Impeller blood pumps, transcatheterly implantable medial devices, and related methods

Abstract

An impeller blood pump, including: an impeller rotatably mounted by first and second bearings, each bearing having a respective adjustable bearing gap. The bearing gaps are adjustable by engagement of a pump body, an impeller shroud, and / or a bearing support element. The impeller receives torque via a magnetic coupling. Methods of adjusting the bearing gaps. A transcatheterly implantable medical device, including: an operable medical device component, a driveline configured for the operable medical device component to be operated therethrough, and an extension configured to be coupled to the driveline. The extension is removable from the driveline or is splitable into two segments thereof. Methods of implanting, explanting, and replacing a transcatheterly implantable medical device, each method relying on two subject's intracorporeal access.

Description

[0001] IMPELLER BLOOD PUMPS, TRANSCATHETERLY IMPLANTABLE MEDIAL DEVICES,

[0002] AND RELATED METHODS

[0003] FIELD

[0004] [1] This disclosure relates to impeller blood pumps, transcatheterly implantable medical devices, and related methods.

[0005] BACKGROUND

[0006] [2] Mechanical circulatory support devices, such as impeller blood pumps, have emerged as novel treatment avenues to improve heart functions and have tremendously improved the quality of life of patients.

[0007] [3] Over the years, multiple designs of impeller blood pumps have been developed; however, it remains challenging to develop such pumps that notably generate sufficient blood flow to provide appropriate hemodynamic support without causing adverse blood damage(s), such as hemolysis, and / or thrombosis.

[0008] [4] Besides, it is desirable to be able to implant, explant, or replace blood pumps in patients in an effective manner in the context of complex or life-threatening medical procedures.

[0009] [5] There is therefore a need for improvement(s) in the field of blood pumps, including impeller blood pumps.

[0010] SUMMARY

[0011] [6] A first aspect on this disclosure is directed to an impeller blood pump, including: an impeller having a first end portion and a second end portion; a first bearing configured for the first end portion of the impeller to be rotatably mounted thereto, the first bearing having an impeller bearing portion and a pump bearing portion defining a first bearing gap therebetween; a second bearing configured for the second end portion of the impeller to be rotatably mounted thereto, the second bearing having an impeller bearing portion and a pump bearing portion defining a second bearing gap therebetween, the first bearing and the second bearing together defining a rotation axis; a pump body configured to support the pump bearing portion of the first bearing; an impeller housing configured to receive the impeller therein and to engage the pump body; the impeller housing defining a first pump port, a second pump port, and a pump passage extending between the first pump port and the second pump port; a bearing support element configured to support the pump bearing portion of the second bearing and to engage the impeller housing; and a driven magnet member associated with the impeller and configured to magnetically couple a driving magnet member rotatably coupled to a drive unit for rotating the impeller and generating a pump flow.

[0012] [7] A second aspect on this disclosure is directed to a transcatheterly implantable medical device, including: an operable medical device component configured to be operated in a subject’s body; a driveline configured for the operable medical device component to be operated therethrough; and an extension configured to be coupled to the driveline.

[0013] [8] A third aspect on this disclosure is directed to a method of adjusting a bearing gap of a bearing of an impeller blood pump, the method including: engaging at least one of a pump body and a bearing support element with an impeller housing; and moving at least one of the pump body, the bearing support element, and the impeller housing relative to each other to adjust at least one of a first bearing gap defined between the pump body and an impeller, and a second bearing gap defined between the impeller and the bearing support element.

[0014] [9] A fourth aspect on this disclosure is directed to a method of adjusting a bearing gap of a slidable bearing of an impeller blood pump, the method including: operating an impeller blood pump such that a rotation of an impeller thereof, which is rotatably mounted to the slidable bearing, causes the slidable bearing to slide to adjust the bearing gap thereof.

[0015]

[0010] A fifth aspect on this disclosure is directed to a method of implanting a transcatheterly implantable medical device in a subject’s body, the method including: advancing the transcatheterly implantable medical device through a first subject’s intracorporeal access, in the subject’s body, and up to a second subject’s intracorporeal access; externalizing an externalizable portion of the transcatheterly implantable medical device through the second subject’s intracorporeal access; and manipulating the extemalizable portion externalized through the second subject’s intracorporeal access to implant the transcatheterly implantable medical device in the subject’s body.

[0016]

[0011] A sixth aspect on this disclosure is directed to a method of explanting a transcatheterly implantable medical device from a subject’s body, the method including: advancing a medical capture instrument through a first subject’s intracorporeal access, in the subject’s body, and up to the transcatheterly implantable medical device; the transcatheterly implantable medical device being implanted in the subject’s body with an extemalizable portion thereof externalized through a second subject’s intracorporeal access; capturing the transcatheterly implantable medical device with the medical capture instrument; and manipulating a portion of the medical capture instrument externalized through the first subject’s intracorporeal access to explant the transcatheterly implantable medical device from the subject’s body.

[0017]

[0012] A seventh aspect on this disclosure is directed to a method of replacing a transcatheterly implantable medical device in a subject’s body, the method including: coupling an extender to an externalizable portion of the transcatheterly implantable medical device; the transcatheterly implantable medical device being implanted in the subject’s body with the extemalizable portion externalized through a first subject’s intracorporeal access; advancing a medical capture instrument through a second subject’s intracorporeal access, in the subject’s body, and up to the transcatheterly implantable medical device; capturing the transcatheterly implantable medical device with the medical capture instrument; manipulating a portion of the medical capture instrument externalized through the second subject’s intracorporeal access to explant the transcatheterly implantable medical device from the subject’s body; uncoupling the extender from the externalizable portion of the transcatheterly implantable medical device; coupling the extender to an externalizable portion of a replacement transcatheterly implantable medical device; and manipulating a portion of the extender externalized through the first subject’s intracorporeal access to implant the replacement transcatheterly implantable medical device in the subject’s body.

[0013] Features and advantages of the disclosed subject-matter will become apparent in view of the following detailed description of selected embodiments, as illustrated in the accompanying drawings.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019]

[0014] In order that this disclosure be readily understood, at least some selected embodiments thereof are illustrated by way of example(s) in the accompanying drawings. Accordingly, the accompanying drawings are illustrative in nature only and are not intended to be construed and interpreted as limiting the extent of the subject-matter protected by the claims.

[0020]

[0015] It is noted that like reference numerals identify similar or equivalent elements and / or features throughout the drawings. If present in the claims, reference numerals are provided only to make claims easier to comprehend and are not intended to be construed and interpreted as limiting the extent of the subject-matter protected by the claims. The elements and / or features illustrated throughout the drawings are not necessarily drawn to scale.

[0021]

[0016] To help understand the drawings, item(s) or components that is / are optional may be generally represented by dashed lines.

[0022]

[0017] FIG. 1 is a schematic representation of an impeller blood pump, in accordance with a first aspect of this disclosure.

[0023]

[0018] FIG. 2 is a partial exploded side view of an impeller blood pump, such as one of FIG. 1 showing an impeller and a bearing support element thereof, in accordance with one or more embodiments.

[0024]

[0019] FIG. 3 is a side view of the impeller blood pump of FIG. 2 that is assembled, in accordance with one or more embodiments.

[0025]

[0020] FIG. 4 is a side view of the impeller blood pump of FIG. 3 showing notably an adjustable engagement between an impeller housing and a pump body thereof and another adjustable engagement between the impeller housing and a bearing support element thereof, in accordance with one or more embodiments. The impeller housing is illustrated in dotted lines as a way to see through it.

[0026]

[0021] FIG. 5 is a longitudinal cross-section perspective side view of the impeller blood pump of FIG. 3 showing notably a first bearing gap and a second bearing gap, in accordance with one or more embodiments. The impeller housing is omitted for the sake of clarity.

[0027]

[0022] FIG. 6 is a top view of the impeller blood pump of FIG. 3 showing an impeller housing thereof being mechanically deformed for an adjustable interference fit engagement with a bearing support element of the impeller blood pump, in accordance with one or more embodiments.

[0028]

[0023] FIG. 7 is a perspective top view of an impeller blood pump, such as one of FIG. 1, showing an impeller housing and a bearing support element thereof configured for an adjustable screwable engagement with the impeller housing, in accordance with one or more embodiments.

[0029]

[0024] FIG. 8 is a perspective side view of an impeller blood pump, such as one of FIG. 1, showing an impeller housing and a pump body thereof configured for an adjustable interference fit engagement with the impeller housing, in accordance with one or more embodiments. The impeller is omitted for the sake of clarity.

[0030]

[0025] FIG. 9 is a perspective side view of an impeller blood pump, such as one of FIG. 1, showing an impeller housing and a pump body thereof configured for an adjustable screwable engagement with the impeller housing, in accordance with one or more embodiments. The impeller is omitted for the sake of clarity.

[0031]

[0026] FIG. 10 is a perspective top view of a ball bearing portion, for example for an impeller blood pump of FIG. 1, in accordance with one or more embodiments.

[0032]

[0027] FIG. 11 is a perspective top view of a socket bearing portion, for example for an impeller blood pump of FIG. 1, in accordance with one or more embodiments.

[0033]

[0028] FIG. 12 is a top view of another ball bearing portion, for example for an impeller blood pump of FIG. 1, in accordance with one or more embodiments.

[0029] FIG. 13 is a top view of still another ball bearing portion, for example for an impeller blood pump of FIG. 1, in accordance with one or more embodiments.

[0034]

[0030] FIG. 14 is a side view of yet another ball bearing portion, for example for an impeller blood pump of FIG. 1, in accordance with one or more embodiments.

[0035]

[0031] FIG. 15 is a longitudinal cross-section side view of the impeller blood pump, such as one of FIG. 1, showing notably a first slidable bearing and a second slidable bearing, in accordance with one or more embodiments. The impeller housing is omitted for the sake of clarity.

[0036]

[0032] FIG. 16 is a longitudinal cross-section side view of the impeller blood pump of FIG. 15 showing a sliding action, in accordance with one or more embodiments. The impeller housing is omitted for the sake of clarity.

[0037]

[0033] FIG. 17 is a longitudinal cross-section side view of the impeller blood pump of FIG. 15 showing another sliding action, in accordance with one or more embodiments. The impeller housing is omitted for the sake of clarity.

[0038]

[0034] FIG. 18 is a side view of the impeller housing of the impeller blood pump of FIG. 3 showing arms and ports thereof, in accordance with one or more embodiments.

[0039]

[0035] FIGS. 19-20 are side views of the impeller housing of the impeller blood pump of FIG. 3 showing arms and fins thereof, in accordance with one or more embodiments.

[0040]

[0036] FIG. 21 is a perspective top view of an impeller blood pump, such as one of FIG. 1, showing a bearing support element thereof, in accordance with one or more embodiments.

[0041]

[0037] FIG. 22 is a side view of an impeller blood pump, such as one of FIG. 1, showing an anchor thereof, in accordance with one or more embodiments.

[0042]

[0038] FIG. 23 is a longitudinal cross-section side view of the impeller blood pump of FIG. 3 showing notably washout blades and washout ports, in accordance with one or more embodiments.

[0039] FIG. 24 is a longitudinal cross-section perspective side view of the impeller blood pump of FIG. 3 showing notably a pump flow and a washout flow for a fluid, in accordance with one or more embodiments.

[0043]

[0040] FIG. 25 is a perspective top view of the impeller of the impeller blood pump of FIG. 3 showing notably a washout blades and washout ports for a fluid, in accordance with one or more embodiments.

[0044]

[0041] FIGS. 26-29 are schematic representations of a transcatheterly implantable medical device, such as the one of FIG. 1, in accordance with a first aspect of this disclosure and one or more embodiments.

[0045]

[0042] FIGS. 30-31 are schematic representations of the transcatheterly implantable medical device of FIGS. 26-27 provided with a slidable coupling, in accordance with one or more embodiments.

[0046]

[0043] FIGS. 32-33 are schematic representations of the transcatheterly implantable medical device of FIGS. 26-27 provided with a compressible coupling, in accordance with one or more embodiments.

[0047]

[0044] FIG. 34 is a schematic representation of a method of adjusting a gap of a bearing of an impeller blood pump, such as one of FIG. 1, in accordance with a third aspect of this disclosure.

[0048]

[0045] FIG. 35 is a schematic representation of a method of adjusting at least one bearing gap of at least one slidable bearing of an impeller blood pump, such as one of FIG. 1, in accordance with a fourth aspect of this disclosure.

[0049]

[0046] FIGS. 36-38 are schematic representations of a method of implanting a medical device, such as the impeller blood pump of FIG. 1, in a subject’s body, in accordance with a fifth aspect of this disclosure.

[0047] FIGS. 39-41 are schematic representations of a method of explanting an implanted medical device, such as the impeller blood pump of FIG. 1, from a subject’s body, in accordance with a sixth aspect of this disclosure.

[0050]

[0048] FIGS. 42-46 are schematic representations of a method of replacing an implanted medical device, such as the impeller blood pump of FIG. 1, in a subject’s body, in accordance with a seventh aspect of this disclosure.

[0051] DETAILED DESCRIPTION

[0052]

[0049] The subject-matter of this disclosure is described and explained in the following detailed description with reference to the non-limiting aspect(s), embodiment(s), example(s), feature(s), element(s), step(s), and / or other piece(s) of information presented herein and illustrated in the accompanying non-limiting drawings and / or figures, as the case may be. Recognizing that the foregoing may vary, the skilled addressee shall readily appreciate that any other variants thereof as well as any combination of these other variants are contemplated without departing from the scope of this disclosure, even if not explicitly disclosed herein.

[0053]

[0050] The explicit and implicit content of this disclosure are intended merely for the purpose of understanding one or more ways in which the subject-matter claimed herein may be reduced to practice by the skilled addressee. Therefore, the explicit and implicit content of this disclosure shall not to be construed as limiting the scope of the subject-matter claimed herein which scope is defined solely by the accompanying claims and applicable law.

[0054]

[0051] Similarly, the terminology used herein is merely for the purpose of describing and explaining the subject-matter claimed and is not intended to limit the scope thereof. Unless defined otherwise, all technical, engineering, scientific, and other relevant terminology used herein have the same meanings as commonly understood by the skilled addressee.

[0055]

[0052] With the foregoing in mind, some embodiments of this disclosure relate, for example, to an impeller blood pump (also referred to herein as a “transcatheterly implantable medical device”) that includes an impeller rotatably supported by two bearings. Each of the two bearings is formed by two respective bearing portions. At least one of the two bearings defines a gap between the two respective bearing portions thereof. The impeller blood pump is configured such that the gap is adjustable, for example, to provide for a hydrodynamic gap. As it will be described herein, the gap may be adjusted, for example, by at least one of the bearing portions being slidable and / or by a bearing support element that may be adjustably engageable with an impeller housing of the impeller blood pump.

[0056]

[0053] Relatedly, some other embodiments of this disclosure relate, for example, to methods of adjusting a gap defined by two bearing portions of an impeller blood pump. Still some other embodiments of this disclosure relate, for example, to methods of transcatheterly implanting and transcatheterly explanting an impeller blood pump, or any other medical device, to and from a subject’s body, respectively. Yet some other embodiments of this disclosure relate, for example, to a method of transcatheterly replacing an impeller blood pump, or any other medical device, in a subject’s body.

[0057]

[0054] At a high level, referring to FIG. 1, there is schematically illustrated an impeller blood pump 100 (which may also be referred to herein as an impeller medical device) that includes a driven magnet member 102 associated with an impeller 104 (which may also be referred to herein as a “propeller”) which is at least partially receivable in an impeller housing 106 and rotatably supported therein by a first bearing 108 and a second bearing 110 between a pump body 112 and a bearing support element 114, according to a first aspect of this disclosure. The first bearing 108 is formed by corresponding pump bearing portion 116 and impeller bearing portion 118, and the second bearing 110 is formed by corresponding pump bearing portion 120 and impeller bearing portion 122.

[0058]

[0055] The impeller blood pump 100 may optionally include a driveline 126 configured to supply energy to the impeller blood pump 100 for rotating the impeller 104.

[0059]

[0056] The impeller blood pump 100 may also optionally include a drive unit 128 configured to be supplied in energy by the driveline 126 and to rotatably couple a driving magnet member 130. The driving magnet member 130 is magnetically couplable to the driven magnet member 102 for rotating the impeller 104.

[0060]

[0057] The impeller blood pump 100 may still optionally include an anchor 132 for anchoring the impeller blood pump 100 in a subject’s body.

[0061]

[0058] The impeller blood pump 100 may yet optionally include a capture element 134 provided to the impeller housing 106, a capture element 136 provided to the bearing support element 114, and / or a capture element 138 provided to the anchor 132 (also referred to herein as a “capturable element 134, 136, or 138”). The capture elements 134, 136, 138 are capturable by a medical capture instrument (not shown), such as a medical snare and the like, for implanting, explanting, or replacing the impeller blood pump 100 in a subject’s body by manipulation of the medical capture instrument capturing the same(s). It will be noted that optional items are represented by dashed lines in FIG. 1.

[0062]

[0059] With reference to FIGS. 2-25, the impeller blood pump 100 will be described herein, according to embodiments. FIG. 2 illustrates the impeller blood pump 100 with both the impeller 104 and the bearing support element 114 unassembled therefrom, according to one or more embodiments.

[0063]

[0060] In particular, the pump body 112 has a first end portion 200 having the driveline 126 projecting therefrom, and a second end portion 202 engaged with the first end portion 202 of the impeller housing 106 such that the driving magnet member 130 and the pump bearing portion 116 of the first bearing 108 are received therein. The second end portion 204 of the pump body 112 and the first end portion 206 of the impeller housing 106 may be non-adjustably, fixedly engageable to each other or may be adjustably engageable to each other, as described herein. It will be noted that the impeller bearing portion 118 of the first bearing 108 is hidden by the impeller 104 in FIG. 2 and thus not visible. Being located inside a cavity 208 extending partially between the first end portion 210 and the second end portion 212 of the impeller 104, the impeller bearing portion 118 of the first bearing 108 is not readily visible in FIG. 2 (the impeller bearing portion 118 is best shown in FIG. 5, for example)

[0061] The second end portion 202 of the impeller housing 106 is configured to engage the bearing support element 114, such that the impeller blood pump 100 may be assembled with the impeller 104 received in the impeller housing 106 between the pump body 112 and the bearing support element 114, as illustrated in one or more embodiments of FIGS. 3-4. As illustrated, the bearing support element 114 includes a hub 400 and three arms 402, 404, 406 (only the arms 402, 404 are shown in FIG. 4; the arms 402, 404, 406 are best shown in FIG. 6) linked to the hub 400. Alternatively, the bearing support element 114 may include two or more such arms. The second end portion 202 of the impeller housing 106 and the bearing support element 114 may be non- adjustably, fixedly engageable to each other or may be adjustably engageable to each other, as described herein. The arms 402, 404, 406 of the bearing support element 114 may be fins that are configured to generate a pump flow that is laminar or laminar-like flow.

[0064]

[0062] FIG. 5 illustrates the impeller 104 rotatably mounted to and between the first and second bearings 108, 110, which together define a rotation axis 500 about which the impeller may rotate in any rotational direction (represented by two curved bold arrows in FIG. 5), according to one or more embodiments.

[0065]

[0063] The first bearing 108 is disposed generally between the pump body 112 and the impeller 104 inside the cavity 208 thereof. The pump bearing portion 116 of the first bearing 108 is received to a projecting end portion 502 of the driving magnet member 130, and the impeller bearing portion 118 of the first bearing 108 is received generally to the first end portion 210 of the impeller 104. The pump and impeller bearing portions 116, 118 of the first bearing 108 define a first bearing gap 504 therebetween (indicated by a dashed line circle 504 in FIG. 5 since such gap is not readily apparent at this scale).

