Micro pump head

Abstract

The invention provides a micro pump head and relates to the technical field of micro pumps, the micro pump head is applied to a left ventricular assist device, the left ventricular assist device further comprises a transmission shaft and a drive control mechanism, and the micro pump head comprises a pump head impeller and a pump head transmission assembly. The near 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 near 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 driving module drives the mandrel and the twisting shell to rotate synchronously so as to drive the far end and the near end of the pump head impeller to rotate together, and the twisting shell driving module drives the twisting shell and the mandrel to rotate relatively so as to drive the near end of the pump head impeller to rotate relative to the far end. The micro pump head can be unfolded or folded to change the outer diameter size of the micro pump head in the human body, so that the blood supply efficiency and the use safety of the auxiliary device are improved.

Description

Technical Field

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

[0002] In the past decade, the number of high-risk cardiovascular interventional surgeries at home and abroad has increased year by year. In order to reduce the risk of death caused by obstruction or cessation of blood circulation during surgery, interventional left ventricular assist devices have been widely used in high-risk cardiovascular interventional surgeries. Interventional left ventricular assist devices are percutaneous mechanical circulatory assist systems that use mechanical micropumps to provide auxiliary blood flow to patients undergoing high-risk cardiovascular interventional surgery during and after surgery. They can partially or completely assist the function of the left ventricle and help the heart deliver oxygenated blood to the whole body. Existing interventional left ventricular assist devices mainly use micropump heads equipped with non-deformable rigid impellers. Due to the size of the device, the auxiliary flow rate they can generate is relatively small. In order to meet the needs of maintaining patient blood circulation during high-risk interventional surgeries, the commonly used solution for interventional left ventricular assist devices with constant impeller size is to increase the impeller speed. However, the high-speed rotation of the impeller will inevitably cause excessive shear force inside the blood, leading to 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, thereby improving the auxiliary blood supply efficiency and safety of the auxiliary device.

[0004] 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 also includes a transmission shaft and a drive control mechanism. The micro pump head includes:

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

[0006] A pump head transmission assembly, wherein 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 transmission-connected to the core shaft driving module of the drive control mechanism through the core shaft of the transmission shaft, wherein the core shaft and the twisting shell are driven to rotate synchronously through the core shaft driving module to drive the distal end and the proximal end of the pump head impeller to rotate together, and the twisting shell and the core shaft are driven to rotate relative to each other through the twisting shell driving module 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 comprises:

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

[0009] A twisting connector, wherein the distal end of the twisting connector is clamped with the proximal end of the foldable impeller, and the proximal end of the twisting connector is fixedly connected to the twisting shell.

[0010] In one embodiment, the foldable impeller comprises:

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

[0012] The impeller blade surface is covered on the outside of the impeller frame.

[0013] In one embodiment, the impeller frame comprises:

[0014] A proximal fixing ring, wherein the proximal fixing ring is fixedly connected to the twisting shell via the twisting connector;

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

[0016] An impeller skeleton wire, wherein the impeller skeleton wire is spirally arranged between the proximal fixing ring and the distal fixing ring;

[0017] Optionally, the impeller skeleton wire is made of elastic material;

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

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

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

[0021] A mandrel sleeve, wherein the mandrel sleeve passes through the impeller frame, the distal end of the mandrel sleeve is fixedly connected to the distal end fixing ring, and the proximal end of the mandrel sleeve is sleeved in the proximal end fixing ring and fixedly connected to the mandrel;

[0022] A top shaft, the proximal end of which 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 a proximal end surface of the top shaft bearing contacts with a 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, the proximal end of which 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 sleeve ring, the proximal end surface of the mandrel sleeve ring 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 ring is sleeved on the core shaft sleeve, the top ring is sleeved on the distal end of the core shaft sleeve, and the distal end surface of the top ring is fixedly connected to the proximal end surface of the top sleeve;

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

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

[0030] A pump head protection assembly, wherein the coaxial cover of the pump head protection assembly is arranged outside the pump head impeller, and the proximal end of the pump head protection assembly is transmission-connected to the protection cover drive module in the drive control mechanism through the protection cover 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 comprises:

[0032] An anchor bracket, the proximal end of which is fixedly connected to the distal end of the protective sleeve of the transmission shaft, and the distal end of which 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 support protection sleeve connecting ring, the distal end of the support protection sleeve connecting ring is embedded and fixed in the annular proximal end of the anchor support, and the distal end surface of the support protection sleeve connecting ring is flush with the distal end surface of the annular proximal end of the anchor support, and

[0035] The support protective sleeve connecting ring 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 provided at the distal end of the top sleeve, and an anchoring rod is provided at the proximal end of the top sleeve tip, and the anchoring rod is plugged into and matched with the anchoring groove to fixedly connect the proximal end of the top sleeve tip with the distal end of the pump head transmission assembly.

