Implantable medical devices and related methods

Abstract

The implantable medical device includes a functional unit, an introducer unit for introducing and / or navigating the functional unit into a lumen of a body conduit of a subject, and an elongated maneuverable element connectable to a controller for operating the functional unit via the elongated maneuverable element within the lumen of the body conduit of the subject. The functional unit, the introducer unit, and the elongated maneuverable element may be in a slidable relationship for assembling and disassembling the implantable medical device in vivo. According to a related method, the implantable medical device is implantable, removable, and maneuverable within the lumen of a body conduit of a subject.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO OTHER RELATED APPLICATIONS

[0001] This patent application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 421,366, filed November 1, 2022, the entire contents of which (including all references incorporated by reference therein, if any) are incorporated by reference herein for all purposes as if fully set forth herein, except for definitions, subject matter disclaimers or disclaimers, and to the extent that incorporated material contradicts the express disclosure of this specification, in which case the language of this disclosure will control.

[0002] Field

[0002] The present disclosure relates generally to medical devices that are implantable in vivo with associated methods. [Background technology]

[0003]

[0003] To name a few examples in the cardiovascular field, minimally invasive procedures such as transcatheter aortic valve replacement (TAVR) and transcatheter pacemaker implantation are attractive because they cause less trauma to the subject's body than more invasive open-chest surgery.

[0004]

[0004] In particular, implantation of medical devices via minimally invasive surgery requires at least one relatively small bodily incision through which one or more medical devices are routed and implanted, particularly via a transcatheter procedure, into one or more corresponding implantation sites in a subject's body. This bodily incision is generally smaller in size compared to the incisions made during more invasive open-heart surgery, which typically requires direct access to the implantation site to implant a medical device. As a result, a subject's recovery and hospital stay, pain, and / or risk of infection are typically significantly reduced when a medical device is implanted via minimally invasive surgery rather than open-heart surgery. Implantation of medical devices via minimally invasive surgery not only improves overall patient outcomes, but also potentially reduces the financial burden typically associated with implantation of medical devices via open-heart surgery.

[0005]

[0005] However, minimally invasive surgical implantation of a medical device is often dependent on the implantation pathway within the subject's body. For example, in the context of minimally invasive surgical implantation within the subject's cardiovascular system, the diameter of one or more blood vessels may be so small that it prevents the implantable medical device from being properly introduced into its lumen and properly routed to the intraluminal implantation site. Additionally or alternatively, the shape of one or more blood vessels may be so tortuous that it prevents the implantable medical device from being properly routed within its lumen to the intraluminal implantation site without traumatizing and / or damaging the vascular intima.

[0006]

[0006] In minimally invasive surgical implantation of medical devices that require relatively long-term percutaneous transluminal access, such as in the case of some cardiovascular implantation of medical devices, it may be desirable to achieve adequate hemostasis at the site of percutaneous transluminal access, ideally while minimizing the impact on the subject's mobility.

[0007]

[0007] Thus, there is a continuing need for improvements in the field of medical devices that can be implanted via minimally invasive surgery. Summary of the Invention [Means for solving the problem]

[0008]

[0008] A first aspect of the present disclosure relates to an implantable medical device including a functional unit and an introducer unit operably connected to the functional unit for operating the functional unit, the introducer unit configured to introduce the functional unit into a lumen of a body conduit and implant the implantable medical device partially inside the body conduit and partially outside the body conduit.

[0009]

[0009] A second aspect of the present disclosure relates to an implantable medical device including a functional unit having an elongated manipulable element connected to and extending from the functional unit, and an introducer unit having a body, the body defining a longitudinal guide hole extending at least partially along the body and for slidably receiving the elongated manipulable element, the introducer unit configured for slidable assembly with the functional unit within the lumen of the body conduit for implanting the implantable medical device partially within the body conduit and partially outside the body conduit.

[0010]

[0010] A third aspect of the present disclosure relates to a method for implanting an implantable medical device, the method comprising: introducing the implantable medical device into a lumen of a body conduit through a first intraluminal access portion; advancing the implantable medical device within the lumen of the body conduit to a second intraluminal access portion; ejecting an end portion of the implantable medical device through the second intraluminal access portion; and manipulating the implantable medical device via the end portion.

[0011]

[0011] A fourth aspect of the present disclosure relates to a method for removing an implantable medical device, the method comprising obtaining a first body conduit intraluminal access on the side where the implantable medical device is intraluminally implanted in a body conduit, partially positioning an end portion of the implantable medical device through a second body conduit intraluminal access located on the opposite side of the implantable medical device, and retrieving the implantable medical device from the body conduit through the first body conduit intraluminal access.

[0012]

[0012] One aspect of the present disclosure relates to an implantable medical device including a functional unit having an elongated manipulable element connected to and extending from the functional unit, and an introducer unit slidably receiving the elongated manipulable element through the introducer unit such that an intermediate portion of the elongated manipulable element is disposed between the functional unit and the introducer unit, the introducer unit configured to introduce and / or navigate the functional unit intraluminally, the intermediate portion configured to hinge such that the functional unit and the introducer unit can hinge intraluminally relative to each other.

[0013]

[0013] One aspect of the present disclosure relates to a medical device assembly including a sheath configured to be introduced into an intraluminal access portion of a subject's body, and an implantable medical device including a tapered shape for widening the intraluminal access portion when introduced through the intraluminal access portion, wherein the implantable medical device is releasably engageable with the sheath such that the implantable medical device is deliverable intraluminally without leaving the sheath behind while the sheath is introduced into the intraluminal access portion of the subject's body to implant the implantable medical device.

[0014] definition

[0014] As intended in this specification, the expression "body conduit" refers to any physiological structure in a subject's body that defines an interior space, such as a blood vessel, lymphatic vessel, hollow organ, etc.

[0015]

[0015] The terms "operate," "operate," "operating," and the like, when used in the context of use of a medical device, encompass operating, controlling, powering, and corresponding actions.

[0016]

[0016] The term "elongated operable element" and corresponding structure encompasses any elongated structure that can slidably move a functional unit or functional element of an implantable medical device and / or transmit power to a functional unit or functional element of an implantable medical device.

[0017] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order that the present disclosure may be readily understood, at least some selected embodiments thereof are shown by way of example in the accompanying drawings, which are therefore merely illustrative in nature and are not intended to be construed or regarded as limiting the scope of the subject matter protected by the claims.

[0018]

[0018] It should be noted that like reference numerals throughout the drawings identify similar or equivalent elements and / or features. When present in the claims, reference numerals are provided solely to facilitate understanding of the claims and are not intended to be interpreted or considered as limiting the scope of the subject matter protected by the claims. Elements and / or features shown throughout the drawings are not necessarily drawn to scale. [Brief explanation of the drawings]

[0019] [Figure 1]

[0019] FIG. 1 is a schematic diagram of an implantable medical device according to a first aspect of the present technology, comprising an introducer unit having an elongated manipulable element and a functional unit in non-slidable relationship with the introducer unit. [Figure 2A]

[0020] 2 is a perspective view of a non-slidable implantable medical device, such as that of FIG. 1, according to one embodiment. FIG. [Figure 2B] FIG. 2 is a perspective view of a non-slidable implantable medical device, such as that of FIG. 1, according to one embodiment. [Figure 3]

[0021] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with raised portions, according to one embodiment. [Figure 4A]

[0022] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with a detachable tip, according to one embodiment. [Figure 4B]

[0022] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with a detachable tip, according to one embodiment. [Figure 5A]

[0023] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 including an anchor, according to one embodiment. [Figure 5B] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with an anchor, according to one embodiment. [Figure 5C] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with an anchor, according to one embodiment. [Figure 5D] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 with an anchor, according to one embodiment. [Figure 6]

[0024] FIG. 2 is a perspective view of the implantable medical device of FIG. 1 comprising multiple pump elements, according to one embodiment. [Figure 7]

[0025] 1 is a schematic illustration of an implantable medical device comprising an introducer unit and a functional unit having an elongated manipulable element in slidable relationship with the introducer unit, according to a second aspect of the present technology; [Figure 8A]

[0026] FIG. 8 is a perspective view of a slidable implantable medical device according to one embodiment, such as that of FIG. 7. [Figure 8B] FIG. 8 is a perspective view of a slidable implantable medical device according to one embodiment, such as that of FIG. 7. [Figure 8C] FIG. 8 is a perspective view of a slidable implantable medical device according to one embodiment, such as that of FIG. 7. [Figure 9A]

[0027] 8 is a perspective view of the implantable medical device of FIG. 7 being navigated within the lumen of a body conduit. [Figure 9B] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 being navigated within the lumen of a body conduit. [Figure 10]

[0028] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with raised portions, according to one embodiment. [Figure 11A]

[0029] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with a detachable tip, according to one embodiment. [Figure 11B]

[0029] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with a detachable tip, according to one embodiment. [Figure 12A]

[0030] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 including an anchor, according to one embodiment. [Figure 12B] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with an anchor, according to one embodiment. [Figure 12C] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with an anchor, according to one embodiment. [Figure 12D] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with an anchor, according to one embodiment. [Figure 13A]

[0031] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 comprising multiple slidable pump elements, according to one embodiment. [Figure 13B] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 comprising multiple slidable pump elements, according to one embodiment. [Figure 14A]

[0032] 8 is a longitudinal cross-sectional view of the implantable medical device of FIG. 7 housed in a sheath. [Figure 14B]

[0032] FIG. 14B is a cross-sectional view taken along plane XIV-B of FIG. 14A. [Figure 14C]FIG. 14B is a cross-sectional view taken along plane XIV-C of FIG. 14A. [Figure 14D]

[0032] For comparison purposes. [Figure 14E]

[0032] For comparison purposes. [Figure 15]

[0033] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with another anchor, according to one embodiment. [Figure 16] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with another anchor, according to one embodiment. [Figure 17] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with another anchor, according to one embodiment. [Figure 18] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with another anchor, according to one embodiment. [Figure 19] FIG. 8 is a perspective view of the implantable medical device of FIG. 7 with another anchor, according to one embodiment. [Figure 20]

[0034] 8 is a plan view of the implantable medical device of FIG. 7 including a sheath and releasably engaging the sheath for delivery, according to one embodiment. [Figure 21]

[0034] FIG. 8 is a plan view of the implantable medical device of FIG. 7 including a sheath and releasably engaging the sheath for delivery, according to one embodiment. [Figure 22]

[0035] FIG. 8 is a perspective view of a compression fixation mechanism of the implantable medical device of FIG. 7, according to one embodiment. [Figure 23A]

[0036] 8 is a schematic illustration of the implantable medical device of FIG. 7 being navigated within a lumen of a body conduit in a subject's body, according to one embodiment. [Figure 23B]

[0036] FIG. 8 is a schematic illustration of the implantable medical device of FIG. 7 being navigated within a lumen of a body conduit in a subject's body, according to one embodiment. [Figure 23C]

[0036] FIG. 8 is a schematic illustration of the implantable medical device of FIG. 7 being navigated within a lumen of a body conduit in a subject's body, according to one embodiment. [Figure 24]

[0037] 8 is a schematic diagram of a method of implanting the implantable medical device of FIGS. 1 and 7, in accordance with a third aspect of the present technology. FIG. [Figure 25A]

[0038] 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25B] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25C] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25D] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25E] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25F] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25G] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25H] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25I] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 25J] FIG. 8 is a schematic diagram of a method of implanting the implantable medical device of FIG. 7, in accordance with a third aspect of the present technology. [Figure 26]

[0039] 10 is a schematic diagram of a method of implanting a pump unit according to a third aspect of the present technology. [Figure 27]

[0040] 8 is a schematic illustration of a method of removing the implantable medical device of FIGS. 1 and 7 according to a fourth aspect of the present technology. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0020]

[0041] The subject matter of the present disclosure, together with its advantages, will be described in the following detailed description with reference to non-limiting aspects, embodiments, examples, features, elements, and / or steps described below and illustrated in the accompanying non-limiting drawings. Those skilled in the art will recognize that these non-limiting aspects, embodiments, examples, features, elements, and steps may vary, and will readily recognize that other variations thereof, and any combination of these other variations, in some cases even if not all of them are explicitly presented and described herein, are contemplated without departing from the scope of the present disclosure.

[0021]

[0042] Accordingly, these non-limiting aspects, embodiments, examples, features, and / or elements are intended to facilitate an understanding of the manner in which the claimed subject matter may be implemented by one of ordinary skill in the art, and as such, these non-limiting aspects, embodiments, examples, features, and / or elements should not be construed as limiting the scope of the claimed subject matter, which is defined solely by the appended claims and applicable law.

[0022]

[0043] The terminology used herein is for the purpose of describing and explaining the claimed subject matter only, and is not intended to limit its scope. Unless otherwise defined, all technical, engineering, scientific, and other related terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0023]

[0044] With the above in mind, the present disclosure relates to medical devices that can be implanted into and removed from a lumen in a subject's body via minimally invasive surgery. For example, the medical devices disclosed herein can be implanted into and / or removed from the lumens of blood vessels, lymphatic vessels, and hollow organs. As will be understood below, the medical devices disclosed herein, along with their implantation and removal modes, are suitable for introduction, navigation, and implantation into, and removal from, lumens in a subject's body that may typically be difficult to treat due to size constraints or size incompatibility for the use of medical devices known in the art.

[0024]

[0045] At a high level, the implantable medical devices disclosed herein include an introducer unit and a functional unit, which may or may not be in a slidable relationship for assembling and / or disassembling the introducer unit and functional unit relative to one another. The introducer unit is configured to introduce and / or navigate the functional unit into a lumen of one or more bodily conduits, such as a blood vessel, for endoluminal implantation of the functional unit within the lumen of the one or more bodily conduits. When so implanted, the introducer unit is at least partially externalized from the bodily conduit for endoluminal operation of the functional unit therethrough.

[0025]

[0046] An implantable medical device 100 according to a first embodiment of the present disclosure will be described with reference to FIGS.

[0026]

[0047] 1 schematically illustrates an implantable medical device 100 according to an embodiment. The implantable medical device 100 includes an introducer unit 102 having an elongated, manipulable element 104 integrated therein, and at least one functional unit 105 operably connected to the elongated, manipulable element 104 for manipulation. In a first aspect of the present disclosure, the introducer unit 102 and the functional unit 105 are physically coupled to each other in a non-slidable relationship, thus forming an integrated, monolithic device. The implantable medical device 100 may be deliverable to, implantable in, and retrievable from a lumen of a body conduit. The introducer unit 102 may function as a percutaneous dilator comprising an elongated manipulable element 104 integrated into the introducer unit 102 such that the functional unit 105 is implanted in vivo with the aid of the introducer unit 102 and manipulated from outside the subject's body through the introducer unit 102. The functional unit 105 is manipulable via the elongated manipulable element 104, such as by being electrically or mechanically manipulated, when the elongated manipulable element 104 is operably connected to a controller (not shown). Such manipulation may produce a hemodynamic effect within the subject's body.

[0027]

[0048] The introducer unit 102 is not only configured to introduce, guide, and navigate the functional unit 105 into the lumen of a body conduit for implantation of the functional unit 105 at its intraluminal implantation site, but is also configured to operate the functional unit 105 intraluminally in the lumen through which the functional unit 105 passes by operational connection to a controller (which connection is made extraluminally outside the lumen).

[0028]

[0049] When the implantable medical device 100 is implanted in the lumen of a body conduit, the introducer unit 102 is partially positioned extraluminally outside the lumen of the body conduit through the intraluminal access portion, while the functional unit 105 is positioned intraluminally in the lumen of the body conduit.

[0029]

[0050] 1, implantable medical device 100 may further include, for example, a guidewire 108, a tip 110, an anchor 112, an anchor rod 114, a capture element 116, and a cover 118 (optional items shown by dashed lines in FIG. 1), as described below. Implantable medical device 100 may also optionally include more than one functional unit 105.

[0030]

[0051] 2A-2B show an implantable medical device 100 including an introducer unit 102 and a pump element 106 provided as a functional unit 105, according to an embodiment. The introducer unit 102 has a body 200 extending between a proximal end portion 202 at which the pump element 106 is physically coupled to the introducer unit 102 and a distal end portion 204 that corresponds to the distal end portion 206 of the implantable medical device 100. The pump element 106 may be physically coupled to the introducer unit 102 by gluing, fusing, welding, or the like.

