CN111166949A - Impeller, method for manufacturing impeller, and percutaneous blood pump - Google Patents

Abstract

The invention relates to the technical field of medical instruments, in particular to an impeller, a manufacturing method of the impeller and a percutaneous blood pump. The impeller comprises an axle and blades fixedly connected with the axle. The blade has a closed profile and includes a skeleton and a blade face. The skeleton forms at least an outer contour of the blade. The profile of blade is filled to the blade surface, the skeleton is different with the material that the blade surface adopted, the material that the skeleton adopted is shape memory alloy, the rigidity of blade has been guaranteed, thereby when the impeller is high-speed rotatory, be difficult for by blood erodeing and slope, make the blade surface can have abundant area of contact with blood, and then be favorable to the impeller to guarantee stable flow output at the during operation, on the other hand, it is very thin to make the blade surface can be done, less volume has after the blade compression, it is inside to be compressed the entering sheath easily.

Description

Impeller, method for manufacturing impeller, and percutaneous blood pump

Technical Field

The invention relates to the technical field of medical instruments, in particular to an impeller, a manufacturing method of the impeller and a percutaneous blood pump.

Background

In a method of treating heart disease, a percutaneous blood pump may be inserted between the left ventricle and the aortic arch to assist the pumping function of the heart. The percutaneous blood pump comprises a sheath and an impeller positioned in the sheath. The blades of the impeller have a compressed state within the sheath and an extended state out of the sheath. When the blades are compressed, the utility model is convenient for entering human body. When the percutaneous blood pump is operated, the blades are stretched, and blood is pumped by the rotation of the impeller. The blades of the impeller and the wheel shaft of the impeller of the traditional blood pump are integrally formed by a high polymer material, the rigidity of the blades is insufficient, the blades are easy to be washed by blood and inclined when the impeller rotates at a high speed, and cannot be stably fixed at a fixed position, so that the actual use effect is influenced, the thickness of the blades can be increased as much as possible in order to improve the rigidity of the blades, the thickness of the blades is basically 0.51-0.64mm at present, but the excessively thick blades make an operator difficult to compress the impeller into a sheath, so that the thickness is expected to be reduced, and the two problems become a pair of shield bodies and troubles technicians in the field.

Disclosure of Invention

Based on this, there is a need for an improved impeller, a method of manufacturing an impeller and a transcutaneous blood pump comprising such an impeller to address at least one of the problems described above.

The present application provides an impeller comprising an axle and a blade fixedly connected to the axle, the blade having a closed profile comprising a connected outer profile and an inner profile, the inner profile being located on the axle; the blade includes:

the framework at least forms the outer contour of the blade, and the material adopted by the framework is shape memory alloy; and

the blade surface, the blade surface with the skeleton is connected, just the shape of blade surface with the skeleton phase-match is in order to fill the profile, the material that the blade surface adopted is elastic polymer material.

In one embodiment, the material used for the axle is a biocompatible polymer material or a shape memory alloy.

In one embodiment, the skeleton is connected with the wheel axle in a manner of embedding, bonding or welding.

In one embodiment, the skeleton forms the entire profile of the blade, and the skeleton includes an inner skeleton and an outer skeleton connected together, the inner skeleton is fixed to the hub, the inner skeleton forms the inner profile of the blade, and the outer skeleton forms the outer profile of the blade.

In one embodiment, the skeleton further forms part of the inner contour of the blade, and part of the outer circumference of the hub forms the remaining part of the inner contour of the blade; or the like, or, alternatively,

the skeleton forms the outer contour of the blade, and part of the outer peripheral surface of the wheel shaft forms the whole inner contour of the blade.

In one embodiment, the skeleton has a thickness that tapers radially outward of the axle; and/or the width of the framework gradually narrows along the radial direction of the wheel shaft.

In one embodiment, the thickness of the thinnest part of the framework ranges from 0.35mm to 0.45mm, and the thickness of the thickest part of the framework ranges from 0.55mm to 0.65 mm.

In one embodiment, the thickness of the leaf surface is 0.05mm-0.5mm, and the thickness of the leaf surface is larger at the position closer to the framework.

In one embodiment, the leaf surface is combined with the skeleton through an electrostatic spinning and sewing process; or the like, or, alternatively,

the leaf surface is combined with the framework through an extraction process.

In one embodiment, the skeleton is integrally formed from a wire of a shape memory alloy material.

In one embodiment, the skeleton is integrally formed with the axle.

The application also provides a percutaneous axial blood pump, which comprises the impeller and a sheath for accommodating the impeller.