[0037] In one embodiment, the anchor bracket comprises:

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

[0039] Anchoring support membrane, the anchoring support membrane is sleeved outside the anchoring support frame.

[0040] In one embodiment, the anchor support frame includes a proximal ring of the anchor support frame, a distal ring of the anchor support frame, and a plurality of anchor support frame wires arranged in parallel between the proximal ring of the anchor support frame and the distal ring of the anchor support frame, the anchor support frame wires bend outward when the proximal ring of the anchor support frame and the distal ring of the anchor support frame approach each other so as to expand the structure of the pump head protection assembly outward, and the anchor support frame wires are tightened inward when the proximal ring of the anchor support frame and the distal ring of the anchor support frame move away from each other so as to retract the structure of the pump head protection assembly inward;

[0041] Optionally, the anchoring stent skeleton wire is made of elastic material.

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

[0043] The micro pump head provided by the above-mentioned scheme of the present invention is mainly used in a left ventricular assist device, which also includes a transmission shaft and a drive control mechanism. The micro pump head includes: a pump head impeller, the proximal end of the pump head impeller is transmission-connected to the twisting shell driving module of the drive control mechanism through the twisting shell of the transmission 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 transmission-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, so as to drive the distal end and the proximal end of the pump head impeller to rotate together, at this time, the pump head impeller as a whole rotates in a single direction with a fixed outer diameter; and the twisting shell driving module drives the twisting shell and the core shaft to rotate relative to each other, so as to drive the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller is folded or unfolded 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 is helpful to implant the pump head impeller in a folded state into a designated position in the human body through minimally invasive interventional surgery. The pump head impeller can then be deformed and unfolded into a spiral shape with a larger outer diameter in the human body, so that 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 safety of use of the auxiliary device; at the same time, the pump head impeller with adjustable outer diameter can also help reduce the resistance of the entire micro pump head when entering and passing through the catheter, which is more conducive to the rapid and safe deployment and recovery of the auxiliary device. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

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

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

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

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

[0051] Figure 8 It is a schematic diagram of a foldable impeller provided by an optional embodiment of the present invention rotating and twisting in the direction shown in the figure under normal conditions;

[0052] Fig. 9 yes Figure 8 Schematic diagram of the foldable impeller in a folded state after rotation and twisting;

[0053] Fig.10 It is a three-dimensional structural schematic diagram of a pump head transmission assembly provided by an optional embodiment of the present invention;

[0054] Fig.11 is an exploded view of a pump head transmission assembly provided by an optional embodiment of the present invention;

[0055] Fig.12 It is a three-dimensional structural schematic diagram of a pump head protection assembly provided by an optional embodiment of the present invention;

[0056] Fig.13 is an exploded view of a pump head protection assembly provided by an optional embodiment of the present invention;

[0057] Fig.14 It is a cross-sectional schematic diagram of a drive control mechanism provided in an optional embodiment of the present invention.

[0058] Description of Figure Numbers:

[0059] 100. Left ventricular assist device;

[0060] 1. Drive control mechanism;

[0061] 11. Protective cover driving module; 12. Twisting shell driving module; 13. Mandrel driving module;

[0062] 2. Micro pump head;

[0063] 21. Pump head protection assembly; 211. Top sleeve tip; 212. Anchor bracket; 2121. Anchor bracket skeleton; 2122. Anchor bracket membrane; 213. Bracket protection sleeve connecting ring;

[0064] 22. Pump head impeller; 221. Foldable impeller; 2211. Impeller skeleton; 2212. Impeller blade; 22111. Distal end fixing ring; 22112. Impeller skeleton wire; 22113. Proximal end fixing ring; 222. Twisted connector;

[0065] 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;

[0066] 3. Transmission shaft; 31. Protective cover; 32. Twisting shell; 33. Mandrel;

[0067] 4. Fiber optic pressure sensor. DETAILED DESCRIPTION

[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 accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0069] In the following description, certain specific details are set forth for the purpose of illustrating 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 may be practiced without one or more of these specific details. In other cases, 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.

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

[0071] In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but the words "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", "down", etc. should be understood as convenient terms and should not be understood as restrictive 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, which ensures that the micro pump head can be implanted through minimally invasive interventional surgery, while increasing the outer diameter of the pump head impeller 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 Figure 1-3 as well as Fig.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 also 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, 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, 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 transmission connected to the core shaft driving module 13 of the drive control mechanism 1, and the core shaft driving module 13 drives the core shaft 33 and the twisting shell 32 to rotate synchronously, so as 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 by the twisting shell driving module 12, so as 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 Fig.14 The proximal end of the twisting shell driving module 12 is detachably connected to the distal end of the core shaft driving module 13. 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 transmission assembly 23 runs through the entire pump head impeller 22, 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 fixedly connected to the distal end of the mandrel 33 in the transmission shaft 3, and the distal end of the pump head impeller 22 is transmission-connected to the mandrel drive module 13 of the drive control mechanism 1 through the pump head transmission assembly 23 and the mandrel 33 in turn (the proximal end of the mandrel 33 is transmission-connected to the mandrel 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 transmission-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 transmission-connected to the twisting shell drive module 12).

