Implantable medical devices and related methods thereof

Abstract

An implantable medical device includes a functional unit, an introducer unit for guiding and / or navigating the functional unit in a lumen of one or more body catheters of a patient, and an elongate operable element connectable to a controller, the controller is used for operating the functional unit through an elongated operable element in a lumen of one or more body catheters of a patient. The functional unit, introducer unit, and elongate operable element may be in slidable relationship for assembling and unassembling the implantable medical device in vivo. In accordance with an associated method, an implantable medical device is implantable, removable, and operable in a lumen of one or more body catheters of a patient.

Description

[0001] Cross - reference to related patent applications

[0002] This patent application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 421,366, filed on November 1, 2022. The entire content of the said patent application, including all references (if any) incorporated by reference therein, is incorporated herein by reference for all purposes as if fully set forth herein, except for any definitions, disclaimers of subject matter, or denials, and also except where the incorporated material is inconsistent with the express disclosure herein, in which case the representation of this disclosure shall prevail. Technical Field

[0003] The present disclosure generally relates to medical devices implantable in vivo by related methods. Background Art

[0004] Minimally invasive procedures, such as transcatheter aortic valve replacement (TAVR) and transcatheter pacemaker implantation (only a few examples in the cardiovascular field), are attractive because they cause less trauma to the patient's body than more invasive open surgeries.

[0005] In particular, implanting a medical device via a minimally invasive procedure requires at least one relatively small body incision through which one or more medical devices are routed (especially via one or more transcatheter procedures) to be implanted at one or more corresponding implantation sites in the patient's body. The size of this body incision (or incisions) is typically smaller compared to the incision(s) formed in a more invasive open surgery, where direct access to the implantation site(s) is usually required to implant the medical device. Thus, compared to open surgery, when implanting a medical device via a minimally invasive procedure, the patient's recovery time, hospital stay, pain, and / or risk of infection are typically significantly reduced. Implanting a medical device via a minimally invasive procedure can not only improve the overall treatment outcome for the patient but also reduce the economic burden typically associated with implanting a medical device via an open surgery.

[0006] However, the minimally invasive implantation of medical devices depends to a large extent on the implantation path (or paths) in the patient's body. For example, in the case of minimally invasive implantation in a patient's cardiovascular system, the diameter of one or more blood vessels may be so small that it may prevent an implantable medical device from being properly guided and routed within the lumen of the blood vessel to an intraluminal implantation site. Additionally or alternatively, one or more blood vessels may be so tortuous in shape that it may prevent an implantable medical device from being routed within the lumen of the blood vessel to an intraluminal implantation site without damaging and / or injuring the vascular endothelium.

[0007] For minimally invasive implantation of medical devices that require a percutaneous transluminal access for a relatively long continuous period (such as in the case of implantation of certain cardiovascular medical devices), it may be desirable to achieve appropriate hemostasis at the site of the percutaneous transluminal access while ideally minimizing the impact on the patient's mobility.

[0008] Accordingly, there is a continuing need for improvement in the field of medical devices that can be implanted via minimally invasive procedures. Summary of the Invention

[0009] A first aspect of the present disclosure relates to an implantable medical device comprising: a functional unit; and a guide unit operatively connected to the functional unit for operating the functional unit, the guide unit being configured to guide the functional unit into the lumen of a body conduit and to partially implant the implantable medical device inside and outside the body conduit.

[0010] A second aspect of the present disclosure relates to an implantable medical device comprising: a functional unit having an elongate operable element connected to and extending from it; and a guide unit having a body defining a longitudinal guide bore extending at least partially along the body for slidably receiving the elongate operable element therein, the guide unit being configured to slidably assemble with the functional unit in the lumen of a body conduit for partially implanting the implantable medical device inside and outside the body conduit.

[0011] A third aspect of the present disclosure relates to a method of implanting an implantable medical device, the method comprising: guiding the implantable medical device into the lumen of a body conduit via a first intraluminal access; advancing the implantable medical device in the lumen of the body conduit to a second intraluminal access; causing an end portion of the implantable medical device to exit through the second intraluminal access; and operating the implantable medical device via the end portion.

[0012] A fourth aspect of the present disclosure relates to a method of removing an implantable medical device, the method comprising: obtaining a first body conduit intraluminal access on one side of the implantable medical device, the implantable medical device being implanted intraluminally in a body conduit and an end portion thereof being partially positioned to extend through a second body conduit intraluminal access 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.

[0013] One aspect of the present disclosure relates to an implantable medical device comprising: a functional unit having an elongate operable element connected to and extending from it; and a guide unit that slidably receives the elongate operable element therethrough such that an intermediate portion of the elongate operable element is disposed between the functional unit and the guide unit, the guide unit being configured to guide and / or navigate the functional unit within a lumen, the intermediate portion being configured to articulate such that the functional unit and the guide unit can articulate relative to each other within the lumen.

[0014] One aspect of the present disclosure relates to a medical device assembly comprising: a sheath configured to be guided within a luminal passageway of a patient's body; and an implantable medical device comprising a tapered shape for dilating the luminal passageway when being guided through the luminal passageway, the implantable medical device being capable of releasably engaging with the sheath so as to be deliverable within the lumen when the sheath is guided within the luminal passageway of the patient's body for implanting the implantable medical device and not leaving the sheath behind thereafter.

[0015] Definitions

[0016] As contemplated herein, the expression "body conduit" refers to any physiological structure in a patient's body that defines an internal space, such as a blood vessel, lymphatic vessel, hollow organ, etc.

[0017] The terms "operate", "being operated", etc. cover operations, controls, power supplies, and corresponding actions in the context of the use of medical devices.

[0018] The terms "elongate operable element" and corresponding structures cover any elongate structure capable of slidably moving a functional unit or functional element of an implantable medical device and / or capable of transmitting power to a functional unit or functional element of an implantable medical device. Brief Description of the Drawings

[0019] To make the present disclosure easy to understand, at least some selected embodiments of the present disclosure are illustrated by way of example (examples) in the drawings. Therefore, the drawings are essentially illustrative only and are not intended to be understood and interpreted as limiting the scope of the subject matter protected by the claims.

[0020] It should be noted that in all the drawings, the same reference numerals denote similar or equivalent elements and / or features. If there are reference numerals in the claims, the reference numerals are only for making the claims easier to understand and are not intended to be understood and interpreted as limiting the scope of the subject matter protected by the claims. In all the drawings, the illustrated elements and / or features are not necessarily drawn to scale.

[0021] Figure 1 Schematic representation of an implantable medical device according to a first aspect of the present technology, the implantable medical device being provided with a guide unit having an elongate operable element and a functional unit in a non-slidable relationship with the guide unit.

[0022] Figures 2A - 2B Perspective view of a non-slidable implantable medical device according to an embodiment, the implantable medical device being, for example, Figure 1 the implantable medical device.

[0023] Figure 3 Is Figure 1 Perspective view of an implantable medical device according to an embodiment, the implantable medical device being provided with a bulge.

[0024] Figures 4A - 4B Is Figure 1 Perspective view of an implantable medical device according to an embodiment, the implantable medical device being provided with a removable tip.

[0025] Figures 5A - 5D Is Figure 1 Perspective view of an implantable medical device according to an embodiment, the implantable medical device being provided with an anchor.

[0026] Figure 6 Is Figure 1 Perspective view of an implantable medical device according to an embodiment, the implantable medical device being provided with a plurality of pump elements.

[0027] Figure 7 Schematic representation of an implantable medical device according to a second aspect of the present technology, the implantable medical device being provided with a guide unit and a functional unit in a slidable relationship with the guide unit, the functional unit having an elongate operable element.

[0028] Figures 8A - 8C Perspective view of a slidable implantable medical device according to an embodiment, the implantable medical device being, for example, Figure 7 the implantable medical device.

[0029] Figure 9A And Figure 9B Is Figure 7 Perspective view of an implantable medical device, the implantable medical device being navigated within the lumen of a body conduit.

[0030] Figure 10 Is Figure 7 Perspective view of an implantable medical device according to an embodiment, the implantable medical device being provided with a bulge.

[0031] Figures 11A - 11B For Figure 7 FIG. Figure 7 is a perspective view of an implantable medical device according to one embodiment, the implantable medical device being provided with a removable tip.

[0032] Figures 12A - 12D For Figure 7 FIG. Figure 7 is a perspective view of an implantable medical device according to one embodiment, the implantable medical device being provided with an anchor.

[0033] Figures 13A - 13B For Figure 7 FIG. Figure 7 is a perspective view of an implantable medical device according to one embodiment, the implantable medical device being provided with a plurality of slidable pump elements.

[0034] Figure 14A For Figure 7 FIG. Figure 7 is a longitudinal cross-sectional view of an implantable medical device received within a sheath, FIG. 14B is a transverse cross-sectional view taken along plane XIVB of Figure 14A , FIG. 14C is a transverse cross-sectional view taken along plane XIVC of Figure 14A , and FIGS. 14D - 14E are used for comparison. Figure 14A Figure 14A Figure 14A FIG. Figure 14A is a transverse cross-sectional view taken along plane XIVC of Figure 14A , and FIGS. 14D - 14E are used for comparison.

[0035] Figures 15 - 19 For Figure 7 FIG. Figure 7 is a perspective view of an implantable medical device according to one embodiment, the implantable medical device being provided with another anchor.

[0036] Figures 20 - 21 For Figure 7 FIG. Figure 7 is a plan view of an implantable medical device according to one embodiment, the implantable medical device being provided with a sheath and removably engaged within the sheath for delivery.

[0037] Figure 22 For an implantable medical device according to one embodiment for Figure 7 FIG. Figure 7 is a perspective view of a compression fixation mechanism of an implantable medical device for

[0038] Figures 23A - 23C For Figure 7 FIG. Figure 7 is a schematic representation of an implantable medical device according to one embodiment, the implantable medical device being navigated within the lumen of a body conduit of a patient's body.

[0039] Figure 24 For a method of implanting an implantable medical device according to a third aspect of the present technology Figure 1 and Figure 7 FIG. Figure 7 is a schematic representation of a method of implanting an implantable medical device.

[0040] Figures 25A - 25J For a method of implanting an implantable medical device according to a third aspect of the present technology Figure 7Schematic representation of a method for an implantable medical device.

[0041] Figure 26 Schematic representation of a method for an implant pump unit according to a third aspect of the present technology.

[0042] Figure 27 For removing according to a fourth aspect of the present technology Figure 1 and Figure 7 Schematic representation of a method for an implantable medical device. Detailed implementation

[0043] In the following detailed description, the subject matter of the present disclosure and any advantages thereof are described and explained with reference to one or more non - restrictive aspects, embodiments, examples, features, elements, and / or steps presented hereinafter and illustrated in non - restrictive drawings. It should be recognized that these one or more non - restrictive aspects, embodiments, examples, features, elements, and steps may have variations, which those skilled in the art should readily recognize, and that any other variations and any combinations of these other variations may be considered according to the specific circumstances without departing from the scope of the present disclosure, even if they are not explicitly presented and stated herein.

[0044] Therefore, these one or more non - restrictive aspects, embodiments, examples, features, and / or elements are merely for facilitating the understanding by those skilled in the art of the manner in which the claimed subject matter may be practiced. Accordingly, these one or more non - restrictive aspects, embodiments, examples, features, and / or elements should not be construed as limiting the scope of the claimed subject matter, which is defined only by the appended claims and the applicable law.

[0045] The terms used herein are merely for describing and explaining the claimed subject matter and are 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 those skilled in the art.

[0046] In view of the above, the present disclosure relates to a medical device that can be implanted into a lumen of a patient's body through minimally invasive surgery and can be removed from the lumen of the patient's body. For example, the medical device disclosed herein can be implanted into and / or removed from the lumens of blood vessels, lymphatic vessels, and hollow organs. As will be understood hereinafter, the medical device disclosed herein, together with its implantation and removal methods, is suitable for guiding, navigating, implanting, and removing in the lumen(s) of a patient's body, which are typically difficult to handle due to size limitations or incompatibility of the size with the use of medical devices known in the art.

[0047] Generally speaking, the implantable medical device disclosed in this document includes a guide unit and a functional unit. The guide unit and the functional unit may or may not have a slidable relationship for assembling the guide unit and the functional unit together and / or disassembling the guide unit and the functional unit from each other. The guide unit is configured to guide and / or navigate the functional unit in the lumen of one or more body conduits (such as blood vessels) for implanting the functional unit into the lumen of one or more body conduits within the lumen. After such implantation, the guide unit is at least partially externalized from the body conduit for operating the functional unit within the lumen through the guide unit.

[0048] Reference Figures 1 - 6 , an implantable medical device 100 according to a first aspect of the present disclosure will be described.

[0049] Figure 1 An implantable medical device 100 according to an embodiment is schematically shown. The implantable medical device 100 includes a guide unit 102 and at least one functional unit 105. The guide unit has an elongated operable element 104 integrated therewith, and the functional unit is operatively connected to the elongated operable element 104 for operation. In the first aspect of the present disclosure, the guide unit 102 and the functional unit 105 are physically coupled together in a non-slidable relationship to form an integral single-piece device. The implantable medical device 100 can be delivered to, implanted in, and retrievable from the lumen of a body conduit (multiple body conduits). The guide unit 102 can be used as a percutaneous dilator provided with an integrated elongated operable element 104 such that the functional unit 105 is implanted in the body with the help of the guide unit 102 and operated from outside the patient's body through the guide unit 102. When the elongated operable element 104 is operatively connected to a controller (not shown), the functional unit 105 can be operated via the elongated operable element 104, such as by electrical operation or mechanical operation. Such an operation can produce a hemodynamic effect in the patient's body.

[0050] The guide unit 102 is not only configured to guide, direct, and navigate the functional unit 105 in the lumen of a body conduit (multiple body conduits) for implanting the functional unit 105 into its lumen implantation site, but also configured to operate the functional unit 105 in the lumen through the guide unit by an operative connection with a controller (the connection occurs outside the lumen).

[0051] When the implantable medical device 100 is implanted into the lumen of a body conduit (a plurality of body conduits), the introducer unit 102 is partially positioned outside the lumen of the body conduit (a plurality of body conduits) through the intraluminal access, while the functional unit 105 is positioned inside the lumen of the body conduit (a plurality of body conduits).

[0052] As Figure 1 schematically illustrated, the implantable medical device 100 may further include, for example, a guide wire 108, a tip 110, an anchor 112, an anchor rod 114, a capture element 116, and a cap 118 (optional items are Figure 1 represented by dashed lines), as will be described hereinafter. The implantable medical device 100 may also optionally include more than one functional unit 105.

[0053] Figures 2A - 2B An implantable medical device 100 according to an embodiment is illustrated, the implantable medical device including an introducer unit 102 and a pump element 106 provided as a functional unit 105. The introducer unit 102 has a body 200 extending between a proximal end portion 202 and a distal end portion 204, and the pump element 106 is physically coupled to the introducer unit at the proximal end portion, and the distal end portion 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, etc.

[0054] Although the proximal end portion 202 and the distal end portion 204 of the introducer unit 102 may be of any shape, the distal end portion 204 may be more specifically shaped to facilitate guiding the implantable medical device 100 through the intraluminal access of the body conduit. The distal end portion 204 may also be shaped to mitigate or prevent damage or injury to the lumen wall (such as the intima in the case of a blood vessel), which may be caused by guiding and navigating 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 dimensions and / or shape gradually increase from the distal end portion 204 of the introducer unit 102 toward the proximal end portion 202.

[0055] As Figures 2A - 2BAs illustrated by the examples shown, for example, the distal end portion 204 of the introducer unit 102 is conical and / or shaped irregularly (referred to herein as "conical"). However, the distal end portion 204 of the introducer unit 102 can have any other suitable shape, such as a circular or convex shape, an oval shape, a pyramidal shape, a blunt shape with rounded edges (multiple rounded edges), or any other shape that does not damage the lumen wall. In all cases, the distal end portion 204 of the introducer unit 102 can be without sharp edges (multiple sharp edges) and corresponding structures that may damage or injure the lumen wall, such as by undesired abrasion, scratching, cutting, piercing, rupturing, and / or peeling of the lumen wall when the implantable medical device 100 is being guided and / or navigated through the lumen. Regardless of its shape, the distal end portion 204 of the introducer unit 102 can be capable of attaching to a cable or other corresponding structure that can be pulled to guide and / or navigate the implantable medical device 100 within the lumen of a body conduit (multiple body conduits). In such a case, such attachment is secure enough to withstand the appropriate pulling forces in a medical procedure situation without breaking.