The present application further provides a method for manufacturing an impeller according to any one of the above technical solutions, the method including the steps of:

preparing a wheel shaft;

preparing a framework of the blade by adopting shape memory alloy;

fixedly connecting the framework with the wheel shaft;

assembling a leaf surface made of an elastic polymer material to a closed contour of the leaf, or filling the closed contour with an elastic polymer material to form the leaf.

In one embodiment, the axle is prepared by a mold-open injection molding or 3D printing process.

In one embodiment, the skeleton is prepared by a process of laser cutting and heat setting or a process of 3D printing.

In one embodiment, the leaf surface is formed by an electrospinning spray technique and sewn to the skeleton; or the like, or, alternatively,

and filling the elastic high polymer material to the contour surrounded by the framework through a leaching process to form the leaf surface.

The present application also provides another method for manufacturing an impeller according to any one of the above technical solutions, the method comprising the steps of:

preparing frameworks of the wheel shaft and the blades by adopting shape memory alloy through an integral forming process;

assembling a leaf surface made of an elastic polymer material to a closed contour of the leaf, or filling the closed contour with an elastic polymer material to form the leaf.

Impeller among the above-mentioned technical scheme, the skeleton adopts different materials to make with the blade surface, because the skeleton of blade forms the outline of blade at least, its material of adopting is shape memory alloy, better rigidity has, consequently, can guarantee the rigidity of blade, thereby when the impeller is rotatory at a high speed, be difficult for by blood washing and slope, make the blade surface can have abundant area of contact with blood, and then be favorable to the impeller to guarantee stable flow output at the during operation, under the condition that the skeleton provides higher rigidity for the blade, the blade surface adopts elastic polymer material to make, can do very thin, and then make the blade compress the back have less volume, easily compressed get into inside the sheath.

Drawings

FIG. 1 is a side view of an impeller according to one embodiment.

Fig. 2 is a front view of the impeller of fig. 1.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

When a portion is referred to as being "fixed to" another portion, it may be directly on the other portion or may be fixed to the other portion by a connecting portion. When a portion is said to be "connected" to another portion, it may be directly connected to the other portion or the connection of the portion to the other portion may be made through a connecting portion. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 and 2, animpeller 100 is provided in an embodiment of the present application. Theimpeller 100 is intended to be mounted on a transcutaneous axial blood pump (not shown). Theimpeller 100 includes ahub 110 and a plurality ofblades 120 fixedly coupled to thehub 110.

In this embodiment, the material used for thewheel shaft 110 may be a polymer material with biocompatibility, so that thewheel shaft 110 has better compatibility with a human body when theimpeller 100 enters the human body, and is easy to bend and enter the human body. Specifically, the material used for theaxle 110 is, for example, silicone rubber, polyurethane, or the like. In other embodiments, the material used for theaxle 110 may also be a bioceramic or a shape memory alloy, such as nitinol. Theaxle 110 may be manufactured by using processes such as mold-open injection molding and stereolithography.

Eachblade 120 includes askeleton 121 and ablade face 122. The material used for theskeleton 121 is a shape memory alloy, such as nitinol. Preferably, theskeleton 121 may be integrally made of a wire of a shape memory alloy material. Illustratively, theskeleton 121 may be formed by a process of stereolithography. Theskeleton 121 may be formed by laser cutting a nickel-titanium wire and heat setting the cut nickel-titanium wire. Theskeleton 121 integrally made of the metal wire made of the shape memory alloy material has good stability and is not easily broken or bent.

Theframe 121 may be fixedly connected to thewheel shaft 110 by bonding, welding, or embedding.

Eachblade 120 has a closed profile. The profile comprises a connecting outer profile and an inner profile, the inner profile being located on the axle. Theskeleton 121 forms at least an outer contour of theblade 120. In this embodiment, theskeleton 121 may form the entire contour of theblade 120. Theframe 121 includes anouter frame 1211 and aninner frame 1212 connected to theouter frame 1211, theouter frame 1211 and theinner frame 1212 together forming a closed structure. Theouter skeleton 1211 forms an outer contour of theblade 120 and theinner skeleton 1212 forms an inner contour of theblade 120. Theinner frame 1212 may be attached to theaxle 110 by bonding, welding, or embedding, so that theframe 121 may be fixedly connected to theaxle 110.

