Impeller assembly, injection mold and intrusive catheter device

Abstract

The utility model relates to an impeller assembly, an injection mold and an intrusive guide pipe device, the impeller assembly comprises a rotating shaft and an impeller, the rotating shaft is provided with a hollow structure in the axial direction, and the side wall of the rotating shaft is provided with an injection opening communicating with the hollow structure. The impeller comprises a hub and blades which are integrally formed through injection molding. The hub comprises an inner-layer hub body and an outer-layer hub body, the inner-layer hub body is embedded in the hollow-out structure, the outer-layer hub body at least partially covers the outer wall face of the side wall of the rotating shaft, the inner-layer hub body and the outer-layer hub body are correspondingly connected to the injection molding opening, and the blades are arranged on the outer-layer hub body and extend outwards in the radial direction of the rotating shaft. According to the impeller assembly, the reliability of the impeller can be improved, and meanwhile the size of the folded impeller assembly is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an impeller assembly, an injection mold, and an interventional catheter device. Background Art

[0002] Interventional catheter devices are commonly used fluid pumping devices that are widely used to assist the heart blood circulation of patients with heart failure.

[0003] The impeller assembly is a key component of interventional catheter devices, capable of folding and unfolding. It folds during insertion or removal and unfolds after insertion, minimizing the size of the catheter and preventing damage to blood vessels or related organs. However, existing impeller assemblies, particularly those with insert-molded components, remain relatively large when folded. Therefore, reducing the size of the impeller assembly, particularly its folded size, is an urgent issue. Utility Model Content

[0004] In view of this, the present application provides an impeller assembly, an injection mold, and an interventional catheter device, which can improve the reliability of the impeller and reduce the size of the impeller assembly after folding.

[0005] In the first aspect, an embodiment of the present application provides an impeller assembly, comprising: a rotating shaft, which is provided with a hollow structure along the axial direction, and the side wall of the rotating shaft is provided with an injection molding opening connected to the hollow structure; an impeller, comprising an integrally injection-molded hub and blades, the hub comprising an inner hub and an outer hub, the inner hub is embedded in the hollow structure, and the outer hub at least partially covers the outer wall surface of the side wall of the rotating shaft, the inner hub and the outer hub are correspondingly connected at the injection molding opening, the blades are arranged on the outer hub, and the blades extend outward along the radial direction of the rotating shaft.

[0006] According to an embodiment of one aspect of the present application, the impeller is made of an elastic material, and the impeller can be rolled up or unfolded around the rotation axis.

[0007] According to an embodiment of one aspect of the present application, a distal end of the injection molding opening is spaced apart from a distal end of the rotating shaft.

[0008] According to an embodiment of one aspect of the present application, the hollow structure passes through the distal end of the rotating shaft along the axial direction, and the inner hub and the outer hub are connected at the distal end of the rotating shaft to form a hub end.

[0009] According to an embodiment of one aspect of the present application, in the axial direction, along the direction from the proximal end to the distal end, the radial dimension of the hub end is gradually reduced to form a guide cone surface.

[0010] According to an embodiment of one aspect of the present application, the guide surface is a guide cone surface, and the top angle of the guide cone surface is 30° to 80°.

[0011] According to an embodiment of one aspect of the present application, at the distal end of the rotating shaft, the outer wall surface of the side wall is provided with a chamfer, and the hub end is covered by the chamfer.

[0012] According to an embodiment of one aspect of the present application, along the circumference of the rotating shaft, the outer hub is annularly covered on the outer wall surface of the side wall.

[0013] According to an embodiment of one aspect of the present application, the radial thickness from the outer edge of the outer hub to the inner edge of the inner hub is 0.05 mm to 0.1 mm.

[0014] According to an embodiment of one aspect of the present application, an extension trajectory of the injection molding opening matches the shape of a joining position between the blade and the outer hub.

[0015] According to an embodiment of one aspect of the present application, the impeller assembly further includes a boost unit, which is located at the proximal end of the rotating shaft and sleeved on the side wall of the rotating shaft. In the axial direction, the outer hub cooperates with the boost unit stopper.

[0016] According to an embodiment of one aspect of the present application, in the axial direction, the boost unit is inclined toward one side surface of the blade, and the outer diameter of the boost unit gradually increases from the distal end to the proximal end of the rotating shaft.

[0017] In second aspect, an embodiment of the present application provides an injection mold for manufacturing the impeller assembly of the above embodiment, wherein a molding cavity is provided in the injection mold, and the molding cavity comprises: a first cavity, extending axially and used to accommodate a rotating shaft, the first cavity being radially fitted with a clearance of the rotating shaft; a second cavity, connected to the first cavity and extending radially by a preset distance from the side wall of the first cavity, the cavity shape of the second cavity matching the blade, and the second cavity being used to mold the blade.

[0018] According to an embodiment of one aspect of the present application, the first cavity is a cylindrical structure, and the second cavity is radially extended from the cylindrical wall of the first cavity.

