An interventional blood pump with an actively adjustable support

Abstract

This application relates to the field of medical device technology, providing an interventional blood pump with an actively adjustable stent, comprising: a pump body and an actively adjustable stent assembly; the pump body includes: a pump housing, a front guide, a rear guide, a helical component, a sliding component, a drive assembly, a cannula assembly, and an impeller, the sliding component being located inside the pump housing, the helical component being disposed within the sliding component and threadedly connected to the sliding component, the two ends of the impeller being rotatably connected to the front guide and the rear guide respectively, and the drive assembly being disposed within the sliding component and drivenly connected to the impeller; the actively adjustable stent assembly includes: a deformable stent and an actively adjustable assembly, the deformable stent enclosing the impeller and being hinged at one end to the front guide and at the other end to the sliding component, the actively adjustable assembly being drivenly connected to the helical component through the cannula assembly; the actively adjustable assembly drives the helical component to rotate clockwise or counterclockwise to cause the sliding component to reciprocate, thereby causing the deformable stent to expand or contract. This interventional blood pump has an actively adjustable radial dimension and can be supported against the inner wall of the blood vessel.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and more specifically, relates to an interventional blood pump with an actively adjustable stent. Background Technology

[0002] Interventional blood pumps are mainly used to assist the normal blood flow of patients with heart failure. The blood pump is inserted into a blood vessel through the patient's skin and delivered to a designated working position through the blood vessel. The negative pressure generated by the rotation of the impeller draws blood from the left ventricle into the aorta, thereby assisting the heart in pumping blood to maintain the blood flow required by the patient.

[0003] During interventional procedures, blood pumps need to maintain a minimal radial dimension to avoid rupturing blood vessels, especially at the implantation site where the vessel is thinner (with an inner diameter not exceeding 8mm) and at the working location where the vessel is thicker (25-30mm in diameter). Most existing interventional blood pumps use a small-sized structure directly implanted into the blood vessel. To achieve the desired auxiliary flow rate, the impeller speed typically reaches 20,000 rpm, inevitably leading to poor blood flow properties and even hemolysis and thrombosis. A smaller number of interventional blood pumps employ a folding structure. For example, patent CN116271502A designs a foldable pump head. The core component of this invention is a stent made of shape-memory metal with a multi-mesh design. It is unfolded in its natural state and can retract under external constraints. This stent needs to be used in conjunction with an external implantation device. Another example is patent CN116251289A, which uses a folding sheath and a transition sheath to progressively fold the foldable pump head before inserting it into the blood vessel through an interventional sheath. Therefore, existing foldable blood pumps all adopt a passive adjustment mode and have limited radial adjustable size, and still require a relatively large speed to maintain normal blood flow in the human body during operation.

[0004] Blood pumps need to minimize vibration during operation to avoid damage to blood vessels and blood. Most existing interventional blood pumps use a pigtail catheter structure at the distal end, which is inserted into the left ventricle and fitted against the inner wall for support. However, this provides poor support and is prone to damaging blood vessels and blood. Summary of the Invention

[0005] To address the shortcomings of the prior art, the purpose of this application is to provide an interventional blood pump with an actively adjustable stent, whose radial dimension can be actively adjusted while being supported on the inner wall of the blood vessel.

[0006] To achieve the above objectives, the technical solution adopted in this application is: to provide an interventional blood pump with an actively adjustable stent, comprising: a pump body and an actively adjustable stent assembly;

[0007] The pump body includes: a pump casing, a front guide, a rear guide, a spiral component, a sliding component, a drive assembly, a sleeve assembly, and an impeller. The sliding component is located inside the pump casing. The spiral component is disposed inside the sliding component and threadedly connected to the sliding component. The two ends of the impeller are rotatably connected to the front guide and the rear guide, respectively. The drive assembly is disposed inside the sliding component and is drivenly connected to the impeller.

[0008] The actively adjustable support assembly includes a deformable support and an active adjustment component. The deformable support encloses the impeller and is hinged at one end to the guide and at the other end to the sliding member. The active adjustment component is connected to the auger through the sleeve assembly. The active adjustment component drives the auger to rotate forward or backward to make the sliding member reciprocate, thereby causing the deformable support to expand or contract.

[0009] In one embodiment, the deformable support is a mesh structure with a cylindrical center and frustum-shaped ends, specifically including a front support leg, a main support portion, a secondary support portion, a rear support leg, and a circumferential connecting portion. One end of the front support leg is connected to one end of the main support portion, and the other end of the front support leg is hinged to the front guide. One end of the rear support leg is connected to the other end of the main support portion, and the other end of the rear support leg is hinged to the sliding member. The secondary support portion is staggered with the main support portion, and both ends of the secondary support portion are respectively connected to the main support portion through the circumferentially connected portion.

