Blood pumping device and ventricular assist system

Abstract

The application discloses a blood pumping device and a ventricular assist system. The blood pumping device comprises a casing, a rotor assembly and a stator assembly. The casing is enclosed to form a containing cavity. The rotor assembly is at least partially located in the containing cavity. The stator assembly is connected with the casing and located in the containing cavity. The stator assembly comprises a winding arranged around the rotor assembly and a barrier layer. The barrier layer is closely combined with the surface of the winding to isolate the winding from the surrounding. By making the stator assembly comprise the barrier layer which is closely combined with the surface of the winding to isolate the winding from the surrounding, the barrier layer protects the winding from the external environment, thereby prolonging the service life of the winding. The barrier layer is coated on the surface of the winding to isolate the winding from the external environment, so that the blood pumping device can guarantee a high safety level even after long-time soaking, avoids winding leakage and improves the safety and reliability of the blood pumping device.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to blood pumping devices and ventricular assist systems. Background Technology

[0002] During cardiac surgery, due to the patient's underlying medical condition or the needs of the procedure, the patient's heart function may be weakened, resulting in insufficient pumping capacity. In such cases, active interventional medical devices, such as ventricular assist devices (VADs), are needed to assist the heart in pumping blood. Existing VADs utilize the principle of cardiac pumping, pumping blood out of the heart through a pumping mechanism and diverting it to the aorta outside the heart for distribution throughout the body.

[0003] In related technologies, an electric motor is used as the blood pumping mechanism. The motor has a stator and a rotor. When energized, the windings in the stator generate a magnetic field, which drives the rotor to rotate and achieve the blood pumping function. In existing blood pumping motors, the protective layer on the outside of the windings has defects, making it difficult to cope with the complex working environment of the blood pumping motor. Utility Model Content

[0004] This application provides a blood pumping device and a ventricular assist system, which are designed to improve the protection performance of the windings.

[0005] An embodiment of the first aspect of this application provides a blood pumping device for percutaneous insertion into a patient's blood vessel, comprising a housing, a rotor assembly, and a stator assembly, the housing enclosing a receiving cavity. The rotor assembly is at least partially located within the receiving cavity; the stator assembly is connected to the housing and located within the receiving cavity, the stator assembly including windings disposed around the rotor assembly and a barrier layer, the barrier layer being tightly bonded to the surface of the windings to isolate the windings from the surroundings.

[0006] According to an embodiment of the first aspect of this application, the barrier layer includes an insulating layer covering at least a portion of the winding, the insulating layer including at least one of a polyethylene terephthalate layer, a polyetheretherketone layer, and a polyimide layer.

[0007] According to an embodiment of the first aspect of this application, the barrier layer further includes a paraffin coating that covers at least a portion of the insulating layer.

[0008] According to an embodiment of the first aspect of this application, the barrier layer further includes a first adhesive layer: the insulating layer is a cylindrical insulating film, which is tightly attached to and covers the inner peripheral surface of the winding, and the outer peripheral surface of the winding is connected to the inner wall surface of the housing through the first adhesive layer; or, the insulating layer is a cylindrical insulating film, which is tightly attached to and covers the inner peripheral surface of the winding through a third adhesive layer, and the outer peripheral surface of the winding is connected to the inner wall surface of the housing through the first adhesive layer; or, the insulating layer includes two cylindrical insulating films, one of which is tightly attached to and covers the inner peripheral surface of the winding, and the other is tightly attached to and covers the outer peripheral surface of the winding, and the outer peripheral surface of the winding is connected to the inner wall surface of the housing through the first adhesive layer.

[0009] According to an embodiment of the first aspect of this application, the barrier layer further includes an axial sealing plate located on at least one side of the far end and near end of the winding, and the axial sealing plate is sealed to at least one cylindrical insulating film.

[0010] According to the first aspect of this application, the winding is provided with axial sealing plates at both the far end and the near end, and the insulation layer includes two cylindrical insulating films respectively attached to the inner and outer circumferential surfaces of the winding. The two axial sealing plates and the two cylindrical insulating films are mutually sealed and connected to isolate the winding from the surroundings.

[0011] According to the embodiment of the first aspect of this application, the thickness of the insulating layer in the radial direction is 0.01~0.2mm; the thickness of the axial sealing plate in the axial direction is 0.05~0.5mm.

[0012] According to an embodiment of the first aspect of this application, the barrier layer includes a paraffin coating covering at least a portion of the winding.

[0013] According to an embodiment of the first aspect of this application, the barrier layer further includes a second adhesive layer: the second adhesive layer covers the entire outer surface of the winding, and the pyrene coating covers the entire outer surface of the second adhesive layer; or, the pyrene coating covers the entire outer surface of the winding, and the second adhesive layer covers the entire outer surface of the pyrene coating; or, the pyrene coating covers the inner peripheral surface of the winding, and covers at least one of the proximal end face and the distal end face of the winding, and the second adhesive layer at least covers the outer peripheral surface of the winding.

[0014] According to an embodiment of the first aspect of this application, it further includes: a connecting wire, one end of which passes through the barrier layer and is electrically connected to the winding in the winding, and the other end of the connecting wire is exposed for electrical connection with the control device; a second barrier layer is tightly attached to the outer peripheral surface between the two ends of the connecting wire to isolate the connecting wire from the surrounding environment.

