MAMMALIAN BODY IMPLANTABLE FLUID FLOW INFLUENCING DEVICE

Abstract

Mammalian body implantable fluid flow influencing device, comprising a modular impeller having: An impeller hub module dimensioned and shaped to be deliverable to a delivery site within a conduit of a conduit system of the mammalian body via a catheter. An impeller vane module having at least a portion of an impeller vane; having, with respect to the impeller hub module, an assembled configuration in which the impeller vane module mates with the impeller hub module, and an unassembled configuration, in which the impeller vane module is unmated with the impeller hub module and being dimensioned and shaped to be deliverable to the delivery site via the catheter when in the unassembled configuration. The modular impeller being formed when the impeller vane module is retained in its assembled configuration, and dimensioned and shaped to be operable within at least one conduit of the conduit system. Method of implantation disclosed.

Claims

1-54. (canceled)

55. An implantable modular impeller device, comprising: an impeller hub module; an impeller vane module; and a control wire actuatable for mating the impeller vane module with the impeller hub module.

56. The implantable modular impeller device according to claim 55, wherein the control wire is further actuatable for unmating the impeller vane module with the impeller hub module.

57. The implantable modular impeller device according to claim 55, wherein the control wire is contactable to the impeller vane module for mating the impeller van module with the impeller hub module.

58. The implantable modular impeller device according to claim 55, wherein the control wire is attached to the impeller vane module for mating the impeller van module with the impeller hub module.

59. The implantable modular impeller device according to claim 58, wherein the control wire is releasably attached to the impeller vane module for mating the impeller van module with the impeller hub module.

60. The implantable modular impeller device according to claim 55, wherein the control wire is detached from the impeller vane module for operating the implantable modular device.

61. The implantable modular impeller device according to claim 55, wherein the control wire is slidably actuatable relative to the impeller hub module.

62. The implantable modular impeller device according to claim 55, wherein the impeller hub module comprises a passage configured for slidably receiving the control wire therein.

63. The implantable modular impeller device according to claim 55, wherein the impeller hub module comprises an impeller hub module connector, and the impeller vane module comprises an impeller vane module connector configured for releasably connecting to the impeller vane module connector.

64. The implantable modular impeller device according to claim 63, wherein the impeller hub module connector comprises a channel, and the impeller vane module connector comprises a cylinder portion that is slidably receivable in the channel.

65. The implantable modular impeller device according to claim 64 wherein the control wire is disposed along the channel.

66. The implantable modular impeller device according to claim 55, further comprising a secondary connector configured for releasably retaining the impeller hub module and the impeller vane module together.

67. The implantable modular impeller device according to claim 55, further comprising a motor and a drive shaft operatively connectable between the motor and the impeller hub module for driving the impeller hub module.

68. The implantable modular impeller device according to claim 67, further comprising a control cable extending distally from the motor, the control cable having a lumen configured for receiving the drive shaft and the control wire therein.

69. The implantable modular impeller device according to claim 67, further comprising a control cable extending proximally from the motor, the control cable having a lumen configured for receiving the control wire therein.

70. The implantable modular impeller device according to claim 55, further comprising an anchor configured for anchoring the implantable modular impeller device in a lumen of a body conduit, the anchor surrounding at least partially the impeller hub module.

71. The implantable modular impeller device according to claim 70, wherein the control wire passes through a portion of the anchor.

72. The implantable modular impeller device according to claim 70, wherein the impeller vane module is configured for passing through a portion of the anchor in an expanded configuration upon actuation of the control wire.

73. The implantable modular impeller device according to claim 55, comprising two impeller vane modules and two control wires, a first one of the two control wires actuatable for mating the first one of the two impeller vane modules with the impeller hub module, and a second one of the two control wires actuatable for mating the second one of the two impeller vane modules with the impeller hub module.

74. The implantable modular impeller device according to claim 73, wherein the two control wires are simultaneously actuatable.

75. The implantable modular impeller device according to claim 55, wherein the implantable modular impeller device is implantable via a sheath.

76. The implantable modular impeller device according to claim 55, wherein the impeller hub module and the impeller vane module are arrangeable substantially in series when unmated from one another and both received in a sheath.