[0010] In one embodiment, the front support leg and the rear support leg have the same structure. The front support leg includes a first support portion, a first deformable portion, and a first columnar boss. The first support portion is straight, and the first deformable portion is curved and connected to the main support portion and one end of the first support portion, and is tangent to the radial inner surface of the main support portion. The first columnar boss is located at the end of the first support portion and is hinged to the front guide.

[0011] The rear support leg includes a second support part, a second deformable part, and a second columnar boss. The second deformable part is connected to one end of the main support part and the second support part, respectively. The second columnar boss is located at the end of the second support part and is hinged to the sliding member.

[0012] When the deformable bracket expands or contracts, the bending arc of the first deformable part and the second deformable part gradually increases or decreases.

[0013] In one embodiment, the thickness of the first support portion is half the thickness of the main support portion, the thickness of the first deformable portion is half the thickness of the first support portion, and the curved side length of the first deformable portion is 2 / 10 to 3 / 10 of the total length of the front support leg.

[0014] In one embodiment, the main support and the secondary support are straight strips with a square cross-section, and the length of the secondary support is half the length of the main support. The number of main support is 10-16, and two secondary support with a certain axial interval are provided between two adjacent main support. The number of secondary support is twice that of the main support.

[0015] In one embodiment, the circumferential connecting portion is an S-shaped strip, with its bending apex being a third deformed portion. The third deformed portion is connected to the end of the main support portion or the secondary support portion, wherein the third deformed portion connected to the main support portion is close to the center plane; the thickness of the third deformed portion is half of the circumferential connecting portion; and the length of the curved edge of the third deformed portion is 1 / 10 to 2 / 10 of the total length of the circumferential connecting portion.

[0016] In one embodiment, the drive assembly includes: a motor housing and a micro motor, the motor housing being disposed within the sliding member, one end of the motor housing being an open end and connected to the rear guide, the micro motor being disposed within the motor housing, and the output shaft of the micro motor rotatably passing through the rear guide and being connected to the impeller;

[0017] The sliding member has a connecting groove and a connecting hole for hinged connection of the rear support leg at one end near the deformable bracket, and the pump housing has a through groove for the rear support leg to pass through.

[0018] In one embodiment, the sleeve assembly includes a motor sleeve, a spiral sleeve, and a pump housing sleeve arranged from the inside out. One end of the motor sleeve is fixedly connected to the motor housing and communicates with the interior of the motor housing, while the other end is a free end for a conductive wire to pass through. One end of the spiral sleeve is fixedly connected to a spiral component, and the other end is fixedly connected to an active adjustment component. The active adjustment component drives the spiral sleeve to rotate, thereby causing the spiral component to rotate. One end of the pump housing sleeve is connected to the pump housing, and the other end is connected to the housing of the active adjustment component.

[0019] In one embodiment, the active adjustment component includes: an outer ring fixing member, an inner ring fixing member, and a knob. The inner ring fixing member is rotatably disposed within the outer ring fixing member and is used to install the knob. The knob portion protrudes from the outer ring fixing member. The outer surface of the outer ring fixing member is provided with a starting position mark and a rotation direction mark. The protruding portion of the knob is provided with a scale pointer mark.

[0020] In one embodiment, the spiral sleeve includes a first spiral coil and a second spiral coil, which are coaxially mounted. Both the first and second spiral coils are formed by spirally winding 4-12 flat steel wires around the same axis in parallel, and the winding directions of the first and second spiral coils are opposite.

[0021] The pump casing sleeve includes a third spiral coil and a fourth spiral coil, which are coaxially mounted. Both the third and fourth spiral coils are formed by 4-12 flat steel wires spirally wound side by side around the same axis, and the winding directions of the third and fourth spiral coils are opposite. The winding directions of the second and third spiral coils are the same.

[0022] The beneficial effects of the interventional blood pump with deformable stent provided in this application are as follows:

[0023] The active adjustment component drives the spiral component to rotate, causing the sliding component to move back and forth along the axial direction, thereby deforming the deformable bracket and achieving its expansion and contraction. The active adjustment component allows for adjustment of any radial dimension of the deformable bracket within a certain range. It is simple to operate, offers more flexible expansion and contraction, and has the advantages of a large adjustable size and controllability.

[0024] The interventional blood pump provided in this application can shrink the deformable stent through an active adjustment component during implantation or removal, minimizing the radial dimension of the blood pump, thereby reducing the difficulty of implantation or removal and minimizing trauma. After the blood pump enters the working position, the deformable stent is expanded through the active adjustment component, allowing the blood pump to be supported on the inner wall of the blood vessel by the deformable stent. Under the condition of the self-locking function of the helical component, the support stability can be improved, effectively reducing the damage to the blood caused by vibration due to poor support. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a three-dimensional schematic diagram of an interventional blood pump provided in an embodiment of this application.