[0015] According to an embodiment of the first aspect of this application, a flow channel for circulating perfusion fluid is formed within the blood pumping device, and a barrier layer isolates the winding and the flow channel at the wall of the flow channel formed in the stator assembly.

[0016] According to an embodiment of the first aspect of this application, the flow path includes a first flow path located on the side of the winding facing the rotor assembly, with at least a partial barrier layer isolating the winding and the first flow path; and / or, the flow path includes a second flow path formed by the gap between the winding and the housing, with at least a partial barrier layer isolating the winding and the second flow path.

[0017] A second aspect of this application provides a ventricular assist system including an outflow channel, a sheath, and a pumping device as described in any of the above embodiments, wherein the outflow channel is connected to the distal end of the pumping device, and the sheath is connected to the proximal end of the pumping device.

[0018] The blood pumping device of this application includes a barrier layer that is tightly fitted to the winding surface of the stator assembly to isolate the winding from its surroundings. This barrier layer protects the winding from external environmental influences, thereby increasing the winding's service life. The barrier layer, coated on the winding surface, isolates the winding from the external environment, ensuring a high level of safety even after prolonged immersion, preventing winding leakage, and improving the safety and reliability of the blood pumping device. By tightly bonding the barrier layer to the winding surface, the barrier layer's isolation effect is enhanced, reducing the probability of the winding being exposed to the surrounding environment due to barrier layer damage. This further improves the protective performance of the barrier layer for the winding, further extending the winding's service life. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the structure of a ventricular assist system including a blood pumping device according to some embodiments of this application;

[0021] Figure 2 The diagram shows a longitudinal cross-sectional view of the windings, barrier layers, and connecting wires of some examples of this application;

[0022] Figure 3 The diagram shows a longitudinal cross-sectional view of the windings, barrier layers, and connecting wires of other examples of this application;

[0023] Figure 4 This application also shows longitudinal cross-sectional structural schematic diagrams of windings, barrier layers, and connecting wires as examples;

[0024] Figure 5 This application shows some examples. Figure 4 A perspective structural diagram of the barrier layer and connecting lines in the middle.

[0025] Figure label:

[0026] 10. Blood pumping device; 20. Sheath; 21. Power supply line;

[0027] 100. Housing; 110. Receiving cavity;

[0028] 200. Rotor assembly; 210. Shaft; 220. Magnet;

[0029] 300. Stator assembly; 310. Winding; 320. Barrier layer; 321. Perylene coating; 322. Second adhesive layer; 323. Insulating layer; 324. Axial sealing plate; 325. First through hole;

[0030] 400. Connecting cable;

[0031] 500. Proximal end cap; 510. Proximal end bearing housing;

[0032] 600. Distal end cap; 610. First shaft hole;

[0033] 700. Distant bearing housing;

[0034] 800, bearings;

[0035] x, the first direction. Detailed Implementation

[0036] The features and exemplary embodiments of various aspects of this application will be described in detail below. To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain this application and not to limit it. For those skilled in the art, this application can be implemented without some of these specific details. The following description of the embodiments is merely to provide a better understanding of this application by illustrating examples.

[0037] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of additional identical elements in the process, method, article, or apparatus that includes said element.

[0038] To address the technical problems mentioned in the background art, the applicant proposes a blood pumping device, including a housing, a rotor assembly, and a stator assembly, the housing enclosing a receiving cavity. The rotor assembly is at least partially located within the receiving cavity; the stator assembly is connected to the housing and located within the receiving cavity, the stator assembly including windings surrounding the rotor assembly and a barrier layer, the barrier layer being tightly bonded to the surface of the windings to isolate the windings from their surroundings.

[0039] The blood pumping device of this application includes a barrier layer that is tightly fitted to the winding surface of the stator assembly to isolate the winding from its surroundings. This barrier layer protects the winding from external environmental influences, thereby increasing the winding's service life. The barrier layer, coated on the winding surface, isolates the winding from the external environment, ensuring a high level of safety even after prolonged immersion, preventing winding leakage, and improving the safety and reliability of the blood pumping device. By tightly bonding the barrier layer to the winding surface, the barrier layer's isolation effect is enhanced, reducing the probability of the winding being exposed to the surrounding environment due to barrier layer damage. This further improves the protective performance of the barrier layer for the winding, further extending the winding's service life.

[0040] Before describing the pumping device, a brief description of the ventricular assist system including the pumping device is provided with reference to the accompanying drawings to help understand the operating environment of the pumping device. It should be noted that in the accompanying drawings, the direction extending from the distal end to the proximal end of the pumping device, pointing towards the proximal end, is the first direction, denoted as x. For ease of drawing, the dimensions in the accompanying drawings are not necessarily proportional to actual dimensions.

