the distal end of the pump head protection assembly is fixedly connected with the distal end of the pump head transmission assembly.

In one embodiment, the pump head protection assembly comprises:

The proximal end of the anchoring support is fixedly connected with the distal end of the protective sleeve of the transmission shaft, 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 of the transmission shaft in a sliding manner and is fixedly connected with the distal end of the protective sleeve of the transmission shaft;

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.

In one embodiment, the anchor stent comprises:

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

And the anchoring support membrane is sleeved outside the anchoring support framework.

In one embodiment, the anchor stent scaffold includes 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 curving outwardly to expand the structure of the pump head protection assembly 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 when the anchor stent scaffold proximal ring and the anchor stent scaffold distal ring are in proximity to each other;

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

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

The miniature pump head is mainly applied to a left ventricle auxiliary device, the left ventricle auxiliary device further comprises a transmission shaft and a driving control mechanism, the miniature pump head comprises a pump head impeller, the proximal end of the pump head impeller is in transmission connection with a twisting shell driving module of the driving control mechanism through a twisting shell of the transmission shaft, 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 a mandrel driving module of the driving control mechanism through a mandrel of the transmission shaft, the mandrel is driven to synchronously rotate with the twisting shell through the mandrel driving module so as to drive the distal end and the proximal end of the pump head impeller to jointly rotate, at the moment, the pump head impeller integrally rotates in a fixed outer diameter in a single direction, and the twisting shell is driven to relatively rotate with the mandrel through the twisting shell driving module so as to drive the proximal end of the pump head impeller to relatively rotate, and accordingly the pump head impeller is folded or unfolded, and the outer diameter of the pump head impeller is adjusted. The pump head impeller is controlled to be folded or unfolded, so that the pump head impeller can be implanted to a designated position in a human body in a folded state through minimally invasive intervention operation, then the pump head impeller can be deformed and unfolded in the human body to be in a spiral shape with a larger outer diameter, the auxiliary device can provide sufficient auxiliary blood flow for a patient at a low rotating speed, the blood supply efficiency and the use safety of the auxiliary device are improved, and meanwhile, the pump head impeller with the adjustable outer diameter is also beneficial to reducing the resistance of the whole micro pump head when entering and passing through a catheter, and the quick and safe deployment and recovery of the auxiliary device are realized.

Drawings

FIG. 1 is a schematic illustration of the connection of a micropump head in a left ventricular assist device according to an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of an alternative embodiment of the present invention for connecting a micropump head to a driving shaft;

FIG. 3 is a schematic perspective view of an alternative embodiment of the pump head impeller according to the present invention when the impeller is deployed (normal state);

FIG. 4 is an exploded view of a pump head impeller provided in an alternative embodiment of the present invention;

FIG. 5 is a schematic perspective view of an alternative embodiment of the present invention showing the impeller skeleton in a (normal) open position;

FIG. 6 is a schematic perspective view of an impeller blade face provided by an alternative embodiment of the present invention;

FIG. 7 is a schematic perspective view of an alternative embodiment of the impeller skeleton according to the present invention;

FIG. 8 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. 9 is a schematic view of the foldable impeller of FIG. 8 in a folded condition after rotational twisting;

FIG. 10 is a schematic perspective view of a pump head drive assembly according to an alternative embodiment of the present invention;

FIG. 11 is an exploded view of a pump head drive assembly provided by an alternative embodiment of the present invention;

FIG. 12 is a schematic perspective view of a pump head protection assembly according to an alternative embodiment of the present invention;

FIG. 13 is an exploded view of a pump head protection assembly provided by an alternative embodiment of the present invention;

Fig. 14 is a schematic cross-sectional view of a drive control mechanism provided in an alternative embodiment of the present invention.

Reference numerals illustrate:

100. a left ventricular assist device;

1. A drive control mechanism;

11. a protective sleeve driving module; 12, twisting shell driving module 13, mandrel driving module;

2. A micro pump head;

21. Pump head protection components, 211, top sleeve tips, 212, anchoring supports, 2121, anchoring support frameworks, 2122, anchoring support membranes and 213, support protection sleeve connecting rings;

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. A transmission shaft; 31, a protective sleeve, 32, a twisting shell, 33, a mandrel;

4. An optical fiber pressure sensor.

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.