[0027] Figure 2 This is a three-dimensional schematic diagram of the internal structure of the interventional blood pump provided in the embodiments of this application.

[0028] Figure 3 This is a structural schematic diagram of the deformable bracket provided in an embodiment of this application.

[0029] Figure 4 for Figure 3 A cross-sectional view at point NN.

[0030] Figure 5 This is a three-dimensional schematic diagram of the drive assembly, spiral component, and sliding component of the interventional blood pump provided in the embodiments of this application.

[0031] Figure 6 This is a cross-sectional schematic diagram of a portion of the structure of the interventional blood pump provided in an embodiment of this application.

[0032] Figure 7 for Figure 6 A magnified view of a portion of point A in the middle.

[0033] Figure 8 This is a schematic diagram of the pump housing sleeve and spiral sleeve of the interventional blood pump provided in the embodiments of this application.

[0034] Figure 9 This is a cross-sectional schematic diagram of the active adjustment component in the interventional blood pump provided in an embodiment of this application.

[0035] Figure 10 This is a three-dimensional schematic diagram of the active adjustment component in the interventional blood pump provided in the embodiments of this application.

[0036] Figure 11 This is a schematic diagram showing the position of the interventional blood pump provided in the embodiment of this application during operation.

[0037] The following are the labeling elements in the figure:

[0038] 1. Pump body; 11. Rear guide; 12. Pump casing; 121. Through groove; 13. Helical component; 131. Helical groove; 14. First bearing; 15. Second bearing; 16. Front guide; 161. First connecting groove; 162. First connecting hole; 17. Sliding component; 171. Third columnar platform; 172. Limiting block; 173. Slider; 174. Second connecting groove; 175. Second connecting hole; 2. Actively adjustable support assembly; 3. Sleeve assembly; 31. Pump casing sleeve; 311. Third solenoid coil; 312. Fourth solenoid coil; 32. Helical sleeve; 321. First solenoid coil; 322. Second solenoid coil; 33. Motor sleeve; 4. Active adjustment assembly; 41. 411 Outer ring fastener; 42 Inner ring fastener; 421 Inner ring sleeve; 43 Knob; 5 Impeller; 51 Hub; 511 Impeller shaft; 512 Impeller hole; 52 Blade; 6 Deformable bracket; 61 Main support; 62 Secondary support; 63 Front support leg; 631 First support; 632 First deformable part; 633 First columnar boss; 64 Circumferential connection; 641 Third deformable part; 65 Rear support leg; 651 Second support; 652 Second deformable part; 653 Second columnar boss; 7 Drive assembly; 71 Motor housing; 711 Guide groove; 72 Micro motor; 73 Output shaft. Detailed Implementation

[0039] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0040] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0041] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0042] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0043] like Figures 1-11 As shown, an interventional blood pump with an actively adjustable stent provided in this application embodiment will now be described in detail. This interventional blood pump includes: a pump body 1 and an actively adjustable stent assembly 2; wherein, the pump body 1 includes a pump housing 12, a front guide 16, a rear guide 11, a helical member 13, a sliding member 17, a drive assembly 7, a cannula assembly 3, and an impeller 5; the sliding member 17 is located inside the pump housing 12, the helical member 13 is disposed within the sliding member 17 and threadedly connected to the sliding member 17, and the sliding member 17 can achieve a certain range of axial movement by rotating the helical member 13; the two ends of the impeller 5 are rotatably connected to the front guide 16 and the rear guide 11 respectively, and the drive assembly 7 is disposed within the sliding member 17 and is drively connected to the impeller 5 for driving the impeller 5 to rotate. The actively adjustable assembly 4 drives the sliding member 17 to move axially back and forth through the rotation of the helical member 13, thereby realizing the expansion and contraction of the deformable stent 6, which supports the blood vessel when expanded.

[0044] The adjustable support assembly 2 includes a deformable support 6 and an active adjustment assembly 4. The deformable support 6 is set to wrap around the impeller 5 and is hinged at one end to the guide 16 and at the other end to the sliding member 17. When the sliding member 17 moves back and forth along the axis, it can drive the deformable support 6 to expand and contract through deformation.

[0045] Specifically, the active adjustment component 4 drives the spiral component 13 to rotate forward or reverse so that the sliding component 17 moves back and forth, thereby causing the deformable support 6 to expand or contract.

