An interventional catheter device

Abstract

The application relates to an interventional catheter device, belonging to the technical field of medical instruments. The device comprises a catheter and a blood-pumping pump conveyed into a body of a subject through the catheter; a distal end of the catheter is connected with the pump; the pump comprises a pump shell, a power assembly and an impeller; the power assembly and the impeller are arranged in the pump shell; the distal end of the catheter is sequentially provided with the power assembly and the impeller; the pump shell is provided with a blood inlet end and a blood outlet end; the power assembly is arranged as a power device driven by fluid. Compared with a traditional mode of driving a flexible shaft by a motor and then driving the impeller to rotate by the flexible shaft, the application greatly shortens the length of a power transmission link by arranging the power assembly in a built-in mode. Therefore, the defects of the prior art are overcome, and problems such as large vibration, high transmission abrasion and heat generation in the transmission process of the flexible shaft do not exist any more, and the transmission performance is more optimized.

Description

Technical Field

[0001] This invention relates to an interventional catheter device, belonging to the field of medical device technology. In this invention, the end closer to the operator is designated as the proximal end, and the end farther from the operator is designated as the distal end. Background Technology

[0002] Interventional catheter devices (referred to as blood pumps) can pump blood. Taking left ventricular assist as an example, current technology generally places the pump body of the catheter device in the left ventricle of the subject, and then drives the impeller of the pump through a flexible shaft, which is driven by a motor, which is usually located outside the subject. In this way, the flexible shaft connects the external motor and the internal pump body to achieve transmission. However, this method has the problem of a long transmission chain, which leads to problems such as large vibration, high wear and tear in power transmission, and heat generation during flexible shaft transmission. Summary of the Invention

[0003] The purpose of this invention is to overcome the shortcomings of the prior art and solve the technical problems of large vibration, high frictional resistance of the transmission shaft, and easy overheating of the transmission shaft due to the external motor.

[0004] To address the aforementioned problems, the present invention provides an interventional catheter device, comprising a catheter and a pump for pumping blood into the subject's body via the catheter; the distal end of the catheter is connected to the pump; the pump includes a pump housing, a power assembly, and an impeller; the power assembly and impeller are disposed within the pump housing, and the power assembly and impeller are sequentially disposed at the distal end of the catheter; the pump housing has a blood inlet end and a blood outlet end; the power assembly is a fluid-driven power device.

[0005] Preferably, the conduit is provided with a pipe for the flow of the working fluid medium that drives the power assembly.

[0006] Preferably, the power assembly includes a housing, a stator, and a rotor; the stator is provided on the inner wall of the housing, and the rotor driven by the working fluid medium passes through the stator, and the rotor is connected to the impeller; the housing and the stator are provided with channels for the working fluid medium to enter and exit.

[0007] Preferably, a sealed cavity is provided between the stator and the rotor; the cavity is connected to a channel for the inlet and outlet of the working liquid medium provided on the stator, the channel being a medium inlet and a medium outlet; the rotor is cylindrical, and a shank is provided radially on the outer peripheral wall of the rotor pointing towards the inner wall of the stator.

[0008] Preferably, the outer peripheral wall of the rotor is provided with a slot, one end of which is provided in the slot, and the other end of the slot is connected to the inner wall of the stator; the inner wall of the stator, the two adjacent slots and the outer wall of the rotor form a closed working fluid cavity; the inner wall of the stator has different thicknesses; the volume of the working fluid cavity when it is connected to the medium inlet is greater than the volume of the working fluid cavity when it is connected to the medium outlet.

[0009] Preferably, the impeller includes an impeller shaft, a hub, and blades. One end of the impeller shaft is connected to the rotor, and the other end is connected to a bearing located at the far end of the pump casing. The outer periphery of the impeller shaft is provided with a hub, and the hub is provided with blades.

[0010] Preferably, the pump casing is provided with a telescopic bracket; the distal end of the pump is provided with a flexible non-invasive support.

[0011] Preferably, the flexible non-invasive support has a hollow cavity, the impeller shaft has an axial channel communicating with the hollow cavity, the conduit has a guide channel, and the rotor has a central channel communicating with the axial channel and the guide channel; the hollow cavity, axial channel, central channel, and guide channel are sequentially connected to form a guide wire passage channel for the guide wire to pass through.

[0012] Preferably, the conduit is provided with an infusion channel, and the end of the infusion channel near the operator is provided with an infusion fluid inlet; the infusion channel is connected to the pipeline through which the working fluid medium flows.

[0013] Preferably, the pipe through which the working fluid medium flows is connected to the guide channel.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] Compared to the traditional method of driving a flexible shaft with a motor, which in turn drives an impeller, this invention significantly shortens the power transmission link by integrating the power component. Therefore, it overcomes the shortcomings of existing technologies, eliminating problems such as high vibration, high wear, and heat generation during flexible shaft transmission, resulting in optimized transmission performance. Attached Figure Description

[0016] Figure 1 This is a three-dimensional structural schematic diagram of an interventional catheter device according to an embodiment of the present invention;

[0017] Figure 2 for Figure 1 Cross-sectional structural diagram;

[0018] Figure 3 This is a cross-sectional view of an interventional catheter device according to another embodiment of the present invention;

[0019] Figure 4 yes Figure 3 Cross-sectional view of the power assembly.