Of course, it is understood that in other embodiments, theskeleton 121 may also form only the outer contour and part of the inner contour of theblade 120, and the remaining part of the inner contour of theblade 120 is formed by part of the outer circumferential surface of thehub 110, i.e. theskeleton 121 and part of the outer circumferential surface of thehub 110 together enclose the entire contour of theblade 120. Alternatively, theskeleton 121 forms only the outer contour of theblade 120, i.e., only both ends of theskeleton 121 are connected to thehub 110, and the inner contour is entirely formed by a partial outer circumferential surface of thehub 110.

Compared with theskeleton 121 forming the outer contour and a part of the inner contour of theblade 120 or only forming the outer contour of theblade 120, in the embodiment, theouter skeleton 1211 and theinner skeleton 1212 together form a closed structure, so that theskeleton 121 integrally forms a closed whole contour, and therefore, theskeleton 121 has good stability, and is more firmly and stably combined with thehub 110, and the stability and operability of theblade 120 are improved while the rigidity of theblade 120 is increased.

The material used for theleaf surface 122 is an elastic polymer material, such as polyurethane, silicon rubber, etc. The shape of theblade surface 122 matches the shape of theskeleton 121 to fill the contour enclosed by theskeleton 121, thereby forming theblade 120. Specifically, in the present embodiment, theleaf surface 122 fills the closed contour surrounded by theouter skeleton 1211 and theinner skeleton 1212.

In other embodiments, when theframe 121 and a portion of the outer peripheral surface of thehub 110 jointly enclose the entire contour of theblade 120, theblade surface 122 is filled in the contour enclosed by theframe 121 and a portion of the outer peripheral surface of thehub 110.

Preferably, the thickness of theskeleton 121 is gradually reduced radially outward of thehub 110. I.e., radially inward of thehub 110, theskeleton 121 becomes thicker and thicker. Since the portion of theframe 121 closer to thehub 110 is thicker when theimpeller 100 rotates, theblades 120 can bear a higher hydraulic load and are less likely to be inclined when being impacted by blood. Meanwhile, as the thickness of theskeleton 121 becomes thinner along the radial direction of thehub 110, theskeleton 121 can be easily compressed, so that theimpeller 100 can easily enter the sheath. The thickness of the thinnest portion of thebobbin 121 may range from 0.35mm to 0.45mm, and preferably, the thickness of the thinnest portion of thebobbin 121 is 0.4 mm. The thickness of the thickest part of the skeleton is in the range of 0.55mm to 0.65mm, and preferably, the thickness of the thickest part of theskeleton 121 is 0.6 mm. The thickness here refers to a dimension in the circumferential direction of theblade 120.

In other embodiments, the width of theskeleton 121 tapers radially outward of thehub 110. I.e., radially inward of thehub 110, the width of thecage 121 becomes wider and wider. Since the wider the portion of theframe 121 closer to thehub 110 when theimpeller 100 rotates, theblades 120 can receive a higher hydraulic load and are less likely to be inclined when being impacted by blood. Meanwhile, since the width of theframe 121 is gradually narrowed outward in the radial direction of thehub 110, theframe 121 can be easily compressed, so that theimpeller 100 can easily enter the inside of the sheath. The width here refers to a dimension in a radial direction of theblade 120.

Preferably, theleaf surface 122 may be formed by a leaching process. Specifically, after theskeleton 121 and thewheel axle 110 are fixedly connected, theskeleton 121 is completely immersed in the elastic polymer solution, and then theskeleton 121 is lifted, so that the elastic polymer solution forms a film in an area surrounded by theskeleton 121 under the action of its own tension. After the film is thermally cured, theleaf surface 122 is formed and filled in the region surrounded by theskeleton 121. The formation of theleaf surface 122 through the leaching process can make the thickness of theleaf surface 122 thin, and does not need to open the mold, which is convenient for manufacturing, for example, the thickness of theleaf surface 122 is about 0.1 mm.

Further, since theleaf surface 122 is directly formed on theskeleton 121 through the leaching process, theleaf surface 122 that is thicker near theskeleton 121 and thinner far from theskeleton 121 can be naturally formed, so that theleaf surface 122 achieves an ideal strength change.

In other embodiments, theleaf surface 122 may be formed by an electrospinning process and further sewn to theskeleton 121. Specifically, under the action of an electric field, elastic polymer solution with charges is sprayed in an area which is formed by independent enclosure of theframework 121 or enclosure of the framework and thewheel shaft 110 through a micro-nano-aperture spray head, the thickness of theleaf surface 122 can be controlled by controlling spraying time, so that the thickness of theleaf surface 122 can be made very thin, mold opening is not needed, and the manufacturing is facilitated. After theleaves 122 are formed, theleaves 122 may be sewn to theframe 121 by hand or by machine so that theleaves 122 fill the contours of theframe 121 alone or in combination with theaxle 110.