[0046] In this embodiment, as Figure 1-4As shown, the deformable support 6 is a mesh structure with a cylindrical center and frustum-shaped ends, and is symmetrical about the central plane S; the impeller 5 is located inside the mesh structure. Specifically, the deformable support 6 includes a main support 61, a secondary support 62, a front support leg 63, a circumferential connecting part 64, and a rear support leg 65; one end of the front support leg 63 is connected to one end of the main support 62, and the other end of the front support leg 63 is hinged to the guide 16; one end of the rear support leg 65 is connected to the other end of the main support 61, and the other end of the rear support leg 65 is hinged to one end of the sliding member 17. Among them, the main support 61 and the secondary support 62 provide radial support, equivalent to the cylindrical part, while the front support leg 63 and the rear support leg 65 are equivalent to the frustum part, and their tilt angle can change. In this embodiment, the secondary support portion 62 and the main support portion 61 are arranged alternately at intervals, and the two ends of the secondary support portion 62 are respectively connected to the main support portion 61 through the circumferentially arranged circumferential connecting portion 64. The circumferential connecting portion 64 can be deformed so that the diameter of the cylindrical portion formed by the secondary support portion 62 and the main support portion 61 can be adjusted to achieve expansion or contraction.

[0047] In this embodiment, as Figure 3 and 4 As shown, the front support leg 63 and the rear support leg 65 have the same structure. Specifically, the front support leg 63 includes a first support portion 631, a first deformable portion 632, and a first columnar boss 633. The first support portion 631 is straight, and the first deformable portion 632 is curved and connected to the main support portion 61 and one end of the first support portion 631. The first deformable portion 632 is tangent to the radially inner surface of the main support portion 61. The first columnar boss 633 is located at the end of the first support portion 631 and is hinged to the front guide 16. Specifically, the rear support leg 65 includes a second support portion 651, a second deformable portion 652, and a second columnar boss 653. The second deformable portion 652 is connected to the main support portion 61 and one end of the second support portion 651, respectively. The second deformable portion 652 is tangent to the radially inner surface of the main support portion 61. The second columnar boss 653 is located at the end of the second support portion 651 and is hinged to the sliding member 17.

[0048] When the deformable support 6 expands or contracts, the spiral member 13 drives the sliding member 17 to move along the axis, thereby pushing the second deformable part 652 on the rear support leg 65 to move. Since the front guide 16 is stationary, the bending arc of the first deformable part 632 and the second deformable part 652 gradually increases or decreases synchronously, thereby driving the main support part 61 and the secondary support part 62 to expand or contract.

[0049] In this embodiment, the thickness of the first support portion 631 is half the thickness of the main support portion 61, the thickness of the first deformable portion 632 is half the thickness of the first support portion 631, and the curved edge length of the first deformable portion 632 is 2 / 10 to 3 / 10 of the total length of the front support leg 63. This allows the first deformable portion 632 to achieve large-angle bending, enabling the front support leg 63 to change angles in both the axial and radial directions. Similarly, the thickness of the second support portion 651 is half the thickness of the main support portion 61, the thickness of the second deformable portion 652 is half the thickness of the second support portion 651, and the curved edge length of the second deformable portion 652 is 2 / 10 to 3 / 10 of the total length of the front support leg 63.

[0050] In this embodiment, the main support 61 and the secondary support 62 are straight strips with a cross-section of a square with a side length of 0.1mm-0.2mm, and the long side is distributed along the axial direction; the length of the secondary support 62 is half the length of the main support 61; the main support 61 is arranged at intervals along the circumference, and the number of main support 61 is 10-16; there are two secondary support 62s with a certain axial interval between two adjacent main support 61s, and the number of secondary support 62s is twice that of the main support 61s.

[0051] It should be noted that the two secondary support parts 62 between two adjacent main support parts 61 are provided with a certain axial interval. This arrangement is to avoid interference between the circumferential connecting parts 64.

[0052] In this embodiment, the circumferential connecting portion 64 is S-shaped, with its two curved apexes forming third deformable portions 641. The third deformable portions 641 are connected to the ends of the main support portion 61 or the secondary support portion 62, respectively. The third deformable portion 641 connected to the main support portion 61 is closer to the central plane. The thickness of the third deformable portion 641 is half that of the circumferential connecting portion 64. The length of the curved edge of the third deformable portion 641 is 1 / 10 to 2 / 10 of the total length of the circumferential connecting portion 64. Specifically, one end of the circumferential connecting portion 64 is perpendicularly connected to the axial side of the main support portion 61, and the other end is perpendicularly connected to the axial side of the secondary support portion 62. The end connected to the main support portion 61 is closer to the central plane S. When the deformable bracket 6 expands or contracts, the circumferential connecting portion 64 can adapt to the change in circumferential dimension by changing its axial dimension. Specifically, when the deformable bracket 6 contracts, the axial dimension of the circumferential connecting portion 64 increases, causing the secondary support portion 62 to move away from the central plane S, while simultaneously reducing the circumferential dimension.

