A blood pumping device

Abstract

The present disclosure provides a blood pumping device. The blood pumping device comprises a drive assembly outer periphery, the drive assembly outer periphery comprising a proximal port, the proximal port being disposed at a proximal end of the drive assembly outer periphery; a distal port, the distal port being disposed at a distal end of the drive assembly outer periphery, and a perfusion structure, the perfusion structure comprising an expandable passage, at least a portion of the expandable passage being formed by an expandable structure, the expandable structure being disposed on the drive assembly outer periphery, the expandable passage being in communication with the proximal port and the distal port. The blood pumping device provided by the present disclosure can solve the problem of blood entering the perfusion pipeline and the bearing gap due to the reciprocating oscillation of the pulsatile pressure, and also reduces the intervention size.

Description

Technical Field

[0001] This application relates to the field of cardiac assist devices, specifically to a blood pumping device. Background Technology

[0002] During cardiac surgery, due to the patient's underlying medical condition or the demands of the procedure, the heart's function may be weakened, resulting in insufficient pumping capacity. In such cases, a ventricular assist device (VAD) is inserted to assist the heart's pumping action. Existing VADs utilize the heart's pumping principle, using a pumping mechanism to pump blood out of the heart and channel it to the aorta for distribution throughout the body. Current VADs consist of a catheter and a pumping mechanism. The pumping mechanism is located at the distal end of the catheter (away from the operator or physician). The catheter is inserted into the left ventricle of the patient's heart via the femoral, axillary, or carotid arteries, and the pumping mechanism subsequently enters the left atrium. Alternatively, the pumping mechanism can be inserted into the right ventricle via a catheter through a vein such as the femoral vein. The pumping motor is a critical component; while ensuring sufficient pumping flow, the device must be safe and reliable.

[0003] Generally, a biocompatible metal or non-metal tube is configured around the motor for perfusion. The perfusion pressure at the distal end of the pump motor is used to balance and resist the pressure of the heart blood entering the motor, and another part is used to set up a return channel inside the motor to remove particles generated by the rotating parts of the motor from the body.

[0004] Furthermore, in current blood pumping products, the use of biocompatible metal or non-metal tubing around the pump motor results in a large external dimension of the pump motor, which is not conducive to interventional procedures. In addition, the relatively rigid perfusion tubing and fluctuations in intracardiac blood pressure complicate perfusion and return control.

[0005] Therefore, existing technologies still need to be improved and enhanced. Summary of the Invention

[0006] According to an example embodiment of this disclosure, a blood pumping device is provided, which not only blocks the influence of the pulsating pressure of blood in the human heart on the flow state of the perfusion tubing, reduces the difficulty of perfusion and reflux control, and prevents blood from entering the drive components (e.g., the blood pumping motor) due to the pulsating pressure oscillation of blood in the human heart, such as bearing clearances and other parts, causing the blood pumping motor to degrade or fail, but also reduces the outer contour size of the blood pumping motor, making catheter intervention more user-friendly.

[0007] In a first aspect of this disclosure, a blood pumping device is provided, including a peripheral drive assembly, wherein the peripheral drive assembly includes a proximal port and a distal port, the proximal port being disposed at the proximal end of the peripheral drive assembly; the distal port being disposed at the distal end of the peripheral drive assembly, the blood pumping device further including a perfusion structure, the perfusion structure including an expandable passage, at least a portion of the expandable passage being formed by an expandable structure, the expandable structure being disposed on the peripheral drive assembly, the expandable passage connecting the proximal port and the distal port.

[0008] In some embodiments, the expandable pathway includes a hollow cavity formed between the expandable structure and a portion of the outer surface of the drive assembly, and the near port, the far port, and the hollow cavity are interconnected.

[0009] In some embodiments, all of the above-mentioned expandable pathways are composed of expandable structures, which can wrap around the outer surface of the outer periphery of the drive component to form a hollow cavity, wherein the hollow cavity is connected to the near port and the far port respectively.

[0010] In some embodiments, the expandable structure described above includes an elastomer structure or a thin film.

[0011] In some embodiments, the outer periphery of the drive component is provided with a groove or cross-section along the axial direction of the outer periphery of the drive component, the groove or cross-section starting from the near port and ending at the far port, the groove or cross-section being used to arrange the expandable passage.

[0012] In some embodiments, the number of the grooves or facets is multiple, and the grooves or facets are configured to be arranged uniformly or non-uniformly along the circumference of the drive assembly.

[0013] In some embodiments, the groove is provided with an uneven structure, or the cross-section is provided with an uneven structure.

[0014] In some embodiments, the aforementioned convex-concave structure includes one or more raised ribs along the axial direction of the aforementioned blood pumping device, wherein the raised ribs are configured to be continuous or discontinuous.

[0015] In some embodiments, the blood pumping device further includes a drive component and a drive component housing, wherein the outer periphery of the drive component is configured as the outer surface of the drive component housing, wherein the expandable passage includes a gap channel between the inner surface of the drive component housing and the outer surface of the drive component, and the expandable passage disposed on the outer surface of the drive component housing; wherein the expandable passage communicates with the gap channel.

[0016] In some embodiments, the blood pumping device further includes a drive assembly and a plastic layer covering the outer surface of the drive assembly.

[0017] In some embodiments, the number of near ports is one or more, and the number of far ports is one or more, wherein the near ports and the far ports are arranged in pairs or not in pairs, and the two openings at both ends of the expandable path respectively connect the near ports and the far ports.

[0018] It should be noted that the periphery of the aforementioned drive component can be configured as the outer surface of the aforementioned drive component or the outer surface of the drive component housing, and the corresponding outer surface can come into contact with the external environment (blood after intervention in the body).

[0019] In some embodiments, the drive component may be, for example, a motor or a blood pump motor; the outer periphery of the drive component may be the outer periphery of the motor or the outer periphery of the blood pump motor; the perfusion structure may be, for example, a perfusion line or a perfusion line for introducing perfusion fluid; the expandable passage may be a line with expandable capability, such as, but not limited to, a line composed of an elastomer structure.

[0020] In a second aspect of this disclosure, a blood pumping device is provided, comprising a distal shaft, a blood pumping motor, a proximal conduit, and a motor periphery. The distal shaft, the blood pumping motor, and the proximal conduit are sequentially connected. The blood pumping motor includes a proximal port and a distal port. The proximal port is disposed at the proximal end of the motor periphery, and the distal port is disposed at the distal end of the motor periphery. The motor periphery is configured as the outer surface of the blood pumping motor or the outer surface of the motor housing. The blood pumping device further includes an infusion inflow structure, which includes an inflow passage. At least a portion of the inflow passage is formed by an expandable structure disposed on the motor periphery. The inflow passage connects the proximal port and the distal port.

[0021] In some embodiments, the infusion inflow structure is formed by an expandable structure and a portion of the outer surface of the motor periphery, creating a hollow cavity, and the near port, the far port, and the hollow cavity are interconnected.

[0022] In some embodiments, the infusion inflow structure is configured to have two openings, and the inflow passage is entirely composed of an expandable structure that can wrap around the outer surface of the motor to form a hollow cavity, wherein the openings are respectively connected to the near port and the far port.

[0023] In some embodiments, the expandable structure described above includes an elastomer structure or a thin film.

[0024] In some embodiments, the outer periphery of the motor is provided with a groove or cross-section along the axial direction of the outer periphery of the motor, the groove or cross-section starting from the near port and ending at the far port, the groove or cross-section being used to arrange the infusion inflow structure.

[0025] In some embodiments, the number of the grooves or cut surfaces is multiple, and the grooves or cut surfaces are configured to be arranged uniformly or non-uniformly along the circumference of the outer periphery of the motor.

[0026] In some embodiments, the groove is provided with raised ribs, or the cross-section is provided with raised ribs.

[0027] In some embodiments, the aforementioned raised ribs are one or more ribs along the axial direction of the aforementioned blood pumping device, wherein the aforementioned raised ribs are configured to be continuous or discontinuous.

[0028] In some embodiments, the outer periphery of the motor is configured as the outer surface of the motor housing, wherein the infusion inflow structure includes a gap channel between the inner surface of the motor housing and the outer surface of the blood pump motor, and an elastic conduit disposed on the outer surface of the outer periphery of the motor; wherein the elastic conduit is constructed by the expandable structure and communicates with the gap channel.