[0041] Figure 1 This is a schematic diagram of the structure of a ventricular assist system including a blood pumping device, according to some embodiments of this application. (In conjunction with...) Figure 1 This application provides a ventricular assist system, which includes a pumping device 10, a sheath 20, an impeller, and an outflow channel (not shown). The outflow channel is connected to the distal end of the pumping device 10, and the sheath 20 is connected to the proximal end of the pumping device 10. The pumping device 10 includes a rotor assembly 200 and a stator assembly 300. The outflow channel has an intake window and an outflow window, and the impeller is located within the outflow channel and connected to the rotor assembly 200. The sheath 20 contains a power supply line 21 and an infusion tube (not shown). The power supply line 21 is electrically connected to the winding 310, and the infusion tube communicates with the pumping device 10 to deliver perfusion fluid to the pumping device 10. During use, the pumping device 10 and the outflow channel are pushed through the patient's blood vessels by the sheath 20 until the pumping device 10 and the outflow channel are located at a designated position in the patient's circulatory system. At this time, the outflow window and the intake window are located at different positions in the circulatory system. Then, power is supplied to the stator assembly 300 through the power supply line 21, so that the stator assembly 300 drives the rotor assembly 200 to rotate. The rotor assembly 200 drives the impeller located in the outflow channel to rotate, and drives the blood to enter the outflow channel from the suction window and flow out from the outflow window, thereby realizing the blood pumping function of the blood pumping device.

[0042] When the blood pumping device 10, sheath 20, and outflow channel are inserted into the patient's body, the end of sheath 20 facing away from the blood pumping device 10 extends out of the patient's body and connects to equipment such as a reservoir (not shown), power supply equipment (not shown), and control switch (not shown). The blood pumping device 10 has a flow path for the perfusion fluid. The perfusion fluid is delivered to the flow path through the perfusion tube, carrying away the heat generated during the operation of the blood pumping device 10 and providing a certain perfusion fluid pressure at the distal end of the blood pumping device 10, reducing the probability of blood flowing into the blood pumping device 10 and forming a thrombus. The perfusion fluid can be at least one of physiological saline, glucose, and an anticoagulant, with heparin being a possible anticoagulant. The anticoagulant in the perfusion fluid reduces the probability of blood clotting, thereby reducing the probability of the blood pumping device 10 failing due to clotting. The blood pumping device 10 also includes a housing 100, which encloses a cavity 110 for accommodating a stator assembly 300 and at least a portion of the rotor assembly 200. The stator assembly 300 also includes a winding 310. The gap between the winding 310 and the rotor assembly 200, the gap between the winding 310 and the housing 100, and the pipes provided on the housing 100 can all serve as flow channels for the blood pumping device 10. At least a portion of these flow channels are connected to an infusion tube.

[0043] It is understood that in this application, the proximal end refers to the end facing or close to the operator or physician, and the distal end refers to the end away from the operator or physician, with the proximal and distal ends being opposite in position. The proximal end of the blood pumping device 10 faces the sheath 20, and the distal end of the blood pumping device 10 faces the outflow channel.

[0044] After describing the structure of the blood pumping device, the pump motor provided in the embodiments of this application will be further described below with reference to the accompanying drawings. Figure 2 The diagram shows longitudinal cross-sectional views of some examples of the windings, barrier layers, and connecting wires of this application.

[0045] Combination Figure 1 and Figure 2 As can be seen, this application provides a blood pumping device 10, including a housing 100, a rotor assembly 200, and a stator assembly 300, with the housing 100 enclosing a receiving cavity 110. The rotor assembly 200 is at least partially located within the receiving cavity 110. The stator assembly 300 is connected to the housing 100 and located within the receiving cavity 110. The stator assembly 300 includes a winding 310 surrounding the rotor assembly 200 and a barrier layer 320, with the barrier layer 320 tightly bonded to the surface of the winding 310 to isolate the winding 310 from its surroundings.

[0046] Understandably, the winding 310 is a cylindrical structure formed by multiple windings. Therefore, the surroundings of the winding 310 include the outer side of its outer peripheral surface, the inner side of its inner peripheral surface, the outside of its proximal end face, and the outside of its distal end face. Therefore, in the following description, the entire outer surface of the winding 310 refers not only to the outer peripheral surface, inner peripheral surface, proximal end face, and distal end face of the winding 310, but also to the exposed outer surfaces of the specific windings within the winding 310. The barrier layer 320 in this application is tightly fitted to the surface of the winding 310 to isolate the winding 310 from the aforementioned surrounding environment, and the barrier layer 320 is tightly fitted to each exposed winding in the winding 310.

[0047] It should be noted that, since winding 310 is an axisymmetric figure, it has a central axis, and the direction in which the central axis extends is consistent with the direction of the line connecting the near and far ends of the pumping device 10, i.e., direction x in the figure. Winding 310 has a cylindrical structure and therefore two circumferential surfaces: the circumferential surface of the outer wall of the cylinder is the outer circumferential surface, and the circumferential surface of the inner wall of the cylinder is the inner circumferential surface. Furthermore, the axial direction of winding 310 refers to the direction in which the central axis extends. The circumferential direction of winding 310 refers to the circumferential direction of the outer perimeter of the cylinder. Radial direction refers to the direction passing through the central axis in the radial plane, usually also referring to a straight line along the diameter or radius, or a straight line perpendicular to the central axis. Radial dimension generally refers to the radius or diameter of the axisymmetric part. It is understood that in this application, the axial, circumferential, radial, and circumferential surfaces of other components can be referenced to the aforementioned description of winding 310.