[0019] According to an embodiment of one aspect of the present application, the first mold cavity is divided into a first sub-mold cavity and a second sub-mold cavity which are connected in sequence along the axial direction; the first sub-mold cavity is sleeved on the outside of the rotating shaft and is gap-fitted with the rotating shaft along the radial direction, and the second sub-mold cavity is used to cover the distal part of the rotating shaft, and the second sub-mold cavity is gap-fitted with the distal part of the rotating shaft.

[0020] According to an embodiment of one aspect of the present application, the cross section of the second sub-cavity is tapered toward the distal end.

[0021] In a third aspect, an embodiment of the present application provides an interventional catheter device, comprising: a pump head, comprising a pump casing and an impeller assembly as described in the above embodiment, wherein the impeller assembly is arranged in the pump casing; a drive assembly, connected to the rotating shaft of the impeller assembly, and the drive assembly is used to drive the rotating shaft to rotate.

[0022] An impeller assembly provided in an embodiment of the present application includes a rotating shaft and an impeller, wherein the impeller includes an integrally injection-molded hub and blades. By dividing the hub into an inner hub and an outer hub, disposing the inner hub within the hollow structure of the rotating shaft, and connecting the inner hub and the outer hub via an injection-molded opening in the rotating shaft, the support strength of the impeller assembly can be ensured by the simultaneous load-bearing of the inner and outer hubs, thereby reducing the deformation of the blades under fluid reaction force during high-speed operation, and improving the stability of the impeller during retraction and expansion, thereby enhancing the reliability of the impeller assembly. Furthermore, while maintaining the same support strength, the thickness of the outer hub can be reduced, thereby reducing the radial dimension of the retracted impeller assembly. This can reduce the size of the intervention during ventricular assist device intervention, reduce damage to blood vessels or related organs, and alleviate patient pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The features, advantages and technical effects of exemplary embodiments of the present application will be described below with reference to the accompanying drawings.

[0024] Figure 1 is a schematic structural diagram of an impeller assembly provided in some embodiments of the present application;

[0025] Figure 2 is a cross-sectional view of an impeller assembly provided in some embodiments of the present application;

[0026] Figure 3 is a schematic structural diagram of a rotating shaft provided in some embodiments of the present application;

[0027] Figure 4 is a cross-sectional view of a rotating shaft provided in some embodiments of the present application;

[0028] Figure 5 is a schematic structural diagram of an impeller assembly in an expanded state provided by some embodiments of the present application;

[0029] Figure 6 is a schematic structural diagram of an impeller assembly in a compressed state provided by some embodiments of the present application;

[0030] Figure 7 is a schematic structural diagram of an impeller provided in some embodiments of the present application;

[0031] Figure 8 is a cross-sectional view of an impeller provided in some embodiments of the present application;

[0032] Figure 9 is a front view of an impeller provided in some embodiments of the present application;

[0033] Figure 10 This is a flow chart of the injection molding method of the impeller assembly provided in some embodiments of the present application.

[0034] In the attached figure:

[0035] 10-Impeller assembly;

[0036] 1-rotating shaft; 11-hollow structure; 12-injection molding opening; 13-chamfer; 14-positioning groove; 2-impeller; 21-hub; 211-inner hub; 212-outer hub; 213-hub end; 22-blade; 3-boost unit;

[0037] X-axial direction; Y-radial direction.

[0038] In the drawings, like parts are given like reference numerals, but the drawings are not necessarily drawn to scale. DETAILED DESCRIPTION

[0039] In order to make the application purpose, technical solutions and beneficial technical effects of this application clearer, the application is further described in detail below with reference to the embodiments. It should be understood that the implementation regulations described in this specification are only for the purpose of explaining this application and are not intended to limit this application.

[0040] For simplicity, this application only explicitly discloses certain numerical ranges. However, any lower limit can be combined with any upper limit to form an unspecified range; and any lower limit can be combined with other lower limits to form an unspecified range, and similarly, any upper limit can be combined with any other upper limit to form an unspecified range. In addition, although not explicitly stated, each point or individual value between the endpoints of a range is included in the range. Thus, each point or individual value can serve as its own lower limit or upper limit and be combined with any other point or individual value, or with other lower limits or upper limits, to form an unspecified range.

[0041] In the description of this application, it should be noted that, unless otherwise specified, “above” and “below” are inclusive of the number themselves, and “several” in “one or several” means two or more.

[0042] In addition, 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 "in vitro" means outside the patient's tissues and organs. Furthermore, in the embodiments of this application, "distal" means the direction away from the physician, and "proximal" means the direction toward the physician.

[0043] The above disclosure of the present application is not intended to describe every disclosed embodiment or every implementation in the present application. The following description more specifically illustrates exemplary embodiments. In many places throughout the application, guidance is provided through a series of examples, and these implementation regulations can be used in various combinations. In each example, the enumeration is only intended to be representative and should not be construed as exhaustive.