77. The implantable modular impeller device according to claim 55, wherein the impeller hub module and the impeller vane module are mateable in a lumen of a body conduit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0086] For a better understanding of the present technology, as well as other aspects and further features thereof, reference is made to the following description, which is to be used in conjunction with the accompanying drawings, where:

[0087] FIG. 1A is a prior art expandable impeller as shown in FIG. 1A of McBride et al. and described therein.

[0088] FIG. 1B is a prior art expandable impeller as shown in FIG. 1B of McBride et al. and described therein.

[0089] FIG. 2 is a prior art expandable impeller as shown in FIG. 2 of McBride et al. and described therein.

[0090] FIG. 3A is a prior art expandable impeller as shown in FIG. 3A of McBride et al. and described therein.

[0091] FIG. 3B is prior art expandable impeller as shown in FIG. 3B of McBride et al. and described therein.

[0092] FIG. 4 is an isometric view of a percutaneously transcatheterly implantable intravascular blood pump being a first embodiment of the present invention, taken from the distal end thereof.

[0093] FIG. 5 is another isometric of the blood pump of FIG. 4.

[0094] FIG. 6 is an isometric view of the impeller hub module of the blood pump of FIG. 4, taken from the distal end thereof.

[0095] FIG. 7 is an isometric view of a first impeller vane module of the blood pump of FIG. 4, taken from the distal end thereof.

[0096] FIG. 8 is an isometric view of the first impeller vane module of FIG. 7, taken from the proximal end thereof.

[0097] FIG. 9 is view of a single implantable unit (motor housing, impeller hub, anchor) and two impeller vane units in an unassembled configuration of the blood pump of FIG. 4, within a delivery sheath (with the anchor being in the compact configuration), with part of the delivery sheath having been cut away to show the components inside.

[0098] FIG. 10 is an isometric view of the blood pump of FIG. 4, taken from the distal end thereof, with both of the impeller pump modules in an unassembled configuration.

[0099] FIG. 11 is an isometric view of the anchor of the blood pump of FIG. 4, in its expanded configuration, taken from the distal end thereof.

[0100] FIG. 12 is an isometric view of the anchor of the blood pump of FIG. 4, in its compact configuration, taken from towards the proximal end thereof.

[0101] FIG. 13 is a side elevation view of the impeller hub module and a first impeller vane module of the blood pump of FIG. 4, in an unassembled configuration.

[0102] FIG. 14 is an isometric view of blood pump of FIG. 4, with the first impeller vane being pulled towards its assembled configuration.

[0103] FIG. 15 is an isometric close-up view of the proximal end of the first impeller vane module and the proximal end of the impeller hub module as the first impeller vane module is approaching its assembled configuration.

[0104] FIG. 16 is a side elevation view of the impeller hub module and the first impeller vane module of the blood pump of FIG. 4, in the assembled configuration, with second impeller vane (not shown) being in an unassembled configuration.

[0105] FIG. 17 is an isometric view of the blood pump of FIG. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.

[0106] FIG. 18 is another isometric view of the blood pump of FIG. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.

[0107] FIG. 19 is still another isometric view of the blood pump of FIG. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.

[0108] FIG. 20 is a plan view of the distal end of the fully assembled impeller shown in FIGS. 18 & 19.

[0109] FIG. 21 is a side elevation view of the blood pump of FIG. 4 with the fully assembled impeller shown in FIGS. 18 & 19.

[0110] FIG. 22 is a side elevation view of the blood pump of FIG. 4, similar to FIG. 21, but with the housing of the drive unit and the control cable being shown as transparent.

[0111] FIG. 23 is a schematic view of the distal end of the first control wire and the interior of the first impeller vane unit.