[0056] When the implantable medical device 100 is properly used, the conical shape of the distal end portion 204 can assist and / or facilitate guiding the introducer unit 102 through the lumen of a body conduit (multiple body conduits) by gradually expanding the inner lumen passage of the body conduit (which can be a percutaneous intraluminal passage) as the introducer unit 102 is being guided through the lumen. As a result, the size and / or shape of the inner lumen passage becomes acceptable for the pump element 106 to pass through it.

[0057] Still referring to Figures 2A - 2B , according to an embodiment, the introducer unit 102 is provided with an elongate operable element 104 (shown in dashed lines so as to be visible through the introducer unit 102), which is operatively connected to the pump element 106 at its proximal end portion 208 and is removably and operatively connectable at its distal end portion 210 to an optional controller 226 (illustrated by example in Figure 2B . The elongate operable element 104 extends at least partially along the introducer unit 102 and can be located at any position, such as within the body 200 (as illustrated by example in Figures 2A - 2B ) or at the surface of the body 200 of the introducer unit 102. The connector 212 is integrated into the distal end portion 204 of the introducer unit 102 and can be located at its periphery, as illustrated by example in Figures 2A - 2B , or at its end.

[0058] As illustrated by the example, the elongate operable element 104 is an electrical conductor configured to transmit electrical power from a controller to the pump element 106 when connected to the controller. In particular, the electrical conductor operably interconnects the pump element 106 to the controller 226 through a removable electrical connection provided by the connector 212 such that the pump element 106 can be electrically operated by the controller from the distal end portion 206 of the implantable medical device 100.

[0059] Alternatively, the elongate operable element 104 can be a drive shaft configured to transmit torque from a controller, such as an actuator or a motor, to the pump element 106. In this case, the drive shaft can operate the pump element 106 or any other functional unit 105 in various ways, including by rotational movement and / or reciprocating movement.

[0060] Additionally, alternatively, the implantable medical device 100 can be provided with a wireless module integrated into the introducer unit 102. The wireless module is operably connected to the elongate operable element 104, in which case the elongate operable element can include an electrical conductor and is configured to wirelessly connect to a controller for operating the pump element 106.

[0061] To enable or facilitate intraluminal navigation, the introducer unit 102 and the elongate operable element 104 can be made of a bendable, flexible, and / or elastic material to adapt to or conform to various body conduit morphologies, but still be rigid enough to be pushed through an intraluminal passage. For example, the introducer unit 102 can be made of a polymer, such as thermoplastic polyurethane, while the elongate operable element 104 can include an electrical conductor or be a drive shaft made of a suitable bendable, flexible, and / or elastic material.

[0062] As Figure 2A further illustrated in, according to an embodiment, the implantable medical device 100 is provided with an optional cover 118. Depending on the nature of the connector 212, such as when the electrical connector 212 is an electrical connector, it may be desirable to protect the connector 212 from environmental factors, such as blood, to ensure proper connectivity. The cover 118 can be removed from the implantable medical device 100 for operably connecting the connector 212 to the controller 226. For example, the cover 118 can be removably attached to the peripheral cavity 224 provided with the connector 212 (as illustrated by the example), or can be removably directly attached to the connector 212. The removable attachment of the cover 118 to the implantable medical device 100 can be achieved by an interference fit, a threaded connection, etc.

[0063] Figure 3Example illustrates the introducer unit 102 according to an embodiment, the introducer unit being provided with an optional bulge 300 at its distal end portion 204. The cap 118 is removed from Figure 3 omitted, but may be present. Although illustrated as being near the distal end portion 204 of the introducer unit 102, the bulge 300 may be located at any position along the length of the introducer unit 102, such as at the middle portion of the introducer unit 102 or near the proximal end portion 202. The size and shape of the bulge 300 are set to interrupt the gradual increase in the transverse cross-sectional dimension of the tapered shape of the distal end portion 204. In particular, the bulge 300 increases the transverse cross-sectional dimension of the introducer unit 102 more abruptly than the tapered shape. In addition, the introducer unit 102 may include a plurality of bulges 300 spaced apart from each other along the length of the introducer unit 102. In this case, when moving from the distal end portion 204 of the introducer unit 102 towards the proximal end portion 202, each of the plurality of bulges 300 has an increasing transverse cross-sectional dimension relative to the previous bulge.

[0064] In use, after the distal end portion 204 of the introducer unit 102 has been guided through the intraluminal passage and hemostasis may have been achieved, further guiding one or more bulges 300 through the intraluminal passage can promote or improve hemostasis by further dilating the intraluminal passage to provide a fluid-tight engagement. The difference in the transverse cross-sectional dimension between the distal end portion 204 of the introducer unit 102 and the bulge(s) 300 can be about 0.5 Fr, 1.0 Fr, 1.5 Fr, or 2.0 Fr.

[0065] Figures 4A - 4B Example illustrates an implantable medical device 100 according to an embodiment, the implantable medical device having a distal end portion 204 of an introducer unit 102 provided with an optional tip 110 that can be removably attached to the remainder of the introducer unit 102 and coupled to a guidewire 108. The tip 110 has a tapered shape similar to the tapered shape of the distal end portion 204 of the Figures 2A - 2B introducer unit 102. As illustrated, the tip 110 also has an optional bulge 400 similar to the bulge 300 of the distal end portion 204 of the Figure 3 introducer unit 102. The tip 110 may be capable of attaching to a cable or other corresponding structure that can be pulled for guiding and / or navigating the implantable medical device 100 within the lumen of a body catheter(s). In this case, such an attachment is strong enough to withstand the appropriate pulling force in a medical surgical situation without breaking.

[0066] As for the cap 118, the end 110 is configured to protect the connector 212 from environmental factors (such as blood) when attached to the implantable medical device 100, and the end is removable for operatively connecting the connector 212 to a controller. For example, the end 110 may be removably attached to the distal cavity 402 (as illustrated) provided with the connector 212 or may be removably attached directly to the connector 212. The removable attachment of the end 110 to the implantable medical device 100 may be achieved by a threaded connection (as illustrated), an interference fit, etc. The elongate operable element 104 (shown in dashed lines in Figures 4A - 4B so as to be visible through the introducer unit 102) is shown in Figures 4A - 4B as an electrical conductor configured to transmit electrical power from a controller (not shown) to the pump element 106 when connected to the controller.

[0067] The end 110 is generally similar to the distal end portion 204 of the introducer unit 102, particularly in terms of its tapered shape and the bulge(s), and for the sake of brevity, the end 110 will not be further described herein. Thus, it should be understood that, where applicable and with the necessary changes that would be understood by a person skilled in the art, a similar description applies to the end 110 and the distal end portion 204 of the introducer unit 102.

[0068] As Figure 4A illustrated, according to an embodiment, the implantable medical device 100 is provided with an optional locking mechanism 404 configured to lock the end 110 in place on the introducer unit 102 to prevent the end 110 from being undesirably detached from the introducer unit 102, such as when a pulling force is applied to the guide wire 108. As illustrated, the locking mechanism 404 is integrated into the cavity 402 of the introducer unit 102; alternatively, the locking mechanism 404 may be integrated at any position along the length of the introducer unit 102. The locking mechanism 404 may be useful when the end 110 is removably attached to the introducer unit 102 by an interference fit.

[0069] The locking mechanism 404 can include a positioning screw and other similar engagement structures that are set to the introducer unit 102, and the positioning screw and other similar engagement structures removably engage the end 110 to lock the end. Alternatively, the locking mechanism 404 can also include a first part that is set to the introducer unit 102 and a second part that is set to the end 110. The first part and the second part are configured to selectively engage with each other to lock them together. In this case, the first part can be a pin and other corresponding engagement structures, and the second part can be a hole and other corresponding engagement structures, and the hole and other corresponding engagement structures are configured to cooperatively engage the first part.

[0070] Figures 5A - 5D Example illustrates an implantable medical device 100 according to an embodiment, and the implantable medical device is provided with an optional anchor 112, and the optional anchor has a contracted configuration ( Figure 5A , Figure 5C ) and an expanded configuration ( Figure 5B , Figure 5D ). As illustrated in Figure 5A , Figure 5C , the anchor 112 in the contracted configuration can be received in 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 illustrated as having an end 110 in Figures 5A - 5D , the implantable medical device 100 can alternatively be provided with a cap 118.

[0071] The anchor 112 in the contracted configuration (which is received or not received in the sheath) can be guided and navigated in the lumen of a body catheter (multiple body catheters). The anchor 112 in the expanded configuration is configured to removably anchor the implantable medical device 100 in the lumen of a body catheter (multiple body catheters) by removably engaging the lumen wall of the body catheter. The anchor 112 can be deployed in the lumen of a body catheter (multiple body catheters), for example, at the intraluminal implantation site where it is desired to fix the pump element 106 for operation. The anchoring of the implantable medical device 100 not only allows the pump element 106 to be maintained in the proper position at the intraluminal implantation site for generating a suitable hemodynamic effect, but also allows the distal end portion 204 of the introducer unit 102 to be properly maintained in the proper position through an intraluminal access (such as a percutaneous intraluminal access) to facilitate or help maintain hemostasis.

[0072] As Figure 5BBest illustrated in, the anchor 112 has a tubular wall 500 defining a central opening 502, and includes at least one anchor arm (e.g., six anchor arms 504A - 504F as illustrated), the at least one anchor arm connecting the tubular wall 500 to the pump element 106 and positioning the pump element 106 and / or the guide unit 102 at least partially within the central opening 500. Alternatively, the tubular wall 500 may be attached to the guide unit 102 by at least one anchor arm (such as anchor arms 504A - 504F) to position the pump element 106 and / or the guide unit 102 at least partially within the central opening 502. Thus, the anchor 112 can generally be configured as a bracket-like structure, an array-like structure, and / or a scaffold-like structure.

[0073] As Figures 5C - 5D Illustrated in, according to an embodiment, the implantable medical device 100 is provided with an optional anchor rod 114 that supports the anchor 112. The distal end portion 506 of the anchor rod 114 is attached to the pump element 106. At least one anchor arm (e.g., anchor arms 504A, 504F as illustrated) connects the proximal end portion 508 of the anchor rod 114, at least one anchor arm (e.g., anchor arms 504B, 504E as illustrated) connects the distal end portion 506 of the anchor rod 114, and at least one anchor arm (e.g., anchor arms 504C, 504D as illustrated) connects the pump element 106. Alternatively, at least one anchor arm (specifically, three anchor arms 504) may only connect the proximal end portion 508 of the anchor rod 114. The pump element 106 and / or the guide unit 102 connected by one or more anchor arms 504A - 504F are at least partially positioned within the central opening 502 defined by the tubular wall 500.

[0074] As Figure 5B 、 5D Illustrated in, the size and shape of the anchor 112 are set such that its transverse cross-sectional dimensions gradually increase from its proximal end portion 510 towards its distal end portion 512. Thus, as illustrated, the anchor 112 is of a conical and / or irregular shape (referred to herein as "conical"). Such a conical shape may not be limited to Figure 5B 、 Figure 5D The shape illustrated in, since the anchor 112 may not have a tubular wall 500 and only has three anchor arms 504, in which case the three anchor arms may include anti-damage lumen wall engagement end portions.

[0075] The anchor 112 can be in a contracted configuration (as Figure 5A 、 Figure 5C Illustrated in) and an expanded configuration (as Figure 5B 、 Figure 5DConvert between the configurations illustrated as examples herein. In the contracted configuration, the tubular wall 500 and the anchoring arms 504A - 504F are radially disposed relatively closer to the pump element 106 and / or the guide unit 102 as compared to the expanded configuration. In the expanded configuration, the tubular wall 500 and the anchoring arms 504A - 504F are radially disposed relatively farther from the pump element 106 and / or the guide unit 102 as compared to the contracted configuration, such that the anchor 112 can removably engage the lumen wall of a body conduit (body conduits) in use and thus removably anchor the implantable medical device 100 to the lumen wall.

[0076] The anchor 112 can be self - expandable (also referred to herein as a "self - expandable anchor"), and thus can be biased towards the expanded configuration in a manner that can be overcome. In such a case, as Figures 5A - 5C illustrated as an example herein, the self - expandable anchor 112 can be restricted to the contracted configuration by a sheath that houses the implantable medical device 100. When self - expandable, the anchor 112 can be made of a material that imparts such properties, such as nitinol, stainless steel, polymers, plastics, etc.

[0077] In use, the implantable medical device 100 housed within the sheath (i.e., "sheathed") is capable of being delivered and / or implanted at an intraluminal implantation site within the lumen of a body conduit (body conduits), where the self - expandable anchor 112 is constrained by the sheath to the contracted configuration, as Figure 5A 、 Figure 5C illustrated as an example herein. After the sheath is guided through the intraluminal access of the body conduit (such as a percutaneous intraluminal access) into the lumen of the body conduit (body conduits) and the sheath is navigated to the intraluminal implantation site, the implantable medical device 100 is removed from the sheath for implantation (i.e., "unsheathed"), thereby releasing the constraint exerted by the sheath on the self - expandable anchor 112 and causing the self - expandable anchor 112 to automatically convert from the contracted configuration to the expanded configuration, as Figure 5B 、 Figure 5D illustrated as an example herein.

[0078] Alternatively, the anchor 112 can be converted from a collapsed configuration to an expanded configuration within the lumen of a body conduit (body conduits) by a balloon catheter that is inserted into the central opening 500 and then inflated. In such a case, the anchor 112 is not self - expandable, but is expandable. Thus, the anchor 112 can be made of a material that imparts such properties, such as cobalt - chromium alloy, etc.

[0079] In the absence of the self-expanding anchor 112, the implantable medical device 100 can be delivered and / or implanted into the lumen of a body conduit (body conduits) with or without a sheath.

[0080] Additionally, in use, the implantable medical device 100 can be retrieved from an intraluminal implantation site within the lumen of a body conduit (body conduits) using a sheath. Guided through a first intraluminal access (such as a percutaneous intraluminal access) into the lumen of the body conduit (body conduits) and approaching the implantable medical device 100 from the impeller side portion (i.e., the proximal portion) of the implantable medical device 100, the sheath gradually slides onto the self-expanding anchor 112 in an expanded configuration. To hold the implantable medical device 100 in place within the lumen, the distal portion 206 of the implantable medical device 100 can be held and fixed by the operator through a second intraluminal access (such as a percutaneous intraluminal access). Alternatively, the distal portion 206 of the implantable medical device 100 can be pushed by the operator through the second intraluminal access towards the sheath. As the sheath slides over the expandable anchor 112, the sheath applies pressure to the proximal portion 510 of the self-expanding anchor 112 (which is tapered as illustrated), causing the self-expanding anchor 112 to gradually transition from an expanded configuration to a contracted configuration. Then, the sheath containing the implantable medical device 100 (i.e., "sheathed") is removed from the lumen of the body conduit, thereby removing the implantable medical device 100.

[0081] In the absence of the self-expanding anchor 112, the implantable medical device 100 can be retrieved and / or removed from the lumen of a body conduit (body conduits) with or without a sheath.

[0082] Still referring to Figures 5A - 5D , according to an embodiment, the implantable medical device 100 is provided with an optional capture element 116 that can be captured in vivo by a tool (such as a snare, etc.) to pull the implantable medical device 100 within the lumen of a body conduit (body conduits) or to hold the implantable medical device in place. The capture element 116 can be located on the pump element 106 (as illustrated in Figures 5A - 5B ) or on the proximal portion 508 of the anchor rod 114 (as illustrated in Figures 5C - 5D ), and in use can be captured from the proximal portion 510 of the anchor 112.

[0083] The capture element 116 can have any size and shape that enables it to be captured by a tool within the lumen. For example, as in Figures 5A - 5DAs illustrated by the example shown, the capture element 116 defines an annular recess 514 around which the noose of the snare can be looped to capture the capture element 116. Alternatively, the capture element 116 can be a hook that can be captured within the lumen by a snare or similar tool, or can be a loop that can be captured within the lumen by a hook tool or similar tool.