[0076] Here, the twisting shell 32 of the transmission shaft 3 is sleeved on the outside of the core shaft 33, and the driving control mechanism 1 drives the core shaft 33 and the twisting shell 32 to rotate synchronously (here, synchronous rotation refers to rotation at the same angular velocity) or relative rotation through the core shaft driving module 13 and the twisting shell driving module 12. Specifically, when the core shaft driving module drives the core shaft 33 and the twisting shell 32 to rotate synchronously, the pump head impeller 22 is driven to rotate in one direction with a fixed outer diameter as a whole. When the twisting shell driving 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, thereby realizing the folding or unfolding of the pump head impeller 22. In the process of folding or unfolding the pump head impeller 22, the outer diameter of the pump head impeller 22 changes, specifically: when the pump head impeller 22 is folded, the overall outer diameter is reduced, so that the micro pump head 2 as a whole can enter the patient's body in a folded state through a minimally invasive intervention, thereby improving the safety and convenience of the use of the auxiliary device. After the folded pump head impeller 22 enters the patient's body, it deforms and expands into an expanded state with a larger outer diameter in the body. At this time, the outer diameter of the pump head impeller 22 is much larger than the outer diameter in the folded state, so that the left ventricular assist device has the ability to provide the patient with sufficient auxiliary blood flow at a low speed, thereby improving the blood supply efficiency of the assist device and reducing the risk of hemolysis.

[0077] In addition, the folding and unfolding function of the pump head impeller 22 also helps to reduce the resistance of the micro pump head 2 when entering and passing through the catheter, which is more conducive to the rapid and safe deployment and recovery of the left ventricular assist device. The drive control mechanism 1 at the proximal end of the left ventricular assist device uses a twisting method to achieve the controlled folding and unfolding of the pump head impeller 22 of the distal micro pump head 2 of the left ventricular assist device, which is convenient for clinical operation. In the folding and unfolding process of the pump head impeller 22, only the outer diameter changes, and its axial size remains unchanged, so that the deformation process of the pump head impeller 22 has a high controllability.

[0078] like Figures 3 to 4As shown, in an optional embodiment of the present invention, the pump head impeller 22 includes a foldable impeller 221 and a twisting connector 222, the distal end of the foldable impeller 221 is fixedly connected to the core shaft 33 through the pump head transmission assembly 23, the proximal end of the foldable impeller 221 is clamped with the distal end of the twisting connector 222, and the proximal end of the twisting connector 222 is fixedly connected to the twisting shell 32.

[0079] In this embodiment, the proximal end of the foldable impeller 221 is fixedly engaged with the distal end of the twisting connector 222, and is fixedly connected to the distal end of the twisting 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 transmission-connected to the twisting shell driving module 12 in the driving control mechanism 1. When the twisting shell 32 is driven to rotate by the twisting shell driving module 12, the twisting shell 32 drives the twisting connector 222 to rotate, and drives the proximal end of the foldable impeller 221 to rotate through the twisting connector 222. Since the distal end of the foldable impeller 221 is fixedly connected to 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 transmission-connected to 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 drives the distal end of the foldable impeller 221 to rotate through the pump head transmission assembly 23.

[0080] When the core shaft 33 rotates synchronously with the twisting shell 32, the distal end and the proximal end of the foldable impeller 221 rotate synchronously, so that the pump head impeller 22 as a whole rotates with the outer diameter fixed. When the twisting shell 32 rotates relative to the core shaft 33, the distal end and the proximal end of the foldable impeller 221 rotate relative to each other, and the foldable impeller 221 will be unfolded or folded 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 (increase the outer diameter when unfolded, and reduce the outer diameter when folded).

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

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

[0083] In this embodiment, the impeller skeleton 2211 as a whole can be twisted and folded or twisted and unfolded, the impeller blade surface 2212 is covered on the outside of the impeller skeleton 2211, and the distal end and proximal end of the impeller blade surface 2212 are respectively bonded and fixed to the distal end and proximal end of the impeller skeleton 2211 to ensure that the impeller blade surface 2212 will not fall off during the folding and auxiliary blood supply process.