[0029] In some embodiments, the blood pumping device further includes a plastic layer covering the outer surface of the blood pumping motor, and the plastic layer forming the motor housing.

[0030] In some embodiments, the number of the near ports is one or more, and the number of the far ports is one or more, wherein the near ports and the far ports are arranged in pairs or not in pairs, and the two openings at both ends of the infusion inflow structure are respectively connected to the near ports and the far ports.

[0031] Furthermore, in some embodiments, the infusion inflow structure described above can also be an infusion outflow structure. In some embodiments, the infusion inflow structure can also be an infusion structure or other infusion structures.

[0032] In another aspect of this disclosure, a blood pumping device with a perfusion structure is also provided, comprising: a motor periphery having a distal region near a distal shaft, a proximal region near a proximal catheter, and an intermediate section between the distal region and the proximal region, the motor periphery being located between the distal shaft and the proximal catheter, wherein the distal region, the proximal region, and the intermediate section of the motor periphery are integrally formed as a strip; a blood pumping motor constructed inside the motor periphery and capable of driving the distal shaft; a proximal port disposed in the proximal region of the motor periphery for inputting perfusion fluid; a distal port disposed in the distal region of the motor periphery for inputting perfusion fluid into the interior of the blood pumping motor; and a perfusion structure comprising a perfusion conduit at least partially formed of an elastomer, at least partially disposed on the outer surface of the motor periphery and connecting the proximal port and the distal port.

[0033] Furthermore, in the above-mentioned blood pumping device, the perfusion structure is formed by the above-mentioned elastomer being attached to the outer surface of the outer periphery of the motor to form a sealed structure, so that the above-mentioned elastomer and the outer surface of the outer periphery of the motor form a closed hollow cavity, and the perfusion fluid can flow into the hollow cavity from the above-mentioned proximal port and flow out of the hollow cavity from the above-mentioned distal port into the interior of the blood pumping motor, wherein the above-mentioned elastomer includes an elastic soft membrane made of TPU or Pebax.

[0034] Furthermore, in the aforementioned blood pumping device, the perfusion structure is a tubular soft membrane structure made of an elastic soft membrane, wherein the tubular soft membrane structure has two openings at both ends and a hollow cavity between the two openings, wherein the openings are respectively sealed to the proximal port and the distal port, so that the perfusion fluid can flow into the perfusion structure through the proximal port, through the hollow cavity of the tubular soft membrane structure, and out of the perfusion structure through the distal port, thereby finally entering the interior of the blood pumping motor.

[0035] Furthermore, in the aforementioned blood pumping device, the outer surface of the outer periphery of the motor is provided with a shallow recessed groove, the shallow recessed groove starting from the near port and ending at the far port, and is constructed to be interconnected, wherein the shallow recessed groove is one or more grooves along the axial direction of the aforementioned blood pumping device.

[0036] Furthermore, in the aforementioned blood pumping device, the outer periphery of the motor is constructed as a cylindrical structure, wherein the outer surface of the outer periphery of the motor is constructed as a plane, the plane originating from the near port and ending at the far port, and is constructed as an interconnected structure, wherein the plane is one or more planes along the axial direction of the aforementioned blood pumping device.

[0037] Furthermore, in the aforementioned blood pumping device, the concave portion of the aforementioned shallow groove is provided with raised ribs, or the aforementioned flat surface is provided with raised ribs, wherein the raised ribs can increase the ability of the aforementioned elastomer to adhere to the outer peripheral surface of the aforementioned motor.

[0038] Furthermore, in the aforementioned blood pumping device, the aforementioned protruding ribs are one or more ribs along the axial direction of the aforementioned blood pumping device, wherein the aforementioned protruding ribs are configured to be continuous or discontinuous.

[0039] Furthermore, in the aforementioned blood pumping device, the blood pumping motor can be enclosed by a rigid or flexible housing, and the blood pumping motor further includes a motor shaft, a permanent magnet, an iron core, and windings. The motor shaft has a cylindrical structure, is a rigid body with a slender cylindrical structure, and is connected to and can drive the distal shaft portion. The permanent magnet is disposed on the outer surface of a section of the motor shaft, and the permanent magnet can rotate with the rotation of the motor shaft. The windings are disposed close to the outer surface of the permanent magnet, and the iron core is disposed on the outer layer of the windings. The outer periphery of the motor includes the outer surface of the iron core. The infusion structure is attached to the outer surface of the iron core of the blood pumping motor, and the distal port is an opening near the distal shaft portion, allowing the infusion fluid to flow into the infusion structure through the proximal port and out of the infusion structure through the distal port, thereby entering the interior of the blood pumping motor.

[0040] Furthermore, in the above-mentioned blood pumping device, the number of the proximal ports is one or more, and the number of the distal ports is one or more, wherein the proximal ports and the distal ports are arranged in pairs or not in pairs, wherein the two openings at both ends of the perfusion structure are respectively connected to the proximal ports and the distal ports, and wherein the number of the perfusion structures is one or more.

[0041] Furthermore, the above-mentioned blood pumping device also includes a blood pump housing, which covers the outer periphery of the blood pump. The infusion structure is disposed between the outer periphery of the motor and the blood pump housing, and is configured to connect the proximal port and the distal port. The infusion structure includes a proximal port covering portion covering the proximal port, a distal port covering portion covering the distal port, and an infusion intermediate section connecting the proximal port covering portion and the distal port covering portion. One or all of the distal port covering portion, the proximal port covering portion, and the infusion intermediate section are made of an elastomer or at least partially of an elastomer.

[0042] Compared with the prior art, the present invention has the following advantages:

[0043] The perfusion structure of the blood pumping device includes an expandable passage, at least partially composed of an expandable structure disposed on the periphery of the drive assembly. The expandable passage connects the proximal and distal ports, allowing real-time blood pressure pulsations within the heart to be transmitted to the perfusion tubing at that location via the expandable structure. The pulsating pressure within the expandable structure and the real-time blood pressure pulsations within the heart are perfectly synchronized in amplitude and frequency, thus achieving the blocking of blood pressure pulsations within the expandable passage from the heart's blood pressure pulsations. This results in stable, directional flow within the perfusion tubing, resolving the problem of blood entering the perfusion tubing and motor bearing clearances due to reciprocating pulsating pressure, causing performance degradation or failure of the motor. Furthermore, the expandable passage can be entirely constructed as an elastic membrane or membrane structure, allowing for complete collapse during intervention, reducing the interventional size. Attached Figure Description

[0044] The above and other features, advantages, and aspects of the embodiments of this disclosure will become more apparent from the accompanying drawings and the following detailed description. In the drawings, the same or similar reference numerals denote the same or similar parts, wherein:

[0045] Figure 1 A schematic diagram of a blood pumping device 100 according to some embodiments of the present disclosure is shown;

[0046] Figure 2 A schematic diagram of a blood pumping device 200 according to some embodiments of the present disclosure is shown;

[0047] Figure 3 A schematic diagram of a blood pumping device 300 according to some embodiments of the present disclosure is shown;

[0048] Figure 4 A schematic diagram of a blood pumping device 400 according to some embodiments of the present disclosure is shown;

[0049] Figure 5 A schematic diagram showing a portion of the structure of a blood pumping device 500 with internal details according to some embodiments of the present disclosure is shown;

[0050] Figure 6 A left cross-sectional view of a blood pumping device 300 according to some embodiments of the present disclosure is shown;

[0051] Figure 7 A schematic diagram of a single-layer diaphragm of the perfusion conduit of a blood pumping device 300 according to some embodiments of the present disclosure is shown.

[0052] Figure 8 A schematic diagram of a blood pumping device 300-1 with a tubular diaphragm structure configured according to some embodiments of the present disclosure is shown;

[0053] Figure 9A schematic diagram of an infusion line 350-1 with a tubular diaphragm structure configured in a blood pumping device 300 in a relaxed state is shown according to some embodiments of the present disclosure.

[0054] Figure 10 A schematic diagram of an infusion line 350-1 with a tubular soft membrane structure configured in a blood pumping device 300 in a filled state is shown according to some embodiments of the present disclosure.