[0084] The capture element 116 can be used to remove the implantable medical device 100 from the lumen of a body conduit (body conduits). In particular, in use, the sheath is guided through a first intraluminal access (such as a percutaneous intraluminal access) into the lumen of the body conduit (body conduits) and navigated therein to approach the self-expanding anchor 112 from the proximal end portion 510 of the self-expanding anchor 112. A snare passing through the sheath captures the capture element 116. The snare is pulled to cause the implantable medical device 100 to enter the sheath. The sheath can be pushed towards the implantable medical device 100 through the first intraluminal access when the snare is pulled or not pulled. The distal end portion 206 of the implantable medical device 100 can also be pushed towards the sheath through a second intraluminal access (such as a percutaneous intraluminal access) that receives the implantable medical device 100 when the snare is pulled or not pulled. Then, the sheath containing the implantable medical device 100 is removed from the lumen of the body conduit (body conduits) to remove the implantable medical device 100.

[0085] The capture element 116 can also be used to convert the self-expanding anchor 112 from an expanded configuration to a collapsed configuration during the removal process. In particular, in the case where the sheath abuts the proximal end portion 510 of the self-expanding anchor 112 in the expanded configuration, the snare is pulled so that the sheath applies pressure on the proximal end portion 510 (the proximal end portion being conical in shape) of the self-expanding anchor 112, thereby causing the self-expanding anchor 112 to convert from the expanded configuration to the collapsed configuration. As described above, the sheath can be pushed through the first intraluminal access towards the implantable medical device 100 when the snare is pulled or not pulled, and / or the distal end portion 206 of the implantable medical device 100 can be pushed through the second intraluminal access to assist in the conversion.

[0086] The coaxial arrangement of the capture element 116 relative to the implantable medical device 100 facilitates enclosing the implantable medical device 100 within the sheath and facilitates converting the anchor 112 from the expanded configuration to the collapsed configuration because the pressure is applied evenly by the sheath to the proximal end portion 510 of the anchor 112.

[0087] The capture element 116 can be made of a radiopaque material, such as nitinol, which is visible by medical imaging (such as by fluoroscopy) to assist or facilitate the capture of the capture element 116 within the lumen by a tool. To facilitate viewing by medical imaging of the capture element 116, which may be relatively close to the impeller, as Figures 5A - 5B illustrated, the impeller can be made of a non-radiopaque material.

[0088] Referring again to Figure 1 FIG. 5, according to an embodiment, the implantable medical device 100 is provided with an optional guidewire 108 that can be attached to the implantable medical device 100 and pulled to move the implantable medical device 100 within the lumen of a body catheter (body catheters). As Figures 2A - 2B illustrated in FIGS. 5, the guidewire 108 has a proximal end portion 216 that is attached to the distal end portion 204 of the introducer unit 102 (the distal end portion 204 can be the tip 110), for example, attached to its tapered farthest distal end portion 218. The attachment of the guidewire 108 to the introducer unit 102 or the tip 110 can be rotatable and / or removable.

[0089] The distal end portion 220 of the guidewire 108 can also be capable of being captured within the lumen by a tool (such as by a snare, etc.) that can be pulled to guide and / or navigate the implantable medical device 100 within the lumen of a body catheter (body catheters). In particular, the distal end portion 220 of the guidewire 108 can be floppy. The distal end portion 220 of the guidewire 108 can be more floppy than the proximal end portion 216 of the guidewire 108, i.e., the proximal end portion 216 can be stiffer than the distal end portion 220. Such a stiffer characteristic can assist in deploying the guidewire 108 within the lumen (lumens) of the body catheter by pushing the proximal end portion 216 of the guidewire 108. Alternatively, the entire guidewire 108 can be floppy in nature. The floppy nature of the guidewire 108 enables the tool to capture it within the lumen by folding the floppy portion of the guidewire 108 back onto itself at the kink formed by the snare. After such folding, the guidewire 108 and the tool can move along the lumen of the body catheter (body catheters) and through the luminal passageway without significant resistance and / or without damaging or injuring the lumen wall.

[0090] Alternatively, the distal end portion 220 of the guidewire 108 can be provided with a hook that can be captured within the lumen by a snare or similar tool, or can be provided with a loop that can be captured by a tool equipped with a hook or a similar structure that can capture the loop.

[0091] The attachment between the guide wire 108 and the introducer unit 102, between the guide wire 108 and the tip 110, and between the tip 110 and the remainder of the introducer unit 102 can be, as the case may be, sufficiently secure to maintain an appropriate pull on the guide wire 108 without detaching the tip 110 and / or damaging the implantable medical device 100. Thus, as the case may be, such attachment can be achieved by gluing, fusing, welding, or threading the components together, or by implementing the locking mechanism 404.

[0092] According to an embodiment, the guide wire 108 can include an electrical conductor that extends at least partially between its proximal end portion 216 and its distal end portion 220, and the electrical conductor can be floppy or not. The electrical conductor is electrically connected to the elongate operable element 104 at the proximal end portion 216, where, in this case, the elongate operable element 104 is also an electrical conductor as described above. The guide wire 108 integrates an electrical connector at the distal end portion 220, and the electrical connector is capable of removably connecting to a controller for operating the pump element 106.

[0093] In use, the distal end portion 220 of the guide wire 108 is guided through a first luminal passageway (such as a first percutaneous passageway), and the guide wire 108 is disposed within the lumen of a body conduit (body conduits). The distal end portion 220 of the guide wire 108 is captured by a tool (such as a snare) that is disposed through a second luminal passageway (such as a second percutaneous passageway). The snare that has captured the guide wire 108 is then pulled to move the guide wire 108 along the lumen of the body conduit (body conduits) until it reaches and passes through the second luminal passageway. Thus, depending on the length of the guide wire 108, the implantable medical device 100 can be guided within the first luminal passageway and / or navigated within the lumen of the body conduit (body conduits) in which the guide wire 108 was initially disposed. When the guide wire 108 is pulled, the proximal end portion 202 of the introducer unit 102 can be pushed to assist or facilitate the guiding and / or movement.

[0094] In some cases, it may be desirable to pull the guidewire 108 to advance the implantable medical device 100 within the lumen of a body conduit (body conduits), because pushing the implantable medical device 100 alone may cause the implantable medical device 100 to advance in an undesired direction. Advantageously, integrating the guidewire 108 into the implantable medical device 100 enables the implantable medical device 100 to be guided and navigated within the lumen of a body conduit (body conduits), which would not be possible in the absence of the guidewire 108. In fact, depending on the morphology of the body conduit, the body conduit (body conduits) may be very tortuous such that one or more acute angles may impede proper guidance and / or navigation of other implantable medical devices within the body conduit without damaging or injuring the lumen wall. In particular, the size, shape, and / or stiffness properties of other implantable medical devices may be such that they cannot traverse such acute angles. On the other hand, the guidewire 108, having appropriate dimensions and generally being smaller and more flexible than at least some implantable medical devices, can traverse these acute angles. Such cases are illustrated in Figures 23A - 23C and Figures 25A - 25J and will be described in further detail below. When the guidewire 108 is disposed within the lumen of a body conduit (body conduits), advantageously, the guidewire 108 can be pulled to assist or facilitate the guidance and / or navigation of the implantable medical device 100, and, optionally, the implantable medical device can be pushed simultaneously. The combined action of pulling and pushing can achieve a smoother medical procedure that causes less damage to the lumen wall.

[0095] The guidewire 108 enables the implantable medical device 100 to be pulled in one direction within the lumen, while the implantable medical device 100 can be pulled in the opposite direction via the capture element 116, both of which pulls are desirable to properly position the implantable medical device 100 within the lumen depending on the medical procedure being performed.

[0096] In addition, the connection between the guidewire 108 and the implantable medical device 100 is advantageously more secure than a typical attachment between a tool, such as a snare, and the implantable medical device. Such a more secure connection enables the implantable medical device 100 to withstand an appropriate pulling force during a medical procedure without breaking. This is not necessarily the case for a typical attachment between a snare and an implantable medical device.

[0097] It should be understood that these advantages exist regardless of whether the implantable medical device 100 is pulled by the guidewire 108 or by a tool, such as a snare, at the distal end portion 206 of the implantable medical device 100.

[0098] Figure 6Example of an implantable medical device 100 according to an embodiment. The implantable medical device includes a plurality of optional pump elements 106 provided as functional units 105, such as the three pump elements 106A - 106C illustrated. Each of the pump elements 106A - 106C is coupled to the proximal end portion 202 of the guide unit 102 and is arranged substantially parallel to each other and also relative to the guide unit 102. The guide unit 102 is provided with a corresponding plurality of optional elongated operable elements, such as the three elongated operable elements 104A - 104C (shown in dashed lines so as to be visible through the guide unit 102). Each of the elongated operable elements 104A - 104C extends at least partially along the guide unit 102 and is operatively connected to a corresponding one of the three pump elements 106A - 106C at the respective proximal end portion of the guide unit, and is operably connectable to at least one controller (not shown) at the respective distal end portion of the guide unit through respective connectors 212A - 212C. Each of the connectors 212A - 212C is disposed in a respective peripheral cavity 224, as illustrated, and may be provided with a corresponding optional cover. Alternatively, the connectors 212A - 212C may be disposed in a single common peripheral cavity and may be provided with an optional cover.

[0099] The pump elements 106A - 106C may be longitudinally offset relative to each other such that each of the impeller end portions of the pump elements 106A - 106C is longitudinally positioned in a different manner. Additionally or alternatively, the pump elements 106A - 106C may be arranged parallel or non - parallel to each other such that the distance between each of the impeller end portions of the pump elements 106A - 106C is greater than the distance between each of the guide unit contact end portions of the pump elements 106A - 106C. According to the pump elements 106A - 106C, such positioning and spacing can improve the performance of the pump, including better fluid outflow and reduced fluid shear stress, in the latter case, high fluid shear stress may cause hemolysis and / or thrombosis of the blood.

[0100] The pump elements 106A - 106C and the guide unit 102 may have the same transverse cross - sectional dimensions, as Figure 6 illustrated. Alternatively, the pump elements 106A - 106C may have a transverse cross - sectional dimension greater than that of the guide unit 102, as Figure 13B described and illustrated for the implantable medical device 700 in an assembled configuration.

[0101] Figure 6The implantable medical device 100 may also be provided with an optional tip 110 and an optional locking mechanism 404, an optional anchor 112, an optional anchor rod 114, one or more optional capture elements 116, and an optional guide wire 108. When the anchor 112 is provided, the pump elements 106A - 106C 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 - 504F may connect the anchor 112 to one or more of the pump elements 106A - 106C and / or to the introducer unit 102. When the anchor rod 114 is provided, the pump elements 106A - 106C may be disposed around the anchor rod 114. When provided, the capture elements 116 may be present on one or more of the pump elements 106A - 106C.

[0102] The implantable medical device 100 provided with multiple pump elements 106A - 106C is similar to the implantable medical device 100 provided with a single pump element 106. For the sake of brevity, the implantable medical device 100 provided with multiple pump elements 106A - 106C will not be further described herein. Therefore, it should be understood that, where applicable and with the necessary changes that would be understood by a person skilled in the art, the description of the implantable medical device 100 provided with a single pump element 106 applies to the implantable medical device 100 provided with multiple pump elements 106A - 106C.

[0103] Now referring to Figures 7 to 14A - Figure 14D, the implantable medical device 700 according to the second aspect of the present disclosure will be described.

[0104] Figure 7 The implantable medical device 700 according to an embodiment is schematically shown. The implantable medical device 700 includes an introducer unit 702 and at least one functional unit 705 having a functional element 704 and an elongate operable element 708 operatively connected to the functional element 704 for operation. In the second aspect of the present disclosure, the introducer unit 702 and the functional unit 705 are in a slidable relationship and form two different, separate devices that work together.

[0105] In particular, by the relative sliding movement between the introducer unit 702 and the elongate operable element 708, the introducer unit 702 and the functional element 704 can be assembled together and can also be disassembled from each other. When the introducer unit 702 and the functional element 704 are disassembled from each other, the implantable medical device 700 can be delivered into the lumen of a body conduit (multiple body conduits) and retrieved from the lumen. When the introducer unit 702 and the functional element 704 are assembled together or when the introducer unit 702 and the functional element 704 are disassembled from each other, the implantable medical device 700 can be implanted into the lumen of a body conduit (multiple body conduits). The introducer unit 702 can be used as a percutaneous dilator that slidably receives the elongate operable element 708 of the functional unit 705 therethrough, such that the functional unit 705 is implanted in vivo with the assistance of the introducer unit 702 and is operated from outside the patient's body through the elongate operable element 708. When the elongate operable element 708 is operatively connected to a controller (not shown), the functional unit 705 can be operated via the elongate operable element 708, such as by electrical operation or mechanical operation. Such an operation can produce a hemodynamic effect in the patient's body.

[0106] The introducer unit 702 is configured to not only be guided, directed, and navigated within the lumen of a body conduit (multiple body conduits), but also to deploy the elongate operable element 708 of the functional unit 705 along the lumen of the body conduit (multiple body conduits) for implanting the functional unit 705 into its intraluminal implantation site through their slidable relationship. Thus, the functional unit 705 is operated within the lumen via the elongate operable element 708, which is slidably received by the introducer unit 702 and is operatively connected to a controller outside the lumen.

[0107] When the implantable medical device 700 is implanted into the lumen of a body conduit (multiple body conduits) with the introducer unit 702 and the functional unit 705 assembled together, the introducer unit 702 is partially positioned outside the lumen of the body conduit (multiple body conduits) through the intraluminal passage, while the functional unit 705 is positioned within the lumen of the body conduit (multiple body conduits) within the lumen.

[0108] As Figure 7 schematically illustrated, the implantable medical device 700 can further include, for example, a guide wire 710, a tip 712, an anchor 714, an anchor rod 716, a first capture element 718, a second capture element 720, a cap 818, and a fixation mechanism 824 (optional items are indicated by dashed lines in Figure 7 ), which will be described hereinafter. The implantable medical device 700 can also optionally include more than one functional unit 705.

[0109] Figures 8A - 8C Example of an implantable medical device 700 according to an embodiment, the implantable medical device 700 includes a guide unit 702 and a pump unit 706 provided as a functional unit 705. The guide unit 702 has a body 800 that defines a longitudinal guide hole 802 (shown in dashed lines in Figure 8A , Figure 8C so as to be visible through the guide unit 702). The pump unit 706 has a pump element 707 provided as a functional element 704 and an elongated operable element 708 operatively connected to the pump element 707. The elongated operable element 708 of the pump unit 706 can be slidably received in the longitudinal guide hole 802 of the guide unit 702 to move the pump element 707. As Figures 8A - 8B illustrated, the elongated operable element 708 is slidably received in the longitudinal guide hole 802, and the relative sliding movement between the elongated operable element 708 and the guide unit 702 is indicated by a double arrow.

[0110] The longitudinal guide hole 802 extends at least partially between a proximal end portion 804 of the guide unit 702 (which, when assembled together, is the position where the guide unit 702 contacts the pump element 707) and a distal end portion 806 (the distal end portion corresponding to the distal end portion 808 of the implantable medical device 700). The longitudinal guide hole 802 has a proximal opening 810 located at the proximal end portion 804 of the guide unit 702 and a distal opening 812 located at the distal end portion 806 of the guide unit 702. The positioning of the distal opening 812 relative to the guide unit 702 enables the elongated operable element 708 to freely and slidably move within the longitudinal guide hole 802 and within the lumen of the body catheter(s) without the potential to damage or injure the lumen wall adjacent to the distal end portion 806 of the guide unit 702.

[0111] The elongate operable element 708 received in the longitudinal guide bore 802 extends at least partially along the guide unit 702, and its proximal end portion 814 projects proximally outwardly from the proximal opening 810 (e.g., when the implantable medical device 700 is disassembled as illustrated), and its distal end portion 816 projects distally outwardly from the distal opening 812. The proximal opening 810 of the longitudinal guide bore 802 may include an optional sealing element 824 that provides a fluid-tight engagement between the proximal opening 810 of the guide unit 702 and the elongate operable element 708, thereby preventing fluid (such as blood) from entering and contaminating the longitudinal guide bore 802. When there is fluid such as blood, the fluid may cause the elongate operable element 708 to malfunction, and thus may affect the sliding of the elongate operable element responsible for assembling and disassembling the implantable medical device 700.

[0112] When the elongate operable element 708 is received in the longitudinal guide bore 802, the pump element 707 connected to the proximal end portion 814 of the elongate operable element 708 is positioned on the proximal end portion 804 of the guide unit 702.