[0053] The deformation of the circumferential connecting part 64 mainly occurs at the two third deformation parts 641. The thickness of the third deformation part 641 is half the thickness of the other parts of the circumferential connecting part 64. The curved edge length of the third deformation part 641 is 1 / 10 to 2 / 10 of the total length of the circumferential connecting part 64, which enables the third deformation part 641 to achieve large-angle bending and realize the change of circumferential and axial dimensions of the circumferential connecting part 64.

[0054] In this embodiment, adjacent main support parts 61 and secondary support parts 62 are connected in the circumferential direction by 2-3 circumferential connecting parts 64, which can make the main support parts 61 and secondary support parts 62 bear force evenly and remain stable.

[0055] like Figure 2 , Figure 5 and Figure 6 As shown, the guide 16 is connected to one end of the impeller 5 via the first bearing 14, which constrains the axial displacement of the guide 16. The guide 16 has a bullet-shaped structure. The end of the guide 16 near the impeller is provided with a first connecting groove 161 and a connecting hole 162 in the same number as the main support part 61 along the circumferential direction. The first connecting hole 162 is provided on both sides of the first connecting groove 161. The first connecting hole 162 is used to rotately connect with the first columnar boss 633 of the front support leg 63, so as to realize the hinge between the front support leg 63 and the guide 16, constrain the rotational movement of the guide 16, so that the guide 16 has 0 degrees of freedom. The guide 16 is located at the blood inlet and adopts a streamlined bullet-shaped structure design so that the inflowing blood still has a good velocity vector after flowing through it.

[0056] In this embodiment, the impeller 5 includes a hub 51 and blades 52. An impeller shaft 511 is provided at the end of the hub 51 near the front guide 16, and the impeller shaft 511 is connected to the first bearing 14 to achieve a rotatable connection with the front guide 16. An impeller hole 512 is provided at the end of the hub 51 near the rear guide 11 for connection to the output shaft 73 of the drive assembly 7. To achieve adjustment of the radial dimension of the blades 52, the blades 52 are telescopic blades, and can adopt telescopic structures in the prior art. For example, the blades 52 include a rigid part and a flexible part. The flexible part is fixedly connected to the radially outer end of the rigid part, and the rigid part drives the flexible part to move. The flexible part can deform and fold under pressure and recover its expansion when no external force is applied. Another example is that the blades 52 include a first blade and a second blade. The second blade can slide relative to the first blade, and a spring connects the second blade and the first blade. Under centrifugal force, the blades 52 extend, and under no centrifugal force, the blades 52 contract.

[0057] In this embodiment, the drive assembly 7 includes a motor housing 71 disposed within the pump housing 12 and a micro motor 72 disposed within the motor housing 71. The micro motor 72 has an output shaft 73. The output shaft 73 extends from the micro motor 72, passes through a rear guide 11, and connects to the impeller 5. The rear guide 11 is located at the blood outlet and is used to guide the outflowing blood. Its side profile features a streamlined design, ensuring that the outflowing blood retains a good velocity vector after passing through it. Multiple positioning grooves are provided at the end of the rear guide 11 near the motor housing 71 for positioning and connection with the second bearing 15, the motor 72, the motor housing 71, and the pump housing 12. The rear guide 11 is connected to the output shaft 73 via the second bearing 15, providing support for the output shaft 73. To avoid friction, a gap is left between the rear guide 11 and the impeller 5, and the aperture of the rear guide 11 is slightly larger than the shaft diameter of the output shaft 73.

[0058] like Figure 2 , Figures 5-7 As shown, the sliding member 17 is located inside the pump housing 12 and outside the motor housing 71. The sliding member 17 has a straight tubular structure. A third columnar boss 171 is provided on the inner side of the sliding member 17. The third columnar boss 171 is placed in the helical groove 131 of the helical member 13 located inside the sliding member 17, realizing helical transmission (the principle is similar to existing lead screws and lead screw pairs). A limiting block 172 is provided on the inner side of the sliding member 17, and the limiting block 172 is constrained by the displacement of the pump housing 12 and the helical member 13. A slider 173 is provided on the inner side of the limiting block 172, and a guide groove 711 is provided on the outer side of the motor housing 71. The slider 173 is placed in the guide groove 711 of the motor housing 71, realizing axial sliding constraint. The sliding member 17 has a second connecting groove 174 and a second connecting hole 175 with the same size, number and radial position as the guide 16 on the outer side of the end near the impeller 5, so that the sliding member 17 and the second columnar boss 53 of the rear support leg 65 are connected in a hinged manner.

[0059] like Figure 2 As shown, the pump housing 12 is connected to the rear guide 11. The pump housing 12 is provided with a through groove 121 so that the rear support leg 65 of the connecting sliding member 17 can pass through the inside of the pump housing 12 and thus connect with the main support part 61.