[0055] Figure 11 A left cross-sectional view of a blood pumping device 400 according to some embodiments of the present disclosure is shown;

[0056] Figure 12 A schematic diagram of a single-layer PVC membrane in the perfusion conduit of a blood pumping device 400 according to some embodiments of the present disclosure is shown; and

[0057] In the various figures, the same or corresponding reference numerals indicate the same or corresponding parts; wherein the reference numerals are: blood pumping device 100, 200, 300, 300-1, 400, 500; motor outer periphery 110, 210, 310, 410, 510; blood pumping motor 520; proximal catheter 130, 230, 330, 430; distal shaft 140, 240, 340, 440, 540; distal region 111, 211, 311, 411; proximal region 112, 212, 3 12, 412, intermediate sections 113, 213, 313, 413, motor shaft 521, permanent magnet 522, casing core 523, winding 524, filling pipes 350, 350-1, 450, 550, far-port covering 356, 356-1, 556, near-port covering 357, 357-1, filling intermediate section 358, 358-1, far-port 116, 216, near-port 117, 217, impeller 141, 241, 341, 441, intermediate section plane 219. Detailed Implementation

[0058] Embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While some embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of this disclosure. It should be understood that the accompanying drawings and embodiments of this disclosure are for illustrative purposes only and are not intended to limit the scope of protection of this disclosure.

[0059] In the description of embodiments of this disclosure, the term "comprising" and similar terms should be understood as open-ended inclusion, i.e., "including but not limited to". The term "based on" should be understood as "at least partially based on". The term "one embodiment" or "the embodiment" should be understood as "at least one embodiment". The terms "first", "second", etc., may refer to different or the same objects. Other explicit and implicit definitions may also be included below.

[0060] Furthermore, it should be noted that in the description of the embodiments of this application, unless otherwise explicitly defined, "in vivo" means inside the patient's tissues and organs, and "outside the body" means outside the patient's tissues and organs. Also, in the embodiments of this application, "distal" refers to the direction away from the physician, and "proximal" refers to the direction closer to the physician.

[0061] The blood pump is located within the heart's bloodstream. As the heart contracts and relaxes, it inevitably generates pulsating pressure. To prevent blood from entering the pump motor and protect it, blood needs to be pumped from within the motor to balance or counteract the pressure of the blood entering the motor. In current pump designs with perfusion structures, the real-time pressure pulsations within the aorta cannot be transmitted to the rigid perfusion tubing. Furthermore, the pulsating pressure in the rigid perfusion tubing and the real-time pressure pulsations within the aorta are not synchronized, creating pressure pulsations between the rigid perfusion tubing and the aorta. If the perfusion pressure in the tubing is not adjusted in real-time according to the rhythm of the blood pulsations, blood may enter the motor (e.g., through bearing gaps) due to the pulsating pressure within the heart or when the heart's blood pressure is higher than the perfusion pressure. This can seriously damage the pump that is inserted into the heart. Alternatively, if the perfusion pressure within the tubing is higher than the external heart blood pressure, excessive perfusion fluid may flow back into the heart's bloodstream, directly impacting the patient's life and health. Therefore, when using relatively rigid perfusion tubing, it is extremely difficult to adjust the hydraulic pressure of the perfusion fluid according to the blood pulsation pressure. In addition, since the blood pumping device for interventional cardiology has an additional rigid perfusion tubing around its periphery, which increases the cross-sectional dimensions of the original blood pumping device, it inevitably makes the intervention less patient-friendly.

[0062] To address at least one of the aforementioned problems, and one or more other potential problems, exemplary embodiments of this disclosure provide a blood pumping device with an infusion structure, including a periphery of a drive assembly, wherein the periphery of the drive assembly includes a proximal port and a distal port, the proximal port being disposed at the proximal end of the periphery of the drive assembly; the distal port being disposed at the distal end of the periphery of the drive assembly, the blood pumping device further including an infusion structure (e.g., in some embodiments, the infusion structure particularly refers to an infusion conduit portion disposed outside the motor), the infusion structure including an expandable passage, at least a portion of which is formed by the expandable structure, the expandable structure being disposed on the periphery of the drive assembly, the expandable passage connecting the proximal port and the distal port. It should be noted that in some embodiments, the motor periphery is provided as the outer surface of the motor itself; such an outer surface of a motor, in particular, can be directly formed by a housing core; in other embodiments, the motor periphery can also be provided as the outer surface of a motor housing, such as a motor in which the internal stator and rotor assemblies can be encapsulated by the motor housing. Furthermore, in some embodiments, the infusion structure specifically refers to the infusion conduit portion in the blood pumping device. In some embodiments, a perfusion structure specifically refers to a perfusion inflow portion in a perfusion line. In some embodiments, a perfusion structure specifically refers to a perfusion inflow structure in a blood pumping device. In some embodiments, the perfusion inflow structure described above may also be a perfusion outflow structure. In some embodiments, the perfusion inflow structure may also be other perfusion structures. In some embodiments, a perfusion structure may also be a perfusion inflow structure.

[0063] Figure 1 A schematic diagram of a blood pumping device 100 according to some embodiments of the present disclosure is shown. The device provides a corresponding arrangement area for the perfusion tubing, such as providing corresponding interfaces, structures, and arrangement positions. In this example, the blood pumping device 100 includes: a motor periphery 110, a blood pumping motor, a proximal conduit 130, and a distal shaft 140.

[0064] Furthermore, for example Figure 1As shown, the outer periphery 110 of the motor is generally configured to be positioned in an artery or heart. Further, the outer periphery 110 is positioned between a distal region 111 near the distal shaft portion 140 and a proximal region 112 near the proximal duct 130. Further, the outer periphery 110 has an intermediate section 113 located between the distal region 111 and the proximal region 112. Further, the intermediate section 113 of the outer periphery 110 has a cylindrical shape and presents a cylindrical structure; specifically, the central axis of the cylindrical intermediate section 113 can coincide with the central axis of both the distal region 111 and the proximal region 112, and the distal region 111 smoothly transitions to the intermediate section 113 at one end. In some embodiments, the distal region 111 has a curved conical structure with a gradually decreasing base radius from the middle section 113 of the motor periphery 110 towards the end near the distal shaft 140. In some embodiments, the distal region 111 has a frustum structure with a gradually decreasing base radius from the middle section 113 of the motor periphery 110 towards the end near the distal shaft 140. Further, the motor periphery 110 has a cylindrical structure with a cylindrical central axis that coincides with the central axis of the proximal region 112 connected to the proximal conduit 130, and the proximal region 112 smoothly transitions to the middle section 113 of the motor periphery 110 at one end. In some embodiments, the proximal region 112 has a curved conical structure with a gradually decreasing base radius from the middle section 113 of the motor periphery 110 towards the end connected to the proximal conduit 130. In some embodiments, the proximal region 112 has a frustum structure with a gradually decreasing base radius from the middle section 113 of the outer periphery of the motor to the end connected to the proximal conduit 130.

[0065] Furthermore, in the blood pumping device 100, a blood pumping motor (not shown) is disposed inside the outer periphery 110 of the motor, for example, covered by the outer periphery 110 of the motor; and the blood pumping motor is connected to a wire, which is connected from inside the patient's body to an external power control circuit, and the power control circuit supplies current to various electrical devices inside the body, wherein the blood pumping motor includes a rotor portion with driving capability. In some embodiments, the rotor portion of the blood pumping motor may include, for example, a motor shaft and a permanent magnet. Furthermore, the motor shaft has a cylindrical structure, for example, its central axis is coaxial with the central axis of the cylindrical structure presented by the outer periphery 110 of the motor. Furthermore, the permanent magnet is fixed and covered on the motor shaft. Furthermore, the rotor portion is connected to the distal shaft portion 140, and can drive the motor shaft to rotate at various speeds by the rotation of the permanent magnet itself, and then the motor shaft drives the impeller 141 to rotate, thereby pumping blood.

[0066] Furthermore, in this blood pumping device 100, the proximal catheter 130 has a corresponding distal region and a proximal region, wherein the distal region of the proximal catheter 130 is one end that can be connected to the proximal region 112 of the motor periphery 110, and is also obviously one end that can be connected to the blood pumping motor, while the proximal region of the proximal catheter 130 is the other end that can be connected to other cannulas. Similarly, in some exemplary blood pumping devices 100, the distal shaft portion 140 is located near the distal region 111 of the motor periphery 110, and obviously the distal shaft portion 140 can be connected to the blood pumping motor via the motor shaft.

[0067] Furthermore, in the blood pumping device 100, a proximal port 117 (or proximal hole) is provided on the outer periphery 110 of the motor for the input of perfusion fluid, and a distal port 116 (or distal hole) is provided for the perfusion fluid to enter the distal end of the motor for diversion.