[0113] Reference Figures 8A - 8C , in use, the relative sliding movement between the elongate operable element 708 of the pump unit 706 and the guide unit 702 causes the pump element 707 to move closer to or farther from the proximal end portion 804 of the guide unit 702. In particular, a pulling force applied to the distal end portion 816 of the elongate operable element 708 causes the pump element 707 to move closer to the proximal end portion 804 of the guide unit 702. A pushing force applied to the distal end portion 816 of the elongate operable element 708 causes the pump element 707 to move away from the proximal end portion 804 of the guide unit 702. Alternatively or additionally, a pushing force may be applied to the distal end portion 806 of the guide unit 702 to cause the proximal end portion 804 of the guide unit 702 to move closer to the pump element 707. Still alternatively or additionally, a pulling force may be applied to the distal end portion 806 of the guide unit 702 to cause the proximal end portion 804 of the guide unit 702 to move away from the pump element 707. Although not illustrated for clarity in Figures 8A - 8C , it should be understood that the relative slidable movement between the elongate operable element 708 and the guide unit 702 that causes the pump element 707 to move correspondingly can of course occur in the lumen of a body catheter (body catheters), for example by an operator manipulating the distal end portion 816 of the elongate operable element 708.

[0114] The relative slidable movement between the elongate operable element 708 and the guide unit 702 that causes the pump element 707 to move causes the implantable medical device 700 to be in a disassembled configuration (inFigures 8A - 8B as illustrated in [ ]; also referred to herein as the “unfixed configuration” and the “undocked configuration”) and the assembled configuration (as Figure 8C illustrated in [ ]; also referred to herein as the “fixed configuration” and the “docked configuration”) are arranged or rearranged. Generally, the sheath is used to deliver the implantable medical device 700 in the disassembled configuration to an intraluminal implantation site within the lumen of a body conduit (body conduits) for implantation purposes, and to retrieve the implantable medical device 700 in the disassembled configuration from the intraluminal implantation site within the lumen of a body conduit (body conduits) for removal purposes. The implantable medical device 700 can be implanted at the intraluminal implantation site in the assembled or disassembled configuration, and can be operated in the assembled or disassembled configuration to produce a hemodynamic effect.

[0115] In the disassembled configuration, as Figures 8A - 8B illustrated in [ ], the introducer unit 702 and the pump element 707 slide away from each other relative to each other so as to be physically separated by a portion of the elongate operable element 708 therebetween. In particular, the pump element 707 can be positioned distal and spaced from the proximal end portion 804 of the introducer unit 702, with the proximal end portion 814 of the elongate operable element 708 being at least partially disposed between the pump element 707 and the proximal end portion 804 of the introducer unit 702.

[0116] Advantageously, as Figure 9A illustrated in [ ], the proximal end portion 814 of the elongate operable element 708, which is at least partially disposed between the proximal end portion 804 of the introducer unit 702 and the pump element 707, can have an intermediate portion 900 that serves as a hinge between the pump element 707 and the introducer unit 702. In particular, as Figure 9A illustrated in [ ], when the implantable medical device 700 in the disassembled configuration passes through an acute-angle lumen or tortuous lumen segment of a body conduit (shown in dashed lines in Figure 9A [ ]), the intermediate portion 900 moves in a hinged manner such that the introducer unit 702 and the pump element 707 move relative to each other in a hinged manner and can pass through individually. As illustrated, the elongate operable element 708 is held within a distal cavity 402 (not shown) covered by the tip 110. When the implantable medical device 100 is moved along the body conduit, for example by pulling a guide wire, the held elongate operable element 708 drives the movement of the pump element 707.

[0117] In comparison, as Figure 9B illustrated in [ ], the implantable medical device 700 in the assembled configuration may be too long to pass through an acute-angle lumen or tortuous lumen segment of a body conduit (in Figure 9Bshown in dashed lines). In other words, in the Figures 9A - 9B example illustrated in, an implantable medical device 700 in a disassembled configuration can pass through an acute or tortuous lumen segment of a body catheter (i.e., as Figure 9A illustrated), while an implantable medical device 700 in an assembled configuration cannot pass through at the same location due to its longer overall length (i.e., as Figure 9B illustrated). Implantable medical devices that are too long and / or not assemblable and / or not disassemblable as known in the prior art may also encounter such limitations in navigating through a lumen. Thus, in the disassembled configuration, the overall length of the implantable medical device 700 is divided into smaller length portions corresponding to the respective individual lengths of the introducer unit 702 and the pump element 707 such that the implantable medical device 700 can be guided and / or navigated through an acute or tortuous lumen segment of a body catheter (body catheters).

[0118] In the assembled configuration, again referring to Figure 8C , the introducer unit 702 and the pump element 707 can be in contact with and / or engaged with each other so as not to have to be separated by a portion of the elongate operable element 708 therebetween. In particular, the pump element 707 can be positioned close enough to contact and / or engage the proximal end portion 804 of the introducer unit 702, while the distal end portion 816 of the elongate operable element 708 is disposed on the distal end portion 806 of the introducer unit 702. As described below, the introducer unit 702 and the pump element 707 can be removably assembled together in various ways (i.e., the introducer unit 702 and the pump element 707 can be assembled and disassembled) or non-removably assembled together (i.e., when assembled together, the introducer unit 702 and the pump element 707 cannot be disassembled from each other).

[0119] Although the proximal end portion 804 and the distal end portion 806 of the introducer unit 702 can be of any shape, the distal end portion 806 can be shaped to facilitate guiding the implantable medical device 702 through the luminal passageway of a body catheter (e.g., a percutaneous luminal passageway) and to reduce or prevent damage or injury to the lumen wall. As Figures 8A - 8C illustrated, for example, the distal end portion 806 of the introducer unit 702 is tapered.

[0120] 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 tapered shape and the bulge(s). For the sake of brevity, the distal end portion 806 of the introducer unit 702 will not be further described herein. Accordingly, it should be understood that, where applicable and with the necessary changes made that would be understood by those skilled in the art, similar descriptions apply to the distal end portion 806 of the introducer unit 702 and the distal end portion 204 of the introducer unit 102.

[0121] As such, the proximal end portion 804 of the introducer unit 702 can be configured to contact and / or engage the pump unit 706 (the pump unit including the proximal end portion 814 of the pump element 707 and / or the elongate operable element 708) for assembling the pump element 707 to the proximal end portion 804 of the introducer unit 702. In particular, as Figure 8B illustrated, the implantable medical device 700 can be provided with an optional first connector 818 configured to removably or non-removably connect the pump element 707 and the introducer unit 702 together. The implantable medical device 700 can also be provided with an optional second connector 820 configured to removably or non-removably connect the elongate operable element 708 and the introducer unit 702 together. The connectors 818, 820 can be implemented as interference fits, latch-type connectors, etc. In the absence of the first and second connectors 826, 828, a simple action of bringing the pump element 707 closely adjacent to the proximal end portion 804 of the introducer unit 702 so as to ultimately abut the proximal end portion 804 can be sufficient to assemble or fix the pump element 707 and the introducer unit 702 together.

[0122] As Figure 8C illustrated, the elongate operable element 708 can be provided with an indicator 822, such as a visual marker. The indicator 822 is visible only when the elongate operable element 708 is properly pulled through the introducer unit 702 to indicate to the user that the pump unit 706 and the introducer unit 702 are properly assembled together.

[0123] According to an embodiment, Figures 8A - 8C further illustrated is the implantable medical device 700 provided with an optional fixing mechanism 824 configured to fix the elongate operable element 708 in place to the introducer unit 702. As illustrated, the fixing mechanism 824 is integrated into the distal end portion 806 of the introducer unit 702; alternatively, the fixing mechanism 824 can be integrated at any position along the length of the introducer unit 702.

[0124] AsFigures 8A - 8B As illustrated by the example shown, the fixing mechanism 824 is in an unfixed configuration, and thus the elongated operable element 708 is not fixed, such that the elongated operable element 708 can slide freely in the longitudinal guiding hole 802 to move the pump element 707 relative to the guide unit 702 - the implantable medical device 700 can be arranged between a disassembled configuration and an assembled configuration. As Figure 8C As illustrated by the example shown, the fixing mechanism 824 is in a fixed configuration, and thus the elongated operable element 708 is fixed, such that the elongated operable element 708 cannot slide in the longitudinal guiding hole 802 and thus the pump element 707 remains assembled or fixed to the guide unit 702 - the implantable medical device 700 cannot be arranged between a disassembled configuration and an assembled configuration. When the implantable medical device 700 is in the disassembled configuration and the assembled configuration, the fixing mechanism 824 can be adjusted between an unfixed configuration and a fixed configuration.

[0125] The fixing mechanism 824 can include a mechanism provided to the guide unit 702 that frictionally engages at least a portion of the elongated operable element 708 to fix it. In this case, the fixing mechanism 824 can be a pressure element, as Figures 8A - 8C illustrated by the example shown. Alternatively, the fixing mechanism 824 can include a first portion provided to the guide unit 702 and a second portion provided to the elongated operable element 708. The first portion and the second portion are configured to selectively engage each other to fix them together. In this case, the first portion can be a pin and other similar engaging structures, while the second portion can be a notch, a groove, and other similar engaging structures configured to cooperatively engage the first portion.

[0126] Still referring to Figures 8A - 8C , in a second aspect of the present disclosure, according to an embodiment, the elongated operable element 708 can not only be used to move the pump element 707, but also to operate the pump 70. For example, as Figure 8B illustrated by the example shown, according to an embodiment, the elongated operable element 708 includes an electrical conductor (also referred to herein as an "elongated electrical element"), and thus can be a cable or a wire configured to transmit electrical power from a controller 226 (shown in dashed lines as an optional component of the implantable medical device 700) to the pump element 707. In particular, the proximal end portion 814 of the elongated operable element 708 is operatively connected to the pump element 707, while the distal end portion 816 of the elongated operable element 708 can be removably operatively connected to the controller 226 through a connector 832 (also referred to herein as an "electrical connector").

[0127] The connector 832 can be configured to be receivable within the longitudinal guide hole 802 such that the elongated operable element 708 can slide fully into and out of the longitudinal guide hole 802. Alternatively, the connector 832 can be configured to abut against the distal opening 812 of the longitudinal guide hole 802 of the guide unit 702 to prevent the distal end portion 816 of the elongated operable element 708 from fully moving inside the longitudinal guide hole 802. Additionally, alternatively, the distal end portion 816 of the elongated operable element 708 can have an optional stop element 834, the size and shape of the optional stop element being set to abut against the distal opening 812 of the longitudinal guide hole 802 of the guide unit 702 to prevent the distal end portion 816 of the elongated operable element 708 from fully moving inside the longitudinal guide hole 802. The stop element 834 can be disposed at any position along the elongated operable element 708.

[0128] Alternatively, the elongated operable element 708 can be a drive shaft (not shown) configured to transmit torque from a controller (such as an actuator or a motor) to the pump element 707. In this case, the drive shaft can operate the pump element 707 or any other functional unit 705 in various ways, including by rotational movement and / or reciprocating movement.

[0129] Additionally, alternatively, the implantable medical device 100 can be provided with a wireless module 836 that is integrated within the body 800 of the guide unit 702. The wireless module 836 can be operably connected to the elongated operable element 708, in which case the elongated operable element 708 can include an electrical conductor. The wireless module 836 can be directly operably connected to the pump element 707, and in this case, the elongated operable element 708 does not necessarily need to be configured to operate the pump element 707 as described previously, such as by including an electrical conductor. In each case, the wireless module 836 is configured to be wirelessly connected to a wireless controller (not shown) to operate the pump element 707.

[0130] To enable or facilitate intraluminal navigation, the guide unit 702 and the elongated operable element 708 (such as in the case of an elongated electrical element) can be made of a bendable, flexible, and / or elastic material to adapt to or conform to various body conduit morphologies, but still be rigid enough to be pushed through an intraluminal passage. For example, the guide unit 102 can be made of a polymer, such as thermoplastic polyurethane, while the elongated operable element 708 can be made of a suitable bendable, flexible, and / or elastic material.

[0131] As Figure 8AFurther illustrated in, according to an embodiment, the implantable medical device 100 is provided with an optional cover 818. Depending on the nature of the connector 832, such as when the electrical connector 832 is an electrical connector, it may be desirable to protect the connector 832 from environmental factors (such as a fluid like blood) to ensure proper operation. The cover 818 can be removed from the implantable medical device 700 for operatively connecting the connector 832 to the controller 226, as Figure 8B illustrated. For example, the cover 818 can be removably attached to a peripheral cavity (as illustrated) provided with the connector 832, or can be removably attached directly to the connector 832. The removable attachment of the cover 818 to the implantable medical device 100 can be achieved by an interference fit, a threaded connection, etc.

[0132] Figure 10 and Figures 9A - 9B 、 Figures 11A - 11B Illustrating a guide unit 702 provided with an optional ridge 1000 according to an embodiment. The cover 818 is removed from Figure 10 omitted, but may be present.

[0133] The ridge 1000 is similar to the ridge 300 and, for the sake of brevity, will not be described herein. Thus, it should be understood that, where applicable and with the necessary changes made that would be understood by a person skilled in the art, similar descriptions apply to the ridge 1000 and the ridge 300.

[0134] Figures 11A - 11B Illustrating an implantable medical device 700 according to an embodiment, the implantable medical device having a distal end portion 806 of the guide unit 702 provided as an optional tip 712, the optional tip being removably attachable to the remainder of the guide unit 702 and coupled to a guide wire 710. Figure 11A Illustrating the implantable medical device 700 in an assembled configuration with the tip 712 removed from the guide unit 702. Figure 11B Illustrating the implantable medical device 700 in a disassembled configuration with the tip 712 attached to the guide unit 702. Further illustrating an optional locking mechanism 1100 for locking the tip 712 to the guide unit 702.

[0135] As illustrated, the tip 712 is removably attachable to a distal cavity 1102 from which a slender operable element 708 projects outwardly. The slender operable element 708 is slidable relative to the cavity 1104 such that the connector 832 itself is movable into and out of the cavity 1102. As illustrated, the tip 712 also has an optional ridge 1102, which is similar to the ridges 300 and 1000.

[0136] The distal end 712 is generally similar to the distal end portion 806 of the introducer unit 702, particularly with respect to its conical shape and the bulge(s). For the sake of brevity, the distal end 712 will not be further described herein. Thus, it should be understood that, where applicable and with the necessary changes made that would be understood by those skilled in the art, a similar description applies to both the distal end 712 and the distal end portion 806 of the introducer unit 702.

[0137] Figures 12A - 12D Example illustrates an implantable medical device 700 according to an embodiment, the implantable medical device 700 being provided with an optional anchor 714 having a contracted configuration ( Figure 12A , Figure 12C ) and an expanded configuration ( Figure 12B , Figure 12D ). The cover 818 is omitted from Figures 12A - 12D but may be present. Although Figures 12A - 12D the implantable medical device 700 may be provided with a cover 818, the implantable medical device 100 may alternatively be provided with a distal end 712.

[0138] As Figures 12A - 12B illustrates by way of example, the anchor 714 has a tubular wall 1200 defining a central opening 1202 and includes at least one anchor arm, such as the three anchor arms 1204A - 1204C illustrated, which converge to the tubular wall 1200 and connect the tubular wall 1200 to the introducer unit 702, thereby positioning the introducer unit 702 at least partially within the central opening 1202. In use, the relative sliding movement between the elongate operable element 708 of the pump unit 706 and the introducer unit 702 moves the pump element 707 closer to or farther from the proximal end portion 804 of the introducer unit 702 such that the pump element 707 can be assembled to and disassembled from the introducer unit 702 outside the central opening 1202 when the anchor 714 is in either the contracted position or the expanded position.

[0139] As Figures 12C - 12D illustrates by way of example, according to an embodiment, the implantable medical device 700 is provided with an optional anchor rod 716 that supports the anchor 714. The distal end portion 1206 of the anchor rod 716 is attached to the proximal end portion 804 of the introducer unit 702, while the proximal end portion 1208 of the anchor rod 716 is attached to at least one anchor arm, such as the three anchor arms 1204A - 1204C illustrated. The anchor arms 1204A - 1204C converge to the tubular wall 1200 and connect the tubular wall 1200 to the anchor rod 716, thereby positioning the anchor rod 716 at least partially within the central opening 1202.

[0140] As Figure 12D best illustrated therein, the anchoring arms 1204A - 1204C define corresponding radial openings 1210A - 1210C therebetween. Although not readily visible from Figures 12C - 12D it, the elongate operable element 708 is disposed through one of the radial openings 1210A - 1210C such that when the elongate operable element 708 slides relative to the guide unit 702 to assemble the pump element 707 to the guide unit 702 and to disassemble the pump element 707 from the guide unit 702, the pump element 707 passes through one of the radial openings. When inside the central opening 1202, such as when assembled to the guide unit 702, the pump element 707 is disposed about the anchoring rod 716, as Figure 12D illustrated therein.