[0048] The blood pumping device 10 of this application embodiment further includes a barrier layer 320 that is tightly attached to the surface of the winding 310 to isolate the winding 310 from its surroundings. The barrier layer 320 protects the winding 310 from external environmental influences, thereby improving the service life of the winding 310. The barrier layer 320, coated on the surface of the winding 310, isolates the winding 310 from the external environment, ensuring a high safety level even after prolonged immersion, preventing leakage of the winding 310, and improving the safety and reliability of the blood pumping device 10. By tightly bonding the barrier layer 320 to the surface of the winding 310, the barrier effect of the barrier layer 320 is improved, and the probability of the winding 310 being completely exposed to the surrounding environment due to damage to the barrier layer 320 is reduced, thereby improving the protective performance of the barrier layer 320 for the winding 310 and further extending the service life of the winding 310.

[0049] After describing the overall structure of the blood pumping device, the following section will introduce the barrier layer 320 in the blood pumping device with reference to the attached drawings.

[0050] Figure 3 This diagram shows longitudinal cross-sectional views of windings, barrier layers, and connecting wires, representing other examples of this application. (In conjunction with...) Figure 2 and Figure 3It is understood that, in some alternative embodiments, the barrier layer 320 includes a paraffin coating 321 covering at least a portion of the winding 310.

[0051] Among them, the Parylene coating 321 is a coating prepared by vacuum vapor deposition of p-xylene polymer. It has high volume resistivity and surface resistivity, low water molecule and gas permeability, and excellent moisture-proof, waterproof, rust-proof, and acid and alkali corrosion resistance. The vacuum vapor deposition process ensures that the p-xylene polymer is uniformly deposited and tightly adhered to the surface of the winding 310, including covering the gap between the two windings. This ensures that the Parylene coating 321 is tightly adhered to the winding 310 after molding, and there are no cavities between the Parylene coating 321 and the winding 310. In this application, the barrier layer 320 includes the Parylene coating 321, which ensures that the barrier layer 320 is tightly adhered to the surface of the winding 310. Even if the barrier layer 320 is partially damaged, other areas of the winding 310 are still isolated from the surrounding environment by the tight adhesion of the barrier layer 320, reducing the impact of the winding 310 being exposed to the surrounding environment due to the damage of the barrier layer 320.

[0052] In some embodiments, the barrier layer 320 further includes a second adhesive layer 322. The second adhesive layer 322 covers the entire outer surface of the winding 310, and the pyrene coating 321 covers the entire outer surface of the second adhesive layer 322; or, the pyrene coating 321 covers the entire outer surface of the winding 310, and the second adhesive layer 322 covers the entire outer surface of the pyrene coating 321 (e.g., Figure 2 (As shown); or, the Piriton coating 321 covers the inner peripheral surface of the winding 310, and covers at least one of the proximal end face and the distal end face of the winding 310, and the second adhesive layer 322 covers at least the outer peripheral surface of the winding 310 (as shown). Figure 3 (As shown).

[0053] The second adhesive layer 322 covers the entire outer surface of the winding 310, and the plane of the second adhesive layer 322 facing away from the winding 310 is flat. The pyrene coating 321 covers the entire outer surface of the second adhesive layer 322. The pyrene coating 321 allows for a more uniform and smooth film formation, better showcasing its high volume resistivity, surface resistivity, and low water molecule and gas permeability. By utilizing the composite second adhesive layer 322 and pyrene coating 321, the barrier layer 320 can be tightly adhered to the surface of the winding 310, while also fulfilling the functions of each layer of the barrier layer 320.

[0054] It is understood that the aforementioned layout scheme of the paraffin coating 321 and the second adhesive layer 322 is only a part of the scope of this application. Other combined layout schemes of the paraffin coating 321 and the second adhesive layer 322 that can achieve the blocking effect of the barrier layer 320 are also within the scope of protection of this application.

[0055] The second adhesive layer 322 is made of epoxy resin and is coated onto the surface of the winding 310. In addition to having high volume resistivity and surface resistivity, the second adhesive layer 322 also has high thermal conductivity, improving the heat dissipation performance of the winding 310. Furthermore, the adhesiveness of the second adhesive layer 322 can be used to connect the winding 310 to other components, for example, by coating the outer peripheral surface of the winding 310 with the second adhesive layer 322 and using the second adhesive layer 322 to connect to the inner wall surface of the housing 100.

[0056] Of course, in other embodiments, the barrier layer 320 may also be without the second adhesive layer 322, and the paraffin coating 321 may directly cover the entire outer surface of the winding 310, with the outer surface of the paraffin coating 321 in direct contact with the surrounding environment.

[0057] The blood pumping device 10 of this application embodiment includes a paraffin coating 321 prepared by vacuum phase deposition in the barrier layer 320. This ensures that the paraffin coating 321 has a uniform thickness after film formation and adheres tightly to the surface of the winding 310. The paraffin coating 321 possesses high volume resistivity and surface resistivity, low water molecule and gas permeability, and excellent moisture-proof, waterproof, rust-proof, and acid / alkali corrosion-resistant properties, thereby improving the protective effect of the barrier layer 320 on the winding 310. Furthermore, by including a second adhesive layer 322 in the barrier layer 320, which also has high volume resistivity, surface resistivity, and high thermal conductivity, the heat dissipation performance of the winding 310 is improved. In addition, the winding 310 can be connected to other components through the second adhesive layer 322, saving additional connection steps. By including both the paraffin coating 321 and the second adhesive layer 322 in the barrier layer 320, the barrier layer 320 not only has the characteristics of high volume resistivity and surface resistivity, but also high thermal conductivity and low water molecule and gas permeability, thereby further improving the functionality of the barrier layer 320 and thus improving the protective performance of the barrier layer 320 for the winding.