Firstly, it should be noted that the micro pump head provided in the following embodiments of the present invention is applied to a left ventricular assist device, the micro pump head directly enters a patient, and in the process of using the left ventricular assist device, the blood supply performance of the left ventricular assist device is largely determined by the size and shape of the pump head impeller of the micro pump head that directly interacts with blood. All the prior interventional left ventricular assist devices follow the basic hydrodynamic law, namely, the blood supply efficiency is positively related to the size of the impeller, and the blood supply capacity is inevitably gradually reduced along with the continuous reduction of the outer diameter of the impeller. Therefore, according to the invention, the miniature pump head with the adjustable outer diameter is provided, the outer diameter of the pump head impeller in the auxiliary blood supply state is increased while the miniature pump head can be implanted through minimally invasive intervention operation, so that the pump head impeller of the auxiliary device has the capability of providing sufficient auxiliary blood flow for a patient at a low rotating speed, and the blood supply efficiency and the use safety of the auxiliary device are further improved.

As shown in fig. 1-3 and fig. 10, an embodiment of the present invention relates to a micro pump head 2 applied to a left ventricular assist device 100, the left ventricular assist device 100 further includes a transmission shaft 3 and a drive control mechanism 1, the micro pump head 2 includes a pump head impeller 22 and a pump head transmission assembly 23, a proximal end of the pump head impeller 22 is in transmission connection with a twisting shell driving module 12 of the drive control mechanism 1 through a twisting shell 32 of the transmission shaft 3, a distal end of the pump head transmission assembly 23 is fixedly connected with a distal end of the pump head impeller 22, a proximal end of the pump head transmission assembly 23 is in transmission connection with a mandrel driving module 13 of the drive control mechanism 1 through a mandrel 33 of the transmission shaft 3, the mandrel 33 is driven to rotate synchronously with the twisting shell 32 through the mandrel driving module 13 to drive the distal end and the proximal end of the pump head impeller 22 to rotate together, at this time, the pump head impeller 22 rotates in a single direction with a fixed outer diameter integrally, and the twisting shell 32 is driven to rotate relative to the mandrel 33 through the twisting shell driving module 12 to drive the twisting shell 32 to rotate relatively to the proximal end of the pump head impeller 22, thereby adjusting the outer diameter of the pump head impeller 22.

Specifically, referring to fig. 14, the proximal end of the twisting shell driving module 12 is detachably connected to the distal end of the mandrel driving module 13, when the distal end of the mandrel driving module 13 is connected to the proximal end of the twisting shell driving module 12, the mandrel driving module 3 drives the mandrel 33 to rotate and drives the twisting shell driving module 12 to synchronously rotate, the twisting shell driving module 12 drives the twisting shell 32 to rotate and further drives the twisting shell 32 to synchronously rotate with the mandrel 33, and when the distal end of the mandrel driving module 13 is separated from the proximal end of the twisting shell driving module 12, the twisting shell driving module 12 drives the twisting shell 32 to rotate and can rotate relative to the mandrel 33.

In this embodiment, the pump head transmission assembly 23 penetrates through the whole pump head impeller 22, 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 fixedly connected with the distal end of the mandrel 33 in the transmission shaft 3, and the distal end of the pump head impeller 22 is in transmission connection with the mandrel driving module 13 of the driving control mechanism 1 (the proximal end of the mandrel 33 is in transmission connection with the mandrel driving module) sequentially through the pump head transmission assembly 23 and the mandrel 33. The proximal end of the pump head impeller 22 is fixedly connected with the distal end of the twisting shell 32 in the transmission shaft 3, and the proximal end of the pump head impeller 22 is in transmission connection with the twisting shell driving module 12 of the driving control mechanism 1 through the twisting shell 32 (the proximal end of the twisting shell 32 is in transmission connection with the twisting shell driving module 12).

Here, the twisting shell 32 of the transmission shaft 3 is sleeved outside the mandrel 33, and the driving control mechanism 1 is matched with the twisting shell driving module 12 through the mandrel driving module 13 to drive the mandrel 33 to rotate synchronously (synchronous rotation here means rotation at the same angular speed) or relatively to the twisting shell 32. Specifically, when the spindle drive module drives the spindle 33 to rotate in synchronization with the twisting housing 32, the pump head impeller 22 as a whole is driven to rotate in one direction with a fixed outer diameter. When the twisting shell driving module 12 drives the twisting shell 32 to rotate relative to the mandrel 33, the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end, so that folding or unfolding of the pump head impeller 22 is realized, and in the process of folding or unfolding the pump head impeller 22, the outer diameter of the pump head impeller 22 is changed, specifically, when the pump head impeller 22 is folded, the overall outer diameter is reduced, so that the whole micro pump head 2 can enter a patient in a folded state in a minimally invasive intervention mode, and the safety and convenience of using an auxiliary device are 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 has the capacity of providing sufficient auxiliary blood flow for the patient at a low rotating speed, the blood supply efficiency of the auxiliary device is improved, and the hemolysis risk is reduced.