[0031]

[0052] While the proximal and distal end portions 202, 204 of the introducer unit 102 may be of any shape, the distal end portion 204 may be more particularly shaped to facilitate introduction of the implantable medical device 100 through an intraluminal access in a body conduit. The distal end portion 204 may also be shaped to reduce or prevent damage or injury to the lumen wall, such as the intima in the case of a blood vessel, that may result from introduction and navigation of the implantable medical device 100 in the lumen. Thus, the distal end portion 204 of the introducer unit 102 may be shaped such that its cross-sectional size and / or shape gradually increases from the distal end portion 204 to the proximal end portion 206 of the introducer unit 102.

[0032]

[0053] 2A-2B , for example, the distal end portion 204 of the introducer unit 102 has a tapered and / or profiled shape (referred to herein as "tapered"). However, the distal end portion 204 of the introducer unit 102 may have any other suitable shape, such as a rounded or convex shape, an oval shape, a pyramidal shape, a blunt shape with rounded edges, or any other shape that is atraumatic to the lumen wall. In all cases, the distal end portion 204 of the introducer unit 102 may be free of sharp edges and corresponding structures that may damage or injure the lumen wall, such as by undesirably scraping, scratching, cutting, puncturing, tearing, and / or dissecting, while the implantable medical device 100 is being introduced and / or navigated through the lumen. Regardless of its shape, the distal end portion 204 of the introducer unit 102 may be attachable to a wireline or other corresponding structure that can be pulled to introduce and / or navigate the implantable medical device 100 within the lumen of a body conduit, where such attachment is strong enough to maintain an adequate pulling force without breaking under the conditions of a medical procedure.

[0033]

[0054] When the implantable medical device 100 is properly used, the tapered shape of the distal end portion 204 may aid and / or facilitate introduction of the introducer unit 102 through a lumen of a body conduit by gradually widening the intraluminal access, which may be a percutaneous intraluminal access, as the introducer unit 102 is introduced therethrough, such that the intraluminal access is sized and / or shaped to accommodate passage of the pump element 106.

[0034]

[0055] 2A-2B, the introducer unit 102, according to an embodiment, comprises an elongate steerable element 104 (shown in dashed lines to provide a perspective view of the introducer unit 102) operably connected at its proximal end portion 208 to the pump element 106 and removably operably connectable at its distal end portion 210 to an optional controller 226 (shown in FIG. 2B) by a connector 212. The elongate steerable element 104 extends at least partially along the introducer unit 102 and may be located anywhere, such as within the body 200 (as shown in FIGS. 2A-2B) or on the surface of the body 200 of the introducer unit 102. The connector 212 may be integrated into the distal end portion 204 of the introducer unit 102 and may be located at its periphery or at its end, as shown in FIGS. 2A-2B.

[0035]

[0056] As shown, the elongated steerable element 104 is an electrical conductor configured, when connected to the controller, to transmit electricity from the controller to the pump element 106. In particular, the electrical conductor operably interconnects the pump element 106 to the controller 226 via a detachable electrical connection provided by the connector 212 such that the pump element 106 may be electrically operated by the controller from the distal end portion 206 of the implantable medical device 100.

[0036]

[0057] Alternatively, the elongated manipulable element 104 may be a drive shaft configured to transmit torque from a controller, such as an actuator or motor, to the pump element 106. In this case, the drive shaft may operate the pump element 106 or any other functional unit 105 in a variety of ways, including rotational and / or reciprocal motion.

[0037]

[0058] Further alternatively, the implantable medical device 100 may include a wireless module integrated into the introducer unit 102. The wireless module is operably connected to the elongated steerable element 104, which in this case may include electrical conductors, and is configured to wirelessly connect to a controller for operating the pump element 106.

[0038]

[0059] To enable or facilitate endoluminal navigation, the introducer unit 102 and elongated steerable element 104 may be made of bendable, flexible, and / or resilient materials to accommodate or conform to various body conduit morphologies, yet be rigid enough to be pushed through an endoluminal access. For example, the introducer unit 102 may be made of a polymer such as thermoplastic polyurethane, while the elongated steerable element 104 may include electrical conductors or may be a drive shaft made of a suitable bendable, flexible, and / or resilient material.

[0039]

[0060] 2A , according to an embodiment, implantable medical device 100 includes an optional cover 118. Depending on the nature of connector 212, such as when electrical connector 212 is an electrical connector, it may be desirable to protect connector 212 from environmental elements, such as blood, to ensure proper connectivity. Cover 118 is removable from implantable medical device 100 for operably connecting connector 212 to controller 226. For example, cover 118 may be removably attachable to peripheral cavity 224 in which connector 212 is disposed (as shown), or may be removably attachable directly to connector 212. Removable attachment of cover 118 to implantable medical device 100 may be by interference fit, threaded fastening, etc.

[0040]

[0061] FIG. 3 illustrates an introducer unit 102 including an optional ridge 300 on its distal end portion 204, according to an embodiment. The cover 118 is omitted from FIG. 3 but may be present. The ridge 300 is shown located near the distal end portion 204 of the introducer unit 102, but may be located anywhere along the length of the introducer unit 102, such as near the intermediate or proximal end portions 204 of the introducer unit 102. The ridge 300 is sized and shaped to disrupt the gradual increase in cross-sectional size of the tapered shape of the distal end portion 204. In particular, the ridge 300 increases the cross-sectional size of the introducer unit 102 more abruptly than the tapered shape does. Additionally, the introducer unit 102 may include multiple ridges 300 spaced apart from one another along the length of the introducer unit 102. In this case, each of the plurality of ridges 300 has an increasing cross-sectional size relative to the preceding ridge 300 when moving from the distal end portion 204 towards the proximal end portion 202 of the introducer unit 102 .

[0041]

[0062] In use, after introducing the distal end portion 204 of the introducer unit 102 through the intraluminal access and optionally achieving hemostasis, further introducing one or more ridges 300 through the intraluminal access may facilitate or improve hemostasis by further widening the intraluminal access and providing a fluid-tight engagement. The difference in cross-sectional size between the distal end portion 204 of the introducer unit 102 and the ridges 300 may be about 0.5 Fr, 1.0 Fr, 1.5 Fr, or 2.0 Fr.

[0042]

[0063] 4A-4B show an implantable medical device 100 having a distal end portion 204 of the introducer unit 102 provided as an optional tip 110 that is removably attachable to the remainder of the introducer unit 102 and coupled to a guidewire 108, according to an embodiment. The tip 110 has a tapered shape similar to the tapered shape of the distal end portion 204 of the introducer unit 102 of FIGS. 2A-2B. As shown, the tip 110 also has an optional ridge 400 similar to the ridge 300 of the distal end portion 204 of the introducer unit 102 of FIG. 3. The tip 110 may be attachable to a wireline or other corresponding structure that can be pulled to introduce and / or navigate the implantable medical device 100 within a lumen of a body conduit, where such attachment is strong enough to maintain an appropriate pulling force without breaking under the circumstances of a medical procedure.

[0043]

[0064] With respect to the cover 118, the tip 110, when attached to the implantable medical device 100, is adapted to protect the connector 212 from environmental elements, such as blood, and is removable from the implantable medical device 100 for operably connecting the connector 212 to a controller. For example, the tip 110 may be removably attachable to the distal cavity 402 (as shown) in which the connector 212 is disposed, or may be removably attachable directly to the connector 212. Removable attachment of the tip 110 to the implantable medical device 100 may be by threading (as shown), an interference fit, or the like. The elongated steerable element 104 (shown in dashed lines in FIGS. 4A-4B as a perspective view of the introducer unit 102) is depicted in FIGS. 4A-4B as an electrical conductor configured to transmit electricity from the controller (not shown) to the pump element 106 when connected to the controller.

[0044]

[0065] The tip 110 is generally similar to the distal end portion 204 of the introducer unit 102, particularly with respect to its tapering and ridges, and for the sake of brevity, the tip 110 will not be further described herein. It will therefore be understood that similar descriptions, where applicable, apply to the tip 110 and the distal end portion 204 of the introducer unit 102, mutatis mutandis, as would be understood by one of ordinary skill in the art.

[0045]

[0066] 4A , according to an embodiment, the implantable medical device 100 includes an optional locking mechanism 404 configured to lock the tip 110 in place on the introducer unit 102 to prevent undesired detachment of the tip 110 from the introducer unit 102, such as upon application of a pulling force to the guidewire 108. As shown, the locking mechanism 404 is integrated into the cavity 402 of the introducer unit 102, or alternatively, the locking mechanism 404 may be integrated anywhere along the length of the introducer unit 102. The locking mechanism 404 may be useful when the tip 110 is removably attached to the introducer unit 102 by an interference fit.

[0046]

[0067] The locking mechanism 404 may include a set screw or other similar engagement structure on the introducer unit 102 that removably engages and locks the tip 110. Alternatively, the locking mechanism 404 may also include a first portion on the introducer unit 102 and a second portion on the tip 110. The first and second portions are configured to selectively engage with each other to lock them together. In this case, the first portion may be a pin or other corresponding engagement structure, while the second portion may be a hole or other corresponding engagement structure configured to cooperatively engage with the first portion.

[0047]

[0068] 5A-5D show an implantable medical device 100 including an optional anchor 112 having a contracted configuration (FIGS. 5A, 5C) and an expanded configuration (FIGS. 5B, 5D), according to an embodiment. As shown in FIGS. 5A-5C, the anchor 112 in the contracted configuration may be housed within a sheath (shown in dashed lines as an optional component of the implantable medical device 100) for implanting and / or removing the implantable medical device 100. Although the implantable medical device 100 is shown in FIGS. 5A-5D with a tip 110, the implantable medical device 100 may alternatively include a cover 118.

[0048]

[0069] The anchor 112 in the contracted configuration is introduceable and navigable within a lumen of a body conduit, whether or not housed within a sheath. The anchor 112 in the expanded configuration is configured to removably anchor the implantable medical device 100 to a lumen of a body conduit by removably engaging the lumen wall. The anchor 112 is deployable within the lumen of the body conduit, for example, at an intraluminal implantation site where the pump element 106 is desired to be immobilized for operation. Anchoring the implantable medical device 100 not only ensures that the pump element 106 remains in place at the intraluminal implantation site to provide an appropriate hemodynamic effect, but also allows the distal end portion 204 of the introducer unit 102 to remain appropriately in place through an intraluminal access, such as a percutaneous intraluminal access, to help promote or maintain hemostasis.

[0049]

[0070] 5B , anchor 112 has a tubular wall 500 defining a central opening 502 and includes at least one anchor arm, such as six anchor arms 504A-F as shown, that couples tubular wall 500 to pump element 106 and positions pump element 106 and / or introducer unit 102 at least partially within central opening 500. Alternatively, tubular wall 500 may be attached to introducer unit 102 by at least one anchor arm, such as anchor arms 504A-F, so as to position pump element 106 and / or introducer unit 102 at least partially within central opening 502. Thus, anchor 112 may be generally structured as a stent-like structure, an array-like structure, and / or a scaffold-like structure.

[0050]

[0071] 5C-5D, according to an embodiment, the implantable medical device 100 includes an optional anchor rod 114 supporting the anchor 112. A distal end portion 506 of the anchor rod 114 is attached to the pump element 106. At least one anchor arm, such as anchor arms 502A-F as shown, connects to the proximal end portion 508 of the anchor rod 114, at least one anchor arm, such as anchor arms 502B-E as shown, connects to the distal end portion 506 of the anchor rod 114, and at least one anchor arm, such as anchor arms 502C-D as shown, connects to the pump element 106. Alternatively, at least one anchor arm, particularly three anchor arms 504, may connect only to the proximal end portion 508 of the anchor rod 114. The pump element 106 and / or introducer unit 102 are connected by one or more of the anchor arms 504A-F and are positioned at least partially within a central opening 502 defined by the tubular wall 500.

[0051]

[0072] 5B and 5D, anchor 112 is sized and shaped such that its cross-sectional size gradually increases moving from its proximal end portion 510 toward its distal end portion 512. Thus, as shown, anchor 112 has a tapered and / or profiled shape (referred to herein as "tapered"). Such a tapered shape need not be limited to the shape shown in FIGS. 5B and 5D, as anchor 112 may not have a tubular wall 500 and may, in that case, have only three anchor arms 504, which may include atraumatic lumen wall-engaging end portions.

[0052]

[0073] Anchor 112 is convertible between a retracted configuration (as shown in FIGS. 5A and 5C) and an expanded configuration (as shown in FIGS. 5B and 5D). In the retracted configuration, tubular wall 500 and anchor arms 504A-F are positioned radially closer to pump element 106 and / or introducer unit 102 than in the expanded configuration. In the expanded configuration, tubular wall 500 and anchor arms 504A-F are positioned radially farther from pump element 106 and / or introducer unit 102 than in the retracted configuration so that anchor 112 can releasably engage the lumen wall of a body conduit during use, thereby releasably anchoring implantable medical device 100 to the lumen wall of a body conduit.

[0053]

[0074] Anchor 112 may be self-expandable (also referred to herein as a "self-expandable anchor") and thus may be biased toward an expanded configuration such that it can be overcome. In this case, self-expandable anchor 112 may be constrained in a contracted configuration by a sheath that houses implantable medical device 100 therein, as shown in FIGS. 5A-5C. If self-expandable, anchor 112 may be made of a material that imparts such properties, such as nitinol, stainless steel, a polymer, a plastic, or the like.

[0054]

[0075] In use, implantable medical device 100 housed within a sheath (i.e., "sheathed") can be delivered to and / or implanted at an intraluminal implantation site within a lumen of a body conduit with self-expandable anchor 112 restrained in a contracted configuration by the sheath. After introducing the sheath into the lumen of the body conduit through the intraluminal access, such as a percutaneous intraluminal access, and navigating the sheath to the intraluminal implantation site, implantable medical device 100 is removed from the sheath (i.e., "unsheathed") for implantation, thereby releasing the restraint imposed on self-expandable anchor 112 by the sheath and causing self-expandable anchor 112 to automatically transform from the contracted configuration to the expanded configuration as shown in Figures 5B and 5D.

[0055]

[0076] Alternatively, anchor 112 may be transformed from the collapsed configuration to the expanded configuration within the lumen of a body conduit by a balloon catheter that is inserted into central opening 500 and then inflated. In this case, anchor 112 is not self-expandable but is malleable. Thus, anchor 112 may be made of a material that imparts this property, such as a cobalt-chromium alloy.

[0056]

[0077] In the absence of self-expandable anchor 112, implantable medical device 100 may be deliverable and / or implantable within the lumen of a body conduit with or without the use of a sheath.

[0057]

[0078] Furthermore, during use, the implantable medical device 100 can be retrieved from an intraluminal implantation site within a lumen of a body conduit using a sheath. The sheath is introduced into the lumen of the body conduit through a first intraluminal access, such as a percutaneous intraluminal access, approaches the implantable medical device 100 from its impeller end portion (i.e., the proximal end portion of the implantable medical device 100), and is gradually slid over the self-expandable anchor 112 in the expanded configuration. To maintain the implantable medical device 100 in place within the lumen, the distal end portion 206 of the implantable medical device 100 can be held and secured by an operator through a second intraluminal access, such as a percutaneous intraluminal access. Alternatively, the distal end portion 206 of the implantable medical device 100 can be pushed toward the sheath by the operator through the second intraluminal access. As the sheath is slid over the expandable anchor 112, the sheath applies pressure to the proximal end portion 510 of the self-expandable anchor 112, which is tapered as shown, gradually transforming the self-expandable anchor 112 from an expanded configuration to a contracted configuration. The sheath containing (i.e., "sheathed") the implantable medical device 100 is then removed from the lumen of the body conduit, thereby extracting the implantable medical device 100.

[0058]

[0079] In the absence of self-expandable anchor 112, implantable medical device 100 may be retrievable and / or removable from the lumen of the body conduit with or without the use of a sheath.

[0059]

[0080] 5A-5D, according to an embodiment, the implantable medical device 100 comprises an optional capture element 116 that can be captured in vivo by a tool, such as a snare, to pull or maintain the implantable medical device 100 in place within the lumen of a body conduit. The capture element 116 can be located on the pump element 106 (as shown in FIGS. 5A-5B) or on the proximal end portion 508 of the anchor rod 114 (as shown in FIGS. 5C-5D) and can be captured from the proximal end portion 510 of the anchor 112 in use.

