Micro pump head

Abstract

The present invention provides a micro pump head, which relates to the technical field of micro pumps. This micro pump head is applied to a left ventricular assist device, and the left ventricular assist device further includes a transmission shaft and a drive control mechanism. The micro pump head includes a pump head impeller and a pump head transmission assembly. The proximal end of the pump head impeller is drivingly connected to the twisting shell driving module of the drive control mechanism through the twisting shell of the transmission shaft, and the proximal end of the pump head transmission assembly is drivingly connected to the core shaft driving module of the drive control mechanism through the core shaft of the transmission shaft. The core shaft driving module drives the core shaft and the twisting shell to rotate synchronously to drive the distal end and the proximal end of the pump head impeller to rotate together, and the twisting shell driving module drives the twisting shell and the core shaft to rotate relative to each other to drive the proximal end of the pump head impeller to rotate relative to the distal end. The micro pump head of the present invention can be unfolded or folded to change the outer diameter size of the micro pump head in the human body, thereby improving the blood supply efficiency and the use safety of the assist device.

Description

Technical Field

[0001] The present invention relates to the technical field of micro pumps, and particularly to a micro pump head. Background Art

[0002] In the past decade or so, the number of high-risk cardiovascular intervention surgeries at home and abroad has been increasing year by year. In order to reduce the risk of death caused by blood circulation obstruction or cessation during the surgery, implantable left ventricular assist devices have been widely used in high-risk cardiovascular intervention surgeries. An implantable left ventricular assist device is a percutaneous mechanical circulatory assist system that provides auxiliary blood flow for patients undergoing high-risk cardiovascular intervention surgeries during and after the surgery. It can partially or completely assist the function of the left ventricle and help the heart deliver oxygenated blood to the whole body. The existing implantable left ventricular assist devices mainly use micro pump heads equipped with non-deformable rigid impellers. Limited by the device size, the auxiliary flow that can be generated is small. To meet the need to maintain the patient's blood circulation during high-risk intervention surgeries, for implantable left ventricular assist devices with a constant impeller size, the commonly adopted solution is to increase the impeller speed. However, the high-speed rotating impeller will inevitably cause too high internal shear force of the blood, resulting in changes in red blood cell permeability and irreversible cell damage, thereby increasing the risk of hemolysis in patients. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a micro pump head that can be folded and unfolded in the human body, thereby changing the outer diameter of the entire micro pump head in the human body and improving the auxiliary blood supply efficiency and use safety of the assist device.

[0004] To solve the above technical problem, 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:

[0005] A pump head impeller, the proximal end of the pump head impeller is drivingly connected to the twisting shell drive module of the drive control mechanism through the twisting shell of the transmission shaft; and

[0006] A pump head transmission assembly, the distal end of the pump head transmission assembly is fixedly connected to the pump head impeller, and the proximal end of the pump head transmission assembly is drivingly connected to the core shaft drive module of the drive control mechanism through the core shaft of the transmission shaft. Wherein, the core shaft is driven by the core shaft drive module to rotate synchronously with the twisting shell to drive the distal end and the proximal end of the pump head impeller to rotate together, and the twisting shell is driven by the twisting shell drive module to rotate relative to the core shaft to drive the proximal end of the pump head impeller to rotate relative to the distal end.

[0007] In one embodiment, the pump head impeller includes:

[0008] A deployable impeller, the distal end of the deployable impeller is fixedly connected to the core shaft through the pump head transmission assembly; and

[0009] A twisting connector, the distal end of the twisting connector is clamped to the proximal end of the deployable impeller, and the proximal end of the twisting connector is fixedly connected to the twisting housing.

[0010] In one embodiment, the deployable impeller includes:

[0011] An impeller skeleton, the proximal end of the impeller skeleton is fixedly connected to the twisting housing through the twisting connector, and the distal end of the impeller skeleton is fixedly connected to the core shaft through the pump head transmission assembly; and

[0012] An impeller blade surface, the impeller blade surface covers the outside of the impeller skeleton.

[0013] In one embodiment, the impeller skeleton includes:

[0014] A proximal fixing ring, the proximal fixing ring is fixedly connected to the twisting housing through the twisting connector;

[0015] A distal fixing ring, the distal fixing ring is fixedly connected to the core shaft through the pump head transmission assembly; and

[0016] Impeller skeleton wires, the impeller skeleton wires are spirally arranged between the proximal fixing ring and the distal fixing ring;

[0017] Optionally, the impeller skeleton wires are made of an elastic material;

[0018] Optionally, the distal end of the twisting connector is provided with a plurality of rotation limiting bosses, and correspondingly, a plurality of limiting grooves are formed on the outer edge of the proximal end of the proximal fixing ring. The twisting connector and the proximal fixing ring are rotationally limited by the insertion and cooperation of the rotation limiting bosses and the limiting grooves.

[0019] In one embodiment, the distal end and the proximal end of the impeller blade surface respectively cover the outside of the distal fixing ring and the proximal fixing ring, and are pushed outwards by the impeller skeleton wires to form an impeller.

[0020] In one embodiment, the pump head transmission assembly includes:

[0021] A core shaft sleeve, the core shaft sleeve penetrates through the impeller skeleton, the distal end of the core shaft sleeve is fixedly connected to the distal fixing ring, and the proximal end of the core shaft sleeve is sleeved inside the proximal fixing ring and fixedly connected to the core shaft;

[0022] A top shaft, the proximal end of the top shaft is fixedly embedded in the core shaft sleeve;

[0023] A top shaft bearing, wherein the top shaft bearing is sleeved at the distal end of the top shaft, and the proximal end surface of the top shaft bearing contacts the distal end surface of the core shaft sleeve;

[0024] A top shaft sleeve, wherein the top shaft sleeve is fixedly sleeved on the distal end of the top shaft, and the inner edge of the top shaft bearing is limited to be located between the distal end surface of the core shaft sleeve and the proximal end surface of the top shaft sleeve; and

[0025] A top sleeve, wherein the proximal end of the top sleeve is sleeved on the distal end of the top shaft;

[0026] Optionally, the proximal fixing sleeve of the mandrel sleeve is provided with a mandrel collar, the proximal end surface of the mandrel collar is flush with the proximal end surface of the mandrel sleeve, and is limited to be located between the proximal end of the proximal fixing ring and the distal end of the twisting connector;

[0027] Optionally, a top collar is sleeved on the core shaft sleeve, the top collar is sleeved on the distal end of the core shaft sleeve, and the distal end surface of the top collar is fixedly connected to the proximal end surface of the top collar;

[0028] Optionally, the proximal end of the top sleeve is provided with an annular groove adapted to the top shaft bearing, the top shaft bearing is embedded in the proximal annular groove of the top sleeve, and the outer edge of the top shaft bearing is limited to be located between the proximal annular groove of the top sleeve and the top sleeve ring.