In addition, the collapsing function of the pump head impeller 22 also helps to reduce the resistance of the micropump head 2 as it enters and passes through the catheter, and further helps to achieve rapid and safe deployment and retrieval of the left ventricular assist device. The driving control mechanism 1 at the proximal end of the left ventricular assist device realizes the controlled folding and unfolding of the pump head impeller 22 of the micro pump head 2 at the distal end of the left ventricular assist device by adopting a twisting mode, is convenient for clinical operation, and only the outer diameter changes in the folding and unfolding process of the pump head impeller 22, and the axial dimension of the driving control mechanism is unchanged, so that the deformation process of the pump head impeller 22 has higher controllability.

As shown in fig. 3 to 4, in an alternative embodiment of the present invention, the pump head impeller 22 includes a foldable impeller 221 and a twisting connection piece 222, the distal end of the foldable impeller 221 is fixedly connected to the mandrel 33 through the pump head transmission assembly 23, the proximal end of the foldable impeller 221 is clamped to the distal end of the twisting connection piece 222, and the proximal end of the twisting connection piece 222 is fixedly connected to the twisting shell 32.

In this embodiment, the proximal end of the foldable impeller 221 is fixedly clamped with the distal end of the twisting connector 222, and is fixedly connected with the distal end of the twisting shell 32 in the transmission shaft 3 through the proximal end of the twisting connector 222, and the proximal end of the twisting shell 32 is in transmission connection with the twisting shell driving module 12 in the driving control mechanism 1. When the twisting shell driving module 12 drives the twisting shell 32 to rotate, the twisting shell 32 drives the twisting connecting piece 222 to rotate, and the twisting connecting piece 222 drives the proximal end of the foldable impeller 221 to rotate. Since the distal end of the foldable impeller 221 is fixedly connected with the distal end of the mandrel 33 in the transmission shaft 3 through the pump head transmission assembly 23, the proximal end of the mandrel 33 is in transmission connection with the mandrel driving module 13 in the driving control mechanism 1. When the mandrel 33 is driven to rotate by the mandrel driving module 13, the mandrel 33 drives the pump head transmission assembly 23 to rotate, and the distal end of the foldable impeller 221 is driven to rotate by the pump head transmission assembly 23.

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 distal end and the proximal end of the collapsible impeller 221 are rotated relative to each other, and the collapsible impeller 221 expands or collapses when the distal end and the proximal end are rotated relative to each other to change the outer diameter of the entire 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. 5 to 6, 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 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 impeller 22 of the pump head can be reduced, on the other hand, the impeller 22 of the pump head can be guaranteed to have a large folding ratio deformation capability (when the impeller skeleton 2211 is twisted and unfolded, the impeller blade 2212 can be jacked outwards by the impeller skeleton 2211 to form a spiral impeller and increase the outer diameter of the whole impeller 22 of the pump head, and when the impeller skeleton 2211 is twisted and folded, the impeller blade 2212 can shrink inwards to be cylindrical and reduce the outer diameter of the whole impeller 22 of the pump head), preferably, the medical silica gel material can be prepared by stirring and solidifying the Dragon Skin silicone with a mass ratio of 2:1 and SLIC THINNER diluent at normal temperature, and has a good elastic deformation capability, 100% Young modulus of 21.75kPa, and 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 impeller 2 when in use.

Further, as shown in fig. 5, the impeller skeleton 2211 includes a proximal fixation ring 22113, a distal fixation ring 22111, and an impeller skeleton wire 22112. 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 may 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 may 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 material with certain rigidity 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.

The collapsible impeller 221 may be prepared in the following manner. Twisting and pre-tightening the impeller skeleton 2211 in the unfolded state (shown in fig. 5) to the folded state (shown in fig. 7), and sleeving the impeller blade surface 2212 on the surface of the impeller skeleton 2211 to obtain the foldable impeller 221 in the folded state shown in fig. 9. According to the rotation direction shown in fig. 9, 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. 8 can be obtained. Conversely, twisting in the direction of rotation shown in fig. 8 results in the foldable impeller 221 in the folded state shown in fig. 9.

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.

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.