[0141] In use, relative sliding movement between the elongate operable element 708 of the pump unit 706 and the guide unit 702 moves the pump element 707 closer to or farther from the proximal end portion 804 of the guide unit 702 such that the pump element 707 can be assembled to and disassembled from the guide unit 702 within the central opening 1202 when the anchor 714 is in the expanded position. Thus, the implantable medical device 700 can be arranged in the assembled configuration only when the anchor 714 is in the expanded configuration, while the implantable medical device 700 can be arranged in the disassembled configuration when the anchor 714 is in either the contracted configuration or the expanded configuration.

[0142] The anchor 714 and the anchoring rod 716 are generally similar to the anchor 112 and the anchoring rod 114, respectively, and for the sake of brevity, the anchor 714 and the anchoring rod 716 will not be further described herein. Accordingly, it should be understood that where applicable and with the necessary changes made that would be understood by a person skilled in the art, similar descriptions apply to the anchor 714 and the anchoring rod 716 and the anchor 112 and the anchoring rod 114, respectively.

[0143] Figures 12A - 12D Further illustrating an implantable medical device 700 according to an embodiment, the implantable medical device is provided with an optional first capture element 718 associated with the guide unit 702 (such as associated with the anchoring rod 716 as Figures 12C - 12D illustrated therein), and an optional second capture element 720 associated with the pump unit 706 (such as associated with, for example, Figures 12A - 12BAn optional second capture element 720 (associated with the anchor bar 716 as illustrated). Either or both of the first and second capture elements 718, 720 can be provided to the implantable medical device 700. For example, the first capture element 718 can be provided to the introducer unit 702, while the second capture element 720 can be simultaneously provided to the pump unit 706. The first and second capture elements 718, 720 can be captured separately from each other, or can be captured together by an in vivo tool (such as a snare, etc.) in order to pull or hold the introducer unit 702 and the pump element 706 in proper positions within the lumen of a body catheter (multiple body catheters).

[0144] The first capture element 718 can be captured within the lumen by a tool (such as a snare, etc.) during use, and then the tool can be pulled to move the entire implantable medical device 700 within the lumen.

[0145] For example, when provided to the pump element 707, the second capture element 720 can be captured within the lumen by a tool (such as a snare, etc.) during use, and then the tool can be pulled to arrange the implantable medical device 700 from an assembled configuration to a disassembled configuration. The elongate operable element 708 can be simultaneously pushed towards the introducer element 702 to assist or aid in such an arrangement. However, depending on its stiffness, pushing the elongate operable element 708 may be sufficient to arrange the implantable medical device 700 from an assembled configuration to a disassembled configuration. In all cases, the arrangement can occur in the presence or absence of the anchor 714 and / or the anchor bar 716.

[0146] When the fixing mechanism 824 is present and fixes the elongate operable element 708 in position to the introducer unit 702, thereby holding the implantable medical device 700 in the assembled configuration, the entire implantable medical device 700 can be moved within the lumen by pulling a snare that captures and attaches to the second capture element 720.

[0147] Referring again to Figures 7 to 12A - Figure 12D , according to an embodiment, the implantable medical device 700 can be provided with an optional guide wire 710.

[0148] The guide wire 710 is generally similar to the guide wire 108, and for the sake of brevity, the guide wire 710 will not be further described herein. Therefore, it should be understood that, where applicable, similar descriptions apply to the guide wire 710 and the guide wire 108 with the necessary changes made that are understandable to those skilled in the art.

[0149] Figure 13AExample illustrates an implantable medical device 700 according to an embodiment. The implantable medical device 700 includes a plurality of optional pump units 706 provided as functional units 705, such as three pump units 706 as illustrated. Each pump unit 706 has a corresponding one of pump elements 707A - 707C provided as functional elements 704, and a corresponding one of elongated operable elements 708A - 708C. The elongated operable elements 708A - 708C are operatively connected to the corresponding pump elements 707A - 707C and are capable of being operatively connected to at least one controller through a corresponding one of connectors 212A - 212C. The guide unit 702 defines a corresponding plurality of optional longitudinal guide holes, such as three longitudinal guide holes 802A - 802C (shown in dashed lines so as to be visible through the guide unit 702), each guide hole slidably receiving a corresponding one of the elongated operable elements 708A - 708C therein. Alternatively, the guide unit 702 may be provided with a single longitudinal guide hole 802 for slidably receiving all of the elongated operable elements 708A - 708C therein.

[0150] As Figure 13A illustrated, each of the elongated operable elements 708A - 708C is slidably received in a corresponding one of the longitudinal guide holes 802A - 802C, and the relative sliding movement between the elongated operable elements 708A - 708C and the guide unit 702 is represented by double arrows. The relative slidable movement between the elongated operable elements 708A - 708C and the guide unit 702 that moves the pump elements 707A - 707C arranges or rearranges the implantable medical device 700 between a disassembled configuration (also referred to herein as an "unfixed configuration" and an "undocked configuration"), an assembled configuration (also referred to herein as a "fixed configuration" and a "docked configuration"), a partially disassembled configuration (also referred to herein as a "partially unfixed configuration" and a "partially undocked configuration"), and a partially assembled configuration (also referred to herein as a "partially fixed configuration" and a "partially docked configuration"). In the disassembled configuration, all of the pump elements 707A - 707C are not assembled to the guide unit 702. In the assembled configuration, all of the pump elements 707A - 707C are assembled to the guide unit 702. In the partially disassembled configuration, one or two of the pump elements 707A - 707C are not assembled to the guide unit 702. In the partially assembled configuration, one or two of the pump elements 707A - 707C are assembled to the guide unit 702. It is readily understood that the assembled configuration, the disassembled configuration, the partially disassembled configuration, and the partially assembled configuration are possible for any number of pumps 707 without departing from the scope of the present disclosure.

[0151] For placement or rearrangement between configurations, each of the elongate operable elements 708A - 708C can slide relative to the guide 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 respective pump elements 707A - 707C at different times or all at the same time.

[0152] In the disassembled configuration, the guide unit 702 and the pump elements 707A - 707C slide away from each other so as to be physically separated by portions of the elongate operable elements 708A - 708C therebetween. In the disassembled configuration, as Figure 13B illustrated, where the pump elements 707A - 707C are received within a sheath (shown in dashed lines as an optional component of the implantable medical device 700), the pump elements 707A - 707C are longitudinally arranged one after another and may be precisely coaxial or not precisely coaxial with respect to each other and / or the guide unit 702 (hereinafter referred to as an "end - to - end" arrangement). Such an arrangement can also occur without the sheath, such as when the pump elements 707A - 707C are within the lumen of a body conduit (body conduits). As described and illustrated above for Figures 9A - 9B when the implantable medical device 700 is in the disassembled configuration, a given portion of each of the elongate operable elements 708A - 708C can serve as a hinge to advantageously enable the corresponding one of the pump elements 707A - 707C to pass through an acute - angled lumen or a tortuous lumen segment of a body conduit (body conduits).

[0153] In the assembled configuration, the guide unit 702 and the pump elements 707A - 707C can be in contact with and / or engaged with each other so as to not be separated by a portion of the elongate operable elements 708A - 708C therebetween. In particular, the pump elements 707A - 707C can be positioned close enough to contact and / or engage the proximal end portion 804 of the guide unit 702, while the distal end portions 816 of the elongate operable elements 708A - 708C are disposed on the distal end portion 806 of the guide unit 702. In as Figure 13BIn the assembly configuration illustrated, the pump elements 707A - 707C are arranged laterally adjacent to each other (hereinafter referred to as "adjacent arrangement"). The pump elements 707A - 707C can also be longitudinally offset relative to each other to improve their outflow performance and characteristics. The guide unit 702 and the pump elements 707A - 707C can be removably assembled together in various ways (i.e., the guide unit 702 and the pump elements 707A - 707C can be assembled and disassembled), or can be non - removably assembled together (i.e., when assembled together, the guide unit 702 and the pump elements 707A - 707C cannot be disassembled from each other), as described below.

[0154] The proximal end portion 804 of the guide unit 702 can be configured to contact and / or engage the pump units 706A - 706C (the pump units comprising the proximal end portions 814 of the pump elements 707A - 707C and / or the elongated operable elements 708A - 708C) for assembling the pump elements 707A - 707C to the proximal end portion 804 of the guide unit 702. In particular, the implantable medical device 700 can be provided with a plurality of optional first connectors 818 configured to removably or non - removably connect the corresponding pump elements 707A - 707C and the guide unit 702 together, as described above. The implantable medical device 700 can also be provided with a plurality of optional second connectors 820 configured to removably or non - removably connect the corresponding elongated operable elements 708A - 708C and the guide unit 702 together, as described above. Further, in the assembly configuration, the pump units 706A - 706C can be coupled together via the interaction between: (i) at least two of the pump elements 707A - 707C, (ii) at least two of the elongated operable elements 708A - 708C, and / or (iii) at least one of the pump elements 707A - 707C and at least one of the elongated operable elements 708A - 708C.

[0155] In the assembly configuration, the pumps 707A - 707C can be longitudinally offset relative to each other such that each of the impeller end portions of the pump elements 707A - 707C is longitudinally positioned in a different manner. The pumps 707A - 707C can also be arranged non - parallel to each other such that the distance between each of the impeller end portions of the pump elements 707A - 707C is greater than the distance between each of the guide unit contact end portions of the pump elements 707A - 707C. Depending on the pump elements 707A - 707C, such positioning and spacing can improve the performance of the pump, including better fluid outflow and reduced fluid shear stress, in the latter case, high fluid shear stress may cause hemolysis and / or thrombosis of the blood.

[0156] As Figure 13B Illustrated by the examples, in the assembled configuration, the lateral cross-sectional dimensions commonly possessed by the pump elements 707A - 707C (which can be averaged as the lateral cross-sectional dimensions of the circle including the lateral cross-sectional portions of the pump elements 707A - 707C) are greater than the lateral cross-sectional dimensions of the guide unit 702. For example, as illustrated by the examples, this may be the case when each of the pump elements 707A - 707C has a lateral cross-sectional dimension approximately the same as the lateral cross-sectional dimension of the guide unit 702. Alternatively, the lateral cross-sectional dimensions commonly possessed by the pump elements 707A - 707C in the assembled configuration (which are averaged as described above) are equal to or less than the lateral cross-sectional dimensions of the guide unit 702. For example, this may be the case when each of the pump elements 707A - 707C has a lateral cross-sectional dimension significantly smaller than the lateral cross-sectional dimension of the guide unit 702.

[0157] Figures 13A - 13B The implantable medical device 700 may further be provided with an optional tip 712 and an 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 guide wire 710, and an optional fixation mechanism 824.

[0158] When provided, the anchor rod 716 is connected by at least one of its anchor arms (such as anchor arms 1204A - 1204C) such that the guide unit 702 is at least partially positioned within the central opening 1202 and / or each of the pump elements 707A - 707C can be slidably positioned within the central opening 1202. In this case, each of the elongated operable elements 708A - 708C is disposed through a corresponding one of the radial openings 1210A - 1210C defined by the corresponding anchor arms 1204A - 1204C such that when a corresponding one of the elongated operable elements 708A - 708C slides relative to the guide unit 702 to assemble the pump elements 707A - 707C to the guide unit 702 and to disassemble the pump elements 707A - 707C from the guide unit 702, each of the pump elements 707A - 707C can pass through a corresponding one of the radial openings 1210A - 1210C. When located inside the central opening 1202, such as when assembled to the guide unit 702, each of the pump elements 707A - 707C is disposed around the anchor rod 716.

[0159] When present, the first capture element 718 is disposed on the introducer unit 702, such as on the anchor bar 716. When present, an optional second capture element 720 may be disposed on each of the pump units 706A - 706C, such as on the pump elements 707A - 707C. In particular, the second capture element 720 of each pump element 707A - 707C may be captured within the lumen by a tool (such as a snare, etc.) during use, and then the tool may be pulled to move the pump elements 707A - 707C away from the introducer unit 702 individually within the lumen, so as to position the implantable medical device 700 among the disassembled configuration, assembled configuration, partially disassembled configuration, and partially assembled configuration.

[0160] When present, the fixation mechanism 824 may be disposed on the introducer unit 702 and / or on each of the elongate operable elements 708A - 708C. A single fixation mechanism 824 may be provided to fix all of the elongate operable elements 708A - 708C. Alternatively, multiple fixation mechanisms 824 may be provided to fix a respective one of the elongate operable elements 708A - 708C. In this case, the fixation mechanisms 822 may act independently of each other. When the fixation mechanism 824 fixes one or more of the elongate operable elements 708A - 708C, the entire implantable medical device 700 may be moved within the lumen by pulling a snare that captures and attaches to one or more second capture elements 720 corresponding to one or more of the elongate operable elements 708A - 708C fixed by the fixation mechanism 824.

[0161] The implantable medical device 700 provided with multiple pump units 706 is similar to the implantable medical device 700 provided with a single pumping unit 706, and for the sake of brevity, the implantable medical device 700 provided with multiple pump units 706 will not be further described herein. Therefore, it should be understood that, where applicable and with the necessary changes that can be understood by those skilled in the art, the description of the implantable medical device 700 provided with a single pumping unit 706 applies to the implantable medical device 700 provided with multiple pump units 706A - C.

[0162] As illustrated in FIG. 13C, according to an embodiment, the implantable medical device 700 may be provided with at least one extension wire, such as the three extension wires 1300A - 1300C as illustrated. Similar to the elongate operable elements 708A - 708C, each of the extension wires 1300A - 1300C can be slidably received in a respective one of the longitudinal guide holes 802A - 802C (or, depending on the circumstances, in a single longitudinal guide hole 802), and can be removably attached to a respective one of the elongate operable elements at the distal end portions 816 of the elongate operable elements 708A - 708C. The extension wires 1300A - 1300C can be slid to arrange the implantable medical device 700 between a disassembled configuration, an assembled configuration, a partially disassembled configuration, and a partially assembled configuration. The implantable medical device 700 provided with a single pumping unit 706 may similarly include a single extension wire 1300.

[0163] Each of the extension wires 1300A - 1300C may be provided with a respective stop element 834, as described for the elongate operable elements 708A - 708C. Each of the extension wires 1300A - 1300C may also be provided with a sealing element configured to sealingly engage the distal openings 812 of the longitudinal guide holes 802A - 802C. Since the cross-sectional dimensions of the extension wires 1300A - 1300C are smaller than the cross-sectional dimensions of the elongate operable elements 708A - 708C, there is some space in the longitudinal guide holes when the extension wires 1300A - 1300C are received in the longitudinal guide holes 802A - 802C. Fluids such as blood may leak through these spaces.

[0164] As Figure 14A illustrated, the implantable medical device 700 in the disassembled configuration is received in a sheath (shown in dashed lines as an optional component of the implantable medical device 700), where the pump elements 707A - 707C are arranged one after another. Each of the extension wires 1300A - 1300C is slidably received through a guide unit 702 and is removably attached to a respective one of the elongate operable elements 708A - 708C.

[0165] Still referring Figure 14A to, and additionally as illustrated in FIGS. 14B - 14E, the 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, in the absence of a sheath, the lumen wall). Figure 14A, (Figure 14B). The first and second elongate filaments 1300A, 1300B, which are associated with the first and second pump elements 707A, 707B respectively, both pass through the second space 1308, which is defined between the third pump element 707C and the sheath (or, in the absence of a sheath, the lumen wall). Figure 14A , (Figure 14C).

[0166] Further, as best illustrated in FIGS. 14B - 14D, the transverse cross-sectional dimensions of the elongate filaments 1300A, 1300B (and additionally 1300C) are smaller than the transverse cross-sectional dimensions of the elongate operable elements 708A - 708B (and 708C). This dimensional difference advantageously enables the implantable medical device 700 equipped with the elongate filaments 1300A - 1300B (and additionally 1300C as illustrated) extending along the pump elements 707B, 707C to have a smaller transverse cross-sectional dimension (i.e., ɖ1) compared to the transverse cross-sectional dimension (i.e., ɖ2) of the implantable medical device 700 having elongate operable elements 708A, 708B (i.e., not equipped with the elongate filaments 1300A - 1300B) extending along the pump elements 707B, 707C.