[0060] like Figure 2-7As shown, based on the above description, the position of the guide 16 is fixed, and the sliding member 17 can move along the axial direction. The movement of the sliding member 17 can realize the expansion and contraction of the deformable support 6. Specifically, when the slider 17 moves away from the guide 16, the axial dimension of the front support leg 63 and the rear support leg 65 of the deformable bracket 6 increases and the radial dimension decreases, thereby causing the main support part 61 and the secondary support part 62 to contract inward; when the limiting block 172 of the slider 17 contacts and limits the screw 13, the radial dimension of the deformable bracket 6 reaches its minimum value; when the slider 17 moves closer to the guide 16, the axial dimension of the front support leg 63 and the rear support leg 65 of the deformable bracket 6 decreases and the radial dimension increases, thereby causing the main support part 61 and the secondary support part 62 to expand outward; when the limiting block 172 of the slider 17 contacts the inner side of the pump housing 12 near the guide 16, the radial dimension of the deformable bracket 6 reaches its maximum value; in other embodiments, its reciprocating motion direction can be limited by the length of the guide groove 711.

[0061] It should be noted that when the deformable support 6 is in its natural state, that is, when it is not deformed, its radial dimension should be within the range of adjustment of the dimension during the working process, and should be as close to the middle value as possible, so that the maximum strain generated by the deformable support 6 during the contraction and expansion process is minimized.

[0062] In this embodiment, the spiral component 13 is disposed inside the sliding component 17 and outside the motor sleeve 33 used for conveying motor wires. It can rotate around the motor sleeve 33. One end is in rotatable contact with the outer side of the motor housing 71, and the other end is in rotatable contact with the inner side wall of the pump housing 12. Its axial position is fixed. The outer side of the spiral component 13 is provided with several spiral grooves 131, which form a spiral drive with the third columnar boss 171 of the sliding component 17, thereby realizing the adjustment of the size of the deformable bracket 6 by rotating the spiral component 13, and at the same time realizing self-locking.

[0063] In this embodiment, the sleeve assembly 3 is used to connect the blood pump to the external auxiliary device. It is flexible and includes, from the outside to the inside, a pump housing sleeve 31, a spiral sleeve 32, and a motor sleeve 33. The pump housing sleeve 31 is fixedly connected to the pump housing 12, the spiral sleeve 32 is fixedly connected to the spiral component 13, and the motor sleeve 33 is fixedly connected to the motor housing 71 and communicates with the interior of the motor housing 71. The motor sleeve 33 has a free end for a conductive wire to pass through, supplying power to the micro motor 72. From the outside to the inside, the components are: pump housing sleeve 31, spiral sleeve 32, and motor sleeve 33. To enable the adjustment of the deformable support 6 size by means of the rotation of the spiral sleeve 32, the spiral sleeve 32 needs to be able to rotate relative to the pump housing sleeve 31 and simultaneously drive the spiral component 13 to rotate. At least the spiral sleeve 32 and the pump housing sleeve 31 should have a flexible structure capable of transmitting kinetic energy, such as a hollow flexible shaft structure as used in the prior art. Figure 8As shown, the spiral sleeve 32 includes a first spiral coil 321 and a second spiral coil 322, which are coaxially mounted. Both the first and second spiral coils are formed by spirally winding 4 to 12 flat steel wires around the same axis in parallel. The winding directions of the first and second spiral coils are opposite to each other. The pump casing sleeve 31 includes a third spiral coil 311 and a fourth spiral coil 312, which are coaxially mounted. Both the third and fourth spiral coils are formed by spirally winding 4 to 12 flat steel wires around the same axis in parallel. The winding directions of the third and fourth spiral coils are opposite to each other. The second spiral coil 322 and the third spiral coil 311 are wound in the same direction to ensure that the spiral sleeve and the pump casing sleeve can rotate relative to each other. The spiral sleeve 32 and the pump casing sleeve 31 have the characteristics of high flexibility and the ability to transmit kinetic energy.

[0064] It should be noted that, in order to facilitate the connection of the sleeve assembly 3 with other auxiliary equipment, the spiral sleeve 32 should extend a certain distance beyond the pump casing sleeve 31, and the motor sleeve 33 should extend a certain distance beyond the spiral sleeve 32. When the sleeve assembly 3 transmits kinetic energy, it will bend to a certain extent, so that there is a certain stroke difference between the spiral sleeve 32 and the spiral component 13. However, the mapping relationship between the rotation angle of the spiral sleeve 32 and the rotation angle of the spiral component 13 is fixed and does not affect the adjustment of the spiral component 13.