[0066]

[0064] The second bearing 110 is disposed between the impeller 104 and the bearing support element 114. The impeller bearing portion 120 of the second bearing 110 is received to the second end portion 212 of the impeller 104, and the pump bearing portion 122 of the second bearing 110 is received to the bearing support element 114. The impeller and pump bearing portions 120, 122 of the second bearing 110 define a second bearing gap 506 therebetween (also indicated by a dashed line circle 506 in FIG. 5 since such gap is not readily apparent at this scale).

[0065] FIG. 5 further illustrates the driving magnet(s) 508 of the driving magnet member 130 that is rotatably coupled to the drive unit 128 present in the pump body 112, and the driven magnet 510 of the driven magnet member 102 which defines the cavity 208 that receives the driving magnet member 130 therein, according to one or more embodiments. The driving and driven magnet members 130, 102 define a magnetic coupling gap 512 (represented by two dotted line rectangles 512) and are radially magnetically coupled together. As illustrated, the magnetic coupling gap 512 is part of the cavity 208.

[0067]

[0066] Alternatively, the driving and driven magnet members 130, 102 may be axially magnetically coupled to each other, i.e. in the same direction as the rotation axis 500. In particular, the driving and driven magnet member 130, 102 may be configured as a hydrodynamic thrust bearing (not shown) that support at least partially the thrust force generated by the impeller 104 in operation. Each of the driving and driven magnet member 130, 102 may be configured as a respective disk, which at least one of the disk having fin(s) configured to move blood into an axial magnetic gap thereof. In this case, the first bearing 108 may be optional.

[0068]

[0067] The impeller housing 106 and the bearing support element 114 may or may not be adjustably engageable to each other. When adjustably engageable, one or both of the first and second bearing gaps 504, 506 may be adjusted. In particular, the relative longitudinal adjustment between the impeller housing 106 and the bearing support element 114, as represented by a doubleheaded bold arrow 600 referring back to FIG. 4, causes the first and second bearing gaps 504, 506 to be adjusted as well.

[0069]

[0068] The impeller housing 106 and the bearing support element 114 may be configured to adjustably engage each other by an adjustable interference fit engagement. As illustrated in FIG. 6, the impeller housing 106 may be mechanically deformed by the application of one or more external forces thereto, such as by three opposing force(s) (each represented by a respective bold arrow) applied transversally to the impeller housing 106, according to one or more embodiments. So deformed, the bearing support element 114 may be inserted in the impeller housing 106 and moved therealong. This movement (as represented by the double-headed bolt arrow 600 referring back to FIG. 4) enables the bearing support element 114 to be longitudinally positioned in the impeller housing 106 along the second end portion 202 thereof before the force constraint s) is / are released to immobilize the bearing support element 114 relative to the impeller housing 106.

[0070]

[0069] The impeller housing 106 may be mechanically deformable into a shape that is complementary to the shape of the bearing support element 114. As further illustrated in FIG. 6, the impeller housing 106 is mechanically deformed into a shape having three bulged portions 602, 604, 606 (somewhat similar to the outer periphery of a Borromean-like shape) into which corresponding arms 402, 404, 406 of the bearing support element 114 are received, according to one or more embodiments. To this end, the impeller housing 106 may be made of any deformable material, such as titanium, stainless steel, polymers, and the like.

[0071]

[0070] The impeller housing 106 may be mechanically deformable into any shape that is complementary to the shape of any bearing support element, including anyone having any number of arms, without departing from the scope of this disclosure. For example, one or more external forces may be applied to the impeller housing 106 to mechanically deform the same into an ovaloid shape that is complementary to a bearing support element having only two arms. One or more external forces may be applied to the impeller housing 106 to mechanically deform the same into a star-like shape that is complementary to a bearing support element having more than three arms.

[0072]

[0071] The adjustable interference fit engagement may be achieved without mechanically deforming the impeller housing 106 by external force(s) since the bearing support element 114 may be insertable in the impeller housing 106 by pression for this purpose. However, deforming the impeller housing 106 advantageously facilitates a precise and accurate positioning and adjustment of the bearing support element 114 by reducing or eliminating the friction forces that opposes the longitudinal movement of the bearing support element 114 along the impeller housing 106, as the case may be.

[0073]

[0072] Alternatively, the impeller housing 106 may include the arms 402, 404, 406, which are adjustably engageable by interference fit with the hub 400 of the bearing support element 114, with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable.

[0073] The impeller housing 106 and the bearing support element 114 may also be configured to adjustably engage each other by an adjustable screwable engagement. As illustrated in FIG. 7, the bearing support element 114 includes a ring 700 provided with a thread 702 and linked by the three arms 402, 404, 406 (only the arms 402, 404 are shown in FIG. 7), at the circumferential end portions 702, 704, 706 thereof (only the circumferential end portions 702, 704 are shown in FIG. 7). The second end portion 202 of the impeller housing 106 includes a corresponding thread 708 that is adjustably engageable with the thread 702 of the bearing support element 114, according to one or more embodiments. Alternatively, each of the arms 402, 404, 406 may be provided, at a respective circumferential end portions 702, 704, 706 thereof, with a respective thread (not shown) that is adjustably engageable with the thread 708 of the impeller housing 106. With the threads of the bearing support element 114 and the impeller housing 106 inter-engaged, rotation of the impeller housing 106 and / or the bearing support element 114 relative to each other moves (as represented by the double-headed bold arrow 600 referring back to FIG. 4) and positions the bearing support element 114 (as represented by a double-headed bold arrow 710 in FIG. 4) in the impeller housing 106 along the second end portion 202 thereof.

[0074]

[0074] The impeller housing 106 and the pump body 112 may or may not be adjustably engageable to each other. When adjustably engageable, one or both of the first and second bearing gaps 504, 506 may be adjusted. In particular, the relative longitudinal adjustment between the impeller housing 106 and the pump body 112, as represented by the double-headed bold arrow 710 referring back to FIG. 4, causes the first and second bearing gaps 504, 506 to be adjusted as well.

[0075]

[0075] The impeller housing 106 and the pump body 112 may be configured to adjustably engage each other by an adjustable interference fit engagement, as similarly described herein. As illustrated in FIG. 8, an engagement portion 800 of the pump body 112, which is adjacent to the driving magnet member 130, is configured to adjustably engage by interference fit a corresponding engagement portion 802 at the first end portion 206 of the impeller housing 106, according to one or more embodiments. So engaged, the first end portion 206 of the impeller housing 106 may be moved (as represented by the double-headed bold arrow 710 in FIG. 4) relative to the pump body 112. This movement enables the engagement portion 800 of the pump body 112 and the engagement portion 802 of the impeller housing 106 to be longitudinally positioned relative to each other. The engagement portion 800 may be disposed anywhere on the pump body 112 such that the driving magnet member 130 and the pump bearing portion 116 of the first bearing 108 may be received more or less far in the impeller housing 106 depending on this disposition.

[0076]

[0076] The impeller housing 106 is not necessarily required to be mechanically deformed, as described herein in relation to FIG. 6, to adjustably engage the engagement portion 800 since the engagement portion 800 may be insertable in the impeller housing 106 by pression. However, the impeller housing 106 may be deformed to adjustably engage the engagement portion 800 therewith, which may provide for a stronger interference fit engagement upon release of the constraint force used for deformation. In this case, for example, the engagement portion 800 may have any shape, such as a Borromean-like shape, an ovaloid shape, a star-like shape, and accordingly the impeller housing 106 may be deformed is a complementary shape, as described herein.

[0077]

[0077] The impeller housing 106 and the pump body 112 may also be configured to adjustably engage each other by an adjustable screwable engagement, as similarly described herein. As illustrated in FIG. 9, the engagement portion 800 of the pump body 112 includes a thread 900, while the engagement portion 802 of the impeller housing 106 includes a corresponding thread 902 that is adjustably engageable with the thread 900, according to one or more embodiments.

[0078]

[0078] Adjustably engageable or not, the engagement portion 800 and the second end portion 204 of the pump body 112 as well as the first end portion 206 and the engagement portion 802 of the impeller housing 106 are configured so that there is no recess defined therebetween. Such recess may create a zone of blood stagnation that may induce thrombogenesis during operation of the impeller blood pump 100.

[0079]

[0079] The impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be adjustably engaged to each other in various ways without departing from the scope of the present disclosure.

[0080]

[0080] For example, the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be engaged, adjusted, and crimped or swagged relative to each other. Such crimped or swagged engagement may provide for an interference fit engagement in which the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be moved relative to each other to frictionally adjust the position of the same.

[0081]

[0081] The impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be engaged, adjusted, and glued relative to each other. The glue may be a permanent glue or a glue that may be removed to adjust or re-adjust the position of the same. Then, the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be re-engaged and reglued to each other.

[0082]

[0082] The impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be heated to expand its / their cross-sectional size(s), and then engaged and adjusted relative to each other. Cooling down the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may provide for an interference fit engagement in which the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be moved relative to each other to frictionally adjust the position of the same.

[0083]

[0083] The impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be engaged and adjusted relative to each other. Then, heating the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may heat shrink the same and provides for an interference fit engagement in which the impeller housing 106 and the bearing support element 114 and / or the pump body 112 may be moved relative to each other to frictionally adjust the position of the same.

[0084]

[0084] Although, as illustrated herein, the impeller housing 106 may be adjustably engaged with the bearing support element 114 and / or the pump body 112 by being received therein, the impeller housing 106 may be adjustably engageable with the bearing support element 114 and / or the pump body 112 by being received in the bearing support element 114 and / or the pump body 112.

[0085]

[0085] The impeller blood pump 100 may include a locking mechanism for preventing the repositioning and de-adjustment of the bearing support element 114 and / or the engagement portion 800 of the pump body 112 relative to the impeller housing 106 when adjustably engaged to each other, for example by the adjustable interference fit engagement and the adjustable screwable engagement. For example, as illustrated referring back to FIG. 8, the impeller housing 106 may define at least one hole 804 at each of the first and second end portions 206, 202 thereof. Each hole 804 is configured to receive a corresponding set pin or set screw (not shown) therethrough that abuts the engagement portion 800 of the pump body 112 and the bearing support element 114, respectively, to prevent the re-positioning and de-adjustment of the same.

[0086]

[0086] Also, to facilitate the positioning or the reproducibility of positioning of the engagement portion 800 of the pump body 112 and / or the bearing support element 114 relative to the impeller housing 106 for a given adjustment, the impeller blood pump 100 may include at least one abutment stop and / or at least one spacer.

[0087]

[0087] Referring back to FIG. 4, an abutment stop 408 may be provided at a predetermined location along the second end portion 202 of the impeller housing 106, such that the engagement portion 800 of the pump body 112 may be moved until it abuts the abutment stop to position the same relative to the impeller housing 106. Similarly, an abutment stop may be provided at a predetermined location along the second end portion 202 of the impeller housing 106, such that the bearing support element 114 may be moved until it abuts the abutment stop to position the same relative to the impeller housing 106.

[0088]

[0088] Referring to FIG. 15, at least one spacer 1434 of a predetermined thickness may be disposed between the pump and impeller bearing portions 116, 118 of the first bearing 108 and / or between the impeller and pump bearing portions 120, 122 of the second bearing 110. So disposed, the spacer sets or preserves a predetermined space, which generally corresponds to the thickness of the pacer, between the corresponding bearing portions and thus positions the engagement portion 800 of the pump body 112 and / or the bearing support element 114 relative to the impeller housing 106 when adjustably engaged together. This in turn adjust the first and second bearing gaps 504, 506. The spacer is removed before operation of the impeller blood pump 100 and, for this purpose, the spacer may be dissolvable in blood, blood-like solvents, or any other solvents.

[0089] The adjustable interference fit engagement and / or the adjustable screwable engagement between the impeller housing 106 and one or more of the bearing support element 114 and the pump body 112 (referred herein simply as an “adjustable engagement”) is / are repeatable engagement(s) that may be repeated multiple times, as needed, in order to adjust at least one of the first and second bearing gaps 504, 506. The repeatable engagement is advantageous over a nonrepeatable, permanent engagement since it enables the first and second bearing gaps 504, 506 to be modified for testing purpose or in response to the operating conditions of the impeller blood pump 100, such as the impeller rotational speed, the impeller rotational direction, and / or the blood viscosity.

[0089]

[0090] Further, the adjustable engagement described herein is advantageous over at least some non-adjustable, permanent engagements since it does not induce significant material stress to the pump material(s) and components that negatively impact the tolerance generally required to appropriately adjust the first and second bearing gaps 504, 506 at the micron scale or smaller scale, for example. Such pump components may include the pump body 112, the impeller housing 106, and the bearing support element 114. Indeed, some non-adjustable, permanent engagements, such as welding and the like, can create a stress in the pump material and component(s) that is incompatible with a precise and exact adjustment of the first and second bearing gaps 504, 506.

[0090]

[0091] Furthermore, the adjustable engagement described herein advantageously enables the impeller blood pump 100 to be efficiently disassembled in some of its components.

[0091]

[0092] The pump body 112, the impeller housing 106, the bearing support element 114, and any combination thereof may be adjustably engageable together for adjusting one or more of the first and second bearing gap 504, 506. For example, the engagement portion 800 of the pump body 112 and the engagement portion 802 of the impeller housing 106 may be adjustably engageable to each other, while the second end portion 202 of the impeller housing 106 and the bearing support element 114 may also be adjustably engageable to each other. The engagement portion 800 of the pump body 112 and the engagement portion 802 of the impeller housing 106 may be adjustably engageable to each other, while the second end portion 202 of the impeller housing 106 and the bearing support element 114 may be non-adjustably engageable to each other. The engagement portion 800 of the pump body 112 and the engagement portion 802 of the impeller housing 106 may be non-adjustably engagement portion to each other, while the second end portion 202 of the impeller housing 106 and the bearing support element 114 may be adjustably engageable to each other. Finally, the engagement portion 800 of the pump body 112 and the engagement portion 802 of the impeller housing 106 may be non-adjustably engageable to each other, while the second end portion 202 of the impeller housing 106 and the bearing support element 114 may also be non- adjustably engageable to each other.

[0092]

[0093] The first and second bearing gaps 504, 506 may have a same gap distance or a different gap distance between the pump and impeller bearing portions 116, 118 of the first bearing 108 and between the impeller and pump bearing portions 120, 122 of the second bearing 110, respectively. Different gap distances are notably possible depending on difference of the characteristics of the fluid films in the first and second bearing gaps 504, 506. Different gap distances are also notably possible depending on the establishment or not of fluid films in one of the first and second bearing gaps 504, 506, such as in the first bearing gap 504 due to the thrust force of the impeller 104 in operation.

[0093]

[0094] The first and second bearings 108, 110 may be any types of bearings that can define the first and second bearing gaps 504, 506, respectively. Such bearing includes but is not limited to frictionless bearings and fluid film bearings, such as hydrodynamic bearings and hydrostatic bearings. In this regard, each of the first and second bearings 108, 110 may be implemented as a ball and socket bearing that has a ball bearing portion 514 and a socket bearing portion 516. The ball and socket bearing portions 514, 516 may be any bearing portions that have a convex bearing portions and a concave bearing portion, respectively, that are configured for rotatable interengagement. The pump bearing portion 116 of the first bearing 108 may be one of the ball bearing portion 514 and the socket bearing portion 516, while the impeller bearing portion 118 of the first bearing 108 may be the other one of the ball bearing portion 514 and the socket bearing portion 516. Similarly, the impeller bearing portion 120 of the second bearing 110 may be one of the ball bearing portion 514 and a socket bearing portion 516, while the pump bearing portion 122 of the second bearing 110 may be the other one of the ball bearing portion 514 and the socket bearing portion 516. The pump bearing portions 116, 122 of the first and second bearings 108, 110, respectively, may be referred to herein as static or non-rotating bearing portions, while the impeller bearing portions 1118, 120 of the first and second bearings 108, 110, respectively, may be referred to herein as mobile or rotating bearing portions.

[0094]

[0095] As illustrated referring back to FIG. 5 and as also illustrated in FIG. 15, for example, the pump bearing portion 116 of the first bearing 108 is the socket bearing portion 516, and the impeller bearing portion 118 of the first bearing 108 is the ball bearing portion 514, while the impeller bearing portion 120 of the second bearing 110 is the socket bearing portion 516, and the pump bearing portion 122 of the second bearing 110 is the ball bearing portion 514, according to one or more embodiments.

[0095]

[0096] FIGS. 10-14 illustrate one or the other of the ball bearing portion 514 and the socket bearing portion 516. As illustrated, the socket bearing portion 516 may include one or more of passageways 1000, 1002 and a chamber 1012, according to one or more embodiments. The ball bearing portion 514 may include one or more of passageways 1000, 1002, and a chamber 1012 or a flat surface 1300, according to one or more embodiments.

[0096]

[0097] FIG. 10 illustrates the ball bearing portion 514 that defines one or more passageways, such as two passageways 1000, 1002, on a corresponding bearing engagement surface 1004, which is a convex bearing engagement surface in this case, according to one or more embodiments. FIG. 11 illustrates the socket bearing portion 516 that defines one or more passageways, such as the two passageways 1000, 1002, on a corresponding bearing engagement surface 1006, which is a concave bearing engagement surface in this case, according to one or more embodiments. As illustrated, the passageways 1000, 1002 intersects at or near a transversal center portion 1008 of the bearing surfaces 1004, 1006, respectively.

[0097]

[0098] The passageways 1000, 1002 enable blood to circulate therethrough for evacuating or for facilitating the evacuation of build-up material that may occur during operation of the impeller blood pump 100 in presence of a blood. For example, depending on the operating conditions, biomaterial may accumulate in one or both of the first and second bearing gaps 504, 506 when the impeller blood pump 100 is operated in presence of blood. Such biomaterial may be evacuated from the first and second bearing gaps 504, 506 through the corresponding passageways 1000, 1002.

[0098]

[0099] The passageways 1000, 1002 may be configured to facilitate the circulation of blood therethrough, which in turn may facilitate the evacuation of build-up material. As illustrated in FIG. 12 for the ball bearing portion 514, a first peripheral portion 1200 of the passageways 1000, 1002 is oriented is the same direction as the rotational direction, creating a zone of relative high pressure that forces blood therethrough upon rotation, while a second peripheral portion 1202 of the passageways 1000, 1002 is oriented in the opposite direction to the rotational direction, creating a zone of relative low pressure that evacuates blood therethrough upon rotation, according to one or more embodiments. The first and second passageways 1000, 1002 do not intersect each other at or near the transversal center portion 1008 of the of the bearing surfaces 1004 and are in fluid communication through a chamber 1012, as described herein.

[0099]

[0100] The rotational direction is represented by a bold arrow and the blood movement through the first and second passageways 1000, 1002 are represented by two dashed lines arrows in FIG. 12. The passageways 1000, 1002 of the socket bearing portion 516 may also be configured accordingly.