[0020] Reference numerals: 1. Power assembly; 2. Conduit; 21. Proximal end; 22. Distal end; 3. Pump casing; 31. Inlet end; 32. Outlet end; 4. Support; 5. Impeller; 51. Impeller shaft; 52. Blade; 53. Hub; 510. Axial channel; 6. Distal bearing chamber; 7. Bearing; 8. Flexible non-invasive support; 81. Hollow cavity; 9. Medium inlet channel; 10. Medium return channel; 15. Guide channel; 152. Connecting hole; 151. Flexible check valve; 100. Shell; 101. Central channel; 110. Medium inlet; 111. High-pressure section; 112. High-pressure liquid hole; 120. Medium outlet; 121. Low-pressure section; 122. Low-pressure liquid hole; 131. Flange; 130. Rotor; 135. Stator. Detailed Implementation

[0021] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0022] like Figure 1-4As shown, the technical solution adopted by the present invention is to provide an interventional catheter device, including a catheter 2 and a pump for pumping blood into the subject's body through the catheter 2; the distal end 22 of the catheter 2 is connected to the pump; the pump includes a pump housing 3, a power assembly 1, and an impeller 5; the power assembly 1 and the impeller 5 are disposed inside the pump housing 3, and the power assembly 1 and the impeller 5 are sequentially disposed at the distal end 22 of the catheter 2; the pump housing 3 is provided with a blood inlet end 31 and a blood outlet end 32; the power assembly 1 is configured as a fluid-driven power device. The catheter 2 is provided with a pipe for driving the flow of the working fluid medium of the power assembly. The power assembly 1 includes a housing 100, a stator 135, and a rotor 130; the stator 135 is disposed on the inner wall of the housing 100, and the rotor 130 driven by the working fluid medium passes through the stator 135, and the rotor 130 is connected to the impeller 5; the housing 100 and the stator 135 are provided with channels for the entry and exit of the working fluid medium. A sealed cavity is provided between the stator 135 and the rotor 130. The cavity is connected to a working fluid medium inlet / outlet channel provided on the stator 135, which is configured as a medium inlet 110 and a medium outlet 120. The rotor 130 is cylindrical, and a shank 131 is provided radially on the outer peripheral wall of the rotor 130, pointing towards the inner wall of the stator 135. A slot is provided on the outer peripheral wall of the rotor 130, and one end of the shank 131 is located in the slot. The other end of the shank 131 is connected to the inner wall of the stator 135. A closed working fluid cavity is formed between the inner wall of the stator 135, two adjacent shanks 131, and the outer wall of the rotor 130. The inner wall of the stator 135 has different thicknesses. The volume of the working fluid cavity when it is connected to the medium inlet 110 is greater than the volume of the working fluid cavity when it is connected to the medium outlet 120. The impeller 5 includes an impeller shaft 51, a hub 53, and blades 52. One end of the impeller shaft 51 is connected to the rotor 130, and the other end is connected to a bearing 7 located at the far end of the pump casing 3. The hub 53 is located on the outer periphery of the impeller shaft 51, and the blades 52 are located on the hub 53. A telescopic bracket 4 is located inside the pump casing 3. A flexible non-invasive support 8 is located at the far end of the pump. The flexible non-invasive support 8 has a hollow cavity 81. The impeller shaft 51 has an axial channel 510 communicating with the hollow cavity 81. The guide tube 2 has a guide channel 15. The rotor 130 has a central channel 101 communicating with the axial channel 510 and the guide channel 15. The hollow cavity 81, the axial channel 510, the central channel 101, and the guide channel 15 are sequentially connected to form a guide wire passage channel for the guide wire to pass through. The guide tube 2 has an infusion channel, and the end of the infusion channel near the operator has an infusion fluid inlet. The infusion channel is connected to the pipeline through which the working fluid medium flows.

[0023] Example

[0024] The interventional catheter device of this invention is powered and can be delivered to the desired location on the heart to pump blood. For example... Figure 1 , Figure 2 and Figure 4As shown, the interventional conduit device includes a drive mechanism, a pump casing 3, and an impeller 5.

[0025] A drive mechanism transmits power to the impeller 5, causing it to rotate within the pump housing 3, thereby pumping blood. The drive mechanism can enter the subject's blood vessels along with the impeller 5, bending according to the vascular structure until it reaches the desired location in the heart. The drive mechanism includes a catheter 2 and a power assembly 1 connected to the distal end of the catheter 2. During operation, the power assembly 1 is at least partially implanted in the subject's body to drive the rotation of the impeller 5.

[0026] In one embodiment, the power assembly 1 includes a power input end and a power output end. The power input end has a medium inlet 110 and a medium outlet 120, and the power output end is connected to the impeller 5. The conduit 2 has a media inlet channel 9 and a media return channel 10 that are isolated from each other. The outlet of the media inlet channel 9 is connected to the media inlet 110, and the inlet of the media return channel 10 is connected to the media outlet 120. The flow direction of the fluid medium in the media inlet channel 9 is opposite to the flow direction of the fluid medium in the media return channel 10.