[0167] In fact, the smaller transverse cross-sectional dimension of the elongate filaments compared to the transverse cross-sectional dimension of the elongate operable elements advantageously enables the use of a relatively smaller diameter sheath (commonly expressed in FR units) for implanting and removing the implantable medical device 700. Such a reduction in sheath size in turn enables the implantable medical device 700 to be guided and navigated within the lumen of a body conduit that may not be suitable for use with an implantable medical device.

[0168] It should be noted that the elongate filaments can have a relatively smaller transverse cross-sectional dimension than the elongate operable elements because the elongate filaments are not configured to conduct electricity - they do not have integrated electrical conductors in their structure. It should be understood that any other means of reducing the transverse cross-sectional dimension of the elongate structure to which the elongate control elements can be attached would have the same advantages.

[0169] For comparison with FIG. 14B, FIG. 14D illustrates a first elongate operable element 708A from a first pump element 707A, the first elongate operable element passing through a first space 1306 defined between a second pump element 707B and a sheath (or, in the absence of a sheath, the lumen wall). For comparison with FIG. 14C, FIG. 14E illustrates first and second elongate operable elements 708A-708B from first and second pump elements 707A-707B, the first and second elongate operable elements passing through a second space 1308 defined between a third pump element 707C and a sheath (or, in the absence of a sheath, the lumen wall). It can be readily observed that, due to the difference in cross-sectional dimensions between the elongate operable elements and the extension wires, the sheaths in FIGS. 14D-14E need to have a larger cross-sectional dimension than the sheaths in FIGS. 14B-14C in order to accommodate the implantable medical device 700.

[0170] In summary, because it can be assembled within the lumen, the implantable medical device advantageously has a reduced operating profile for guiding and navigating within the lumen of a body catheter (multiple body catheters), while being able to expand to a larger operating profile within the lumen for performing desired functions and / or operations, such as hemodynamic effects or synergistic effects. For example, the implantable medical device in the disassembled configuration can have a reduced operating profile that substantially corresponds to one of a guide unit and a functional unit having a larger cross-section. When arranged in the assembled configuration, the implantable medical device can have a larger operating profile that substantially corresponds to the cross-sectional dimension of the guide unit plus a portion of the cross-sectional dimension of the functional unit.

[0171] Now referring Figures 15 - 19 , an implantable medical device 1500 according to an embodiment will be described. The implantable medical device 1500 is generally similar to the implantable medical device 700, and for the sake of brevity, only some features of the implantable medical device 1500 will be described below. Therefore, it should be understood that, where applicable and where necessary changes that are understandable to those skilled in the art have been made, the description of the implantable medical device 700 applies to the implantable medical device 1500.

[0172] Figures 15 - 19 An implantable medical device 1500 according to an embodiment is illustrated, the implantable medical device being provided with an optional anchor 1502 having at least one proximal anchor arm, such as the three proximal anchor arms 1504A-1504C illustrated, and at least one distal anchor arm, such as the three distal anchor arms 1506A-1506C illustrated. In Figure 15In FIG. 0, the implantable medical device 1500 is provided with pump units 1508A - 1508B in an assembled configuration, and pump unit 1508C is in a disassembled configuration; thus, the implantable medical device 1500 is in a partially disassembled configuration and a partially assembled configuration. In Figure 16 FIG. 1, pump units 1508A - 1508B are in an assembled configuration, and for clarity, pump unit 1508C is omitted. In Figures 17 - 19 FIG. 2, pump units 1508A - 1508C are omitted for clarity.

[0173] As Figures 15 - 19 illustrated by way of example in FIG. 3, according to an embodiment, the proximal end portion 1510 of the introducer unit 1512 includes an optional protruding portion 1514 that protrudes distally from the proximal end portion and is configured to attach the anchor 1502. The protruding portion 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 single-piece unit. In particular, as Figures 15 - 18 best illustrated in FIG. 4, each of the proximal anchor arms 1504A - 1504C attaches to the protruding portion 1514 at a proximal location of the protruding portion, while each of the distal anchor arms 1506A - 1506C attaches to the protruding portion 1514 at a distal location of the protruding portion. The proximal and distal anchor arms 1504A - 1504C, 1506A - 1506C may attach the anchor 1502 at any location on the introducer unit 1512.

[0174] When anchored in the lumen of a body conduit (multiple body conduits), the longitudinal attachment at two spaced-apart locations along the protruding portion 1514 advantageously provides anchoring stability to the implantable medical device 1500 in a disassembled or assembled configuration. In fact, depending on the implantable medical device and the intraluminal implantation site, compared to an implantable medical device that attaches to the anchor at a single location, the proximal and distal anchor arms 1504A - 1504C, 1506A - 1506C reduce the pivoting of the implantable medical device 1500. In the former case, the single location where the anchor is attached may act as a pivot point, and when there are two attachment locations, such a pivot point is reduced if not eliminated. Generally, pivoting movement of an intraluminal-anchored implantable medical device is to be avoided because such movement may damage or injure the lumen wall, especially when contacting moving components (such as pump impellers) that are not encapsulated in a shield.

[0175] Refer to Figure 17, according to an embodiment, the connection of the proximal anchoring arms 1504A - 1504C and the distal anchoring arms 1506A - 1506C to the protruding portion 1514 can be a captive attachment, as Figure 17 illustrated. In particular, each of the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C has a corresponding attachment end portion that is restricted within a recess by a cap 1700 that covers the recess. The size and shape of the attachment end portion are configured such that the attachment end portion cannot be removed from the recess when covered by the cap 1700, and due to the presence of the cap 1700, the attachment end portion together with the recess is Figure 17 not easily observable in Figure 17 . Additionally, only the caps 1700 of the proximal and distal anchoring arms 1504B, 1506B are shown in

[0176] Captive attachment is advantageous when the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C and the protruding portion 1514 are made of one or more incompatible materials such that they cannot be directly attached, fixed, or joined together. For example, this is the case when the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C and possibly the anchor 1502 are made of nitinol, while the protruding portion 1514 is made of stainless steel. Other incompatible materials are possible. Nitinol and stainless steel generally cannot be directly attached, fixed, or joined together (such as by welding), and these methods would not meet the strict requirements of at least some implantable medical devices.

[0177] The cap can be fixed to the protruding portion 1514 in various ways, including but not limited to welding, fusing, gluing, mechanical interengagement, etc. When welded, the cap 1700 is made of a material that is compatible with the material of the protruding portion 1514. For example, both the cap 1700 and the protruding portion 1514 can be made of stainless steel, thus alleviating the associated limitations of the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C being made of nitinol and the protruding portion 1514 being made of incompatible stainless steel and unable to be directly attached, fixed, or joined.

[0178] The capture attachment of one or more attachment end portions of the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C is not limited to the protrusion 1514 and can be implemented at any location on the introducer unit 1512. Further, the implementation of the capture attachment is not limited to the interaction between the proximal and distal anchoring arms 1504A - 1504C, 1506A - 1506C and the protrusion 1514. The capture attachment can be implemented for any other component of the implantable medical device 1500 described herein. In any case, for example, depending on manufacturing requirements, the capture attachment does not necessarily require the use of materials that are incompatible and cannot be directly attached, fixed, or coupled.

[0179] As Figures 15 - 17 illustrated by way of example, according to an embodiment, the anchor 1502 has a biconical shape, which can approximate an elliptical, ovoid, or oblong shape. The conical proximal end portion 1516 of the anchor 1502 is formed by the junction of the proximal anchoring arms 1504A - 1504C, which converge together towards the protrusion 1514, while the conical distal end portion 1518 of the anchor 1502 is formed by at least two of the most distal anchoring arms (the most distal anchoring arms 1520A - 1520C), which converge together towards the most distal convergence point 1522. According to an embodiment, the conical distal end portion 1518 defines at least one radial opening (as Figure 19 illustrated by way of example, three radial openings 1530A - 1530C), through which the corresponding pump units 1508A - 1508C pass for assembly and disassembly.

[0180] The biconical shape enables the anchor 1502 to be converted from its expanded configuration to its contracted configuration from its conical proximal end portion 1516 and conical distal end portion 1518. As described above for the conversion of the anchors 112, 714, the introducer unit 1512 can be pulled while in the sheath to initiate such a conversion starting from the conical proximal end portion 1516. While in the sheath, a tool (such as a snare) attached to the capture element 1524 (described below) can be pulled to initiate such a conversion starting from the conical distal end portion 1518.

[0181] As Figures 15 - 19As illustrated by the example shown, an optional capture element 1524 may be provided at the most distal convergence point 1522, which may correspond to the first capture element 718 of the implantable medical device 700. Alternatively, the capture element 1524 may bring the most distal anchoring arms 1520A - 1520C together and attach to the most distal anchoring arms. The capture element 1524 may at least partially form the tapered distal end portion 1518 of the anchor 1502. As illustrated by the example 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 a structure that can be captured within the lumen.

[0182] As Figures 16 - 18 illustrated by the example shown, according to an embodiment, the protrusion 1514 is provided with at least one optional receiving surface 1526 (as illustrated by the example shown, three receiving surfaces 1526A - 1526C), and / or is provided with at least one optional distal guiding hole (as Figure 19 best illustrated by the example shown, three distal guiding holes 1528A - 1528C). In particular, the protrusion 1514 may be provided with a plurality of receiving surfaces 1526 and a plurality of distal guiding holes 1528 corresponding to a plurality of pump units 1508. The protrusion 1514 may be configured to removably or non - removably assemble and disassemble the pump units 1508A - 1508C relative to the proximal end portion 1510 of the introducer unit 1512, or be configured to facilitate the removably or non - removably assembling and disassembling of the pump units 1508A - 1508C relative to the proximal end portion 1510 of the introducer unit 1512.

[0183] Each of the receiving surfaces 1526A - 1526C extends at least partially longitudinally along the protruding portion 1514 and, as illustrated, may or may not be equally spaced from each other. Thus, when assembled, the pump units 1508 are disposed around the protruding portion 1514. Additionally, the receiving surfaces 1526A - 1526C may be concave to increase or improve their contact surface with the pump units 1508A - 1508C when the pump units 1508A - 1508C are assembled thereto. Each of the receiving surfaces 1526A - 1526C may be configured to reduce or prevent blood coagulation between the receiving surface and the corresponding pump unit 1508A - 1508C when the corresponding pump unit 1508A - 1508C is assembled thereto. For example, the size and shape of each of the receiving surfaces 1526A - 1526C may be set to conform to or match the corresponding one of the pump units 1508A - 1508C so as to substantially exclude the presence of blood between the receiving surface and the corresponding pump unit 1508A - 1508C when the corresponding pump unit 1508A - 1508C is assembled thereto. Alternatively or additionally, each of the receiving surfaces 1526A - 1526C may be provided with a seal for providing a fluid - tight contact with the corresponding pump unit 1508A - 1508C when the corresponding pump unit 1508A - 1508C is assembled to the receiving surface.

[0184] Each of the receiving surfaces 1526A - 1526C may be associated with a corresponding one of the distal guide holes 1528A - 1528C, as Figures 16 - 18 further illustrated, or may not be associated with a corresponding one of the distal guide holes 1528A - 1528C. In particular, each of the distal guide holes 1528A - 1528C may be configured to removably or non - removably engage a proximal engagement portion 1532 of the corresponding one of the pump units 1508A - 1508C when the pump units 1508A - 1508C are assembled thereto. For example, as Figure 15 illustrated, the proximal engagement portion 1532 may include a pin connector coupled to a corresponding elongated operable element 1534 of the pump unit 1508C. In this case, the size and shape of the pin are set to removably or non - removably engage the distal guide hole 1528C.

[0185] Instead of conforming or mating the receiving surfaces 1526A - 1526C with the pump units 1508A - 1508C and / or providing seals to the receiving surfaces 1526A - 1526C to mitigate or prevent blood clotting, the receiving surfaces 1526A - 1526C and / or the distal guide holes 1528A - 1528C can be configured to create a flow gap between the receiving surfaces 1526A - 1526C and the pump units 1508A - 1508C when the pump units 1508A - 1508C are assembled thereto. The flow gap promotes blood flow between the receiving surface and the pump unit to achieve the same purpose. Further, fins or similar structures can be provided to direct or alter the blood flow through the flow gap to mitigate or prevent blood clotting therein.

[0186] When applicable and with the necessary changes made that would be understood by a person skilled in the art, the optional anchor 1502 can be implemented to the implantable medical device 700. The optional anchors 112, 714 with or without the optional anchor rods 114, 716 can be implemented to the introducer unit 1512 of the implantable medical device 1500.

[0187] Figures 20 - 21 An example illustrates an implantable medical device 1500 (also collectively referred to herein as a "medical device assembly") provided with a sheath 2000 according to an embodiment. The introducer unit 1512 of the implantable medical device 1500 is capable of releasably engaging with the sheath 2000. Figure 20 An example illustrates an implantable medical device 1500 provided with a tip 2002 similar to the tips 110, 712 and a guide wire 2004 similar to the guide wires 108, 710. The tip 2002 is releasably attached to the introducer unit 1512, and the guide wire 2004 is attached to the tip 2002. The introducer unit 1512 projects distally outward from the sheath 2000. The attachment between the guide wire 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 enables the implantable medical device 1500 to be delivered within the lumen when the sheath is guided within the lumen of a body catheter (multiple body catheters) for implanting the implantable medical device, and the sheath is not left behind afterwards as the sheath is removed after the operation.

[0188] As Figure 21As illustrated by the examples shown, the proximal end portion 1510 of the introducer unit 1512 can be releasably engaged within the engagement end portion 2006 of the sheath 2000 such that the introducer unit 1512 can be removed from the sheath 2000 to be delivered into the lumen of a body conduit (body conduits) and implanted at an intraluminal implantation site. The pump units 1508A - 1508C may or may not be accommodated within the sheath 2000. When accommodated within the sheath 2000, the pump units 1508A - 1508C are in an end - to - end arrangement and the implantable medical device 1500 is in a disassembled configuration. When not accommodated within the sheath 2000, the pump units 1508A - 1508C are accommodated within the sheath 2000 and slidably received within the introducer unit 1512. Extension wires 2502A - 2502C similar to the extension wires 1300A - 1300C are not shown in Figure 21 because they are hidden by the introducer unit 1514 and the sheath 2002. The extension wires extend along the entire combined length of the sheath 2000 and the introducer unit 1512. The extension wires can be attached to corresponding elongate operable elements of the pump units 1508A - 1508C, and when the extension wires are pulled from the distal end portion of the introducer unit 1512, the corresponding elongate operable elements can move internally along the sheath 2000.

[0189] As Figure 21 best illustrated in, the engagement end portion 2006 of the sheath 2000 has the tapered shape as described above, but may generally be less obvious. In use, the engagement end portion 2006 of the sheath 2000 is the second taper encountered by the intraluminal passageway (such as a percutaneous intraluminal passageway) after the taper at the tip 2002. Typically, such an intraluminal passageway is first dilated by the tip 2002 and then further dilated by the engagement end portion 2006 as the implantable medical device 1500 and the sheath 2000 are advanced therethrough. Although the tip 2002 is illustrated in Figure 20 this may not necessarily be the case because, as described above, the distal end portion 2008 of the introducer unit 1512 itself can have a tapered shape.

[0190] 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 therewith. The sealing engagement may be provided by making the proximal end portion 1510 of the introducer unit 1512 slightly larger than the engagement end portion 2006 of the sheath 2000 so as to slightly expand the engagement section portion. Alternatively, a tight fit may be employed. A sealing engagement between the implantable medical device 1500 and the sheath 2000 may be advantageous in the presence of blood, which may be the cause of failure inside the sheath 2000 and / or the implantable medical device 1500, depending on the circumstances.

[0191] Although in Figures 20 - 21 the implantable medical device 1500 and the sheath 2000 are described and illustrated as engaging at the level of the proximal end portion 1510 of the introducer unit 1512, such an engagement may occur at any position along the introducer unit 1512 of the implantable medical device 1500.

[0192] Figure 22 An exemplary optional compression fixation mechanism 2200 as an embodiment of the fixation mechanism 824 is illustrated, which may be provided to the implantable medical device 1500 as well as the implantable medical device 700 for fixing all the elongate operable elements of the pump units 1508A - 1508C to the introducer unit 1512. The fixation mechanism 2200 may be integrated at any position on the implantable medical device 1500, such as integrated on the proximal end portion 1510 of the introducer unit 1512 near the distal end 2002 so as to be operable when the implantable medical device 1500 is implanted.