[0029] In one embodiment, the micro pump head further comprises:

[0030] The pump head protection assembly, the coaxial cover of the pump head protection group is arranged outside the pump head impeller, and the proximal end of the pump head protection assembly is connected to the protective cover drive module in the drive control mechanism through the protective cover of the transmission shaft, and the distal end of the pump head protection assembly is fixedly connected to the distal end of the pump head transmission assembly.

[0031] In one embodiment, the pump head protection assembly includes:

[0032] An anchor bracket, the proximal end of the anchor bracket is fixedly connected to the distal end of the protective sleeve of the transmission shaft, and the distal end of the anchor bracket is sleeved and fixed to the distal end of the pump head transmission assembly; and

[0033] A top sleeve tip, the top sleeve tip is arranged at the distal end of the anchor bracket, and the proximal end of the top sleeve tip is fixedly connected to the distal end of the pump head transmission assembly;

[0034] Optionally, the pump head protection assembly further comprises a bracket protection sleeve connecting ring, the distal end of the bracket protection sleeve connecting ring is embedded and fixed in the annular proximal end of the anchor bracket, and the distal end surface of the bracket protection sleeve connecting ring is flush with the distal end surface of the annular proximal end of the anchor bracket, and

[0035] The connecting ring of the bracket protective sleeve is slidably sleeved outside the twisting shell of the transmission shaft and is fixedly connected to the distal end of the protective sleeve of the transmission shaft;

[0036] Optionally, an anchoring groove is formed at the distal end of the top sleeve, and an anchoring rod is provided at the proximal end of the top sleeve tip. The anchoring rod is inserted into and cooperates with the anchoring groove to fixedly connect the proximal end of the top sleeve tip to the distal end of the pump head transmission assembly.

[0037] In one embodiment, the anchoring bracket includes:

[0038] An anchoring bracket skeleton, the proximal end of the anchoring bracket skeleton is fixedly connected to the distal end of the protective sleeve of the transmission shaft, and the distal end of the anchoring bracket skeleton is sleeved and fixed to the distal end of the pump head transmission assembly; and

[0039] An anchoring bracket film, the anchoring bracket film is sleeved outside the anchoring bracket skeleton.

[0040] In one embodiment, the anchoring bracket skeleton includes an anchoring bracket skeleton proximal ring, an anchoring bracket skeleton distal ring, and a plurality of anchoring bracket skeleton wires arranged in parallel between the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring. When the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring approach each other, the anchoring bracket skeleton wires bend outward to expand the structure of the pump head protection assembly, and when the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring move away from each other, the anchoring bracket skeleton wires tighten inward to contract the structure of the pump head protection assembly;

[0041] Optionally, the anchoring bracket skeleton wires are made of an elastic material.

[0042] The above solution of the present invention has at least the following beneficial effects:

[0043] The micro pump head provided by the above solution of the present invention is mainly applied to a left ventricular assist device, which also includes a drive shaft and a drive control mechanism. The micro pump head includes: a pump head impeller, the proximal end of the pump head impeller is drivingly connected to the twisting shell drive module of the drive control mechanism through the twisting shell of the drive shaft; and a pump head transmission assembly, the distal end of the pump head transmission assembly is fixedly connected to the distal end of the pump head impeller, and the proximal end of the pump head transmission assembly is drivingly connected to the core shaft drive module of the drive control mechanism through the core shaft of the drive shaft; the core shaft drive module drives the core shaft and the twisting shell to rotate synchronously to drive the distal end and the proximal end of the pump head impeller to rotate together. At this time, the entire pump head impeller rotates in a single direction with a fixed outer diameter; and the twisting shell drive module drives the twisting shell and the core shaft to rotate relative to each other to drive the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller folds or unfolds to adjust the outer diameter of the pump head impeller. By controlling the folding or unfolding of the pump head impeller in the micro pump head, it helps to implant the pump head impeller in a folded state into a designated position in the human body through minimally invasive interventional surgery. Subsequently, the pump head impeller can be deformed and unfolded in the human body into a spiral shape with a larger outer diameter, so that the assist device has the ability to provide sufficient auxiliary blood flow for the patient at a low rotational speed, thereby improving the blood supply efficiency and use safety of the assist device; at the same time, the pump head impeller with an adjustable outer diameter also helps to reduce the resistance when the entire micro pump head enters and passes through the catheter, which is more conducive to the rapid and safe deployment and recovery of the assist device. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 is a schematic connection diagram of the micro pump head provided by the embodiment of the present invention in the left ventricular assist device;

[0045] Figure 2 is a schematic cross-sectional view of the connection between the micro pump head and the drive shaft provided by an alternative embodiment of the present invention;

[0046] Figure 3 is a schematic three-dimensional structure diagram of the pump head impeller when unfolded (normal state) provided by an alternative embodiment of the present invention;

[0047] Figure 4 is an exploded view of the pump head impeller provided by an alternative embodiment of the present invention;

[0048] Figure 5 is a schematic three-dimensional structure diagram of the impeller skeleton when unfolded (normal state) provided by an alternative embodiment of the present invention;

[0049] Figure 6 is a schematic three-dimensional structure diagram of the impeller blade surface provided by an alternative embodiment of the present invention;

[0050] Figure 7 is a schematic three-dimensional structure diagram of the impeller skeleton when folded provided by an alternative embodiment of the present invention;

[0051] Figure 8 It is a schematic diagram of the twist added during the rotation of the deployable impeller provided by an alternative embodiment of the present invention in the normal state in the illustrated direction;

[0052] Figure 9 is Figure 8 A schematic diagram of the deployable impeller in the folded state after rotation and twisting;

[0053] Figure 10 It is a three-dimensional structure schematic diagram of the pump head drive assembly provided by an alternative embodiment of the present invention;

[0054] Figure 11 It is an exploded view of the pump head drive assembly provided by an alternative embodiment of the present invention;

[0055] Figure 12 It is a three-dimensional structure schematic diagram of the pump head protection assembly provided by an alternative embodiment of the present invention;

[0056] Figure 13 It is an exploded view of the pump head protection assembly provided by an alternative embodiment of the present invention;

[0057] Figure 14 It is a cross-sectional schematic diagram of the drive control mechanism provided by an alternative embodiment of the present invention.

[0058] Explanation of the reference numerals in the drawings:

[0059] 100, left ventricular assist device;

[0060] 1, drive control mechanism;

[0061] 11, protective sleeve drive module; 12, twisting shell drive module; 13, core shaft drive module;

[0062] 2, micro pump head;

[0063] 21, pump head protection assembly; 211, tip of the top sleeve; 212, anchoring bracket; 2121, skeleton of the anchoring bracket; 2122, film of the anchoring bracket; 213, connecting ring of the bracket protective sleeve;

[0064] 22, pump head impeller; 221, deployable impeller; 2211, impeller skeleton; 2212, impeller blade surface; 22111, distal fixing ring; 22112, impeller skeleton wire; 22113, proximal fixing ring; 222, twisting connecting piece;

[0065] 23, pump head drive assembly; 231, top sleeve; 232, top shaft sleeve; 233, top shaft bearing; 234, top sleeve ring; 235, top shaft; 236, core shaft sleeve, 237, core shaft sleeve ring;

[0066] 3. Drive shaft; 31. Protective sleeve; 32. Twisting shell; 33. Core shaft;

[0067] 4. Fiber optic pressure sensor. Detailed implementation manners

[0068] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0069] In the following description, certain specific details are set forth for the purpose of explaining various disclosed embodiments to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments can be practiced without one or more of these specific details. In other instances, well-known devices, structures, and techniques associated with the present application may not be shown or described in detail so as not to unnecessarily obscure the description of the embodiments.