Whether the leaching process or the electrospinning and sewing process is adopted, the thickness of theleaf surface 122 in the embodiment of the present invention may be much smaller than that in the prior art, and the thickness of theleaf surface 122 ranges from 0.05mm to 0.5 mm.

In other embodiments, theaxle 110 and theframe 121 may be made of the same material, for example, both made of shape memory alloy, and theaxle 110 and theframe 121 may be integrally formed.

In the above embodiments, theframe 121 and theleaf surface 122 are made of different materials. Theframework 121 at least forms the outer contour of theblade 120, the adopted material is shape memory alloy, and the rigidity is better, so that the rigidity of theblade 120 can be ensured, when theimpeller 100 rotates at a high speed, the blade is not easy to be washed by blood and incline, theblade surface 122 can have a sufficient contact area with the blood, and further theimpeller 100 can ensure stable flow output in work, under the condition that theframework 121 provides higher rigidity for theblade 120, theblade surface 122 is made of an elastic high polymer material through an extraction or electrostatic spinning process, so that theblade surface 122 can be made to be very thin, and theblade 120 has a smaller volume after being compressed, and is easy to be compressed to enter the protective sheath.

An embodiment of the present application also provides a percutaneous axial blood pump (not shown). The percutaneous axial blood pump includes theimpeller 100 in any of the above embodiments and a sheath (not shown) that houses theimpeller 100.

An embodiment of the present application further provides a method for manufacturing theimpeller 100. The method comprises the following steps:

s110: thehub 110 is prepared.

The material used for theaxle 110 may be a polymer material, such as thermoplastic polyurethane TPU, silicone rubber, high density polyethylene HDPE, polypropylene PP, resin, or the like. Theaxle 110 may be prepared by a mold-open injection molding or 3D printing process.

S130: theskeleton 121 of theblade 120 is made of a shape memory alloy.

Theskeleton 121 may be formed by cutting a nickel-titanium wire with laser and then heat-setting the cut nickel-titanium wire. Theskeleton 121 may also be formed through a process of 3D printing.

S150: theframe 121 is fixedly connected to thewheel shaft 110.

Theframe 121 and theaxle 110 may be fixedly connected by bonding, welding or embedding.

S170: theblade surface 122 made of elastic polymer material is assembled to the contour enclosed by theframe 121, or the contour enclosed by theframe 121 alone or the contour enclosed by theframe 121 and thehub 110 together is filled with the elastic polymer material to form theblade 120.

Specifically, under the action of an electric field, elastic polymer material solution with charges can be sprayed in an area which is formed by independent enclosure of theframework 121 or enclosure of the framework and thewheel shaft 110 together through a micro-nano-aperture spray head, the thickness of theleaf surface 122 can be controlled by controlling the spraying time, so that the thickness of theleaf surface 122 can be made very thin, the die opening is not needed, and the manufacturing is convenient. After theleaf surface 122 is formed, theleaf surface 122 can be sewn on theframework 121 manually or by a machine, so that theleaf surface 122 is assembled to the contour of theframework 121 which is enclosed by theframework 121 alone or together with thewheel shaft 110, and then theleaf 120 is formed.

After theskeleton 121 and thewheel shaft 110 are fixedly connected, theskeleton 121 is completely immersed in the elastic polymer material solution, and then theskeleton 121 is lifted, so that the elastic polymer material solution forms a film in an area surrounded by theskeleton 121 under the action of the tension of the elastic polymer material solution. After the film is thermally cured, theblade surface 122 is formed and filled in the region surrounded by theskeleton 121, thereby forming theblade 120.

Another embodiment of the present invention also provides another method for manufacturing theimpeller 100. The method comprises the following steps:

s210: thewheel shaft 110 and theframe 120 are manufactured by an integral molding process using a shape memory alloy.

Both theaxle 110 and theframe 120 may be formed of a shape memory alloy. Since the same material is used for theaxle 110 and theframe 120, theaxle 110 and theframe 120 can be integrally formed. Specifically, theaxle 110 and theframe 120 may be prepared through a mold-open injection molding or 3D printing process.

S230: theblade surface 122 made of elastic polymer material is assembled to the contour of theskeleton 121 and thehub 110, or the contour of theskeleton 121 and thehub 110 is filled with the elastic polymer material to form theblade 120.