[0068] Further, the aforementioned proximal port 117 is an inwardly recessed slot to facilitate the arrangement of the infusion tubing and the infusion of infusion fluid. In some embodiments, the aforementioned proximal port 117 is a radial annular groove. In some embodiments, the aforementioned proximal port 117 is a radial groove. In some embodiments, the aforementioned proximal port 117 is a U-shaped groove, wherein the bottom end of the U-shaped groove faces the middle section 113 of the outer periphery of the motor 110, and the opening end of the U-shaped groove faces the proximal conduit 130, so that the infusion tubing can be better arranged here. Further, the aforementioned proximal port 117 is disposed on the proximal region 112 of the outer periphery of the motor 110. Further, the proximal port 117 is disposed at the junction of the middle section 113 of the outer periphery of the motor 110 and the proximal region 112 of the outer periphery of the motor 110, wherein the junction has a rounded, smooth, and gradually changing structure. Further, a connecting hole is provided at the bottom of the groove of the aforementioned proximal port 117, through which the outside enters the interior of the motor to facilitate the infusion of infusion fluid.

[0069] Similarly, in some embodiments, the distal port 116 is an inwardly recessed slot to facilitate the arrangement of the infusion pipeline and to facilitate the diversion of the infusion fluid into the distal end of the motor. In some embodiments, the distal port 116 is a radial annular groove. In some embodiments, the distal port 116 is a radial groove. In some embodiments, the distal port 116 is a U-shaped groove, wherein the bottom end of the U-shaped groove faces the middle section 113 of the outer periphery 110 of the motor, and the opening end of the U-shaped groove faces the distal shaft portion 140, so that the infusion pipeline can be better arranged here. Further, the distal port 116 is provided on the distal region 111 of the outer periphery 110 of the motor. Further, the distal port 116 is provided at the junction of the middle section 113 of the outer periphery 110 of the motor and the distal region 111 of the outer periphery 110 of the motor, wherein the junction has a rounded, smooth, and gradually changing structure. Further, a connecting hole is provided at the bottom of the groove of the distal port 116, through which the outside enters the interior of the motor to facilitate the infusion of the infusion fluid.

[0070] In some embodiments, the distal port 116 and the proximal port 117 need to be paired. For example, the line connecting the geometric center of the distal port 116 to the geometric center of the proximal port 117 is parallel to or intersects the central axis of the outer periphery 110 of the motor. Further, the distal port 116 and the proximal port 117 need to be paired, and the line connecting the geometric center of the proximal port 117 to the geometric center of the distal port 116 intersects the central axis of the cylindrical structure formed by the outer periphery 110 of the motor at a more distal end, i.e., at the end furthest from the physician, to facilitate the overall intervention of the device into the human body.

[0071] In some embodiments, the aforementioned distal port 116 may include a plurality of distal ports, and the aforementioned proximal port 117 may also include a plurality of proximal ports. Further, the plurality of distal ports are arranged uniformly or non-uniformly around the central axis of the pumping device 100 along the surface of the outer periphery 110 of the motor, and the geometric midpoints of the plurality of distal ports lie on a plane, with the central axis of the pumping device perpendicularly passing through this plane. Similarly, the corresponding plurality of proximal ports are arranged uniformly or non-uniformly around the central axis of the pumping device 100 along the surface of the outer periphery 110 of the motor, and the geometric midpoints of the plurality of proximal ports lie on a plane, with the central axis of the pumping device perpendicularly passing through this plane. In some embodiments, the number of the plurality of distal ports is three, which are uniformly arranged around the surface of the outer periphery 110 of the motor, and the geometric midpoints of the three distal ports lie on a plane, with the central axis of the pumping device 100 perpendicularly passing through this plane at an intersection point, and the three geometric midpoints are respectively connected to this intersection point, thereby forming three included angles of 120 degrees on the plane. In some embodiments, the number of the plurality of distal ports is four, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the four distal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the four geometric midpoints are respectively connected to the intersection point, thereby forming four included angles of 90 degrees on the plane. Similarly, in some embodiments, the number of the plurality of distal ports is five, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the five distal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the five geometric midpoints are respectively connected to the intersection point, thereby forming five included angles of 72 degrees on the plane. Similarly, in some embodiments, the number of the aforementioned plurality of remote ports is six, which are uniformly arranged around the outer periphery 110 surface of the motor, and the geometric midpoints of the six remote ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the six geometric midpoints are respectively connected to the intersection point, thereby forming six included angles on the plane, each of which is 60 degrees. Similarly, in some embodiments, the number of the aforementioned plurality of remote ports is n, which are uniformly arranged around the outer periphery 110 surface of the motor, and the geometric midpoints of the n remote ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the n geometric midpoints are respectively connected to the intersection point, thereby forming n included angles on the plane, each of which is 360 / n degrees. Obviously, the number of the aforementioned plurality of remote ports can also be two or one.

[0072] In some embodiments, the plurality of proximal ports 117 are arranged uniformly or non-uniformly around the central axis of the pumping device 100 along the outer periphery 110 surface of the motor, and the geometric midpoints of the plurality of proximal ports lie on a plane, with the central axis of the pumping device perpendicularly passing through the plane. Similarly, the corresponding plurality of proximal ports are arranged uniformly or non-uniformly around the central axis of the pumping device 100 along the outer periphery 110 surface of the motor, and the geometric midpoints of the plurality of proximal ports lie on a plane, with the central axis of the pumping device perpendicularly passing through the plane. In some embodiments, the number of the plurality of proximal ports is three, which are arranged uniformly around the outer periphery 110 surface of the motor, and the geometric midpoints of the three proximal ports lie on a plane, with the central axis of the pumping device 100 perpendicularly passing through the plane at an intersection point, and the three geometric midpoints are respectively connected to the intersection point, thereby forming three included angles of 120 degrees on the plane. In some embodiments, the number of the plurality of proximal ports is four, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the four proximal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the four geometric midpoints are respectively connected to the intersection point, thereby forming four included angles of 90 degrees on the plane. Similarly, in some embodiments, the number of the plurality of proximal ports is five, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the five proximal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the five geometric midpoints are respectively connected to the intersection point, thereby forming five included angles of 72 degrees on the plane. Similarly, in some embodiments, the number of the aforementioned plurality of proximal ports is six, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the six proximal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the six geometric midpoints are respectively connected to the intersection point, thereby forming six included angles on the plane, each of which is 60 degrees. Similarly, in some embodiments, the number of the aforementioned plurality of proximal ports is n, which are uniformly arranged around the surface of the motor outer periphery 110, and the geometric midpoints of the n proximal ports lie on a plane. The central axis of the pumping device 100 perpendicularly passes through the plane at an intersection point, and the n geometric midpoints are respectively connected to the intersection point, thereby forming n included angles on the plane, each of which is 360 / n degrees. Obviously, the number of the aforementioned plurality of proximal ports can also be two or one.

[0073] Furthermore, the aforementioned plurality of near ports and the aforementioned plurality of far ports are arranged in pairs, wherein the line connecting the geometric centers of each pair of near ports and far ports is parallel to or intersects the central axis of the blood pumping device 100. Preferably, three near ports and three far ports are arranged in pairs on the outer periphery 110 of the motor of the blood pumping device 100.

[0074] Furthermore, the specific arrangement of the injection pipeline will be described in detail in the corresponding embodiments of this disclosure, rather than implying that the structure may not include the corresponding injection structure or injection pipeline.

[0075] Furthermore, Figure 2 A schematic diagram of a blood pumping device 200 according to some embodiments of the present disclosure is shown. Similarly, the device reserves a corresponding arrangement area for the infusion line, such as reserving corresponding interfaces, structures, and arrangement positions. In this example, the blood pumping device 200 includes: a motor periphery 210, a blood pumping motor, a proximal conduit 230, and a distal shaft 240. Similar to the blood pumping device 100, the blood pumping device 200 differs in that the corresponding arrangement area reserved for the infusion line is different. For example, the blood pumping device 200 can be formed based on the blood pumping device 100, such as by removing a small amount of the outer surface material of the motor periphery 110 in the middle section 113 of the motor periphery 110 of the blood pumping device 100, or by making part of the outer surface of the motor periphery 110 recessed inward, thereby forming a planar structure or a shallow recessed groove from the distal port 116 to the proximal port 117, thus forming... Figure 2 The blood pump device 200 is shown. Furthermore... Figure 2 The impeller 241 shown is also driven to rotate by a corresponding motor shaft, thereby pumping blood. In addition, the outer periphery 210 of the motor also includes a distal region 211, a proximal region 212, and an intermediate section 213.