[0058] Figure 4 This application also shows longitudinal cross-sectional structural schematic diagrams of windings, barrier layers, and connecting wires as examples; Figure 5 This application shows some examples. Figure 4 A perspective structural diagram of the barrier layer and connecting lines in the middle.

[0059] Combination Figure 4 and Figure 5 It is understood that, in some optional embodiments, the barrier layer 320 includes an insulating layer 323 covering at least a portion of the winding 310, the insulating layer 323 including at least one of a polyethylene terephthalate layer, a polyetheretherketone layer, and a polyimide layer.

[0060] In this application, the insulation layer 323 is reasonably selected to ensure the stability of the barrier layer 320 under the condition of use, so that the blood pumping device can maintain a high level of safety even after long-term immersion, avoid winding leakage, and improve the safety and reliability of the blood pumping device 10.

[0061] In some embodiments, the barrier layer 320 further includes a first adhesive layer (not shown). The insulating layer 323 is a cylindrical insulating film that is tightly adhered to and covers the inner peripheral surface of the winding 310, and the outer peripheral surface of the winding 310 is connected to the inner wall surface of the housing 100 through the first adhesive layer; or, the insulating layer 323 is a cylindrical insulating film that is tightly adhered to and covers the inner peripheral surface of the winding 310 through a third adhesive layer (not shown), and the outer peripheral surface of the winding 310 is connected to the inner wall surface of the housing 310 through the first adhesive layer; or, the insulating layer 323 includes two cylindrical insulating films, one of which is tightly adhered to and covers the inner peripheral surface of the winding 310, and the other is tightly adhered to and covers the outer peripheral surface of the winding 310, and the outer peripheral surface of the winding 310 is connected to the inner wall surface of the housing 100 through the first adhesive layer. By including a cylindrical film in the insulating layer 323, which is generally prepared by a plastic integral molding process, the insulating layer 323 can be tightly attached to the surface of the winding 310, and it is also more convenient to combine the insulating layer 323 and the winding 310 into one piece after they are prepared independently. This facilitates the automated production of the insulating layer 323 on the production line, thereby improving the production efficiency of the blood pumping device 10.

[0062] In some embodiments, the barrier layer 320 further includes an axial sealing plate 324, which is located on at least one side of the distal and proximal ends of the winding 310. The axial sealing plate 324 is sealed to at least one cylindrical insulating film. By including the axial sealing plate 324 in the barrier layer 320, which is generally manufactured using a one-piece molding process of plastic, it is beneficial to manufacture the axial sealing plate 324 and the winding 310 separately and then combine them into one piece. This facilitates the automated production of the axial sealing plate 324 on a production line, thereby improving the production efficiency of the blood pumping device 10.

[0063] In some embodiments, axial sealing plates 324 are provided at both the distal and proximal ends of the winding 310. The insulation layer 323 includes two cylindrical insulating films respectively attached to the inner and outer circumferential surfaces of the winding 310. The two axial sealing plates 324 and the two cylindrical insulating films are mutually sealed and connected, isolating the winding 310 from its surroundings. Alternatively, the two axial sealing plates 324 and the two cylindrical insulating films can be understood as forming a space to accommodate the winding 310. The axial sealing plates 324 and the cylindrical insulating films can be directly and tightly attached to the internal winding 310, or other materials, such as a first adhesive layer, a second adhesive layer 322, and a perylene coating 321, can be filled between the axial sealing plates 324, the cylindrical insulating films, and the winding 310.

[0064] Of course, in other embodiments, only one axial sealing plate 324 is located at the far end or near end of the winding 310.

[0065] In some embodiments, the cylindrical insulating film is prepared by a melt extrusion process. Due to the flexible nature of the cylindrical insulating film, it can be tightly adhered to the surface of the winding 310.

[0066] In some embodiments, the materials of the first adhesive layer, the third adhesive layer, and the second adhesive layer 322 may be the same or different.

[0067] In some embodiments, the axial sealing plate 324 is made of at least one of a polyethylene terephthalate layer, a polyetheretherketone layer, and a polyimide layer. In some embodiments, the insulating layer 323 has a radial thickness of 0.01 to 0.2 mm; and the axial sealing plate 324 has an axial thickness of 0.05 to 0.5 mm.