DETAILED DESCRIPTION OF SOME EMBODIMENTS AND IMPLEMENTATIONS

Introduction

[0112] Referring to FIGS. 4 and 5, there is shown a mammalian body implantable fluid flow influencing device 100, which is one embodiment of the present technology. It is to be expressly understood that the device 100 is merely one embodiment, amongst many, of the present technology. Other embodiments are also described hereinbelow. Thus, the description thereof that follows is intended to be only a description of illustrative examples of the present technology. This description is not intended to define the scope or set forth the bounds of the present technology. In some cases, what are believed to be helpful examples of modifications to the device 100 and/or other embodiments may also be set forth hereinbelow. This is done merely as an aid to understanding, and, again, not to define the scope or set forth the bounds of the present technology. These modifications are not an exhaustive list, and, as a skilled addressee would understand, other modifications are likely possible. Further, where this has not been done (i.e., where no examples of modifications have been set forth), it should not be interpreted that no modifications are possible and/or that what is described is the sole manner of implementing that element or feature of the present technology. As a skilled addressee would understand, this is likely not the case. In addition, it is to be understood that the device 100 may provide in certain instances a simple embodiment of the present technology, and that where such is the case it has been presented in this manner as an aid to understanding. As a skilled addressee would understand, various embodiments of the present technology are of a greater complexity.

Additional Information & Incorporations-by-Reference

[0113] Device 100 is a percutaneously transcatheterly implantable intravascular blood pump, which may be used as a ventricular assist device (a “VAD”). As a skilled addressee would understand, percutaneously transcatheterly implantable intravascular blood pumps are well known in the art. Thus, for purposes of brevity, no has been made to describe herein details of the device 100 (or other embodiments of the present technology) with which the skilled addressee would be familiar. However, to facilitate understanding of such devices (e.g., by readers not skilled in the art), reference may be had to one or more of the following patent documents, which are incorporated herein by reference in their entirety for all purposes: [0114] U.S. Pat. No. 4,625,712 (Wampler), issued Dec. 2, 1986, entitled “High-Capacity Intravascular Blood Pump Utilizing Percutaneous Access”; [0115] U.S. Pat. No. 7,022,100 B1 (Aboul-Hosn et al.), issued Apr. 4, 2006, entitled “Guidable Intravascular Blood Pump and Related Methods”; [0116] U.S. Pat. No. 7,070,555 B2 (Siess), issued Jul. 4, 2006, entitled “Intracardiac Blood Pump”; [0117] U.S. Pat. No. 7,393,181 B2 (McBride et al.), issued Jul. 1, 2008, entitled “Expandable Impeller Pump”; [0118] U.S. Pat. No. 7,841,976 B2 (McBride et al.), issued Nov. 30, 2010, entitled “Heart Assist Device with Expandable Impeller Pump”; [0119] U.S. Pat. No. 7,998,954 B2 (Bollin), issued Aug. 16, 2011, entitled “Implantable Heart Assist System and Method of Applying Same”; [0120] U.S. Pat. No. 9,421,311 B2 (Tanner et al.), issued Aug. 23, 2016, entitled “Motor Assembly for Catheter Pump”; [0121] U.S. Pat. No. 9,446,179 B2 (Keenan et al.), issued Sep. 20, 2016, entitled “Distal Bearing Support”; [0122] U.S. Pat. No. 9,872,947 B2 (Keenan et al.), issued Jan. 23, 2018, entitled “Sheath System for Catheter Pump”; [0123] U.S. Pat. No. 10,478,538 B2 (Scheckel et al.), issued Nov. 19, 2019, entitled “Flexible Catheter with a Drive Shaft”; [0124] U.S. Pat. App. Pub. No. 2010/0268017 A1 (Siess), published Oct. 21, 2010, entitled “Intracardiac Pumping Device”; [0125] U.S. Pat. App. Pub. No. 2011/0004046 A1 (Campbell et al.), published Jan. 6, 2011, entitled “Blood Pump with Expandable Cannula”; [0126] U.S. Pat. App. Pub. No. 2012/0101455 A1 (Liebing), published Apr. 26, 2012, entitled “Shaft Arrangement Having a Shaft Which Extends within a Fluid-Filled Casing”; [0127] U.S. Pat. App. Pub. No. 2012/0172655 A1 (Campbell et al.), published Jul. 5, 2012, entitled “Impeller Housing for Percutaneous Heart Pump”; [0128] U.S. Pat. App. Pub. No. 2012/0178985 A1 (Walters et al.), published Jul. 12, 2012, entitled “Percutaneous Heart Pump”; [0129] U.S. Pat. App. Pub. No. 2012/0178986 (Campbell et al.), published Jul. 12, 2012, entitled “Percutaneous Heart Pump”; [0130] U.S. Pat. App. Pub. No. 2016/0256620 A1 (Scheckel et al.), published Sep. 8, 2016, entitled “Flexible Catheter with a Drive Shaft”; and [0131] U.S. Pat. App. Pub. No. 2020/0330665 A1 (Josephy et al.), published Oct. 22, 2020, entitled “Cooled Mechanical Circulatory Support System and Method of Operation”.