[0084] Preferably, the impeller blade surface 2212 can be prepared by a biocompatible superelastic medical silicone material, which can reduce the damage to the human body and blood cells caused by the pump head impeller 22 during use, and ensure that the pump head impeller 22 has a large folding and unfolding ratio deformation capability (when the impeller skeleton 2211 is twisted and unfolded, the impeller blade surface 2212 can be pushed outward by the impeller skeleton 2211 to form a spiral impeller and increase the outer diameter of the overall pump head impeller 22. When the impeller skeleton 2211 is twisted and folded, the impeller blade surface 2212 will shrink inward to a cylindrical shape and reduce the outer diameter of the overall pump head impeller 22). Preferably, the medical silicone material can be made of Dragon Skin silicone and Slice silicone in a mass ratio of 2:1. Thinner diluent is stirred and prepared at room temperature and heated to cure into a film; the medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be sustained is 675.3kPa, which can meet the needs of the entire micro pump head 2 when in use.

[0085] Further, such as Figure 5 As shown, the impeller skeleton 2211 includes a proximal fixing ring 22113, a distal fixing ring 22111 and an impeller skeleton wire 22112. The proximal fixing ring 22113 is fixedly connected to the twisting shell 32 through a twisting connector 222. The distal fixing ring 22111 is fixedly connected to the core shaft 33 through a pump head transmission assembly 23. The impeller skeleton wire 22112 is spirally arranged between the proximal fixing ring 22113 and the distal fixing ring 22111.

[0086] In this embodiment, the proximal fixing ring 22113 and the distal fixing ring 22111 are both annular cylinders, and the outer diameters of the proximal fixing ring 22113 and the distal fixing ring 22111 can be set according to the inner diameter of the medical catheter when in use. Preferably, the outer diameter of the proximal fixing ring 22113 and the outer diameter of the distal fixing ring 22111 are equal and slightly smaller than the inner diameter of the medical catheter. The setting 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 the implantation of the foldable impeller 221 into a suitable position through the human blood vessels through minimally invasive interventional surgery.

[0087] Here, the distal fixing ring 22111, the proximal fixing ring 22113 and the impeller skeleton wire 22112 can be prepared in an integrated manner by metal 3D printing to obtain the impeller skeleton 2211. The distal fixing ring 22111, the proximal fixing ring 22113 and the impeller skeleton wire 22112 can also be prepared by cutting a nickel-titanium alloy tube by femtosecond laser to obtain the impeller skeleton 2211.

[0088] There are multiple impeller skeleton wires 22112 disposed between the proximal fixing ring 22113 and the distal fixing ring 22111, and the multiple impeller skeleton wires 22112 are connected in parallel along the same spiral direction between the proximal fixing ring 22113 and the distal fixing ring 22111. Preferably, the multiple impeller skeleton wires 22112 can be inserted into the proximal assembly hole of the distal fixing ring 22111 and the distal assembly hole of the proximal fixing ring 22113, and assembled with the distal fixing ring 22111 and the proximal fixing ring 22113 in a form-locked manner, and more preferably, biocompatible glue can be applied at the assembly site for bonding and fixing.

[0089] In one embodiment, the impeller skeleton wire 22112 is made of a superelastic material with a certain rigidity. Preferably, the elastic material is a superelastic nickel-titanium metal material with a certain rigidity. The impeller skeleton wire 22112 can be prepared by heat treating the nickel-titanium metal wire with a mold. The impeller skeleton wire 22112 made of a superelastic material with a certain rigidity can provide a certain rigidity for the unfolded foldable impeller 221, ensuring the stability of the foldable impeller 221 during the rotation process.

[0090] When the foldable impeller 221 is in the unfolded state (normal state), the impeller skeleton wire 22112 is in a spiral shape, preferably a few-cycle spiral shape, for example, a single-cycle spiral or a double-cycle spiral, and the outer edge of the spiral extends outward. When the foldable impeller 221 is in the unfolded state, when the proximal fixing ring 22113 rotates in the spiral direction relative to the distal fixing ring 22111, the spiral period of the impeller skeleton wire 22112 will increase, and the impeller skeleton wire 22112 will be further twisted and folded, so that the outer edge of the spiral is retracted inward, and the outer diameter of the foldable impeller 221 is reduced.

[0091] The foldable impeller 221 can be prepared in the following manner. Figure 5 The impeller frame 2211 is twisted and pre-tightened to a folded state (as shown in FIG. Figure 7 As shown), and the impeller blade surface 2212 is sleeved onto the surface of the impeller skeleton 2211 to obtain Fig. 9 The foldable impeller 221 is shown in the folded state. Fig. 9The preload force is released in the rotation direction shown, so that the impeller skeleton wire 22112 recovers at least a periodic spiral shape under the action of elasticity, and the outer edge of the spiral extends outward, and the outer diameter of the foldable impeller 221 is increased, so as to obtain the following Figure 8 The foldable impeller 221 shown in FIG. Figure 8 By twisting in the direction of rotation shown, the following can be obtained: Fig. 9 The foldable impeller 221 is shown in a folded state.