[0076] Furthermore, in the exemplary blood pumping device 200, the infusion conduit can be arranged from the near port 217, along the intermediate plane 219 (or intermediate groove), to the far port 216, thereby enabling the infusion conduit to be arranged along the planar structure or shallow recessed groove on the outer periphery of the motor 210. Further, the near port 217 and the far port 216 are connected by the intermediate plane 219 (or intermediate groove), forming an interconnected structure, for example, a single, integrally connected planar structure or shallow recessed groove. In other embodiments, the near port 217, the far port 216, and the intermediate plane 219 (or intermediate groove) are integrally referred to as an infusion planar structure or infusion groove, which can be disposed on the outer surface portion of the motor 210 of the blood pumping device 200. Further, this infusion planar structure or infusion groove is arranged along the axial direction of the blood pumping device 200. Furthermore, the perfusion planar structure or perfusion groove is arranged along the axial direction of the pumping device 200 and is uniformly arranged on the outer surface portion of the motor outer periphery 210 around the central axis of the motor outer periphery 210. Furthermore, the number of perfusion planar structures or perfusion grooves can be n, preferably 6, more preferably 4, most preferably 3, and of course, 2 or 1. For example, when the number of perfusion planar structures or perfusion grooves is 3, the geometric midpoints of the 3 perfusion planar structures or perfusion grooves form a plane, for example, this plane intersects perpendicularly with the central axis of the motor outer periphery 210 at the intersection point, and the 3 geometric midpoints are respectively connected to the intersection point, forming an angle with the plane, the angle being 120 degrees. Similarly, for example, when the number of perfusion planar structures or perfusion grooves is n, the corresponding angle is 360 / n degrees.

[0077] Furthermore, in other embodiments, the infusion planar structure or infusion groove does not necessarily begin at one of the near port 217 or the far port 216 and extend along a single mid-section plane 219 (or mid-section groove) to the other end (i.e., the other end of the near port 217 or the far port 216 that is not the beginning). Instead, for example, the two near ports extend along two planar structures or grooves to another far port, intersecting at a point on the motor periphery 210, then sharing the planar structure or groove and leading to that far port, thus forming a planar structure or groove with a two-headed and one-tailed "Y" shape. Additionally, planar structures or grooves with corresponding structures of three heads and one tail, four heads and one tail, ..., N heads and one tail may also be included. In some embodiments, planar structures or grooves with corresponding structures of one head and two tails, one head and three tails, ..., one head and N tails may also be included. In some embodiments, planar structures or grooves with corresponding structures of one head and one tail, two heads and two tails, three heads and three tails, ..., N heads and N tails may also be included. In some embodiments, the corresponding planar structure or groove may also include N-head and M-tail structures, where N and M are different natural numbers.

[0078] Furthermore, in the aforementioned infusion planar structure or infusion groove, particularly in the middle section plane 219 (or middle section groove) of the aforementioned infusion planar structure or infusion groove, a single axially protruding rib is provided on its planar structure or groove surface. This single protruding rib facilitates the subsequent arrangement of infusion pipelines within the planar structure or groove by increasing the attachment points, making it easier for the soft membrane or other elastomer to adhere to the planar structure or groove without easily falling off. It should be noted that without this axially protruding rib, the planar structure or groove surface is too smooth, which inevitably leads to a lack of leverage points for the soft membrane or other elastomer to be attached. When the corresponding infusion pipeline is filled, the soft membrane or other elastomer is easily detached due to the impact of the infusion hydraulic pressure or the corresponding pulse pressure, affecting the normal operation of the equipment and even endangering the health and safety of the patient. In other words, regardless of whether the planar structure or groove is a simple plane or a simple curved surface, since the surface of the planar structure or groove is, for example, milled, it must be smooth for human-friendly use. This makes it relatively difficult to attach a soft membrane or other elastomer to the corresponding smooth bottom plane or concave bottom surface of the planar structure or groove. Furthermore, the raised rib can be a single rib or multiple ribs. Furthermore, from the perspective of human-friendly use, the raised portion of the raised rib should not extend beyond the shallow groove or beyond the cylindrical outer surface of the original motor. Furthermore, the aforementioned raised rib is one or more ribs along the axial direction of the aforementioned blood pumping device, wherein the raised rib can be continuous or discontinuous throughout the plane or groove.

[0079] Accordingly, the specific arrangement of the injection pipeline will be described in detail in the corresponding embodiments of this disclosure, rather than saying that the structure cannot include the corresponding injection pipeline.

[0080] Furthermore, Figure 3 A schematic diagram of a blood pumping device 300 according to some embodiments of the present disclosure is shown. The device includes an infusion conduit 350. In this example, the blood pumping device 300 includes: a motor periphery 310, a blood pumping motor, a proximal conduit 330, and a distal shaft portion 340, and an infusion conduit 350, such as a diaphragm or other elastomer infusion conduit, attached to the outer surface of the motor periphery 310 along the axial direction of the blood pumping device 300. In some instances, the infusion conduit may be an expandable passage. Furthermore, the motor periphery 310 also includes a distal region 311, a proximal region 312, and an intermediate section 313.

[0081] In some embodiments, the blood pumping device 300 may be based on the blood pumping device 100, wherein the infusion line 350 correspondingly covers the distal port 116 of the blood pumping device 100 with a single-layer soft membrane, forming a distal port covering portion 356 in the blood pumping device 300. It should be noted that at the distal port 116, the single-layer soft membrane is adhered and sealed along its opening on the outer surface of the motor periphery. Similarly, the proximal port 117 of the blood pumping device 100 is correspondingly covered with a single-layer soft membrane, forming a proximal port covering portion 357 in the blood pumping device 300. It should be noted that at the proximal port 117, It utilizes a single-layer soft film to be adhered and sealed along its opening on one side of the outer surface of the motor periphery; correspondingly, the injection line 350 starts from the distal port covering part 356, extends axially along the outer surface of the motor periphery 310, passes through the injection intermediate section 358 and adheres to the outer surface of the motor periphery 310, and finally reaches the proximal port covering part 357, or the injection line 350 may also start from the proximal port covering part 357, extend axially along the outer surface of the motor periphery 310, passes through the injection intermediate section 358 and adheres to the outer surface of the motor periphery 310, and finally reach the distal port covering part 356. It should be noted that the aforementioned perfusion intermediate section 358 refers to the perfusion pipeline structure formed by covering the outer surface of the motor periphery of the blood pumping device 100 with a single-layer soft membrane, that is, by attaching and sealing the edge of the single-layer soft membrane to the outer surface of the motor periphery of the blood pumping device 100, thereby forming a hollow cavity composed of a single-layer soft membrane on one side and the outer periphery of the motor on the other side. Obviously, in this embodiment, the perfusion pipeline 350 includes a distal port covering part 356, a proximal port covering part 357, and a perfusion intermediate section 358, so that the perfusion fluid can flow from the proximal port covering part 357 through the perfusion intermediate section 358 to the distal port covering part 356, thereby allowing the perfusion fluid to enter the interior of the blood pumping device 300 through the distal port as a working fluid. It should be noted that the above-mentioned perfusion tubing can be formed by a whole elastic soft membrane, which is attached to the outer surface of the blood pump peripheral 310 by the edge to form a hollow chamber. In particular, the hollow chamber includes two openings, one of which corresponds to the distal port 116 and the other of which corresponds to the proximal port 117. The entire chamber is sealed inside except for the two connected openings.

[0082] In some embodiments, an elastic soft film is adhered and sealed to the outer surface of the motor periphery 310, and the near port covering portion 357 is sealed and enclosed therein, and the far port covering portion 356 is sealed and enclosed therein. The filling intermediate section 358 itself is composed of a single layer of soft film that is adhered and sealed to the outer surface of the motor periphery through edge adhesion. The near port covering portion 357 is formed by the single layer of soft film being adhered and sealed along the opening edge of the near port on the outer surface of the motor periphery, and the far port covering portion 356 is formed by the single layer of soft film being adhered and sealed along the opening edge of the far port on the outer surface of the motor periphery. The filling intermediate section 358 is a hollow cavity formed by the outer edge of the single layer of soft film and the outer surface of the motor periphery, thereby realizing the filling pipeline 350 jointly formed by the single layer of soft film and the motor periphery. In other words, the infusion line 350 has two openings, which are connected to the far port and the near port respectively. In addition, part of the cavity wall of the hollow chamber of the infusion line 350 is formed by the outer surface of the motor outer periphery 310, and the other part is formed by an elastic soft membrane, so that the infusion fluid can flow into the hollow chamber from the near port, and after passing through the hollow chamber, finally flow into the motor through the far port.