Specifically, under the action of an electric field, elastic polymer material solution with charges can be sprayed in an area defined by theframework 121 and thewheel shaft 110 together through a micro-nano-aperture spray head, and the thickness of theleaf surface 122 can be controlled by controlling spraying time, so that the thickness of theleaf surface 122 can be made very thin, the die is not required to be opened, and the manufacturing is facilitated. After theleaf surface 122 is formed, theleaf surface 122 can be sewn on theframework 121 manually or by a machine, so that theleaf surface 122 is assembled to the outline which is formed by theframework 121 and thewheel shaft 110 together, and then theblade 120 is formed.

After theskeleton 121 and thewheel shaft 110 are fixedly connected, theskeleton 121 is completely immersed in the elastic polymer material solution, and then theskeleton 121 is lifted, so that the elastic polymer material solution forms a film in an area surrounded by theskeleton 121 under the action of the tension of the elastic polymer material solution. After the film is thermally cured, ablade surface 122 is formed and filled in the area enclosed by theskeleton 121 and thehub 110, thereby forming theblade 120.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (17)

1. An impeller comprising an axle and a blade fixedly connected to the axle, the blade having a closed profile comprising a connected outer profile and an inner profile, the inner profile being located on the axle; the blade includes:

the framework at least forms the outer contour of the blade, and the material adopted by the framework is shape memory alloy; and

the blade surface, the blade surface with the skeleton is connected, just the shape of blade surface with the skeleton phase-match is in order to fill the profile, the material that the blade surface adopted is elastic polymer material.

2. The impeller according to claim 1, characterized in that the material used for the hub is a biocompatible polymer material or a shape memory alloy.

3. The impeller according to claim 1, characterized in that the skeleton is connected to the hub by means of inlay, adhesive or welding.

4. The impeller as claimed in claim 1, wherein said skeleton forms all of said profile of said blade and comprises an inner skeleton and an outer skeleton connected, said inner skeleton being fixed in abutment with the hub, said inner skeleton forming said inner profile of the blade and said outer skeleton forming said outer profile of the blade.

5. The impeller according to claim 1,

the skeleton also forms part of the inner contour of the blade, and part of the outer circumferential surface of the hub forms the rest of the inner contour of the blade; or the like, or, alternatively,

the skeleton forms the outer contour of the blade, and part of the outer peripheral surface of the wheel shaft forms the whole inner contour of the blade.

6. The impeller according to any one of claims 1 to 5,

the thickness of the framework is gradually reduced along the radial direction of the wheel shaft; and/or the presence of a gas in the gas,

the width of the skeleton gradually narrows radially outward of the wheel axle.

7. The impeller according to claim 6, characterized in that the thickness of the thinnest part of the skeleton ranges from 0.35mm to 0.45mm, and the thickness of the thickest part of the skeleton ranges from 0.55mm to 0.65 mm.

8. The impeller according to any one of claims 1 to 7, wherein the thickness of the blade surface is 0.05mm to 0.5mm, and the thickness of the blade surface is greater closer to the skeleton.

9. The impeller of claim 1, wherein said blade surface is bonded to said backbone by an electrospinning and sewing process; or the leaf surface is combined with the framework through an extraction process.

10. The impeller of claim 1, wherein the skeleton is integrally formed from a wire of a shape memory alloy material.

11. The impeller of claim 1, wherein the skeleton is integrally formed with the hub.

12. A percutaneous blood pump comprising an impeller as claimed in any one of claims 1 to 11 and a sheath housing the impeller.

13. A method of manufacturing an impeller according to any one of claims 1 to 10, comprising the steps of:

preparing a wheel shaft;

preparing a framework of the blade by adopting shape memory alloy;

fixedly connecting the framework with the wheel shaft;

assembling a leaf surface made of an elastic polymer material to a closed contour of the leaf, or filling the closed contour with an elastic polymer material to form the leaf.

14. The method for manufacturing an impeller according to claim 13, wherein the hub is manufactured by a mold-open injection molding or 3D printing process.

15. The method for manufacturing an impeller according to claim 13, wherein the skeleton is manufactured by a process of laser cutting and heat setting or a process of 3D printing.

16. The method of manufacturing an impeller according to claim 13,

forming the leaf surface by an electrostatic spinning spraying process and sewing the leaf surface and the framework; or the like, or, alternatively,

and filling the elastic high polymer material to the contour surrounded by the framework through a leaching process to form the leaf surface.

17. A method of manufacturing an impeller according to claim 11, comprising the steps of:

preparing frameworks of the wheel shaft and the blades by adopting shape memory alloy through an integral forming process;

assembling a leaf surface made of an elastic polymer material to a closed contour of the leaf, or filling the closed contour with an elastic polymer material to form the leaf.

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