[0070] References to "an embodiment" or "one embodiment" throughout the specification mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in an embodiment" or "in one embodiment" throughout the specification need not all refer to the same embodiment. Additionally, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0071] In the following description, in order to clearly show the structure and working mode of the present invention, many directional terms will be used for description. However, words such as "front", "rear", "left", "right", "outer", "inner", "outward", "inward", "up", "down", etc. should be understood as convenient terms and should not be understood as limiting terms.

[0072] First of all, 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, and the micro pump head directly enters the patient's body; during the use of 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 the blood. At present, all interventional left ventricular assist devices comply with the basic laws of fluid mechanics, that is, their blood supply efficiency is positively correlated with the impeller size; as the outer diameter of the impeller continues to decrease, its blood supply capacity inevitably decreases gradually. Therefore, according to the present invention, a micro pump head with an adjustable outer diameter is provided. While ensuring that the micro pump head can be implanted through minimally invasive interventional surgery, the outer diameter of the pump head impeller is increased in the auxiliary blood supply state, so that the pump head impeller of the auxiliary device has the ability to provide the patient with sufficient auxiliary blood flow at a low speed, thereby improving the blood supply efficiency and use safety of the auxiliary device.

[0073] like Figures 1-3 as well as Figure 10 As shown, one 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 comprising a transmission shaft 3 and a drive control mechanism 1, the micro pump head 2 comprising a pump head impeller 22 and a pump head transmission assembly 23, the proximal end of the pump head impeller 22 is transmission-connected to the twisting shell drive module 12 of the drive control mechanism 1 through the twisting shell 32 of the transmission shaft 3, the distal end of the pump head transmission assembly 23 is fixedly connected to the distal end of the pump head impeller 22, the proximal end of the pump head transmission assembly 23 is transmission-connected to the twisting shell drive module 12 of the drive control mechanism 1 through the twisting shell 32 of the transmission shaft 3, the distal end of the pump head transmission assembly 23 is fixedly connected to the distal end of the pump head impeller 22, and the proximal end of the pump head transmission assembly 23 is transmission-connected to the twisting shell drive module 12 of the drive control mechanism 1 through the twisting shell 32 of the transmission shaft 3. The shaft 33 is connected to the core shaft drive module 13 of the drive control mechanism 1, and the core shaft 33 and the twisting shell 32 are driven to rotate synchronously through the core shaft drive 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 as a whole rotates in a single direction with a fixed outer diameter, and the twisting shell 32 is driven to rotate relative to the core shaft 33 through the twisting shell drive module 12 to drive the proximal end of the pump head impeller 22 to rotate relative to the distal end, and the pump head impeller 22 is folded or unfolded, thereby adjusting the outer diameter of the pump head impeller 22.

[0074] Specifically, refer to Figure 14 The proximal end of the twisting shell driving module 12 and the distal end of the core shaft driving module 13 are detachably connected. When the distal end of the core shaft driving module 13 is connected to the proximal end of the twisting shell driving module 12, the core shaft driving module 3 drives the core shaft 33 to rotate, and drives the twisting shell driving module 12 to rotate synchronously. The twisting shell driving module 12 drives the twisting shell 32 to rotate, and then drives the twisting shell 32 and the core shaft 33 to rotate synchronously; when the distal end of the core shaft 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 realize rotation relative to the core shaft 33.

[0075] In this embodiment, the pump head drive assembly 23 penetrates through the entire pump head impeller 22. The distal end of the pump head drive assembly 23 is fixedly connected to the distal end of the pump head impeller 22, and the proximal end of the pump head drive assembly 23 is fixedly connected to the distal end of the core shaft 33 in the transmission shaft 3. The distal end of the pump head impeller 22 is sequentially connected to the core shaft drive module 13 of the drive control mechanism 1 through the pump head drive assembly 23 and the core shaft 33 (the proximal end of the core shaft 33 is connected to the core shaft drive module). The proximal end of the pump head impeller 22 is fixedly connected to the distal end of the twisting shell 32 in the transmission shaft 3, and the proximal end of the pump head impeller 22 is connected to the twisting shell drive module 12 of the drive control mechanism 1 through the twisting shell 32 (the proximal end of the twisting shell 32 is connected to the twisting shell drive module 12).

[0076] Here, the twisting shell 32 of the transmission shaft 3 is sleeved outside the core shaft 33. The drive control mechanism 1 drives the core shaft 33 and the twisting shell 32 to rotate synchronously (the synchronous rotation here means rotating at the same angular velocity) or relatively rotate through the cooperation of the core shaft drive module 13 and the twisting shell drive module 12. Specifically, when the core shaft drive module drives the core shaft 33 and the twisting shell 32 to rotate synchronously, the entire pump head impeller 22 is driven to rotate in one direction with a fixed outer diameter. When the twisting shell drive module 12 drives the twisting shell 32 to rotate relative to the core shaft 33, the proximal end of the pump head impeller 22 is driven to rotate relative to the distal end, so as to realize the folding or unfolding of the pump head impeller 22. During the folding or unfolding process of the pump head impeller 22, the outer diameter of the pump head impeller 22 changes. Specifically, when the pump head impeller 22 folds, the overall outer diameter decreases, so that the entire micro pump head 2 can enter the patient's body in a folded state through minimally invasive intervention, thereby improving the safety and convenience of using the auxiliary device. After the folded pump head impeller 22 enters the patient's body, it deforms and unfolds in the body into an unfolded state with a larger outer diameter, and at this time, the outer diameter of the pump head impeller 22 is much larger than that in the folded state, so that the left ventricular assist device has the ability to provide sufficient auxiliary blood flow for the patient at a low rotation speed, thereby improving the blood supply efficiency of the auxiliary device and reducing the hemolysis risk.

[0077] In addition, the folding and unfolding function of the pump head impeller 22 helps to reduce the resistance when the micro pump head 2 enters and passes through the catheter, and is more conducive to the rapid and safe deployment and recovery of the left ventricular assist device. The drive 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 method, which is convenient for clinical operation. And during the folding and unfolding process of the pump head impeller 22, only the outer diameter changes, and its axial dimension remains unchanged, making the deformation process of the pump head impeller 22 have high controllability.