[0027] In this embodiment, the power assembly 1 is driven by the fluid medium transported within the conduit 2. The general operating process is as follows: the outlet of the medium inlet channel 9 is connected to the medium inlet 110 of the power input end of the power assembly 1, and the inlet of the medium return channel 10 is connected to the medium outlet 120 of the power input end of the power assembly 1. The fluid medium flows into the power input end of the power assembly 1 from the medium inlet channel 9 and then flows out from the medium return channel 10. Thus, the power assembly 1 can generate power using the flowing fluid medium, and output this power to the impeller 5 through the power output end connected to the impeller 5, thereby driving the impeller 5 to rotate.

[0028] Therefore, the drive mechanism provided in this embodiment of the invention directly drives the impeller 5 to rotate through the power output end of the power component 1, instead of driving the flexible shaft through a motor and then having the flexible shaft drive the impeller 5 to rotate. Thus, it avoids the problems of large vibrations, high wear during power transmission, and heat generation found in the prior art during flexible shaft transmission, resulting in optimized transmission performance.

[0029] The drive mechanism provided in this embodiment drives the rotation of the impeller 5 through the input and output of a fluid medium. It eliminates the need for a flexible shaft to transmit power from the external motor to the body, and consequently eliminates the need for a perfusion fluid (e.g., coolant) to dissipate heat from the rotation of the flexible shaft. The transmission structure is simple and easy to manufacture. Furthermore, when inserted into the body, since a flexible shaft is not required within the catheter 2, the problem of relative movement between the flexible shaft and the catheter during bending can be avoided.

[0030] Fluid media can be non-rejectable fluid media such as physiological saline. As a feasible approach, some fluid media can be infused into the body to compensate for fluid loss or replenish the subject's needs.

[0031] It should be noted that the flow direction of the fluid medium in the medium inlet channel 9 and the flow direction of the fluid medium in the medium return channel 10 are opposite, meaning that the two flow directions have opposite components. More preferably, the two flow directions can be completely opposite, with the two flow directions set at 180 degrees opposite each other. Figure 2 The arrows in the diagram indicate the flow direction of the fluid medium.

[0032] The medium inlet channel 9 and the medium return channel 10 can both extend along the axial direction of the conduit 2 and be symmetrically distributed within the conduit 2. Of course, the present invention does not impose a unique limitation on the number and shape of the medium inlet channel 9 and the medium return channel 10, and can design them as needed.

[0033] In one feasible embodiment, there is one medium inlet channel 9 and one medium return channel 10, which are arranged in parallel and extend along the axial direction of the conduit 2. In the radial cross-section of the conduit 2, the axes of the medium inlet channel 9 and the medium return channel 10 are both located on the diameter of the conduit 2, and the distances from the axes of the medium inlet channel 9 and the medium return channel 10 to the center of the conduit 2 are equal.

[0034] In another feasible embodiment, multiple media inlet channels 9 and media return channels 10 are provided, and the number of them is equal and they are arranged in parallel, extending along the axial direction of the conduit 2. On the radial cross-section of the conduit 2, the axes of the media inlet channels 9 and the media return channels 10 are on the same circle, and the media inlet channels 9 and the media return channels 10 are spaced apart, with the distance between adjacent media inlet channels 9 and media return channels 10 being equal.

[0035] In other feasible embodiments, multiple media inlet channels 9 and multiple media return channels 10 are provided, and the number of them is equal and they are arranged in parallel, extending along the axial direction of the conduit 2. In the radial cross-section of the conduit 2, the axes of the media inlet channels 9 and the media return channels 10 are on the same circle, and the multiple media inlet channels 9 are located on the same side of a diameter of the conduit 2, while the multiple media return channels 10 are located on the other side of the same diameter of the conduit 2.

[0036] In this embodiment, the inlet of the medium inlet channel 9 and the outlet of the medium return channel 10 are both located at the end of the conduit 2 away from the power component 1 (i.e., the proximal end 21). That is, the inlet of the medium inlet channel 9 and the outlet of the medium return channel 10 are located on the same side of the conduit 2, which facilitates the input and output of the fluid medium.

[0037] In this embodiment, catheter 2 is a flexible catheter, allowing it to bend and deform to adapt to the vascular structure of the subject. Catheter 2 has a proximal end 21 away from power component 1 and a distal end 22 close to power component 1. The distal end 22 of catheter 2 is provided with a receiving space for accommodating power component 1. This receiving space has a spatial proximal end close to proximal end 21 and a spatial distal end away from proximal end 21. The power input end of power component 1 is located at the spatial proximal end, and the power output end is located at the spatial distal end, thereby enabling catheter 2 to provide an installation position for power component 1 and to protect power component 1.

[0038] Of course, the power unit can also be connected to the distal end 22 of the conduit 2 via the tubular housing 100, without being housed within the distal end 22 of the conduit 2.