[0092] In an achievable example of the present invention, the distal end and the proximal end of the impeller blade 2212 are respectively covered outside the distal fixing ring 22111 and the proximal fixing ring 22113, and are pushed outward by the impeller skeleton wire 22112 to form an impeller. Here, the impeller blade 2212 and the distal fixing ring 22111 and the proximal fixing ring 22113 can be bonded by biocompatible glue to ensure that the impeller blade 2212 will not fall off during the folding and auxiliary blood supply process, and the biocompatible glue can also avoid causing harm to the human body.

[0093] In an achievable example of the present invention, the far end of the twisting connector 222 may be provided with a plurality of rotation limiting bosses, and the outer edge of the proximal end of the proximal fixing ring 22113 may be provided with a plurality of limiting grooves accordingly, and the twisting connector 222 and the proximal fixing ring 22113 are rotationally limited by plugging and matching the rotation limiting bosses and the limiting grooves. The assembly connection of the rotation limiting bosses and the limiting grooves between the twisting connector 222 and the proximal fixing ring 22113 can better transmit the twisting torque to the foldable impeller 221 through the twisting connector 222, so as to realize the one-step twisting and folding of the foldable impeller 221.

[0094] like Figures 10 to 11 As shown, in an optional embodiment of the present invention, the pump head transmission 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 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. 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 at 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 at 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 an annular groove matching with the top shaft bearing 233 is formed 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, and the proximal end of the mandrel sleeve 236 is sleeved on 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, and 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, 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 foldable impeller 221 can be axially positioned by the distal end face of the core shaft ring 237, and on this basis, the distal fixing ring 22111 can be bonded to the core shaft sleeve 236 using biocompatible glue. Since the core shaft 33 is inserted and fixed in the core shaft sleeve 236, when the core shaft 33 is inserted into the core shaft sleeve 236 until the distal end face of the core shaft 33 contacts the proximal end face of the top shaft 235, the core shaft sleeve 236 and the core shaft 33 can be bonded and fixed using biocompatible glue.

[0097] Optionally, a top ring 234 is sleeved on the core shaft sleeve 236 , and 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 .

[0098] Optionally, the proximal end of the top sleeve 231 is sleeved on the distal end of the top shaft 235 through the top shaft bearing 233, and the top shaft bearing 233 is embedded in the annular groove opened at the proximal end of the top sleeve 231, and the outer edge of the top shaft bearing 233 is limited between the annular groove and the top sleeve ring 234. Here, the top shaft sleeve 232 and the top shaft 235 can be bonded and fixed using biocompatible glue to ensure that the top shaft sleeve 232 will not fall off the top shaft 235. After the top sleeve 231 is sleeved outside the top shaft bearing 233, while ensuring that the top sleeve 231 is in contact with the distal end surface of the top shaft bearing 233 and the top sleeve ring 234 is in contact with the proximal end surface of the top shaft bearing 233, the top sleeve 231 and the top sleeve ring 234 can be bonded and fixed using biocompatible glue.

[0099] By fixing the distal end of the mandrel sleeve 236 in the pump head transmission assembly 23 with the distal end fixing ring 22111 in the foldable impeller 221, and fixing the proximal end of the mandrel sleeve 236 with 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 keeps rotating synchronously with the mandrel 33 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 drive module 12 in the drive control mechanism 1, the twisting shell 32 rotates and drives the proximal end of the foldable impeller 221 to keep rotating synchronously with the twisting shell 32 through the twisting connector 222. When the mandrel 33 and the twisting shell 32 rotate synchronously, the distal end and the proximal end of the foldable impeller 221 rotate synchronously, thereby realizing that the 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 relative to each other, the distal end and the proximal end of the foldable impeller 221 rotate relative to each other, thereby realizing the folding and unfolding of the foldable impeller 221, so as 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 driving 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 sleeved outside the twisting shell 32, and the proximal end of the protective sleeve 31 is transmission-connected to 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, thereby controlling the pump head protection assembly 21 to fold or unfold, so as 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 anchor bracket 212 and a top sleeve tip 211, wherein the proximal end of the anchor 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 anchor bracket 212 is sleeved and fixed to the distal end of the pump head transmission assembly 23. The top sleeve tip 211 is disposed at the distal end of the anchor bracket 212, and the proximal end of the top sleeve tip 211 is fixedly connected to the distal end of the pump head transmission assembly 23.

[0103] In this embodiment, the proximal end and the distal end of the anchor bracket 212 can be set to be ring-shaped, and the proximal end of the top sleeve tip 211 is fixedly connected to the distal end of the top sleeve 231 in the pump head transmission assembly 23.

[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 top sleeve tip 211 , and the proximal end of the top sleeve tip 211 is installed in the top sleeve 231 by plugging and matching the anchoring rod with the anchoring groove.

[0105] Optionally, the distal end of the top sleeve tip 211 is configured to be a smooth dome-shaped, so that the entire micro pump head 2 can be easily inserted into the patient's body through minimally invasive intervention and reduce the resistance encountered by blood flow when passing through the micro pump head 2 .