[0132] The above list is not intended to be a complete list for any purpose. It is only intended to provide some examples of some documents believed to be useful. Percutaneously transcatheterly implantable intravascular blood pumps have been described in the literature at least since the 1980's, and thus there are many documents that might be helpful that are not set forth above.

[0133] In addition, the following patent documents commonly owned by the assignee of the present application are also incorporated herein by reference in their entirety for all purposes. These documents may also provide additional background, especially to the unskilled reader: [0134] Int'l. Pat. App. Pub. No. WO 2020/198765 A2 (Puzzle Medical Devices Inc.), published Oct. 1, 2020, entitled “Modular Mammalian Body Implantable Fluid Flow Influencing Device and Related Methods”; and [0135] Int'l Pat. App. No. PCT/US2021/012083 (Puzzle Medical Devices Inc, et al.), filed Jan. 4, 2021, entitled “Mammalian Body Conduit Intralumenal Device and Lumen Wall Anchor Assembly, Components Thereof and Methods of Implantation and Explantation Thereof”.

General

[0136] At a high level, device 100, has the following major components: an axial impeller 104, a drive unit 120, and an anchor 126. Device 100 also has a control cable 134 extending proximally from the proximal end of the drive unit 120, and a proximal end unit 136 at the proximal end of the control cable 134. Each of the foregoing components is discussed in further detail hereinbelow.

[0137] The device 100 being a percutaneously transcatheterly implantable intravascular blood pump, in use, when appropriately implanted within the vasculature of a patient, is operable to increase the patient's native blood flow rate. Typically, the device is employed as a VAD or a cardiac assist device in cases where the patient's heart is unable to pump a sufficient amount of blood on its own to provide enough blood flow to their peripheral organs (in the case of the left heart) or to their lungs (in the case of the right heart).

Impeller

[0138] Referring to FIGS. 18 and 19 in particular, the impeller 104 of the device 100 has a central hub 105 and two vanes 114a, 114b projecting outward from the hub 105. The impeller 104 is considered axial impeller, in view of its overall dimensions and as the fluid being pumped by the impeller is pushed by the vanes generally in a direction parallel to the longitudinal axis of the impeller 104 (e.g., an axis colinear with the longitudinal axis 138 of the device 100—hereinafter, for ease of understanding, the longitudinal axes of the impeller 104, the device 100, the impeller hub module 106, and the impeller hub 105 are all colinear in this embodiments and are all thus labeled as 138).

[0139] As would be understood by the skilled addressee, in most embodiments, the entirety of the flow fluid generated by axial impellers is not axial, there is some radial component. The presence of such radial component is generally tolerable and does not mean that the impeller in question is not an axial impeller.

[0140] Impeller 104 is a modular impeller. Thus, impeller 104 is made of different modules that are separate structures from one another, but that are combinable together (e.g., assemblable) in vivo to make a complete, fully operational impeller 104. In FIGS. 18 and 19, the assembled fully-operational impeller 104 is shown. In this embodiment, the impeller 104 has three separate modules, one impeller hub module 106 and two impeller vane modules (i.e., a first impeller vane module 110a and a second impeller vane module 110b).