[0039] Preferably, the distal end 22 of the conduit 2, the distal end of the accommodating space, and the power output end of the power assembly 1 are coaxially aligned, so that the accommodating space is basically occupied by the power assembly 1, thereby making the structure more compact and the connection more secure. The outlet of the medium inlet channel 9 and the inlet of the medium return channel 10 are both located at the proximal end of the accommodating space, and they are connected to the power input end of the power assembly 1 at the proximal end of the space, thereby enabling them to cooperate with the power assembly 1.

[0040] To facilitate the device's insertion into the desired location within the subject's body, a guidewire is pre-inserted and the device moves along the guidewire path within the blood vessel. A guide channel 15, independent of the media inlet channel 9 and the media return channel 10, can also be provided within the catheter 2. The guide channel 15 extends to the power assembly 1. The power assembly 1 has a central channel 101 that connects the guide channel 15 and the axial channel 510 of the impeller shaft 51, forming a guidewire insertion path for the guidewire to pass through.

[0041] The cross-sectional area or inner diameter of the guide channel 15 is smaller than that of the medium inlet channel 9, and the cross-sectional area or inner diameter of the guide channel 15 is smaller than that of the medium return channel 10. The guide channel 15 is used to accommodate and allow the guide wire to pass through. To facilitate the insertion and exit of the guide wire, the guide channel 15 is preferably a circular channel.

[0042] The medium inlet channel 9 and the medium return channel 10 are spaced apart. The cross-sectional area or inner diameter of the medium inlet channel 9 is less than or equal to the cross-sectional area or inner diameter of the medium return channel 10. The guide channel 15, the medium inlet channel 9, and the medium return channel 10 can all be circular channels.

[0043] like Figure 3 As shown, the guide channel 15 is located between the medium entry channel 9 and the medium return channel 10. Of course, the three channels can be arranged in various ways, such as a triangle vertices arrangement, etc., as long as they are spaced apart in pairs.

[0044] The distal end of the impeller shaft 51 is connected to the distal bearing chamber 6, and the distal end of the distal bearing chamber 6 is also fixedly connected to the flexible non-invasive support 8. The flexible non-invasive support 8 is a flexible tubular structure with a hollow cavity 81 inside. The hollow cavity 81 is connected to the axial channel 510 of the impeller shaft 51, forming the distal part of the guide wire insertion path, through which the guide wire passes.

[0045] The flexible non-invasive support 8 is characterized by a flexible protrusion (Pigtail or TipMember) with an arc-shaped or coiled end. This flexible end supports the ventricular wall in a non-invasive or non-damaging manner, separating the pump's suction port (blood inlet) from the ventricular wall. This prevents the pump's suction port from adhering to the ventricular wall due to the reaction force of the fluid (blood) during operation, thus ensuring the effective suction area of ​​the pump.

[0046] The inner diameter of the hollow cavity 81 of the flexible non-invasive support 8 is equal to or slightly larger than the outer diameter of the guidewire. Specifically, the inner diameter of the hollow cavity 81 of the flexible non-invasive support 8 is 1-1.2 times the diameter of the guidewire.

[0047] The proximal end of the flexible non-invasive support 8 is inserted into the distal bearing chamber 6, constituting a distal limit on the impeller shaft 51. The distal end of the impeller shaft 51 extends slidably into the distal bearing chamber and is rotatably supported. The proximal end face of the flexible non-invasive support 8 forms a limiting step in the distal bearing chamber 6 for distal limit on the impeller shaft 51. This allows for a margin of axial relative movement of the impeller shaft 51 relative to the outer casing as the pump moves along the blood vessel through bends.

[0048] Specifically, the inner diameter of the hollow cavity 81 is 0.2-0.9 mm. The hollow cavity 81 of the flexible non-invasive support 8 is small enough, so the resistance to blood entering the cavity is large, which avoids blood from entering the pump through the hollow cavity 81 of the flexible non-invasive support 8, reduces damage to the blood, and facilitates the input of blood into the pump through the blood inlet at the inlet end of the pump housing 3.

[0049] like Figure 4 As shown, the power assembly 1 in this embodiment of the invention has a housing 100 and a rotor 130 located within the housing 100. The rotor 130 moves using the pressure transmitted by the aforementioned fluid medium. The rotor 130 is fixed to a rotating shaft and is driven to rotate by the input fluid, causing the rotating shaft to rotate as well. The output end of the rotating shaft is connected to an impeller shaft 51, causing the impeller shaft 51 to rotate as well. The impeller shaft 51 has an axial channel 510 that passes through it along the axial direction.

[0050] Specifically, the power assembly 1 is fixed to the distal end of the conduit 2 and can be inserted into the subject's body. By placing the power assembly 1 inside the body and directly connecting it to the impeller 5, and using fluid to transmit power, the impeller 5 can be driven to rotate more effectively, while avoiding vibration, wear, and heat generation.

[0051] The power assembly 1 includes a housing 100 and a rotor 130 located within the housing 100. The rotor 130 is connected to a rotating shaft, the output end of which is rotatably connected to an impeller shaft 51. The rotating shaft may be provided with a guide wire through hole (central channel 101), which is located between the guide channel 15 and the axial channel 510, connecting the guide channel 15 and the axial channel 510 to form the purging fluid and guide wire through path.