[0100]

[0101] Referring back to FIGS. 10 and 12, the ball bearing portion 514 defines a chamber 1012 on the bearing engagement surface 1004, at or near the transversal center portion 1008 thereof, according to one or more embodiments. Also referring back to FIG. 11, the socket bearing portion 516 defines a chamber 1012 on the bearing engagement surface 1006, at or near the transversal center portion 1008 thereof, according to one or more embodiments. Being in fluid communication with the chamber 1012, the passageways 1000, 1002 may evacuate or may facilitate the evacuation of build-up material in the chamber 1012, as described herein. Referring specifically to FIG. 12, the passageways 1000, 1002 are in fluid communication with each other at the chamber 1012, according to one or more embodiments. However, the passageways 1000, 1002 may not necessarily be in fluid communication with each other at the chamber 1012. For example, a wall (not shown) in the chamber 1012 may separate the passageways 1000, 1002 from each other so that there is no fluid communication therebetween. Also, as illustrated in FIG. 13, each of the passageways 1000, 1002 may be disposed on a respective side of the chamber 1012, between the chamber 1012 and the periphery of the ball bearing portion 514. The passageways 1000, 1002 of the socket bearing portion 516 may also be configured accordingly.

[0101]

[0102] Generally, when free from the chamber 1012, each of the ball and socket bearing portions 514, 516 have a zero or near-zero tangential speed at or near the respective transversal center portions 1008 thereof when one of the ball and socket bearing portions 514, 516 is rotated relative to the other one of the ball and socket bearing portions 514, 516. Depending on the operating conditions, such tangential speed may promote blood stagnation and material build-up, as may be the case in presence of blood. Due to the absence of bearing material, the chamber 1012 may mitigate or may help to mitigate this effect by having a non-zero or near-zero tangential speed at or near the transversal center portion 1008 of the ball and socket bearing portions 514, 516, respectively.

[0102]

[0103] A lubricant (not shown) may be contained in the chamber 1012 for lubricating and / or for preserving blood from entering the chamber 1012. The lubricant may be a biocompatible lubricant, such as a silicone-based lubricant. The lubricant may have a viscosity of about between 20 and 100 centipoise, 30 and 90 centipoise, 40 and 80 centipoise, 50 and 70 centipoise, 50 and 60 centipoise, 60 and 70 centipoise, 20 and 90 centipoise, 20 and 80 centipoise, 20 and 70 centipoise, 20 and 60 centipoise, 20 and 50 centipoise, 20 and 40 centipoise, 20 and 30 centipoise, 20 and 100 centipoise, 30 and 100 centipoise, 40 and 100 centipoise, 50 and 100 centipoise, 60 and 100 centipoise, 70 and 100 centipoise, 80 and 100 centipoise, and 90 and 100 centipoise.

[0103]

[0104] Selection of the appropriate viscosity is generally guided by one or more of the following parameters: electrical pump consumption (the higher the viscosity, the higher electrical pump consumption); appropriated bearing lubrication, for example, during long-term use; and the ability of the lubricant to remain in the chamber so as to exclude foreign therefrom.

[0104]

[0105] FIG. 14 illustrates the ball bearing portion 514 that defines a flat surface 1300 on the bearing engagement surface 1004, at or near the transversal center portion 1008 thereof, in replacement of the chamber 1012, according to one or more embodiments. The flat surface 1300 1 creates a space between each of the transversal center portions 1008 of the respective ball and socket bearing portions 514, 516 when rotatably coupled to each other. Similarly to the chamber 1012, the flat surface 1300 provides for a non-zero or near-zero tangential speed. When provided to the ball bearing portion 514, the passageways 1000, 1002 intersect on the flat surface 1300 and are defined on the bearing surface 1004 as described in relation to and illustrated in FIG. 10, according to one or more embodiments. Alternatively, still when provided to the ball bearing portion 514, the passageways 1000, 1002 may not intersect on the flat surface 1300 and may be defined on the bearing surface 1004 as described in relation to and illustrated in FIG. 12, according to one or more embodiments.

[0105]

[0106] The first and second bearings 108, 110, including the ball and socket bearing portions 514, 516, may be made of one or more of ceramic and gemstones materials, including but not limited to silicone nitrite, silicon carbide, sapphire, ruby, zirconium dioxide, Zirconia Toughened Alumina (Ceram Alloy™), and aluminum oxide. The first and second bearings 108, 110 may be made of a same or different material(s).

[0106]

[0107] One or both of the first and second bearings 108, 110 may or may not be slidable. When slidable, one or both of the first and second bearings 108, 110 may be used for adjusting one or both of the first and second bearing gaps 504, 506. FIG. 15 illustrates the pump bearing portion 116 of the first bearing 108 that is slidably receivable inside a bore 1400 defined in the projecting end portion 502 of the driving magnet member 130, and the impeller bearing portion 118 of the first bearing 108, which is located in the cavity 208, that is slidably receivable inside a bore 1402 defined in the first end portion 210 of the impeller 104, according to one or more embodiments. FIG. 15 also illustrates the impeller bearing portion 120 of the second bearing 110 that is slidably receivable inside a bore 1404 defined in the second end portion 212 of the impeller 104, and the pump bearing portion 122 of the second bearing 110 that is slidably receivable inside a bore 1406 defined in the hub 400 of the bearing support element 114, according to one or more embodiments. Instead of having the two bores 1402, 1404, as illustrated, the impeller 104 may have a single bore (not shown) that extends between the cavity 208 at the first end portion 210 and the second end portion 212 of the impeller 104. This single bore may help in keeping the impeller 104 co-axial with the rotation axis 500, as compared to the impeller 104 provided with the two bores 1402, 1404.

[0107]

[0108] As illustrated, the pump and impeller bearing portions 116, 118 of the first bearing 108 as well as the impeller and pump bearing portions 120, 122 of the second bearing 110 are slidable along the rotation axis 500. Each of the pump and impeller bearing portions 116, 118, 120, 122 of the first and second bearing 108, 110 may define on a respective sliding portion thereof a respective chamfer (not shown) for facilitating the sliding action of the pump and impeller bearing portions 116, 118, 120, 122 in the corresponding bores 1400, 1402, 1404, 1406. The distances between the pump and impeller bearing portions 116, 118 themselves and relative to the corresponding bores 1400, 1402, as well as the distances between the impeller and pump bearing portions 120, 122 themselves and relative to the corresponding bores 1404, 1406 are exaggerated in FIG. 15 notably to better see the corresponding double-headed arrows 1408, 1410, 1412, 1414 that indicate the sliding actions.

[0108]

[0109] One or both of the first and second bearings 108, 110 may be non-rotatably slidable. FIG. 15 further illustrates inserts 1416, 1418, 1420 that are provided with respective sliding surfaces 1422, 1424, 1426 (the sliding surfaces 1424, 1426 are also shown in FIGS. 16-17), respectively, according to one or more embodiments. Each of the inserts 1416, 1418, 1420 can be disposed in a respective one of the bores 1402, 1404, 1406 such that rotation thereof is prevented. For example, the inserts 1402, 1404, 1406 can be press fitted inside the corresponding bores 1402, 1404, 1406 for this purpose. The sliding surfaces 1422, 1424, 1426 of the inserts 1416, 1418, 1420 slidably contact sliding surfaces 1428, 1430, 1432 (the sliding surfaces 1430, 1432 are also shown in FIGS. 16-17) of the impeller bearing portion 118, the impeller bearing portion 120, and the pump bearing portion 122, respectively, when the latter are slidably received in the corresponding bores 1402, 1404, 1406. These sliding contacts prevent rotation of the of the impeller bearing portion 118, the impeller bearing portion 120, and the pump bearing portion 122. Alternatively, one or more of the bores 1402, 1404, 1406 may be shaped to define the corresponding sliding surfaces 1422, 1424, 1426 to this end. [HO] A lubricant (not shown) may be present between the corresponding sliding surfaces of the impeller and pump bearing portions 118, 120, 122 and the inserts 1416, 1418, 1420, namely the sliding surfaces 1422, 1428, the sliding surfaces 1424, 1430, and / or the sliding surfaces 1426, 1432 for lubrification purpose and / or for preserving blood from entering the bores 1402, 1404, 1406. The lubricant may be the same as described hereinbefore, including the same viscosity.

[0109]

[0111] Although not illustrated referring back to FIG. 15, the projecting end portion 502 of the driving magnet member 130 may include a corresponding insert (not shown), according to one or more embodiments. This insert is in a slidable interrelationship with the pump bearing portion 116 of the first bearing 108, as generally described herein with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable.

[0110]

[0112] The impeller 104 may be provided without the inserts 1416, 1418, 1420 such that the impeller bearing portion 118 of the first bearing 108, and the impeller and pump bearing portions 120, 122 of the second bearing 110 may be slidably received into the corresponding bores 1402, 1404, 1406.

[0111]

[0113] FIGS. 16-17 illustrate some sliding actions of the second bearing 110 during operation of the impeller blood pump 100, according to one or more embodiments. In particular, rotation (represented by a circular bold arrow on the rotation axis 500 in FIGS. 16-17) of the impeller 104 in a rotational direction creates a fluid film in the second bearing gap 506 (indicated by a dashed line circle 506 in FIGS. 16-17 since such gap is not readily apparent at this scale) and generates a thrust force (represented by a bold arrow 1500 on the impeller 104 in FIGS. 16-17) in an opposite direction to a pump flow generated by the impeller 104. The thrust force may displace the impeller 104 along the rotation axis 500 toward the pump body 112 (also referred to herein as a “thrust force-induced impeller displacement”).

[0112]

[0114] Referring to FIG. 16, the fluid film may be created in the second bearing gap 506 by the sliding (represented by a bold arrow 1502) of the socket bearing portion 516 of the second bearing 110 partially out from the bore 1404 of the impeller 104 in response to the rotation of the impeller 104, according to one or more embodiments. In particular, the rotation of the impeller 104 causes the rotation of the socket bearing portion 516 which is attracted by the ball bearing portion 514, causing the sliding action of the socket bearing portion 516 toward the ball bearing portion 514. In FIG. 16, the ball bearing portion 514 may or may not be slidable.

[0113]

[0115] Similarly, referring to FIG. 17, the fluid film may be created in the second bearing gap 506 by the sliding (represented by a bold arrow 1600) of the socket bearing portion 516 of the second bearing 110 partially out from the bore 1406 of the bearing support element 114 in response to the rotation of the impeller 104, according to one or more embodiments. In particular, the rotation of the impeller 104 causes the rotation of the socket bearing portion 516 which attracts the ball bearing portion 514, causing the sliding action of the ball bearing portion 514 toward the socket bearing portion 516. In FIG. 17, the socket bearing portion 516 may or may not be slidable.

[0114]

[0116] The distance between the insert 1424 and the impeller bearing portion 120, as illustrated in FIG. 16, as well as the distance between the pump bearing portion 122 and the insert 1420, as illustrated in FIG. 17, are exaggerated notably to better see the corresponding bold arrows 1502,

[0115]

[0117] Although FIGS. 16-17 illustrate the sliding actions of the socket bearing portion 516 (and the impeller bearing portion 120) and the ball bearing portion 514 (and the pump bearing portion 122) as independently or separately occurring in response to the impeller rotation, respectively, both the ball and socket bearing portions 514, 516 (and the impeller and pump bearing portions 120, 122) may have simultaneous or cooperative sliding actions in response to the impeller rotation.

[0116]

[0118] When slidable and in response to the thrust force-induced impeller displacement, the impeller bearing portion 118 of the first bearing 108 may be slid in the bore 1402 of the impeller 104, and / or the pump bearing portion 116 of the first bearing position 108 may be slid in the bore 1400 of the driving magnet member 130. Doing so, the ball and bearing portions 514, 516 of the second bearing 110 may be slid accordingly due to the attractive effect of a fluid film created therebetween.

[0117]

[0119] Rotation of the impeller 104 in a opposite rotational direction may correspondingly slide one or more of the pump and impeller bearing portions 116, 118 of the first bearing 108 and / or one or more of the impeller and pump bearing portions 120, 122 of the second bearing 110, similar to what is described herein with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable. In particular, depending on the operating conditions, a fluid film may be created in the first bearing gap 504 such that a ball bearing portion 514 thereof and a socket bearing portion 516 thereof may be slid accordingly, as described herein.

[0118]

[0120] It will be appreciated that one or more of the pump and impeller bearing portions 116, 118 of the first bearing 108 and / or one or more of the impeller and pump bearing portions 120, 122 of the second bearing 110 may be slid in response to the impeller rotation and / or the thrust force- induced impeller displacement.

[0119]

[0121] The sliding action of one or both of the first and second bearings 108, 110 advantageously enables the continuous adjustment, such as in real-time, of one or both of the first and second bearing gaps 504, 506 depending on the operating conditions, such as the impeller rotational speed, the impeller rotational direction, and / or the blood viscosity.

[0120]

[0122] The adjustment of one or both of the first and second bearing gaps 504, 506 may be achieved by the adjustable engagement between the impeller housing 106 and at least one of the bearing support element 114 and the pump body 112, as described herein, and / or by the sliding action of at least one of the first and second bearings 108, 110, as also described herein.

[0121]

[0123] The impeller blood pump 100 may be sized and shaped to be implantable in and / or explantable from a subject’s body, such as the vasculature and the heart chambers thereof by transcatheter approaches. As illustrated referring back to in FIGS. 3, the pump body 112 and the impeller housing 106 have an elongated shape, and the first end portion 200 of the pump body 112 have a tapered shape from which the driveline 126 projects therefrom, according to one or more embodiments.

[0122]

[0124] The driveline 126 is configured to supply power to the impeller blood pump 100 for operating the same. As illustrated, the driveline 126 is a power cable that can supply electricity from a power source (not shown) to the drive unit 128 (best shown in FIG. 5), such as a brushless electric motor, present in the pump body. Alternatively, the driveline 126 may be a driveshaft (not shown) rotatably coupled between the impeller 104 and a drive unit that is external to the pump body 112.

[0123]

[0125] The driveline 126 may also be configured to be navigated in a subject’s body (i.e., “intracorporeally”), such as in a lumen of a subject’s body conduit (i.e., “intraluminally”), and to be manipulated for moving the impeller blood pump 100 therein. In particular, referring to FIG. 18 and also to FIGS. 29, 31, 33, 34, the driveline 126 may be introduced through a first body access, navigated in the subject’s body, and externalized through a second body access such that an externalizable portion 1700 of the driveline 126 is disposed outside the subject’s body (i.e., “extracorporeally”) or outside a lumen of a subject’s body conduit (i.e., “extraluminally”), according to one or more embodiment. Then, referring to FIG. 29, the externalizable portion 1700 of the driveline 126 may be pulled (represented by a bold arrow in FIG. 29) through the second body access to introduce the impeller blood pump 100 through the first body access and / or to move the impeller blood pump 100 intraluminally up to an implantation site. The driveline 126 may be so flexible that it may be navigated intraluminally through tortuous or sinuous anatomical structures, such as body conduit(s).

[0124]

[0126] When taper in shape, the first end portion 200 of the pump body 112 is configured to facilitate the introduction of the impeller blood pump 100 through the first body access, which may be dilated by the tapered shape, and not to cause damage to the subject’s body, such as to the inner wall of a subject’s body conduit, during navigation. The driveline 126 may also be pushed through the second body access to move the impeller blood pump 100 in a backward direction. In the context of a subject’s body conduit, the first and second body accesses are first and second intraluminal accesses that provide access to a lumen of a subject’s body conduit.

[0125]

[0127] FIG. 18 illustrates the impeller housing 106 that includes a plurality of legs, such as three legs 1800, 1802, 1804 (only the legs 1800, 1802 are shown in FIG. 18; the legs 1800, 1802, 1804 are best shown in FIG. 9), having a “Y” shape and extending at least partially between the first and second end portions 206, 202 of the impeller housing 106, according to one or more embodiments. Together, the legs 1800, 1802, 1804 define a plurality of six corresponding first pump ports 1806, 1808, 1810, 1812, 1814, 1816 (only the first pump ports 1806, 1812, 1816 are shown in FIG. 18; first pump ports 1806, 1808, 1810, 1812, 1814, 1816 are best shown in FIG. 9). In particular, each of the legs 1800, 1802, 1804 has a single leg member 1818 and two split leg members 1820, 1822 (only the single leg member 1818 and the two split leg members 1820, 1822 of the leg 1802 are labelled in FIG. 18 for the sake of clarity). The three first pump ports 1806, 1808, 1810 are defined by the single leg member 1818 and the two split leg members 1820, 1822, while the three first pump ports 1812, 1814, 1816 are defined by the two split leg members 1820, 1822. Still referring to FIG. 18, a second pump port 1824 is also defined at the second end portion 202 of the impeller housing 106, where the bearing support element 114 may be adjustably engaged therewith. A pump passage 2204 (best shown in FIG. 24) defined at least partially by the impeller housing 106 and the impeller 104 extends between the first pump ports 1806, 1808, 1810, 1812, 1814, 1816 and the second pump port 1824 for circulating pumped blood.

[0126]

[0128] As illustrated, the split leg members 1820, 1822 are oriented toward the first end portion 206 of the impeller housing 106, and the single leg member 1818 is oriented toward the second end portion 202 of the impeller housing 106. Alternatively, the split leg members 1820, 1822 may be oriented toward the second end portion 202 of the impeller housing 106, and the single leg member 1818 may be oriented toward the first end portion 206 of the impeller housing 106. Also, instead of having a “Y” shape, each of the legs 1800, 1802, 1804 may have only a single leg member 1818 that extend between the first and second end portions 206, 202 of the impeller housing 106.

[0127]

[0129] As further described herein, still as illustrated in FIG. 18 and as also illustrated in FIGS. 23-24, a first washout port 1826 may be defined to the first end portion 210 of the impeller 104 by the driving magnet member 130 and the driven magnet member 102, when the driving magnet member 130 is received into the driven magnet member 102 of the impeller, according to one or more embodiments. Further, one or more second washout ports 1828 may be defined at an intermediate portion 1830 of the impeller 104 (best shown in FIG. 23). As further illustrated in FIG. 18, at least one of the split leg members 1820, 1822 has a thinner portion 1832 thereof that registers with the first washout port 1826 and enlarges a corresponding portion of the first pump ports 1806, 1808, 1810, as the case may be, that leads to the first washout port 1826, according to one or more embodiments. Such enlargement of the corresponding portion of the first pump ports 1806, 1808, 1810 facilitates blood flow through the first washout port 1826. Only the thinner portion 1832 of the split leg 1822 is labelled in FIG. 18 for the sake of clarity, the labelled thinner portion 1832 of the split leg 1822 enlarging the corresponding portion of the first pump port 1806 that leads to the first washout port 1826. Also, at least one of the single leg members 1818 may have a thinner portion thereof that facilitates blood flow through a corresponding portion of the first pump ports 1806, 1808, 1810, as the case may be, for generating a pump flow through the second pump port 1824.

[0128]

[0130] Furthermore, as illustrated in FIGS. 19-20, at least one of the split leg members 1820, 1822 is configured as a fin 2110 that is generally oriented toward the rotation axis 500 for generating a laminar or laminar-like flow through the corresponding portion(s) of the first pump ports 1806, 1808, 1810, as the case may be, that registers with the first washout port 1826, according to one or more embodiments. Also, at least one of the single leg members 1818 may be configured as a fin 2112 that is generally oriented toward the rotation axis 500 for generating a laminar or laminar- like flow through the corresponding portion(s) of the first pump ports 1806, 1808, 1810, as the case may be, for generating a pump flow through the second pump port 1824. Alternatively, the fin may extend along the entire length of the legs 1800, 1802, 1804.

[0129]

[0131] The impeller housing 106 may have a cross-sectional size that is bigger than the cross- sectional size of the pump body 112 and / or drive unit 128.

[0130]

[0132] The second pump port 1824 of the impeller housing 106 may be coupled to a cannula (not shown) so as to be in fluid communication therewith for a pump flow and / or a washout flow, which will be described hereinafter, to be discharged from the impeller blood pump 100 by the cannula.