As shown in fig. 10-11, 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 at 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, 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 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 in the pump head transmission assembly 23 with the distal end fixing ring 22111 in the foldable impeller 221, the proximal end of the core sleeve 236 is fixedly connected with the distal end of the core shaft 33 in the transmission shaft 3 (the proximal end of the core sleeve 236 is sleeved outside the distal end of the core shaft 33 and is fixedly connected), and the core shaft 33 can be driven to rotate by the core shaft driving module 13 in the driving control mechanism 1. 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 12 in the driving control mechanism 1, 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. 12 to 13, in an alternative embodiment of the present invention, the micro pump head 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 a protection sleeve driving module in the driving control mechanism 1 through a protection sleeve 31 of the transmission shaft 3, 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 distal end of the pump head protection assembly 21 is fixedly connected to the distal end of the pump head transmission assembly 23, and the proximal end of the pump head protection assembly 21 is fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3. 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 11 in the driving control mechanism 1, when the protective sleeve driving module 11 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 then the pump head protection assembly 21 is controlled to fold or unfold so as to adjust the outer diameter of the pump head protection assembly 21 (when the protective sleeve 31 slides 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 31 slides 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 so as to match the increase or decrease of the outer diameter of the foldable impeller 221 in 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 of the transmission shaft 3, 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 and distal ends of the anchor bracket 212 may be configured in a ring shape, and the proximal end of the top hub tip 211 is fixedly connected to the distal end of the top hub 231 of the pump head transmission assembly 23.

Optionally, the distal end of the top sleeve 231 is provided with an anchoring slot, 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 mounted in the top sleeve 231 by inserting and matching the anchoring rod with the anchoring slot.

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.

Further, the anchor bracket 212 includes an anchor bracket frame 2121 and an anchor bracket film 2122, the proximal end of the anchor bracket frame 2121 is fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3, the distal end of the anchor bracket frame 2121 is sleeved and fixed to the distal end of the pump head transmission assembly 23, and the anchor bracket film 2122 is sleeved and arranged outside the anchor bracket frame 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 present 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 being bent outwardly when the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring are brought into proximity with each other to expand the structure of the pump head protection assembly 21, and the anchor stent skeleton wires being tensioned inwardly when the anchor stent skeleton proximal ring and the anchor stent skeleton distal ring are brought 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, the plurality of the anchoring stent skeleton wires 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, the anchoring stent skeleton wires 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 close to each other so as to outwards expand the cage-shaped structure, and conversely, the anchoring stent skeleton wires can be stretched towards two ends so as to inwards contract the cage-shaped structure.

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, bonding and fixing the top shaft 235 and the core shaft sleeve 236, sleeving the top collar 234 to the core shaft sleeve 236 and sleeving the top shaft bearing 233 to the top shaft 235 in sequence, and axially positioning the top shaft bearing 233 by using the distal end of the core shaft sleeve 236; finally, sleeving the top sleeve 231 to the top shaft bearing 233, and adhesively fixing the top sleeve 231 and the top sleeve 234 with ensuring that the top sleeve 231 is contacted with the distal end face of the top shaft bearing 233 and the top sleeve 234 is contacted with the proximal end face of the top shaft bearing 233;

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;

The mandrel 33 in the transmission shaft 3 is driven to synchronously rotate or relatively rotate with the twisting shell 32 by the driving control mechanism 1, when the mandrel 33 synchronously rotates with the twisting shell 32, the pump head impeller 22 integrally rotates in a single direction with a fixed outer diameter to realize the blood pumping function, when the twisting shell 32 rotates relatively with the mandrel 33, the proximal end of the pump head impeller 22 rotates relatively with the distal end, the foldable impeller 221 can be unfolded or folded to change the outer diameter of the whole pump head impeller 22 (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 11 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, the outer diameter of the pump head impeller 22 is far larger than the outer diameter in the folded state, the auxiliary device can provide sufficient auxiliary blood flow for the patient at a low rotating speed, the blood supply efficiency of the auxiliary device 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 quick deployment and recovery of the auxiliary device are more beneficial to realization.

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 micro pump head applied in a left ventricular assist device, the left ventricular assist device further comprising a transmission shaft (3) and a drive control mechanism (1), characterized in that the micro pump head comprises:

a pump head impeller (22), wherein the proximal end of the pump head impeller (22) is in transmission connection with a twisting shell driving module (12) of the driving control mechanism (1) through a twisting shell (32) of the transmission shaft (3), and

The pump head transmission assembly (23), the distal end of the pump head transmission assembly (23) is fixedly connected with the pump head impeller (22), and the proximal end of the pump head transmission assembly (23) is in transmission connection with the mandrel driving module (13) of the driving control mechanism (1) through the mandrel (33) of the transmission shaft (3), wherein