[0141] The impeller hub module 106 is shown by itself in FIG. 6. As can be seen in FIG. 6, the impeller hub module 106 is elongate body generally having the form of a right circular cylinder. Thus, a cross-section of the impeller hub module 106 taken in a plane perpendicular to the longitudinal axis 138 would be a circle were it not for the present of the impeller hub module connectors 150a, 150b (described hereinbelow); and, this is the case for cross-sections taken anywhere along the longitudinal axis 138 (in this embodiment).

[0142] The impeller hub module has a distal end 148 and a proximal end 166. In the context of the present specification, the terms “distal” and “proximal” are defined with respect to the location at which the surgeon is accessing the vasculature of the of the patient into which the device is being implanted. Thus, “distal” is further from the surgeon, and “proximal” is closer to the surgeon. The distal end of a component enters the body of the patient before the proximal end in this embodiment.

[0143] The impeller hub module 106 has two impeller hub module connectors, a first impeller hub module connector 150a associated with the first impeller vane module 110a and a second impeller hub connector 150b associated with the second impeller vane module 110b. In this embodiment, the first impeller hub module connector 150a and the second impeller hub module connector 150b are identical. (This is not the case in all embodiments, as in some embodiments each of the impeller hub module connectors are not identical.)

[0144] As can be well seen in FIG. 6, each impeller hub module connector 150a, 150b is accessible and viewable from the exterior of the impeller hub module 106. Each impeller hub module connector 150a, 150b has a channel 152a, 152b that extends parallel to the longitudinal axis 138 of the device 100 (and the longitudinal axis 138 of the impeller hub module 106 itself). In this embodiment, each channel 152, 152b, is generally circular in cross section (albeit with a small arc missing), as can be seen in FIG. 6. The ends 155a, 157a of the missing arc the plane perpendicular to the longitudinal axis 138, when joined together by a line 159a, form a segment of the circle in that plane that has a length that is less than the diameter of that circle.

[0145] Each channel 152a, 152b has a proximal end (not labelled) at the proximal end 166 of the impeller hub module 106 and a distal end (not labelled) at the distal end 148 of the impeller hub module 106. Each proximal end is a “wall” (e.g., a generally planar surface) 160a, 160b that is perpendicular to the longitudinal axis 138. In each wall are located a passage 164a, 164b (through a control wire 116a, 116b (respectively) will pass—as is described in further detail below) and the cavity 162a, 162b of a secondary connector 189a, 189b which will also be described hereinbelow. The distal end of each channel 152a, 152b is an opening 154a, 154b. As the distal end 148 of the impeller hub module 106 has a tapered portion 146 (e.g., see FIG. 6), the distal opening 154a, 154b of each channel 152a, 152b are sloped as they extend through the tapered portion 146. Each channel 152a, 152b, thus forms a socket of a dovetail joint, as is further described hereinbelow. Finally, extending on each side of each channel 152a, 152b, is a longitudinally extending shelf 156a, 158a (on the sides of channel 152a), 156b, 158b (on the sides of channel 152b).

[0146] In this embodiment, the impeller hub module 106 is made of titanium. In other embodiments, the impeller hub module 106 is made of any other suitable medical grade material (or combination of materials) including composites, metals, alloys or plastics (e.g., PEEK). The impeller hub module 106 is manufactured using conventional techniques appropriate to the material(s) of which it is made.

[0147] Referring now to FIGS. 7 and 8, the first impeller vane module 110a is shown. (In this embodiment, the second impeller vane module 110b is identical to the first impeller vane module 110a and thus, will not be specifically described herein. (In other embodiments this is not the case.)) The first impeller vane module 110a is an elongate structure having a proximal end 182a and a distal end 184a. The first impeller vane module 110a has a base 112a, an impeller vane 114a projecting from the base 112a and a first impeller vane module connector 118a extending from the side of the base 112a opposite to that one from which the impeller vane 114a projects. Each of the base 112a, the impeller vane 114a, and the first impeller vane module connector 118a extends the entire length of the impeller vane module 110a from the proximal end 182a to the distal end 184a in this embodiment.