[0052] like Figure 4 As shown, the housing 100 has a stator 135 that accommodates a rotor 130, and the stator 135 has an internal cavity for the rotor 130 to rotate. The cross-section of this cavity is approximately elliptical, for example, a non-circular structure. The outer wall of the rotor 130 has a plurality of radially arranged slots, and a lever 131 is movably disposed in each of the radial slots. The radially outer end of the lever 131 contacts the inner wall of the cavity. Thus, the lever 131 can move radially and is limited by the cavity wall to prevent it from dislodging from the radial slot.

[0053] The housing 100 is provided with a medium inlet 110 and a medium outlet 120. The medium inlet 110 is connected to the medium inlet channel 9, and the medium outlet 120 is connected to the medium return channel 10. An annular cavity is formed between the outer wall of the rotor 130 and the inner wall of the cavity. This annular cavity includes a high-pressure section 111 communicating with the medium inlet 110 and a low-pressure section 121 communicating with the medium outlet 120. The inner wall of the cavity is configured such that the distance between it and the outer wall of the rotor 130 is greater when it is in the high-pressure section 111 than when it is in the low-pressure section 121. When the rotor 130 rotates, the paddle 131 contacts and adheres to the cavity wall under the action of centrifugal force, and an annular cavity is formed between two adjacent paddles 131.

[0054] The medium inlet 110 and medium outlet 120 respectively connect to different parts of the cavity wall in the circumferential direction, thereby connecting to different annular cavity sections 111 and 121. For example... Figure 4 As shown, the medium inlet 110 connects to two high-pressure liquid holes 112, leading into the high-pressure chamber section 111, and the medium outlet 120 connects to two low-pressure liquid holes 122, leading into the low-pressure chamber section 121. The two high-pressure liquid holes 112 are spaced apart by low-pressure liquid holes 122, and the two low-pressure liquid holes 122 are spaced apart by high-pressure liquid holes 112, each located in a different annular chamber section 111 or 121 in the circumferential direction of entry. The circumferential distance between the high-pressure liquid holes 112 and the low-pressure liquid holes 122 is greater than the circumferential distance between two adjacent levers 131.

[0055] The volume of the space formed between any two adjacent levers 131 in the high-pressure section 111 and the outer wall of the rotor 130 and the inner wall of the cavity is greater than the volume of the space formed between any two adjacent levers 131 in the low-pressure section 121 and the outer wall of the rotor 130 and the inner wall of the cavity. Thus, the volume of the annular cavity changes during rotation, thereby discharging the fluid medium outward in the low-pressure region.

[0056] After the high-pressure fluid medium is introduced into the high-pressure liquid port 112, the high-pressure fluid medium pushes the paddle 131 to move towards the low-pressure side in the high-pressure chamber section 111, which in turn drives the rotor 130 to rotate. When it rotates to connect with the low-pressure liquid port 122, the pressure-reducing fluid medium due to the volume change is discharged outward, forming a low-pressure fluid medium.

[0057] In other embodiments, the medium outlet 120 can also be connected to the axial channel 510 of the impeller shaft 51. By setting a throttling structure, the proportion of fluid medium entering the medium return channel 10 and the axial channel 510 can be controlled, so that the fluid medium with the desired flow rate enters the flexible non-invasive support 8 through the impeller shaft 51, avoiding blood from entering the flexible non-invasive support 8, and ensuring that blood is input into the pump casing through the blood inlet under the pump suction action.

[0058] The medium inlet channel 9 and the medium return channel 10 constitute the power flow channel of the power assembly. As a feasible embodiment, the power flow channel is configured as an input flow channel for injecting fluid medium, and the injection channel includes a portion of the power flow channel.

[0059] The internal pressure of the medium return channel 10 is relatively low. The medium return channel 10 is connected to the guide channel 15, so that the fluid medium in the medium return channel 10 enters the guide channel 15 and then enters the flexible non-invasive support 8 for perfusion, avoiding blood from entering the flexible non-invasive support and replenishing body fluids or nutrients.

[0060] In this embodiment, the power flow channel (medium inlet channel 9 or medium return channel 10) not only inputs power energy to the power component, but also uses the fluid medium to provide perfusion fluid medium, avoiding blood from entering the flexible non-invasive support 8 and reducing blood damage.

[0061] A connecting hole 152 is provided between the medium return channel 10 and the guide channel 15. The connecting hole 152 is located on the proximal side of the power assembly 1, and thus a portion of the guide channel 15 constitutes a flow channel for the perfusion fluid. A flexible check element 151 is also provided in the guide channel 15. The flexible check element 151 provides a path for the guidewire to pass through. After the guidewire is withdrawn, the flexible check element 151 maintains a fluid medium blockage state to prevent the fluid medium from flowing to the proximal end of the catheter 2.

[0062] For example, the flexible check element 151 can be made of sealing rubber or silicone. When the guide wire passes through the flexible check element 151, the flexible check element 151 fits against the guide wire and maintains the sealing state. After the guide wire is removed, the flexible check element 151 resets and closes the wire hole, still maintaining the sealing state at its position.