[0044] The present application provides an interventional catheter device, which is commonly used to assist patients with heart failure in cardiac blood circulation. The interventional catheter device includes a pump head and a drive assembly connected to the pump head. The pump head includes a pump housing and an impeller assembly. The impeller assembly is arranged in the pump housing. The drive assembly is connected to the rotating shaft of the impeller assembly. The drive assembly is used to drive the rotating shaft to rotate, provide blood flow power, thereby providing stable blood delivery support for the patient and reducing the burden on the heart.

[0045] The impeller assembly is an important component of the pump head. In order to reduce the interventional size of the interventional catheter device, most interventional catheter devices currently use a foldable impeller assembly, which can be folded during the intervention process and unfolded after the intervention is in place, thereby reducing the interventional size and preventing damage to blood vessels or corresponding organs.

[0046] Existing foldable impeller assemblies primarily include: one that uses a telescopic structure to drive an elastically deformable impeller to change size; and another type of insert-molded impeller, in which the blades are injection-molded onto the rotating shaft through a hub, with only the blades being foldable. However, the telescopic structure-driven elastically deformable impeller is prone to generating wear particles during the process, and the structure is relatively complex, creating dead zones in the mating areas of blood flow and potentially forming blood clots. While the insert-molded impeller has a simpler structure, the hub thickness must be increased to ensure blade support strength, resulting in a still-large radial dimension even after the impeller is retracted, making it difficult to insert an invasive catheter device.

[0047] To overcome the above-mentioned drawbacks, the present invention provides a novel impeller assembly in an embodiment. The impeller assembly can be used in an invasive catheter device and serve as a component of the invasive catheter device. Of course, the impeller assembly can also be produced or sold separately as an independent component. To better understand the present invention, the following describes the impeller assembly, injection mold, and invasive catheter device in accordance with an embodiment of the present invention in conjunction with the accompanying drawings.

[0048] Please also refer to Figure 1 and Figure 2 , Figure 1 Schematic diagrams of the structure of the impeller assembly 10 in some embodiments of the present application are shown. Figure 2 A cross-sectional view of an impeller assembly 10 according to some embodiments of the present application is shown.

[0049] The impeller assembly 10 in the embodiment of the present application includes a rotating shaft 1 and an impeller 2. The rotating shaft 1 is provided with a hollow structure 11 along the axial direction X, and the side wall of the rotating shaft 1 is provided with an injection molding opening 12 connected to the hollow structure 11. The impeller 2 includes a hub 21 and blades 22 that are integrally injection molded. The hub 21 includes an inner hub 211 and an outer hub 212. The inner hub 211 is embedded in the hollow structure 11, and the outer hub 212 at least partially covers the outer wall surface of the side wall of the rotating shaft 1. The inner hub 211 and the outer hub 212 are correspondingly connected at the injection molding opening 12. The blades 22 are provided on the outer hub 212, and the blades 22 extend outward along the radial direction Y of the rotating shaft 1.

[0050] The impeller assembly 10 in the embodiment of the present application divides the hub 21 into an inner hub 211 and an outer hub 212. The inner hub 211 is disposed within the hollow structure 11 of the rotating shaft 1, and the inner hub 211 and outer hub 212 are aligned with the injection molding opening 12 on the rotating shaft 1. This ensures the support strength of the impeller assembly 10 by allowing the inner hub 211 and outer hub 212 to bear the load simultaneously, thereby reducing the deformation of the blades 22 under the reaction force of the fluid during high-speed operation, improving the stability of the impeller 2 during the retraction and deployment processes, and enhancing the reliability of the impeller assembly 10. Furthermore, while maintaining the same support strength, the thickness of the outer hub 212 can be reduced, thereby reducing the radial Y dimension of the retracted impeller assembly 10. This reduces the size of the intervention during ventricular assist device intervention, minimizes damage to blood vessels or related organs, and alleviates patient pain.

[0051] It can be understood that, compared with the insert-molded impeller 2 in the related art, which only uses the outer hub 212 to bear the axial force or radial force of the blade 22, the impeller assembly 10 in the embodiment of the present application can bear the force simultaneously through the inner hub 211 and the outer hub 212, and can reduce the size of the outer hub 212 as much as possible, thereby reducing the overall diameter of the hub 21 and reducing the radial Y-gripping size of the impeller 2.

[0052] Furthermore, by retaining an outer hub 212 of a certain thickness in the impeller assembly 10 of the embodiment of the present application, it is easier to fit the rotating shaft 1 into the injection mold, reducing the difficulty of injection molding, compared to providing only the inner hub 211. At the same time, the formed inner hub 211 and outer hub 212 both fit tightly against the rotating shaft 1, reducing the risk of blood entering the gap between the hub 21 and the rotating shaft 1 during blood pumping using the interventional catheter device. Furthermore, by providing the inner hub 211 and outer hub 212, the connection strength between the impeller 2 and the rotating shaft 1 in the axial X and radial Y directions is increased, thereby improving the support strength for the blades 22, reducing the deformation of the blades 22 due to the fluid reaction force during high-speed operation, and enhancing blood pumping performance.