[0065] like Figure 9 As shown, to facilitate the adjustment of the deformable support 6 size, an active adjustment component 4 is used to drive the spiral sleeve 32 to rotate, thereby achieving size adjustment of the deformable support 6. The active adjustment component 4 includes an outer ring fixing member 41, an inner ring fixing member 42, and a knob 43. The distal end of the outer ring fixing member 41 (the end closer to the guide 16) is provided with an outer ring sleeve 411, which is fixedly connected to the spiral sleeve 32. The inner ring fixing member 42 is located inside the proximal end of the outer ring fixing member 41 (the end away from the guide 16), and the proximal end of the inner ring fixing member 42 is provided with an inner ring sleeve 421, which is fixedly connected to the spiral sleeve 32. The knob 43 is located inside the outer ring fixing member 41, and its axial position is fixed. Its proximal end achieves synchronous rotation with the inner ring fixing member 42 through a keyway or other means. It can be understood that rotating the knob 43 can achieve relative rotation between the spiral sleeve 32 and the pump housing sleeve 31, thereby adjusting the size of the deformable support 6.

[0066] like Figure 9 and Figure 10As shown, the active adjustment component 4 adopts a detachable design and can be manually installed or removed as needed. The surface of the active adjustment component 4 is engraved with markings to facilitate operation. Specifically, the knob 43 is marked with a scale pointer indicating "0-360", the outer ring fixing part 41 is marked with a starting position marking to provide the operator with a reference for the degree of adjustment, and the outer ring fixing part 41 is marked with a rotation direction marking to provide the operator with a reference for the direction of rotation.

[0067] like Figure 11 As shown, it should be noted that the interventional blood pump provided in this embodiment is implanted through the femoral artery, passes through the descending aorta and aortic arch in sequence, and is finally supported on the inner wall of the ascending aorta. The blood is pumped by generating negative pressure through the rotation of the impeller 5. The active adjustment component 4 in this embodiment is located outside the human body during use and is not implanted in the body with the blood pump. In addition, the active adjustment component 4 needs to be zeroed before use. Specifically, when the deformable stent 6 is in its smallest size state, the "0 mark" in the scale pointer is aligned with the starting position mark.

[0068] The interventional blood pump provided in this embodiment can adjust the size of the deformable stent 6 through the active adjustment component 4. The operation process of the interventional blood pump in this embodiment is described in detail below:

[0069] (1) Zero the scale of the active adjustment component 4. Rotate the knob 43 according to the marking in the active adjustment component 4 until the deformable bracket 6 reaches the desired size. Record the number of rotations of the knob 43 and the angle pointed to by the scale pointer during the process.

[0070] (2) The operator rotates the knob 43 according to the markings in the active adjustment component 4 so that the sliding part 17 contacts the screw part 13 so that the radial dimension of the deformable bracket 6 is minimized.

[0071] (3) The operator implants the contracted interventional blood pump from the femoral artery and advances the blood pump along the femoral artery, descending aorta and aortic arch through the cannula assembly 3. The position of the blood pump is monitored in real time with the help of medical imaging until it reaches the working position at the ascending aorta.

[0072] (4) The operator rotates the knob 43 according to the markings on the active adjustment component 4, rotating it the number of turns and angles in step (1), or monitors the size of the deformable stent 6 in real time with the help of medical imaging, so that the deformable stent 6 can support the inner wall of the ascending aorta. After adjustment, the active adjustment component 4 can be selectively removed. If medical imaging is used, step (1) can be skipped.

[0073] (5) After the blood pump is used up, the operator rotates the knob 43 according to the markings in the active adjustment component 4, and rotates the number of turns and the angle obtained in step (1) to make the radial dimension of the deformable support 6 reach its minimum. Then the operator pulls the pump housing sleeve 31 to remove the constricted blood pump along the path of ascending aorta, aortic arch, descending aorta and femoral artery.

[0074] It should be noted that the size of the blades 52 of the impeller 5 can change synchronously with or asynchronously with the deformable stent 6. Furthermore, the motor 82 should start after the deformable stent 6 is supported on the inner wall of the ascending aorta and stop before the deformable stent 6 begins to contract.

