Drive shaft support assembly for expandable blood pump

Abstract

A self-expandable blood pump includes a housing, an impeller, and a drive shaft support, assembly. The impeller is operatively connected to a. drive shaft arranged along a longitudinal axis of the housing. The drive shaft support assembly is movably connected to the drive shaft and arranged in the housing. The drive shaft support assembly includes a hub and a plurality of struts. The hub is slidably connected to and surrounding the drive shaft. The plurality of struts extends radially outward from the hub. Each of the plurality of the struts is connected to the housing with a fastener.

Description

DRIVE SHAFT SUPPORT ASSEMBLY FOR EXPANDABLE BLOOD PUMP CLAIM OF PRIORITY

[0001] This application claims the benefit of priority to U.S. Patent Application Serial No. 63 / 688,834, filed on August 29, 2024, which is incorporated by reference herein in its entirety. BACKGROUND

[0002] A blood pump can assist cardiac patients with insufficient blood flow. For example, a Left Ventricular Assist Device (LVAD) can include a blood pump configured to be located at least partially in a left ventricle (LV) of a heart of a patient. One approach to introducing a blood pump into the LV is transapical, that is, via an incision made in an apex region of the heart. Another approach to introducing the blood pump at least partially into the LV is percutaneously and then intravascularly via the aorta.

[0003] A percutaneous ventricular assist device (pVAD) can be used to percutaneously introduce a blood pump through the vasculature into a left ventricle of a patient, such as to help move blood from the left ventricle into the aorta and provide temporary blood circulatory support for patients with weakened or failing hearts. SUMMARY

[0004] This document describes, among other things, a self-expandable blood pump including a housing, an impeller, and a drive shaft support assembly. The impeller is operatively connected to a drive shaft arranged along a longitudinal axis of the housing. The drive shaft support assembly is movably connected to the drive shaft and arranged in the housing. The drive shaft support assembly includes a hub and a plurality of struts. The hub is slidably connected to and surrounding the drive shaft. The plurality of struts extends radially outward from the hub. Each of the plurality of the struts is connected to the housing with a fastener.

[0005] In an example, a self-expandable blood pump includes a housing, an impeller, and a drive shaft support assembly. The impeller is operatively connected to a drive shaft arranged along a longitudinal axis of the housing. The drive shaft support assembly is movably connected to the drive shaft and arranged in the housing. The drive shaft support assembly includes a hub and a plurality of struts. The hub is slidably connected to and surrounding the drive shaft. The plurality of struts extends radially outward from the hub. Each of the plurality of the struts is connected to the housing with a fastener.

[0006] This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0008] FIG. 1 schematically depicts an example blood pump according to this disclosure.

[0009] FIGS. 2A and 2B schematically depict an example drive shaft support / bearing assembly of the blood pump of FIG. 1.

[0010] FIG. 3A is a perspective view depicting another example drive shaft support assembly according to this disclosure.

[0011] FIGS.3B-3D are perspective, side, and end views, respectively, of a hub of the example drive shaft support assembly of FIG. 3A.

[0012] FIGS. 3E and 3F are perspective and side views, respectively, of a bridge the example drive shaft support assembly of FIG. 3A.

[0013] FIGS. 4A-4C are orthogonal section views of another example drive shaft support assembly according to this disclosure.DETAILED DESCRIPTION

[0014] FIG. 1 depicts example blood pump 100, which can be percutaneously and intravascularly introduced toward and extending to a desired location such as into a left ventricle (LV) of a heart of a patient. For example, pump 100 can be delivered to a location that is at or near an aortic valve of the patient’s heart. This can be carried out using a delivery sheath, with portions of blood pump 100 being in a radially or laterally collapsed configuration while in the delivery sheath. When such portions of blood pump 100 are at the desired location, the delivery sheath can be retracted. In response to retracting the sheath, portions of blood pump 100, e.g. the housing and impeller can self-expand, such as before the blood pump is activated. Similarly, for removal of blood pump 100, the delivery sheath can be re-deployed and advanced to allow portions of the pump to become radially or laterally collapsed upon retracting into the delivery sheath or another sheath. This can help assist intravascular removal of such portions of blood pump 100 together with the delivery sheath or other sheath being used for retrieval.