[0106] Optionally, the pump head protection assembly 21 may further include a support protective sleeve connecting ring 213, the distal end of which is embedded and fixed in the annular proximal end of the anchor support 212, and the distal end surface of the support protective sleeve connecting ring 213 is flush with the distal end surface of the annular proximal end of the anchor support 212. In addition, the support protective sleeve connecting ring 213 is slidably sleeved outside the twisting shell 32 and fixedly connected to the distal end of the protective sleeve 31 of the 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 anchor support 212.

[0107] Here, after the annular proximal end of the anchoring stent 212 is sleeved outside the stent protective sleeve connecting ring 213 and the distal end surface of the stent protective sleeve connecting ring 213 is flush with the distal end surface of the annular proximal end of the anchoring stent 212, the proximal end of the anchoring stent 212 can be bonded and fixed to the stent protective sleeve connecting ring 213 using biocompatible glue. Subsequently, the protective sleeve 31 is sleeved to the proximal end of the stent protective sleeve connecting ring 213, and after the distal end surface of the protective sleeve 31 is in contact with the proximal end surface of the annular proximal end of the anchoring stent 212, the protective sleeve 31 can be bonded and fixed to the stent protective sleeve connecting ring 213 and the anchoring stent 212 using biocompatible glue.

[0108] Furthermore, 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 cover 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. The anchoring bracket membrane 2122 is sleeved outside the anchoring bracket skeleton 2121.

[0109] In this embodiment, the anchoring support skeleton 2121 provides a certain anchoring support force for the entire pump head protection component 21, and the anchoring support membrane 2122 is sleeved outside the anchoring support skeleton 2121, which can be used to reduce the contact stress between the anchoring support 212 and the blood vessel; preferably, the anchoring support skeleton 2121 and the anchoring support membrane 2122 can be bonded and fixed by biocompatible glue. Here, the anchoring support skeleton 2121 can be prepared by laser cutting the nickel-titanium alloy tube, and the anchoring support membrane 2122 can be prepared by inverting the medical silicone material; preferably, the medical silicone material can be prepared by mixing DragonSkin silicone and Slic Thinner diluent with a mass ratio of 2:1 at room temperature, and heated to cure into a film; the medical silicone material has good elastic deformation ability, its 100% Young's modulus is 21.75kPa, the maximum strain that can be achieved is 1328.2%, and the maximum stress that can be tolerated is 675.3kPa, so as to meet the needs of the entire micro pump head 2 when in use.

[0110] In an optional embodiment of the present invention, the anchoring support skeleton 2121 includes a proximal ring of the anchoring support skeleton, a distal ring of the anchoring support skeleton, and a plurality of anchoring support skeleton wires arranged in parallel between the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton, the anchoring support skeleton wires bend outward when the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton approach each other so as to expand the structure of the pump head protection assembly 21, and the anchoring support skeleton wires are tightened inward when the proximal ring of the anchoring support skeleton and the distal ring of the anchoring support skeleton move away from each other so as to retract the structure of the pump head protection assembly 21.

[0111] In this embodiment, the proximal ring of the anchoring stent skeleton is embedded with the stent protective sleeve connecting ring 213, and the fixed connection with the protective sleeve 31 is further strengthened through the stent protective sleeve connecting ring 213. The distal ring sleeve of the anchoring stent skeleton is fixed outside the distal end of the top sleeve 231.

[0112] The anchoring stent skeleton wire is arranged in plurality, and the plurality of anchoring stent skeleton wires are arranged in parallel between the distal ring of the anchoring stent skeleton and the proximal ring of the anchoring stent skeleton, and form an anchoring stent skeleton 2121 with a cage-like structure; the anchoring stent skeleton wire can bend outward when the proximal ring of the anchoring stent skeleton and the distal ring of the anchoring stent skeleton are close to each other, so that the cage-like structure expands outward; conversely, the anchoring stent skeleton wire can be stretched to both ends, so that the cage-like structure shrinks inward.

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

[0114] Step 11, align the proximal end surfaces of the mandrel sleeve 236 and the mandrel collar 237 and fix them by gluing, then put the foldable impeller 221 onto the mandrel sleeve 236, and axially position the foldable impeller 221 through the distal end surface of the mandrel collar 237, and glue and fix the distal fixing ring 22111 to the mandrel sleeve 236;

[0115] Step 12, insert the top shaft 235 into the core shaft sleeve 236 to a specific position and glue the two together, then successively put the top sleeve ring 234 on the core shaft sleeve 236, and the top shaft bearing 233 on the top shaft 235, and use the distal end face of the core shaft sleeve 236 to axially position the top shaft bearing 233; then put the top shaft sleeve 232 on the top shaft 235, and glue the top shaft sleeve 232 and the top shaft 235 together on the basis of axially positioning the top shaft sleeve 232 through the distal end face of the top shaft bearing 233; finally, put the top sleeve 231 on the top shaft bearing 233, and glue the top sleeve 231 and the top sleeve ring 234 together while ensuring that the top sleeve 231 is in contact with the distal end face of the top shaft bearing 233 and the top sleeve ring 234 is in contact with the proximal end face of the top shaft bearing 233;