[0075] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An interventional blood pump with an actively adjustable stent, characterized in that, include: Pump body and actively adjustable support assembly; The pump body includes: a pump casing, a front guide, a rear guide, a spiral component, a sliding component, a drive assembly, a sleeve assembly, and an impeller. The sliding component is located inside the pump casing. The spiral component is disposed inside the sliding component and threadedly connected to the sliding component. The two ends of the impeller are rotatably connected to the front guide and the rear guide, respectively. The drive assembly is disposed inside the sliding component and is drivenly connected to the impeller. The actively adjustable support assembly includes a deformable support and an actively adjustable component. The deformable support encloses the impeller and is hinged at one end to the guide and at the other end to the sliding member. The actively adjustable component is connected to the helical member via the sleeve assembly. The actively adjustable component drives the helical member to rotate clockwise or counterclockwise, causing the sliding member to reciprocate, thereby expanding or contracting the deformable support. The deformable support is a mesh structure with a cylindrical center and frustum-shaped ends, specifically including a front support leg, a main support portion, a secondary support portion, a rear support leg, and a circumferential connecting portion. One end of the front support leg is connected to one end of the main support portion, and the other end of the front support leg is hinged to the guide. One end of the rear support leg is connected to the other end of the main support portion, and the other end of the rear support leg is hinged to the sliding member. The secondary support... The secondary support and the main support are staggered at intervals, and both ends of the secondary support are connected to the main support through circumferentially connected portions. The front support leg and the rear support leg have the same structure. The front support leg includes a first support, a first deformable portion and a first columnar boss. The first support is straight, the first deformable portion is curved and connected to one end of the main support and the first support, and the first deformable portion is tangent to the radial inner surface of the main support. The first columnar boss is located at the end of the first support and is hinged to the front guide. The rear support leg includes a second support part, a second deformable part, and a second columnar boss. The second deformable part is connected to one end of the main support part and the second support part, respectively. The second columnar boss is located at the end of the second support part and is hinged to the sliding member. When the deformable bracket expands or contracts, the bending arc of the first deformable part and the second deformable part gradually increases or decreases.

2. The interventional blood pump with an actively adjustable stent as described in claim 1, characterized in that: The thickness of the first support part is half the thickness of the main support part, the thickness of the first deformable part is half the thickness of the first support part, and the curved side length of the first deformable part is 2 / 10-3 / 10 of the total length of the front support leg.

3. The interventional blood pump with an actively adjustable stent as described in claim 2, characterized in that: The main support and the secondary support are straight strips with a square cross-section. The length of the secondary support is half the length of the main support. There are 10-16 main support sections. There are two secondary support sections with a certain axial spacing between two adjacent main support sections. The number of secondary support sections is twice that of the main support sections.

4. The interventional blood pump with an actively adjustable stent as described in claim 3, characterized in that: The circumferential connecting part is S-shaped, with its bending apex being the third deformed part. The third deformed part is connected to the end of the main support part or the secondary support part, wherein the third deformed part connected to the main support part is close to the center plane; the thickness of the third deformed part is half of the circumferential connecting part; the length of the curved edge of the third deformed part is 1 / 10 to 2 / 10 of the total length of the circumferential connecting part.

5. The interventional blood pump with an actively adjustable stent as described in any one of claims 2-4, characterized in that: The drive assembly includes a motor housing and a micro motor. The motor housing is disposed within the sliding member. One end of the motor housing is an open end and is connected to the rear guide. The micro motor is disposed within the motor housing. The output shaft of the micro motor rotates through the rear guide and is connected to the impeller. The sliding member has a connecting groove and a connecting hole for hinged connection of the rear support leg at one end near the deformable bracket, and the pump housing has a through groove for the rear support leg to pass through.

6. The interventional blood pump with an actively adjustable stent as described in claim 5, characterized in that: The sleeve assembly includes a motor sleeve, a spiral sleeve, and a pump housing sleeve arranged from the inside out. One end of the motor sleeve is fixedly connected to the motor housing and communicates with the interior of the motor housing, while the other end is a free end for the conductive wire to pass through. One end of the spiral sleeve is fixedly connected to a spiral component, and the other end is fixedly connected to an active adjustment component. The active adjustment component drives the spiral sleeve to rotate, thereby causing the spiral component to rotate. One end of the pump housing sleeve is connected to the pump housing, and the other end is connected to the housing of the active adjustment component.

7. The interventional blood pump with an actively adjustable stent as described in claim 6, characterized in that: The active adjustment component includes an outer ring fixing member, an inner ring fixing member, and a knob. The inner ring fixing member is rotatably disposed within the outer ring fixing member and is used to install the knob. The knob protrudes from the outer ring fixing member. The outer surface of the outer ring fixing member is provided with a starting position mark and a rotation direction mark. The protruding part of the knob is provided with a scale pointer mark.

8. The interventional blood pump with an actively adjustable stent as described in claim 6, characterized in that: The spiral sleeve includes a first spiral coil and a second spiral coil, which are coaxially mounted. Both the first and second spiral coils are made of 4-12 flat steel wires spirally wound side by side around the same axis, and the winding directions of the first and second spiral coils are opposite. The pump casing sleeve includes a third spiral coil and a fourth spiral coil, which are coaxially mounted. Both the third and fourth spiral coils are formed by 4-12 flat steel wires spirally wound side by side around the same axis, and the winding directions of the third and fourth spiral coils are opposite. The second and third spiral coils are wound in the same direction.

Images