[0053] See also Figures 3 and 4 , Figure 3 shows a schematic structural diagram of the rotating shaft 1 in some embodiments of the present application, Figure 4 A cross-sectional view of the rotating shaft 1 according to some embodiments of the present application is shown.

[0054] In some optional embodiments, the rotating shaft 1 can be a structure with a single diameter, that is, the rotating shaft 1 has a uniform thickness. For example, the outer diameter of the rotating shaft 1 is 0.6 mm to 2 mm, for example, 0.8 mm to 1.2 mm. In practice, a material with a certain degree of rigidity, such as metal, can be selected, and the hollow structure 11 and the injection molding opening 12 can be processed into it.

[0055] Optionally, the axial X-section shape of the hollow structure 11 can be circular, square or other shapes, preferably circular, which is easier to process and manufacture.

[0056] It is understood that when a material with suitable stiffness and strength is selected to manufacture the rotating shaft 1, the outer diameter of the rotating shaft 1 can be further reduced, thereby further compressing the radial Y dimension of the impeller assembly 10 of the present application. At the same time, the rotating shaft 1 provides a mounting cavity for the inner hub 211. The hollow structure 11 can stably support and protect the inner hub 211, allowing the outer hub 212 to provide stable rotational support for the blades 22 without requiring a large radial dimension, while also preventing damage to the hub 211 from the reaction of the impeller 2.

[0057] Optionally, the radial thickness from the outer edge of the outer hub 212 to the inner edge of the inner hub 211 is 0.05mm to 0.1mm. By making the radial thickness from the outer edge of the outer hub 212 to the inner edge of the inner hub 211 greater than or equal to 0.05mm, it is possible to more easily match the rotating shaft 1 with the injection mold, reducing the difficulty of injection molding. By making the radial thickness from the outer edge of the outer hub 212 to the inner edge of the inner hub 211 less than or equal to 0.1mm, it is possible to reduce the size of the outer hub 212 while providing stable rotational support force for the blades 22, thereby reducing the overall diameter of the hub 21, reducing the intervention size of the impeller assembly 10, and reducing the patient's pain.

[0058] See also Figures 5 and 6 , Figure 5 Schematic diagram of the structure of the impeller assembly 10 in some embodiments of the present application in an expanded state is shown. Figure 6 A schematic structural diagram of the impeller assembly 10 in some embodiments of the present application in a compressed state is shown.

[0059] In some optional embodiments, the impeller 2 may be made of an elastic material, and the blades 22 may be rolled up or unfolded around the rotating shaft 1 .

[0060] The impeller 2 can be driven to rotate around the rotation axis so as to transport fluid in the axial direction X. Moreover, by making the impeller 2 from an elastic material, the impeller 2 can switch between a compressed state and an expanded state, wherein the compressed state refers to the state in which the blades 22 are squeezed in the radial direction Y by an external force during storage, transportation, assembly, etc. and are in a radially contracted state, and the expanded state refers to the natural expanded state of the blades 22 when there is no external force.

[0061] Specifically, during the compression process, blades 22 retract toward the axis of rotating shaft 1 to reduce the overall outer diameter of impeller assembly 10, bringing the outer diameter of blades 22 to D2. The compressed state is maintained during the intervention. Upon reaching the target point, the radial Y constraint on blades 22 disappears, and blades 22 recover their deformation through their own elasticity and fully expand, bringing the outer diameter of blades 22 to D1. The deformation of blades 22 through their inherent elastic properties allows for controllable shape and outer diameter, enabling them to achieve the design target.

[0062] Strength-reinforcing materials are provided in the blades 22. It is understandable that since the blades 22 need to switch between folded and unfolded states and be able to effectively promote blood circulation, they need to have both sufficient elasticity and sufficient strength. To this end, in a preferred embodiment, an injection molding material with sufficient elasticity is selected to form the blades 22 by injection molding, and a reinforcing material is added to the blades 22 to ensure that the blades 22 have sufficient strength. For example, fibers are added. Preferably, the Shore hardness of the injection molding material is greater than 90A, and the injection molding material contains fibers, thereby improving the injection molding efficiency and ensuring the strength of the blades 22.

[0063] See also Figures 1 to 6 Since the blood exerts a reverse force on the impeller 2 when the impeller 2 drives the blood to move, thereby causing the impeller 2 to have a tendency to move toward the distal end, in some optional embodiments, the distal end of the injection molding opening 12 is spaced a certain distance from the distal end of the rotating shaft 1 .

[0064] By ensuring that there is a certain distance between the distal end of the injection molding opening 12 and the distal end of the rotating shaft 1, when the impeller 2 tends to slide toward its distal end under the push of the reverse force of the blood during the high-speed rotation of the blades 22, the relative displacement of the impeller 2 along the axial direction X is limited by the rotating shaft 1, so that the relative position between the impeller 2 and the rotating shaft 1 is maintained in a stable state, thereby improving the reliability of the impeller assembly 10.