[0060]

[0081] The capture element 116 may have any size and shape that allows for its intraluminal capture by a tool. For example, as shown in Figures 5A-5D, the capture element 116 defines an annular recess 514 that the loop of a snare may surround to capture the capture element 116. Alternatively, the capture element 116 may be a hook that can be intraluminally captured by a snare or similar tool, or a loop that can be intraluminally captured by a hook tool or similar tool.

[0061]

[0082] The capture element 116 can be used to remove the implantable medical device 100 from the lumen of the body conduit. In particular, in use, a sheath is introduced into the lumen of the body conduit through a first intraluminal access, such as a percutaneous intraluminal access, and navigated there to approach the self-expandable anchor 112 from the proximal end portion 510 of the self-expandable anchor 112. A snare passing through the sheath captures the capture element 116. The snare is pulled to place the implantable medical device 100 into the sheath. The sheath can be pushed through the first intraluminal access toward the implantable medical device 100 while the snare is being pulled or not. The distal end portion 206 of the implantable medical device 100 can also be pushed through a second intraluminal access, such as a percutaneous intraluminal access, that receives the implantable medical device 100, toward the sheath while the snare is being pulled or not. The sheath containing the implantable medical device 100 is then removed from the lumen of the body conduit and the implantable medical device 100 is withdrawn.

[0062]

[0083] The capture element 116 may also be used to convert the self-expandable anchor 112 from the expanded configuration to the contracted configuration during removal. In particular, with the sheath abutting the proximal end portion 510 of the self-expandable anchor 112 in the expanded configuration, the snare is pulled such that the sheath applies pressure to the tapered proximal end portion 510 of the self-expandable anchor 112, converting the self-expandable anchor 112 from the expanded configuration to the contracted configuration. As described herein above, the sheath can be pushed through a first intraluminal access toward the implantable medical device 100, and / or the distal end portion 206 of the implantable medical device 100 can be pushed through a second intraluminal access to assist in the conversion while the snare is being pulled or not.

[0063]

[0084] The coaxial arrangement of the capture element 116 relative to the implantable medical device 100 allows pressure to be applied uniformly by the sheath to the proximal end portion 510 of the anchor 112, facilitating sheathing of the implantable medical device 100 within the sheath and converting the anchor 112 from an expanded configuration to a contracted configuration.

[0064]

[0085] The capture element 116 may be made of a radiopaque material, such as nitinol, that is visible by medical imaging, such as by fluoroscopy, to aid or facilitate intraluminal capture of the capture element 116 by a tool. The impeller may be made of a material that is not radiopaque to facilitate observation by medical imaging of the capture element 116, which may be positioned relatively close to the impeller as shown in Figures 5A-5B.

[0065]

[0086] 1-5, according to an embodiment, the implantable medical device 100 comprises an optional guidewire 108 that is attachable to the implantable medical device 100 and that is pullable to move the implantable medical device 100 within a lumen of a body conduit. As shown in FIGS. 2A-2B through 5, the guidewire 108 has a proximal end portion 216 that is attached to a distal end portion 204 of the introducer unit 102, which may be a tip 110, e.g., at its tapered most distal end portion 218. The attachment of the guidewire 108 to the introducer unit 102 or tip 110 may be rotatable and / or detachable.

[0066]

[0087] The distal end portion 220 of the guidewire 108 may also be endoluminally captureable by a tool, such as a snare, that can be pulled to introduce and / or navigate the implantable medical device 100 into the lumen of a body conduit. In particular, the distal end portion 220 of the guidewire 108 may be flexible. The distal end portion 220 of the guidewire 108 may be more flexible than the proximal end portion 216 of the guidewire 108, i.e., the proximal end portion 216 may be stiffer than the distal end portion 220. Such stiffer characteristics may aid in routing the guidewire 108 within the lumen of a body conduit by pushing the proximal end portion 216 of the guidewire 108. Alternatively, the entire guidewire 108 may be inherently flexible. The flexible nature of the guidewire 108 allows a tool to endoluminally capture the guidewire 108 by folding back its flexible portion at a bend formed by a snare. By being so folded, the guidewire 108 and tools can be moved along the lumen of the body conduit and through the endoluminal access without significant resistance and / or without damaging or injuring the lumen wall.

[0067]

[0088] Alternatively, the distal end portion 220 of the guidewire 108 may be provided with a hook that can be captured intraluminally by a snare or similar tool, or may be provided with a loop that can be captured by a tool provided with a hook or similar structure that can capture the loop.

[0068]

[0089] The attachments between the guidewire 108 and the introducer unit 102, between the guidewire 108 and the tip 110, and between the tip 110 and the remainder of the introducer unit 102 are strong enough to maintain proper tension on the guidewire 108, as the case may be, without detaching the tip 110 and / or damaging the implantable medical device 100. Accordingly, such attachments may be made by gluing, fusing, welding, or screwing the components together, or, as the case may be, by implementing a locking mechanism 404.

[0069]

[0090] According to embodiments, guidewire 108 may include an electrical conductor extending at least partially between its proximal end portion 216 and a distal end portion 220, which may or may not be flexible. The electrical conductor is electrically connected at proximal end portion 216 to elongate steerable element 104, which in this case is also an electrical conductor, as described herein above. At distal end portion 220, guidewire 108 integrates with an electrical connector that is removably connectable to a controller for operating pump element 106.

[0070]

[0091] In use, the distal end portion 220 of the guidewire 108 is introduced through a first intraluminal access, such as a first percutaneous access, and the guidewire 108 is routed within the lumen of a body conduit. The distal end portion 220 of the guidewire 108 is captured by a tool, such as a snare, routed through a second intraluminal access, such as a second percutaneous access. The snare capturing the guidewire 108 is then pulled to move the guidewire 108 along the lumen of the body conduit to and through the second intraluminal access. In doing so, depending on the length of the guidewire 108, the implantable medical device 100 can be introduced into the first intraluminal access and / or navigated within the lumen of the body conduit through which the guidewire 108 was originally routed. While the guidewire 108 is being pulled, the proximal end portion 202 of the introducer unit 102 may be pushed to aid or facilitate introduction and / or movement.

[0071]

[0092] In some situations, it may be desirable to pull the guidewire 108 to advance the implantable medical device 100 within the lumen of a bodily conduit, as simply pushing the implantable medical device 100 would cause the implantable medical device 100 to move in an undesired direction. Advantageously, integrating the guidewire 108 into the implantable medical device 100 allows the implantable medical device 100 to be introduced into and navigated through the lumen of a bodily conduit in ways that would not be possible without the guidewire 108. Indeed, depending on their morphology, bodily conduits may be quite tortuous, with one or more sharp angles that may hinder the proper introduction and / or navigation of other implantable medical devices within the bodily conduit without damaging or injuring the lumen wall. In particular, other implantable medical devices may be sized, shaped, and / or inherently rigid such that they cannot pass through such sharp angles. The guidewire 108, on the other hand, is appropriately sized, generally smaller, and more flexible than at least some implantable medical devices, allowing it to pass through these sharp angles. 23A-23C and 25A-25J, and are described in more detail below. When routed within a lumen of a body conduit, the guidewire 108 may advantageously be pulled to assist or facilitate the introduction and / or navigation of the implantable medical device 100, optionally while the implantable medical device is simultaneously pushed. The combination of pulling and pushing actions may allow for a smoother medical procedure with less trauma to the lumen wall.

[0072]

[0093] The guide wire 108 allows the implantable medical device 100 to be pulled intraluminally in one direction, while the implantable medical device 100 can be pulled in the opposite direction via the capture element 116, which, overall, may be desirable to properly position the implantable medical device 100 intraluminally depending on the medical procedure being performed.

[0073]

[0094] The connection between the guidewire 108 and the implantable medical device 100 is also advantageously stronger than the typical attachment between a tool, such as a snare, and an implantable medical device. Such a stronger connection allows the implantable medical device 100 to maintain adequate tension without breaking under the conditions of a medical procedure, which is not necessarily the case with the typical attachment between a snare and an implantable medical device.

[0074]

[0095] It will be appreciated that these advantages exist whether the implantable medical device 100 is pulled by the guidewire 108 or by the distal end portion 206 of the implantable medical device 100 with a tool such as a snare.

[0075]

[0096] 6 illustrates an implantable medical device 100 including three pump elements 106A-C, as shown, which may be any of a plurality of pump elements 106 provided as a functional unit 105, according to an embodiment. Each of the pump elements 106A-C is coupled to a proximal end portion 202 of the introducer unit 102 and is disposed generally parallel to each other and to the introducer unit 102. The introducer unit 102 includes three elongated steerable elements 104A-C (shown in dashed lines as a perspective view of the introducer unit 102), which may be any of a corresponding plurality of elongated steerable elements. Each of the elongated steerable elements 104A-C extends at least partially along the introducer unit 102, is operably connected at its respective proximal end portion to a corresponding one of the three pump elements 106A-C, and is operably connectable at its respective distal end portion to at least one controller (not shown) by a respective connector 212A-C. Each of the connectors 212A-C may be disposed within a respective peripheral cavity 224 as shown, and may include a corresponding optional cover. Alternatively, the connectors 212A-C may be disposed within a single common peripheral cavity, and may include an optional cover.

[0076]

[0097] The pump elements 106A-C may be longitudinally offset relative to one another such that the impeller end portions of the pump elements 106A-C are each longitudinally positioned differently. Additionally or alternatively, the pump elements 106A-C may or may not be positioned parallel to one another such that the impeller end portions of the pump elements 106A-C are each spaced apart a distance greater than the distance between each of the introducer units that contact the end portions of the pump elements 106A-C. Depending on the pump elements 106A-C, such positioning and spacing may improve pump performance, including better fluid outflow and reduced fluid shear stress (the latter of which can lead to hemolysis and / or blood thrombosis).

[0077]

[0098] The pump elements 106A-C and the introducer unit 102 may have the same cross-sectional size, as shown in Figure 6. Alternatively, the pump elements 106A-C may have a cross-sectional size that is larger than the cross-sectional size of the introducer unit 102, as described and shown in Figure 13B with respect to the implantable medical device 700 in an assembled configuration.

[0078]

[0099] 6 may also include the optional tip 110 and optional locking mechanism 404, the optional anchor 112, the optional anchor rod 114, one or more optional capture elements 116, and the optional guidewire 108. If the anchor 112 is included, the pump elements 106A-C may be at least partially longitudinally received in the central opening 502 of the anchor 112, and at least one of the anchor arms 504A-F may couple the anchor 112 to one or more of the pump elements 106A-C and / or the introducer unit 102. If the anchor rod 114 is included, the pump elements 106A-C may be disposed about the anchor rod 114. If a capture element 116 is provided, it may be present on one or more of the pump elements 106A-C.

[0079]

[0100] Because the implantable medical device 100 with multiple pump elements 106A-C is similar to the implantable medical device 100 with a single pump element 106, the description of the implantable medical device 100 with multiple pump elements 106A-C will not be further described herein for the sake of brevity. Accordingly, it will be understood that the description of the implantable medical device 100 with a single pump element 106 applies, where applicable, to the implantable medical device 100 with multiple pump elements 106A-C mutatis mutandis as would be understood by one of ordinary skill in the art.

[0080]

[0101] 7 through 14A-14D, an implantable medical device 700 according to a second aspect of the present disclosure will now be described.

[0081]

[0102] 7 schematically illustrates an implantable medical device 700 according to an embodiment. The implantable medical device 700 includes an introducer unit 702 and at least one functional unit 705 having a functional element 704 and an elongated, manipulable element 708 operably connected to the functional element 704 for operation. In a second aspect of the disclosure, the introducer unit 702 and the functional unit 705 are in a slidable relationship and form two distinct and separate devices that function together.

[0082]

[0103] In particular, the introducer unit 702 and the functional element 704 can be assembled and disassembled from one another by a relative sliding movement between the introducer unit 702 and the elongate, steerable element 708. The implantable medical device 700 can be delivered to and retrieved from the lumen of a body conduit when the introducer unit 702 and the functional element 704 are in a disassembled state. The implantable medical device 700 can be implanted in the lumen of a body conduit when the introducer unit 702 and the functional element 704 are assembled or when the introducer unit 702 and the functional element 704 are disassembled from one another. The introducer unit 702 may function as a percutaneous dilator that slidably receives the elongated steerable element 708 of the functional unit 705 through the introducer unit 702 such that the functional unit 705 is implanted in vivo with the aid of the introducer unit 702 and manipulated from outside the subject's body via the elongated steerable element 708. The functional unit 705 is manipulable via the elongated steerable element 708, such as by being electrically or mechanically manipulated, when the elongated steerable element 708 is operably connected to a controller (not shown). Such manipulation may produce a hemodynamic effect within the subject's body.

[0083]

[0104] The introducer unit 702 is configured not only to be introduced, guided, and navigated within the lumen of a body conduit, but also to route the elongated, steerable element 708 of the functional unit 705 along the lumen of the body conduit, by their slidable relationship, for implantation of the functional unit 705 at its intraluminal implantation site. Thus, the functional unit 705 is slidably received through the introducer unit 702 and manipulated within the lumen via the elongated, steerable element 708, which is operably connected to a controller external to the lumen.

[0084]

[0105] When the implantable medical device 700 is implanted in the lumen of a body conduit with the introducer unit 702 and functional unit 705 combined, the introducer unit 702 is partially positioned extraluminally outside the lumen of the body conduit through the intraluminal access portion, while the functional unit 705 is positioned intraluminally in the lumen of the body conduit.

[0085]

[0106] 7, implantable medical device 700 may further include, for example, a guidewire 710, a tip 712, an anchor 714, an anchor rod 716, a first capture element 718, a second capture element 720, a cover 818, and a fixation mechanism 824 (optional items shown by dashed lines in FIG. 7), as described below. Implantable medical device 700 may also optionally include more than one functional unit 705.

[0086]

[0107] 8A-8C show an implantable medical device 700 including an introducer unit 702 and a pump unit 706 provided as a functional unit 705, according to an embodiment. The introducer unit 702 has a body 800 defining a longitudinal guide hole 802 (shown in dashed lines in FIGS. 8A and 8C as a perspective view of the introducer unit 702). The pump unit 706 has a pump element 707 provided as a functional element 704 and an elongated manipulable element 708 operably connected to the pump element 707. The elongated manipulable element 708 of the pump unit 706 is slidably receivable in the longitudinal guide hole 802 of the introducer unit 702 for moving the pump element 707. As shown in Figures 8A-8B, the elongated manipulable element 708 is slidably received in the longitudinal guide hole 802, and the relative slidable movement between the elongated manipulable element 708 and the introducer unit 702 is represented by the double-headed arrow.

[0087]

[0108] The longitudinal guide hole 802 extends at least partially between a proximal end portion 804 of the introducer unit 702 (where the introducer unit 702 contacts the pump element 707 when combined) and a distal end portion 806 (corresponding to the distal end portion 808 of the implantable medical device 700). The longitudinal guide hole 802 has a proximal opening 810 positioned at the proximal end portion 804 of the introducer unit 702 and a distal opening 812 positioned at the distal end portion 806 of the introducer unit 702. The positioning of the distal opening 812 relative to the introducer unit 702 allows the elongated steerable element 708 to freely slidably move within the longitudinal guide hole 802 and within the lumen of the body conduit, potentially without damaging or injuring the lumen wall adjacent the distal end portion 806 of the introducer unit 702.

[0088]

[0109] The elongated steerable element 708 received in the longitudinal guide hole 802 extends at least partially along the introducer unit 702, with its proximal end portion 814 protruding proximally outward from the proximal opening 810 (e.g., when the implantable medical device 700 is in a disassembled state as shown) and its distal end portion 816 protruding distally outward from the distal opening 812. The proximal opening 810 of the longitudinal guide hole 802 may include an optional sealing element 824 that provides a fluid-tight engagement between the proximal opening 810 of the introducer unit 702 and the elongated steerable element 708 and prevents fluids such as blood from entering and contaminating the longitudinal guide hole 802. If fluids such as blood are present, they may cause malfunction of the elongated steerable element 708 and thus affect its sliding, which is responsible for the assembly and disassembly of the implantable medical device 700.

[0089]

[0110] The pump element 707 is connected to the proximal end portion 814 of the elongated manipulable element 708 and is positioned at the proximal end portion 804 of the introducer unit 702 when the elongated manipulable element 708 is received in the longitudinal guide hole 802.