[0015] Example blood pump 100 includes housing 102, drive shaft 104, impeller 106, first bearing 108, second bearing 110, inlet tip assembly 112, and pump axis 114. Housing 102 includes inlet portion 116, throat portion 118, and outlet portion 120. In some examples, the housing of example blood pumps may be alternatively or additionally referred to as a cannula. Inlet tip assembly 112 includes tip portion 122 and support arms 124.

[0016] As described in more detail below, second bearing 110, which is an example of a drive shaft support assembly according to this disclosure, is coupled to and supports drive shaft 104. Second bearing 110 includes hub 130 and a plurality of struts 132. Hub 130 is slidably connected to drive shaft 104 and struts 132 extend radially outward from hub 130 to throat portion 118 of housing 102. The radially outer end of each of struts 132 are fixedly connected to housing 102 by a fastener. For example, the radially outer end of each of struts 132 are sutured to housing 102 by sutures 134. In other examples, the struts of a drive shaft support assembly according to this disclosure can be connected to a pump housing / cannula by other fasteners, including, e.g. rivets and / or staples. For example, a metallic or polymer rivet can fasten the radially outer ends of struts 132 to housing 102. Inanother example, a metallic, including, e.g. nitinol staple can fasten the radially outer ends of struts 132 to housing 102.

[0017] Housing 102 can be fluid-impervious and can define a conduit through which blood flows. In examples, housing 102 can include a self- expandable frame and a cover conforming to the shape of and extending over the frame from the proximal end to inlet end 126 of the housing. For example, housing 102 can include a shape-memory metal or other self-expandable cannula frame or scaffolding connected to or embedded within the fluid-impervious cover. Housing 102 can define a housing inlet 126, from which to receive blood toward inlet end 126 of pump 100, and an opposing or other housing outlet 128, from which to expel blood from outlet end 128.

[0018] Housing 102 of the blood pump 100 can be percutaneously and intravascularly or otherwise implantably introduced to a desired location. In a LVAD configuration, for example, housing end outlet 128 can be located more proximally (toward the aorta) than housing end inlet 126, which can be located more distally (toward but spaced apart from the LV apex). For example, housing 102 of blood pump 100 can be located within at least a portion of an aorta of the patient and within at least a portion of a left ventricle of the patient heart, such as at or near an aortic valve.

[0019] In a Right Ventricular Assist Device (RVAD) configuration, housing end outlet 128 can be located more distally (toward but spaced apart from the Right Ventricle (RV) apex) and housing end inlet 126 can be located more proximally, with appropriate modification such that the drive shaft 104 can instead extend proximally outward from the right side of FIG. 1 in an RVAD configuration. For example, housing 102 of the blood pump 100 can be located within at least a portion of a pulmonary artery of the patient and at least a portion of a right ventricle of the patient heart, such as at or near a pulmonary valve. Housing 102 of the blood pump 100 need not be located within the patient’s heart but can be placed at another location within a patient’s circulatory system that is remote from the patient’s heart, such as in a renal artery of the patient to facilitate blood flow to a kidney of the patient.

[0020] Inlet portion 116 of housing 102 forms a converging nozzle, which defines the inlet of and can advantageously affect blood flow in and throughhousing 102. For example, the converging nozzle form of inlet portion 116 can reduce drag at the inlet of and improve the overall efficiency of pump 100. In an example, inlet portion 116 of housing 102 has a first diameter at a first end of the housing connected to inlet tip assembly 112 and a second diameter less than the first diameter at throat portion 118. Thus, the diameter (or other lateral dimension in other examples) decreases (converges) from the end of housing 102 and inlet portion 116 at inlet 126 to the junction between inlet portion 116 and throat portion 118.

[0021] Inlet portion 116 of housing 102 is connected to inlet tip assembly 112 via support arms 124, which can be distributed circumferentially around housing 102 about axis 114. Tip portion 122 of inlet tip assembly 112 is elongated in a direction generally along / parallel to axis 114. Each of support arms 124 can be S-shaped and connected between tip portion 122 of tip assembly 112 and inlet portion 116 of housing 102.