[0065] Optionally, the proximal end of the injection molding opening 12 and the proximal end of the rotating shaft 1 also have a certain distance, so as to further limit the relative position between the impeller 2 and the rotating shaft 1, realize the axial X limitation during the winding process of the impeller 2, avoid the movement of the hub 21 relative to the rotating shaft 1, improve the safety and stability of the blades 22 during high-speed rotation and winding and unfolding, and improve the blood pumping performance.

[0066] See also Figures 1 to 8 , Figure 7 shows a schematic structural diagram of the impeller 2 in some embodiments of the present application, Figure 8 A cross-sectional view of the impeller 2 according to some embodiments of the present application is shown.

[0067] In some optional embodiments, the hollow structure 11 passes through the distal end of the rotating shaft 1 along the axial direction X, and the inner hub 211 and the outer hub 212 are connected at the distal end of the rotating shaft 1 to form a hub end 213 .

[0068] That is, in addition to being connected to each other through the injection molding opening 12, the inner hub 211 and the outer hub 212 are also connected at the distal end of the rotating shaft 1, thereby increasing the axial X and radial Y connection strength between the impeller 2 and the rotating shaft 1, while improving the root support effect of the blade 22, reducing the deformation of the blade 22 caused by the reaction force of the fluid during high-speed operation, and improving the fluid pumping performance.

[0069] See also Figures 1 to 9 , Figure 9 The front view of the impeller 2 provided in some embodiments of the present application is shown. In some optional embodiments, in the axial direction X, from the proximal end to the distal end, the radial dimension of the hub end 213 is gradually reduced to form a guide surface.

[0070] By forming a flow-guiding surface on the outer surface of hub end 213, axial blood flow can be guided evenly and stably into the impeller 2 area, reducing turbulence, improving blood pumping performance, and reducing the probability of red blood cell damage. Optionally, the outer surface of hub end 213 can be configured with an arc-shaped transition, thereby forming a streamlined hub end 213, which has a better flow-guiding effect.

[0071] In some optional embodiments, the guide surface is a guide cone surface, and the top angle α of the guide cone surface is 30° to 80°.

[0072] It can be understood that when the outer surface of the hub end 213 is set in an arc-shaped transition, the top angle of the guide cone is the angle between the tangent planes of the arc-shaped surfaces on both sides. By controlling the top angle α of the guide cone, the drainage angle of the axial X blood flow can be controlled to better improve the blood pumping performance.

[0073] In some optional embodiments, at the distal end of the rotating shaft 1 , an outer wall surface of the side wall is provided with a chamfer 13 , and the hub end portion 213 is covered by the chamfer 13 .

[0074] By providing a chamfer 13 on the outer wall surface of the side wall, the risk of friction between the rotating shaft 1 and the injection mold during the insertion process of the injection mold can be reduced, and damage to the rotating shaft 1 and / or the injection mold can be reduced. At the same time, after the hub end 213 is formed by injection molding, the hub end 213 can be covered by the chamfer 13, so that the connection between the hub end 213 and the outer hub 212 is a transition setting, so as to strengthen the connection strength between the hub end 213 and the outer hub 212.

[0075] Because the blades 22 are disposed on the outer hub 21, when the blades 22 are subjected to force, the force is transmitted from the blades 22 to the inner hub 21 through the outer hub 21, and the force is jointly borne by the outer hub 21 and the inner hub 21. Therefore, in order to improve the force-bearing effect of the outer hub 21, in some optional embodiments, the outer hub 212 is annularly covered on the outer surface of the side wall along the circumference of the rotating shaft 1. By annularly covering the outer hub 212 on the outer surface of the side wall, the injection molding process can be simplified, and the force on the outer hub 212 is more stable, thereby better supporting the blades 22.

[0076] In some optional embodiments, the extension trajectory of the injection molding opening 12 matches the shape of the joint position between the blade 22 and the outer hub 212, so that when the blade 22 is subjected to force, the force transmission path can be shortened, and the force can be more easily transmitted from the outer hub 21 to the inner hub 21, thereby further improving the support effect on the blade 22.

[0077] It can be understood that the extension trajectory of the injection molding opening 12 matches the shape of the joint position of the blade 22 and the outer hub 212, which means that the inlet angle of the injection molding opening 12 is the same as the inner edge inlet angle of the blade 22, the outlet angle of the injection molding opening 12 is the same as the inner edge outlet angle of the blade 22, and the shape and size of the injection molding opening 12 are also the same as the shape and size of the root of the blade 22, that is, the injection molding opening 12 can be designed according to the blade 22 to simplify the structure.

[0078] Optionally, the number of the injection molding openings 12 is greater than or equal to the number of the blades 22. The blades 22 may be one or more. For example, when there are two blades 22, the number of the injection molding openings 12 may be equal to two and provided corresponding to the blades 22. The number of the injection molding openings 12 may also be greater than two, with some of the injection molding openings 12 provided corresponding to the blades 22. By increasing the number of the injection molding openings 12, injection molding is more convenient, while the connection strength between the outer hub 212 and the inner hub 211 is improved.