[0116] Step 13, sleeve the annular proximal end of the anchoring bracket 212 onto the bracket protective sleeve connecting ring 213, and 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, the proximal end of the anchoring bracket 212 is bonded and fixed to the bracket protective sleeve connecting ring 213; then sleeve the protective sleeve 31 onto the proximal end of the bracket protective sleeve connecting ring 213, and under the condition that the distal end face of the protective sleeve 31 is in contact with the proximal end face of the annular proximal end of the anchoring bracket 212, the protective sleeve 31 is successively bonded to the bracket protective sleeve connecting ring 213 and the anchoring bracket 212; assemble the proximal end of the twisting connector 222 to the distal end of the twisting shell 32, and bond and fix the assembly; insert the mandrel 33 into the mandrel sleeve 236 until the distal end face of the mandrel 33 is in contact with the proximal end face of the top shaft 235, and bond and fix the mandrel sleeve 236 and the mandrel 33;

[0117] Step 14, insert the mandrel 33 into the twisting shell 32, plug and assemble the distal end of the twisting connector 222 to the proximal end of the proximal fixing ring 22113, and glue and fix the assembly; then, while inserting the twisting shell 32 into the protective sleeve 31, put the annular distal end of the anchor bracket 212 onto the distal end of the top sleeve 231, and glue the anchor bracket 212 to the top sleeve 231; finally, assemble the top sleeve tip 211 to the distal end of the top sleeve 231; at this point, the transmission shaft 3 and the micro pump head 2 are assembled;

[0118] The core shaft 33 in the transmission shaft 3 is driven by the driving control mechanism 1 to rotate synchronously or relatively with the twisting shell 32; when the core shaft 33 rotates synchronously with the twisting shell 32, the pump head impeller 22 as a whole rotates in a single direction with a fixed outer diameter to achieve the blood pumping function; when the twisting shell 32 and the core shaft 33 rotate relatively, the proximal end of the pump head impeller 22 rotates relative to the distal end, and the foldable impeller 221 will unfold or fold to change the outer diameter of the entire pump head impeller 22 (increase the outer diameter when unfolded, and reduce the outer diameter when folded);

[0119] When the foldable impeller 221 is folded, the outer diameter of the entire pump head impeller 22 is reduced, and the pump head impeller 22 is in a folded state. At this time, the protective cover driving module 11 drives the protective cover 31 to slide proximally, so that the structure of the pump head protection component 21 is contracted inward, so that 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 a 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 is deformed and expanded in the body to an expanded state with a larger outer diameter, and at this time the outer diameter of the pump head impeller 22 is much larger than the outer diameter in the folded state, so that 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 of the auxiliary device and reducing the risk of hemolysis; at the same time, the pump head impeller 22 and the pump head protection component 21 with adjustable outer diameter can effectively reduce the resistance of the entire micro pump head 2 when entering and passing through the catheter, which is more conducive to the rapid and safe deployment and recovery of the auxiliary device.

[0120] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A micro pump head, the micro pump head is used in a left ventricular assist device, the left ventricular assist device also includes a transmission shaft and a drive control mechanism, characterized in that: The micro pump head comprises: A pump head impeller (22), wherein the proximal end of the pump head impeller (22) is drivingly connected to the twisting shell driving module (12) of the driving control mechanism (1) through the twisting shell (32) of the transmission shaft (3); and A pump head transmission assembly (23), wherein the distal end of the pump head transmission assembly (23) is fixedly connected to the pump head impeller (22), and the proximal end of the pump head transmission assembly (23) is transmission-connected to the core shaft drive module (13) of the drive control mechanism (1) via the core shaft (33) of the transmission shaft (3), wherein The core shaft driving module (13) drives the core shaft (33) and the twisting shell (32) to rotate synchronously to drive the distal end and the proximal end of the pump head impeller (22) to rotate together, and the twisting shell driving module (12) drives the twisting shell (32) and the core shaft (33) to rotate relative to each other to drive the proximal end of the pump head impeller (22) to rotate relative to the distal end.

2. The micro pump head according to claim 1, characterized in that: The pump head impeller (22) comprises: A foldable impeller (221), the distal end of the foldable impeller (221) being fixedly connected to the core shaft (33) via the pump head transmission assembly (23); and A twisting connector (222), wherein the distal end of the twisting connector (222) is clamped with the proximal end of the foldable impeller (221), and the proximal end of the twisting connector (222) is fixedly connected to the twisting shell (32).