The mandrel (33) and the twisting shell (32) are driven to synchronously rotate through the mandrel driving module (13) so as to drive the distal end and the proximal end of the pump head impeller (22) to jointly rotate, and the twisting shell (32) and the mandrel (33) are driven to relatively rotate through the twisting shell driving module (12) so as to drive the proximal end and the relatively distal end of the pump head impeller (22) to rotate;

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 fixing ring (22113), a distal fixing ring (22111) and impeller skeleton wires (22112) which are spirally arranged between the proximal fixing ring (22113) and the distal fixing ring (22111), the distal fixing ring (22111) is fixedly connected with the mandrel (33) through the pump head transmission assembly (23), the proximal fixing ring (22113) is fixedly connected with the twisting shell (32) through the twisting connecting piece (222), the foldable impeller (221) is in a small-period spiral shape, the spiral outer edge of the impeller skeleton wires (22112) outwards extends, when the proximal fixing ring (22113) rotates in a spiral direction relative to the distal fixing ring (22111), the spiral period of the impeller skeleton wires (22112) increases, the impeller skeleton wires (22112) are twisted and pre-tightened to be in a folded state, and the foldable impeller (221) can be folded to a size which is not changed in the folded process of the pump head impeller (221).

2. The micropump head according to 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).

3. The micropump head of claim 2, wherein,

The impeller skeleton wire (22112) is made of an elastic material.

4. The micropump head according to claim 1, wherein a plurality of rotation limiting bosses are disposed at a distal end of the twisting connecting piece (222), a plurality of limiting grooves are correspondingly formed in a proximal outer edge of the proximal fixing ring (22113), and the twisting connecting piece (222) and the proximal fixing ring (22113) are in insertion connection and matched with the rotation limiting bosses and the limiting grooves to perform rotation limiting.

5. The micropump head according to claim 2, wherein the distal end and the proximal end of the impeller blade surface (2212) are respectively coated outside the distal end fixing ring (22111) and the proximal end fixing ring (22113), and are jacked outwards by the impeller skeleton wire (22112) to form the impeller.

6. The micropump head according to claim 4, wherein the pump head transmission assembly (23) includes:

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 (22113) 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).

7. The micropump head according to claim 6, wherein the mandrel sleeve (236) is provided with a mandrel collar (237) at a proximal end thereof, the proximal end surface of the mandrel collar (237) being flush with the proximal end surface of the mandrel sleeve (236) and being confined between the proximal end of the proximal fixation ring (22113) and the distal end of the twist connection (222).

8. The micropump head according to claim 6, 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 surface of the top collar (234) is fixedly connected with a proximal end surface of the top collar (231).

9. The micropump head according to claim 8, wherein the proximal end of the top sleeve (231) is provided with a ring groove adapted to the top shaft bearing (233), the top shaft bearing (233) is embedded in the ring groove at the proximal end of the top sleeve (231), and the 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).

10. The micropump head of claim 6, further comprising:

The pump head protection assembly (21), the pump head protection assembly (21) is coaxially covered outside the pump head impeller (22), and the proximal end of the pump head protection assembly (21) is in transmission connection with a protective sleeve driving module (11) in the driving control mechanism (1) through a protective sleeve (31) of the transmission shaft (3), and the distal end of the pump head protection assembly (21) is fixedly connected with the distal end of the pump head transmission assembly (23).

11. The micropump head according to claim 10, wherein the pump head protection assembly (21) includes:

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) of the transmission shaft (3), 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.

12. The micropump head according to claim 11, wherein the pump head protection assembly further comprises a support-protection-sleeve-connecting ring (213), the support-protection-sleeve-connecting ring (213) being fixed in-line at a distal end thereof to the annular proximal end of the anchor support (212), and a distal end face of the support-protection-sleeve-connecting ring (213) being flush with a distal end face of the annular proximal end of the anchor support (212), and

The support protective sleeve connecting ring (213) is sleeved outside the twisting shell (32) of the transmission shaft (3) in a sliding manner and is fixedly connected with the distal end of the protective sleeve (31) of the transmission shaft (3).

13. The micropump head according to claim 11, wherein 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 anchoring rod is in plug-in fit with the anchoring groove, so as to fixedly connect the proximal end of the top sleeve tip (211) with the distal end of the pump head transmission assembly (23).

14. The micropump head according to claim 11, wherein the anchor bracket (212) includes:

An anchor bracket framework (2121), wherein the proximal end of the anchor bracket framework (2121) is fixedly connected with the distal end of a protective sleeve (31) of the transmission shaft (3), 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).

15. The micropump head according to claim 14, wherein the anchor stent scaffold (2121) includes 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.

16. The micropump head of claim 15, wherein the anchor stent skeleton wire is made of an elastic material.