[0078] Such as Figures 3 to 4As shown, in an alternative embodiment of the present invention, the pump head impeller 22 includes a deployable impeller 221 and a twisting connector 222. The distal end of the deployable impeller 221 is fixedly connected to the core shaft 33 through the pump head transmission assembly 23. The proximal end of the deployable impeller 221 is snap-connected to the distal end of the twisting connector 222, and the proximal end of the twisting connector 222 is fixedly connected to the twisting housing 32.

[0079] In this embodiment, the proximal end of the deployable impeller 221 is snap-connected and fixed to the distal end of the twisting connector 222, and is fixedly connected to the distal end of the twisting housing 32 in the drive shaft 3 through the proximal end of the twisting connector 222. The proximal end of the twisting housing 32 is in transmission connection with the twisting housing drive module 12 in the drive control mechanism 1. When the twisting housing 32 is driven to rotate by the twisting housing drive module 12, the twisting housing 32 drives the twisting connector 222 to rotate, and drives the proximal end of the deployable impeller 221 to rotate through the twisting connector 222. Since the distal end of the deployable impeller 221 is fixedly connected to the distal end of the core shaft 33 in the drive shaft 3 through the pump head transmission assembly 23, and the proximal end of the core shaft 33 is in transmission connection with the core shaft drive module 13 in the drive control mechanism 1. When the core shaft 33 is driven to rotate by the core shaft drive module 13, the core shaft 33 drives the pump head transmission assembly 23 to rotate, and drives the distal end of the deployable impeller 221 to rotate through the pump head transmission assembly 23.

[0080] When the core shaft 33 and the twisting housing 32 rotate synchronously, the distal end and the proximal end of the deployable impeller 221 rotate synchronously, so that the entire pump head impeller 22 rotates while the outer diameter size remains fixed. When the twisting housing 32 rotates relative to the core shaft 33, the distal end and the proximal end of the deployable impeller 221 rotate relative to each other. The deployable impeller 221 will expand or fold when the distal end and the proximal end rotate relative to each other, so as to change the outer diameter of the entire pump head impeller 22 (the outer diameter increases when expanding and decreases when folding).

[0081] Optionally, a core shaft hole for the core shaft 33 to pass through is provided on the twisting connector 222, so that the distal end of the core shaft 33 can pass through the twisting connector 222 and is fixedly connected to the distal end of the deployable impeller 221 through the pump head transmission assembly 23.

[0082] As Figures 5 to 6 shown, in an alternative embodiment of the present invention, the deployable impeller 221 includes an impeller skeleton 2211 and an impeller blade surface 2212. The proximal end of the impeller skeleton 2211 is fixedly connected to the twisting housing 32 through the twisting connector 222. The distal end of the impeller skeleton 2211 is fixedly connected to the core shaft 33 through the pump head transmission assembly 23. The impeller blade surface 2212 is coated outside the impeller skeleton 2211.

[0083] In this embodiment, the impeller framework 2211 can be twisted and folded or twisted and unfolded as a whole. The impeller blade surface 2212 is coated on the outside of the impeller framework 2211, and the distal end and the proximal end of the impeller blade surface 2212 are adhesively fixed to the distal end and the proximal end of the impeller framework 2211 respectively, so as to ensure that the impeller blade surface 2212 will not fall off during the folding / unfolding and auxiliary blood supply processes.

[0084] Preferably, the impeller blade surface 2212 can be prepared from a biocompatible superelastic medical silicone material. On the one hand, it can reduce the harm to the human body and blood cells caused by the pump head impeller 22 during use. On the other hand, it can ensure that the pump head impeller 22 has the ability of large folding / unfolding ratio deformation (when the impeller framework 2211 is twisted and unfolded, the impeller blade surface 2212 can be pushed outwards by the impeller framework 2211 to form a spiral impeller and increase the outer diameter of the overall pump head impeller 22. When the impeller framework 2211 is twisted and folded, the impeller blade surface 2212 will contract inwards into a cylindrical shape and reduce the outer diameter of the overall pump head impeller 22); Preferably, the medical silicone material can be prepared by stirring and mixing Dragon Skin silicone and Slic Thinner diluent with a mass ratio of 2:1 at room temperature and heating and curing to form a film; This medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75 kPa, the maximum strain it can reach is 1328.2%, and the maximum stress it can withstand is 675.3 kPa, so as to meet the requirements during the use of the entire micro pump head 2.

[0085] Furthermore, as Figure 5 shown, the impeller framework 2211 includes a proximal fixing ring 22113, a distal fixing ring 22111 and impeller framework wires 22112. The proximal fixing ring 22113 is fixedly connected to the twisting shell 32 through a twisting connecting piece 222. The distal fixing ring 22111 is fixedly connected to the core shaft 33 through a pump head transmission assembly 23. The impeller framework wires 22112 are arranged in a spiral shape between the proximal fixing ring 22113 and the distal fixing ring 22111.

[0086] In this embodiment, both the proximal fixing ring 22113 and the distal fixing ring 22111 are annular cylinders, and the outer diameters of the proximal fixing ring 22113 and the distal fixing ring 22111 can be set according to the inner diameter of the medical catheter during use. Preferably, the outer diameters of the proximal fixing ring 22113 and the distal fixing ring 22111 are equal and slightly smaller than the inner diameter of the medical catheter. The settings of the proximal fixing ring 22113 and the distal fixing ring 22111 can ensure that the foldable impeller 221 is cylindrical as a whole in the folded state, and the outer diameter of the foldable impeller 221 in the folded state is smaller than the inner diameter of the medical catheter, so as to facilitate implanting the foldable impeller 221 into a suitable position through a minimally invasive interventional operation via a human blood vessel.

[0087] Here, the distal fixing ring 22111, the proximal fixing ring 22113, and the impeller frame wires 22112 can be prepared by metal 3D printing in an integrally formed manner to obtain the impeller frame 2211. The distal fixing ring 22111, the proximal fixing ring 22113, and the impeller frame wires 22112 can also be prepared by femtosecond laser cutting of a nitinol tube to obtain the impeller frame 2211.

[0088] There are multiple impeller frame wires 22112 disposed between the proximal fixing ring 22113 and the distal fixing ring 22111. The multiple impeller frame wires 22112 are connected in parallel between the proximal fixing ring 22113 and the distal fixing ring 22111 along the same helical direction. Preferably, the multiple impeller frame wires 22112 can be assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 respectively in a form-locking manner by inserting into the proximal assembly holes of the distal fixing ring 22111 and the distal assembly holes of the proximal fixing ring 22113. More preferably, a biocompatible glue can be applied at the assembly location for adhesive fixation.

[0089] In one embodiment, the impeller frame wires 22112 are made of a superelastic material with a certain stiffness. Preferably, the elastic material is a superelastic nitinol metal material with a certain stiffness. The impeller frame wires 22112 can be prepared by heat treating nitinol wires through a mold. The impeller frame wires 22112 made of a superelastic material with a certain stiffness can provide a certain stiffness for the deployable impeller 221 after deployment, ensuring the stability of the deployable impeller 221 during rotation.