[0090]

[0111] 8A-8C , in use, relative sliding movement between the elongate steerable element 708 of the pump unit 706 and the introducer unit 702 moves the pump element 707 toward or away from the proximal end portion 804 of the introducer unit 702. In particular, a pulling force applied to the distal end portion 816 of the elongate steerable element 708 moves the pump element 707 toward the proximal end portion 804 of the introducer unit 702. A pushing force applied to the distal end portion 816 of the elongate steerable element 708 moves the pump element 707 away from the proximal end portion 804 of the introducer unit 702. Alternatively or additionally, a pushing force may be applied to the distal end portion 806 of the introducer unit 702 to move the proximal end portion 804 of the introducer unit 702 closer to the pump element 707. Further, alternatively or additionally, a pulling force may be applied to the distal end portion 806 of the introducer unit 702 to move the proximal end portion 804 of the introducer unit 702 away from the pump element 707. Although not so shown in FIGS. 8A-8C for clarity, it will of course be understood that relative slidable movement between the elongate steerable element 708 and the introducer unit 702 to correspondingly move the pump element 707 may occur within the lumen of the body conduit, for example, by an operator manipulating the distal end portion 816 of the elongate steerable element 708.

[0091]

[0112] Relative slidable movement between the elongate steerable element 708 and the introducer unit 702 to move the pump element 707 positions or repositions the implantable medical device 700 between a disassembled configuration (shown in FIGS. 8A-8B , also referred to herein as the “unsecured configuration” and “undocked configuration”) and an assembled configuration (shown in FIG. 8C , also referred to herein as the “secured configuration” and “docked configuration”). Typically, a sheath is used to deliver the implantable medical device 700 in the disassembled configuration to an intraluminal implantation site within a lumen of a body conduit for implantation purposes, and to retrieve the implantable medical device 700 in the disassembled configuration from an intraluminal implantation site within a lumen of a body conduit for removal purposes. The implantable medical device 700 may be implanted in either the assembled or disassembled configuration at the intraluminal implantation site and may be operated in either the assembled or disassembled configuration to produce a hemodynamic effect.

[0092]

[0113] 8A-8B , the introducer unit 702 and the pump element 707 are slid apart relative to one another, e.g., physically separated by a portion of the elongate steerable element 708 therebetween. In particular, the pump element 707 may be positioned apart from and spaced apart from the proximal end portion 804 of the introducer unit 702, with the proximal end portion 814 of the elongate steerable element 708 at least partially disposed between the pump element 707 and the proximal end portion 804 of the introducer unit 702.

[0093]

[0114] Advantageously, as shown in FIG. 9A , the proximal end portion 814 of the elongated steerable element 708, which is at least partially disposed between the proximal end portion 804 of the introducer unit 702 and the pump element 707, may have its midsection 900 that functions as a hinge between the pump element 707 and the introducer unit 702. In particular, as shown in FIG. 9A , when the implantable medical device 700 in a disassembled configuration is threaded along a sharp-angled or tortuous lumen segment of a body conduit (shown by dashed lines in FIG. 9A ), the midsection 900 hinges such that the introducer unit 702 and the pump element 707 can hinge relative to each other and pass separately through the midsection 900. As shown, the elongated steerable element 708 is retained within a distal cavity 402 (not shown) covered by the tip 110. The retained elongated steerable element 708 carries the pump element 707 as the implantable medical device 100 is moved along a body conduit, such as by pulling a guidewire.

[0094]

[0115] In comparison, as shown in Figure 9B, the implantable medical device 700 in the assembled configuration may be too long to pass through a sharp-angled lumen or a tortuous lumen segment of a body conduit (shown by the dashed line in Figure 9B). In other words, in the embodiment illustrated in Figures 9A-9B, the implantable medical device 700 in the disassembled configuration can pass through a sharp-angled lumen or a tortuous lumen segment of a body conduit (i.e., as shown in Figure 9A), while the implantable medical device 700 in the assembled configuration cannot pass through the same location due to its longer overall length (i.e., as shown in Figure 9B). Such limitations in terms of intraluminal navigation can also arise from implantable medical devices known in the art that are too long and / or cannot be assembled and / or disassembled. Thus, in the disassembled configuration, the overall length of the implantable medical device 700 is divided into smaller length portions corresponding to the individual lengths of the introducer unit 702 and the pump element 707 to enable introduction and / or navigation of the implantable medical device 700 through sharply angled or tortuous lumen segments of a body conduit.

[0095]

[0116] 8C , in the assembled configuration, the introducer unit 702 and the pump element 707 may contact and / or engage one another without necessarily being separated by a portion of the elongate steerable element 708 between them. In particular, the pump element 707 may be positioned sufficiently proximate to contact and / or engage the proximal end portion 804 of the introducer unit 702, while the distal end portion 816 of the elongate steerable element 708 is disposed at the distal end portion 806 of the introducer unit 702. The introducer unit 702 and the pump element 707 may be removably assembled (i.e., the introducer unit 702 and the pump element 707 may be assembled and disassembled), or may be non-removably assembled in various ways (i.e., once assembled, the introducer unit 702 and the pump element 707 cannot be disassembled from one another), as described below.

[0096]

[0117] The proximal end portion 804 and the distal end portion 806 of the introducer unit 702 may be of any shape, although the distal end portion 806 may be shaped to facilitate introduction of the implantable medical device 702 through an intraluminal access, such as a percutaneous intraluminal access, in a body conduit and to reduce or prevent damage or injury to the lumen wall. As shown in Figures 8A-8C, for example, the distal end portion 806 of the introducer unit 702 is tapered.

[0097]

[0118] The distal end portion 806 of the introducer unit 702 is generally similar to the distal end portion 204 of the introducer unit 102, particularly with respect to its tapering and ridges, and for the sake of brevity, the distal end portion 806 of the introducer unit 702 will not be described further herein. It will therefore be understood that similar descriptions, where applicable, apply to the distal end portion 806 of the introducer unit 702 and the distal end portion 204 of the introducer unit 102, mutatis mutandis, as would be understood by one of ordinary skill in the art.

[0098]

[0119] The proximal end portion 804 of the introducer unit 702 may be configured to contact and / or engage with the pump unit 706, including the pump element 707, and / or the proximal end portion 814 of the elongated steerable element 708, for assembling the pump element 707 to the proximal end portion 804 of the introducer unit 702. In particular, as shown in FIG. 8B , the implantable medical device 700 may include an optional first connector 818 configured to detachably or irremovably connect the pump element 707 and the introducer unit 702 to one another. The implantable medical device 700 may also include an optional second connector 820 configured to detachably or irremovably connect the elongated steerable element 708 and the introducer unit 702 to one another. The connectors 818, 820 may be implemented as interference fit, latching type connectors, etc. In the absence of the first and second connectors 826, 828, a simple action of bringing the pump element 707 close to the proximal end portion 804 of the introducer unit 702 and finally abutting the proximal end portion 804 may be sufficient to combine or secure the pump element 707 and the introducer unit 702.

[0099]

[0120] 8C, the elongated manipulable element 708 may include an indicator 830, such as a visual marker. The indicator 822 is visible only when the elongated manipulable element 708 is properly pulled through the introducer unit 702 to indicate to the user that the pump unit 706 and introducer unit 702 are properly mated.

[0100]

[0121] 8A-8C further illustrate an embodiment of the implantable medical device 700 including an optional fixation mechanism 824 configured to secure the elongate steerable element 708 in place on the introducer unit 702. As shown, the fixation mechanism 824 is integrated into the distal end portion 806 of the introducer unit 702; alternatively, the fixation mechanism 824 may be integrated anywhere along the length of the introducer unit 702.

[0101]

[0122] 8A-8B, the locking mechanism 824 is in an unlocked configuration, thereby unlocking the elongated steerable element 708 so that the elongated steerable element 708 can freely slide within the longitudinal guide hole 802 to move the pump element 707 relative to the introducer unit 702, and the implantable medical device 700 can be arranged between a disassembled configuration and an assembled configuration. As shown in FIG. 8C, the locking mechanism 824 is in a locked configuration, thereby locking the elongated steerable element 708 so that the elongated steerable element 708 cannot slide within the longitudinal guide hole 802, and the pump element 707 remains assembled or locked to the introducer unit 702, and the implantable medical device 700 cannot be arranged between a disassembled configuration and an assembled configuration. The locking mechanism 824 can be adjusted to the unlocked and locked configurations when the implantable medical device 100 is in the disassembled and assembled configurations.

[0102]

[0123] The locking mechanism 824 may include a mechanism on the introducer unit 702 that frictionally engages and secures at least a portion of the elongate manipulable element 708. In this case, as shown in FIGS. 8A-8C , the locking mechanism 824 may be a pressure element. Alternatively, the locking mechanism 824 may include a first portion on the introducer unit 702 and a second portion on the elongate manipulable element 708. The first and second portions are configured to selectively engage with each other to secure them together. In this case, the first portion may be a pin or other similar engagement structure, while the second portion may be a notch, groove, or other similar engagement structure configured to cooperatively engage with the first portion.

[0103]

[0124] 8A-8C , according to embodiments, in a second aspect of the present disclosure, elongated steerable element 708 may be used not only to move pump element 707 but also to operate pump 70. For example, as shown in FIG. 8B , according to embodiments, elongated steerable element 708 includes an electrical conductor (also referred to herein as an “elongated electrical element”) and thus may be an electrical cable or wire configured to transmit electricity from controller 226 (shown in dashed lines as an optional component of implantable medical device 700) to pump element 707. In particular, proximal end portion 814 of elongated steerable element 708 is operably connected to pump element 707, while distal end portion 816 of elongated steerable element 708 is removably operably connectable to controller 226 by connector 832 (also referred to herein as an “electrical connector”).

[0104]

[0125] The connector 832 may be configured to be receivable in the longitudinal guide hole 802 such that the elongate steerable element 708 can slide fully in and out of the longitudinal guide hole 802. Alternatively, the connector 832 may be configured to abut the distal opening 812 of the longitudinal guide hole 802 of the introducer unit 702 to prevent the distal end portion 816 of the elongate steerable element 708 from moving fully into the longitudinal guide hole 802. Further alternatively, the distal end portion 816 of the elongate steerable element 708 may have an optional stop element 834 sized and shaped to abut the distal opening 812 of the longitudinal guide hole 802 of the introducer unit 702 to prevent the distal end portion 816 of the elongate steerable element 708 from moving fully into the longitudinal guide hole 802. The stop element 834 may be located anywhere along the elongate steering element 708 .

[0105]

[0126] Alternatively, the elongated manipulable element 708 may be a drive shaft (not shown) configured to transmit torque from a controller, such as an actuator or motor, to the pump element 707. In this case, the drive shaft may operate the pump element 707 or any other functional unit 705 in a variety of manners, including rotational and / or reciprocal motions.

[0106]

[0127] Further alternatively, implantable medical device 100 may include a wireless module 836 integrated into introducer unit 702 within its body 800. Wireless module 836 may be operably connected to elongate steerable element 708, which in this case may include electrical conductors. Wireless module 836 may also be operably connected directly to pump element 707, in which case elongate steerable element 708 need not necessarily be configured to operate pump element 707, such as by including electrical conductors, as previously described. In either case, wireless module 836 is configured to wirelessly connect to a wireless controller (not shown) for operating pump element 707.

[0107]

[0128] To enable or facilitate endoluminal navigation, the introducer unit 702 and the elongated steerable element 708, such as in the case of the elongated electrical element, may be made of a bendable, flexible, and / or resilient material to accommodate or conform to various body conduit morphologies, yet still be rigid enough to be pushed through an endoluminal access. For example, the introducer unit 102 may be made of a polymer such as thermoplastic polyurethane, while the elongated steerable element 708 may be made of a suitable bendable, flexible, and / or resilient material.

[0108]

[0129] As further shown in FIG. 8A , implantable medical device 100 includes an optional cover 818 according to an embodiment. Depending on the nature of connector 832, such as when electrical connector 832 is an electrical connector, it may be desirable to protect connector 832 from environmental elements, such as fluids like blood, to ensure proper operation. As shown in FIG. 8B , cover 818 is removable from implantable medical device 700 in order to operably connect connector 832 to controller 226. For example, cover 818 may be removably attachable to a peripheral cavity in which connector 832 is disposed (as shown), or may be removably attachable directly to connector 832. Removable attachment of cover 818 to implantable medical device 100 may be by interference fit, threaded fastening, etc.

[0109]

[0130] Figure 10, as well as Figures 9A-9B and 11A-11B, show an introducer unit 702 with an optional ridge 1000, according to an embodiment. Cover 818 is omitted from Figure 10, but may be present.

[0110]

[0131] Because ridge 1000 is similar to ridge 300, ridge 1000 will not be described herein for the sake of brevity, and it will therefore be understood that similar descriptions, where applicable, apply to ridge 1000 and ridge 300, mutatis mutandis as would be understood by one skilled in the art.

[0111]

[0132] 11A-11B show an implantable medical device 700 having a distal end portion 806 of the introducer unit 702 provided as an optional tip 712 that is removably attachable to the remainder of the introducer unit 702 and coupled to a guidewire 710, according to an embodiment. FIG. 11A shows the implantable medical device 700 in an assembled configuration, with the tip 712 detached from the introducer unit 702. FIG. 11B shows the implantable medical device 700 in a disassembled configuration, with the tip 712 attached to the introducer unit 702. Additionally, an optional locking mechanism 1100 is shown for locking the tip 712 to the introducer unit 702.

[0112]

[0133] As shown, tip 712 is removably attachable to distal cavity 1102, with elongated manipulable element 708 protruding outwardly from distal cavity 1102. Elongated manipulable element 708 is slidable relative to cavity 1104, such that connector 832 itself is movable in and out of cavity 1102. As shown, tip 712 also has an optional ridge 1102 similar to ridge 300 and ridge 1000.

[0113]

[0134] The tip 712 is generally similar to the distal end portion 806 of the introducer unit 702, particularly with respect to its tapering and ridges, and for the sake of brevity, the tip 712 will not be described further herein. It will therefore be understood that similar descriptions, where applicable, apply to the tip 712 and the distal end portion 806 of the introducer unit 702, mutatis mutandis, as would be understood by one of ordinary skill in the art.

[0114]

[0135] 12A-12D show an implantable medical device 700 including an optional anchor 714 having a contracted configuration (FIGS. 12A, 12C) and an expanded configuration (FIGS. 12B, 12D), according to an embodiment. A cover 818 is omitted from FIGS. 12A-12D, but may be present. While the implantable medical device 700 of FIGS. 12A-12D may include a cover 818, the implantable medical device 100 may alternatively include a tip 712.

[0115]

[0136] As shown in Figures 12A-12B, the anchor 714 has a tubular wall 1200 defining a central opening 1202 and includes at least one anchor arm, three anchor arms 1204A-C as shown, that converge on the introducer unit 702 to connect the tubular wall 1200 to the introducer unit 702 and position the introducer unit 702 at least partially within the central opening 1202. In use, while the anchor 714 is in either the contracted position or the expanded position, the pump element 707 can be assembled to the introducer unit 702 outside the central opening 1202 and disassembled from the introducer unit 702 by relative sliding movement between the elongated manipulable element 708 of the pump unit 706 and the introducer unit 702, moving the pump element 707 toward or away from the proximal end portion 804 of the introducer unit 702.

[0116]

[0137] 12C-12D , according to an embodiment, the implantable medical device 700 includes an optional anchor rod 716 supporting an anchor 714. A distal end portion 1206 of the anchor rod 716 is attached to the proximal end portion 804 of the introducer unit 702, while a proximal end portion 1208 of the anchor rod 716 is attached to at least one anchor arm, three as shown, 1204A-C. The anchor arms 1204A-C converge on the anchor rod 716 to connect the tubular wall 1200 to the anchor rod 716 and position the anchor rod 716 at least partially within the central opening 1202.

[0117]

[0138] As best shown in FIG. 12D , the anchor arms 1204A-C define corresponding radial openings 1210A-C therebetween. Although not readily visible in FIGs. 12C-12D , the elongated steerable element 708 is routed through one of the radial openings 1210A-C such that sliding the elongated steerable element 708 relative to the introducer unit 702 causes the pump element 707 to pass through one of the radial openings 1210A-C, assembling and disassembling the pump element 707 to and from the introducer unit 702. When within the central opening 1202, such as when assembled to the introducer unit 702, the pump element 707 is disposed about the anchor rod 716, as shown in FIG. 12D .