[0148] Referring to FIG. 8, in this embodiment, the first impeller vane module connector 118a is generally a right circular cylinder portion 193a of which is connected to the base 112a of the first impeller vane module 110a. A segment 195a of a cross-section of the circle 191a formed by the proximal end 182a wall 186a in a plane perpendicular the longitudinal axis 138 is formed by the line jointing the intersections (194a, 196a) of the circle 191a with the connecting portion 193a. At the center of the circle 191a is a passage 190a leading inside the connector 118a. As will be discussed further below, the passage 190a is for the control wire 116a. Also, projecting proximally from the proximal end 182a wall 186a are detents 188a that form the part of a secondary connector 189a that is disposed on the first impeller vane module 110a. Finally, the distal end 184a has a sloped face 180a (with respect to the longitudinal axis 138)

[0149] In this embodiment, the base 112a and the first impeller vane module connector 118a are dimensioned and shaped to complete the part of the hub 105 of the impeller hub module 106 that is “missing” because of the presence of the impeller hub module connector 150a. Thus, the length of the first impeller vane module 110a is the same as the length of the first impeller hub module connector 150a. The first impeller vane module connector 118a has a diameter just slightly smaller than the diameter of the channel 152a, and the length of the segment 159a is just slightly smaller than the length of the segment 195a. The base 112a has a shape that conforms to both the shelves 156a, 158a and to the outer surface 140 of the impeller hub module 106.

[0150] In this embodiment, the impeller vane modules 110a, 110b are each made of titanium. In other embodiments, the impeller vane modules 110a, 110b are made of any other suitable medical grade material (or combination of materials) including composites, metals, alloys or plastics (e.g., PEEK). The impeller vane modules 110a, 110b are manufactured using conventional techniques appropriate to the material(s) of which they are made.

[0151] Units of the device 100 to be implanted within the patient's body (e.g., the impeller vane modules 110a, 110b, the single implantable unit 102 (the impeller hub module 106 and the motor housing 120)) are dimensioned and shaped to be deliverable through the vasculature of the patient's body via a catheter (e.g., a delivery sheath 198). Depending on the particular patient and the particular delivery site, the maximum size of the catheter that may be used in a particular transcatheter procedure varies. Thus, the surgeon has to select a catheter sized such that the catheter will pass through the minimum available cross-section of the blood vessels of the patient along the path to the delivery site. So, for example, if it were determined that a 12 Fr (4 mm) catheter was to be used in a particular procedure, any units of the device 100 to be delivered through that catheter must be designed such that their dimensions and shapes permit them to be delivered through a catheter of 12 Fr. Thus, the diameter of the minimum-bounding right circular cylinder of each one of those units can be no greater than 4 mm (its radius no greater than 2 mm). In this embodiment, the diameter of the minimum-bounding right circular cylinder of each one of the impeller vane modules 110a, 110b, the impeller hub module 106, and the motor housing 120 (combined to make the single implantable unit 102) is slightly less than 4 mm, so they would be able to be used in the above exemplary procedure. Thus, the diameter of the impeller 104, once assembled, will be larger than 4 mm, without being expendable.

[0152] To connect the first impeller vane module 110a to the impeller hub module 106, the proximal end 182a of the first impeller vane module connector 118a of the first impeller vane module 110a is slidden into the channel 152a of the first impeller hub module connector 150a via the distal opening 154a at the distal end 148 of the impeller hub module 106. When the first impeller vane module connector 118a is fully slidden into the channel 152a of the first impeller hub module connector 150a, the proximal end wall 186a at the proximal end of the first impeller vane module 110a registers completely with the proximal end wall 160a of the proximal end of the channel 152a. The first impeller vane module connector 118a acts as the tail in the sliding dovetail connection (with, as was described above, the channel 152a of the first impeller hub connector module 106 acting as the socket). This arrangement results because the outer diameter of the right circular cylinder of the first impeller vane module connector 118a is greater than the length of the segment 159a. Thus, during normal operation of the device, when the impeller 104 is rotating, the first impeller vane module 110a can neither be pulled nor pushed away from its assembled configuration in a direction perpendicular to (or having a component that is perpendicular to) the longitudinal axial 134 of the impeller hub module 106.