[0090] In the deployed state (normal state) of the deployable impeller 221, the impeller frame wires 22112 are helical, preferably a few-cycle helix, such as a single-cycle helix or a double-cycle helix, and the outer edge of the helix extends outward. In the deployed state of the deployable impeller 221, when the proximal fixing ring 22113 rotates relative to the distal fixing ring 22111 along the helical direction, the helical period of the impeller frame wires 22112 increases, and the impeller frame wires 22112 are further twisted and folded, causing the outer edge of the helix to retract inward and the outer diameter of the deployable impeller 221 to decrease.

[0091] The deployable impeller 221 can be prepared in the following manner. Twist and pre-tighten the impeller frame 2211 in the deployed state (as shown in Figure 5 ) to the folded state (as shown in Figure 7 ), and sleeve the impeller blade surface 2212 onto the surface of the impeller frame 2211 to obtain the deployable impeller 221 in the folded state as shown in Figure 9 . As shown in Figure 9The rotation direction shown releases the pre-tightening force, enabling the impeller frame wire 22112 to recover to at least a periodic spiral shape under elastic action. The outer edge of the spiral extends outwards, increasing the outer diameter of the deployable impeller 221, and thus obtaining as Figure 8 the deployable impeller 221 shown. Conversely, by twisting in the rotation direction shown as Figure 8 shown, the deployable impeller 221 in the folded state as shown in Figure 9 can be obtained.

[0092] In an achievable example of the present invention, the distal and proximal ends of the impeller blade surface 2212 are respectively coated outside the distal fixed ring 22111 and the proximal fixed ring 22113, and are pushed outwards by the impeller frame wire 22112 to form the impeller. Here, the impeller blade surface 2212 can be adhesively bonded to the distal fixed ring 22111 and the proximal fixed ring 22113 respectively through biocompatible glue to ensure that the impeller blade surface 2212 will not fall off during the deployment and auxiliary blood supply processes. At the same time, the biocompatible glue can also avoid harm to the human body.

[0093] In an achievable example of the present invention, the distal end of the twisting connecting piece 222 can be provided with a plurality of rotation limiting bosses, and a plurality of limiting grooves are correspondingly opened on the outer edge of the proximal end of the proximal fixed ring 22113. The twisting connecting piece 222 and the proximal fixed ring 22113 are rotationally limited by the insertion and cooperation of the rotation limiting bosses and the limiting grooves. The assembly connection of the rotation limiting bosses and the limiting grooves between the twisting connecting piece 222 and the proximal fixed ring 22113 can better transmit the twisting torque to the deployable impeller 221 through the twisting connecting piece 222 to achieve the one-step twisting and deployment of the deployable impeller 221.

[0094] As Figures 10 to 11 shown, in an alternative embodiment of the present invention, the pump head drive assembly 23 includes a core shaft sleeve 236, a top shaft 235, a top shaft bearing 233, a top shaft sleeve 232, and a top sleeve 231. The core shaft sleeve 236 penetrates through the impeller frame 2211. The distal end of the core shaft sleeve 236 is fixedly connected to the distal fixed ring 22111. The proximal end of the core shaft sleeve 236 is sleeved inside the proximal fixed ring 22113 and is fixedly connected to the core shaft 33. The proximal end of the top shaft 235 is fixedly embedded in the distal end of the core 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 contacts 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 a ring groove adapted to the top shaft bearing 233 is opened at the proximal end of the top sleeve 231.

[0095] In this embodiment, the mandrel sleeve 236 passes through the proximal fixing ring 22113 and the distal fixing ring 22111, and the distal end of the mandrel sleeve 236 is fixedly connected to the distal fixing ring 22111. The proximal end of the mandrel sleeve 236 is sleeved outside the distal end of the mandrel 33 in the transmission shaft 3. Preferably, a mandrel sleeve ring 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236. The mandrel sleeve ring 237 is fixedly sleeved on the proximal end of the mandrel sleeve 236 on the premise that its proximal end face is flush with the proximal end face of the mandrel sleeve 236, and the mandrel sleeve ring 237 is limited between the proximal end of the proximal fixing ring 22113 and the distal end of the twisting connector 222. Here, a biocompatible glue can be used to bond and fix the mandrel sleeve 236 and the mandrel sleeve ring 237 to ensure that the mandrel sleeve ring 237 will not fall off the mandrel sleeve 236.

[0096] Preferably, the axial positioning of the deployable impeller 221 can be performed through the distal end face of the mandrel sleeve ring 237. On this basis, a biocompatible glue can be used to bond the distal fixing ring 22111 and the mandrel sleeve 236. Since the mandrel 33 is inserted and fixed in the mandrel sleeve 236, when the mandrel 33 is inserted into the mandrel sleeve 236 until the distal end face of the mandrel 33 contacts the proximal end face of the jackshaft 235, a biocompatible glue can be used to bond and fix the mandrel sleeve 236 and the mandrel 33.

[0097] Optionally, a top sleeve ring 234 is sleeved on the mandrel sleeve 236. The top sleeve ring 234 is sleeved on the distal end of the mandrel sleeve 236, and the distal end face of the top sleeve ring 234 is fixedly connected to the proximal end face of the top sleeve 231.

[0098] Optionally, the proximal end of the top sleeve 231 is sleeved on the distal end of the jackshaft 235 through a jackshaft bearing 233. The jackshaft bearing 233 is embedded in a ring groove opened at the proximal end of the top sleeve 231, and the outer edge of the jackshaft bearing 233 is limited between the ring groove and the top sleeve ring 234. Here, a biocompatible glue can be used to bond and fix the jackshaft sleeve 232 and the jackshaft 235 to ensure that the jackshaft sleeve 232 will not fall off the jackshaft 235. After the top sleeve 231 is sleeved outside the jackshaft bearing 233, when ensuring that the distal end face of the top sleeve 231 contacts the distal end face of the jackshaft bearing 233 and the proximal end face of the top sleeve ring 234 contacts the proximal end face of the jackshaft bearing 233, a biocompatible glue can be used to bond and fix the top sleeve 231 and the top sleeve ring 234.

[0099] By fixedly connecting the distal end of the mandrel sleeve 236 in the pump head transmission assembly 23 to the distal fixing ring 22111 in the foldable impeller 221, and fixing the proximal end of the mandrel sleeve 236 to the distal end of the mandrel 33 in the transmission shaft 3 (the proximal end of the mandrel sleeve 236 is sleeved outside the distal end of the mandrel 33 and fixedly connected), the mandrel 33 can be driven to rotate by the mandrel drive module 13 in the drive control mechanism 1. When the mandrel 33 rotates, the distal end of the foldable impeller 221 and the mandrel 33 rotate synchronously with each other under the coordinated action of the components in the pump head transmission assembly 23. When the twisting housing 32 is driven to rotate by the twisting housing drive module 12 in the drive control mechanism 1, the twisting housing 32 rotates and drives the proximal end of the foldable impeller 221 and the twisting housing 32 to rotate synchronously through the twisting connector 222. When the core shaft 33 and the twisting housing 32 rotate synchronously, the distal and proximal ends of the foldable impeller 221 rotate synchronously, thereby enabling the foldable impeller 221 to rotate in a single direction with a fixed outer diameter. When the core shaft 33 and the twisting housing 32 rotate relative to each other, the distal and proximal ends of the foldable impeller 221 rotate relative to each other, thereby enabling the folding and unfolding of the foldable impeller 221 to adjust the outer diameter of the entire foldable impeller 221.