[0083] In some embodiments, the infusion tubing can be entirely composed of an elastic membrane (e.g., replacing the single-layer membrane structure with a tubular membrane structure or a balloon membrane structure). Specifically, the infusion tubing is constructed from an integral tubular membrane structure, including a proximal port covering, a distal port covering, and an infusion intermediate section. The proximal port covering has an opening that is fitted and sealed to the edge of the outer surface of the motor periphery at the proximal port, thus enclosing the proximal port. Similarly, the distal port covering has an opening that is fitted and sealed to the edge of the outer surface of the motor periphery 310 at the distal port, thus enclosing the distal port. Thus, the infusion fluid can flow from the proximal port into a sealed, leak-proof hollow chamber entirely composed of the tubular membrane structure, and after passing through the hollow chamber, finally flow into the motor interior through the distal port.

[0084] In some embodiments, the blood pumping device may be based on the blood pumping device 200, wherein the infusion line correspondingly covers the distal port 216 of the blood pumping device 200 to form a distal port covering portion in the blood pumping device; similarly, it correspondingly covers the proximal port 217 of the blood pumping device 200 to form a proximal port covering portion in the blood pumping device; correspondingly, the infusion line starts from the distal port covering portion and extends axially along the middle plane or middle groove of the outer surface of the motor peripheral 310, passes through the infusion intermediate section and attaches to the outer surface of the motor peripheral 310, and finally reaches the proximal port covering portion; or the infusion line may also start from the proximal port covering portion and extend axially along the middle plane or middle groove of the outer surface of the motor peripheral 310, passes through the infusion intermediate section and attaches to the outer surface of the motor peripheral 310, and finally reaches the distal port covering portion. Obviously, in this embodiment, the perfusion line includes a distal end covering, a proximal end covering, and an intermediate perfusion section, so that the perfusion fluid can flow from the proximal end covering through the intermediate perfusion section to the distal end covering, thereby allowing the perfusion fluid to enter the blood pumping device through the distal end as a working fluid.

[0085] In the aforementioned blood pumping device with a mid-section plane or mid-section groove, an elastic diaphragm is fitted and sealed to the outer surface of the motor periphery 310. The proximal port is sealed within the proximal port covering portion, and the distal port is sealed within the distal port covering portion. The mid-section plane or mid-section groove is sealed within the plane or groove outer edge of the outer surface of the motor periphery. This ensures that the proximal port covering portion, the distal port covering portion, and the perfusion intermediate section are all fitted and sealed to the mid-section plane or mid-section groove of the motor periphery 310, thereby forming a hollow chamber that can be filled with perfusion fluid. The perfusion fluid can fill the mid-section plane or mid-section groove (since the mid-section plane or mid-section groove becomes the reserved expansion space for the elastic diaphragm) without excessively expanding to the outer surface of the motor periphery 310, thereby avoiding adverse results for the interventional cardiac procedure. Similarly, the hollow chamber of the injection pipeline still has two openings, connecting the distal port and the proximal port respectively. The cavity wall of the hollow chamber is partly composed of an elastic soft membrane, and partly composed of the outer surface of the motor periphery 310 (i.e., the distal port, the proximal port, and the middle section plane or the middle section groove). This allows the injection fluid to flow into the hollow chamber from the proximal port, and after passing through the hollow chamber, it finally flows into the motor through the distal port. After the injection pipeline is filled with injection fluid, it mainly expands towards the aforementioned middle section plane or the middle section groove. Specifically, in this embodiment, a single axially protruding rib is provided on the bottom plane or curved surface of the middle section plane or the middle section groove. As mentioned above, this protruding rib increases the attachment points, facilitating the elastic membrane's adhesion to the groove and preventing it from easily detaching. Furthermore, it allows the hollow cavity formed by the infusion pipeline to be divided in two by the protruding rib during the middle section of infusion. While this affects the expansion of the elastic membrane, it provides more points of contact, making it less prone to detachment. In some embodiments, the concave portion of the aforementioned shallow groove is provided with a protruding rib, or the aforementioned plane is provided with a protruding rib, wherein the protruding rib increases the elastic membrane's ability to adhere to the outer peripheral surface of the motor. Further, in the aforementioned blood pumping device, the planar portion of the aforementioned concave plane is provided with a protruding rib, or the concave portion of the aforementioned shallow groove is provided with a protruding rib, wherein the protruding rib increases the elastic membrane's ability to adhere to the outer peripheral surface of the motor. Furthermore, in the aforementioned blood pumping device, the raised ribs are one or more ribs along the axial direction of the blood pumping device, wherein the raised ribs are configured to be continuous or discontinuous. In some embodiments, an axially oriented raised or recessed structure is provided on the bottom plane or curved surface of the intermediate section plane or the intermediate section groove. Such a structure facilitates stronger adhesion of the soft membrane by increasing the contact surface (points). Furthermore, the axially oriented raised structure provided on the bottom plane or curved surface of the intermediate section plane or the intermediate section groove can correspondingly lift the soft membrane, facilitating rapid filling of the perfusion tubing soft membrane portion with perfusion fluid during operation.

[0086] Similarly, in some embodiments, the infusion tubing can be entirely composed of an elastic diaphragm (e.g., a single-layer diaphragm structure can be replaced with a tubular diaphragm structure or a balloon diaphragm structure). Specifically, the infusion tubing is constructed from a single tubular diaphragm structure, comprising a proximal end cover (sealed and fixed by one end opening of the tubular diaphragm structure along the outer surface edge of the motor periphery at the proximal end opening), a distal end cover (sealed and fixed by one end opening of the tubular diaphragm structure along the outer surface edge of the motor periphery at the distal end opening), and an infusion intermediate section (the intermediate section of the tubular diaphragm structure), wherein the proximal end cover is attached to one side of the outer surface of the motor periphery 310 at the proximal end, enclosing the proximal end therein. Similarly, the distal port covering is attached to one side of the outer surface of the motor peripheral 310 at the distal port, enclosing the distal port therein. Specifically, the tubular soft membrane structure of the middle section of the injection pipeline is attached to the middle plane or middle groove of the outer surface of the motor peripheral 310 near the outer surface of the motor peripheral. Thus, the injection fluid can flow from the near port into the hollow cavity composed entirely of the tubular soft membrane structure, and after passing through the hollow cavity on the middle plane or middle groove of the outer surface of the motor peripheral 310, it finally flows into the motor interior through the distal port. In particular, in this embodiment, it should be noted that the bottom plane or curved surface of the middle plane or middle groove is provided with a single axially raised rib. As mentioned above, the raised rib increases the attachment points, making it easier for the elastic soft membrane to adhere to the groove and preventing it from falling off. Furthermore, the hollow chamber structure composed of this double-layer soft membrane structure has better sealing performance than the hollow chamber formed by only a single layer of soft membrane attached to the outer surface of the motor 310, thus solving the problem of leakage of injection fluid caused by the elastic soft membrane falling off the bonding point with the outer surface of the motor 310.

[0087] It should be noted that the number of perfusion lines can be 1, 2, 3...N. Further, multiple perfusion lines can be evenly arranged around the central axis of the blood pumping device on the outer surface of the motor periphery 310. Further, each perfusion line has 1 distal port and 1 proximal port. In some embodiments, the perfusion line has 2 distal ports and 2 proximal ports, or 3 distal ports and 3 proximal ports, or 4 distal ports and 4 proximal ports, or N distal ports and N proximal ports. Correspondingly, in some embodiments, the number of distal and proximal ports of the perfusion line is inconsistent; for example, it may have M distal ports and N proximal ports, where M and N are arbitrary natural numbers.