[0153] Again, when the first impeller vane connection module 118a is fully slidden into the channel 152a until its assembled configuration, the detents 188a of the secondary connector 189a on the first impeller vane module 118a are inserted into and releasably secured within the cavity 162a of the second connector 189a on the end wall 162a of the first impeller hub module connector 150a. Thus, during normal operation of the device, when the impeller 104 is rotating, the first impeller vane module 110a cannot be slidden out of its assembled configuration either.

[0154] Again, when the first impeller vane module connector 118a is fully slidden into the channel 152a into its assembled configuration, a portion 192a of the outer surface of the base 112a of the first impeller vane module is shaped to align with and complete the outer surface 140 of the impeller hub module 106, such that the impeller hub 105 (but for the vanes) has the shape of a right circular cylinder. And, the sloped face 180a of the distal end 184a of the first impeller vane module 110a aligns with and completes the tapered portion 146 of the distal end 148 of the impeller hub module 106.

[0155] Each of the impeller vane modules 110a, 110b has a center of mass (not shown). The impeller hub module 106 also has a center of mass (not shown), which is located along the longitudinal axis 138 of the impeller hub module 106. The impeller vane modules 110a, 110b are designed (e.g., size, shape, materials of construction, vane design, etc.) such that when the first impeller vane module connector 118a is fully slidden into the channel 152a into its assembled configuration and when the second impeller vane module 118b is fully slidden into the channel 152b into its assembled configuration (e.g., in FIGS. 18 and 19), the center of mass (not shown) of the assembled impeller 104 is located same location as (i.e., is coincident with) the center of mass of the impeller hub module 106. Thus, in this embodiment, the centers of mass of the impeller vane modules 110a, 110b are all equally angularly spaced (i.e., at 180° degrees from one another) around the axis of rotation (i.e., the longitudinal axis 138) of the impeller 104 in a plane perpendicular to the axis 138 containing the center of mass of the impeller hub module 106. And, the centers of mass of the impeller vane modules 110a, 110b are equally radially distant from the axis 138 of the impeller hub module 106 in that plane. In this manner the impeller 104 will be mass balanced, which is optimal for its rotation.

Drive Unit

[0156] Referring to FIG. 21, attached to the impeller hub module 106 is a drive unit 120. The drive unit 120 has a housing 122 containing an electric motor 176 and a drive shaft 174. The electric motor 176 drives the drive shaft 174, and the drive shaft 174 drives the impeller 104. In this embodiment, the housing 122 an elongate generally right circular cylindrical in shape, having a diameter which is generally the same as the diameter of the impeller hub module 106 (and thus the hub 105 of the impeller 104). In this embodiment the impeller hub module 106 and the drive unit 120 are connected together to form single implantable unit 102 (as they are implanted and explanted as a single unit in this embodiment).

[0157] At the proximal end 121 of the drive unit 120, extending proximally, is a control cable 134. The control cable 134 is hollow, having a lumen 172 therein. The lumen 172 communicates with the interior of the housing 122 containing the motor 176. Electrical wiring 178 for providing electricity to power the motor 176 extends from the motor 176 through the cavity of the housing 122 and then through the lumen 172 of the control cable 134 to the proximal end unit 136 of the device 100, where the wiring can be put into electric communication with an appropriate power source. The control cable 134 is of a conventional design.

Anchor

[0158] Referring to FIGS. 17, 18, 19, and 20, attached to the housing 122 of the drive unit 120 is a wire network anchor 126. In this embodiment, anchor 126 is a wire network having a compact configuration and an expanded configuration. In the expanded configuration, the anchor 126 exerts a force on the walls of the conduit into which the device 100 has been implanted. That force is sufficient to anchor the device 100 in place within the conduit when the device is being assembled, disassembled, and operating normally. Further, in the expanded configuration the wire network is sized and dimensioned such that the impeller 104 is able to rotate during normal operation of the device 100 without contacting the wire network (or any other part of the anchor 126) nor the conduit itself.

[0159] The wire network 126 has three different groups of wires. It is the second group of wires 128 that abut up against the walls of the conduit into which the device has been implanted in order to secure the device 100 in place. As can be seen in the Figs., in this embodiment when the anchor 126 is in the expanded configuration the wires of the second group 128 generally surround the impeller 104.