[0068] The blood pumping device 10 of this application embodiment further includes an insulating layer 323 and an axial sealing plate 324 in the barrier layer 320. The insulating layer 323 and the axial sealing plate 324 are made of insulating and stable plastic. The insulating layer 323 and the axial sealing plate 324 can be sealed together to form a space for accommodating the winding 310. When other barrier layer 320 materials are filled in the space, the insulating layer 323 and the axial sealing plate 324 can isolate the other barrier layer 320 materials inside from the surrounding environment, reduce the direct impact of the external environment (such as the perfusion fluid) on the internal barrier layer 320 materials, thereby improving the stability of the barrier layer 320, ensuring that the winding 311 can maintain a high safety level when immersed in liquid media such as medicine for a long time, and is not prone to safety hazards such as leakage current, thus improving the safety and reliability of the blood pumping device 10. Secondly, the insulation layer 323 and the axial sealing plate 324 are generally prepared by a plastic integral molding process, which is conducive to the axial sealing plate 324, the insulation layer 323 and the winding 310 being prepared independently and then combined into one, which facilitates the automated production of the axial sealing plate 324 and the insulation layer 323 on the production line, thereby improving the production efficiency of the blood pumping device 10.

[0069] In other embodiments, the insulating layer 323 includes an inner ring plate and an outer ring plate. The inner ring plate is disposed around the rotor assembly 200 and between the winding 310 and the rotor assembly 200, and the outer ring plate is disposed around the winding 310 and between the winding 310 and the housing 100. The inner ring plate, the outer ring plate, and the two axial sealing plates 324 together enclose a space for accommodating the winding 310. The space is also filled with at least one of the following materials: a first adhesive layer, a second adhesive layer 322, and a perylene coating 321, so that the winding 310 is tightly adhered to the barrier layer 320.

[0070] The inner and outer ring plates are manufactured using processes such as blow molding, compression molding, and casting. Due to their smooth inner and outer circumferential surfaces, additional barrier layer 320 material needs to be filled between the inner ring plate, outer ring plate, and winding 310 to ensure that the barrier layer 320 can adhere tightly to the surface of the winding 310. In some optional embodiments, the blood pumping device 10 also includes a connecting wire 400. One end of the connecting wire 400 passes through the barrier layer 320 and is electrically connected to the winding in the winding 310, while the other end of the connecting wire 400 is exposed for electrical connection to a control device. A second barrier layer (not shown) is tightly adhered to the outer circumferential surface between the two ends of the connecting wire 400 to isolate the connecting wire 400 from its surroundings.

[0071] In some embodiments of this application, the barrier layer 320 further includes a paraffin coating 321, and the paraffin coating 321 covers at least a portion of the insulating layer. In some implementations, the paraffin coating 321 covers the outer surface of the insulating layer 323, wherein the outer surface of the insulating layer 323 can be understood as the surface of the insulating layer 323 facing away from the winding 310.

[0072] In some embodiments, axial sealing plates 324 are provided at both the distal and proximal ends of the winding 310. The insulating layer 323 includes two cylindrical insulating films respectively attached to the inner and outer circumferential surfaces of the winding 310. The two axial sealing plates 324 and the two cylindrical insulating films are mutually sealed and connected, surrounding the winding 310. At least one of a pyrene coating 321 and a second adhesive layer 322 is also provided between the axial sealing plates 324, the cylindrical insulating films, and the winding 310. The specific relationship between the pyrene coating 321, the second adhesive layer 322, and the winding 311 can refer to the scheme in the above embodiments. The insulating layer 323 can be either a cylindrical film or an annular plate.

[0073] In some embodiments, axial sealing plates 324 are provided at both the distal and proximal ends of the winding 310. The insulating layer 323 includes a cylindrical insulating film adhered to the inner circumferential surface of the winding 310. The two axial sealing plates 324 and the cylindrical insulating film are mutually sealed and connected, sealingly surrounding the winding 310 within the inner wall of the housing 100. It can be understood that at least one of a pyrene coating 321 and a second adhesive layer 322 is also provided between the axial sealing plate 324, the cylindrical insulating film, and the winding 310. The specific relationship between the pyrene coating 321, the second adhesive layer 322, and the winding 311 can refer to the scheme in the above embodiments.

[0074] In some embodiments, at least one of the Perylene coating 321 and the second adhesive layer 322 covers at least a portion of the insulating layer 323. Preferably, the winding 310 has axial sealing plates 324 at both its distal and proximal ends. The insulating layer 323 includes two cylindrical insulating films respectively attached to the inner and outer circumferential surfaces of the winding 310. The two axial sealing plates 324 and the two cylindrical insulating films are mutually sealingly connected and isolate the winding 310 from its surroundings. The Perylene coating 321 covers the outer circumferential surface of the insulating layer 323 facing away from the winding 310 and the surface of the axial sealing plate 324 facing away from the winding 310. The insulating layer 323 can be either a cylindrical film or an annular plate.

[0075] In some embodiments, a first through hole 325 is provided on the barrier layer 320 near the end of the winding 310, and the connecting wire 400 passes through the first through hole 325 and connects the winding 310 and the power supply line 21.

[0076] In some embodiments, the second barrier layer exposes the outer surface of the connecting wire 400 with an axial length of at least 2 mm to facilitate the connection of the connecting wire 400 to the power supply wire 21.

[0077] In some embodiments, the material of the second barrier layer may be the same as or different from the material of the barrier layer 320.

[0078] After describing the overall structure of the barrier layer 320, the following section will introduce the other components of the blood pumping device with reference to the accompanying drawings.