[0063] In other embodiments, the interventional catheter device may also include an additional infusion channel. The infusion channel is independent of the power flow channel. For example, an infusion channel is formed by the guide channel 15, the central channel 101, the axial channel 510, and the hollow cavity 81. The proximal end of the guide channel 15 has an infusion fluid inlet, and the distal end of the flexible non-invasive support 8 has an infusion fluid outlet. By setting the fluid medium and the infusion fluid independently, the requirements for the fluid medium are reduced.

[0064] In this embodiment, the pump housing 3 has a blood outlet at its output end. The pump housing 3 has a proximal conical section, a distal conical section, and a cylindrical section located between the proximal and distal conical sections. The proximal conical section is located at the proximal end of the pump housing, and the distal conical section is located at the distal end of the pump housing. The cylindrical section (specifically, a membrane) is cylindrical in its unfolded state and is supported by an internal support.

[0065] Specifically, at any two axial locations of the blood outlet, the circumferential width of the downstream location is less than or equal to the circumferential width of the upstream location. The circumferential width of the proximal end of the blood outlet is less than the circumferential width of its distal end. The circumferential width of the blood outlet gradually decreases from the distal end to the proximal end of the pump housing 3 or along the internal fluid flow direction.

[0066] Multiple blood outlets are arranged circumferentially. The axial length of the blood outlets is greater than the axial length of the blood inlets. Specifically, the blood outlets span the cylindrical section and the proximal conical section. The circumferential width of the blood outlets in the cylindrical section is greater than the circumferential width in the proximal conical section.

[0067] A portion of the blood outlet is located in the proximal conical section, while the other portion is located in the cylindrical section. The axial length of the blood outlet located in the proximal conical section is greater than the axial length of the blood outlet located in the cylindrical section.

[0068] Some blood outlets are located in the cylindrical section, where the output blood forms a centrifugal flow. This, combined with the multiple blood outlets, stabilizes the pump's position and ensures stable blood flow. Other blood outlets are located in the proximal conical section, where the output blood forms a roughly axial flow. This, along with the blood outlets in the cylindrical section, ensures the blood flow rate and prevents flow direction loss.

[0069] In this embodiment, the impeller 5 is housed within the pump casing 3 and mounted on an impeller shaft 51, which is connected to the power output end of the power assembly 1. The impeller 5 is driven to rotate by the power assembly 1 to draw blood from the inlet end 31 into the pump casing 3 and discharge it from the outlet end 32.

[0070] like Figure 2 As shown, the impeller 5 includes a hub 53 and blades 52. The hub 53 is fixedly mounted on the impeller shaft 51. The blades 52 are supported on the outer wall of the hub 53. The impeller shaft 51 is connected to the power output end. The blades 52 can be configured such that, in the pump's engagement configuration, the blades 52 wrap around the outer wall of the hub 53 and at least partially contact the inner wall of the pump casing 3. In the pump's operating configuration, the impeller 5 extends radially outward from the hub 53 and is spaced apart from the inner wall of the pump casing 3.

[0071] In this embodiment, the distal end of the pump housing 3 is connected to the distal bearing chamber 6, and the distal bearing chamber 6 is provided with a distal bearing 7. The distal bearing 7 is sleeved on the end of the impeller shaft 51 away from the power assembly 1. The distal end of the distal bearing chamber 6 away from the pump housing 3 can be connected to a flexible non-invasive support member 8.

[0072] One end (proximal end) of the impeller shaft 51 is connected to the output shaft of the power assembly 1 to input power. The other end (distal end) of the impeller shaft 51 is rotatably supported in the distal bearing chamber 6 and is spaced apart from the proximal end of the flexible non-invasive support member 8. The distal bearing chamber 6 is fixed with a distal bearing 7, and the distal end of the impeller shaft 51 is rotatably fitted inside the distal bearing 7 and supported by the distal bearing 7.

[0073] In the axial direction of hub 53, at least a portion of hub 53 is aligned with medium inlet channel 9 or medium return channel 10, thereby facilitating the threading of guide wires. In other feasible embodiments, the axis of hub 53 coincides with the axis of medium inlet channel 9, or the axis of hub 53 coincides with the axis of medium return channel 10. The axis of power assembly 1, i.e., the axis of the accommodating space, may coincide with the axis of hub 53.

[0074] like Figure 2 As shown, the pump housing 3 has an inlet end 31 and an outlet end 32, and the proximal end of the pump housing 3 is connected to the distal end 22 of the conduit 2. Specifically, the proximal end of the pump housing 3 is connected to the outer wall of the distal end 22 of the conduit 2, thereby circumferentially surrounding the power assembly 1. The end of the pump housing 3 connected to the outer wall of the conduit 2 is provided with an outlet end 32, and the pump housing 3 can be formed by covering with a membrane.

[0075] The pump casing 3 also includes a foldable bracket 4, which is fitted onto the pump casing 3. The portion of the foldable bracket 4 not covered by the pump casing 3 is opened to form an inlet end 31. The inlet end 31 is located on the side of the impeller 5 away from the guide tube 2, and the outlet end 32 is located on the side of the impeller 5 closer to the guide tube 2. The foldable bracket 4 can support the pump casing 3 to form a pump chamber, with its proximal end connected to the distal end 22 of the guide tube 2, and its distal end connected to the distal bearing chamber 6.