[0088] In particular, Figure 4A schematic diagram of a blood pumping device 400 according to some embodiments of the present disclosure is shown. The device has an infusion conduit. In this example, the blood pumping device 400 includes: a motor periphery 410, a blood pumping motor, a proximal conduit 430, and a distal shaft 440. A single-layer soft membrane is attached to the outer surface of the motor periphery 410, thereby forming an infusion conduit that covers the entire motor periphery 410 as a whole. The infusion conduit is a hollow cavity that can be filled with infusion fluid, allowing the infusion fluid to flow into the hollow cavity from the proximal port and into the interior of the blood pumping motor within the blood pumping device 400 from the distal port. Furthermore, the motor periphery 410 also includes a distal region 411, a proximal region 412, and an intermediate section 413. Furthermore, from the outer surface, the injection pipeline has covered part of the distal region 411, part of the proximal region 412, and the entire intermediate section 413 of the outer periphery 410 of the motor.

[0089] In some embodiments, a portion of the distal region 411 of the covered motor periphery 410 is used to cover the distal port on the motor periphery 410, and a portion of the proximal region 412 of the covered motor periphery 410 is used to cover the proximal port on the motor periphery 410, such that the elastic soft membrane and the covered surface of the motor periphery 410 form a hollow cavity that can be filled with perfusion fluid, that is, one side of the hollow cavity is a soft membrane structure and the other side is composed of the motor periphery 410, so that the perfusion fluid can flow into the hollow cavity from the proximal port and flow into the interior of the blood pumping motor in the blood pumping device 400 from the distal port. This single-layer soft membrane structure not only reduces pulsating pressure but also saves on the use of elastic soft membrane material. Furthermore, as long as the elastic soft membrane is used as a whole, it can be attached and sealed in the part of the distal region 411 of the outer periphery of the motor that extends beyond the distal port but does not reach the distal shaft 440 (and in the part of the proximal region 412 of the outer periphery of the motor that extends beyond the proximal port but does not reach the proximal conduit 430). This greatly reduces the difficulty of attaching and sealing multiple points on the outer periphery of the motor of the blood pumping device 400.

[0090] In some embodiments, a portion of the distal region 411 of the covered motor periphery 410 is used to cover the distal port of the motor periphery 410, and a portion of the proximal region 412 of the covered motor periphery 410 is used to cover the proximal port of the motor periphery 410. Further, the soft membrane portion covering the above-mentioned portions is then covered by another soft membrane, so that both sides of the entire hollow chamber are soft membrane structures, integrally attached to the surface of the motor periphery 410. This allows the perfusion fluid to flow into the hollow chamber from the proximal port and into the interior of the pumping motor within the pumping device 400 from the distal port. This double-layer soft membrane structure, in addition to reducing pulsating pressure, also facilitates the relatively independent processing of the perfusion tubing and its convenient application to the pumping device 400. This double-layer soft membrane structure also treats the soft membrane as a whole, and it can be attached and sealed in the part of the distal region 411 of the outer periphery of the motor that extends beyond the distal port but does not reach the distal shaft 440 (and the part of the proximal region 412 of the outer periphery of the motor that extends beyond the proximal port but does not reach the proximal catheter 430). At the same time, multiple attachment points are added to the side of the soft membrane attached to the outer periphery of the motor 410, which also greatly reduces the difficulty of attaching and sealing multiple points on the outer periphery of the motor of the blood pumping device 400.

[0091] To further explain the details of the perfusion fluid entering the pumping device, especially the details of entering the pumping motor, and the pulse pressure caused by the heart's pulsation on the rigid perfusion tubing, the following detailed explanation is provided in conjunction with the accompanying drawings.

[0092] Figure 5A schematic diagram showing a partial structure of a blood pumping device 500 with internal details according to some embodiments of the present disclosure is provided. In this example embodiment, a blood pumping motor 520 may be enclosed by a motor periphery 510, and the blood pumping motor 520 includes a rotor assembly and a stator assembly. The rotor assembly may be, for example, arranged as shown in the figure, including a motor shaft 521 and a permanent magnet 522, while the stator assembly may be, for example, arranged as shown in the figure, including a housing core 523, windings 524, etc. Furthermore, since the rotor assembly is composed of permanent magnets 522, such as permanent magnet steel, a permanent magnet magnetic field can be formed. Furthermore, the stator assembly can be powered in an orderly manner by a blood pumping motor drive controller to generate an excitation magnetic field, thereby causing the permanent magnet magnetic field to interact with the excitation magnetic field, which in turn causes the blood pumping motor 520 to rotate, and subsequently drives the impeller of the distal shaft portion 540 to pump blood via the motor shaft 521. In some embodiments, the blood pumping device 500 described above includes a motor periphery 510, a distal shaft portion 540, and a proximal conduit. The blood pumping motor 520 is further enclosed by a rigid housing containing, for example, a motor shaft 521, a permanent magnet 522, a housing core 523, and windings 524. The motor shaft 521 itself has a cylindrical structure, is a rigid body with a slender cylindrical structure, and is coaxial with the axis of the blood pumping motor 520, which also has a cylindrical structure. The motor shaft 521 can connect to and drive the impeller of the distal shaft portion 540. A section of the motor shaft 521 has a permanent magnet 522 disposed on its outer surface, and the motor shaft 521 and the permanent magnet 522 are on the same axis. The permanent magnet 522 rotates as the motor shaft 521 rotates. Furthermore, the permanent magnet 522, which also has a cylindrical structure, encloses a section of the motor shaft 521. Furthermore, a winding 524 is disposed close to the outer surface of the permanent magnet 522, and a housing core 523 is disposed on the outer layer of the winding 524. Specifically, the outer periphery 510 of the motor may include the outer surface of the housing core 523. In some embodiments, the outer periphery of the motor may be entirely composed of the housing core 523. In some embodiments, for example, as... Figure 5As shown, the stator assembly, consisting of the housing core 523, windings 524, etc., is powered to generate an excitation magnetic field, which acts on the permanent magnet magnetic field formed by the rotor assembly, consisting of permanent magnets 522 and motor shaft 521, etc., thereby driving the rotor assembly to rotate, and subsequently driving the impeller of the distal shaft portion 540 to rotate. Furthermore, the outer surface of the motor periphery 510 covering the blood pump motor 520 is also provided with an infusion line 550, which allows coolant to be introduced externally from the proximal conduit via an interventional conduit. This infusion line 550 can inject liquid into various parts inside the blood pumping device 500. Furthermore, the infusion line 550 is close to the outer surface of the motor periphery 510 outside the blood pump motor 520, and has an opening from the impeller portion of the distal shaft portion 540, injecting liquid into the blood pumping device 500 from the distal end to the proximal end, thereby lubricating the interior of the motor periphery 510, especially the parts carrying the blood pump motor 520. Furthermore, a near-port covering portion (not shown) and a far-port covering portion 556 are respectively provided at the near-port and far-port of the outer periphery 510 of the motor. Figure 5 The image shows an example of a single perfusion line 550. It can be seen that the perfusion fluid enters the pump motor 520 of the pumping device 500 through the perfusion line 550 from the distal end cover 556.

[0093] To more clearly describe the corresponding embodiments described above, this disclosure provides further explanation of the corresponding components in conjunction with the accompanying drawings.

[0094] Figure 6 A left cross-sectional view of a blood pumping device 300 according to some embodiments of the present disclosure is shown. In this embodiment, a soft diaphragm is adhered and sealed to the outer surface of the outer periphery of a motor, forming a hollow chamber therebetween capable of being filled with perfusion fluid. In particular, Figure 6 The planar structure formed on the outer periphery of the motor by removing a small amount of material is shown, thus forming an infusion conduit 350 together with the soft film. Furthermore, Figure 6 In the embodiment described, this planar structure forms two injection pipes 350, which are symmetrically arranged on both sides of the outer periphery of the motor. It should be noted that... Figure 6 The number of infusion lines 350 shown is illustrative and not necessarily limited to two. Furthermore, the planar structure can also be a shallow, recessed groove. Further, taking the planar structure as an example, the blood pumping device 300 has a cylindrical structure, wherein the vertical distance from the central axis to the plane should be greater than 0.95 times the radius of the circle formed by the cross-section; in short, as... Figure 6As shown, the central axis of the blood pumping device 300 is the center point of the circular structure. The vertical distance from this center point to the cut planar structure 350 is r0, and the distance from this center point to the uncut outer surface of the original curved surface is r1. Therefore, r0 should be greater than 0.95 times r1. In this way, the cutting on the outer periphery of the motor and even the outer surface of the blood pumping motor housing is minimized to ensure the original performance of the blood pumping motor inside the outer periphery of the motor. That is, by reducing milling or grooving, the motor performance can be maintained with minimal sacrifice.