[0022] Pump 100 can be connected to a motor via drive shaft 104 operatively attached to impeller 106. In examples, impeller 106 can be connected to an impeller shaft, which impeller shaft is operatively connected to drive shaft 104. In an example, drive shaft 104 extends from blood pump 100 through vasculature and out of the body of the patient to connect to an externally located motor. Example blood pump 100 can be operated by energizing the motor to turn drive shaft 104, which, in turn, rotates impeller 106.

[0023] Drive shaft 104, first bearing 108, and second bearing 110 support impeller 106 located at least partially within housing 102. Impeller 106 can include one or more blades extending radially / laterally outward from a central impeller hub, such as in a helically-wound arrangement. Impeller 106 can be located entirely within housing 102, such as between housing inlet 126 and outlet 128. In examples, impeller 106 can be located entirely within housing 102, such as with at least a portion of the impeller extending longitudinally into the outwardly tapering outlet portion 120 of housing 102 without protruding longitudinally beyond an edge of the housing that is adjacent to outlet 128. Housing 102 can define longitudinal pump axis 114, about which impeller 106 (and drive shaft 104) rotates supported on first and second bearings 108, 110.

[0024] Outlet portion 120 of housing 102 can define a fluid-impervious diffuser nozzle extending from throat portion 118. Throat portion 118 of housing 102 can have a relatively constant radial or other similar lateral dimension along its longitudinal extent. By contrast, outlet portion 120 can include a radially outwardly flaring radial or other similar lateral dimension, such as providing an outward flaring in the longitudinal direction along axis 114 in a direction of fluid flow toward outlet 128. Thus, the junction between throat portion 118 and outlet portion 120 can be defined at a location along axis 114 at which there is a transition between: (1) housing 102 having a relatively constant radial or other similar lateral inner dimension; and (2) outlet portion 120 having a radially outwardly flaring radial or other similar lateral inner dimension outward flaring. Although FIG. 1 shows the transition from throat portion 118 to outlet portion 120 as having a piecewise linear radial / lateral dimension as a function of position along axis 114, the transition at this junction need not be so abrupt. For example, the transition from throat portion 118 to outlet portion 120 can be defined by a tangent, or more generally by a fillet, to a more smooth and less abrupt transition in the radial / lateral dimension as a function of position along axis 114.

[0025] FIGS. 2A and 2B schematically depict second bearing 110 and some other portions of pump 100 in a collapsed configuration and an expanded configuration, respectively. In FIG.2A, pump 100 is in a collapsed configuration, for example, before the pump has been delivered to a target location within a body of a patient and been deployed from a delivery system. In the collapsed state of pump 100, each of struts 132 is collapsed radially inward as depicted in FIG. 2A. In the schematically depicted example of FIG. 2A, struts 132 are depicted in a substantially straight, linear shape in the collapsed configuration. However, in other examples, struts 132 can take other shapes as long as the radially outer end of each strut (the end connected to housing 100 by suture 134) is collapsed radially inward relative to strut position in the expanded configuration.

[0026] In FIG. 2B, pump 100 is in an expanded configuration, for example, after the pump has been delivered to the target location and deployed from the delivery system. In the expanded configuration, struts 132 (along with housing 102, which is not shown in FIGS. 2A and 2B) expand radially outward relative to their position in the collapsed configuration and assume an S-shape. Oncondition of radial expansion or contraction of struts 132, hub 130 slides axially on drive shaft 104 while an end of each of struts 132 connected to housing 102 (see FIG.1) with suture 134 remains fixed axially. For example, as pump 100 goes from the collapsed configuration to the expanded configuration, hub 130 slides axially (e.g. in a distal direction or toward inlet end 126) as shown in FIG. 2B.

[0027] FIG. 3A is a perspective view depicting example drive shaft support assembly (DSSA) 300 according to this disclosure. DSSA 300 includes hub 302 and bridge 304. In examples according to this disclosure, hub 302 can include a variety of structures that are configured to support moving contact between hub 302 and a drive shaft of a blood pump, e.g., a collapsible and expandable pVAD. For example, hub 302 can include a variety of types of bearings, including, e.g., ball, roller, and plain bearings. Additionally, hub 302 can include a bushing, e.g, a bushing with a bearing gap that is configured to form a hydrodynamic bearing that can receive a fluid or other lubricant, such as blood, saline, or glucose. In examples, hub 302 includes an elongated annular tube with central bore 306 configured for a sliding and rotational connection with a drive shaft of a pump, e.g., pump 100 of the example of FIG. 1.