[0118]

[0139] In use, relative sliding movement between the elongate manipulable element 708 of the pump unit 706 and the introducer unit 702 moves the pump element 707 toward or away from the proximal end portion 804 of the introducer unit 702 so that the pump element 707 can be assembled to and disassembled from the introducer unit 702 within the central opening 1202 while the anchor 714 is in the expanded position. Thus, while the implantable medical device 700 can be disposed in an assembled configuration only when the anchor 714 is in the expanded configuration, the implantable medical device 700 can be disposed in a disassembled configuration when the anchor 714 is in either the contracted or expanded configuration.

[0119]

[0140] Anchor 714 and anchor rod 716 are generally similar to anchor 112 and anchor rod 114, respectively, and for the sake of brevity, anchor 714 and anchor rod 716 will not be described further herein. It will therefore be understood that similar descriptions, where applicable, apply to anchor 714 and anchor rod 716 and anchor 112 and anchor rod 114, respectively, mutatis mutandis as would be understood by one skilled in the art.

[0120]

[0141] 12A-12D further illustrate an implantable medical device 700, according to an embodiment, including an optional first capture element 718 associated with the introducer unit 702, such as by an anchor rod 716 as shown in FIGS. 12C-12D, and an optional second capture element 720 associated with the pump unit 706, such as by an anchor rod 716 as shown in FIGS. 12A-12B. Either or both of the first capture element 718 and the second capture element 720 may be provided on the implantable medical device 700. For example, the first capture element 718 may be provided on the introducer unit 702, and the second capture element 720 may simultaneously be provided on the pump unit 706. The first capture element 718 and the second capture element 720 may be captureable separately from each other or may be captureable together in vivo by a tool such as a snare or the like to pull or hold the introducer unit 702 and pump element 706 in place within the lumen of a body conduit.

[0121]

[0142] In use, the first capture element 718 can be captured intraluminally by a tool such as a snare, which can then be pulled to move the implantable medical device 700 as a whole intraluminally.

[0122]

[0143] If the second capture element 720 is provided on the pump element 707, for example, in use, it can be captured endoluminally by a tool, such as a snare, which can then be pulled to deploy the implantable medical device 700 from the assembled to the disassembled configuration. The elongated manipulable element 708 can simultaneously be pushed toward the introducer element 702 to aid or assist in such deployment. However, depending on its stiffness, pushing the elongated manipulable element 708 may be sufficient to deploy the implantable medical device 700 from the assembled to the disassembled configuration. In all cases, deployment can occur with or without the anchor 714 and / or anchor rod 716 present.

[0123]

[0144] With the fixation mechanism 824 present and securing the elongated manipulable element 708 in place in the introducer unit 702 and maintaining the implantable medical device 700 in an assembled configuration, the implantable medical device 700 can be moved intraluminally as a whole by capturing the second capture element 720 and pulling the snare attached to the second capture element 720.

[0124]

[0145] Referring again to FIGS. 7 through 12A-12D, according to embodiments, implantable medical device 700 may include an optional guidewire 710.

[0125]

[0146] Because guidewire 710 is generally similar to guidewire 108, for the sake of brevity, guidewire 710 will not be further described herein. It will therefore be understood that similar descriptions, where applicable, apply to guidewire 710 and guidewire 108, mutatis mutandis, as would be understood by one of ordinary skill in the art.

[0126]

[0147] 13A illustrates an implantable medical device 700 including three pump elements 706, as shown, which may be any plurality of pump elements 706 provided as functional units 705, according to an embodiment. Each pump unit 706 includes a pump element 707A-C provided as a functional element 704 and a respective elongated steerable element 708A-C operably connected to the corresponding pump element 707A-C and operably connectable to at least one controller by a respective connector 212A-C. The introducer unit 702 defines three longitudinal guide holes 802A-C (shown in dashed lines as a perspective view of the introducer unit 702), as shown, which may be any plurality of corresponding longitudinal guide holes, each of which slidably receives a respective one of the elongated steerable elements 708A-C. Alternatively, the introducer unit 702 may include a single longitudinal guide hole 802 for slidably receiving all of the elongate steerable elements 708A-C.

[0127]

[0148] 13A, each of the elongated steerable elements 708A-C is slidably received in a respective longitudinal guide hole 802A-C, and the relative slidable movement between the elongated steerable elements 708A-C and the introducer unit 702 is represented by a double-headed arrow. The relative slidable movement between the elongated steerable elements 708A-C and the introducer unit 702 for moving the pump elements 707A-C allows the implantable medical device 700 to be configured in a disassembled configuration in which all of the pump elements 707A-C are not assembled to the introducer unit 702 (also referred to herein as the "unclamped configuration" and "undocked configuration"), and an assembled configuration in which all of the pump elements 707A-C are assembled to the introducer unit 702 (also referred to herein as the "unclamped configuration" and "docked configuration"). 707A-C) and a partially assembled configuration (also referred to herein as a "partially secured configuration" and a "partially docked configuration") in which one or two of the pump elements 707A-C are assembled to the introducer unit 702. It will be readily understood that assembled, disassembled, partially disassembled, and partially assembled configurations are possible for any number of pumps 707 without departing from the scope of the present disclosure.

[0128]

[0149] To position or reposition between configurations, each of the elongate manipulable elements 708A-C may be slid relative to the introducer unit 702 at different times (e.g., one at a time) or all at the same time (i.e., simultaneously) to correspondingly move each of the pump elements 707A-C at different times or all at the same time.

[0129]

[0150] In the disassembled configuration, the introducer unit 702 and pump elements 707A-C are slid apart relative to one another, e.g., physically separated by a portion of the elongate steerable element 708A-C therebetween. In the disassembled configuration, as shown in FIG. 13B , with the pump elements 707A-C housed within a sheath (shown in dashed lines as an optional component of the implantable medical device 700), the pump elements 707A-C are arranged longitudinally in a sequential manner, which may or may not be precisely coaxial with one another and / or with the introducer unit 702 (hereinafter referred to as a "sequential" arrangement). Such an arrangement may also be performed without a sheath, such as when the pump elements 707A-C are within a lumen of a body conduit. As described and illustrated in Figures 9A-9B herein above, when the implantable medical device 700 is in a disassembled configuration, a given portion of each of the elongated manipulable elements 708A-C can advantageously function as a hinge to enable each of the pump elements 707A-C to be threaded along sharply angled or tortuous lumen segments of a body conduit.

[0130]

[0151] In the assembled configuration, the introducer unit 702 and the pump elements 707A-C may contact and / or engage one another without necessarily being separated by a portion of the elongate steerable elements 708A-C between them. In particular, the pump elements 707A-C may be positioned sufficiently proximate to contact and / or engage the proximal end portion 804 of the introducer unit 702, while the distal end portions 816 of the elongate steerable elements 708A-C are disposed at the distal end portion 806 of the introducer unit 702. In the assembled configuration, the pump elements 707A-C are disposed transversely adjacent to one another (hereinafter also referred to as "side-by-side arrangement"), as shown in FIG. 13B . The pump elements 707A-C may also be longitudinally offset relative to one another to improve their flow performance and characteristics. The introducer unit 702 and the pump elements 707A-C may be removably combined (i.e., the introducer unit 702 and the pump elements 707A-C may be assembled and disassembled), or may be non-removably combined in various ways (i.e., once combined, the introducer unit 702 and the pump elements 707A-C cannot be disassembled from one another), as described below.

[0131]

[0152] The proximal end portion 804 of the introducer unit 702 can be configured to contact and / or engage the proximal end portion 814 of the pump units 706A-C, including the pump elements 707A-C, and / or the elongate steerable elements 708A-C, for assembling the pump elements 707A-C to the proximal end portion 804 of the introducer unit 702. In particular, as described herein above, the implantable medical device 700 can include any of a plurality of first connectors 818 configured to detachably or non-detachably connect the corresponding pump elements 707A-C to the introducer unit 702. As described herein above, the implantable medical device 700 can also include any of a plurality of second connectors 820 configured to detachably or non-detachably connect the corresponding elongate steerable elements 708A-C to the introducer unit 702. Furthermore, in the assembled configuration, pump units 706A-C may be coupled together by interaction between (i) at least two of pump elements 707A-C, (ii) at least two of elongated manipulable elements 708A-C, and / or (iii) at least one of pump elements 707A-C and at least one of elongated manipulable elements 708A-C.

[0132]

[0153] In an assembled configuration, the pumps 707A-C may be longitudinally offset relative to one another such that each of the impeller end portions of the pump elements 707A-C is longitudinally positioned differently. The pumps 707A-C may also be non-parallel positioned relative to one another such that each of the impeller end portions of the pump elements 707A-C is separated by a distance greater than the distance between each of the introducer units contacting the end portions of the pump elements 707A-C. Depending on the pump elements 707A-C, such positioning and spacing may improve pump performance, including better fluid outflow and reduced fluid shear stress (the latter of which may lead to hemolysis and / or blood thrombosis).

[0133]

[0154] 13B, in the assembled configuration, the pump elements 707A-C collectively have a cross-sectional size that may average to the cross-sectional size of a circle containing cross-sectional portions of the pump elements 707A-C that is larger than the cross-sectional size of the introducer unit 702. This may be the case, for example, when the pump elements 707A-C each have a cross-sectional size that is substantially the same as the cross-sectional size of the introducer unit 702, as shown. Alternatively, the pump elements 707A-C in the assembled configuration may collectively have a cross-sectional size that averages to be equal to or smaller than the cross-sectional size of the introducer unit 702, as described above. This may be the case, for example, when the pump elements 707A-C each have a cross-sectional size that is substantially smaller than the cross-sectional size of the introducer unit 702.

[0134]

[0155] The implantable medical device 700 of Figures 13A-13B may also include an optional tip 712 and optional locking mechanism 1100, an optional anchor 714, an optional anchor rod 716, at least one optional first capture element 718 and / or at least one optional second capture element 720, an optional guidewire 710, and an optional fixation mechanism 824.

[0135]

[0156] When provided, the anchor rod 716 is coupled by at least one anchor arm thereof, such as anchor arms 1204A-C, such that the introducer unit 702 is at least partially positioned within the central opening 1202 and / or such that each of the pump elements 707A-C is slidably positionable within the central opening 1202. In this case, to assemble and disassemble the pump elements 707A-C to and from the introducer unit 702, each of the elongate manipulable elements 708A-C is routed through each of the radial openings 1210A-C defined by a corresponding anchor arm 1204A-C such that each of the pump elements 707A-C can pass through each of the radial openings 1210A-C when the corresponding one of the elongate manipulable elements 708A-C is slid relative to the introducer unit 702. When within central opening 1202 , such as when assembled to introducer unit 702 , each of pump elements 707 AC is disposed around anchor rod 716 .

[0136]

[0157] A first capture element 718, if present, is provided on the introducer unit 702, such as anchor rod 716. An optional second capture element 720, if present, may be provided on each of the pump units 706A-C, such as pump elements 707A-C. In particular, the second capture element 720 of each pump element 707A-C may be endoluminally captured by a tool, such as a snare, during use, which may then be pulled to endoluminally move the pump elements 707A-C separately from one another and away from the introducer unit 702 to position the implantable medical device 700 among disassembled, assembled, partially disassembled, and partially assembled configurations.

[0137]

[0158] If present, the locking mechanism 824 may be provided on the introducer unit 702 and / or on each of the elongate steerable elements 708A-C. A single locking mechanism 824 may be provided to lock all of the elongate steerable elements 708A-C. Alternatively, multiple locking mechanisms 822 may be provided to lock each of the elongate steerable elements 708A-C. In this case, the locking mechanisms 822 may function independently of one another. When the locking mechanism 824 locks one or more of the elongate steerable elements 708A-C, the implantable medical device 700 as a whole may be moved endoluminally by capturing the second capture element 720 corresponding to the elongate steerable element 708A-C secured by the locking mechanism 824 and pulling the snare attached to the second capture element 720.

[0138]

[0159] Because the implantable medical device 700 with multiple pump units 706 is similar to the implantable medical device 700 with a single pumping unit 706, for the sake of brevity, the description of the implantable medical device 700 with multiple pump units 706 will not be further described herein. Accordingly, it will be understood that the description of the implantable medical device 700 with a single pump unit 706 applies, where applicable, to the implantable medical device 700 with multiple pump units 706A-C, mutatis mutandis, as would be understood by one of ordinary skill in the art.

[0139]

[0160] 13C , according to an embodiment, the implantable medical device 700 may include at least one extension wire, three extension wires 1300A-C as shown. Each of the extension wires 1300A-C, like the elongate steerable elements 708A-C, is slidably receivable in a respective longitudinal guide hole 802A-C (or possibly a single longitudinal guide hole 802) and removably attachable at its distal end portion 816 to each of the elongate steerable elements 708A-C. The extension wires 1300A-C may be slid to position the implantable medical device 700 among a disassembled configuration, an assembled configuration, a partially disassembled configuration, and a partially assembled configuration. An implantable medical device 700 with a single pumping unit 706 may similarly include a single extension wire 1300.

[0140]

[0161] Each of the extension wires 1300A-C may include a respective stop element 834 as described for the elongate steerable elements 708A-C. Each of the extension wires 1300A-C may also include a sealing element configured to sealingly engage the distal opening 812 of the longitudinal guide hole 802A-C. Because the cross-sectional size of the extension wires 1300A-C is smaller than the cross-sectional size of the elongate steerable elements 708A-C, spaces exist within the longitudinal guide holes 802A-C when the extension wires 1300A-C are received. Fluids, such as blood, may leak through these spaces.

[0141]

[0162] 14A, implantable medical device 700 in a disassembled configuration is housed within a sheath (shown in dashed lines as optional components of implantable medical device 700) with pump elements 707A-C in a sequential arrangement. Each of extension wires 1300A-C is slidably received through introducer unit 702 and removably attached to each of elongated steerable elements 708A-C.

[0142]

[0163] Continuing to refer to FIG. 14A, and also shown in FIGS. 14B-14E, a first extension wire 1300A associated with the first pump element 707A passes through a first space 1306 defined between the second pump element 707B and the sheath (or the lumen wall if no sheath is present) (FIGS. 14A, 14B). First and second extension wires 1300A, 1300B associated with the first and second pump elements 707A, 707B, respectively, both pass through a second space 1308 defined between the third pump element 707C and the sheath (or the lumen wall if no sheath is present) (FIGS. 14A, 14C).

[0143]

[0164] 14B-14D, the cross-sectional size of extension wires 1300A-B (and also 1300C) is smaller than the cross-sectional size of elongate steerable elements 708A-B (and 708C). This size difference advantageously allows an implantable medical device 700 equipped with extension wires 1300A-B (and also extension wire 1300C, as shown) extending along pump elements 707B,C to have a smaller cross-sectional size (i.e., d1) compared to the cross-sectional size (i.e., d2) of an implantable medical device 700 having elongate steerable elements 708A,B extending along pump elements 707B,C (i.e., not equipped with extension wires 1300A-B).

[0144]

[0165] Indeed, the small cross-sectional size of the extension wire, compared to the cross-sectional size of the elongate steerable element, advantageously allows for the use of a relatively small diameter (as typically reported in FR units) sheath for implanting and removing the implantable medical device 700. Such a reduction in sheath size, in turn, allows for the introduction and navigation of the implantable medical device 700 into lumens of body conduits that are not necessarily suitable for the use of implantable medical devices.

[0145]

[0166] In particular, because the extension wire is not configured to transmit electricity, i.e., the extension wire does not have electrical conductors integrated into its structure, the extension wire can have a relatively smaller cross-sectional size than the elongate steerable element, It will be appreciated that any other approach to reducing the cross-sectional size of the elongate structure to which the elongate control element can be attached will have the same advantages.

[0146]

[0167] For purposes of comparison with Figure 14B, Figure 14D shows a first elongate steerable element 708A from the first pump element 707A passing through a first space 1306 defined between the second pump element 707B and the sheath (or the lumen wall if no sheath is present). For purposes of comparison with Figure 14C, Figure 14E shows a first elongate steerable element 708A and a second elongate steerable element 708B from the first pump element 707A and the second pump element 707B passing through a second space 1308 defined between the third pump element 707C and the sheath (or the lumen wall if no sheath is present). As can be readily appreciated, the sheath in Figures 14D-14E must have a larger cross-sectional size to accommodate the implantable medical device 700 than the sheath in Figures 14B-14C due to the cross-sectional size difference between the elongate steerable element and the extension wire.