[0079] Combination Figure 1 It is understood that the blood pumping device 10 also includes a proximal end cap 500 and a distal end cap 600. The proximal end cap 500 is connected to the proximal end of the housing 100 and is used to seal the proximal end of the receiving cavity 110. The distal end cap 600 is connected to the distal end of the housing 100 and is used to seal the distal end of the receiving cavity 110. The proximal end cap 500 has a second through hole (not shown) communicating with the inside and outside of the receiving cavity 110. The second through hole communicates with the first through hole 325. At least a portion of the connecting wire 400 passes through the first through hole 325 and the second through hole, extends out of the receiving cavity 110, and is connected to the power supply wire 21. The distal end cap 600 has a first shaft hole 610 communicating with the inside and outside of the receiving cavity 110. The rotor assembly 200 includes a rotating shaft 210, which extends out of the receiving cavity 110 from the first shaft hole 610 and is connected to the impeller.

[0080] In some implementations, the rotor assembly 200 further includes a magnet 220, which is sleeved on and connected to the shaft 210, with a gap between the magnet 220 and the winding 310 for the flow of injection fluid. The stator assembly 300 may also include an iron core for providing a magnetic field, located inside or outside the winding 310.

[0081] In some implementations, the blood pumping device 10 also includes a distal bearing housing 700 and a bearing 800, with the bearing 800 mounted on the rotating shaft 210. The proximal cover 500 has a proximal bearing chamber 510, and both the proximal bearing chamber 510 and the distal bearing housing 700 are used to accommodate the bearing 800.

[0082] In other embodiments, the two bearings 800 are respectively mounted in the receiving cavity 110 via two bearing seats.

[0083] In other embodiments, both the proximal cap 500 and the distal cap 600 are provided with bearing chambers for accommodating the bearing 800.

[0084] In some optional embodiments, the sheath 20 is further provided with an infusion tube (not shown) communicating with the blood pumping device 10. The infusion tube is used to pump infusion fluid into the blood pumping device 10. The proximal end cap 500 is provided with an infusion hole communicating with the infusion tube. The infusion fluid enters the blood pumping device 10 through the infusion tube and the infusion hole. A flow channel for the flow of infusion fluid is formed within the blood pumping device 10. At the wall of the flow channel formed in the stator assembly 300, a barrier layer 320 blocks the winding 310 and the flow channel.

[0085] In some implementations, the flow path includes a first flow path located on the side of the winding 310 facing the rotor assembly 200, with at least a partial barrier layer 320 isolating the winding 310 from the first flow path; and / or, the flow path includes a second flow path formed by the gap between the winding 310 and the housing 100, with at least a partial barrier layer 320 isolating the winding 310 from the second flow path. Without increasing the size of the blood pumping device 10, the barrier layer 320 between the winding 310 and liquid media such as medication prevents the winding 310 from being inadequately protected by the adhesive layer, thus avoiding a decrease in the safety level of the blood pumping device 10 and failure to meet requirements such as leakage current, thereby improving the safety and reliability of the blood pumping device 10. In some implementations, the housing 100 has a third flow path communicating with the flow path, the sheath 20 also has a return pipe (not shown) communicating with the blood pumping device 10, and the proximal end cap 500 has a return hole (not shown) connecting the flow path and the return pipe. At least one of the first, second, and third flow lines is connected to the perfusion line, and at least one is connected to the return line. The perfusion fluid flows through the perfusion line to the blood pumping device 10. A portion of the perfusion fluid flows through the first shaft hole 610 to the outflow channel, preventing blood from entering the blood pumping device 10, while the other portion flows out of the blood pumping device 10 through the return line. In this embodiment, most of the perfusion fluid flows out of the body, reducing the impact of the perfusion fluid on the patient and improving safety. Furthermore, the perfusion fluid flows from distal to proximal and flushes the bearing 800, carrying away particles generated by the rotation of the bearing 800, reducing the harm caused by particles entering the bloodstream, and further improving safety.

[0086] In some implementations, the second flow line is connected to the injection line, and the first flow line is connected to the return line.

[0087] In some implementations, the third flow line is connected to the injection line, and the second flow line is connected to the return line.

[0088] In some implementations, there is no return tube inside the sheath 20, and the perfusion fluid in the pumping device 10 flows directly into the patient's blood vessels through the first shaft hole 610.

[0089] In some implementations, the housing 100 can be two shells with an inner and an outer shell, the two shells fitting together, the inner shell having a groove recessed toward the receiving cavity 110, and a third flow channel forming between the groove and the outer shell.

[0090] In other embodiments, the third flow pipe can also be directly formed by drilling holes in the housing 100, or integrally formed with the housing 100 through processes such as casting or 3D printing.

[0091] Of course, new solutions formed by recombining the above-mentioned solutions are also within the scope of this application.

[0092] In addition, this application also provides a ventricular assist system, including an outflow channel, a sheath 20, and a blood pumping device 10 as provided in any of the above embodiments, wherein the outflow channel is connected to the distal end of the blood pumping device 10, and the sheath 20 is connected to the proximal end of the blood pumping device 10.

[0093] Since the blood pumping device provided in the second aspect of this application includes the pumping motor of any of the above embodiments, the blood pumping device provided in the second aspect of this application has the beneficial effects of the pumping motor of any of the above embodiments, which will not be repeated here.