[0028] Bridge 304 of example DSSA 300 is connected to hub 302 and configured to be connected to a housing, e.g., a cannula of a blood pump including a pVAD. Bridge 304 includes collar 308 and a plurality of struts 310 extending axially and radially from collar 308. In the example of FIGS. 3A-3F, collar 308 and struts 310 are integral and bridge 304 is thereby formed as a single monolithic component. In other examples according to this disclosure, however, a bridge for connecting a movable drive shaft support hub to a housing of a pump could include a collar and plurality of struts formed as individual and separate components and connected to one another to form the bridge.

[0029] FIGS.3B-3D are perspective, side, and end views, respectively, of hub 302 of example DSSA 300. Referring to FIGS. 3B-3D, hub 302 includes central bore 306, first end 312, second end 314, thru apertures 316, and circumferential channel 318. Each of first end 312 and second end 314 including opposing tapers defining an outer diameter of hub 302 that decreases from circumferential channel 318 toward the respective end. Tapered first end 312 and circumferential channel 318 define first shoulder 320. Tapered second end 314and circumferential channel 318 define second shoulder 322. Referring to FIG. 3D, second shoulder 322 extends radially outward past first shoulder 320 and thus the outer dimeter of hub 302 is greater at second shoulder 322 than at first shoulder 320.

[0030] FIGS.3E-3F are perspective and side views, respectively, of bridge 304 of example DSSA 300. As explained, bridge 304 of example DSSA 300 is a monolithic component including integral collar 308 and struts 310. Struts 310 are distributed circumferentially and extend axially and radially outward from collar 308. Collar 308 includes bore 324 is configured to receive hub 302 of DSSA 300. Each of struts 310 include apertures 326. In the example of FIGS. 3A-3F, each of struts 310 include two apertures 326. In examples according to this disclosure, however, example bridges of a DSSA can include struts with more or fewer apertures. Apertures 326 are configured to receive a fastener, e.g., a suture to fixedly connect the radially outer ends of struts 310 to a housing / cannula of a blood pump, e.g., a pVAD.

[0031] Referring again to FIG. 3A, bridge 304 is configured for an interference fit with hub 302. For example, bridge 304 can be snap fit to hub 302. In examples, the diameter of bore 324 of collar 308 of bridge 304 can be greater than or approximately equal to the diameter of hub 302 at circumferential channel 318 and less than the diameter of hub 302 at first and second shoulders 320 and 322, respectively. Elongated thru apertures 316 provide relief in hub 302 to allow compression of second end 314 and second shoulder 322 such that collar 308 of bridge 304 can snap onto hub 302 and into circumferential channel 318. Additionally, thru apertures 316 provide clearance for and are configured to receive a portion of struts 310 extending from collar 308.

[0032] DSSA 300 is configured to be coupled to and support a drive shaft of a blood pump, e.g. toward a distal end / end of a pVAD within a housing / cannula between inlet and outlet of the pump. Hub 302 is configured to be slidably connected to the drive shaft. Struts 310 extend radially outward from hub 302 to and are configured to be coupled to a portion of the pump housing. Bridge 304 is thereby configured to position hub 302 and the drive shaft of the pump centrally within the housing of the blood pump. The radially outer end of each of struts 310 is configured to be fixedly connected to the pump housing, including, e.g., beingsutured or otherwise fastened or joined or affixed to the housing, such as by passing a suture through a wall of the housing and apertures 326.

[0033] In a similar manner as described with the examples of FIGS. 2A and 2B, portions of example DSSA 300 are configured for radial contraction and expansion, e.g., in a collapsed and expanded configuration of a self-expandable pump to which DSSA 300 is connected. For example, before a pump including DSSA 300 has been delivered to a target location within a body of a patient and been deployed from a delivery system, each of struts 310 can be radially collapsed / contracted inward. And after the pump including DSSA 300 has been delivered to the target location and deployed from the delivery system, struts 310 (along with housing 102, which is not shown in FIGS. 2A and 2B) can expand radially outward relative to their position in the collapsed configuration, which is the condition of struts 310 depicted in FIGS. 3A, 3E, and 3F. struts 132 (along with housing 102, which is not shown in FIGS. 2A and 2B) In the expanded configuration, struts 310 assume an S-shape, as shown in FIGS. 3A, 3E, and 3F. On condition of radial expansion or contraction of struts 310 with DSSA 300 connected to a drive shaft of the pump, hub 302 slides axially on the drive shaft while the end of each of struts 310 including apertures 326 and connected to a housing of the pump remains fixed axially.