[0131]

[0133] Referring back to FIG. 18, the impeller housing 106 may include, at the second end portion 202 thereof, a capture element 134 that is configured to be captured by a medical capture instrument (not shown), such as a medical snare, for moving the impeller blood pump 100 in vivo, according to one or more embodiments. The capture element 134 may be a hook, as illustrated, or any other structures capable of being captured by a medical capture instrument in a subject’s body. When the capture element 134 is captured by a medical capture instrument, the medical capture instrument may be manipulated for moving the impeller blood pump 100 intracorporeally for implanting and / or explanting the impeller blood pump 100.

[0132]

[0134] FIG. 21 illustrates the bearing support element 114 that includes a capture element 136 configured to be captured by a medical capture instrument (not shown) for moving the impeller blood pump 100 in vivo and also configured to generate a laminar or laminar-like pump flow, according to one or more embodiments. In this case, the capture element 136 includes a hub 1900 and one or more fins, such as a plurality of three fins 1902, 1904, 1906 as illustrated, projecting therefrom. As such, the fins 1902, 1904, 1906 generate a pump flow coming from the second pump port 1824 that is laminar or laminar-like. The capture element 136 is capturable, for example, by capturing the hub 1900 such that a portion of the medical capture instrument may abut against the fins 1902, 1904, 1906 when the medical capture instrument is pulled for moving the impeller blood pump 100, or may abut against the bearing support element 114 when the medical capture instrument is pushed for moving the impeller blood pump 100. The capture element 136 may be provided with any numbers of fins. For example, the capture element 136 may include a single fin extending transversely on each side of the hub 1900. Alternatively, the bearing support element 114 may include a capture element 136 that is not configured to generate a laminar or laminar-like pump flow.

[0133]

[0135] The bearing support element 114 provided with the capture element 138 may include a locking mechanism, as described herein, such that pulling and / or pushing on the capture element 136 with the medical capture instrument does not cause re-positioning and de-adjustment of the bearing support element 114 and / or the pump body 112 when adjustably engageable with the impeller housing 106.

[0134]

[0136] FIG. 22 illustrates the impeller blood pump 100 that includes an anchor 132, according to one or more embodiments. The anchor 132 has an anchorage state (as shown) and a delivery state. In the anchorage state, the anchor is configured to immobilize the impeller blood pump 100 at an implantation site in a subject’s body, such as intraluminally. In the delivery state, the anchor 132 is containable in a sheath (not shown) for implanting and / or explanting the impeller blood pump 100, such as by transcatheter approaches. The anchor 132 may be attached to the impeller blood pump 100 by two sets of attachment legs 1900, 1902 thereof (as shown; one of the attachment legs 1902 being behind the pump body 112 and thus not visible) or by only one of these two attachment leg sets 1900, 1902. As illustrated, the two sets of attachment legs 1900, 1902 are attached to the pump body 112. Alternatively, the two sets of attachment legs 1900, 1902 may be attached to the impeller housing 106, or the set of attachment legs 1900 may be attached to the pump body 122 and the set of attachment legs 1902 may be attached to the impeller housing 106. When the anchor 132 is attached to the impeller housing 106, the bearing support element 114 may be provided with a locking mechanism, as described herein.

[0135]

[0137] Two sets of attachment leg 1900, 1902 generally provides for more intraluminal immobilization and intraluminal stability as compared to only one of the two sets of attachment legs 1900, 1902.

[0136]

[0138] As further illustrated in FIG. 22, the anchor 132 includes a capture element 138, which may be used for moving the impeller blood pump 100, as described herein, according to one or more embodiments. The capture element 138 is integrated to the anchor 132 so as to be positioned beyond the second end portion 202 of the impeller housing 106. Also, the capture element 138 may be used as an attachment point for some anchor legs 2000, 2002, 2004 of the anchor 132. One or more of the capture elements 134, 136, 138 may be provided to the impeller blood pump 100.

[0137]

[0139] The capture element 138 may be used to convert the anchor 132 from the anchorage state to the delivery state by transcatheter approaches. In particular, with the capture element 138 captured by a medical capture instrument (not shown), such as a medical snare, a sheath (not shown) may be slid over the medical capture instrument so as to be approached from the anchor 132 by the second end portion 202 of the impeller housing 106 until the sheath abuts the anchor legs 2000, 2002, 2004. So abutted, the sheath may be pushed and / or the medical capture instrument may be pulled such that the sheath applies a force on the anchor legs 2000, 2002, 2004 that progressively coverts the anchor 132 from the anchorage state to the delivery state as the anchor 132 enters the sheath.

[0140] FIGS. 23-24 illustrate the impeller 104 having the cavity 208 thereof that receives the driving magnet member 130 therein such that the first washout port 1826 is defined by the driving and driven magnet members 130, 102 at the first end portion 210 of the impeller 104, according to one or more embodiments. Further illustrated is a washout passage 2106 that extends between the first washout port 1826 and one or more second washout ports 1828 (only two second washout ports 1828 are shown in FIGS. 23-24) at the intermediate portion 1830 of the impeller 104, according to one or more embodiments. In absence of the driving magnet member 130 received in the cavity 208, the first washout port 1826 is defined by the entrance of the cavity 208 at the first end portion 210 of the impeller 104.

[0138]

[0141] The magnetic coupling gap 512 (represented by two dotted line rectangles 512 in FIG. 24) defined between the driving and driven magnet members 130, 102 correspond at least partially to the washout passage 2106. Depending on the configuration of the magnetic coupling between the driving and driven magnet members 130, 102 and / or the magnetic coupling gap 512, however, the magnetic coupling gap 512 may not necessarily correspond at least partially to the washout passage 2106.

[0139]

[0142] The impeller 104 includes the driven magnet member 102, an impeller hub 2100 projecting from the driven magnet member 102, and one or more impeller blades, such as two impeller blades 2102, 2104 disposed on the impeller hub 2100 and configured to generate a pump flow 2202 (represented as a dotted arrow 2202 in FIG. 24).

[0140]

[0143] Referring to FIG. 23, the impeller 104 also includes one or more washout blades 2108 extending between the first and second washout ports 1826, 1828, along the washout passage 2106, for generating the washout flow 2200 (represented as a dotted arrow 2200 in FIG. 24) in the cavity 208, according to one or more embodiments. Alternatively, the washout blade 2108 may not be so extended between the first and second washout ports 1826, 1828 and may instead be limited to the first washout port 1826 and the entrance of the cavity 208 at the first end portion 210 of the impeller 104.

[0144] FIGS. 23-24 also illustrates one or more second washout ports 1828 provided as a second washout channel port 1828 that is configured to generate the washout flow 2200 (represented as a dotted arrow 2200 in FIG. 24), according to one or more embodiments. In particular, the second washout channel port 1828 is formed at such an angle through the wall forming the cavity 208 that rotation of the impeller 104 in a rotational direction sucks blood from the cavity 208, moves blood through the second washout channel port 1828, and discharges blood from the second washout channel port second outside the cavity 208. The rotation of the impeller 104 in an opposite rotational direction sucks blood from outside the cavity 208, moves blood through the second washout channel port 1828, and discharges blood in the cavity 208. One or more of the second washout channel ports 1828 may be formed anywhere along wall forming the cavity 208 between the intermediate portion 1830 and the first end portion 210 of the impeller 104.

[0141]

[0145] FIG. 25 illustrate one or more second washout ports 1828 formed by corresponding washout blades, such as four washout blades 2300, 2302, 2304, 2306 in the case of four second washout ports 1828 as illustrated (only the three washout blades 2300, 2302, 2304 are shown in FIG. 25) that are configured to generate the washout flow 2200 (represented as a dotted arrow 2200 in FIG. 24), according to one or more embodiments. In particular, rotation of the impeller 104 in a rotational direction sucks blood from the cavity 208, moves blood through the second washout ports 1828, and discharges blood from the second washout ports 1828 outside the cavity 208. The rotation of the impeller 104 in an opposite rotational direction sucks blood from outside the cavity 208, moves blood through the second washout ports 1828, and discharges blood in the cavity 208. One or more washout blades 2300, 2302, 2304, 2306 may be formed anywhere along wall forming the cavity 208 between the intermediate portion 1830 and the first end portion 210 of the impeller 104.

[0142]

[0146] The impeller 104 may include one or more washout blades 2108, either extending along the washout passage 2106 or limited to the first washout port 1826 and the entrance of the cavity 208, one or more second washout channel ports 1828, and / or one or more washout blades 2300, 2302, 2304, 2306.

[0147] Referring back to FIG. 24 the impeller blood pump 100 creates the pump flow 2202 and the washout flow 2200 via rotation of the impeller 104, which as illustrated is provided with the second washout channel port 1828, according to one or more embodiments. The impeller blood pump 100 is operable in a rotational direction to generate the pump flow 2202 (represented as a dotted arrow 2202 arrow in FIG. 24) which is intake mainly through the first pump port 1806, 1808, 1810 (depending on the configuration of the impeller blood pump 100, blood may also be intake by the first pump port 1812, 1814, 1816), moved along the pump passage 2204, and discharged through the second pump port 1824.

[0143]

[0148] A washout flow 2200 (represented by a dotted arrow 2200 in FIG. 24) is also generated which is intake through the first washout port 1826, moved along the washout passage 2106, and discharged through the one or more of the second washout channel port 1828. The washout flow 2200 reduces the residency time of blood in the cavity 208. Being located in the cavity 208 along the washout flow 2200, the first bearing 108 is washed out by the washout flow 2200 for preventing or for helping to prevent the formation of thrombus at this location. As illustrated, the washout flow 2000 merged downstream of the second washout channel port(s) 1828 (and thus the second washout port(s) 1828) with the pump flow 2200 and flows along the pump passage 2204 to be discharged through the second pump port 1824. Some portion of the washout flow 2000 may be discharged through one or more of the first pump ports 1806, 1808, 1810, 1812, 1814, 1816. Alternatively, depending on the configuration of the impeller blood pump 100, the washout flow 2200 may be discharged through one or more ofthe first pump ports 1806, 1808, 1810, 1812, 1814, 1816.

[0144]

[0149] As illustrated, the pump flow 2202 and the washout flow 2200 are generated in the same direction relative to the impeller blood pump 100. In this case, the first pump ports 1806, 1808, 1810, 1812, 1814, 1816 and the first washout port 1826 are pump inlets and washout inlets, respectively. The second pump port 1824 and the second washout channel ports 1828 (and the second washout ports 1828) are pump outlets and washout outlets, respectively. However, the impeller blood pump 100 may be so operated in a opposite rotational direction, such that the inlets become the outlets, and vice-versa. In this case, the pump flow 2202 and the washout flow 2200 are also generated in a same direction relative to the impeller blood pump 100.

[0150] The impeller blood pump 100 may be sized and shaped to be amenable to transcatheter implantation and / or transcatheter explantation. For example, the impeller blood pump 100 may be implanted in and / or explanted from a subject’s vasculature or heart, including the left ventricle, right ventricle, ascending aorta, aortic arch, descending aorta, femoral and axillary arteries. Accordingly, the impeller blood pump 100 may have a length of about between 40 and 100 mm and a cross-sectional size of about between 3 and 8 mm.

[0145]

[0151] The impeller blood pump 100 may also be sized and shaped to be implanted and / or explanted by open surgery. Accordingly, the impeller blood pump 100 may have a length of about between 5 and 200 cm and a cross-sectional size of about between 1 and 50 mm.

[0146]

[0152] The impeller blood pump 100, including the pump body 112 and the impeller housing 106, generally have a tubular shape; however, other shapes, including ones that are not amenable to transcatheter approaches, are possible.

[0147]

[0153] The impeller blood pump 100 may be an axial flow impeller blood pump and / or a percutaneously implantable impeller blood pump.

[0148]

[0154] The impeller blood pump 100 is operable at a rotational speed about between 1,000 and 50,000 rpm.

[0149]

[0155] The impeller blood pump 100 may generate a pump flow about between 0.1 and 15 L / minute (with the pump inlet and outlet being physically separated such that there is no fluid passing from the inlet toward the outlet outside the impeller blood pump 1000).

[0150]

[0156] The impeller blood pump 100 may be made of one or more biocompatible materials, such as titanium, titanium, stainless steel, polymers, and the like.

[0151]

[0157] Although the impeller blood pump 100 is presented herein as being particularly suited for blood, it will be appreciated that any other fluid, including any other biological fluid, such as lymphatic fluid, are contemplated herein without departing from the scope of this disclosure.

[0158] One or more of the pump and impeller bearing portion 116, 118 of the first bearing 108 and one or more of the impeller and pump bearing portions 120, 122 of the second bearing 110, including in any case the ball and socket bearing portions 514, 516, may have a same cross- sectional size or a different cross-sectional size. For example, one or more of the pump and impeller bearing portion 116, 118 and one or more of the impeller and pump bearing portions 120, 122 may have a cross-sectional size about between 1.0 and 5.0 mm.

[0152]

[0159] FIGS. 26-27 illustrates a transcatheterly implantable medical device 2600 that includes an operable medical device component 2602 configured to be operated in a subject’s body, a driveline 2604 configured for the operable medical device component 2602 to be operated therethrough, an extension 2606 (also referred to herein as a “driveline extension”) configured to be coupled to the driveline 2604, and a capture element 2608 (also referred to herein as a “capturable element 2608”) attached to the operable medical device component 2602 and capturable in a subject’s body by a medical capture instrument (not shown), according to a second aspect of this disclosure.

[0153]

[0160] The transcatheterly implantable medical device 2600 may be a transcatheterly implantable blood pump, such as the impeller blood pump 100. In the case of the impeller blood pump 100, the operable medical device component 2602 may correspond to the pump body 112 having an electrical motor configured to rotate the impeller 104, and the driveline 2604 may correspond to the driveline 126. Alternatively, the operable medical device component 2602 may be any medical device that can be transcatheterly implanted in a subject’s body and optionally electrically or mechanically operated in the subject’s body through the driveline 2604.

[0154]

[0161] As illustrated in FIGS. 26, the capture element 2608 includes a post 2610 attached to a first end portion 2612 of the operable medical device component 2602, and a protuberance 2614 associated with the post 2610, according to one or more embodiment s). The capture element 2608 is capturable by a medical capture instrument (not shown), such as a medical loop snare, by closing a loop over the post 2610 such that the loop may abut to the protuberance 2614 and / or to the first end portion 2612 of the operable medical device component 2602. Once so captured, the transcatheterly implantable medical device 2600 may be moved in the subject’s body, such as along a cardiovascular system thereof, by manipulation of the medical capture instrument outside the subject’s body. One or more capture element 2608 may be provided anywhere to the operable medical device component 2602, such as to a second end portion 2616 of the operable medical device component 2602. In the case of the impeller blood pump 100, the capture element 2608 may correspond to the capture elements 134, 136, and / or 138. The capture element 2608 may have any size and shape, such as a hook-like shape, allowing any medical capture instrument to capture it in a subject’s body.

[0155]

[0162] As illustrated in FIGS. 26, the driveline 2604 has a first end portion 2618 configured to be attached to the operable medical device component 2602, such as to the second end portion 2616 thereof, and a second end portion 2620 configured to the extension 2606, according to one or more embodiment s). As such, the driveline 2604 is configured to project from the operable medical device component 2602. As illustrated, an optional connector 2622 is provided to the second end portion 2620 of the driveline 2604. The connector 2622 is operatively connectable to a controller (not shown) configured for the operable medical device component 2602 to be operated through the driveline 2604. Such an operative connection includes an electrical connection and / or a mechanical connection of the connector 2622 to the controller for electrically and / or mechanically operating the operable medical device component 2602. Accordingly, the connector 2622 may be an electrical and / or a mechanical connector.

[0156]

[0163] The driveline 2604 may have a tapered portion (not shown), which increases in cross- sectional size running from the second end portion 2620 toward the first end portion 2618 thereof, that is configured to sealingly engage, or engage in a fluid-thigh manner, such as by snug fit, a subject’s intracorporeal access. The driveline 2604 may also be provided with a bulge portion (not shown) positioned along a portion of the length thereof for the same purpose. The tapered portion and the bulge portion may be positioned along the driveline 2604 to so engage the subject’s intracorporeal access once the transcatheterly implantable medical device 2600 is implanted. The positioning of the tapered portion and the bulge portion may be determined based on anatomical and / or physiological marker(s) of the body of the subject to be implanted, such as makers derived from medical imaging.

[0164] As illustrated in FIGS. 26, the extension 2606 projects from the connector 2622 at the second end portion 2620 of the driveline 2604, according to one or more embodiment(s). The extension 2606 has a first end portion 2624 and a second end portion 2626. In absence of the optional connector 2622, the extension 2606 may project from the second end portion 2620 of the driveline 2604. As described herein, the extension 2606 is configured to be removed from the driveline 2604 and / or to be split into two segments thereof, for example by cutting, separating, detaching, or disconnecting the extension 2606.

[0157]

[0165] FIG. 27 illustrates the transcatheterly implantable medical device 2600 having a segment 2700 (also referred to herein as a “driveline-associated extension segment 2700”) of the extension 2606 that remains with the driveline 2604 once a removable or splitable segment (not shown) of the extension 2600 has been removed from the driveline 2604 and / or once the extension 2600 has been split into two segments thereof.

[0158]

[0166] Depending on how the removable or splitable segment is removed from the driveline 2604 or on how the removable or splitable segment is split into two segments, the free end portion of the driveline-associated extension segment 2700 may be left with a traumatic end portion 2702. For example, cutting off the extension 2606 with a wire cutter pliers may leave a traumatic end portion 2702 with a sharp and / or cutting edge(s). The extension 2606 may be provided with a split marker (not shown), such as a visual, haptic, and / or tactile marker(s), indicating a split location along the extension 2606. Moving the transcatheterly implantable medical device 2600 having the traumatic end portion 2702 in a subject’s body can traumatize or damage the subject’s body, such as when the transcatheterly implantable medical device 2600 is navigated and / or routed for implantation or explantation purpose.

[0159]

[0167] FIG. 28 illustrates the extension 2606 coupled, either directly or indirectly, to the driveline 2604 and extending partially along and / or through the driveline 2604, according to one or more embodiment s). For example, the extension 2606 may be coupled, either directly or indirectly, to the second end portion 2620 of the driveline 2604. Alternatively, the extension 2606 may be coupled, either directly or indirectly, to the connector 2622.

[0168] FIG. 29 illustrates the extension 2606 coupled, either directly or indirectly, to the operable medical device component 2602 and extending entirely along and / or through the driveline 2604, according to one or more embodiment s).

[0160]

[0169] The coupling of the extension 2606 to either one of the driveline 2604, as illustrated in FIG. 28, or the operable medical device component 2602, as illustrated in FIG. 29, may be a slidable coupling 2628 or a compressible coupling 2636.

[0161]

[0170] FIGS. 30-31 illustrate the slidable coupling 2628 where the driveline 2604 is in a slidable relationship with the extension 2606, according to one or more embodiment s). In particular, the extension 2606 includes a stop element 2630, such as a stop ferrule crimped to the extension 2606, that is configured to slide along a sliding portion, between a first abutment portion 2632 and a second abutment portion 2634, of the driveline 2604. The first and second abutment portions 2632, 2634 limit and stop the slidable movement of the stop element 2630, preventing the extension 2606 from being decoupled from the driveline 2604. The stop element 2630 may captive inside the sliding portion of the driveline 2604.