[0094] In addition, this application also provides a pump motor, including a housing 100, a rotor assembly 200, and a stator assembly 300, the housing 100 enclosing a receiving cavity 110. The rotor assembly 200 is at least partially located within the receiving cavity 110. The stator assembly 300 is connected to the housing 100 and located within the receiving cavity 110, the stator assembly 300 including a winding 310 surrounding the rotor assembly 200 and a barrier layer 320, the barrier layer 320 being tightly bonded to the surface of the winding 310 to isolate the winding 310 from its surroundings.

[0095] It is understood that the pump motor in this application can be applied to applications such as blood pumping devices, tissue fluid pumping devices, and digestive fluid pumping devices to achieve the purpose of pumping fluids such as blood, tissue fluid, and digestive fluid.

[0096] The above description is merely a specific implementation of this application. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, modules, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. It should be understood that the protection scope of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and these modifications or substitutions should all be covered within the protection scope of this application.

Claims

1. A blood pumping device for percutaneous insertion into a patient's blood vessel, characterized in that, include: The casing, enclosing and forming a receiving cavity; The rotor assembly is at least partially located within the receiving cavity; A stator assembly, connected to the housing and located within the receiving cavity, includes windings surrounding the rotor assembly and a barrier layer tightly bonded to the surface of the windings to isolate the windings from their surroundings.

2. The blood pumping device according to claim 1, characterized in that, The barrier layer includes an insulating layer covering at least a portion of the winding, the insulating layer comprising at least one of a polyethylene terephthalate layer, a polyetheretherketone layer, and a polyimide layer.

3. The blood pumping device according to claim 2, characterized in that, The barrier layer also includes a paraffin coating that covers at least a portion of the insulating layer.

4. The blood pumping device according to claim 2 or 3, characterized in that, The barrier layer further includes a first adhesive layer: The insulating layer is a cylindrical insulating film, which is closely attached to and covers the inner circumferential surface of the winding. The outer circumferential surface of the winding is connected to the inner wall of the housing through the first adhesive layer. Alternatively, the insulating layer is a cylindrical insulating film, which is tightly bonded to and covers the inner circumferential surface of the winding through a third adhesive layer, and the outer circumferential surface of the winding is connected to the inner wall of the housing through the first adhesive layer. Alternatively, the insulating layer comprises two cylindrical insulating films, one of which is tightly attached to and covers the inner circumferential surface of the winding, and the other is tightly attached to and covers the outer circumferential surface of the winding, wherein the outer circumferential surface of the winding is connected to the inner wall of the housing through the first adhesive layer.

5. The blood pumping device according to claim 4, characterized in that, The barrier layer further includes an axial sealing plate located on at least one side of the far end and near end of the winding, and the axial sealing plate is sealed to at least one of the cylindrical insulating films.

6. The blood pumping device according to claim 5, characterized in that, The winding is provided with axial sealing plates at both its far and near ends. The insulation layer includes two cylindrical insulating films that are respectively attached to the inner and outer circumferential surfaces of the winding. The two axial sealing plates and the two cylindrical insulating films are mutually sealed and connected to isolate the winding from its surroundings.

7. The blood pumping device according to claim 6, characterized in that, The thickness of the insulating layer in the radial direction is 0.01 to 0.2 mm; the thickness of the axial sealing plate in the axial direction is 0.05 to 0.5 mm.

8. The blood pumping device according to claim 1, characterized in that, The barrier layer includes a paraffin coating that covers at least a portion of the winding.

9. The blood pumping device according to claim 8, characterized in that, The barrier layer further includes a second adhesive layer: The second adhesive layer covers the entire outer surface of the winding, and the Perylene coating covers the entire outer surface of the second adhesive layer; Alternatively, the paraffin coating covers the entire outer surface of the winding, and the second adhesive layer covers the entire outer surface of the paraffin coating; Alternatively, the paraffin coating covers the inner peripheral surface of the winding, and at least one of the proximal end face and distal end face of the winding, and the second adhesive layer covers at least the outer peripheral surface of the winding.

10. The blood pumping device according to claim 1, characterized in that, Also includes: A connecting wire, one end of which passes through the barrier layer and is electrically connected to the winding in the winding, and the other end of which is exposed for electrical connection with the control device; a second barrier layer is tightly fitted to the outer peripheral surface between the two ends of the connecting wire to isolate the connecting wire from the surrounding environment.

11. The blood pumping device according to claim 1, characterized in that, The blood pumping device forms a flow channel for the perfusion fluid, and at the wall of the flow channel formed in the stator assembly, the barrier layer isolates the winding and the flow channel.

12. The blood pumping device according to claim 11, characterized in that, The flow path includes a first flow path located on the side of the winding facing the rotor assembly, and at least part of the barrier layer isolates the winding and the first flow path; And / or, the flow path includes a second flow path formed by the gap between the winding and the housing, and at least part of the barrier layer isolates the winding and the second flow path.

13. A ventricular assist system, characterized in that, It includes an outflow channel, a sheath, and a blood pumping device as described in any one of claims 1 to 12, wherein the outflow channel is connected to the distal end of the blood pumping device, and the sheath is connected to the proximal end of the blood pumping device.

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