[0076] In this embodiment, along the axial direction of the conduit 2, at least a portion of the projection of the power component 1 lies within the projection of the pump housing 3, thereby further protecting the power component 1. More preferably, along the axial direction of the conduit 2, the connection point between the pump housing 3 and the outer wall of the conduit 2 is closer to the proximal end 21 of the conduit 2 than the power component 1. That is, the shortest distance between a point on the pump housing 3 and the proximal end 21 is less than the shortest distance between a point on the power component 1 and the proximal end 21.

[0077] The device in this embodiment, as a surgical medical device, needs to have a sufficiently compact structure, and the dimensions of each component need to be sufficiently precise and small. In one embodiment, to facilitate interventional surgery, the pump can have both an interventional configuration and a working configuration.

[0078] In the pump-corresponding intervention configuration, the pump housing 3 and impeller 5 are in a folded state so that the pump can intervene in the subject's vascular system and / or deliver blood within the vascular system with a first outer diameter. In the pump-corresponding operational configuration, the pump housing 3 and impeller 5 are in an unfolded state so that the pump can pump blood at the desired location with a second outer diameter larger than the first outer diameter.

[0079] The impeller 5 includes a hub 53 connected to the distal end of the impeller shaft 51 and blades 52 supported on the outer wall of the hub 53. The blades 52 can be helical blades, thereby driving fluid through rotation. In the pump's intervention configuration, the blades 52 wrap around the outer wall of the hub 53 and at least partially contact the inner wall of the pump casing 3. In the pump's operating configuration, the blades 52 extend radially outward from the hub 53 and are spaced apart from the inner wall of the pump casing 3, preventing the pump casing 3 from affecting the blade rotation and preventing the rotation of the blades 52 from damaging the pump casing 3.

[0080] When the device is in use, the pump and part of catheter 2 (specifically the tip portion of catheter 2) are inserted into and held in the body of the subject (e.g., a patient). The size of the pump and part of catheter 2 needs to be as small as possible. Therefore, the axial projected area of ​​the pump and part of catheter 2 is smaller than the axial projected area of ​​other components of the working mechanism including the pump.

[0081] Therefore, a smaller pump and part of the catheter 2 can reduce the patient's discomfort during insertion and retention, and can minimize complications caused by excessively large interventional sizes. Other parts of the working mechanism can have relatively larger dimensions to meet structural design requirements.

[0082] This device can replace blood in the heart, pumping blood from the left ventricle into the blood vessels to support blood circulation, reduce the workload of the subject's heart, or provide additional continuous pumping power support when the heart's pumping capacity is insufficient.

[0083] Of course, the device can also be placed in the target location of the subject's body, such as inside a blood vessel or other organ, through interventional surgery to pump blood or body fluids.

[0084] In this embodiment, the pump is retractable, having a retracted state and an extended state. Specifically, in the interventional configuration, the pump housing 3 and impeller 5 are in the retracted state, allowing the pump to deliver blood into the subject's vascular system with a smaller first outer diameter. In the operational configuration, the pump housing 3 and impeller 5 are in the extended state, allowing the pump to pump blood at the desired location with a second radial dimension larger than the first radial dimension.

[0085] As those skilled in the art should know, pump size and hydrodynamic performance are two contradictory parameters. Specifically, to reduce patient discomfort and facilitate intervention, a small pump size is desirable. However, to provide stronger assistive functions for the patient, a high flow rate is desired, which generally requires a large pump size.

[0086] By designing a collapsible pump, the pump has a smaller collapsible size and a larger unfolded size, thus balancing the need to reduce patient discomfort and facilitate intervention during the procedure / delivery process with the need to provide a large flow rate.

[0087] In this embodiment, the multi-mesh design of the pump housing 3, especially the diamond-shaped mesh, enables better folding and unfolding, while the shape memory properties of the nickel-titanium alloy facilitate its deployment. The blades 52 are made of a flexible material that stores energy when folded. After the external constraints are removed, the stored energy in the blades 52 is released, causing the blades to unfold.

[0088] The pump achieves its folding state with the aid of external constraints, and self-unfolds after the constraints are removed. In this embodiment, the "folded state" refers to the state in which the pump is radially constrained, that is, the pump is radially compressed and folded to its minimum radial dimension under external pressure. The "unfolded state" refers to the state in which the pump is not radially constrained, that is, the support and impeller are radially unfolded to their maximum radial dimension.

[0089] The aforementioned external constraints are applied via a folded sheath (not shown) that slides over the outside of conduit 2. When the folded sheath moves forward outside conduit 2, the entire pump can be housed within it, achieving forced retraction of the pump. When the folded sheath moves backward, the radial constraint on the pump disappears, and the pump self-deploys.

[0090] As described above, the pump's retraction is achieved by the radial constraint force applied by the folded sheath. Since the impeller 5 is housed within the pump casing 3, the pump's retraction process is essentially as follows: the folded sheath applies a radial constraint force to the pump casing 3, and when the pump casing 3 is radially compressed, it applies a radial constraint force to the impeller 5.