[0162]

[0171] In such a slidable relationship, the extension 2606 and / or the stop element 2630 may be rotatable or non-rotatable relative to the driveline 2604. Also, the extension 2606 and / or the stop element 2630 may frictionally engage or may non-frictionally engage the driveline 2604. The frictional engagement prevents unwanted sliding and / or rotating movement(s) of one or both the extension 2606 and the stop element 2630 relative to the driveline 2604. For example, an appropriate pulling or pushing force may be required to be applied to the extension 2606 to slide the extension 2606 and the stop element 2630 relative to the driveline 2604. The non-frictional engagement allows the extension 2606 and the stop element 2630 to freely move relative to the driveline 2604.

[0163]

[0172] The slidable coupling 2628 may also be provided to the operable medical device component 2602 for the extension 2606 to be in a slidable relationship therewith, with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable. In this case, notably, the first and second abutment portions 2632, 2634 are associated with the operable medical device component 2602. For example, the first and second abutment portions 2632, 2634 may be provided inside the operable medical device component 2602.

[0164]

[0173] The slidable coupling 2628 is advantageous notably in that it enables to protect and / or shield the traumatic end portion 2702 of the driveline-associated extension segment 2700 once the extension 2606 has been removed or split, preventing trauma and damage to a subject’s body, as described herein. Indeed, the extension 2606 may be split so that the traumatic end portion 2702 thereof has a length equal to or shorter than the sliding portion of the extension 2606. To this end, the split marker may be positioned on the extension 2606 to indicate where to split to obtain such a length. The traumatic end portion 2702 may then be slid or pushed inside the driveline 2604, sliding the stop element 2630 between the first abutment portion 2632 and the second abutment portion 2634. The length of the traumatic end portion 2702 being equal to or shorter than the length of the sliding portion, the traumatic end portion 2702 is contained or enclosed inside the driveline 2604, including the connector 2622 and / or the slidable coupling 2628, as illustrated in the embodiment of FIG. 31. The frictional engagement maintains the traumatic end portion 2702 contained or enclosed inside the driveline 2604, preventing the traumatic end portion 2702 from coming out of the driveline 2604.

[0165]

[0174] FIGS. 32-33 illustrate the compressible coupling 2636 maintained in a compressed state (also referred to herein as a “shorten state”) and receiving the extension 2606 therethrough, according to one or more embodiment(s). In particular, the compressible coupling 2636 is maintained in the compressed state by and between the connector 2622 and an abutment element 2638, such as a stop ferrule crimped to the extension 2606, provided to the first end portion 2624 of the extension 2606. The compressible coupling 2636 is fixed to the connector 2622 and may or may not be fixed to the abutment element 2638. Alternatively, in absence of the optional connector 2622, the compressible coupling 2636 is maintained in the compressed state by and between the second end portion 2620 of the driveline 2604 and the abutment element 2638 of the extension 2606.

[0166]

[0175] The compressible coupling 2636 is convertible from the compressed state to a decompressed state (also referred to herein as a “lengthen state”) by splitting the extension 2606 into two segments, as described herein, between the connector 2622 and the abutment element 2638. The compressible coupling 2636 may be converted to the decompressed state by splitting both the extension 2606 and the compressible coupling 2636. In this case, the compressible coupling 2636, which surrounds the extension 2606, may be first split into two respective segments thereof, then the compressible coupling 2636 may be split into two respective segments thereof. For example, a wire cutter pliers may be used to cut through the compressible coupling 2636 and the extension 2606. The compressible coupling 2636 may also be converted to the decompressed state by splitting only the extension 2606. In this case, the compressible coupling 2636 may be further compressed, such as by an operator manually or using a specially designed tool for that purpose, to expose and split the extension 2606, for example with a wire cutter pliers or the specially designed tool. As described herein, the splitting of the extension 2606 leaves a driveline- associated extension segment 2700 with the traumatic end portion 2702.

[0167]

[0176] The splitting of the extension 2606 releases the compression constraint applied to the compressible coupling 2636 by the connector 2622, or the second end portion 2620 of the driveline 2604 in absence of the optional connector 2622, and the abutment element 2638, causing the compressible coupling 2636 to convert from the compressed state to the decompressed state.

[0168]

[0177] FIG. 33 illustrates the compressible coupling 2636 in the decompressed state provided to the second end portion 2620 of the driveline 2604, projecting from the connector 2622, according to one or more embodiment(s). In the decompressed state, the compressible coupling 2636 contains or encloses, and thus protects and / or shields, the traumatic end portion 2702 of the driveline- associated extension segment 2700. In the compressed state, the compressible coupling 2636 has the capacity or potential to expand in length along the traumatic end portion 2702 to contain or shield the traumatic end portion 2702, when converted in the decompressed state.

[0169]

[0178] The compressible coupling 2636 is advantageous notably in that it enables to protect and / or shield the traumatic end portion 2702 of the driveline-associated extension segment 2700, as described herein for the slidable coupling 2628. Indeed, the extension 2606 may be split so that the traumatic end portion 2702 thereof has a length equal to or shorter than the compressible coupling 2636 in the decompressed state. The split marker may be positioned on the extension 2606 and / or the compressible coupling 2636 to indicate where to split to obtain such a length. The length of the traumatic end portion 2702 being equal to or shorter than the compressible coupling 2636 in the decompressed state, the traumatic end portion 2702 is contained or enclosed inside the driveline 2604, including the compressible coupling 2636 and the optional connector 2622.

[0170]

[0179] Alternatively, the compressible coupling 2636 may be provided anywhere along the driveline 2604, such as to the first end portion 2620 of the driveline 2604, at the interface of the operable medical device component 2602 and the driveline 2604, or inside the operable medical device component 2602. In this case, the abutment element 2638 abuts against the connector 2622, or against the second end portion 2620 of the driveline 2604 in absence of the connector 2622, to maintain the compressible coupling 2636 in the compressed state. Then, the extension 2606 is split, as described herein, between the abutment element 2638 and the connector 2622, or the second end portion 2620 of the driveline 2604 in absence of the optional connector 2622. The splitting of the extension 2606 causes the compressible coupling 2636 to transition from the compressed state to the decompressed state for the connector 2622, or the second end portion 2620 of the driveline 2604 in absence of the connector 2622, to protect and / or shield the traumatic end portion 2702 of the driveline-associated extension segment 2700.

[0171]

[0180] The compressible coupling 2636 may include any structural element capable of physical expansion upon removing a constraint applied thereto that maintains the structural element in a compressed state. For example, the compressible coupling 2636 may be a sleeve made of biocompatible polymer, a sleeve made of a shape memory material biased toward the decompressed state, and the like.

[0172]

[0181] The transcatheterly implantable medical device 2600 may further include a cap (not shown) configured to engage connector 2622 and / or the second end portion 2620 of the driveline 2604 in presence of the traumatic end portion 2702, protecting and / or shielding the traumatic end portion 2702 to prevent damage or trauma the subject’s body, as described herein.

[0182] Referring back to FIG. 26, the second end portion 2626 of the extension 2606 may optionally have a “J” shaped portion to facilitate the capture of the extension 2606 by a medical capture instrument, such as a medical snare.

[0173]

[0183] The driveline 2604 and / or the extension 2606 are configured to be navigated and / or routed in a subject’s body, such as in a subject’s body lumen like one of a subject’s cardiovascular system. For this purpose, similar to medical guidewires, the driveline 2604 and / or the extension 2606 may have appropriate flexibility and stiffness properties, the balance of these properties allowing for the trackability of the driveline 2604 and / or the extension 2606. The respective first end portions 2618, 2624 of the driveline 2604 and / or the extension 2606 may be stiffer than the respective second end portions 2620, 2626 thereof for pushability and torquability. The respective second end portions 2620, 2626 of the driveline 2604 and / or the extension 2606, including the “J” shaped portion, may be flexier or floppier than the respective first end portions 2618, 2624 thereof to avoid damaging or traumatizing vessel walls or tissues during navigation and / or routing.

[0174]

[0184] Further, the driveline 2604 and / or the extension 2606 may have appropriate coating(s) along at least a respective portion thereof, such as hydrophilic coating(s) to reduce friction and / or hydrophobic coating(s) (e.g., PTFE) to provide smoothness and support “rail-like” functions.

[0175]

[0185] Furthermore, the driveline 2604 and / or the extension 2606 may have appropriate radiopaque marker(s), such as ones including platinum, tungsten, gold or coil(s), to allow visualization under fluoroscopy or X-ray imaging.

[0176]

[0186] The driveline 2604 may be an electrical driveline, such as an electrical cable or an electrical wire, configured to electrically operate the operable medical device component 2602, or may be a mechanical driveline, such as a driveshaft rotatably received in a sleeve and configured to mechanically operate the operable medical device component 2602.

[0177]

[0187] The extension 2606 may be a cable or a wire, such as one made of stainless steel or nitinol.

[0178]

[0188] With reference now to FIGS. 34-46, methods will be described, according to some aspects of this disclosure. Optional items are represented by dashed line boxes in FIGS. 34-46. It is to be noted that references to the impeller blood pump 100, the transcatheterly implantable medical device 2600, and their respective structures and functions described herein, as well as to any other elements described herein, as the case may be, are made for the sole purpose of describing how these methods may be implemented and / or practiced. Accordingly, such reference(s) is / are not intended to limit the scope of these methods.

[0179]

[0189] FIG. 34 schematically illustrates a method 2400 of adjusting a gap of a bearing of an impeller blood pump, according to a third aspect of this disclosure. The method 2400 may rely on the adjustable engagement between the bearing support element 114 and the impeller housing 106 for adjusting one or more of the first and second bearing gaps 504, 506, according to one or more embodiments. The method 2400 may rely on the adjustable engagement between the pump body 112 and the impeller housing 106 for adjusting one or more of the first and second bearing gaps 504, 506, according to one or more embodiments. The method 2400 may rely on the adjustable engagement between the bearing support element 114 and the impeller housing 106 as well as between the pump body 112 and the impeller housing 106 for adjusting one or more of the first and second bearing gaps 504, 506, according to one or more embodiments.

[0180]

[0190] The method 2400 includes: engaging at least one of the pump body 112 and the bearing support element 114 with the impeller housing 106, at 2402.

[0181]

[0191] The method 2400 further includes: moving at least one of the pump body 112, the bearing support element 114, and the impeller housing 106 relative to each other in order to adjust at least one of the first bearing gap 504, which is defined between the pump body 112 and the impeller 104, and the second bearing gap 506, which is defined between the impeller 104 and the bearing support element 114, at 2404.

[0182]

[0192] Engaging the pump body 112 with the impeller housing 106, at 2402, may include engaging the pump body 112 and the impeller housing 106 to each other by an interference fit engagement. In this case, moving the pump body 112 and / or the impeller housing 106 relative to each other, at 2404, may include at least one of pulling and pushing the pump body 112 and / or the impeller housing 106 relative to each other.

[0193] Engaging the pump body 112 with the impeller housing 106, at 2402, may include engaging the pump body 112 and the impeller housing 106 to each other by a screwable engagement. In this case, moving the pump body 112 and / or the impeller housing 106 relative to each other, at 2404, may include rotating the pump body 112 and / or the impeller housing 106 relative to each other.

[0183]

[0194] Engaging the bearing support element 114 with the impeller housing 106, at 2402, may include engaging the bearing support element 114 and the impeller housing 106 to each other by an interference fit engagement. In this case, moving the bearing support element 114 and / or impeller housing 106 relative to each other, at 2404, may include at least one of pulling and pushing the bearing support element 114 and / or the impeller housing 106 relative to each other.

[0184]

[0195] Engaging the bearing support element 114 with the impeller housing 106, at 2402, may include engaging the bearing support element 114 and the impeller housing 106 to each other by a screwable engagement. In this case, moving the bearing support element 114 and the impeller housing 106 relative to each other, at 2404, may include rotating the bearing support element 114 and / or the impeller housing 106 relative to each other.

[0185]

[0196] Moving at least one of the pump body 112, the bearing support element 114, and the impeller housing 106 relative to each other, at 2404, may include moving at least one of the pump body 112, the bearing support element 114, and the impeller housing 106 until abutment to each other in order to adjust at least one of the first and second bearing gaps 504, 506. The abutment stop is so integrated to the pump body 112, the bearing support element 114, and / or the impeller housing 106 that it may be used to adjust the first bearing gap 504 and / or the second bearing gap 506 to a corresponding pre-determined gap.

[0186]

[0197] The method 2400 may include: mechanically deforming the impeller housing 106, at 2406, in order to achieve the interference fit engagement of the bearing support element 114 with the impeller housing 106, and / or to achieve the movement of the bearing support element 114 and / or the impeller housing 106 relative to each other. Indeed, the impeller housing 106 may be deformed to insert the bearing support element 114 therein before being reformed to achieve the interference fit engagement and / or may be deformed to move the bearing support element 114 relative to the impeller housing 106 for positioning the bearing support element 114 relative to the impeller housing 106.

[0187]

[0198] The method 2400 may include: putting a spacer of a pre-determined thickness in the first bearing gap 504 and / or the second bearing gap 506, at 2408. Being of a pre-determined thickness, the spacer may be used to adjust the first bearing gap 504 and / or the second bearing gap 506 to a pre-determined gap generally corresponding to the thickness of the spacer. The spacer may be put before the movement, such as by pulling and pushing, or rotating, as described herein, that is used to adjust the first and second bearing gap 504, 506.

[0188]

[0199] The method 2400 may include: removing the spacer from the first bearing gap 504 and / or the second bearing gap 506, at 2410.

[0189]

[0200] Removing the spacer, at 2410, may include dissolving the spacer with a solvent.

[0190]

[0201] The method 2400 may include: locking the pump body 112 and / or the bearing support element 114 to the impeller housing 106, at 2412. Such locking prevent or help to prevent repositioning and de-adjustment of the pump body 112 and / or the bearing support element 114 relative to the impeller housing 106, which generally impacts the adjustment of the first and second bearing gaps 504, 506.

[0191]

[0202] In the method 2400, one or more of the first and second bearings 108, 110 may be a spider bearing and / or a hydrodynamic bearing. One or more of the first and second bearing gaps 504, 506 may be a hydrodynamic bearing gap. The impeller blood pump 100 may be an axial flow impeller blood pump and / or a percutaneously implantable impeller blood pump.

[0192]

[0203] FIG. 35 schematically illustrates a method 2500 of adjusting at least one bearing gap of at least one slidable bearing of an impeller blood pump, according to a fourth aspect of this disclosure.

[0193]

[0204] The method 2500 may rely on a single slidable bearing for adjusting a bearing gap, according to one or more embodiments. In particular, the slidable bearing may be the first bearing 108 that has one or more of the pump and impeller bearing portions 116, 118 thereof that is slidable for adjusting one or more of the first and second bearing gaps 504, 506, while the second bearing 110 is non-slidable. The slidable bearing may be the second bearing 110 that has one or more of the impeller and pump bearing portions 120, 122 thereof that is slidable for adjusting one or more of the first and second bearing gaps 504, 506, while the first bearing 108 is non-slidable.

[0194]

[0205] The method 2500 may also rely on two slidable bearings for adjusting at least one of two bearing gaps, according to one or more embodiments. In particular, a bearing may be the first bearing 108, which one or more of the pump and impeller bearing portions 116, 118 thereof is slidable, and the other bearing may be the second bearing 110, which one or more of the impeller and pump bearing portions 120, 122 thereof is slidable. The first bearing 108 may adjust one or more of the first and second bearing gaps 504, 506. The second bearing 110 may adjust one or more of the first and second bearing gaps 504, 506. Both the first and second bearings 108, 110 may adjust one or more of the first and second bearing gaps 504, 506.

[0195]

[0206] The method 2500 includes: operating the impeller blood pump 100 such that rotation of the impeller 104 thereof, which is rotatably mounted to the first and second bearings 108, 110, causes one or more of the first and second bearings 108, 110 to slide in order to adjust one or more of the first and second bearing gaps 504, 506 thereof, at 2502. In particular, the rotation of the impeller 104 may cause the pump bearing portion 116 and / or the impeller bearing portion 118 of the first bearing 108 to slide, and / or may cause the impeller bearing portion 120 and / or the pump bearing portion 122 of the second bearing 110 to slide.

[0196]

[0207] Operating the impeller blood pump 100, at 2502, may cause the pump bearing portion 116 and / or the impeller bearing portion 118 of the first bearing 108 to slide toward the impeller 104, and / or may cause the impeller bearing portion 120 and / or the pump bearing portion 122 of the second bearing 110 to slide toward the impeller 104.

[0197]

[0208] Operating the impeller blood pump 100, at 2502, may cause the pump bearing portion 116 and / or the impeller bearing portion 118 of the first bearing 108 to slide away from the impeller 104, and / or may cause the impeller bearing portion 120 and / or the pump bearing portion 122 of the second bearing 110 to slide away from the impeller 104.

[0209] Operating the impeller blood pump 100, at 2502, may cause the pump bearing portion 116 and the impeller bearing portion 118 of the first bearing 108 to slide toward each other, and / or may cause the impeller bearing portion 120 and / or the pump bearing portion 122 of the second bearing 110 to slide toward each other.

[0198]

[0210] Operating the impeller blood pump 100, at 2502, may include operating the impeller blood pump 100 in a rotational direction and in an opposite rotational direction to cause the sliding action.

[0199]

[0211] Operating the impeller blood pump 100, at 2502, may include a continuous adjustment, such as an adjustment in real-time depending on the operating conditions of the impeller blood pump 100, of the first bearing gap 504 and / or the second bearing gap 506.

[0200]

[0212] Operating the impeller blood pump 100, at 2502, may include sequentially operating the impeller blood pump 100, such as according to one or more pre-determined rpm and / or time operating sequences.

[0201]

[0213] Operating the impeller blood pump 100, at 2502, may include operating the impeller blood pump 100 in vivo, such as in presence of blood.

[0202]

[0214] Operating the impeller blood pump 100, at 2502, may include operating the impeller blood pump 100 ex vivo.

[0203]

[0215] Operating the impeller blood pump 100, at 2502, may include operating the impeller blood pump 100 in vitro.

[0204]

[0216] Operating the impeller blood pump 100, at 2502, may include operating the impeller blood pump 100 in a blood-like fluid, such as 30% (v / v) glycerol.

[0205]

[0217] In the method 2500, one of the first and second bearings 108, 110 may be downstream relative to the pump flow 2202 generated by the impeller 104.

[0206]

[0218] In the method 2500, one of the first and second bearings 108, 110 may be upstream relative to the pump flow 2202 generated by the impeller 104.

[0219] In the method 2500, one or more of the first and second bearings 108, 110 may be a hydrodynamic bearing. One or more of the first and second bearing gaps 504, 506 may be a hydrodynamic bearing gap. The impeller blood pump 100 may be an axial flow impeller blood pump and / or a percutaneously implantable impeller blood pump.

[0207]

[0220] FIGS. 36-46 schematically illustrate methods 2800, 3100, and 3400 of using a medical device, such as the impeller blood pump 100 and the transcatheterly implantable medical device 2600, in a subject’s body, according to various aspects of this disclosure. It is to be noted that references to the impeller blood pump 100 and the transcatheterly implantable medical device 2600, or to any other elements described herein, are made for the sole purpose of describing how these methods may be implemented and / or practiced. Accordingly, such reference(s) is / are not intended to limit the scope of these methods.

[0208]

[0221] FIGS. 36-38 schematically illustrate a method 2800 of implanting the transcatheterly implantable medical device 2600 in a subject’s body, according to a fifth aspect of this disclosure.

[0209]

[0222] In particular, FIG. 36 illustrates a block diagram of the method 2800, according to one or more embodiment s).