[0193] The compression fixation mechanism 2200 includes a housing 2204 that encloses 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 which, as illustrated, has three channels for slidably receiving therein the elongate operable elements of the pump units 1508A - 1508C. The sleeve 2210 is disposed between the fixed compression element 2206 and the movable compression element 2208 and can be compressed by them. The sleeve 2210 is configured to prevent damage to the elongate operable elements when they slide therein and is also configured to sealingly engage the elongate operable elements for providing a fluid-tight engagement therewith. Thus, the sleeve 2210 may be made of a polymer or an elastomer. The sizes and shapes of the fixed and movable compression elements 2206, 2208 may be set to conform to the outer shape of the sleeve 2210.

[0194] As illustrated, the compression fixation mechanism 2200 is in an unfixed configuration, in which the fixed compression element 2206 and the movable compression element 2208 are spaced apart from each other by a space 2212. The compression fixation mechanism 2200 is adjusted from the unfixed configuration to the fixed configuration by operating an actuator 2210 (which is a set screw as illustrated), so that the movable compression element 2208 moves towards the fixed compression element 2206 to compress the sleeve 2210, thereby reducing the space 2212. In the fixed configuration, the sleeve 2210 frictionally engages the elongated operable element.

[0195] The compression fixation mechanism 2200 can be provided to the implantable medical device 100.

[0196] Now referring Figures 23A - 23C and Figure 24 , a method 2400 for implanting the implantable medical devices 100 and 700 according to a third aspect of the present disclosure will be described.

[0197] The implantation method 2400 includes the following steps.

[0198] According to an embodiment, in 2402, a first intraluminal access (also referred to herein as the first body catheter intraluminal access) to the lumen of the first body catheter and a second intraluminal access (also referred to herein as the second body catheter intraluminal access) to the lumen of the second body catheter of a patient to be treated by the implantable medical devices 100 and 700 are respectively obtained. The first intraluminal access may be located in the lower body of the patient, such as on the femoral artery of the patient. The second intraluminal access may be located in the upper body of the patient, such as on the subclavian artery / axillary artery of the patient. Each of the first intraluminal access and the second intraluminal access may be a percutaneous body catheter access obtained by one or more medical procedures known in the art (e.g., via the Seldinger technique), or may be one or more natural body catheter accesses, such as esophageal, tracheal, urethral, and / or rectal accesses, which may require anesthesia or any other medical or surgical preparation. For example, the first intraluminal access may be a percutaneous body catheter access obtained by one or more medical procedures, while the second intraluminal access may be a natural access or a percutaneous body catheter access obtained by one or more medical procedures. Alternatively, the first intraluminal access and the second intraluminal access may be obtained and thus located on the same body catheter, which may have an acute angle or be essentially tortuous.

[0199] According to an embodiment, in 2404, optionally, the method may further include delivering guide wires 108, 710 from the first intraluminal access to the second intraluminal access (optional items are in Figure 24(shown by the dashed line). In particular, the guidewires 108, 710 can be transferred between the first intraluminal access and the second intraluminal access in the following manner: guiding the guidewires 108, 710 through the lumen of the first body catheter via the first intraluminal access, such as by capturing the distal end portions of the guidewires 108, 710 via the second intraluminal access using, for example, a snare or any other suitable tool to guide the guidewires 108, 710 to the second intraluminal access; and causing the guidewires to exit through the second intraluminal access. Depending on the vasculature of the patient, the interconnect between the first body catheter and the second body catheter may have an acute angle, or any one of the first body catheter and the second body catheter may be tortuous in nature, which may together make it difficult to navigate the implantable medical devices 100, 700 (and certain other medical devices in the art). In such cases, it may be desirable to use the guidewires 108, 710 to prevent or minimize damage to the intima in the case of blood vessels.

[0200] Referring again to 2404, according to an embodiment, optionally, the method may further comprise pulling the guidewires 108, 710 from the second intraluminal access such that (i) guiding the implantable medical devices 100, 700 through the lumen of the first body catheter via the first intraluminal access (optionally, while pushing the proximal end portions of the implantable medical devices 100, 700), (ii) advancing the implantable medical devices 100, 700 in the lumen of at least one of the first body catheter and the second body catheter to the second intraluminal access, and (iii) causing the distal end portions of the implantable medical devices 100, 700 to exit through the second intraluminal access.

[0201] According to an embodiment, in 2406, the implantable medical devices 100, 700 with the introducer unit 102 or the introducer unit 702 are first guided through the lumen of the first body catheter via the first intraluminal access. For example, the sheath (e.g., a delivery sheath or an implantation sheath) that houses the implantable medical devices 100, 700 can be pushed through the first intraluminal access. Alternatively, the implantable medical devices 100, 700 can be guided through the first intraluminal access by pushing the proximal end portions of the implantable medical devices 100, 700 without using a sheath.

[0202] According to an embodiment, in 2408, the implantable medical devices 100, 700 in the lumen of the first body catheter are advanced to the lumen of the second body catheter up to the second intraluminal access. In particular, the implantable medical devices 100, 700 can be advanced by pushing the sheath that houses the implantable medical devices 100, 700 or by pushing the proximal end portions of the implantable medical devices 100, 700.

[0203] According to an embodiment, in 2410, the distal end portions of the implantable medical devices 100, 700 are caused to exit through the second intraluminal passageway such that the implantable medical devices 100, 700 are partially positioned inside the lumen of at least one of the first body conduit and the second body conduit. In this way, the pump elements 106, 106A - 106C or the pump elements 707, 707A - 707C (or functional units, as the case may be) are positioned within the lumen, while the distal end portions of the introducer unit 102 or the introducer unit 702 may be partially positioned outside the lumen or outside the body. Additionally, hemostasis may be achieved partially or completely at the second intraluminal passageway as the implantable medical devices 100, 700 exit. For example, the bulges 300, 400, 1000, 1100 of the introducer unit 102 or the introducer unit 702 may engage the second intraluminal passageway in a fluid - tight manner to achieve hemostasis partially or completely. In particular, the implantable medical devices 100, 700 may be caused to exit by pushing the sheath that houses the implantable medical devices 100, 700 or by pushing the proximal end portions of the implantable medical devices 100, 700.

[0204] According to an embodiment, in 2412, optionally, the method may further comprise anchoring the implantable medical devices 100, 700 by converting the anchors 112, 714 from a contracted configuration (e.g., the configuration that the anchors 112, 714 have when the implantable medical devices 100, 700 are housed within the sheath during delivery and / or implantation of the implantable medical devices 100, 700) to an expanded configuration to removably engage the lumen wall of any one of the first body conduit and the second body conduit.

[0205] According to an embodiment, in 2414, optionally, particularly when implanting an implantable medical device 700, the method may further include slidably actuating any one of the elongate operable elements 708, 708A - 708C relative to a corresponding other one of the elongate operable elements 708, 708A - 708C and the longitudinal guide holes 802, 802A - 802C to achieve at least one of the following: (i) guiding a corresponding one of the pump elements 707, 707A - 707C through a first luminal access into the lumen of a first body conduit, and (ii) slidably assembling one of the pump elements 707, 707A - 707C with a corresponding one of the guide units 702 within the lumen. For example, to advance or navigate within the lumen of a body conduit for implanting the implantable medical device 700, the method may further include preventing any one of the corresponding elongate operable elements 708, 708A - 708C from sliding within a corresponding one of the longitudinal guide holes 802, 802A - 802C when pulling a corresponding pump element 106, 707A - 707C through a corresponding guide wire 108, 710.

[0206] According to an embodiment, in 2416, the implantable medical devices 100, 700 are operated via a distal end portion of the implantable medical devices 100, 700 that is positioned outside the lumen or extracorporeally. In particular, the implantable medical devices 100, 700 may be operated by operably connecting the distal end portion including the connectors 212, 832 to a controller configured to operate the implantable medical devices 100, 700. When there are tips 110, 712, the tips 110, 712 may also be removed to operably connect the implantable medical devices 100, 700 to the controller. Alternatively, the implantable medical devices 100, 700 may be operated wirelessly.

[0207] According to an embodiment, in 2418, optionally, the method may further include closing at least one of such accesses when the first luminal access and the second luminal access are percutaneous body conduit accesses obtained through a medical procedure.

[0208] Now referring Figures 25A - 25J , an example of an implantable medical device 1500 according to an embodiment and a method of implanting the implantable medical device into a blood vessel will be described.

[0209] Figure 25AAn example illustrates an example of an implantable medical device 1500, the implantable medical device being provided with a guide wire 2004 attached to a tapered tip 2002, the tapered tip being detached from a guide unit 1512 such that the distal end portions of the extension wires 2502A - 2502C are visible. The extension wires 2502A - 2502C correspond to the extension wires 1300A - 1300C. The distal end portions of the extension wires 2502A - 2502C project outwardly from the distal cavity of the guide unit 1512. When the tip 2002 is attached to the guide unit 1512, the distal cavity is located below the tip 2002. The extension wires 2502A - 2502C are slidably received in the distal cavity and the guide unit 1512, pass through three radial openings of an anchor 1502 (the anchor 1502 being located beside the proximal end portion 1510 of the guide unit 1512), and extend in a sheath 2000 up to its handle 2504.

[0210] A capture element disposed on the anchor 1502 can be removably attached to a rod 2506. The handle 2504 can be manipulated by an operator to slidably move the rod 2506 in the sheath 2000, such that the guide unit 1512 can be pushed outside the sheath 2000, and / or such that the guide unit can be pulled inside the sheath 2000 when attached to the rod 2506.

[0211] Figure 25B An example illustrates an example of an implantable medical device 1500, wherein the tip 2002 is attached to the guide unit 1512, and the proximal end portion 1510 of the guide unit 1512 is removably engaged in the engagement end portion 2006 of the sheath 2000, so that the implantable medical device 1500 is ready for implantation. Also illustrated are pump units 1508A - 1508C, which will be removably attached to the corresponding extension wires 2502A - 2502C for being pulled inside the sheath 2000. Further illustrated is an optional snare 2508, which can be used to capture the guide wire 2004.

[0212] Regarding the method of implantation, Figure 25C it involves guiding, for example by pushing, the guide wire 2004 of the implantable medical device 1500 into a first luminal passage 2510 (such as a first percutaneous arterial or venous luminal passage); positioning the guide wire 2004 at an intermediate position 2512 (also referred to herein as "intermediate luminal position") in the lumen of a blood vessel; guiding, for example by pushing, the snare 2508 into a second luminal passage 2514 (such as a second percutaneous arterial or venous luminal passage); positioning the snare at the intermediate position 2512; and capturing the guide wire 2004 with the snare 2508. The positioning of the snare 2508 can be performed before, during, or after the positioning of the guide wire 2004.

[0213] Figure 25D Involves pulling the snare 2508 through the second intraluminal passage 2514 for moving or navigating the implantable medical device 1500 along the lumen of a blood vessel (or blood vessels) until the second intraluminal passage 2514; optionally, at least partially passing the distal end portion of the introducer unit 1512 through the second intraluminal passage 2514 or exposing the distal end portion through the second intraluminal passage 2514; and, optionally, detaching the snare 2508 from the guide wire 2004. Optionally, the first and second intraluminal passages can be formed by performing or obtaining a second intraluminal passage 2514 having a diameter smaller than the diameter of the first intraluminal passage 2510, in which the implantable medical device 1500 is initially guided. Thus, the distal end portion of the introducer unit 1512 having a tapered shape sealingly engages the second intraluminal passage 2514 in a fluid-tight manner when at least partially passing through or being exposed through the second intraluminal passage 2514, and at least partially achieves hemostasis.

[0214] Figure 25E Involves, optionally, manipulating the handle 2504 of the implantable medical device 1500 to anchor the implantable medical device 1500 at the intraluminal implantation site.

[0215] Figures 25F - 25H Involves, optionally, attaching one or more extension wires 2502A - 2502C to the corresponding pump units 1508A - 1508C, such as to one or more respective elongate operable elements thereof (if not already attached thereto); pulling the extension wire 2504A through the second intraluminal passage 2514 to move the pump unit 1508A inside the sheath 2000 until the intraluminal implantation site and finally assembling the pump unit 1508A to the introducer unit 1512; pulling the extension wire 2504B through the second intraluminal passage 2514 to move the pump unit 1508B inside the sheath 2000 until the intraluminal implantation site and finally assembling the pump unit 1508B to the introducer unit 1512; pulling the extension wire 2504C through the second intraluminal passage 2514 to move the pump unit 1508C inside the sheath 2000 until the intraluminal implantation site and finally assembling the pump unit 1508C to the introducer unit 1512. One or more of the pump units 1508A - 1508C can be positioned inside or outside the sheath 2000 and / or before or after the first intraluminal passage 2510 before being moved by pulling the corresponding extension wires 2502A - 2502C.

[0216] Figure 25IInvolves, optionally, detaching the implantable medical unit 1500 from the sheath 2000, such as from the rod 2506 (if attached to the rod 2506).

[0217] Figure 25J Involves, optionally, removing the sheath 2000 from the blood vessel through the first intraluminal passageway 2510, and optionally closing the first intraluminal passageway 2510.

[0218] The implantation method may further optionally include connecting the distal end portions (e.g., their respective elongate operable elements) of one or more pump units 1508A - 1508C to one or more corresponding controllers, and optionally operating the pump units 1508A - 1508C.

[0219] It should be understood that the reference to the implantable medical device 1500 and its components used to describe the implantation method 2500 is only by way of example, as the implantation method 2500 can be implemented with any suitable implantable medical device.

[0220] Now referring Figure 26 , a method 2600 for implanting a pump unit will be described. The pump unit includes a pump element and an elongate operable element that is operatively connected to the pump element for operating the pump element by a controller connectable to the elongate operable element through the elongate operable element. The pump unit may include a tapered portion oriented towards the elongate operable element such that when pulled through the intraluminal passageway by the elongate operable element, the tapered portion expands the intraluminal passageway as it passes through the intraluminal passageway.

[0221] The implantation method 2600 includes the following steps (optional elements of the implantation method 2600 are represented by dashed lines in Figure 26 ).

[0222] In 2602, optionally, obtain a first intraluminal passageway, such as a first percutaneous arterial or venous intraluminal passageway, and a second intraluminal passageway, such as a second percutaneous arterial or venous intraluminal passageway.

[0223] In 2604, navigate the elongate operable element (such as a pump cable or a pump drive shaft) of the pump unit from the first intraluminal passageway to the second intraluminal passageway to position the pump element within the lumen of the blood vessel and to position a portion of the elongate operable element near or at least partially through the second intraluminal passageway.

[0224] The navigable elongate manipulable element can include, optionally guiding the elongate manipulable element through a first intraluminal passageway and optionally positioning the elongate manipulable element at an intermediate position within the lumen of a blood vessel; optionally guiding a snare through a second intraluminal passageway, optionally positioning the snare at the intermediate position, optionally capturing the elongate manipulable element with the snare, optionally pulling the snare to expose the elongate manipulable element through the second intraluminal passageway, and / or optionally pulling the elongate manipulable element with or without the snare to position the pump element at an intraluminal implantation site within the lumen of a body conduit (body conduits).

[0225] In 2606, optionally connect the elongate manipulable element to the controller and optionally operate the fluid displacement portion.

[0226] Now referring to Figure 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 patient such that the pump element 106, 106A - B or the pump element 707, 707A - 707C is positioned within the lumen of a first body conduit, and the introducer unit 102 or the introducer unit 702 extends along the lumen of the first body conduit and also along the lumen of a second body conduit until a second intraluminal passageway (also referred to herein as the second body conduit intraluminal passageway), and the introducer unit 102 or the introducer unit 702 is positioned to extend partially through the second intraluminal passageway. Thus, the second intraluminal passageway is located distal to the implantable medical device 100, 700 (i.e., toward the distal end portion of the implantable medical device 100, 700).

[0227] The removal method 2700 includes the following steps.

[0228] According to an embodiment, at 2702, a first intraluminal access (also referred to herein as a first body catheter intraluminal access) to the lumen of the first body catheter is obtained on a section of the first body catheter, the section being proximal to the implantable medical device (i.e., towards the proximal end portion of the implantable medical devices 100, 700). The first intraluminal access may be located in the lower body of the patient, such as on the femoral artery of the patient. The second intraluminal access may be located in the upper body of the patient, such as on the subclavian / axillary artery of the patient. Each of the first intraluminal access and the second intraluminal access may be a percutaneous body catheter access obtained by one or more medical procedures known in the art (e.g., via the Seldinger technique), or may be a natural body catheter access, such as an esophageal, tracheal, urethral, and / or rectal access, which may require anesthesia or any other medical or surgical preparation. For example, the first intraluminal access may be a percutaneous body catheter access obtained by one or more medical procedures, while the second intraluminal access may be a percutaneous body catheter access obtained by one or more medical procedures or a natural access. Alternatively, the first intraluminal access and the second intraluminal access may be obtained and thus located on the same body catheter, which may have an acute angle or be essentially tortuous.