[0100] like Figures 12 to 13 As shown, in an optional embodiment of the present invention, the micro pump head may further include a pump head protection assembly 21, the pump head protection assembly 21 is coaxially covered outside the pump head impeller 22, and the proximal end of the pump head protection assembly 21 is transmission-connected to the protective cover drive module in the drive control mechanism 1 through the protective cover 31 of the transmission shaft 3, 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.

[0101] 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. Since the protective sleeve 31 is arranged outside the twisting shell 32, and the proximal end of the protective sleeve 31 is transmission-connected to the protective sleeve drive module 11 in the drive control mechanism 1, when the protective sleeve drive 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, thereby controlling the folding or unfolding of the pump head protection assembly 21 to adjust the outer diameter of the pump head protection assembly 21 (when the protective sleeve 31 slides toward the distal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 decreases, and the outer diameter of the pump head protection assembly 21 increases; when the protective sleeve 31 slides toward the proximal end, the relative distance between the proximal end and the distal end of the pump head protection assembly 21 increases, and the outer diameter of the pump head protection assembly 21 decreases) to match the increase or decrease in the outer diameter of the foldable impeller 221 in the pump head impeller 22.

[0102] Further, the pump head protection assembly 21 may include an anchoring bracket 212 and a tip sleeve 211. The proximal end of the anchoring bracket 212 is fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3, and the annular distal end of the anchoring bracket 212 is sleeved and fixed to the distal end of the pump head transmission assembly 23. The tip sleeve 211 is disposed at the distal end of the anchoring bracket 212, and the proximal end of the tip sleeve 211 is fixedly connected to the distal end of the pump head transmission assembly 23.

[0103] In this embodiment, both the proximal end and the distal end of the anchoring bracket 212 may be provided as annular. The proximal end of the tip sleeve 211 is fixedly connected to the distal end of the top sleeve 231 in the pump head transmission assembly 23.

[0104] Optionally, an anchoring groove is provided at the distal end of the top sleeve 231, and an anchoring rod is provided at the proximal end of the tip sleeve 211. The proximal end of the tip sleeve 211 is installed in the top sleeve 231 by inserting and mating the anchoring rod with the anchoring groove.

[0105] Optionally, the distal end of the tip sleeve 211 is provided as a smooth dome shape, so as to facilitate the entire micro pump head 2 to enter the patient's body through minimally invasive intervention and reduce the resistance suffered by the blood flow when passing through the micro pump head 2.

[0106] Optionally, the pump head protection assembly 21 may further include a bracket protective sleeve connection ring 213. The distal end of the bracket protective sleeve connection ring 213 is embedded and fixed in the annular proximal end of the anchoring bracket 212, and the distal end face of the bracket protective sleeve connection ring 213 is flush with the distal end face of the annular proximal end of the anchoring bracket 212. In addition, the bracket protective sleeve connection ring 213 is slidably sleeved outside the twisted shell 32 and is fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3 to further strengthen the fixed connection between the distal end of the protective sleeve 31 and the proximal end of the anchoring bracket 212.

[0107] Here, under the condition that the annular proximal end of the anchoring bracket 212 is sleeved outside the bracket protective sleeve connection ring 213 and it is ensured that the distal end face of the bracket protective sleeve connection ring 213 is flush with the distal end face of the annular proximal end of the anchoring bracket 212, a biocompatible glue can be used to bond and fix the proximal end of the anchoring bracket 212 and the bracket protective sleeve connection ring 213. Subsequently, the protective sleeve 31 is sleeved on the proximal end of the bracket protective sleeve connection ring 213, and under the condition that it is ensured that the distal end face of the protective sleeve 31 contacts the proximal end face of the annular proximal end of the anchoring bracket 212, a biocompatible glue can be used to bond and fix the protective sleeve 31 to the bracket protective sleeve connection ring 213 and the anchoring bracket 212 successively.

[0108] Further, the anchoring bracket 212 includes an anchoring bracket skeleton 2121 and an anchoring bracket membrane 2122. The proximal end of the anchoring bracket skeleton 2121 is fixedly connected to the distal end of the protective sleeve 31 of the transmission shaft 3, the distal end of the anchoring bracket skeleton 2121 is sleeved and fixed to the distal end of the pump head transmission assembly 23, and the anchoring bracket membrane 2122 is sleeved outside the anchoring bracket skeleton 2121.

[0109] In this embodiment, the anchoring bracket framework 2121 provides a certain anchoring support force for the entire pump head protection assembly 21. The anchoring bracket membrane 2122 is sleeved outside the anchoring bracket framework 2121 and can be used to reduce the contact stress between the anchoring bracket 212 and the blood vessel. Preferably, the anchoring bracket framework 2121 and the anchoring bracket membrane 2122 can be adhesively fixed by a biocompatible glue. Here, the anchoring bracket framework 2121 can be prepared by laser cutting a nitinol tube, and the anchoring bracket membrane 2122 can be prepared by casting a medical silicone material. Preferably, the medical silicone material can be prepared by stirring and mixing DragonSkin silicone and Slic Thinner diluent at a mass ratio of 2:1 at room temperature and heating and curing to form a film. The medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75 kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be borne is 675.3 kPa to meet the requirements during the use of the entire micro pump head 2.

[0110] In an alternative embodiment of the present invention, the anchoring bracket framework 2121 includes an anchoring bracket framework proximal ring, an anchoring bracket framework distal ring, and a plurality of anchoring bracket framework wires arranged in parallel between the anchoring bracket framework proximal ring and the anchoring bracket framework distal ring. The anchoring bracket framework wires bend outward when the anchoring bracket framework proximal ring and the anchoring bracket framework distal ring approach each other, so as to expand the structure of the pump head protection assembly 21, and the anchoring bracket framework wires tighten inward when the anchoring bracket framework proximal ring and the anchoring bracket framework distal ring move away from each other, so as to contract the structure of the pump head protection assembly 21.

[0111] In this embodiment, the inner bracket protection sleeve connection ring 213 is embedded in the anchoring bracket framework proximal ring, and the fixed connection with the protection sleeve 31 is further strengthened through the bracket protection sleeve connection ring 213. The anchoring bracket framework distal ring is sleeved and fixed outside the distal end of the top sleeve 231.