[0210]

[0223] FIG. 37 illustrates the transcatheterly implantable medical device 2600 before its implantation in a subject’s body, according to one or more embodiment s). The transcatheterly implantable medical device 2600 has the driveline 2604 coupled to the extension 2606 (represented by a dash line in FIG. 37). The extension 2606 has been navigated and / or routed in the subject’s body between and through a first subject’s intracorporeal access 2900 (also referred to herein as a “first subject’s intraluminal access”, a “first subject’s intravascular access”, and a “first subject’s percutaneous access”) and a second subject’s intracorporeal access 2902 (also referred to herein as a “second subject’s intraluminal access”, a “second subject’s intravascular access”, and a “second subject’s percutaneous access”). A portion of the extension 2606 is externalized through the first subject’s intracorporeal access 2900, and another portion of the extension 2606 is externalized through the second subject’s intracorporeal access 2902 (each portion is also referred to herein as an “extemalizable extension portion”). Alternatively, a portion of the driveline 2604 (also referred to herein as an “externalizable driveline portion”) and a portion of the extension 2606 may be both internalized through the first subject’s intracorporeal access 2900, with the portion of the driveline 2604 coupled to the portion of the extension 2606.

[0211]

[0224] Alternatively, the extension 2606 or the driveline 2604 may be captured by a medical capture instrument, such as a medical snare, which is navigated and / or routed in the subject’s body between and through the first subject’s intracorporeal access 2900 and the second subject’s intracorporeal access 2902.

[0212]

[0225] The first and / or second subject’s intracorporeal access(es) 2900, 2902 may have any cross- sectional sizes or bores typically used for transcatheter approaches, such as between 1 Fr and 36 Fr. Depending on the transcatheterly implantable medical device 2600 to be implanted and the implantation procedure to be performed, the cross-sectional size or bore of the first subject’s intracorporeal access 2900 may be larger than the cross-sectional size or bore of the second subject’s intracorporeal access 2902. Accordingly, the first subject’s intracorporeal access 2900 may be sized for the operable medical device component 2602 to be able to pass therethrough, and the second subject’s intracorporeal access 2902 may be sized for the driveline 2604 to be able to pass therethrough. The first subject’s intracorporeal access 2900 may be sized to be able to receive a medical sheath of 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 23 Fr, 24 Fr, 25 Fr, 26 Fr, 27 Fr, 28 Fr, 29 Fr, 30 Fr, 31 Fr, 32 Fr, 33 Fr, 34 Fr, 35 Fr, and 36 Fr therethrough. The second subject’s intracorporeal access 2902 may be sized to be able to receive a medical sheath of 1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, and 12 Fr therethrough.

[0213]

[0226] Also, the second subject’s intracorporeal access 2902 may be sized to engage the driveline 2604, such as the tapered portion or the bulge portion thereof, but not necessarily to engage the extension 2606. Such engagement may be a sealing engagement or a fluid-thigh engagement, such as a snug fit engagement, that improves or achieves hemostasis.

[0214]

[0227] FIG. 38 illustrates the transcatheterly implantable medical device 2600 after its implantation in the subject’s body and therefore implanted at an implantation site 2906 (also referred to herein as an “intravascular implantation site”), according to one or more embodiment^ s). The transcatheterly implantable medical device 2600 has been implanted in the subject’s body notably by manipulating or pulling, as represented by the bold arrow in FIG. 37, a portion of the extension 2606 externalized through the second subject’s intracorporeal access 2902. In the case of the medical capture instrument capturing the extension 2606 or the driveline 2604, a portion of the medical capture instrument externalized through the second subject’s intracorporeal access 2902 may be notably manipulated or pulled to implant the transcatheterly implantable medical device 2600 in the subject’s body. So implanted, the transcatheterly implantable medical device 2600 has a portion of the driveline 2604 externalized (also referred herein as “extemalizable driveline portion”) through the second subject’s intracorporeal access 2902. In FIG. 38, the extension 2606 has been removed or split from the driveline 2604 and is therefore not shown.

[0215]

[0228] The implantation site 2906 may include the ascending aorta, such as at a position thereof above the renal arteries (also referred to as a “suprarenal aorta implantation site). According to the method 2800, the impeller blood pump 100 may be implanted anywhere in the cardiovascular system, including for example in the ascending aorta at a position thereof below the renal arteries (also referred to as a “infrarenal aorta implantation site), in the left or right ventricle apex, in the left or right atrium, or in the pulmonary arteries.

[0216]

[0229] Each one of the first and second subject’s intracorporeal accesses 2900, 2902 may be an arterial access and / or a venous access. Also, each one of the first and second subject’s intracorporeal accesses 2900, 2902 may be located on the subject’s lower or upper body, and on the left or right side of the subject’s body. For example, as illustrated in FIGS. 37-38, the first subject’s intracorporeal access 2900 is a femoral access, and the second subject’s intracorporeal access 2902 is an axillary or subclavian access, according to one or more embodiments(s). The transcatheterly implantable medical device 2600 may be implanted in a subject’s cardiovascular system in a retrograde fashion, as illustrated in FIGS. 37-38, or in an antegrade fashion. The first subject’s intracorporeal access 2900 may be a femoral access, and the second subject’s intracorporeal access 2902 may be a peripheral access, such as a radial artery access at the level of the wrist, a brachial artery access like at the level of the upper arm, a carotid access at the level of the neck. The method 2800 may be used in transvenous approach involving transseptal puncture or right-heart interventions. As such, the first or second subject’s intracorporeal accesses 2900, 2902 may be, for example, a femoral vein access, a jugular vein access, and a subclavian vein.

[0217]

[0230] Referring back to FIG. 36, the method 2800 may include: surgically obtaining the first and / or second subject’s intracorporeal access(es) 2900, 2902, at 2802. The first and / or second subject’s intracorporeal access(es) 2900, 2902 may be surgically obtained, for example, using the Sei dinger technique. A medical sheath, such as an introducer sheath, with or without a dilator may be installed through the first and / or second subject’s intracorporeal access(es) 2900, 2902, such that the method 2800 may be performed with a medical sheath installed at the first and / or second subject’s intracorporeal access(es) 2900, 2902. Alternatively, the first and / or second subject’s intracorporeal access(es) 2900, 2902 may be natural body access(es).

[0218]

[0231] The method 2800 includes: navigating or routing (also referred to herein as “advancing”) the extension 2606 through the first subject’s intracorporeal access 2900, along in the subject’s body, such as along in the cardiovascular system thereof, and up to the second subject’s intracorporeal access 2902, at 2804. For example, the extension 2606 may be navigated or routed through the first subject’s intracorporeal access 2900 up to a certain intravascular point, and a medical snare may be navigated or routed through the second subject’s intracorporeal access 2900 up to the certain intravascular point, where the medical snare captures the extension 2606. Then, manipulating or pulling the medical snare through the second subject’s intracorporeal access 2900 passes the extension 2606 from the first subject’s intracorporeal access 2900, along in the cardiovascular system thereof, and up to the second subject’s intracorporeal access 2902. The medical snare may then be removed from the extension 2606.

[0219]

[0232] Alternatively, a medical capture instrument, such as a medical snare, capturing the extension 2606 or the driveline 2604 may be navigated or routed through the first subject’s intracorporeal access 2900, along in the subject’s body, such as along in the cardiovascular system thereof, and up to the second subject’s intracorporeal access 2902.

[0220]

[0233] The method 2800 includes: externalizing the extension 2606 through the second subject’s intracorporeal access 2902, at 2806.

[0234] Alternatively, the medical capture instrument capturing the extension 2606 or the driveline 2604 may be externalized through the second subject’s intracorporeal access 2902.

[0221]

[0235] The method 2800 includes: manipulating or pulling (as represented by the bold arrow in FIG. 37) a portion of the extension 2606 externalized through the second subject’s intracorporeal access 2902 to implant the transcatheterly implantable medical device 2600 in the subject’s body, at 2808.

[0222]

[0236] Manipulating or pulling, at 2808, causes the operable medical device component 2602 to be introduced in the subject’s body, such as in a cardiovascular system thereof, through the first subject’s intracorporeal access 2900, and to be advanced up to the implantation site 2906, and also causes the driveline 2604 to be externalized through the second subject’s intracorporeal access 2902. Additionally, the operable medical device component 2602 may be enclosed or sheathed in a delivery sheath with the driveline 2604 and the extension 2606 projecting therefrom and routed from the first subject’s intracorporeal access 2900 to the second subject’s intracorporeal access 2902. The delivery sheath may be introduced through the first subject’s intracorporeal access 2900 and may be advanced up to the implantation site 2906 for delivery of the operable medical device component 2602.

[0223]

[0237] Alternatively, a portion of the medical capture instrument (also referred herein as “extemalizable instrument portion”) capturing the extension 2606 or the driveline 2604 may be manipulated or pulled through the second subject’s intracorporeal access 2902 to implant the transcatheterly implantable medical device 2600 at the implantation site 2906.

[0224]

[0238] The method 2800 may include: anchoring the transcatheterly implantable medical device 2600 in the subject’s body, at 2810. For example, the operable medical device component 2602 may be anchored at the implantation site 2906. Alternatively or additionally, the driveline 2604 may be anchored in the subject’s cardiovascular system, such as close to the implantation site 2906.

[0225]

[0239] The method 2800 may include: removing the extension 2606 from the driveline 2604 or splitting the extension 2606 into two segments thereof, at 2812. Such removing or splitting may be performed when a portion of the extension 2606 is externalized through the second subject’s intracorporeal access 2902. Removing or splitting, at 2812, may leave a segment of the extension 2606 that remains with the driveline 2604, such as the driveline-associated extension segment 2700. The driveline-associated extension segment may include a traumatic end portion, such as the traumatic end portion 2702.

[0226]

[0240] The method 2800 may include: protecting and / or shielding the driveline-associated extension segment, or causing the driveline-associated extension segment to be protected and / or shielded, at 2814. For example, the driveline-associated extension segment may be protected and / or shielded by sliding or pushing it inside the driveline 2604 and / or a connector thereof, such as the connector 2622. This may be the case when the transcatheterly implantable medical device 2600 is provided with a slidable coupling, such as the slidable coupling 2628. The driveline- associated extension segment may also be protected and / or shielded by capping it, such as when the transcatheterly implantable medical device 2600 is provided with a cap. The driveline- associated extension segment may be caused to be protected and / or shielded by removing or splitting, at 2812. For example, a compressible coupling, such as the compressible coupling 2636, may be caused to convert from a compressed state to a decompressed state for this purpose after removing or splitting, at 2812.

[0227]

[0241] The method 2800 may include: connecting the driveline 2604, with or without the extension 2606 removed or split into two segment thereof, to a controller configured to operate the operable medical device component 2602, at 2816.

[0228]

[0242] The method 2800 may include: operating the operable medical device component 2602 in the subject’s body, such as at the implantation site 2906, via the driveline 2604 externalized through the second subject’s intracorporeal access 2902, at 2818.

[0229]

[0243] The method 2800 may include: surgically closing the first subject’s intracorporeal access 2900, at 2820.

[0230]

[0244] It will be appreciated that the method 2800 may be implemented and / or practiced by a medical capture instrument, such as the medical capture instrument 3204, capturing the transcatheterly implantable medical device 2600, including the driveline 2604, the extension 2606, and / or the operable medical device component 2602, and routed in the subject’s body between and through the first and / or second subject’s intracorporeal accesses 2900, 2902, with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable. The medical capture instrument externalized though the second subject’s intracorporeal access 2902 may be manipulated or pulled therethrough to implant the transcatheterly implantable medical device 2600, as described herein. In such a variation of the method 2800, the extension 2606 is optional.

[0231]

[0245] The method 2800 has multiple advantages. First, because the driveline 2604 may be externalized at the subject’s upper body level, such as through an axillary or subclavian access, the subject enjoys an improved mobility and freedom of movements compared to a medical device implanted in the subject’s body with a driveline thereof externalized at the subject’s lower body level, such as through a femoral access. This is true as well for the driveline 2604 externalized at a radial artery or venous access at the level of the wrist. Such an advantage improves the quality of life of ambulatory patients, notably.

[0232]

[0246] Second, because the second subject’s intracorporeal access 2902 may be smaller in cross- sectional size or bore than the cross-sectional size of the driveline 2604, the driveline 2604, such as a tapered portion or a bulge portion thereof, may engage the second subject’s intracorporeal access 2902 in a sealingly manner or fluid-thigh manner, notably via a snug fit engagement. This advantageously improves or achieves hemostasis.

[0233]

[0247] Third, depending on the transcatheterly implantable medical device 2600 and the cardiovascular anatomy of the subj ect to be implanted with the transcatheterly implantable medical device 2600, a single subject’s intracorporeal access may not be possible or desirable for implantation. For example, the single subject’s intracorporeal access may have a cross-sectional size or bore too small for the transcatheterly implantable medical device 2600 to be navigated or routed therethrough for implantation. The method 2800 advantageously enables such a transcatheterly implantable medical device 2600 to be implanted by navigating or routing the operable medical device component 2602 through an appropriately sized first subject’s intracorporeal access 2900 with assistance of the second subject’s intracorporeal access 2902, which may be sized as required, as described herein.

[0248] FIGS. 39-41 schematically illustrate a method 3100 of explanting the transcatheterly implantable medical device 2600 from a subject’s body, according to a sixth aspect of this disclosure.

[0234]

[0249] In particular, FIG. 39 illustrates a block diagram of the method 3100, according to one or more embodiment s).

[0235]

[0250] FIG. 40 illustrates the transcatheterly implantable medical device 2600 implanted in a subject’s body with (i) a portion of the driveline 2604 externalized (also referred to herein as an “extemalizable driveline portion”) through a first subject’s intracorporeal access 3200 (also referred to herein as a “first subject’s intraluminal access”, a “first subject’s intravascular access”, and a “first subject’s percutaneous access”); and (ii) a medical capture instrument 3204 (represented by a dot line in FIGS. 40-41) capturing the operable medical device component 2602 and having a portion thereof externalized (also referred to herein as an “extemalizable instrument portion”) through a second subject’s intracorporeal access 3102 (also referred to herein as a “second subject’s intraluminal access”, a “second subject’s intravascular access”, and a “second subject’s percutaneous access”), according to one or more embodiment s). The operable medical device component 2602 may be captured by the capture element 2608 thereof. The medical capture instrument 3204 may be, for example, a medical snare.

[0236]

[0251] FIG. 41 illustrates the transcatheterly implantable medical device 2600 after its explantation from the subject’s body, such as from the implantation site 2906 (also referred to herein as an “intravascular implantation site”), according to one or more embodiment(s). The transcatheterly implantable medical device 2600 has been explanted from the subject’s body notably by manipulating or pulling, as represented by the bold arrow in FIG. 40, a portion of the medical capture instrument 3204 externalized through the second subject’s intracorporeal access 3202. During explantation, the driveline 2604 is internalized through the first subject’s intracorporeal access 3200, moved along in the subject’s body, such as a in the cardiovascular system thereof, and externalized through the second subject’s intracorporeal access 3202. In FIG. 41, the medical capture instrument 3204 still captures the operable medical device component 2602.

[0252] The first and / or second subject’s intracorporeal access(es) 3200, 3202 may have any cross- sectional sizes or bores typically used for transcatheter approaches, such as between 1 Fr and 36 Fr. Depending on the transcatheterly implantable medical device 2600 to be explanted and the explantation procedure to be performed, the cross-sectional size or bore of the second subject’s intracorporeal access 3202 may be larger than the cross-sectional size or bore of the first subject’s intracorporeal access 3200. Accordingly, the second subject’s intracorporeal access 3202 may be sized for the operable medical device component 2602 to be able to pass therethrough, and the first subject’s intracorporeal access 3200 may be sized for the driveline 2604 to be able to pass therethrough. The first subject’s intracorporeal access 3200 may be sized to be able to receive a medical sheath of 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 23 Fr, 24 Fr, 25 Fr, 26 Fr, 27 Fr, 28 Fr, 29 Fr, 30 Fr, 31 Fr, 32 Fr, 33 Fr, 34 Fr, 35 Fr, and 36 Fr therethrough. The second subject’s intracorporeal access 3202 may be sized to be able to receive a medical sheath of 1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, and 12 Fr therethrough.

[0237]

[0253] Each one of the first and second subject’s intracorporeal accesses 3200, 3202 may be an arterial access and / or a venous access. Also, each one of the first and second subject’s intracorporeal accesses 3200, 3202 may be located on the subject’s lower or upper body, and on the left or right side of the subject’s body. For example, as illustrated in FIGS. 40-41, the second subject’s intracorporeal access 3202 is a femoral access, and the first subject’s intracorporeal access 3200 is an axillary or subclavian access, according to one or more embodiments(s). The transcatheterly implantable medical device 2600 may be explanted from a subject’s cardiovascular system in an antegrade fashion, as illustrated in FIGS. 40-41, or in a retrograde fashion. The second subject’s intracorporeal access 3202 may be a femoral access, and the first subject’s intracorporeal access 3200 may be a peripheral access, such as a radial artery access at the level of the wrist, a brachial artery access like at the level of the upper arm, a carotid access at the level of the neck. The method 3100 may be used in transvenous approach involving transseptal puncture or right-heart interventions. As such, the first or second subject’s intracorporeal accesses 3200, 3202 may be, for example, a femoral vein access, a jugular vein access, and a subclavian vein.

[0238]

[0254] The implantation site 2906 may be the same for the methods 2800 and 3100; therefore, its description will not be repeated herein for the sake of brevity.

[0255] Referring back to FIG. 39, the method 3100 may include: surgically obtaining the second subject’s intracorporeal access 3202, at 3102. The second subject’s intracorporeal access 3202 may be surgically obtained, for example, using the Seidinger technique. A medical sheath, such as an introducer sheath, with or without a dilator may be installed through the second subject’s intracorporeal access 3202, such that the method 3100 may be performed with a medical sheath installed at the second subject’s intracorporeal access 3202. Alternatively, the second subject’s intracorporeal access 3202 may be a natural body access.

[0239]

[0256] The method 3100 includes: navigating or routing (also referred to herein as “advancing”) a medical capture instrument, such as the medical capture instrument 3204, through the second subject’s intracorporeal access 3202, along in the subject’s body, such as along in the cardiovascular system thereof, and up to the operable medical device component 2602 at the implantation site 2906, at 3104. As illustrated in FIG. 40, the transcatheterly implantable medical device 2600 implanted in the subject’s body has the driveline 2604 thereof externalized through the first subject’s intracorporeal access 3200.

[0240]

[0257] The method 3100 includes: capturing the operable medical device component 2602 at the implantation site 2906 with the medical capture instrument, at 3106. For example, the capture element 2608 may be captured.

[0241]

[0258] The method 3100 may include: unanchoring the transcatheterly implantable medical device 2600 from the subject’s body, at 3108. For example, the operable medical device component 2602 may be unanchored at the implantation site 2906. Alternatively or additionally, the driveline 2604 may be unanchored in the subject’s cardiovascular system, such as close to the implantation site 2906.

[0242]

[0259] The method 3100 may include: stopping an operation of the operable medical device component 2602 being operated in the subject’s body, such as at the implantation site 2906, via the driveline 2604 externalized through the first subject’s intracorporeal access 3200 and operatively connected by a connector, such as the connector 2622, to a controller configured to operate the operable medical device component 2602, at 3110. The operation of the operable medical device component 2602 may be stopped at any moment during the method 3100. However, keeping the operable medical device component 2602 in operation, such as until the explantation is completed or just before completion, may prevent or help to prevent blood flow stagnation in the operable medical device component 2602 and related thrombogenesis.

[0243]

[0260] The method 3100 may include: disconnecting the connector of the driveline 2604, with or without the extension 2606 removed or split into two segment thereof, from the controller, at 3112.