[0079] See also Figures 1 to 9 In some optional embodiments, the impeller assembly 10 further includes a boost unit 3, which is located at the proximal end of the rotating shaft 1 and sleeved on the side wall of the rotating shaft 1. In the axial direction X, the outer hub 212 cooperates with the boost unit 3 stopper.

[0080] By setting a booster unit 3 at the proximal end of the rotating shaft 1, the blood can be pressurized by the booster unit 3 after being transported by the impeller assembly 10, thereby optimizing the speed of the blood after passing through the impeller assembly 10, increasing the flow rate pumped by the interventional catheter device, and improving the pumping effect.

[0081] Among them, the boost unit 3 is interference fit on the rotating shaft 1 and is arranged to rotate synchronously with the rotating shaft 1. The outer hub 212 cooperates with the stop of the boost unit 3, so that it can provide a certain supporting force to the impeller 2 at the proximal end of the rotating shaft 1, reduce the risk of the blade 22 being damaged due to excessive deformation, and improve the reliability of the blade 22.

[0082] In some optional embodiments, in the axial direction X, the side surface of the boosting unit 3 facing the blade 22, that is, the axial X flow surface of the boosting unit 3 is inclined, and the outer diameter of the boosting unit 3 gradually increases from the distal end to the proximal end of the rotating shaft 1.

[0083] After the blood enters the blade 22 through the distal end, it flows toward the downstream booster unit 3. Due to the structural shape and geometric dimensions of the axial X-flow surface of the booster unit 3, the fluid passing through this flow surface is accelerated, its fluid dynamic pressure is increased, and it is quickly pumped out of the fluid pumping device.

[0084] Optionally, the shape of the axial X-flow surface of the boosting unit 3 may be conical, arc-shaped, or a curve with a gradually changing curvature.

[0085] Optionally, the maximum outer diameter of the boosting unit 3 is D3, which is smaller than or equal to the outer diameter D2 of the blades 22 in the compressed state, so as to reduce the intervention size of the impeller assembly 10 during the intervention process.

[0086] An embodiment of the present application also provides an injection mold, in which a molding cavity is provided. The molding cavity includes a first cavity and a second cavity that are connected to each other. The first cavity extends along the axial direction X and is used to accommodate the rotating shaft 1. The first cavity is clearance-matched with the rotating shaft 1 along the radial direction Y. The second cavity is connected to the first cavity and extends a preset distance along the radial direction Y along the side wall of the first cavity. The cavity shape of the second cavity matches the blade 22, and the second cavity is used to mold the blade 22.

[0087] The injection mold in the embodiment of the present application is used to cooperate with the rotating shaft 1, and the hub 21 and the blades 22 are manufactured by an integrated injection molding process. The hub 21 includes an inner hub 211 and an outer hub 212. The inner hub 211 is formed by the hollow structure 11 inside the rotating shaft 1, and the outer hub 212 is formed by the radial gap between the inner wall surface of the first cavity and the rotating shaft 1. The blades 22 are formed by the second cavity.

[0088] The impeller assembly 10 formed by the above-mentioned injection mold can fix the impeller 2 and the rotating shaft 1 together through injection molding. The inner hub 211, the outer hub 212 and the blades 22 are all tightly fitted with the rotating shaft 1, thereby increasing the connection strength between the impeller 2 and the rotating shaft 1 in the axial direction X and the radial direction Y, effectively limiting the relative displacement between the blades 22 and the rotating shaft 1 during high-speed rotation, and increasing the support effect of the roots of the blades 22, reducing the deformation of the blades 22 caused by the reaction force of the fluid during high-speed operation, and improving the fluid pumping performance.

[0089] Moreover, the first cavity can be clearance-matched with the rotating shaft 1 along the radial direction Y, which can make it easier to assemble the rotating shaft 1 in the injection mold, reduce the contact wear on the rotating shaft 1 and / or the injection mold during the assembly process, improve the reliability of the injection molding process, and at the same time increase the life of the mold.

[0090] Optionally, in actual application, the injection mold may include a plurality of injection mold units, and the injection mold is formed by splicing the plurality of injection mold units.

[0091] Specifically, the first cavity is a cylindrical structure, and the second cavity is radially extended from the cylindrical wall of the first cavity.

[0092] Specifically, the first cavity is a cylindrical structure that fits over the sidewall of the rotating shaft 1. The first cavity's cylindrical wall provides a clearance fit with the sidewall of the rotating shaft 1, making it easier to insert the rotating shaft into the first cavity and ensure proper fit between the rotating shaft 1 and the injection mold. Furthermore, after injecting molding material into the hollow structure of the rotating shaft 1, an annular outer hub is formed between the outer wall of the rotating shaft 1 and the cylindrical wall of the first cavity, improving molding reliability.

[0093] In some optional embodiments, the first mold cavity is divided into a first sub-mold cavity and a second sub-mold cavity which are connected in sequence along the axial direction. The first sub-mold cavity is sleeved on the outside of the rotating shaft 1 and is clearance-fitted with the rotating shaft 1 in the radial direction. The second sub-mold cavity is located at the distal end of the first sub-mold cavity. The second sub-mold cavity is used to cover the distal part of the rotating shaft 1, and the second sub-mold cavity is clearance-fitted with the distal part of the rotating shaft 1.