[0147]

[0168] Taken together, because they are endoluminally assemblable, the implantable medical device advantageously has a reduced motion profile for introduction and navigation into a lumen of a body conduit, while being capable of endoluminally expanding to a larger motion profile for performing a desired function and / or operation, such as a hemodynamic or synergistic effect. For example, the implantable medical device in a disassembled configuration may have a reduced motion profile that substantially corresponds to one of the introducer unit and functional unit having a larger cross-section. When placed in an assembled configuration, the implantable medical device may have a larger motion profile that substantially corresponds to the cross-sectional size of the introducer unit plus a fraction of the cross-sectional size of the functional unit.

[0148]

[0169] 15-19, an embodiment of an implantable medical device 1500 will now be described. Implantable medical device 1500 is generally similar to implantable medical device 700, and for the sake of brevity, only certain features of implantable medical device 1500 will be described below. It will therefore be understood that the description of implantable medical device 700, where applicable, applies to implantable medical device 1500 with necessary mutatis mutandis as would be understood by one of ordinary skill in the art.

[0149]

[0170] 15-19 illustrate an implantable medical device 1500 including an optional anchor 1502 having at least one proximal anchor arm, three proximal anchor arms 1504A-C as shown, and at least one distal anchor arm, three distal anchor arms 1506A-C as shown, according to an embodiment. In FIG. 15, implantable medical device 1500 includes pump units 1508A-B in an assembled configuration, and pump unit 1508C is in a disassembled configuration; thus, implantable medical device 1500 is in a partially disassembled and partially assembled configuration. In FIG. 16, pump units 1508A-B are in an assembled configuration, and pump unit 1508C is omitted for clarity. In FIGS. 17-19, pump units 1508A-C are omitted for clarity.

[0150]

[0171] 15-19, according to an embodiment, the proximal end portion 1510 of the introducer unit 1512 includes an optional protrusion 1514 that protrudes distally therefrom and is configured to attach the anchor 1502. The protrusion 1514 may be a component coupled to the introducer unit 1512 or may be a component integrally formed with the introducer unit 1512 to form a monolithic unit. In particular, as best shown in FIGS. 15-18, each of the proximal anchor arms 1504A-C connects to the protrusion 1514 at a location proximal to the protrusion 1514, and each of the distal anchor arms 1506A-C connects to the protrusion 1514 at a location distal to the protrusion 1514. The proximal anchor arms 1504A-C and the distal anchor arms 1506A-C may connect to the anchor 1504 anywhere on the introducer unit 1512.

[0151]

[0172] The longitudinal coupling at two spaced locations along the projection 1514 advantageously provides anchoring stability to the implantable medical device 1500 in either a disassembled or assembled configuration when anchored within the lumen of a body conduit. Indeed, depending on the implantable medical device and intraluminal implantation site, the proximal anchor arms 1504A-C and distal anchor arms 1506A-C reduce pivoting of the implantable medical device 1500 compared to an implantable medical device coupled to an anchor at that single location. In the latter case, the single location of the anchor coupling may serve as a pivot point, whereas the presence of two coupling locations reduces or even completely eliminates such pivot points. In general, pivoting motion of an intraluminally anchored implantable medical device should be avoided because such motion may damage or injure the lumen wall, especially if contact is made with moving parts such as an unshrouded pump impeller.

[0152]

[0173] 17, according to an embodiment, the connection of proximal anchor arms 1504A-C and distal anchor arms 1506A-C to projection 1514 can be a constrained attachment, as shown in FIG. 17. In particular, proximal anchor arms 1504A-C and distal anchor arms 1506A-C each have a respective attachment end portion that is captured within a recess by cap 1700 that caps the recess. The attachment end portions are sized and shaped so that they cannot be removed from the recess when capped by cap 1700, and are not readily visible in FIG. 17, along with the recess, due to the presence of cap 1700. Also, only caps 1700 for proximal anchor arm 1504B and distal anchor arm 1506B are shown in FIG. 17.

[0153]

[0174] Constrained attachment is advantageous when proximal anchor arms 1504A-C and distal anchor arms 1506A-C and projection 1514 are made of one or more materials that are incompatible for direct attachment, fastening, or bonding to one another. This would be the case, for example, if proximal anchor arms 1504A-C and distal anchor arms 1506A-C and possibly anchor 1502 were made of nitinol, while projection 1514 was made of stainless steel. Other incompatible materials are possible. Nitinol and stainless steel generally are not suitable for direct attachment, fastening, or bonding to one another, such as by welding, to meet the stringent requirements of at least some implantable medical devices.

[0154]

[0175] The cap may be secured to the projection 1514 by a variety of techniques, including, but not limited to, welding, fusing, adhesive bonding, mechanical interengagement, etc. If welded, the cap 1700 is made of a material that is compatible with the material of the projection 1514. For example, both the cap 1700 and the projection 1514 may be made of stainless steel, thereby alleviating the limitations associated with the proximal anchor arms 1504A-C and distal anchor arms 1506A-C being made of nitinol and the projection 1514 being made of incompatible stainless steel for purposes of direct attachment, fastening, or bonding.

[0155]

[0176] The constrained attachment of one or more attachment end portions of the proximal anchor arms 1504A-C and the distal anchor arms 1506A-C is not limited to the protrusion 1514, but may be implemented anywhere on the introducer unit 1512. Furthermore, the constrained attachment is not limited to the interaction between the proximal anchor arms 1504A-C and the distal anchor arms 1506A-C and the protrusion 1514. The constrained attachment may be implemented with respect to any other component of the implantable medical device 1500 described herein. In any event, the constrained attachment does not necessarily require incompatible materials for direct attachment, fastening, or bonding, depending, for example, on manufacturing needs.

[0156]

[0177] 15-17, according to embodiments, anchor 1502 has a double-tapered shape that may approximate an ellipse, an oval, or an oval. Tapered proximal end portion 1516 of anchor 1502 is formed by a connection of proximal anchor arms 1504A-C that collectively converge toward protrusion 1514, and tapered distal end portion 1518 of anchor 1502 is formed by at least two distal-most anchor arms 1520A-C that collectively converge together toward a distal-most convergence point 1522. According to embodiments, tapered distal end portion 1518 defines at least one radial opening, three radial openings 1530A-C as shown in FIG. 19, through which corresponding pump units 1508A-C pass for assembly and disassembly.

[0157]

[0178] The double tapered shape allows the anchor 1502 to be transformed from an expanded configuration to a contracted configuration from its tapered proximal end portion 1516 and tapered distal end portion 1518. As described herein above with respect to the transformation of the anchors 112, 714, the introducer unit 1512 may be pulled to initiate such transformation from the tapered proximal end portion 1516 while within the sheath. A tool, such as a snare attached to a capture element 1524 (described below), may be pulled to initiate such transformation from the tapered distal end portion 1518 while within the sheath.

[0158]

[0179] As shown in FIGS. 15-19 , an optional capture element 1524 may be provided at the distal-most convergence point 1522, which may correspond to the first capture element 718 of the implantable medical device 700. Alternatively, the capture element 1524 may gather and attach the distal-most anchor arms 1520A-C to the capture element 1524. The capture element 1524 may at least partially form the tapered distal end portion 1518 of the anchor 1502. As shown, the capture element 1524 is a hook that can be captured by a tool such as a snare. Alternatively, the capture element may be an endoluminally captureable structure.

[0159]

[0180] 16-18 , according to an embodiment, the protrusion 1514 includes at least one optional receiving surface 1526, three receiving surfaces 1526A-C as shown, and / or at least one optional distal guide hole, three distal guide holes 1528A-C as best shown in FIG. 19. In particular, the protrusion 1514 may include a number of receiving surfaces 1526 and a number of distal guide holes 1528 corresponding to the number of pump units 1508. The protrusion 1514 may be configured to detachably or permanently assemble and disassemble the pump units 1508A-C to the proximal end portion 1510 of the introducer unit 1512, or may be configured to facilitate detachable or non-detachable assembly and disassembly of the pump units 1508A-C to the proximal end portion 1510 of the introducer unit 1512.

[0160]

[0181] Each of the receiving surfaces 1526A-C extends longitudinally at least partially along the protrusion 1514 and may or may not be equidistantly spaced from one another as shown. Thus, when assembled, the pump unit 1508 is disposed around the protrusion 1514. Additionally, the receiving surfaces 1526A-C may be concave to increase or enhance their contact surface with the pump units 1508A-C when assembled to the pump units 1508A-C. Each of the receiving surfaces 1526A-C may be configured to reduce or prevent blood clotting between each of the receiving surfaces 1526A-C and the corresponding pump unit 1508A-C when assembled to the receiving surfaces 1526A-C. For example, each of the receiving surfaces 1526A-C may be sized and shaped to conform or mate with each of the pump units 1508A-C so as to substantially preclude the presence of blood between each of the receiving surfaces 1526A-C and the corresponding pump unit 1508A-C when assembled thereto. Alternatively or additionally, each of the receiving surfaces 1526A-C may include a seal to provide fluid-tight contact with the corresponding pump unit 1508A-C when assembled thereto.

[0161]

[0182] Each of the receiving surfaces 1526A-C may or may not be associated with a respective distal guide hole 1528A-C, as further shown in FIGS. 16-18 . In particular, each of the distal guide holes 1528A-C may be configured to releasably or permanently engage a proximal engagement portion 1532 of each of the pump units 1508A-C when assembled thereto. For example, as shown in FIG. 15 , the proximal engagement portion 1532 may include a pin connector that is coupled to a corresponding elongated manipulable element 1534 of the pump unit 1508C. In this case, the pin is sized and shaped to releasably or permanently engage the distal guide hole 1528C.

[0162]

[0183] As opposed to having receiving surfaces 1526A-C that conform or mate with pump units 1508A-C and / or providing seals on receiving surfaces 1526A-C for the purpose of reducing or preventing blood clotting, receiving surfaces 1526A-C and / or distal guide holes 1528A-C may be configured to form a flow gap between receiving surfaces 1526A-C and pump units 1508A-C when assembled with receiving surfaces 1526A-C and / or distal guide holes 1528A-C that facilitates blood flow therebetween, for the same purpose. Additionally, fins or similar structures may be provided to guide or modify blood flow through the flow gap to reduce or prevent blood clotting within the flow gap.

[0163]

[0184] Any anchor 1502, with any necessary modifications understandable to one of ordinary skill in the art, where applicable, may be implemented in the implantable medical device 700. Any anchor 112, 714, with or without any anchor rod 114, 716, may be implemented in the introducer unit 1512 of the implantable medical device 1500.

[0164]

[0185] 20-21 illustrate an implantable medical device 1500 (also collectively referred to herein as a "medical device assembly") comprising a sheath 2000 releasably engageable with an introducer unit 1512 of the implantable medical device 1500, according to an embodiment. FIG. 20 illustrates the implantable medical device 1500 comprising a tip 2002, similar to tips 110, 712, releasably attached to the introducer unit 1512, and a guidewire 2004, similar to guidewires 108, 710, attached to the tip 2002. The introducer unit 1512 projects distally outward from the sheath 2000. The attachment between the guidewire 2004 and the tip 2002 can be removable or non-removable and / or rotatable or non-rotatable. The releasable interaction between the implantable medical device 1500, particularly the introducer unit 1512, and the sheath 2000 allows the implantable medical device 1500 to be delivered intraluminally while the sheath is introduced into the lumen of a body conduit to implant the implantable medical device, without leaving a sheath behind when the sheath is removed after the procedure.

[0165]

[0186] 21 , the proximal end portion 1510 of the introducer unit 1512 is releasably engageable with the engagement end portion 2006 of the sheath 2000 so that the introducer unit 1512 can exit the sheath 2000, be delivered into a lumen of a body conduit, and be implanted at an intraluminal implantation site. The sheath 2000 may or may not house the pump units 1508A-C therein. When housed within the sheath 2000, the pump units 1508A-C are in a sequential arrangement and the implantable medical device 1500 is in a disassembled configuration. When not housed within the sheath 2000, the pump units 1508A-C are housed within the sheath 2000 and are slidably received within the introducer unit 1512. Extension wires 2502A-C, similar to extension wires 1300A-C, are not shown in FIG. 21 because they are hidden by the introducer unit 1514 and the sheath 2002. The extension wires extend along the entire length of the combined sheath 2000 and introducer unit 1512. The extension wires are attachable to corresponding elongate, manipulable elements of pump units 1508A-C that can be moved internally along the sheath 2000 upon pulling the extension wires from the distal end portion of the introducer unit 1512.

[0166]

[0187] As best shown in FIG. 21 , the engagement end portion 2006 of the sheath 2000 has a tapered shape as described above, although the tapered shape may generally be less pronounced. In use, the engagement end portion 2006 of the sheath 2000 is the second taper that encounters an intraluminal access, such as a percutaneous intraluminal access, after the taper of the tip 2002. Typically, such an intraluminal access is first widened by the tip 2002 and then further widened by the engagement end portion 2006 as the implantable medical device 1500 and sheath 2000 advance through the intraluminal access. While the tip 2002 is shown in FIG. 20 , this may not necessarily be the case, as the distal end portion 2008 of the introducer unit 1512 may have an inherently tapered shape as described above.

[0167]

[0188] The proximal end portion 1510 of the introducer unit 1512 may also sealingly engage the engagement end portion 2006 of the sheath 2000 to provide a fluid-tight engagement with the engagement end portion 2006 of the sheath 2000. The sealing engagement may be provided by the proximal end portion 1510 of the introducer unit 1512 being slightly oversized relative to the engagement end portion 2006 of the sheath 2000 so as to slightly spread the engagement end portion 2006 of the sheath 2000. Alternatively, the sealing engagement may be a snug fit. The sealing engagement between the implantable medical device 1500 and the sheath 2000 may be advantageous in the presence of blood, which may potentially cause malfunction within the sheath 2000 and / or implantable medical device 1500.

[0168]

[0189] In Figures 20-21, the implantable medical device 1500 and sheath 2000 are described and illustrated as engaging at the level of the proximal end portion 1510 of the introducer unit 1512, but such engagement may occur anywhere along the introducer unit 1512 of the implantable medical device 1500.

[0169]

[0190] 22 shows an optional compression fixation mechanism 2200 as one embodiment of a fixation mechanism 824 that may be provided on the implantable medical device 1500 and the implantable medical device 700 to secure all of the elongated, manipulable elements of the pump units 1508A-C to the introducer unit 1512. The fixation mechanism 2200 may be integrated anywhere on the implantable medical device 1500, such as in the proximal end portion 1510 of the introducer unit 1512 adjacent the tip 2002, so that it is manipulable when the implantable medical device 1500 is implanted.

[0170]

[0191] The compression locking mechanism 2200 includes a casing 2204 that houses a fixed compression element 2206, a movable compression element 2208, an actuator 2210 coupled to the movable compression element 2208 for moving the movable compression element 2208, and a sleeve 2210 having three passages for slidably receiving elongated manipulable elements of the pump units 1508A-C, as shown. The sleeve 2210 is disposed between the fixed compression element 2206 and the movable compression element 2208 and is compressible by the fixed compression element 2206 and the movable compression element 2208. The sleeve 2210 is configured to prevent damage to the elongated manipulable elements when slid within the sleeve 2210 and is configured to sealingly engage and provide a fluid-tight engagement with the elongated manipulable elements. Accordingly, the sleeve 2210 may be made of a polymer or an elastomer. The fixed compression element 2206 and the movable compression element 2208 may be sized and shaped to fit the contours of the sleeve 2210 .

[0171]

[0192] As shown, the compression locking mechanism 2200 is in an unlocked configuration, with the fixed compression element 2206 and the movable compression element 2208 separated from one another by a space 2212. The compression locking mechanism 2200 is adjusted from the unlocked configuration to a locked configuration by operating an actuator 2210, which as shown is a set screw, to move the movable compression element 2208 toward the fixed compression element 2206 to compress the sleeve 2210, thereby reducing the space 2212. In the locked configuration, the sleeve 2210 frictionally engages the elongated manipulable element.

[0172]

[0193] The compression fixation mechanism 2200 may be provided on the implantable medical device 100 .