[0244]

[0261] The method 3100 may include: removing the extension 2606 from the driveline 2604 or splitting the extension 2606 into two segments thereof, at 3114. This may be the case when the driveline 2604 and the connector thereof are connected to the controller in presence of the extension 2606. Such removing or splitting may be performed when a portion of the extension 2606 is externalized through the first subject’s intracorporeal access 3200. Removing or splitting, at 3114, may leave a segment of the extension 2606 that remains with the driveline 2604, such as the driveline-associated extension segment 2700. The driveline-associated extension segment may include a traumatic end portion, such as the traumatic end portion 2702.

[0245]

[0262] Removing or splitting, at 3114, may cause the driveline 2604 to protect and / or shield the driveline-associated extension segment. For example, a compressible coupling, such as the compressible coupling 2636, may be caused to convert from a compressed state to a decompressed state for this purpose.

[0246]

[0263] The method 3100 may include: protecting and / or shielding the driveline-associated extension segment, at 3116. For example, the driveline-associated extension segment may be slid or pushed inside the driveline 2604 and / or the connector thereof. This may be the case when the transcatheterly implantable medical device 2600 is provided with a slidable coupling, such as the slidable coupling 2628. The driveline-associated extension segment may also be capped, such as when the transcatheterly implantable medical device 2600 is provided with a cap.

[0247] The method 3100 may include: protecting and / or shielding the driveline-associated extension segment, or causing the driveline-associated extension segment to be protected and / or shielded, at 3116. For example, the driveline-associated extension segment may be protected and / or shielded by sliding or pushing it inside the driveline 2604 and / or a connector thereof, such as the connector 2622, or by capping it, as described herein. The driveline-associated extension segment may be caused to be protected and / or shielded by removing or splitting, at 3114, as described herein.

[0248]

[0264] The method 3100 includes: manipulating or pulling (as represented by the bold arrow in FIG. 32) a portion of the medical capture instrument 3204 externalized through the second subject’s intracorporeal access 2902 to explant the transcatheterly implantable medical device 2600 from the subject’s body, at 3118. The driveline 2604 may also be pushed through the first subject’s intracorporeal access 3200 for explantation.

[0249]

[0265] Manipulating or pulling, at 3118, causes the operable medical device component 2602 to be retrieved from the subject’s body, such as from a cardiovascular system thereof, through the second subject’s intracorporeal access 3202, and also causes the driveline 2604 to be internalized through the first subject’s intracorporeal access 3200 and to be retrieved through the second subject’s intracorporeal access 3202. Additionally, the operable medical device component 2602 may be enclosed or sheathed in a retrieval sheath with the driveline 2604 and the extension 2606 projecting therefrom and routed from the implantation site 2906 to the first subject’s intracorporeal access 3200. The retrieval sheath may be manipulated or pulled through the second subject’s intracorporeal access 3202 for retrieval of the transcatheterly implantable medical device 2600.

[0250]

[0266] The method 3100 may include: surgically closing the first and second subject’s intracorporeal accesses 3200, 3202, at 3120.

[0251]

[0267] Depending on the transcatheterly implantable medical device 2600 and the cardiovascular anatomy of the subject from who the transcatheterly implantable medical device 2600 is to be explanted, a single subject’s intracorporeal access may not be possible or desirable for explantation. For example, the single subject’s intracorporeal access may have a cross-sectional size or bore too small for the transcatheterly implantable medical device 2600 to be explanted therethrough, as it may be the case for the first subject’s intracorporeal access 3200. The method 3100 advantageously enables such a transcatheterly implantable medical device 2600 with the driveline 2604 externalized through the first subject’s intracorporeal access 3200 to be explanted by navigating or routing the medical capture instrument 3204 through an appropriately sized second subject’s intracorporeal access 3202 and explanting the transcatheterly implantable medical device 2600 therethrough, as described herein.

[0252]

[0268] FIGS. 42-46 schematically illustrate a method 3400 of replacing the transcatheterly implantable medical device 2600 in a subject’s body, according to a seventh aspect of this disclosure.

[0253]

[0269] In particular, FIG. 42 illustrates a block diagram of the method 3400, according to one or more embodiment s).

[0254]

[0270] FIG. 43 illustrates the transcatheterly implantable medical device 2600 implanted at an implantation site 2906 (also referred to herein as an “intravascular implantation site”) in a subject’s body with (i) the driveline 2604 removably coupled to an extender 3504 (represented by a dash line in FIGS. 43-45); (ii) a portion of the driveline 2604 externalized (also referred to herein as an “extemalizable driveline portion”) through a first subject’s intracorporeal access 3500 (also referred to herein as a “first subject’s intraluminal access”, a “first subject’s intravascular access”, and a “first subject’s percutaneous access”); and (iii) a medical capture instrument 3204 (represented by a dot line in FIGS. 43-44) capturing the operable medical device component 2602 and having a portion thereof externalized (also referred to herein as an “extemalizable instrument portion”) through a second subject’s intracorporeal access 3102 (also referred to herein as a “second subject’s intraluminal access”, a “second subject’s intravascular access”, and a “second subject’s percutaneous access”), according to one or more embodiment(s). The extender 3504 may be removably couplable, connectable, or attachable to the driveline 2604, such as via a connector. The operable medical device component 2602 may be captured by the capture element 2608 thereof. The medical capture instrument 3204 may be, for example, a medical snare. The extender 3504 may also be a medical capture instrument.

[0255]

[0271] The first and / or second subject’s intracorporeal access(es) 3500, 3502 correspond to the first and second subject’s intracorporeal access 2900, 2902, 3200, 3202, which descriptions will not be repeated herein for the sake of brevity.

[0272] The implantation site 2906 may be the same for the methods 2800, 3100, and 3400; therefore, its description will not be repeated herein for the sake of brevity.

[0256]

[0273] FIG. 44 illustrates the transcatheterly implantable medical device 2600 after its explantation from the subject’s body, such as from the implantation site 2906, according to one or more embodiment(s). The transcatheterly implantable medical device 2600 has been explanted from the subject’s body notably by manipulating or pulling, as represented by the bold arrow in FIG. 43, a portion of the medical capture instrument 3204 externalized through the second subject’s intracorporeal access 3502. During explantation, the driveline 2604 and the extender 3504 are internalized through the first subject’s intracorporeal access 3500 and moved along in the subject’s body up to the second subject’s intracorporeal access 3502. The driveline 2604 is entirely externalized through the second subject’s intracorporeal access 3502. The extender 3504 is routed between the first and second subject’s intracorporeal accesses 3500, 3502. A portion of extender 3504 is externalized through the first subject’s intracorporeal access 3500, and another portion of extender 3504 is externalized through the second subject’s intracorporeal access 3502 (each portion is also referred to herein as an “extemalizable extender portion”). In FIG. 44, the medical capture instrument 3204 still captures the operable medical device component 2602.

[0257]

[0274] FIG. 45 illustrates a replacement transcatheterly implantable medical device 2600’ before its implantation in a subject’s body, according to one or more embodiment(s). The replacement transcatheterly implantable medical device 2600’ has the driveline 2604’ removably coupled to the extension 3504 (represented by a dash line in FIGS. 43-45), which is routed between the first and second subject’s intracorporeal accesses 3500, 3502 and externalized therethrough. The extender 3504 may be removably couplable, connectable, or attachable to the driveline 2604’ via the connector thereof.

[0258]

[0275] FIG. 46 illustrates the replacement transcatheterly implantable medical device 2600’ after its implantation in the subject’s body and therefore implanted at an implantation site 2906, according to one or more embodiment s). The replacement transcatheterly implantable medical device 2600 has been implanted in the subject’s body notably by manipulating or pulling, as represented by the bold arrow in FIG. 45, the portion of the extender 3504 externalized through the first subject’s intracorporeal access 3500. So implanted, the replacement transcatheterly implantable medical device 2600’ has a portion of the driveline 2604’ externalized through the first subject’s intracorporeal access 3500.

[0259]

[0276] Referring back to FIG. 42, the method 3400 may include: stopping an operation the operable medical device component 2602 being operated in a subject’s body, such as at the implantation site 2906, via the driveline 2604 externalized through the first subject’s intracorporeal access 3500 and operatively connected by a connector, such as the connector 2622, to a controller configured to operate the operable medical device component 2602, at 3402. The operation of the operable medical device component 2602 may be stopped at any moment during the method 3400. However, keeping the operable medical device component 2602 in operation, such as until the explantation is completed or just before completion, may prevent or help to prevent blood flow stagnation in the operable medical device component 2602 and related thrombogenesis.

[0260]

[0277] The method 3400 may include: disconnecting the connector of the driveline 2604 from the controller, at 3404.

[0261]

[0278] The method 3400 include: coupling an extender, such as the extender 3504, to the driveline 2604 externalized through the first subject’s intracorporeal access 3500, at 3406.

[0262]

[0279] The method 3400 include: surgically obtaining a second subject’s intracorporeal access 3502, at 3408. The second subject’s intracorporeal access 3502 may be surgically obtained, for example, using the Seidinger technique. A medical sheath, such as an introducer sheath, with or without a dilator may be installed through the first and / or second subject’s intracorporeal access(es) 3500, 3502, such that the method 3400 may be performed with a medical sheath installed at the first and / or second subject’s intracorporeal access(es) 3500, 3502. Alternatively, the first and / or second subject’s intracorporeal access(es) 3500, 3502 may be natural body access(es).

[0263]

[0280] The method 3400 includes: navigating or routing (also referred to herein as “advancing”) a medical capture instrument, such as the medical capture instrument 3204, through the second subject’s intracorporeal access 3502, along in the subject’s body, such as along in the cardiovascular system thereof, and up to the operable medical device component 2602 at the implantation site 2906, at 3410. As illustrated in FIG. 43, the transcatheterly implantable medical device 2600 implanted in the subject’s body has the driveline 2604 thereof externalized through the first subject’s intracorporeal access 3500.

[0264]

[0281] The method 3400 includes: capturing the operable medical device component 2602 at the implantation site 2906 with the medical capture instrument, at 3412. For example, the capture element 2608 may be captured.

[0265]

[0282] The method 3400 includes: manipulating or pulling (as represented by the bold arrow in FIG. 35) a portion of the medical capture instrument 3204 externalized through the second subject’s intracorporeal access 3502 to explant the transcatheterly implantable medical device 2600 from the subject’s body, at 3414. The driveline 2604 may also be pushed through the first subject’s intracorporeal access 3500 for explantation.

[0266]

[0283] Manipulating or pulling, at 3414, causes the operable medical device component 2602 to be retrieved from the subject’s body, such as from a cardiovascular system thereof, through the second subject’s intracorporeal access 3502, and also causes the driveline 2604 to be internalized through the first subject’s intracorporeal access 3500 and to be retrieved through the second subject’s intracorporeal access 3502. Additionally, the operable medical device component 2602 may be enclosed or sheathed in a retrieval sheath with the driveline 2604 and the extender 3504 projecting therefrom and routed from the implantation site 2906 to the first subject’s intracorporeal access 3500. The retrieval sheath may be manipulated or pulled through the second subject’s intracorporeal access 3502 for retrieval of the transcatheterly implantable medical device 2600.

[0267]

[0284] The method 3400 may include: unanchoring the transcatheterly implantable medical device 2600 in the subject’s body, at 3416. For example, the operable medical device component 2602 may be unanchored at the implantation site 2906. Alternatively or additionally, the driveline 2604 may be unanchored in the subject’s cardiovascular system, such as close to the implantation site 2906.

[0285] The method 3400 include: uncoupling the extender 3504 from the operable medical device component 2602, and coupling the extender 3504 to a replacement driveline 2604’ of a replacement transcatheterly implantable medical device 2600’, at 3418.

[0268]

[0286] The method 3400 includes: manipulating or pulling (as represented by the bold arrow in FIG. 37) a portion of the extender 3504 externalized through the first subject’s intracorporeal access 3500 to implant the replacement transcatheterly implantable medical device 2600’ in the subject’s body, at 3420.

[0269]

[0287] Manipulating or pulling, at 3420, causes the replacement operable medical device component 2602’ to be introduced in the subject’s body, such as in a cardiovascular system thereof, through the second subject’s intracorporeal access 3502, and to be advanced up to the implantation site 2906, and also causes the replacement driveline 2604’ to be externalized through the first subject’s intracorporeal access 3500. Additionally, the replacement operable medical device component 2602’ may be enclosed or sheathed in a delivery sheath with the replacement driveline 2604’ and the replacement extension 2606’ projecting therefrom and routed from the second subject’s intracorporeal access 3502 to the first subject’s intracorporeal access 3500. The delivery sheath may be introduced through the second subject’s intracorporeal access 3500 and may be advanced up to the implantation site 2906 for delivery of the replacement operable medical device component 2602’.

[0270]

[0288] The method 2800 may include: anchoring the replacement transcatheterly implantable medical device 2600’ in the subject’s body, at 3422. For example, the replacement operable medical device component 2602’ may be anchored at the implantation site 2906. Alternatively or additionally, the replacement driveline 2604’ may be anchored in the subject’s cardiovascular system, such as close to the implantation site 2906.

[0271]

[0289] The method 3400 may include: connecting the replacement driveline 2604’ a controller configured to operate the replacement operable medical device component 2602’, at 3424.

[0290] The method 3400 may include: operating the replacement operable medical device component 2602’ in the subject’s body, such as at the implantation site 2906, via the replacement driveline 2604’ externalized through the first subject’s intracorporeal access 3500, at 3426.

[0272]

[0291] The method 3400 may include: surgically closing the second subject’s intracorporeal access 3502, at 3428.

[0273]

[0292] When a medical device implanted in a subject’s body (also referred to herein as a “first medical device”) is in presence of another medical device (also referred to herein as a “second medical device”) that is also implanted in a subject’s body, the method 2800 advantageously enables the replacement of the first medical device while possibly keeping the second medical device implanted during the replacement of the first medical device. One or more of the first and second medical devices may be kept in operation during the replacement of the first medical device. The second medical device may or may not be replaceable.

[0274] Definitions

[0275]

[0293] The terms “comprising”, “including”, “having”, and variations thereof shall be construed herein as open-ended terms and, thus, are not intended to exclude other elements, technical features, limitations, steps, and the like.

[0276]

[0294] The expression “and / or” is intended herein to mean a grammatical conjunction used to indicate that one or more of the elements or conditions recited may be included or occur. For example, a device comprising a first element, a second element, and / or a third element is intended to be construed as any one of the following structural arrangements: (i) a device comprising a first element; (ii) a device comprising a second element; (iii) a device comprising a third element; (iv) a device comprising a first element and a second element; (v) a device comprising a first element and a third element; (vi) a device comprising a second element and a third element; or (vii) a device comprising a first element, a second element, and a third element.

[0277]

[0295] Adjectives of numbers, also known as definite numeral adjectives, such as first, second, third, etc., and the like are intended herein only to distinguish between the terms they are associated with from one another without necessarily implying or requiring any actual order, ranking, hierarchy, interrelationship, and the like between such associated terms.

[0278]

[0296] Perspective-based terms such as up / down, top / bottom, front / back, proximal / distal, and the like are intended herein, notably in reference to the accompanying non-limiting drawings and / or figures, are only to facilitate the description and explanation of this disclosure. These perspectivebased terms are not necessarily intended to be a limitation, such as a spatial limitation, of the terms they are associated with in any way herein.

[0279]

[0297] The terms “about” and “approximately” when used in conjunction with numbers, values, ranges, and other like features generally are intended herein to refer to these numbers, values, ranges, and like features that are near to the recited numbers, values, ranges, and like features. These terms generally refer to numbers, values, ranges, and like features that the skilled addressee would consider equivalent, for example, to achieve an equivalent result or the same result. In many instances, these terms may include numbers, values, ranges, and like features that are rounded to the nearest significant figure. The terms “about” and “approximately” may be used interchangeably herein.

[0280]

[0298] The term “substantially” when used to define numerical, geometrical, structural, and other like features is intended herein to convey that these so defined features include the nominal features and also some feature variance, although equality may be desirable. Such feature variance may result for example from manufacturing tolerances, approximations, and / or other practical considerations.

[0281]

[0299] Operations and / or method steps may be described and explained herein as multiple discrete operations and / or method steps in turn to facilitate the description and explanation of this disclosure. These operations and / or method steps, including the discrete ones, are intended herein to be order-independent, unless expressly specified otherwise.

Claims

CLAIMSI / We claim:

1. An impeller blood pump, comprising:- an impeller having a first end portion and a second end portion;- a first bearing configured for the first end portion of the impeller to be rotatably mounted thereto, the first bearing having an impeller bearing portion and a pump bearing portion defining a first bearing gap therebetween;- a second bearing configured for the second end portion of the impeller to be rotatably mounted thereto, the second bearing having an impeller bearing portion and a pump bearing portion defining a second bearing gap therebetween, the first bearing and the second bearing together defining a rotation axis;- a pump body configured to support the pump bearing portion of the first bearing;- an impeller housing configured to receive the impeller therein and to engage the pump body; the impeller housing defining a first pump port, a second pump port, and a pump passage extending between the first pump port and the second pump port;- a bearing support element configured to support the pump bearing portion of the second bearing and to engage the impeller housing; and- a driven magnet member associated with the impeller and configured to magnetically couple a driving magnet member rotatably coupled to a drive unit for rotating the impeller and generating a pump flow.

2. The pump according to claim 1, wherein the impeller housing and the pump body are configured to adjustably engage each other for adjusting the first bearing gap and the second bearing gap.

3. The pump according to any one of claims 1-2, wherein the impeller housing and the pump body are configured to adjustably engage each other by an interference fit.

4. The pump according to any one of claims 1-3, wherein the impeller housing is deformable to adjustably engage the pump body.

5. The pump according to any one of claims 1-2, wherein the impeller housing and the pump body are configured to adjustably engage each other by a screwable engagement.

6. The pump according to any one of claims 1-5, wherein the impeller housing and the bearing support element are configured to adjustably engage each other for adjusting the first bearing gap and the second bearing.

7. The pump according to any one of claims 1-6, wherein the impeller housing and the bearing support element are configured to adjustably engage each other by an interference fit.

8. The pump according to any one of claims 1-7, wherein the impeller housing is deformable to adjustably engage the bearing support element.

9. The pump according to claim 8, wherein the bearing support element comprises two or more arms configured to adjustably engage the impeller housing when deformed.

10. The pump according to claim 9, wherein at least one of the two or more arms are configured to make a pump flow laminar or laminar-like.

11. The pump according to any one of claims 1-6, wherein the impeller housing and the bearing support element are configured to adjustably engage each other by screwable engagement.

12. The pump according to any one of claims 1-11, wherein at least one of the impeller bearing portion and the pump bearing portion of at least one of the first bearing and the second bearing is configured to slide along the rotation axis.

13. The pump according to any one of claims 1-12, wherein at least one of the impeller bearing portion and the pump bearing portion of at least one of the first bearing and the second bearing is configured to be slid along the rotation axis in response to the rotation of the impeller.

14. The pump according to any one of claims 1-13, wherein at least one of the impeller bearing portion and the pump bearing portion of at least one of the first bearing and the secondbearing is configured to be slid along the rotation axis for adjusting the first bearing gap and the second bearing gap.

15. The pump according to any one of claims 1-14, wherein the impeller bearing portion of the first bearing is one of a socket bearing portion and a ball bearing portion, and the pump bearing portion of the first bearing is the other one of the socket bearing portion and the ball bearing portion; and the impeller bearing portion of the second bearing is one of a socket bearing portion and a ball bearing portion, and the pump bearing portion of the second bearing is the other one of the socket bearing portion and the ball bearing portion.