[0094] Among them, the first sub-cavity is adapted to the rotating shaft 1, and by setting the second sub-cavity on the side of the first sub-cavity away from the end face of the injection mold, after injection molding, the inner hub 211 and the outer hub 212 formed by injection molding can be connected in the area where the second sub-cavity is located and form a hub end 213, thereby increasing the connection strength between the inner hub 211 and the outer hub 212, further improving the support effect of the blade 22, and improving the reliability of the blade 22.

[0095] Optionally, the cross-section of the second sub-cavity is tapered toward the distal end, so that the hub end 213 is formed into a guide cone, which can guide the axial X blood flow to enter the impeller 2 area evenly and stably, reduce turbulence, improve blood pumping performance, and reduce the probability of red blood cell damage.

[0096] It is understandable that the shape of the area of ​​the first cavity protruding from the rotating shaft 1 can be designed according to the structure of the hub end 213 to be formed, and this application does not impose any specific limitation on this.

[0097] See also Figures 1 to 10 The embodiment of the present application further provides an injection molding method of an impeller assembly 10, comprising:

[0098] S10, providing a rotating shaft 1 and an injection mold as described in the above embodiment, wherein a hollow structure 11 is provided in the axial direction X of the rotating shaft 1, and an injection opening 12 is opened on a side wall of the rotating shaft 1;

[0099] S20, placing the rotating shaft 1 in the first cavity of the injection mold;

[0100] S30, injecting molding material into the hollow structure 11 of the rotating shaft 1, and allowing the molding material to sequentially pass through the hollow structure 11, the injection opening 12, the radial Y gap between the side wall of the rotating shaft 1 and the first cavity, and then enter the second cavity to form the impeller 2 by injection molding.

[0101] In step S10, the rotating shaft 1 having the hollow structure 11 and the injection molding opening 12 can be directly provided, or the rotating shaft 1 can be processed to form the rotating shaft 1 having the hollow structure 11 and the injection molding opening 12. The injection molding opening 12 on the rotating shaft 1 can match the root of the blade 22. Specifically, the injection molding opening 12 can change with the curvature and thickness of the blade 22 to improve the support effect for the blade 22.

[0102] In some embodiments, in step S10, the hollow structure 11 is set along the axial direction X through both ends of the rotating shaft 1 to form a through hole, so there is no need to set an exhaust hole. The characteristics of the through hole itself can be directly used for exhaust, which makes it easier for the injection molding material to be completely filled in the hollow structure 11.

[0103] In step S20, the rotating shaft 1 is fixed in the first cavity of the injection mold and the impeller assembly 10 is injection molded using the rotating shaft 1 as a core, so that the impeller 2 and the rotating shaft are fixed together by injection molding, thereby improving the reliability of the impeller assembly 10 after injection molding.

[0104] In step S30, high-temperature molten injection molding material is injected into the hollow structure 11 from the proximal end of the rotating shaft 1. The injection molding material passes through the hollow structure 11, the injection molding opening 12, the radial Y gap between the side wall of the rotating shaft 1 and the first cavity, and then enters the second cavity. After cooling, the injection molding material located in the hollow structure 11 forms the inner hub 211, the injection molding material located in the radial Y gap between the side wall of the rotating shaft and the first cavity forms the outer hub 212, and the injection molding material located in the second cavity forms the blade 22. The inner hub 211, the outer hub 212 and the blade 22 form an integrated injection molding structure, which increases the connection strength between the hub 21 and the blade 22 in the axial X and radial Y directions, limits the relative position of the blade 22 with the rotating shaft 1 during high-speed rotation, and improves the reliability of the impeller assembly 10.

[0105] In some optional embodiments, a positioning groove 14 is provided on the side wall of the rotating shaft 1, and the step of setting the rotating shaft 1 in the first cavity of the injection mold also includes: positioning the rotating shaft 1 through the positioning groove 14 so that the injection opening 12 of the rotating shaft 1 is relative to the second cavity.

[0106] By setting a positioning groove 14 on the side wall of the rotating shaft 1, the axial X and radial Y relative positions of the rotating shaft and the injection mold can be guaranteed during the molding process of the impeller 2, and the injection molding accuracy can be guaranteed, so that in the impeller assembly 10 formed in step S30, the extension trajectory of the injection molding opening 12 corresponds to the joining position of the blade 22 and the outer hub 212, so that when the blade 22 is subjected to force, the force transmission path can be shortened, and it is more convenient to transmit the force from the outer hub 21 to the inner hub 21, further improving the support effect on the blade 22.

[0107] Optionally, the positioning groove 14 may be provided at the proximal end of the rotating shaft 1 .