[0034] Hub 302 and bridge 304 of DSSA 300 and other example drive shaft support assemblies according to this disclosure can be constructed from a variety of materials. In examples, hub 302 can be constructed from various metals, metal alloys, ceramics, or polymers. In examples, hub 302 can be constructed from polyether ether ketone (PEEK). In examples, bridge 304 can be constructed from various metals or polymers, including various shape-memory materials. In examples, bridge 304 can be constructed from a nickel titanium alloy, sometimes referred to as nitinol.

[0035] In examples, hub 302 functions as a bushing with inner surface 328 (see FIG. 3B) configured as a journal (or plain) or other bearing surface, such as for contact with an outer circumference of the impeller shaft 216. With DSSA 300 included in a blood pump, e.g., a pVAD, a journal bearing gap may be defined between inner surface 328 and the drive shaft of the pump. Such a bearing gap can be sized and configured to facilitate radial motion of the drive shaft supported, inpart, by DSSA 300. The journal bearing gap can provide a specified spacing, such as a diametral clearance between the outer surface of the drive shaft and inner surface 328 of hub 302 can be in a range of about 3 microns to about 20 microns. In an example, the journal bearing gap provides a diametral clearance between the outer surface of the drive shaft and inner surface 328 of hub 302 of about 20 microns. As noted above, the journal bearing gap between inner surface 328 and the drive shaft of the pump can be configured to form a hydrodynamic bearing that can receive a fluid or other lubricant, such as at least one of blood, saline, or glucose.

[0036] In an example, a tubular, e.g., cylindrical bushing liner (not shown) may be added to hub 302, e.g., received by and interference fit into bore 306 of hub 302. In this example, hub 302 can be constructed of PEEK and the bushing liner can be constructed of a ceramic, e.g. a yitrium-stabilized zirconia (YSZ).

[0037] FIGS. 4A-4C are orthogonal section views of another example drive shaft support assembly 400 according to this disclosure. Referring to FIG. 4A, DSSA 400 includes bushing 402, bridge 404, and collar 406. Bridge 404 can include a plurality of struts 408, which can be similar in construction and function to struts 310 of DSSA 300, including apertures 410 at first end 412 configured to receive a fastener, e.g. a suture to fixedly connect first ends 412 of struts 410 to a housing / cannula of a blood pump, e.g., a pVAD. Struts 408 extend axially and radially outward from and are coupled to bushing 402 via collar 406.

[0038] Bushing 402 can include a generally tubular component with first end 414 and second end 416 and a central bore extending longitudinally therebetween. Drive shaft 418 of a pump can be slid into the bore of the bushing 402, such as at first end 414, and can emerge at second end 416. Bushing 402 can include inner surface 420 that can be configured as a journal (or plain) or other bearing surface, such as for contact with an outer circumference of a drive shaft of a pump. Journal bearing gap 422 between the inner surface 420 and drive shaft 418, can be sized and configured to control radial motion of drive shaft 418 within bushing 402. Journal bearing gap 422 can provide a specified spacing, such as a diametral clearance between drive shaft 422 and inner surface 420 of bushing 402, such as a specified spacing that can be in a range of about 0.1 millimeters to about 1.0 millimeters. Journal bearing gap 422 can be configured to form ahydrodynamic bearing that can receive a fluid or other lubricant, such as at least one of blood, saline, or glucose.

[0039] Outer surface 424 of bushing 402 can include a plurality of strut channels 426, each of which can be sized and shaped to receive second end 428 of strut 408 of bridge 404. Strut channels 426 can include a dovetail or other chamfer feature, such as to receive a chamfer or other shaped second end 428 of strut 408, such as to snap-fit or otherwise locate or attach second end 428 to bushing 402.

[0040] Collar 406 can aid in securing or secure second ends 428 of struts 408 to bushing 402. In examples, collar 406 be interference fit with bushing 402 and struts 408, including, e.g. press fit or shrink fit with the bushing and struts. Collar 406 can be configured to apply a radial compressive force around the periphery of the collar, such as to clamp second ends 428 of struts 408 to bushing 402.