[0095] Figure 7 A schematic diagram of a single-layer soft membrane in the perfusion line of a blood pumping device 300 according to some embodiments of the present disclosure is shown. As can be seen from the diagram, as long as the edges of the single-layer soft membrane are adhered and sealed to the outer peripheral surface of the motor, a hollow cavity can be formed together with the outer peripheral surface of the motor.

[0096] Figure 8 A schematic diagram of a blood pumping device 300-1 with a tubular diaphragm structure configured according to some embodiments of the present disclosure is shown. As can be seen from the figure, the blood pumping device 300-1 differs from the blood pumping device 300 in that it adopts an infusion conduit 350-1 with a tubular diaphragm structure, which includes a distal end covering portion 356-1, a proximal end covering portion 357-1, and an intermediate infusion section 358-1.

[0097] Figure 9 A schematic diagram of an infusion line 350-1 with a tubular diaphragm structure configured in a blood pumping device 300 in a relaxed state, according to some embodiments of the present disclosure, is shown. As can be seen from the diagram, in the relaxed state, that is, when the inside is not yet filled with perfusion fluid, the infusion line composed of the tubular diaphragm is contracted (collapsed).

[0098] Figure 10 A schematic diagram of an infusion line 350-1, configured with a tubular diaphragm structure in a blood pumping device 300 according to some embodiments of the present disclosure, is shown in a filled state. As can be seen from the diagram, in the filled state, that is, when the inside is filled with perfusion fluid, the infusion line composed of the tubular diaphragm structure is full (bulging).

[0099] Figure 11 A left sectional view of a blood pumping device 400 according to some embodiments of the present disclosure is shown. In this embodiment, a single-layer soft membrane is integrally and sealed to the outer surface of the motor periphery; that is, the single-layer soft membrane completely covers the outer surface of the motor periphery, forming a hollow cavity capable of being filled with perfusion fluid between the soft membrane and the outer surface of the motor periphery. In particular, the figure shows a planar structure formed on the outer periphery of the motor due to the removal of a small amount of material. Furthermore, in the embodiment shown in the figure, there are two such planar structures, symmetrically arranged on both sides of the outer periphery of the motor. It should be noted that... Figure 11The number of planar structures shown is illustrative and does not necessarily mean there can only be two. Furthermore, the planar structures shown can be replaced with shallow recessed grooves.

[0100] Figure 12 A schematic diagram of a single-layer soft membrane in the perfusion conduit of a blood pumping device 400 according to some embodiments of the present disclosure is shown. In this embodiment, the single-layer soft membrane can completely cover the outer periphery of the motor of the blood pumping device. Only the two ends need to be adhered and sealed at the outermost edges of the proximal and distal regions of the outer periphery of the motor to ensure that the perfusion fluid can fill the hollow cavity between the soft membrane and the outer periphery of the motor, and to allow the perfusion fluid to flow into the hollow cavity from the proximal port on the outer periphery of the motor, and finally flow into the motor interior through the distal port on the outer periphery of the motor.

[0101] In addition, in the above embodiments, in order to increase the connection strength between the soft membrane or elastomer and the pump motor, adhesive can be applied to all or part of the contact surface between the soft membrane or elastomer and the outer periphery of the motor for bonding.

[0102] Furthermore, in some embodiments, the blood pumping device further includes an additional motor housing that may cover the outer periphery of the blood pump (or cover the aforementioned housing core). An infusion conduit is disposed between the outer periphery of the motor and the blood pump housing, configured to connect a proximal port and a distal port. The infusion conduit includes a proximal port covering portion covering the proximal port, a distal port covering portion covering the distal port, and an intermediate infusion section connecting the proximal port covering portion and the distal port covering portion. One or all of the distal port covering portion, the proximal port covering portion, and the intermediate infusion section are composed of an elastomer (e.g., an elastic membrane) or at least partially composed of an elastomer. That is, "partially composed of an elastomer or membrane" means that at least one of the distal port covering portion, the proximal port covering portion, and the intermediate infusion section included in the infusion conduit is composed of an elastic membrane (or composed of a membrane and the outer periphery of the motor).

[0103] It should be noted that in the various embodiments described above, given the expandable structure, particularly the use of the film to transmit pulsating pressure, the film is preferably as thin as possible and possesses sufficient flexibility to stably deform in response to changes in background pressure. It is understood that when the film's thickness and strength are both relatively small, although it can transmit pulsating pressure, it is easily damaged and loses its function under changing pressure fluctuations. Therefore, the thickness and material selection of the film are important design factors. In one embodiment, highly elastic materials such as TPU and Pebax are selected to make the film. For example, a film with a thickness of not less than 0.01 mm and not more than 0.5 mm can be selected, i.e., the thickness range of the film is 0.01 mm to 0.5 mm. Preferably, the thickness range of the film is 0.05 mm to 0.2 mm, and more preferably, the thickness of the film is 0.1 mm. Furthermore, if the film thickness range is greater than 0.5 mm, and the film can also solve the aforementioned technical problems to meet product requirements, then it can also be used. Of course, when the material strength is sufficient, the thickness can be further reduced; no specific limitations are made here.

[0104] The various embodiments of this disclosure have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or technical improvements to the embodiments in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

[0105] The above description is merely an optional embodiment of this disclosure and is not intended to limit this disclosure. Various modifications and variations can be made to this disclosure by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure should be included within the scope of protection of this disclosure.

Claims

1. A blood pumping device, comprising a drive assembly periphery, characterized in that, The peripheral periphery of the drive component includes a proximal port and a distal port. The proximal port is located at the proximal end of the peripheral periphery of the drive component, and the distal port is located at the distal end of the peripheral periphery of the drive component. The blood pumping device further includes a perfusion structure, which includes an expandable passage. At least a portion of the expandable passage is formed by the expandable structure, which is located on the peripheral periphery of the drive component. The expandable passage is an inflow passage that connects the proximal port and the distal port. The peripheral periphery of the drive component is configured to communicate with the interior of the drive component through a gap, thereby enabling the blood from the human heart located on the peripheral periphery of the drive component to contact the perfusion fluid located inside the drive component. The expandable structure is configured to prevent blood from entering the interior of the drive component due to the pulsating pressure oscillation of the blood from the human heart.

2. The apparatus according to claim 1, characterized in that, The expandable pathway includes a hollow cavity formed between the expandable structure and a portion of the outer surface of the drive assembly, and the near port, the far port, and the hollow cavity are interconnected.

3. The apparatus according to claim 1, characterized in that, All the expandable pathways are composed of expandable structures, which can wrap around the outer surface of the drive component to form a hollow cavity, wherein the hollow cavity is connected to the near port and the far port respectively.

4. The apparatus according to claim 1, characterized in that, The expandable structure includes an elastomer structure or a thin film.

5. The apparatus according to claim 1, characterized in that, The outer periphery of the drive assembly is provided with a groove or cross-section along the axial direction of the outer periphery of the drive assembly, the groove or cross-section starting from the near port and ending at the far port, the groove or cross-section being used to arrange the expandable passage.

6. The apparatus according to claim 5, characterized in that, The number of grooves or facets is multiple, and the grooves or facets are configured to be arranged circumferentially along the outer periphery of the drive assembly.

7. The apparatus according to claim 5, characterized in that, The groove is provided with an uneven structure, or the cross-section is provided with an uneven structure.

8. The apparatus according to claim 7, characterized in that, The concave-convex structure includes one or more raised ribs along the axial direction of the blood pumping device, wherein the raised ribs are configured to be continuous or discontinuous.

9. The apparatus according to claim 1, characterized in that, The blood pumping device further includes a drive assembly and a drive assembly housing, the outer periphery of the drive assembly being configured as the outer surface of the drive assembly housing, wherein the expandable passage includes a gap channel between the inner surface of the drive assembly housing and the outer surface of the drive assembly, and the expandable passage being configured on the outer surface of the drive assembly housing. The expandable pathway is connected to the gap channel.

10. The apparatus according to claim 1, characterized in that, The blood pumping device also includes a drive assembly and a plastic layer covering the outer surface of the drive assembly.

11. The apparatus according to claim 1, characterized in that, The number of near ports is one or more, and the number of far ports is one or more, wherein the near ports and the far ports are arranged in pairs or not in pairs, and the two openings at both ends of the expandable path respectively connect the near ports and the far ports.

Images