[0091] In other words, the pump casing 3 is folded directly by the folding sheath, while the impeller 5 is folded directly by the pump casing 3. As mentioned above, the impeller 5 is elastic. Therefore, although it is in a folded state, the energy stored in the folding of the impeller 5 makes it always tend to expand radially, thus the impeller 5 will contact the inner wall of the pump casing 3 and exert a reaction force on the pump casing 3.

[0092] After the constraints of the folded sheath are removed, the pump casing 3, under its own memory characteristics, supports the expansion of the elastic diaphragm, and the impeller 5 expands itself under the released energy storage. In the expanded state, the outer diameter of the impeller 5 is smaller than the inner diameter of the pump casing 3.

[0093] In this way, a gap is maintained between the radially outer end of the impeller 5 (that is, the blade tip) and the inner wall of the pump casing 3 (specifically, the inner wall of the support 4), and this gap is called the pump clearance. The existence of the pump clearance allows the impeller 5 to rotate without obstruction and without hitting the wall.

[0094] Furthermore, from a fluid dynamics perspective, it is desirable for the pump clearance to be small and maintained. In this embodiment, the outer diameter of the impeller 5 is slightly smaller than the inner diameter of the support 4, so that the pump clearance is as small as possible while ensuring that the impeller 5 rotates without hitting the wall. The main means of maintaining the pump clearance is through the support strength provided by the support 4, which can resist the back pressure of the fluid (blood) without deformation, thereby maintaining the shape stability of the pump casing 3, and thus the pump clearance is also stably maintained.

[0095] The following describes the pump's retraction and deployment process when this device is used as a left ventricular assist device:

[0096] During the insertion of the pump into the left ventricle, the pump is in a radially constrained state (folded state) due to the externally applied radial constraint force. After insertion into the left ventricle and removal of the radial constraint force, the stent 4 expands autonomously by utilizing its own memory characteristics and the blades of the impeller 5 through the release of stored energy, so the pump automatically presents its unconstrained shape (expanded state).

[0097] Conversely, when the device needs to be removed from the subject's body after completing its work, the pump is folded up using the folding sheath. Once the pump is completely removed from the subject's body, the constraint of the folding sheath on the pump is removed, allowing the pump to return to its natural state of minimum stress, which is the unfolded state.

[0098] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. An interventional catheter device, characterized in that: It includes a catheter and a pump for pumping blood into the subject's body through the catheter; the distal end of the catheter is connected to the pump; the pump includes a pump housing, a power assembly, and an impeller; the power assembly and impeller are housed inside the pump housing, and the power assembly and impeller are sequentially located at the distal end of the catheter; the pump housing has a blood inlet end and a blood outlet end; the power assembly is a fluid-driven power device. The power assembly includes a housing, a stator, and a rotor; the stator is disposed on the inner wall of the housing, and a rotor driven by a working fluid medium passes through the stator, the rotor being connected to an impeller; the housing and the stator are provided with channels for the working fluid medium to enter and exit; a sealed cavity is provided between the stator and the rotor; the cavity is connected to the channels for the working fluid medium to enter and exit on the stator, the channels being configured as a medium inlet and a medium outlet; the rotor is cylindrical, and the outer peripheral wall of the rotor is provided with radially arranged flaps pointing towards the inner wall of the stator.

2. The interventional catheter device as described in claim 1, characterized in that: The conduit contains a pipe for the flow of the working fluid medium that drives the power assembly.

3. The interventional catheter device as described in claim 1, characterized in that: The rotor has a slot on its outer peripheral wall, and one end of a lever is located in the slot. The other end of the lever is connected to the inner wall of the stator. The inner wall of the stator, two adjacent levers and the outer wall of the rotor form a closed working fluid cavity. The inner wall of the stator has different thicknesses. The volume of the working fluid cavity when it is connected to the medium inlet is greater than the volume of the working fluid cavity when it is connected to the medium outlet.

4. The interventional catheter device as described in claim 3, characterized in that: The impeller includes an impeller shaft, a hub, and blades. One end of the impeller shaft is connected to the rotor, and the other end is connected to a bearing located at the far end of the pump casing. The outer circumference of the impeller shaft is provided with a hub, and blades are provided on the hub.

5. The interventional catheter device as described in claim 4, characterized in that: The pump casing is equipped with a telescopic bracket; the distal end of the pump is equipped with a flexible non-invasive support.

6. The interventional catheter device as described in claim 5, characterized in that: The flexible non-invasive support has a hollow cavity, the impeller shaft has an axial channel communicating with the hollow cavity, the catheter has a guide channel, and the rotor has a central channel communicating with the axial channel and the guide channel; the hollow cavity, axial channel, central channel, and guide channel are sequentially connected to form a guide wire passage channel for the guide wire to pass through.

7. An interventional catheter device as described in claim 6, characterized in that: The conduit is provided with an infusion channel, and the end of the infusion channel near the operator is provided with an infusion fluid inlet; the infusion channel is connected to the pipeline through which the working fluid medium flows.

8. An interventional catheter device as described in claim 6, characterized in that: The pipeline through which the working fluid medium flows is connected to the guide channel.

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