[0041] FIGS. 4B and 4C depict an example bushing 402 connected to struts 408 of bridge 404 by collar 406 in more detail. Referring to FIGS. 4B and 4C, strut 408s include T-shaped second ends 428 and bushing 402 includes L- shaped strut channels 426 sized and shaped to receive radially inner legs 430 of T-shaped second ends 428 in radially inwardly extending legs 432 of the L-shaped channels. Collar 406 can be interference fit to bushing 402 over struts 408 and can abut radially outer legs 434 of T-shaped second ends 428 of struts 408.

[0042] Referring again to FIG. 4A, bridge 408 includes struts 408, which can be configured to splay radially outward / laterally away from and axially along central longitudinal axis 436. In examples, struts 408 can be configured to position bushing 402 centrally with respect to an inner wall of a housing of a blood pump, e.g., a pVAD. The example of FIG. 4A contemplates a set of four (1 not shown in the section view) struts 408. In examples, three or more struts 408 can form bridge 406 set to position bushing 402 in a housing of a pump. Each strut 408 can be formed from a biocompatible material, such as at least one of a polymer or metal including a shape-memory material and can be configured to self-expand with a self-expanding pump. In examples, struts 408 can be constructed from a nickel titanium alloy, sometimes referred to as nitinol.

[0043] First end 412 of struts 408 of bridge 404 can be configured to contact or connect to a housing of a pump. First end 412 can include one or more anchor features, such as apertures 326. Apertures 326 of struts 408 or other anchor feature can be affixed to the housing, such as by weld, adhesive, fastener, or other joining means. For example, apertures 326 or other anchor feature can contact the housing and can be sutured or otherwise fastened or joined or affixed to the housing, such as by passing a suture through a wall of the housing and the apertures to couple the first end 412 to the housing.

[0044] DSSA 400 can assume an expanded configuration, such as shown in FIG. 4A. In the expanded configuration, the splayed portion of struts 408 can self-expand to form an angle with respect to the central longitudinal axis 436, such as an acute angle in a range of about 10 degrees to about 45 degrees, or preferably an acute angle of less than 45 degrees, or more preferably an acute angle in a range between 20 degrees and 40 degrees, inclusive,. Such an angle can help facilitate a transition from the expanded configuration into a collapsed configuration, such as for retrieval into a retrieval sheath after use.

[0045] During transition from an expanded configuration to a collapsed configuration (or similarly from the collapsed configuration to the expanded configuration), bushing 402 can translate axially, e.g. slide along drive shaft 418. For example, bushing 402 can move slide with respect to and along drive shaft 418, and bridge 404 can flatten, such as to change from a generally S-shaped body as shown in FIG. 4A to a generally straight body, as the blood pump transitions from the expanded configuration to the collapsed configuration.

[0046] A non-limiting numbered list of certain Aspects of the present disclosure are included below.

[0047] Aspect 1 can include system, device, or method that can include or use a self-expandable blood pump. The pump can include a housing, an impeller, and a drive shaft support assembly. The impeller is operatively connected to a drive shaft arranged along a longitudinal axis of the housing. The drive shaft support assembly is movably connected to the drive shaft and arranged in the housing. The drive shaft support assembly includes a hub and a plurality of struts. The hub is slidably connected to and surrounding the drive shaft. The plurality ofstruts extends radially outward from the hub. Each of the plurality of the struts is connected to the housing with a fastener.

[0048] Aspect 2 can include or use the system, device, or method of Aspect 1, wherein each of the plurality of struts is configured to radially expand and contract.

[0049] Aspect 3 can include or use the system, device, or method of Aspect 1, wherein, each of the plurality of struts extends axially and radially from the hub.

[0050] Aspect 4 can include or use the system, device, or method of Aspect 1, wherein, each of the plurality of struts comprises an S-shape.

[0051] Aspect 5 can include or use the system, device, or method of Aspect 1, wherein, on condition of radial expansion or contraction of the plurality of struts, the hub slides axially on the drive shaft while an end of each of struts connected to the housing with the fastener remains fixed axially.