16. The pump according to claim 15, wherein the socket bearing portion defines a chamber, the rotation axis passing through the chamber.

17. The pump according to claim 16, further comprising: a lubricant in the chamber.

18. The pump according to any one of claims 15-17, wherein the ball bearing portion defines a planar surface that intersects the rotation axis.

19. The pump according to any one of claims 15-18, wherein at least one of the ball bearing portion and the socket bearing portion comprises a passageway on a bearing engagement surface thereof.

20. The pump according to any one of claims 15-19, wherein the impeller bearing portion of the second bearing is the socket bearing portion and the pump bearing portion of the second bearing is the ball bearing portion.

21. The pump according to claim 1-20, wherein at least one of the first bearing and the second bearing is a hydrodynamic bearing.

22. The pump according to any one of claims 1-21, wherein the second bearing and the bearing support element is a spider bearing.

23. The pump according to any one of claims 1-22, wherein the impeller housing comprises a leg having a “Y” shape defining the first pump port.

24. The pump according to claims 23, wherein the leg comprises a thinner portion for facilitating blood flow through the first pump port.

25. The pump according to any one of claims 23-24, wherein the leg is configured to make at least one of a laminar or laminar-like pump flow and a laminar or laminar-like washout blood flow.

26. The pump according to any one of claims 1-25, wherein the first pump port is a pump inlet and the second pump port is a pump outlet.

27. The pump according to any one of claims 1-26, further comprising: a capture element configured to be captured by an instrument for moving the impeller blood pump in a lumen of a subject’s vasculature by manipulation of the instrument.

28. The pump according to claim 27, wherein the impeller housing comprises the capture element.

29. The pump according to any one of claims 27-28, wherein the bearing support element comprises the capture element.

30. The pump according to any one of claims 27-29, wherein the capture element is configured to make a pump flow laminar or laminar-like.

31. The pump according to any one of claims 1-30, further comprising: an anchor having a delivery state for delivering the impeller blood pump in a lumen of a subject’s vasculature and an anchorage state for anchoring the impeller blood pump in the lumen of the subject’s vasculature.

32. The pump according to claim 31, wherein the anchor comprises another capture element configured to be captured by an instrument for moving the impeller blood pump in a lumen of a subject’s vasculature by manipulation of the instrument.

33. The pump according to any one of claims 1-32, wherein the driven magnet member and the driving magnet member defines a magnetic coupling gap therebetween, a first washout port,a second washout port, and a washout passage for circulating a washout flow therebetween; the magnetic coupling gap extending at least partially through the washout passage.

34. The pump according to claim 33, wherein the driven magnet member is configured to receive the driving magnet member therein; the driven magnet member and the driving magnet member being magnetically radially coupled together.

35. The pump according to any one of claims 33-34, wherein the impeller comprises a blade disposed to the first washout port and configured to generate the washout flow.

36. The pump according to any one of claims 33-35, wherein the second washout port is a channel configured to generate the washout flow.

37. The pump according to any one of claims 33-35, wherein the impeller comprises a blade defining the second washout port and configured to generate the washout flow.

38. The pump according to any one of claims 33-37, wherein the impeller comprises a blade disposed in the washout passage and configured to generate the washout flow.

39. The pump according to any one of claims 33-38, wherein the first bearing is disposed along the washout passage.

40. The pump according to any one of claims 33-39, wherein the driven magnet member and the driving magnet member define the first washout port, and the driven magnet member and the impeller housing define the first pump port.

41. The pump according to any one of claims 33-40, wherein the first washout port is a washout inlet and the second washout port is a washout outlet.

42. The pump according to any one of claims 33-40, wherein the impeller blood pump is configured to generate the washout flow and the pump flow in a same direction.

43. The pump according to any one of claims 1-42, wherein the drive unit is disposed in the pump body.

44. The pump according to claim 43, wherein the drive unit is disposed outside the pump body and is rotatably coupled to the driving magnet member by a driveshaft.

45. The pump according to any one of claims 1-44, wherein at least one of the first bearing gap and the second bearing gap is a hydrodynamic gap.

46. The pump according to any one of claims 1-45, wherein the impeller blood pump is an axial flow impeller blood pump.

47. The pump according to any one of claims 1-46, wherein the impeller blood pump is a percutaneously implantable impeller blood pump.

48. A transcatheterly implantable medical device, comprising:- an operable medical device component configured to be operated in a subject’s body;- a driveline configured for the operable medical device component to be operated therethrough; and- an extension configured to be coupled to the driveline.

49. The device according to claim 48, further comprising: a capturable element attached to the operable medical device component and configured to be captured in a subject’s body by a medical capture instrument.

50. The device according to any one of claims 48-49, wherein the driveline comprises an electrical connector configured for the operable medical device component to be electrically operated through the driveline electrically connected by the electrical connector to a controller.

51. The device according to any one of claims 48-49, wherein the driveline comprises a mechanical connector configured for the operable medical device component to be mechanically operated through the driveline mechanically connected by the mechanical connector to a controller.

52. The device according to any one of claims 48-51, wherein the driveline comprises a tapered portion.

53. The device according to any one of claims 48-52, wherein the driveline comprises a bulge portion.

54. The device according to any one of claims 48-53, wherein the extension is configured to be removed from the driveline, leaving the driveline with a driveline-associated extension segment.

55. The device according to any one of claims 48-53, wherein the extension is configured to be split into two segments thereof, leaving the driveline with a driveline-associated extension segment.

56. The device according to any one of claims 54-55, wherein the driveline-associated extension segment comprises a traumatic end portion that is traumatic for the subject’s body when the transcatheterly implantable medical device is navigated or routed therein.

57. The device according to any one of claims 54-56, further comprising: a slidable coupling configured for the driveline-associated extension segment to be slid into the driveline for protecting or shielding the driveline-associated extension segment therein.

58. The device according to claim 57, wherein the driveline-associated extension segment frictionally engages the slidable coupling and / or the driveline.

59. The device according to any one of claims 57-58, wherein the slidable coupling is provided to the driveline.

60. The device according to any one of claims 57-58, wherein the slidable coupling is provided to the operable medical device component.

61. The device according to any one of claims 54-56, further comprising: a compressible coupling convertible between a compressed state and a decompressed state for protecting or shielding the driveline-associated extension segment.

62. The device according to claim 61, wherein the compressible coupling is configured to be caused to convert from the compressed state to the decompressed state once the extension is removed from the driveline or once the extension is split into two segments thereof.

63. The device according to any one of claims 61-62, wherein the compressible coupling is provided to the driveline.

64. The device according to any one of claims 61-62, wherein the compressible coupling is provided to the operable medical device component.

65. The device according to any one of claims 54-64, further comprising: a cap configured to engage the driveline for protecting or shielding the driveline-associated extension segment therein.

66. A method of adjusting a bearing gap of a bearing of an impeller blood pump, the method comprising:- engaging at least one of a pump body and a bearing support element with an impeller housing; and- moving at least one of the pump body, the bearing support element, and the impeller housing relative to each other to adjust at least one of a first bearing gap defined between the pump body and an impeller, and a second bearing gap defined between the impeller and the bearing support element.

67. The method according to claim 66, wherein said engaging the pump body with the impeller housing comprises engaging the pump body with the impeller housing by an interference fit engagement.

68. The method according to claim 67, wherein said moving at least one of the pump body and the impeller housing relative to each other comprises at least one of pulling and pushing the pump body and the impeller housing relative to each other.

69. The method according to claim 66, wherein said engaging the pump body with the impeller housing comprises engaging the pump body with the impeller housing by a screwable engagement.

70. The method according to claim 69, wherein said moving at least one of the pump body and the impeller housing relative to each other comprises rotating the pump body and the impeller housing relative to each other.

71. The method according to any one of claims 66-70, wherein said engaging the bearing support element with the impeller housing comprises engaging the bearing support element with the impeller housing by an interference fit engagement.

72. The method according to any one of claims 66-71, wherein said moving at least one of the bearing support element and the impeller housing relative to each other comprises at least one of pulling and pushing the bearing support element and the impeller housing relative to each other.

73. The method according to any one of claims 71-72, further comprising: mechanically deforming the impeller housing to achieve at least one of said engaging the bearing support element with the impeller housing by the interference fit engagement and said moving at least one of the bearing support element and the impeller housing relative to each other.

74. The method according to any one of claims 66-70, wherein said engaging the bearing support element with the impeller housing comprises engaging the bearing support element with the impeller housing by a screwable engagement.

75. The method according to claim 74, wherein said moving at least one of the bearing support element and the impeller housing relative to each other comprises rotating the bearing support element and the impeller housing relative to each other.

76. The method according to any one of claims 66-74, wherein said moving comprises moving at least one of the pump body, the bearing support element, and the impeller housing untilabutment to each other to adjust at least one of a first bearing gap and the second bearing gap-77. The method according to any one of claims 66-76, further comprising: putting a spacer of a pre-determined thickness in at least one of the first bearing gap and the second bearing gap before said moving to adjust at least one of the first bearing gap and the second bearing gap to a pre-determined gap.

78. The method according to claim 77, further comprising: removing the spacer from the at least one of the first bearing gap and the second bearing gap.

79. The method according to any one of claim 77-78, wherein removing the spacer comprises dissolving the spacer.

80. The method according to any one of claims 66-79, further comprising: locking at least one of the pump body and the bearing support element to the impeller housing.

81. The method according to any one of claims 66-80, wherein the bearing is a spider bearing.

82. The method according to any one of claims 66-81, wherein the bearing is a hydrodynamic bearing.

83. The method according to any one of claims 66-82, wherein at least one of the first bearing gap and the second bearing gap is a hydrodynamic bearing gap.

84. The method according to any one of claims 66-83, wherein the impeller blood pump is an axial flow impeller blood pump.

85. The method according to any one of claims 66-84, wherein the impeller blood pump is a percutaneously implantable impeller blood pump.

86. A method of adjusting a bearing gap of a slidable bearing of an impeller blood pump, the method comprising:- operating an impeller blood pump such that a rotation of an impeller thereof, which is rotatably mounted to the slidable bearing, causes the slidable bearing to slide to adjust the bearing gap thereof.

87. The method according to claim 86, wherein said operating causes one of two bearing portions of the slidable bearing to slide toward the impeller.

88. The method according to claim 86, wherein said operating causes one of two bearing portions of the slidable bearing to slide away from the impeller.

89. The method according to claim 86, wherein said operating causes two bearing portions of the slidable bearing to slide toward each other.

90. The method according to any one of claims 86-89, wherein said operating comprises operating the impeller blood pump in a rotational direction and in an opposite rotational direction.

91. The method according to any one of claims 66-90, wherein said operating comprises a continuous adjustment of the bearing gap.

92. The method according to any one of claims 66-91, wherein said operating comprises sequentially operating the impeller blood pump.

93. The method according to any one of claims 66-92, wherein said operating comprises operating the impeller blood pump in vivo.

94. The method according to any one of claims 66-92, wherein said operating comprises operating the impeller blood pump ex vivo.

95. The method according to any one of claims 66-92, wherein said operating comprises operating the impeller blood pump in vitro.

96. The method according to any one of claims 94-95, wherein said operating comprises operating the impeller blood pump in a blood-like fluid.

97. The method according to any one of claims 86-96, wherein the slidable bearing is downstream relative to a pump flow generated by the impeller.

98. The method according to any one of claims 86-96, wherein the slidable bearing is upstream relative to a pump flow generated by the impeller.

99. The method according to any one of claims 86-98, wherein the bearing is a hydrodynamic bearing.

100. The method according to any one of claims 86-99, wherein the bearing gap is a hydrodynamic bearing gap.

101. The method according to any one of claims 86-100, wherein the impeller blood pump is an axial flow impeller blood pump.

102. The method according to any one of claims 86-101, wherein the impeller blood pump is a percutaneously implantable impeller blood pump.

103. A method of implanting a transcatheterly implantable medical device in a subject’s body, the method comprising:- advancing the transcatheterly implantable medical device through a first subject’s intracorporeal access, in the subject’s body, and up to a second subject’s intracorporeal access;- externalizing an externalizable portion of the transcatheterly implantable medical device through the second subject’s intracorporeal access; and- manipulating the externalizable portion externalized through the second subject’s intracorporeal access to implant the transcatheterly implantable medical device in the subject’s body.

104. The method according to claim 103, further comprising: surgically obtaining at least one of the first subject’s intracorporeal access and the second subject’s intracorporeal access.

105. The method according to any one of claims 103-104, wherein said manipulating comprises pulling the extemalizable portion externalized through the second subject’s intracorporeal access to implant the transcatheterly implantable medical device in the subject’s body.

106. The method according to any one of claims 103-105, further comprising: anchoring the transcatheterly implantable medical device in the subject’s body.

107. The method according to any one of claims 103-106, wherein the externalizable portion comprises a driveline configured for the transcatheterly implantable medical device to be operated by a controller in the subject’s body therethrough.

108. The method according to claim 107, wherein the externalizable portion comprises an extension that is coupled to a driveline.

109. The method according to claim 108, further comprising: removing the extension from the driveline or splitting the extension into two segments thereof, leaving in each case a driveline-associated extension segment.

110. The method according to claim 109, further comprising: protecting and / or shielding the driveline-associated extension segment.

111. The method according to claim 110, wherein said protecting and / or shielding comprises pushing or sliding the driveline-associated extension segment into the driveline.

112. The method according to claim 109, further comprising: causing the driveline-associated extension segment to be protected and / or shielded.

113. The method according to claim 112, wherein said causing comprises causing the driveline to convert from a compressed state to a decompressed state.

114. The method according to any one of claims 103-113, further comprising: operating the transcatheterly implantable medical device in the subject’s body via the externalizable portion.

115. The method according to claim 114, wherein said operating comprises operating an operable medical device component of the transcatheterly implantable medical device.

116. The method according to any one of claims 114-115, wherein said operating comprises electrically operating.

117. The method according to any one of claims 103-116, further comprising: surgically closing the first subject’s intracorporeal access.

118. The method according to any one of claims 103-117, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump.

119. The method according to any one of claims 103-118, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump having a single blood pump unit.

120. A method of explanting a transcatheterly implantable medical device from a subject’s body, the method comprising:- advancing a medical capture instrument through a first subj ect’ s intracorporeal access, in the subject’s body, and up to the transcatheterly implantable medical device; the transcatheterly implantable medical device being implanted in the subject’s body with an externalizable portion thereof externalized through a second subject’s intracorporeal access;- capturing the transcatheterly implantable medical device with the medical capture instrument; and- manipulating a portion of the medical capture instrument externalized through the first subject’s intracorporeal access to explant the transcatheterly implantable medical device from the subject’s body.

121. The method according to claim 120, further comprising: surgically obtaining the first subject’s intracorporeal access.

122. The method according to any one of claims 120-121, wherein said manipulating comprises pulling the portion of the medical capture instrument externalized through the first subject’s intracorporeal access to explant the transcatheterly implantable medical device in the subject’s body.

123. The method according to any one of claims 120-122, further comprising: unanchoring the transcatheterly implantable medical device from the subject’s body.

124. The method according to any one of claims 120-123, further comprising: stopping an operation of the transcatheterly implantable medical device being operated via the extemalizable portion by a controller.

125. The method according to claim 124, wherein an operable medical device component of the transcatheterly implantable medical device is being operated.

126. The method according to any one of claims 124-125, wherein the transcatheterly implantable medical device is being electrically operated.

127. The method according to any one of claims 124-126, further comprising: disconnecting the extemalizable portion from the controller.

128. The method according to any one of claims 120-127, wherein the externalizable portion comprises a driveline.

129. The method according to claim 128, wherein the externalizable portion comprises an extension that is coupled to a driveline.

130. The method according to claim 129, further comprising: removing the extension from the driveline or splitting the extension into two segments thereof, leaving in each case a driveline-associated extension segment.

131. The method according to claim 130, further comprising: protecting and / or shielding the driveline-associated extension segment.

132. The method according to claim 131, wherein said protecting and / or shielding comprises pushing or sliding the driveline-associated extension segment into the driveline.

133. The method according to claim 130, further comprising: causing the driveline-associated extension segment to be protected and / or shielded.

134. The method according to claim 133, wherein said causing comprises causing the driveline to convert from a compressed state to a decompressed state.

135. The method according to any one of claims 120-134, further comprising: surgically closing the first subject’s intracorporeal access and the second subject’s intracorporeal access.

136. The method according to any one of claims 120-135, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump.

137. The method according to any one of claims 120-136, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump having a single blood pump unit.

138. A method of replacing a transcatheterly implantable medical device in a subject’s body, the method comprising:- coupling an extender to an extemalizable portion of the transcatheterly implantable medical device; the transcatheterly implantable medical device being implanted in the subject’s body with the externalizable portion externalized through a first subject’s intracorporeal access;- advancing a medical capture instrument through a second subject’s intracorporeal access, in the subject’s body, and up to the transcatheterly implantable medical device;- capturing the transcatheterly implantable medical device with the medical capture instrument;- manipulating a portion of the medical capture instrument externalized through the second subject’s intracorporeal access to explant the transcatheterly implantable medical device from the subject’s body;- uncoupling the extender from the extemalizable portion of the transcatheterly implantable medical device;- coupling the extender to an externalizable portion of a replacement transcatheterly implantable medical device; and- manipulating a portion of the extender externalized through the first subject’s intracorporeal access to implant the replacement transcatheterly implantable medical device in the subject’s body.

139. The method according to claim 138, further comprising: surgically obtaining the second subject’s intracorporeal access.

140. The method according to any one of claims 138-139, wherein said manipulating a portion of the medical capture instrument comprises pulling the portion of the medical capture instrument externalized through the second subject’s intracorporeal access to explant the transcatheterly implantable medical device in the subject’s body.

141. The method according to any one of claims 138-140, further comprising: unanchoring the transcatheterly implantable medical device from the subject’s body.

142. The method according to any one of claims 138-141, further comprising: stopping an operation of the transcatheterly implantable medical device being operated via the extemalizable portion by a controller.

143. The method according to claim 142, wherein an operable medical device component of the transcatheterly implantable medical device is being operated.

144. The method according to any one of claims 142-143, wherein the transcatheterly implantable medical device is being electrically operated.

145. The method according to any one of claims 142-144, further comprising: disconnecting the extemalizable portion of the transcatheterly implantable medical device from the controller.

146. The method according to any one of claims 138-145, wherein the externalizable portion of the transcatheterly implantable medical device comprises a driveline.

147. The method according to any one of claims 138-146, wherein said manipulating a portion of the extender comprises pulling the portion of the extender externalized through the first subject’s intracorporeal access to implant the replacement transcatheterly implantable medical device in the subject’s body.

148. The method according to any one of claims 138-147, further comprising: anchoring the replacement transcatheterly implantable medical device in the subject’s body.

149. The method according to any one of claims 142-148, wherein the externalizable portion of the replacement transcatheterly implantable medical device comprises a driveline configured for the replacement transcatheterly implantable medical device to be operated by a controller in the subject’s body therethrough.

150. The method according to any one of claims 138-149, further comprising: operating the replacement transcatheterly implantable medical device in the subject’s body via the extemalizable portion thereof.

151. The method according to claim 150, wherein said operating comprises operating an operable medical device component of the replacement transcatheterly implantable medical device.

152. The method according to any one of claims 150-151, wherein said operating comprises electrically operating the replacement transcatheterly implantable medical device.

153. The method according to any one of claims 138-152, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump.

154. The method according to any one of claims 138-153, wherein the transcatheterly implantable medical device is a transcatheterly implantable blood pump having a single blood pump unit.

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