[0108] Thus, the impeller assembly 10 formed by the injection molding method in the embodiment of the present application can increase support for the roots of the blades 22 through the inner hub 211. The inner hub 211 and the outer hub 212 can simultaneously bear the load, thereby ensuring the support strength of the impeller assembly 10. This reduces the deformation of the blades 22 under the reaction force of the fluid during high-speed operation, while also improving the stability of the impeller 2 during the retraction and deployment processes, thereby enhancing the reliability of the impeller assembly 10. Furthermore, while maintaining the same support strength, the thickness of the outer hub 212 can be reduced, reducing the crimping dimension of the impeller assembly 10, that is, reducing the radial Y dimension of the impeller assembly 10 after retraction. This can reduce the size of the intervention during ventricular assist device intervention, reduce damage to blood vessels or related organs, and alleviate patient pain.

[0109] The interventional catheter device provided in the embodiment of the present application includes the impeller assembly 10 provided in the above embodiments, so it also has the advantages of high injection molding precision, high reliability of the impeller 2, and small radial Y dimension of the impeller assembly 10 after being rolled up, and is easy to promote and apply.

Claims

1. An impeller assembly, characterized in that: include: A rotating shaft is provided with a hollow structure along its axial direction, and a side wall of the rotating shaft is provided with an injection molding opening connected to the hollow structure; The impeller includes an integrally injection-molded hub and blades, the hub including an inner hub and an outer hub, the inner hub being embedded in the hollow structure, the outer hub at least partially covering the outer wall surface of the side wall of the rotating shaft, the inner hub and the outer hub being correspondingly connected at the injection molding opening, the blades being arranged on the outer hub, and the blades extending outward radially along the rotating shaft.

2. The impeller assembly according to claim 1, characterized in that The impeller is made of elastic material, and the blades can be rolled up or unfolded around the rotation axis.

3. The impeller assembly according to claim 1, wherein: In the axial direction, a distance is formed between the distal end of the injection molding opening and the distal end of the rotating shaft.

4. The impeller assembly according to claim 1, wherein: The hollow structure passes through the distal end of the rotating shaft along the axial direction, and the inner hub and the outer hub are connected at the distal end of the rotating shaft to form a hub end portion.

5. The impeller assembly according to claim 4, characterized in that In the axial direction, along the direction from the proximal end to the distal end, the radial dimension of the hub end is gradually reduced to form a guide surface.

6. The impeller assembly according to claim 5, characterized in that The guide surface is a guide cone surface, and the top angle of the guide cone surface is 30° to 80°.

7. The impeller assembly according to claim 4, characterized in that At the distal end of the rotating shaft, an outer wall surface of the side wall is provided with a chamfer, and the hub end is covered by the chamfer.

8. The impeller assembly according to any one of claims 1 to 7, characterized in that: Along the circumference of the rotating shaft, the outer hub is annularly covered on the outer wall surface of the side wall.

9. The impeller assembly according to claim 8, characterized in that The radial thickness from the outer edge of the outer hub to the inner edge of the inner hub is 0.05 mm to 0.1 mm.

10. The impeller assembly according to any one of claims 1 to 7, characterized in that: The extension trajectory of the injection molding opening matches the shape of the joint position of the blade and the outer hub.

11. The impeller assembly according to any one of claims 1 to 7, characterized in that: The impeller assembly further includes a boost unit, which is located at the proximal end of the rotating shaft and sleeved on the side wall of the rotating shaft. In the axial direction, the outer hub cooperates with the boost unit stopper.

12. The impeller assembly according to claim 11, wherein: In the axial direction, the supercharging unit is inclined toward one side surface of the blade, and the outer diameter of the supercharging unit gradually increases from the distal end to the proximal end of the rotating shaft.

13. An injection mold for manufacturing the impeller assembly according to claim 1, characterized in that: A molding cavity is provided in the injection mold, and the molding cavity includes: A first cavity extends in the axial direction and is used to accommodate the rotating shaft, and the first cavity is in clearance fit with the rotating shaft in the radial direction; The second cavity is connected to the first cavity and extends radially from the side wall of the first cavity by a preset distance. The shape of the second cavity matches the blade, and the second cavity is used to form the blade.

14. The injection mold according to claim 13, characterized in that The first cavity is a cylindrical structure, and the second cavity is radially extended from the cylindrical wall of the first cavity.

15. The injection mold according to claim 14, characterized in that The first mold cavity is divided into a first sub-mold cavity and a second sub-mold cavity which are connected in sequence along the axial direction; The first sub-mold is sleeved on the outside of the rotating shaft and is loosely fitted with the rotating shaft along the radial direction. The second sub-mold is located at the distal end of the first sub-mold. The second sub-mold is used to cover the distal part of the rotating shaft, and the second sub-mold is loosely fitted with the distal part of the rotating shaft.

16. The injection mold according to claim 15, characterized in that The cross section of the second sub-cavity is tapered toward the distal end.

17. An interventional catheter device, characterized in that: include: A pump head comprising a pump housing and an impeller assembly according to any one of claims 1 to 12, wherein the impeller assembly is arranged in the pump housing; A driving assembly is connected to the rotating shaft of the impeller assembly, and the driving assembly is used to drive the rotating shaft to rotate.

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