[0052] Aspect 6 can include or use the system, device, or method of Aspect 1, wherein, the hub comprises a bearing configured for rolling contact with the drive shaft.

[0053] Aspect 7 can include or use the system, device, or method of Aspect 6, wherein, the bearing is offset from the drive shaft by a bearing gap less than or equal to about 20 microns.

[0054] Aspect 8 can include or use the system, device, or method of Aspect 1, wherein, the hub comprises a bushing configured for sliding contact with the drive shaft.

[0055] Aspect 9 can include or use the system, device, or method of Aspect 8, wherein, the bushing is offset from the drive shaft by a bushing gap less than or equal to about 20 microns.

[0056] Aspect 10 can include or use the system, device, or method of Aspect 1, wherein, the fastener comprises a suture, a rivet, or a staple.

[0057] Aspect 11 can include or use the system, device, or method of Aspect 1, wherein, each of the plurality of struts comprises an aperture toward a first end of the strut and wherein each of the plurality of struts is connected to the housing by the fastener through the aperture.

[0058] Aspect 12 can include or use the system, device, or method of Aspect 1, wherein, each of the plurality of struts comprises a pair of axially spaced apertures toward a first end of the strut, wherein the fastener comprises a suture, and wherein each of the plurality of struts is connected to the housing by the suture through the pair of apertures.

[0059] Aspect 13 can include or use the system, device, or method of Aspect 1, wherein, each of the plurality of struts comprises a pair of axially spaced apertures toward a first end of the strut, wherein the fastener comprises a staple, and wherein each of the plurality of struts is connected to the housing by the staple through the pair of apertures.

[0060] Aspect 14 can include or use the system, device, or method of Aspect 1, wherein, the hub comprises a bushing slidably connected to and surrounding the drive shaft and a collar surrounding the bushing; and each of the plurality of struts is connected at a second end of each strut between the bushing and the collar.

[0061] Aspect 15 can include or use the system, device, or method of Aspect 14, wherein, the bushing comprises a plurality of circumferentially distributed axially extending channels into which each of the plurality of struts is respectively received.

[0062] Aspect 16 can include or use the system, device, or method of Aspect 14, wherein, the collar is connected to the drive shaft support with an interference fit.

[0063] Aspect 17 can include or use the system, device, or method of Aspect 16, wherein, the interference fit comprises a press fit or a shrink fit.

[0064] Aspect 18 can include or use the system, device, or method of Aspect 14, wherein, the collar is connected to the drive shaft support with a snap fit.

[0065] Aspect 19 can include or use the system, device, or method of Aspect 1, wherein, the drive shaft support assembly comprises a bridge, the bridge including the plurality of struts and a collar connected to the hub.

[0066] Aspect 20 can include or use the system, device, or method of Aspect 19, wherein, the plurality of struts and the collar of the bridge are an integral monolithic structure.

[0067] Aspect 21 can include or use the system, device, or method of Aspect 20, wherein, the hub comprises a plurality of axially extending thru apertures and a circumferential channel; and the collar is received by the circumferential channel and a portion of each of the thru apertures.

[0068] Aspect 22 can include or use the system, device, or method of Aspect 21, wherein, the collar is snap fit to the hub.

[0069] Aspect 23 can include system, device, or method that can include or use a self-expandable blood pump. The pump can include a housing, an impeller, and a drive shaft support assembly. The impeller operatively connected to a drive shaft arranged along a longitudinal axis of the housing. The drive shaft support assembly movably connected to the drive shaft and arranged in the housing. The drive shaft support assembly can include a hub slidably connected to and surrounding the drive shaft, and a bridge connected to the hub and the housing, the bridge including a collar connected to the hub and a plurality of struts extending radially outward from the hub and the collar. The plurality of struts and the collar are an integral monolithic structure.

[0070] Aspect 24 can include system, device, or method that can include or use drive shaft support assembly configured to be connected to a drive shaft of a self-expandable blood pump. The drive shaft support assembly can include a hub and a bridge. The hub is configured to be slidably connected to and surround the drive shaft. The bridge is connected to the hub and configured to be connected to the housing. The bridge can include a collar connected to the hub and a plurality of struts extending radially outward from the hub and the collar. The plurality of struts and the collar are an integral monolithic structure.