[0173]

[0194] 23A-23C and 24, a method 2400 of implanting implantable medical device 100 and implantable medical device 700 according to a third aspect of the present disclosure will be described.

[0174]

[0195] The implantation method 2400 includes the following.

[0175]

[0196] According to embodiments, at 2402, a first intraluminal access (also referred to herein as a first body conduit intraluminal access) and a second intraluminal access (also referred to herein as a second body conduit intraluminal access) are obtained in the lumens of a first body conduit and a second body conduit of a subject to be treated by implantable medical device 100 and implantable medical device 700, respectively. The first intraluminal access may be located in the subject's lower body, such as the subject's femoral artery. The second intraluminal access may be located in the subject's upper body, such as the subject's subclavian / axillary artery. Each of the first and second intraluminal accesses may be percutaneous body conduit accesses obtained by medical procedures known in the art (e.g., by a Seldinger procedure), or may be natural body conduit accesses, such as the esophagus, trachea, urethra, and / or rectum, which may require anesthesia or any other medical or surgical preparation. For example, the first intraluminal access may be a percutaneous body conduit access obtained by a medical procedure, while the second intraluminal access may be a percutaneous body conduit access obtained by a medical procedure or may be a natural access. Alternatively, the first and second intraluminal accesses may be obtained in, and therefore located in, the same body conduit, which may have sharp angles or be tortuous in nature.

[0176]

[0197] At 2404, according to an embodiment, optionally, the method may further include threading the guidewire 108, 710 from the first intraluminal access to the second intraluminal access (optional items shown by dashed lines in FIG. 24). In particular, the guidewire 108, 710 may be threaded between the first and second intraluminal accesses by introducing the guidewire into the lumen of the first body conduit through the first intraluminal access, guiding the guidewire 108, 710 through the second intraluminal access to the second intraluminal access, such as by capturing a distal end portion of the guidewire 108, 710 using, for example, a snare or any other suitable tool, and exiting the guidewire through the second intraluminal access. Depending on the subject's vascular morphology, the interconnection between the first and second body conduits may have sharp angles, or either the first or second body conduit may be tortuous in nature, which may generally make navigating the implantable medical device 100, 700 (and some other medical devices in the art) difficult. In such situations, it may be desirable to use a guidewire 108, 710 to prevent or minimize trauma to the intima of the blood vessel.

[0177]

[0198] Referring again to 2404, according to an embodiment, optionally, the method may further include (i) introducing the implantable medical device 100, 700 into the lumen of the first body conduit through the first intraluminal access (optionally while simultaneously pushing the proximal end portion of the implantable medical device 100, 700), (ii) advancing the implantable medical device 100, 700 within the lumen of at least one of the first body conduit and the second body conduit to a second intraluminal access, and (iii) pulling the guidewire 108, 710 from the second intraluminal access so as to exit the distal end portion of the implantable medical device 100, 700 through the second intraluminal access.

[0178]

[0199] According to embodiments, at 2406, the implantable medical device 100, 700 is introduced into the lumen of the first body conduit through the first intraluminal access, starting with the introducer unit 102 or the introducer unit 702. For example, a sheath (e.g., a delivery or implantation sheath) containing the implantable medical device 100, 700 therein may be pushed through the first intraluminal access. Alternatively, the implantable medical device 100, 700 may be introduced through the first intraluminal access by pushing its proximal end portion without the use of a sheath.

[0179]

[0200] According to embodiments, the implantable medical device 100, 700 within the lumen of the first body conduit is advanced to a second intraluminal access in the lumen of the second body conduit at 2408. In particular, the implantable medical device 100, 700 may be advanced by pushing a sheath containing the implantable medical device 100, 700 or by pushing a proximal end portion of the implantable medical device 100, 700.

[0180]

[0201] According to embodiments, at 2410, the distal end portion of the implantable medical device 100, 700 is exited through the second intraluminal access such that the implantable medical device 100, 700 is partially disposed within the lumen of at least one of the first and second body conduits. Thus, the pump element 106, 106A-C or pump element 707, 707A-C (or functional unit, as the case may be) may be disposed intraluminally, while the distal end portion of the introducer unit 102 or introducer unit 702 may be disposed extraluminally or partially outside the body. Also, upon exiting the second intraluminal access, partial or complete hemostasis may occur at the second intraluminal access. For example, the raised portion 300, 400, 1000, 1100 of the introducer unit 102 or introducer unit 702 may fluid-tightly engage the second intraluminal access to accomplish this. In particular, the implantable medical device 100, 700 may be ejected by pushing the sheath containing the implantable medical device 100, 700 or by pushing the proximal end portion of the implantable medical device 100, 700.

[0181]

[0202] According to an embodiment, at 2412, optionally, the method may further include anchoring the implantable medical device 100, 700 by converting the anchor 112, 714 from a contracted configuration (e.g., as the anchor 112, 714 is configured when the implantable medical device 100, 700 is contained within a sheath during delivery and / or implantation of the implantable medical device 100, 700) to an expanded configuration for releasably engaging the lumen wall of either the first body conduit or the second body conduit.

[0182]

[0203] At 2414, optionally, particularly when the implantable medical device 700 is implanted, the method may further include slidably actuating one of the elongate steerable elements 708, 708A-C and longitudinal guide holes 802, 802A-C relative to a corresponding one of the other of the elongate steerable elements 708, 708A-C and longitudinal guide holes 802, 708A-C to cause at least one of the following: according to an embodiment, (i) introducing the corresponding one of the pump elements 707, 707A-C into the lumen of the first body conduit through the first intraluminal access, and (ii) endoluminally slidably assembling one of the pump elements 707, 707A-C with the corresponding one of the introducer unit 702. For example, to advance or navigate within the lumen of a body conduit to implant the implantable medical device 700, the method may further include preventing any one of the elongated manipulable elements 708, 708A-C from slipping into a corresponding one of the longitudinal guide holes 802, 802A-C when the corresponding pump element 106, 707A-C is pulled by the corresponding guide wire 108, 710.

[0183]

[0204] According to embodiments, at 2416, the implantable medical device 100, 700 is operated via its distal end portion positioned extraluminally or outside the body. In particular, the implantable medical device 100, 700 may be operated by operably connecting the distal end portion, including the connector 212, 832, to a controller configured to operate the implantable medical device 100, 700. The tip 110, 712, if present, may also be detached to operably connect the implantable medical device 100, 700 to the controller. Alternatively, the implantable medical device 100, 700 may be operated wirelessly.

[0184]

[0205] According to an embodiment, at 2418, optionally, the method may further include closing at least one of the first intraluminal access and the second intraluminal access if such access is a percutaneous body conduit access obtained by a medical procedure.

[0185]

[0206] 25A-25J, an example of an implantable medical device 1500 will now be described, along with a method of implanting the implantable medical device 1500 within a blood vessel, according to an embodiment.

[0186]

[0207] 25A shows an example of an implantable medical device 1500 including a guidewire 2004 attached to a tapered tip 2002 detached from an introducer unit 1512 so that the distal end portions of the extension wires 2502A-C are visible. The extension wires 2502A-C correspond to the extension wires 1300A-C. The distal end portions of the extension wires 2502A-C protrude outward from a distal cavity of the introducer unit 1512, which is located below the tip 2002 when attached to the introducer unit 1512. The extension wires 2502A-C are slidably received in the distal cavity and the introducer unit 1512, pass through three radial openings in the anchor 1502 adjacent the proximal end portion 1510 of the introducer unit 1512, and extend within the sheath 2000 to its handle 2504.

[0187]

[0208] A capture element on anchor 1502 may be removably attached to rod 2506. Handle 2504 is operable by an operator to slidably move rod 2506 within sheath 2000 and push introducer unit 1512 out of sheath 2000 and / or pull introducer unit 1512 into sheath 2000 if attached to rod 2506.

[0188]

[0209] 25B shows an example of the implantable medical device 1500 with the tip 2002 attached to the introducer unit 1512 and the proximal end portion 1510 of the introducer unit 1512 releasably engaged with the engagement end portion 2006 of the sheath 2000, preparing the implantable medical device 1500 for implantation. Also shown are pump units 1508A-C releasably attached to corresponding extension wires 2502A-C so that they can be pulled inside the sheath 2000. Also shown is an optional snare 2508 that can be used to capture the guidewire 2004.

[0189]

[0210] 25C illustrates introducing, such as by pushing, a guidewire 2004 of implantable medical device 1500 into a first intraluminal access 2510, such as a first percutaneous arterial or venous intraluminal access, routing the guidewire 2004 to an intermediate location 2512 (also referred to herein as an "intermediate intraluminal location") within the lumen of a blood vessel, introducing, such as by pushing, a snare 2508 into a second intraluminal access 2514, such as a second percutaneous arterial or venous intraluminal access, routing the snare to the intermediate location 2512, and capturing the guidewire 2004 with the snare 2508. The routing of the snare 2508 may be performed before, during, or after the routing of the guidewire 2004.

[0190]

[0211] 25D shows pulling the snare 2508 through the second intraluminal access 2514 to move or navigate the implantable medical device 1500 along the lumen of the blood vessel to the second intraluminal access 2514, optionally passing or externalizing a distal end portion of the introducer unit 1512 at least partially through the second intraluminal access 2514, and optionally disconnecting the snare 2508 from the guidewire 2004. The first and second intraluminal accesses may optionally be created by securing or obtaining the second intraluminal access 2514 having a diameter smaller than the diameter of the first intraluminal access 2510 through which the implantable medical device 1500 is initially introduced. In this manner, the tapered distal end portion of the introducer unit 1512 sealingly engages the second intraluminal access portion 2514 in a fluid-tight manner when partially passed through or externalized through the second intraluminal access portion 2514, thereby at least partially achieving hemostasis.

[0191]

[0212] FIG. 25E illustrates optionally manipulating the handle 2504 of the implantable medical device 1500 to anchor the implantable medical device 1500 at the intraluminal implantation site.

[0192]

[0213] 25F-25H illustrate, optionally, attaching one or more extension wires 2502A-C to corresponding pump units 1508A-C, e.g., to their respective elongate steerable elements, if not already attached thereto; pulling extension wire 2504A through second intraluminal access 2514 to move pump unit 1508A within sheath 2000 to an intraluminal implantation site; final assembly of pump unit 1508A to introducer unit 1512; and 2000 to the endoluminal implantation site, pulling the extension wire 2504B through the second endoluminal access 2514 to move pump unit 1508B within the sheath 2000 to the endoluminal implantation site, final assembly of pump unit 1508B to the introducer unit 1512, pulling the extension wire 2504C through the second endoluminal access 2514 to move pump unit 1508C within the sheath 2000 to the endoluminal implantation site, and final assembly of pump unit 1508C to the introducer unit 1512. One or more pump units 1508A-C can be positioned within or outside the sheath 2000 and / or before or after the first endoluminal access 2510 before being moved by pulling the corresponding extension wire 2502A-C.

[0193]

[0214] FIG. 25I illustrates optionally disconnecting implantable medical unit 1500 from sheath 2000, such as from rod 2506 if attached to rod 2506.

[0194]

[0215] FIG. 25J refers to optionally removing sheath 2000 from the blood vessel through first intraluminal access 2510 and, optionally, closing first intraluminal access 2510.

[0195]

[0216] The implanting method may optionally further include connecting one or more pump units 1508A-C, e.g., a distal end portion of each elongate manipulable element thereof, to one or more corresponding controllers, and, optionally, operating the pump units 1508A-C.

[0196]

[0217] It will be understood that implantation method 2500 may be performed using any suitable implantable medical device, and therefore references to implantable medical device 1500 and its components to describe implantation method 2500 are made by way of example only.

[0197]

[0218] 26, a method 2600 of implanting a pump unit will be described, according to an embodiment. The pump unit includes a pump element and an elongated steerable element operably coupled to the pump element for operating the pump element via the elongated steerable element by a controller connectable to the elongated steerable element. The pump unit may include a tapered portion oriented toward the elongated steerable element such that, when pulled by the endoluminal access through the elongated steerable element, the tapered portion widens the endoluminal access while passing through the endoluminal access. The implantation method 2600 includes the following (optional elements of the implantation method 2600 are shown in dashed lines in FIG. 26):

[0198]

[0219] At 2602, optionally, a first intraluminal access, such as a first percutaneous arterial or venous intraluminal access, and a second intraluminal access, such as a second percutaneous arterial or venous intraluminal access, are obtained.

[0199]

[0220] At 2604, an elongated manipulable element, such as a pump cable or pump drive shaft of a pump unit, is navigated from the first intraluminal access to the second intraluminal access to position the pump element within the lumen of the blood vessel and a portion of the elongated manipulable element adjacent to or at least partially through the second intraluminal access.

[0200]

[0221] Navigating the elongated manipulable element may optionally include introducing the elongated manipulable element through a first intraluminal access, optionally routing the elongated manipulable element to an intermediate position within the lumen of the blood vessel, optionally introducing a snare through a second intraluminal access, optionally routing the snare to the intermediate position, optionally capturing the elongated manipulable element with the snare, optionally pulling the snare to externalize the elongated manipulable element through the second intraluminal access, and / or optionally pulling the elongated manipulable element with or without the snare to position the pump element at an intraluminal implantation site within the lumen of the body conduit.

[0201]

[0222] At 2606, optionally, the elongate manipulable element is connected to a controller, optionally to operate the fluid displacement portion.

[0202]

[0223] 27, a method 2700 for removing an implantable medical device 100, 700 according to a fourth aspect of the present disclosure will be described. The implantable medical device 100, 700 to be removed is implanted in a body conduit of a subject such that the pump element 106, 106A-B or pump element 707, 707A-C is positioned within the lumen of a first body conduit, while the introducer unit 102 or introducer unit 702 extends along the lumen of the first body conduit and also along the lumen of a second body conduit to a second intraluminal access (also referred to herein as the second body conduit intraluminal access) through which the introducer unit 102 or introducer unit 702 is positioned partially. Thus, the second intraluminal access is located distal to the implantable medical device 100, 700 (ie, towards the distal end portion of the implantable medical device 100, 700).

[0203]

[0224] The method 2700 of extraction includes the following.

[0204]

[0225] According to embodiments, at 2702, a first intraluminal access (also referred to herein as a first body conduit intraluminal access) is obtained in a segment of the lumen of a first body conduit located proximal to the implantable medical device (i.e., toward the proximal end portion of the implantable medical device 100, 700). The first intraluminal access may be located in the subject's lower body, such as in the subject's femoral artery. The second intraluminal access may be located in the subject's upper body, such as in the subject's subclavian / axillary artery. Each of the first and second intraluminal accesses may be a percutaneous body conduit access obtained by a medical procedure known in the art (e.g., by a Seldinger procedure), or may be a natural body conduit access, such as the esophagus, trachea, urethra, and / or rectum, which may require anesthesia or any other medical or surgical preparation. For example, the first intraluminal access may be a percutaneous body conduit access obtained by a medical procedure, while the second intraluminal access may be a percutaneous body conduit access obtained by a medical procedure or may be a natural access. Alternatively, the first and second intraluminal accesses may be obtained in, and therefore located in, the same body conduit, which may have sharp angles or be tortuous in nature.

[0205]

[0226] According to an embodiment, at 2704, optionally, a distal end portion of the implantable medical device 100, 700 is disconnected from a controller configured to operate the implantable medical device 100, 700 (optional item shown in dashed lines in FIG. 27). Of course, this is not necessary if the implantable medical device operates wirelessly.

[0206]

[0227] According to an embodiment, at 2706, optionally, particularly when the implantable medical device 700 is being removed, the method may further include slidably actuating one of the elongated manipulable elements 708, 708A-C and longitudinal guide holes 802, 802A-C relative to the other corresponding one of the elongated manipulable elements 708, 708A-C and longitudinal guide holes 802, 802A-C to endoluminally slidably disassemble any one of the pump elements 707, 707A-C (or functional units, as the case may be) from the corresponding one of the introducer unit 702.

[0207]

[0228] According to an embodiment, at 2708, optionally, the method may further include unanchoring the implantable medical device 100, 700 by converting the anchor 112, 714 from an expanded configuration (when the implantable medical device 100, 700 is anchored) to a contracted configuration (e.g., when the implantable medical device 100, 700 is contained within a sheath) to releasably engage the lumen wall of either the first body conduit or the second body conduit.