[0229] According to an embodiment, at 2704, optionally, the distal end portion of the implantable medical devices 100, 700 is disconnected from a controller configured to operate the implantable medical devices 100, 700 (optional items are indicated by dashed lines in Figure 27 . Of course, this is not necessary when the implantable medical device is operated wirelessly.

[0230] At 2706, optionally, particularly when removing the implantable medical device 700, the method may further include slidably actuating either the elongate operable element 708, 708A - 708C relative to the corresponding other one of the elongate operable element 708, 708A - 708C and the longitudinal guide holes 802, 802A - 802C to slidably disassemble any one of the pump elements 707, 707A - 707C from the corresponding one of the pump elements 707, 707A - 707C (or functional unit, as the case may be) within the lumen.

[0231] According to an embodiment, in 2708, optionally, the method may further include unanchoring the implantable medical devices 100, 700 by converting the anchors 112, 714 from an expanded configuration (since the implantable medical devices 100, 700 are anchored) to a contracted configuration (e.g., when the implantable medical devices 100, 700 are received in a sheath), to removably engage the lumen wall of either the first body conduit or the second body conduit.

[0232] According to an embodiment, in 2708, the implantable medical devices 100, 700 are retrieved from the first body conduit and the second body conduit through the first body conduit lumen access. In some embodiments, the implantable medical devices 100, 700 may be retrieved by guiding a sheath (such as a retrieval sheath or an extraction sheath) through the first lumen access into the lumen of the first body conduit; advancing the sheath therein to be close to the proximal end portion of the implantable medical devices 100, 700; placing the implantable medical devices 100, 700 at least partially in the sheath; and removing the sheath from the first lumen access. In some embodiments, the implantable medical devices 100, 700 may be retrieved by, for example, using a snare or any other suitable tool to capture the capture elements 116, 718, 720 of the implantable medical devices 100, 700 via the first body conduit lumen access; and pulling the tool so that the implantable medical devices 100, 700 are placed within the sheath.

[0233] Alternatively, the implantable medical devices 100, 700 may be retrieved by pulling the distal end portion of the implantable medical devices 100, 700 through the second lumen access; in this case, according to an embodiment, obtaining the first lumen access is not required.

[0234] According to an embodiment, in 2810, optionally, the method may further include closing at least one of such accesses when the first lumen access and the second lumen access are percutaneous body conduit accesses obtained through a medical procedure. Typically, the first lumen access and the second lumen access are closed after implantation.

[0235] One or more of the pump elements described and illustrated herein may be provided as one or more endovascular / intravascular pumps that are capable of being percutaneously and / or transcatheter implanted and percutaneously and / or transcatheter removed within the lumen of one or more body conduits, such as one or more blood vessels. One or more pump elements may be one or more axial flow pumps, centrifugal pumps, and / or positive displacement pumps. As illustrated herein, one or more pump elements may not have a shroud surrounding the pump impeller. In such a case, one or more pump elements may be positioned within an anchor of one or more implantable medical devices to protect the lumen wall from damage or injury caused by the impeller during use. Alternatively, one or more pump elements may be provided with a shroud.

[0236] In use, one or more pump elements may be operated to move any biological fluid, such as blood, in a direction that produces proximal fluid outflow relative to one or more implantable medical devices or in the opposite direction that produces distal fluid outflow relative to one or more implantable medical devices. In use, the pump elements may be operated continuously, intermittently, or periodically to simulate the pulsation of the heart. In use, the pump elements are capable of producing a hemodynamic effect within the lumen of a blood vessel (s).

[0237] The functional units described and illustrated herein may or may not require power to achieve their intended purpose in use.

[0238] The functional units are not limited to one or more pump units and may in fact include one or more sensor units, such as one or more physiological sensors for reporting at least one physiological reading, 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.

[0239] One or more functional units may include one or more occluder units for selectively occluding a blood vessel in use such that blood flow is redirected to another blood vessel for selectively enhancing organ perfusion.

[0240] One or more functional units may include one or more substance delivery units for delivering at least one substance within the lumen. In such a case, one or more elongate operable elements may be provided with a tube configured to convey the substance to one or more substance delivery units. The one or more substances delivered may be, for example, a drug or another fluid (e.g., blood, plasma, saline, glucose solution, etc.).

[0241] One or more functional units may include one or more fluid sampling units for sampling a fluid or analyte within the lumen.

[0242] When being assemblable and / or disassemblable, each of the plurality of functional units can be the same functional unit, such as the pump unit described and illustrated herein. Alternatively, each of the plurality of functional units can be a component of an implantable medical device. The components can be assembled intraluminally to construct a functional implantable medical device within a lumen.

[0243] The functions associated with the functional units are not limited to a single identical function. In fact, each of the plurality of functional units can have various functions associated therewith. Thus, when an implantable medical device is provided with a plurality of functional units, a plurality of corresponding functions can be associated with the implantable medical device. Such a plurality of functions can be any combination of the functions described above for one or more sensor units, occluder units, substance delivery units, and / or fluid sampling units. Such a combination of functions may have a synergistic effect.

[0244] The optional controller described and illustrated herein can be a computer, a power source (such as, a power supply and / or a motive power source), etc. and combinations thereof, which are configured to operate one or more functional units and one or more pump elements. Although the controller is illustrated herein as a connectable component physically separated from the implantable medical device, the controller can be at least partially integrated into the implantable medical device so as to form an integral single-piece device.

[0245] Each of the first and second intraluminal passages described and illustrated herein can be an intraluminal percutaneous arterial and / or venous passage. Each of the first and second intraluminal passages can be located on the same blood vessel, or on separate or different blood vessels. Each of the first and second intraluminal passages can be located in the upper part of the patient's body, the lower part of the patient's body, the left part of the patient's body, and / or the right part of the patient's body. Each of the first and second intraluminal passages can be a femoral passage and / or an axillary / subclavian passage. Each of the first and second intraluminal passages can be a surgically formed passage and / or a naturally occurring passage. The first and second intraluminal passages can be fabricated or obtained such that the diameter of one of the first and second intraluminal passages is smaller than the diameter of the other of the first and second intraluminal passages. The body catheter can be naturally occurring or surgically formed, such as by tunneling.

Claims

1. An implantable medical device, comprising: A functional unit having an elongate operable element connected to and extending from it; And A guide unit having a body that defines a longitudinal guide bore extending at least partially along the body for slidably receiving the elongate operable element therein, the guide unit being configured for slidably assembling with the functional unit in the lumen of a body conduit for partially implanting the implantable medical device inside and partially outside the body conduit.

2. The implantable medical device according to claim 1, wherein, The elongate operable element includes a stop element attached thereto for abutting the guide unit at the distal end portion of the guide unit when the elongate operable element is slidably received in the longitudinal guide bore.

3. The implantable medical device according to claim 1, further comprising: An extension wire that can be removably attached to the distal end portion of the elongate operable element and that can be slidably received in the longitudinal guide bore.

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

5. The implantable medical device according to claim 3 or 4, wherein, The cross-sectional dimension of the extension wire is smaller than the cross-sectional dimension of the elongate operable element.

6. The implantable medical device according to claim 1, further comprising: A seal that is associated with the guide unit at the proximal end portion of the guide unit, the seal element for fluid-tight engagement between the longitudinal guide bore and the elongate operable element.

7. The implantable medical device according to claim 1, further comprising: A guide wire attached to the implantable medical device and extending distally away from the guide unit.

8. The implantable medical device according to claim 7, wherein, The guide wire includes a proximal end portion and a distal end portion that is more flexible than the proximal end portion.

9. The implantable medical device according to claim 7 or 8, wherein, The guide wire includes a floppy distal end portion.

10. The implantable medical device according to claim 1, further comprising: A tip that can be removably attached to the distal end portion of the guide unit.

11. The implantable medical device according to claim 10, further comprising: A guide wire attached to the implantable medical device and extending distally away from the tip.

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

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

14. The implantable medical device according to claim 1, wherein, The elongate operable element is operatively connected to the functional unit and can be operatively connected to either a controller and an actuator at the distal end portion of the elongate operable element, the controller being configured to operate the functional unit and the actuator being configured to actuate the functional unit.

15. The implantable medical device according to claim 14, wherein, The elongate operable element includes an elongate conductor that can be operatively connected to the controller.

16. The implantable medical device according to claim 14 or 15, wherein, The elongate operable element includes a drive shaft that can be operatively connected to the actuator.

17. The implantable medical device according to claim 1, further comprising: A capture element that can be captured by a tool, the capture element being provided on the guide unit at the proximal end portion of the guide unit.

18. The implantable medical device according to claim 1, further comprising: An anchor attached to the guide unit for anchoring the implantable medical device in the lumen of the body conduit.

19. The implantable medical device according to claim 18, further comprising: An anchor rod that projects proximally away from the guide unit, with the anchor attached to the anchor rod.

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

21. The implantable medical device according to claim 1, wherein, The guide unit has a tapered distal end portion.

22. The implantable medical device according to claim 21, wherein, When the elongate operable element is slidably received in the longitudinal guide hole, the functional unit is slidably positioned on one side of the proximal end portion of the guide unit.

23. The implantable medical device according to claim 1, wherein, The guide unit includes a raised portion whose transverse cross-sectional dimension is greater than that of the rest of the guide unit.

24. The implantable medical device according to claim 1, wherein, The guide unit is flexible.

25. The implantable medical device according to claim 1, wherein, The functional unit is a first functional unit, and the implantable medical device further includes a second functional unit having an elongate operable element connected to and extending from it. The guide unit has a body that defines two longitudinal guide holes extending at least partially along the body for slidably receiving the elongate operable elements of the first functional unit and the second functional unit. The guide unit is configured to be slidably assembled with the first functional unit and the second functional unit in the lumen of the body conduit for partially implanting the implantable medical device inside and partially outside the body conduit.

26. The implantable medical device according to claim 1, wherein, The functional unit is a pumping unit.

27. An implantable medical device, comprising: A functional unit; And A guide unit operatively connected to the functional unit for operating the functional unit, the guide unit being configured to guide the functional unit in the lumen of a body conduit and for partially implanting the implantable medical device inside and partially outside the body conduit.

28. The implantable medical device according to claim 27, further comprising: A guide wire attached to the implantable medical device and extending distally away from the guide unit.

29. The implantable medical device according to claim 28, wherein, The guide wire includes a proximal end portion and a distal end portion that is more flexible than the proximal end portion.

30. The implantable medical device according to claim 27 or 28, wherein, The guide wire includes a floppy distal end portion.

31. The implantable medical device according to claim 27, further comprising: A tip that is removably attachable to the distal end portion of the guide unit.

32. The implantable medical device according to claim 31, further comprising: A guide wire attached to the implantable medical device and extending distally away from the tip.

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

34. The implantable medical device according to claim 27, further comprising: An elongate operable element extending longitudinally at least partially along the guide unit, the elongate operable element being operatively connected to the functional unit and being operatively connectable at the distal end portion of the elongate operable element to either a controller or an actuator. The controller is configured to operate the functional unit, and the actuator is configured to actuate the functional unit.

35. The implantable medical device according to claim 34, wherein, The elongate operable element includes an elongate electrical conductor that is operatively connectable to the controller.

36. The implantable medical device according to claim 34 or 35, wherein, The elongate operable element includes a drive shaft that is operatively connectable to the actuator.

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

38. The implantable medical device according to claim 27, further comprising: A capture element that can be captured by a tool, the capture element being disposed on the implantable medical device at a proximal end portion of the implantable medical device.

39. The implantable medical device according to claim 27, further comprising: An anchor, the anchor being attached to the implantable medical device for anchoring the implantable medical device in the lumen of the body conduit.

40. The implantable medical device according to claim 39, further comprising: An anchor rod that projects proximally away from the implantable medical device, the anchor being attached to the anchor rod.

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

42. The implantable medical device according to claim 27, wherein, The introducer unit has a tapered distal end portion.

43. The implantable medical device according to claim 27, wherein, The introducer unit includes a raised portion, the transverse cross-sectional dimension of the raised portion being greater than the transverse cross-sectional dimension of the remainder of the introducer unit.

44. The implantable medical device according to claim 27, wherein, The introducer unit is flexible.

45. The implantable medical device according to claim 27, wherein, The functional unit is a first functional unit, the implantable medical device further includes a second functional unit, the introducer unit being operatively connected to the first functional unit and the second functional unit for operating the first functional unit and the second functional unit, the introducer unit being configured to guide the first functional unit and the second functional unit in the lumen of the body conduit and for partially implanting the implantable medical device inside the body conduit and partially outside the body conduit.

46. The implantable medical device according to claim 27, wherein, The functional unit is a pumping component.

47. A method of implanting an implantable medical device, the method comprising: Guiding the implantable medical device through a first intraluminal access into the lumen of a body conduit; Advancing the implantable medical device in 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; And Operating the implantable medical device via the end portion.

48. The method according to claim 47, further comprising: Obtaining a first intraluminal access and a second intraluminal access to one or more body conduits.

49. The method according to claim 47, further comprising: Transmitting a guide wire attached to the implantable medical device from the first intraluminal access to the second intraluminal access and pulling the guide wire through the second intraluminal access to achieve at least one of the following: (i) guiding the implantable medical device through the first intraluminal access into the lumen of the body conduit, (ii) advancing the implantable medical device in the lumen of the body conduit to the second intraluminal access, and (iii) exiting an end portion of the implantable medical device through the second intraluminal access.

50. The method according to claim 49, wherein The transmitting includes guiding the guide wire through the first intraluminal access into the lumen of the body conduit, guiding the guide wire to the second intraluminal access, and exiting the guide wire through the second intraluminal access.

51. The method according to claim 50, wherein, The guiding includes capturing the guide wire with a tool via the second intraluminal access.

52. The method according to claim 47, wherein, Exiting the end portion of the implantable medical device such that hemostasis is achieved at the second intraluminal access.

53. The method according to claim 47, further comprising: Anchoring the implantable medical device in the lumen of the body conduit.

54. The method according to claim 47, wherein, The operating includes operatively connecting the end portion of the implantable medical device to a controller configured to operate the implantable medical device.

55. The method according to claim 47 or 54, wherein, The operation includes removing a tip from an end portion of the implantable medical device for operatively connecting the end portion of the implantable medical device to a controller configured to operate the implantable medical device.

56. The method according to claim 47, wherein, The implantable medical device includes a pump element operatively connected to an elongate operable element and a guide unit defining a longitudinal guide hole. The method further includes: slidably actuating one of the elongate operable element and the longitudinal guide hole relative to the other of the elongate operable element and the longitudinal guide hole to achieve at least one of the following: (i) guiding the pump element through a lumen of the first body conduit through the first lumenal passageway, and (ii) assembling the implantable medical device within the lumen.

57. The method according to claim 47, further comprising: Closing the percutaneous body conduit access.

58. A method of removing an implantable medical device, the method comprising: - obtaining a first body conduit lumenal access on one side of the implantable medical device, the implantable medical device being implanted within a body conduit in the lumen and having an end portion, the end portion being partially positioned through a second body conduit lumenal access located on an opposite side of the implantable medical device; and - retrieving the implantable medical device from the body conduit through the first body conduit lumenal access.

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

60. The method according to claim 58, wherein, The implantable medical device includes a pump element operatively connected to an elongate operable element and a guide unit defining a longitudinal guide hole. The method further includes: slidably actuating one of the elongate operable element and the longitudinal guide hole relative to the other of the elongate operable element and the longitudinal guide hole to disassemble the implantable medical device within the lumen.

61. The method according to claim 58, further comprising releasing the anchoring of the implantable medical device from the body conduit.

62. The method according to claim 58, wherein, The retrieving includes guiding a sheath through the first body conduit lumenal access, placing the implantable medical device at least partially within the sheath, and removing the sheath from the first body conduit lumenal access.

63. The method according to claim 58 or 62, wherein, The retrieving includes capturing a capture element of the implantable medical device by a tool through the first body conduit lumenal access and pulling the tool.

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