[0071] The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “aspects” or “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0072] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0100] Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0101] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0102] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:

1. A self-expandable blood pump comprising: a housing; an impeller operatively connected to a drive shaft arranged along a longitudinal axis of the housing; and a drive shaft support assembly movably connected to the drive shaft and arranged in the housing, the drive shaft support assembly comprising: a hub slidably connected to and surrounding the drive shaft; and a plurality of struts extending radially outward from the hub, each of the plurality of the struts connected to the housing with a fastener.

2. The blood pump of claim 1, wherein each of the plurality of struts is configured to radially expand and contract.

3. The blood pump of claim 1, wherein each of the plurality of struts extends axially and radially from the hub.

4. The blood pump of claim 1, wherein each of the plurality of struts comprises an S-shape.

5. The blood pump of claim 1, wherein, on condition of radial expansion or contraction of the plurality of struts, the hub slides axially on the drive shaft while an end of each of struts connected to the housing with the fastener remains fixed axially.

6. The blood pump of claim 1, wherein the hub comprises a bearing configured for rolling contact with the drive shaft.

7. The blood pump of claim 6, wherein the bearing is offset from the drive shaft by a bearing gap less than or equal to about 20 microns.

8. The blood pump of claim 1, wherein the hub comprises a bushing configured for sliding contact with the drive shaft.

9. The blood pump of claim 8, wherein the bushing is offset from the drive shaft by a bushing gap less than or equal to about 20 microns.

10. The blood pump of claim 1, wherein the fastener comprises a suture, a rivet, or a staple.

11. The blood pump of claim 1, wherein each of the plurality of struts comprises an aperture toward a first end of the strut and wherein each of the plurality of struts is connected to the housing by the fastener through the aperture.

12. The blood pump of claim 1, wherein each of the plurality of struts comprises a pair of axially spaced apertures toward a first end of the strut, wherein the fastener comprises a suture, and wherein each of the plurality of struts is connected to the housing by the suture through the pair of apertures.

13. The blood pump of claim 1, wherein each of the plurality of struts comprises a pair of axially spaced apertures toward a first end of the strut, wherein the fastener comprises a staple, and wherein each of the plurality of struts is connected to the housing by the staple through the pair of apertures.

14. The blood pump of claim 1, wherein: the hub comprises a bushing slidably connected to and surrounding the drive shaft and a collar surrounding the bushing; and each of the plurality of struts is connected at a second end of each strut between the bushing and the collar.

15. The blood pump of claim 14, wherein the bushing comprises a plurality of circumferentially distributed axially extending channels into which each of the plurality of struts is respectively received.

16. The blood pump of claim 14, wherein the collar is connected to the drive shaft support with an interference fit.

17. The blood pump of claim 16, wherein the interference fit comprises a press fit or a shrink fit.

18. The blood pump of claim 14, wherein the collar is connected to the drive shaft support with a snap fit.

19. The blood pump of claim 1, wherein the drive shaft support assembly comprises a bridge, the bridge including the plurality of struts and a collar connected to the hub.

20. The blood pump of claim 19, wherein the plurality of struts and the collar of the bridge are an integral monolithic structure.

21. The blood pump of claim 20, wherein: the hub comprises a plurality of axially extending thru apertures and a circumferential channel; and the collar is received by the circumferential channel and a portion of each of the thru apertures.

22. The blood pump of claim 21, wherein the collar is snap fit to the hub.

23. A self-expandable blood pump comprising: a housing; an impeller operatively connected to a drive shaft arranged along a longitudinal axis of the housing; and a drive shaft support assembly movably connected to the drive shaft and arranged in the housing, the drive shaft support assembly comprising: a hub slidably connected to and surrounding the drive shaft; anda bridge connected to the hub and the housing, the bridge including a collar connected to the hub and a plurality of struts extending radially outward from the hub and the collar, wherein the plurality of struts and the collar are an integral monolithic structure.

24. A drive shaft support assembly configured to be connected to a drive shaft of a self-expandable blood pump, the drive shaft support assembly comprising: a hub configured to be slidably connected to and surround the drive shaft; and a bridge connected to the hub and configured to be connected to the housing, the bridge including a collar connected to the hub and a plurality of struts extending radially outward from the hub and the collar, wherein the plurality of struts and the collar are an integral monolithic structure.

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