3. The micro pump head according to claim 2, characterized in that: The foldable impeller (221) comprises: An impeller skeleton (2211), wherein the proximal end of the impeller skeleton (2211) is fixedly connected to the twisting shell (32) via the twisting connector (222), and the distal end of the impeller skeleton (2211) is fixedly connected to the core shaft (33) via the pump head transmission assembly (23); and An impeller blade surface (2212), wherein the impeller blade surface (2212) is coated on the outside of the impeller frame (2211).

4. The micro pump head according to claim 3, characterized in that: The impeller skeleton (2211) comprises: A proximal fixing ring (22113), wherein the proximal fixing ring (22113) is fixedly connected to the twisting shell (32) via the twisting connector (222); A distal fixing ring (22111), wherein the distal fixing ring (22111) is fixedly connected to the core shaft (33) via the pump head transmission assembly (23); and An impeller skeleton wire (22112), wherein the impeller skeleton wire (22112) is spirally arranged between the proximal fixing ring (22113) and the distal fixing ring (22111); Optionally, the impeller skeleton wire (22112) is made of elastic material; Optionally, the twisting connector (222) is provided with a plurality of rotation limiting bosses at the distal end, and a plurality of limiting grooves are correspondingly provided at the proximal outer edge of the proximal fixing ring (22113). The twisting connector (222) and the proximal fixing ring (22113) are rotationally limited by the rotation limiting bosses being plugged into and fitted into the limiting grooves.

5. The micro pump head according to claim 4, characterized in that: The distal end and the proximal end of the impeller blade surface (2212) are respectively covered by the distal fixing ring (22111) and the proximal fixing ring (22113), and are pushed outward by the impeller skeleton wire (22112) to form an impeller.

6. The micro pump head according to claim 4, characterized in that: The pump head transmission assembly (23) comprises: A core shaft sleeve (236), wherein 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), the proximal end of the top shaft (235) being 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 limitedly 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); Optionally, the proximal fixing sleeve of the mandrel sleeve (236) is provided with a mandrel collar (237), the proximal end surface of the mandrel collar (237) is flush with the proximal end surface of the mandrel 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); Optionally, a top ring (234) is sleeved on the core shaft sleeve (236), the top ring (234) is sleeved on the distal end of the core shaft sleeve (236), and the distal end surface of the top ring (234) is fixedly connected to the proximal end surface of the top sleeve (231); Optionally, a ring groove matching the top shaft bearing (233) is provided at the proximal end of the top sleeve (231), the top shaft bearing (233) is embedded in the proximal ring groove of the top sleeve (231), and the outer edge of the top shaft bearing (233) is limited to be located between the proximal ring groove of the top sleeve (231) and the top sleeve ring (234).

7. 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).

8. The micro pump head according to claim 7, characterized in that: The pump head protection component (21) comprises: An anchor bracket (212), the proximal end of the anchor 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 anchor bracket (212) being sleeved and fixed to the distal end of the pump head transmission assembly (23); and A top sleeve tip (211), wherein 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); Optionally, the pump head protection assembly further comprises a support protection sleeve connecting ring (213), the distal end of the support protection sleeve connecting ring (213) is embedded and fixed in the annular proximal end of the anchor support (212), and the distal end surface of the support protection sleeve connecting ring (213) is flush with the distal end surface of the annular proximal end of the anchor support (212), and The support protective sleeve connecting ring (213) is slidably sleeved outside the twisting shell (32) of the transmission shaft (3), and is fixedly connected to the distal end of the protective sleeve (31) of the transmission shaft (3); 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 top sleeve tip (211), and the anchoring rod is plugged into and matched with the anchoring groove to fixedly connect the proximal end of the top sleeve tip (211) with the distal end of the pump head transmission assembly (23).

9. The micro pump head according to claim 8, characterized in that: The anchor bracket (212) comprises: An anchor support frame (2121), the proximal end of the anchor support frame (2121) is fixedly connected to the distal end of the protective sleeve (31) of the transmission shaft (3), and the distal end of the anchor support frame (2121) is sleeved and fixed to the distal end of the pump head transmission assembly (23); and An anchoring support membrane (2122), wherein the anchoring support membrane (2122) is sleeved outside the anchoring support frame (2121).

10. The micro pump head according to claim 9, characterized in that: The anchor support frame (2121) comprises an anchor support frame proximal ring, an anchor support frame distal ring, and a plurality of anchor support frame wires arranged in parallel between the anchor support frame proximal ring and the anchor support frame distal ring, the anchor support frame wires being bent outward when the anchor support frame proximal ring and the anchor support frame distal ring are close to each other so as to expand the structure of the pump head protection component (21), and the anchor support frame wires being tightened inward when the anchor support frame proximal ring and the anchor support frame distal ring are away from each other so as to retract the structure of the pump head protection component (21); Optionally, the anchoring stent skeleton wire is made of elastic material.

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