[0112] A plurality of anchoring bracket framework wires are provided. The plurality of anchoring bracket framework wires are arranged in parallel between the anchoring bracket framework distal ring and the anchoring bracket framework proximal ring, and form an anchoring bracket framework 2121 with a cage-like structure. The anchoring bracket framework wires can bend outward when the anchoring bracket framework proximal ring and the anchoring bracket framework distal ring approach each other, so as to expand the cage-like structure. On the contrary, the anchoring bracket framework wires can be stretched towards both ends, so as to contract the cage-like structure.

[0113] When the micro pump head 2 provided by the embodiment of the present invention is specifically applied to a left ventricular assist device, it needs to be assembled with the distal end of the transmission shaft 3. The assembly process is as follows:

[0114] Step 11: Align and adhesively fix the proximal end faces of the mandrel sleeve 236 and the mandrel sleeve ring 237. Subsequently, slip the deployable impeller 221 onto the mandrel sleeve 236, axially position the deployable impeller 221 through the distal end face of the mandrel sleeve ring 237, and adhesively fix the distal fixing ring 22111 to the mandrel sleeve 236.

[0115] Step 12: Insert the jackshaft 235 into the mandrel sleeve 236 to a specific position and adhesively fix the two. Then, slip the jackshaft sleeve ring 234 onto the mandrel sleeve 236 and the jackshaft bearing 233 onto the jackshaft 235 in sequence, and axially position the jackshaft bearing 233 using the distal end face of the mandrel sleeve 236. Subsequently, slip the jackshaft sleeve 232 onto the jackshaft 235, axially position the jackshaft sleeve 232 through the distal end face of the jackshaft bearing 233, and then adhesively fix the jackshaft sleeve 232 to the jackshaft 235. Finally, slip the jacking sleeve 231 onto the jackshaft bearing 233, and adhesively fix the jacking sleeve 231 and the jackshaft sleeve ring 234 while ensuring that the distal end face of the jacking sleeve 231 contacts the distal end face of the jackshaft bearing 233 and the proximal end face of the jackshaft sleeve ring 234 contacts the proximal end face of the jackshaft bearing 233.

[0116] Step 13: Slip the annular proximal end of the anchoring bracket 212 onto the bracket protective sleeve connecting ring 213, and adhesively fix the proximal end of the anchoring bracket 212 to the bracket protective sleeve connecting ring 213 on 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. Subsequently, slip the protective sleeve 31 onto the proximal end of the bracket protective sleeve connecting ring 213, and adhesively bond the protective sleeve 31 to the bracket protective sleeve connecting ring 213 and the anchoring bracket 212 in sequence while ensuring that the distal end face of the protective sleeve 31 contacts the proximal end face of the annular proximal end of the anchoring bracket 212. Assemble the proximal end of the twisting connector 222 to the distal end of the twisting housing 32 and adhesively fix the assembly. Insert the mandrel 33 into the mandrel sleeve 236 until the distal end face of the mandrel 33 contacts the proximal end face of the jackshaft 235, and adhesively fix the mandrel sleeve 236 and the mandrel 33.

[0117] Step 14: Insert the mandrel 33 into the twisting housing 32, plug and assemble the distal end of the twisting connector 222 to the proximal end of the proximal fixing ring 22113 and adhesively fix the assembly. Subsequently, while inserting the twisting housing 32 into the protective sleeve 31, slip the annular distal end of the anchoring bracket 212 onto the distal end of the jacking sleeve 231 and adhesively bond the anchoring bracket 212 to the jacking sleeve 231. Finally, assemble the jacking sleeve tip 211 to the distal end of the jacking sleeve 231. Thus, the drive shaft 3 and the micro pump head 2 are assembled.

[0118] Drive the mandrel 33 in the transmission shaft 3 to rotate synchronously or relatively with the twisting shell 32 through the drive control mechanism 1; when the mandrel 33 rotates synchronously with the twisting shell 32, the entire pump head impeller 22 rotates in a single direction with a fixed outer diameter to achieve 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 relative to the distal end, and the deployable impeller 221 will deploy or fold to change the outer diameter of the entire pump head impeller 22 (the outer diameter increases when deployed and decreases when folded).

[0119] When the deployable impeller 221 folds, the outer diameter of the entire pump head impeller 22 decreases, and the pump head impeller 22 is in a folded state. At this time, cooperate with the protective sleeve drive module 11 to drive the protective sleeve 31 to slide proximally, so that the structure of the pump head protection component 21 contracts inward, and then the entire micro pump head 2 can be in a folded state. The micro pump head 2 as a whole enters the patient's body in a folded state through minimally invasive intervention, which can improve the safety and convenience of use; after the folded pump head impeller 22 enters the patient's body, it deforms and unfolds in the body into an unfolded state with a larger outer diameter, and at this time the outer diameter of the pump head impeller 22 is much larger than that in the folded state, so that the auxiliary device has the ability to provide sufficient auxiliary blood flow for the patient at a low rotational speed, thereby improving the blood supply efficiency of the auxiliary device and reducing the risk of hemolysis; at the same time, the pump head impeller 22 with an adjustable outer diameter and the pump head protection component 21 can effectively reduce the resistance when the entire micro pump head 2 enters and passes through the catheter, which is more conducive to the rapid and safe deployment and recovery of the auxiliary device.

[0120] The above is the preferred implementation mode of the present invention. It should be pointed out that for those of ordinary skill in the art of this technology, without departing from the principle described in the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A micro pump head, which is applied to a left ventricular assist device, and the left ventricular assist device further includes a transmission shaft (3) and a drive control mechanism (1), characterized in that, The micro pump head includes: A pump head impeller (22), the proximal end of the pump head impeller (22) is drivingly connected to the twist housing driving module (12) of the drive control mechanism (1) through the twist housing (32) of the transmission shaft (3); and A pump head transmission assembly (23), the distal end of the pump head transmission assembly (23) is fixedly connected to the pump head impeller (22), the proximal end of the pump head transmission assembly (23) is drivingly connected to the core shaft driving module (13) of the drive control mechanism (1) through the core shaft (33) of the transmission shaft (3), wherein The core shaft (33) is driven by the core shaft driving module (13) to rotate synchronously with the twist housing (32) to drive the distal end and the proximal end of the pump head impeller (22) to rotate together, and the twist housing (32) is driven by the twist housing driving module (12) to rotate relative to the core shaft (33) to drive the proximal end of the pump head impeller (22) to rotate relative to the distal end; Wherein, the pump head impeller (22) includes: a deployable impeller (221) and a twist connecting piece (222), the deployable impeller (221) includes an impeller skeleton (2211), the impeller skeleton (2211) includes a proximal fixing ring (22113), a distal fixing ring (22111) and impeller skeleton wires (22112) spirally arranged between the proximal fixing ring (22113) and the distal fixing ring (22111), the distal fixing ring (22111) is fixedly connected to the core shaft (33) through the pump head transmission assembly (23), and the proximal fixing ring (22113) is fixedly connected to the twist housing (32) through the twist connecting piece (222); in the deployed state of the deployable impeller (221), the impeller skeleton wires (22112) are in a multi-period spiral shape, and the spiral outer edge extends outwards. When the proximal fixing ring (22113) rotates relative to the distal fixing ring (22111) along the spiral direction, the spiral period of the impeller skeleton wires (22112) increases, and the impeller skeleton wires (22112) are twist-pre-tightened to the folded state. The deployable impeller (221) in the folded state has a pre-tightening force, and the axial dimension of the deployable impeller (221) of the pump head impeller (22) remains unchanged during the folding and unfolding process.