[0208]

[0229] According to embodiments, the implantable medical device 100, 700 is retrieved from the first body conduit and the second body conduit through the first body conduit intraluminal access at 2708. In some embodiments, the implantable medical device 100, 700 may be retrieved by introducing a sheath (e.g., a retrieval sheath or a removal sheath) into the lumen of the first body conduit through the first intraluminal access, advancing the sheath within the lumen of the first body conduit adjacent a proximal end portion of the implantable medical device 100, 700, at least partially capturing the implantable medical device 100, 700 within the sheath, and removing the sheath from the first intraluminal access. In some embodiments, the implantable medical device 100, 700 can be retrieved by, for example, using a snare or any other suitable tool intraluminally through the first body conduit to capture the capture element 116, 718, 720 of the implantable medical device 100, 700 and pulling the tool so that the implantable medical device 100, 700 is captured within a sheath.

[0209]

[0230] Alternatively, according to embodiments, the implantable medical device 100, 700 may be retrieved by pulling its distal end portion through a second intraluminal access, in which case there is no need to obtain a first intraluminal access.

[0210]

[0231] According to embodiments, at 2810, optionally, the method may further include closing at least one of the first and second intraluminal accesses if such accesses are percutaneous body conduit accesses obtained by a medical procedure. Typically, the first and second intraluminal accesses are closed after implantation.

[0211]

[0232] The pump elements described and illustrated herein may be provided as intravascular / intravascular pumps that are percutaneously and / or transcatheter implantable in a lumen of a body conduit, such as a blood vessel, and percutaneously and / or transcatheter removable. The pump elements may be axial, centrifugal, and / or positive displacement pumps. The pump elements may lack a shroud encasing a pump impeller as shown herein. In this case, the pump elements may be positioned within an anchor of an implantable medical device to protect the lumen wall from damage or injury caused by the impeller during use. Alternatively, the pump elements may include a shroud.

[0212]

[0233] In use, the pump element can be operated to move any biological fluid, such as blood, in a direction that creates a proximal fluid outflow relative to the implantable medical device or in an opposite direction that creates a distal fluid outflow relative to the implantable medical device. In use, the pump element can be operated continuously, intermittently, or cyclically to mimic the beating of the heart. In use, the pump element can create a hemodynamic effect within the lumen of a blood vessel.

[0213]

[0234] The functional units described and illustrated herein, when in use, may or may not need to be powered to achieve their intended purpose.

[0214]

[0235] The functional unit is not limited to a pump unit, but may in fact include a sensor unit such as a physiological sensor for reporting at least one physiological readout such as fluid pressure, fluid flow rate, fluid viscosity, fluid dissolved molecules (e.g., O2 level and / or CO2 level), fluid temperature, fluid pH, fluid metabolite concentration, etc.

[0215]

[0236] The functional unit may include an occluder unit for selectively occluding a blood vessel in use so that blood flow is diverted to another vessel to selectively enhance organ perfusion.

[0216]

[0237] The functional unit may include a substance delivery unit for intraluminally delivering at least one substance. In this case, the elongate manipulable element may comprise a tube configured to convey the substance to the substance delivery unit. The delivered substance may be, for example, a drug or another fluid (e.g., blood, plasma, saline, glucose solution, etc.).

[0217]

[0238] The functional units may include a fluid sampling unit for endoluminally sampling a fluid or analyte.

[0218]

[0239] If assemblable and / or non-disassemblable, each of the multiple functional units may be the same functional unit, such as the pump unit described and illustrated herein, or each of the multiple functional units may be components of an implantable medical device, where the components are endoluminally assemblable to endoluminally construct a functional implantable medical device.

[0219]

[0240] The functions associated with the functional units are not limited to a single identical function. In fact, multiple functional units may each have various functions associated with them. Thus, when an implantable medical device comprises multiple functional units, multiple corresponding functions may be associated with the implantable medical device. Such multiple functions may be any combination of the functions described above with respect to the sensor unit, the occluder unit, the substance delivery unit, and / or the fluid sampling unit. Such combinations of functions may have synergistic effects.

[0220]

[0241] Any controller described and illustrated herein may be a computer, a power source (e.g., an electrical source and / or an electrically powered power source), or the like, and combinations thereof, configured to operate the functional units and pump elements. Although illustrated herein as a connectable component that is physically separate from the implantable medical device, the controller may be at least partially integrated into the implantable medical device to form an integrated, integrated device.

[0221]

[0242] Each of the first and second intraluminal accesses described and illustrated herein may be an intraluminal percutaneous arterial and / or venous access. Each of the first and second intraluminal accesses may be located in the same blood vessel or in separate or different blood vessels. Each of the first and second intraluminal accesses may be located in the upper body portion of the subject, the lower body portion of the subject, the left body portion of the subject, and / or the right body portion of the subject. Each of the first and second intraluminal accesses may be a femoral access and / or an axillary / subclavian access. Each of the first and second intraluminal accesses may be a surgically created access and / or a natural access. The first and second intraluminal accesses may be created or obtained such that the diameter of one of the first and second intraluminal accesses is smaller than the diameter of the other of the first and second intraluminal accesses. The body conduit may be naturally occurring or may be surgically created, such as by tunneling.

Claims

1. 1. An implantable medical device comprising: a functional unit having an elongated manipulable element connected to and extending from said functional unit; an introducer unit having a body, the body defining a longitudinal guide hole extending at least partially therealong and adapted to slidably receive the elongated manipulable element, the introducer unit being configured for slidable assembly with the functional unit within a lumen of the body conduit for implanting the implantable medical device partially within the body conduit and partially outside the body conduit; 1. An implantable medical device, comprising:

2. 2. The implantable medical device of claim 1, wherein the elongated manipulable element includes a stop element attached to the elongated manipulable element at a distal end portion of the elongated manipulable element for abutting against the introducer unit when the elongated manipulable element is slidably received in the longitudinal guide hole.

3. 10. The implantable medical device of claim 1, further comprising an extension wire removably attachable to the elongated manipulable element at a distal end portion thereof, the extension wire being slidably receivable in the longitudinal guide hole.

4. 4. The implantable medical device of claim 3, wherein the extension wire includes a stop element attached to the extension wire at a distal end portion thereof for abutting against the introducer unit when the extension wire is slidably received in the longitudinal guide hole.

5. The implantable medical device of claim 3 or 4, wherein the extension wire has a cross-sectional size smaller than the cross-sectional size of the elongate steerable element.

6. The implantable medical device of claim 1, further comprising a seal associated with the introducer unit at a proximal end portion thereof, the sealing element being for fluid-tight engagement between the longitudinal guide hole and the elongated operable element.

7. The implantable medical device of claim 1 , further comprising a guidewire attached to the implantable medical device and extending distally away from the introducer unit.

8. The implantable medical device of claim 7 , wherein the guidewire includes a proximal end portion and a distal end portion that is more flexible than the proximal end portion.

9. The implantable medical device of claim 7 or 8, wherein the guidewire includes a flexible distal end portion.

10. The implantable medical device of claim 1 , further comprising a tip removably attachable to the introducer unit at a distal end portion of the introducer unit.

11. The implantable medical device of claim 10 , further comprising a guidewire attached to the implantable medical device and extending distally away from the tip.

12. The implantable medical device of claim 10 or 11, wherein the tip has a tapered shape.

13. The implantable medical device of any one of claims 10 to 12, wherein the cross-sectional size of the tip is smaller than the cross-sectional size of the introducer unit.

14. The implantable medical device of claim 1, wherein the elongated operable element is operably connected to the functional unit and, at a distal end portion of the elongated operable element, is operably connectable to either a controller configured to operate the functional unit or an actuator configured to actuate the functional unit.

15. The implantable medical device of claim 14 , wherein the elongated steerable element includes an elongated conductor operably connectable to the controller.

16. The implantable medical device of claim 14 or 15, wherein the elongate manipulable element comprises a drive shaft operably connectable to the actuator.

17. The implantable medical device of claim 1 , further comprising a capture element captureable by a tool, the capture element being disposed on the introducer unit at a proximal end portion thereof.

18. The implantable medical device of claim 1 , further comprising an anchor attached to the introducer unit for anchoring the implantable medical device in the lumen of the body conduit.

19. 20. The implantable medical device of claim 18, further comprising an anchor rod projecting proximally away from the introducer unit, the anchor being attached to the anchor rod.

20. 20. The implantable medical device of claim 18 or 19, wherein the anchor has a tapered shape at a proximal end portion of the anchor.

21. The implantable medical device of claim 1 , wherein the introducer unit has a tapered distal end portion.

22. The implantable medical device of claim 21, wherein the functional unit is slidably positioned on a side of the proximal end portion of the introducer unit when the elongated operable element is slidably received in the longitudinal guide hole.

23. The implantable medical device of claim 1 , wherein the introducer unit includes a raised portion having a cross-sectional size that is larger than a cross-sectional size of the remainder of the introducer unit.

24. The implantable medical device of claim 1 , wherein the introducer unit is flexible.

25. 2. The implantable medical device of claim 1, wherein the functional unit is a first functional unit, the implantable medical device further includes a second functional unit connected to the second functional unit and having an elongated operable element extending from the second functional unit, the introducer unit having a body defining two longitudinal guide holes extending at least partially along the body for slidably receiving the elongated operable elements of the first functional unit and the second functional unit, and the introducer unit is configured to slidably assemble with the first functional unit and the second functional unit within the lumen of the body conduit to implant the implantable medical device partially inside the body conduit and partially outside the body conduit.

26. The implantable medical device of claim 1 , wherein the functional unit is a pumping unit.

27. 1. An implantable medical device comprising: a functional unit; an introducer unit operatively connected to said functional unit for operating said functional unit, said introducer unit configured to introduce said functional unit into the lumen of said body conduit and to implant said implantable medical device partially inside said body conduit and partially outside said body conduit; 1. An implantable medical device, comprising:

28. 28. The implantable medical device of claim 27, further comprising a guidewire attached to the implantable medical device and extending distally away from the introducer unit.

29. 30. The implantable medical device of claim 28, wherein the guidewire includes a proximal end portion and a distal end portion that is more flexible than the proximal end portion.

30. 29. The implantable medical device of claim 27 or 28, wherein the guidewire includes a flexible distal end portion.

31. 28. The implantable medical device of claim 27, further comprising a tip removably attachable to the introducer unit at a distal end portion of the introducer unit.

32. 32. The implantable medical device of claim 31, further comprising a guidewire attached to the implantable medical device and extending distally away from the tip.

33. 33. The implantable medical device of claim 31 or 32, wherein the tip has a tapered shape.

34. 28. The implantable medical device of claim 27, further comprising an elongated manipulable element extending at least partially longitudinally along the introducer unit, the elongated manipulable element being operably connected to the functional unit and operably connectable at a distal end portion of the elongated manipulable element to either a controller configured to operate the functional unit or an actuator configured to actuate the functional unit.

35. 35. The implantable medical device of claim 34, wherein the elongated manipulable element comprises an elongated electrical conductor operably connectable to the controller.

36. 36. The implantable medical device of claim 34 or 35, wherein the elongate manipulable element comprises a drive shaft operably connectable to the actuator.

37. 28. The implantable medical device of claim 27, wherein the functional unit includes a wireless module operably connected to the functional unit and operably wirelessly connectable to a controller for operating the functional unit.

38. 28. The implantable medical device of claim 27, further comprising a capture element captureable by a tool, the capture element being disposed on the implantable medical device at a proximal end portion of the implantable medical device.

39. 28. The implantable medical device of claim 27, further comprising an anchor attached to the implantable medical device for anchoring the implantable medical device within the lumen of the body conduit.

40. 40. The implantable medical device of claim 39, further comprising an anchor rod projecting proximally away from the implantable medical device, the anchor being attached to the anchor rod.

41. 41. The implantable medical device of claim 39 or 40, wherein the anchor has a tapered shape at a proximal end portion of the anchor.

42. 28. The implantable medical device of claim 27, wherein the introducer unit has a tapered distal end portion.

43. 28. The implantable medical device of claim 27, wherein the introducer unit includes a raised portion having a cross-sectional size greater than a cross-sectional size of the remainder of the introducer unit.

44. 28. The implantable medical device of claim 27, wherein the introducer unit is flexible.

45. 28. The implantable medical device of claim 27, wherein the functional unit is a first functional unit, the implantable medical device further includes a second functional unit, the introducer unit is operably connected to the first functional unit and the second functional unit for operating the first functional unit and the second functional unit, and the introducer unit is configured to introduce the first functional unit and the second functional unit into the lumen of the body conduit and implant the implantable medical device partially inside the body conduit and partially outside the body conduit.

46. 28. The implantable medical device of claim 27, wherein the functional unit is a pumping portion.

47. 1. A method of implanting an implantable medical device, comprising: - introducing the implantable medical device into a lumen of a body conduit through a first intraluminal access; - advancing the implantable medical device within the lumen of the body conduit to a second intraluminal access; - exiting an end portion of the implantable medical device through the second intraluminal access; - manipulating the implantable medical device via the end portion; A method comprising:

48. 48. The method of claim 47, further comprising obtaining a first intraluminal access and a second intraluminal access in one or more body conduits.

49. 48. The method of claim 47, further comprising passing a guidewire attached to the implantable medical device from the first intraluminal access to the second intraluminal access, and pulling the guidewire through the second intraluminal access to cause at least one of the following: (i) introducing the implantable medical device through the first intraluminal access into the lumen of the body conduit, (ii) advancing the implantable medical device within the lumen of the body conduit to the second intraluminal access, and (iii) exiting the end portion of the implantable medical device through the second intraluminal access.

50. 50. The method of claim 49, wherein the passing comprises introducing the guidewire into the lumen of the body conduit through the first intraluminal access, guiding the guidewire to the second intraluminal access, and exiting the guidewire through the second intraluminal access.

51. 51. The method of claim 50, wherein the guiding includes capturing the guidewire with a tool through the second intraluminal access.

52. 48. The method of claim 47, wherein the exiting of the end portion of the implantable medical device causes hemostasis at the second intraluminal access.

53. 48. The method of claim 47, further comprising anchoring the implantable medical device within the lumen of the body conduit.

54. 48. The method of claim 47, wherein the operating comprises operably connecting the end portion of the implantable medical device to a controller configured to operate the implantable medical device.

55. 55. The method of claim 47 or 54, wherein the manipulating comprises detaching a tip from the end portion of the implantable medical device to operably connect the end portion of the implantable medical device to a controller configured to operate the implantable medical device.

56. 48. The method of claim 47, wherein the implantable medical device includes a pump element operably connected to an elongated, manipulable element and an introducer unit defining a longitudinal guide hole, the method further comprising slidably actuating either the elongated, manipulable element or the longitudinal guide hole relative to a corresponding one of the elongated, manipulable element and the longitudinal guide hole to cause at least one of the following: (i) introducing the pump element into the lumen of the first body conduit through the first intraluminal access, and (ii) intraluminally assembling the implantable medical device.

57. 48. The method of claim 47, further comprising closing the percutaneous body conduit access.

58. 1. A method of removing an implantable medical device, comprising: obtaining a first body conduit intraluminal access on the side where the implantable medical device is intraluminally implanted in a body conduit, and partially positioning an end portion of the implantable medical device through a second body conduit intraluminal access located on the opposite side of the implantable medical device; - retrieving the implantable medical device from the body conduit through the first body conduit intraluminal access; A method comprising:

59. 59. The method of claim 58, further comprising disconnecting the end portion of the implantable medical device from a controller configured to operate the implantable medical device.

60. 59. The method of claim 58, wherein the implantable medical device includes a pump element operably connected to an elongated, manipulable element and an introducer unit defining a longitudinal guide hole, the method further including slidably actuating one of the elongated, manipulable element and the longitudinal guide hole relative to a corresponding one of the elongated, manipulable element and the longitudinal guide hole to endoluminally disassemble the implantable medical device.

61. 59. The method of claim 58, further comprising unanchoring the implantable medical device from the body conduit.

62. 59. The method of claim 58, wherein the retrieving comprises introducing a sheath through the first body conduit intraluminal access, at least partially capturing the implantable medical device within the sheath, and removing the sheath from the first body conduit intraluminal access.

63. 63. The method of claim 58 or 62, wherein the retrieving comprises capturing a capture element of the implantable medical device with a tool through the first body conduit intraluminal access and pulling the tool.

Images