2. The micro pump head according to claim 1, characterized in that, The deployable impeller (221) further includes: An impeller blade surface (2212), the impeller blade surface (2212) covers the outside of the impeller skeleton (2211).

3. The micro pump head according to claim 2, wherein The impeller skeleton wires (22112) are made of an elastic material.

4. The micro pump head according to claim 1, characterized in that, The distal end of the twist connecting piece (222) is provided with a plurality of rotation limiting bosses, and the proximal outer edge of the proximal fixing ring (22113) is correspondingly provided with a plurality of limiting grooves. The twist connecting piece (222) and the proximal fixing ring (22113) are rotationally limited by the insertion fit of the rotation limiting bosses and the limiting grooves.

5. The micro pump head according to claim 2, characterized in that, The distal end and the proximal end of the impeller blade surface (2212) respectively cover the outside of the distal fixing ring (22111) and the proximal fixing ring (22113), and are pushed outwards by the impeller skeleton wires (22112) to form an impeller.

6. The micro pump head according to claim 4, characterized in that, The pump head transmission assembly (23) comprises: A core shaft sleeve (236), the core shaft sleeve (236) passes through the impeller frame (2211), the distal end of the core shaft sleeve (236) is fixedly connected to the distal fixing ring (22111), and the proximal end of the core shaft sleeve (236) is sleeved in the proximal fixing ring (22113) and fixedly connected to the core shaft (33); A top shaft (235), wherein the proximal end of the top shaft (235) is fixedly embedded in the distal end of the core shaft sleeve (236); A top shaft bearing (233), wherein the top shaft bearing (233) is sleeved on the distal end of the top shaft (235), and a proximal end surface of the top shaft bearing (233) contacts a distal end surface of the core shaft sleeve (236); A top shaft sleeve (232), wherein the top shaft sleeve (232) is fixedly sleeved on the distal end of the top shaft (235), and the inner edge of the top shaft bearing (233) is limited to be located between the distal end surface of the core shaft sleeve (236) and the proximal end surface of the top shaft sleeve (232); and A top sleeve (231), wherein the proximal end of the top sleeve (231) is sleeved on the distal end of the top shaft (235).

7. The micro pump head according to claim 6, characterized in that, The proximal fixing sleeve of the core shaft sleeve (236) is provided with a core shaft ring (237), the proximal end surface of the core shaft ring (237) is flush with the proximal end surface of the core shaft sleeve (236), and is limited to be located between the proximal end of the proximal fixing ring (22113) and the distal end of the twisting connector (222).

8. The micro pump head according to claim 6, characterized in that, A top ring (234) is sleeved on the core shaft sleeve (236), the top ring (234) is sleeved on the distal end of the core shaft sleeve (236), and the distal end surface of the top ring (234) is fixedly connected to the proximal end surface of the top sleeve (231).

9. The micro pump head according to claim 8, characterized in that, The proximal end of the top sleeve (231) is provided with an annular groove adapted to the top shaft bearing (233), the top shaft bearing (233) is embedded in the annular groove at the proximal end of the top sleeve (231), and the outer edge of the top shaft bearing (233) is located between the annular groove at the proximal end of the top sleeve (231) and the top sleeve ring (234).

10. The micro pump head according to claim 6, characterized in that, Also includes: A pump head protection assembly (21), wherein the pump head protection assembly (21) is coaxially covered outside the pump head impeller (22), and the proximal end of the pump head protection assembly (21) is transmission-connected to the protection cover drive module (11) in the drive control mechanism (1) through the protection cover (31) of the drive shaft (3), 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).

11. The micro pump head according to claim 10, characterized in that, The pump head protection assembly (21) comprises: An anchoring bracket (212), the proximal end of the anchoring bracket (212) being fixedly connected to the distal end of the protective sleeve (31) of the transmission shaft (3), and the distal end of the anchoring bracket (212) being sleeved and fixed to the distal end of the pump head transmission assembly (23); and A top sleeve tip (211), the top sleeve tip (211) is arranged at the distal end of the anchor bracket (212), and the proximal end of the top sleeve tip (211) is fixedly connected to the distal end of the pump head transmission assembly (23).

12. The micro pump head according to claim 11, wherein The pump head protection assembly further includes a bracket protection sleeve connecting ring (213). The distal end of the bracket protection sleeve connecting ring (213) is embedded and fixed in the annular proximal end of the anchoring bracket (212), and the distal end face of the bracket protection sleeve connecting ring (213) is flush with the distal end face of the annular proximal end of the anchoring bracket (212). And The bracket protection sleeve connecting ring (213) is slidably sleeved outside the twisting shell (32) of the transmission shaft (3) and is fixedly connected to the distal end of the protection sleeve (31) of the transmission shaft (3).

13. The micro pump head according to claim 11, characterized in that, An anchoring groove is formed at the distal end of the top sleeve (231), and an anchoring rod is provided at the proximal end of the top sleeve tip (211). The anchoring rod is inserted into the anchoring groove in a matching manner to fixedly connect the proximal end of the top sleeve tip (211) to the distal end of the pump head transmission assembly (23).

14. The micro pump head according to claim 11, characterized in that, The anchoring bracket (212) includes: An anchoring bracket skeleton (2121). The proximal end of the anchoring bracket skeleton (2121) is fixedly connected to the distal end of the protection sleeve (31) of the transmission shaft (3), and the distal end of the anchoring bracket skeleton (2121) is sleeved and fixed on the distal end of the pump head transmission assembly (23); and An anchoring bracket film (2122) is sleeved outside the anchoring bracket skeleton (2121).

15. The micro pump head according to claim 14, characterized in that, The anchoring bracket skeleton (2121) includes an anchoring bracket skeleton proximal ring, an anchoring bracket skeleton distal ring, and a plurality of anchoring bracket skeleton wires arranged in parallel between the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring. When the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring approach each other, the anchoring bracket skeleton wires bend outward to expand the structure of the pump head protection assembly (21), and when the anchoring bracket skeleton proximal ring and the anchoring bracket skeleton distal ring move away from each other, the anchoring bracket skeleton wires are tightened inward to contract the structure of the pump head protection assembly (21).

16. The micro pump head according to claim 15, characterized in that, The anchoring bracket skeleton wires are made of an elastic material.

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