[0160] Proximal to the wires of the second group 128 are wires of the first group 129. At their distal end (unlabeled), wires of the first group 129 connect to and extend proximally from the wires of the second group 128. At their proximal end (unlabeled) wires of the first group 129 are connected to a metal band 124 that is non-moveably affixed to the housing 122 of the drive unit 102. The housing 122 of the drive unit 120 does not rotate when the device 100 is in operation and the impeller 104 is rotating.

[0161] Distal to the wires of the second group 128 are wires of the third group 130. At their proximal end (unlabeled), wires of the third group 130 connect to and extend distally from the wires of the second group 128. At the distal end (unlabeled) wires of the third group 130 are connected to a metal band 132 that is non-moveably affixed to the distal tip body 108. The distal tip body 108, rotatably holds the distal spindle 168 of the impeller hub module 106, allowing the impeller 104 to rotate without rotating the distal tip body 108. Referring to FIGS. 20 and 21, there are gaps 170a, 170b in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126 as will be explained in further detail hereinbelow.

[0162] In this embodiment, the anchor 126 is made of nitinol, which is a shape memory alloy. It is the “shape memory” of the nitinol which causes the bias of the wire network 126 of the anchor to its expanded configuration.

Control Wires

[0163] Referring to FIGS. 8, 9, 10, 13, 15, 16, 21, and 23 a first control wire 116a is attached to the first impeller vane module 110a and a second control wire 116b is attached to the second impeller vane module 110b.

[0164] Referring to FIGS. 8, 13 and 23, the distal end 117a of the first control wire 116a enters the interior of the first impeller vane module 110a through the hole 190a in the proximal end wall 186a of the proximal end 182a of first impeller vane module 110a. At the distal end 117a of the first control wire 116a there is a magnet 200a which is in magnetic connection with magnet 202a within the interior of the first impeller vane module 110a. The magnetic connection between magnet 200a and 202a releasably secures the distal end 117a of the first control wire 116a in place within the interior of the first impeller vane module 110a.

[0165] Referring particularly to FIG. 13, the first control wire 116a then extends proximally through the distal opening 154a into the channel 152a of the first impeller hub module connector 150a. Referring particularly to FIG. 15, the first control wire 116a then enters the opening 164a in the wall 160a at the proximal end of the first impeller hub module connector 150a. Finally, referring to FIG. 21, the first control wire 116a passes through a passage (not shown) which starts at the opening 164a in the wall 160a, passes through the body of the impeller hub module 106 and ends up at the very end of the proximal end 166 of the impeller hub module 106. The first control wire 116a then passes through the housing 122 of the drive unit 120 (from its distal end 123 to its proximal end 121) and passes into the lumen 172 of the control cable 134. The first control wire 116a finally passes through the control cable 134 and is accessible by the surgeon at the proximal end unit 136.

[0166] Similarly, the distal end 117b of the second control wire 116b enters the interior of the second impeller vane module 110b through the hole 190b in the proximal end wall 186b of the proximal end 182b of second impeller vane module 110b. At the distal end 117b of the second control wire 116b there is a magnet 200b which is in magnetic connection with magnet 202b within the interior of the second impeller vane module 110b. The magnetic connection between magnet 200b and 202b releasably secures the distal end 117b of the second control wire 116b in place within the interior of the second impeller vane module 110b.

[0167] The second control wire 116b then extends proximally through the distal opening 154b into the channel 152b of the second impeller hub module connector 150b. The second control wire 116b then enters the opening 164b in the wall 160b at the proximal end of the second impeller hub module connector 150b. Finally, referring to FIG. 21, the second control wire 116b passes through a passage (not shown) which starts at the opening 164b in the wall 160b, passes through the body of the impeller hub module 106 and ends up at the very end of the proximal end 166 of the impeller hub module 106. The first control wire 116b then passes through the housing 122 of the drive unit 120 (from its distal end 123 to its proximal end 121) and passes into the lumen 172 of the control cable 134. The second control wire 116b finally passes through the control cable 134 and is accessible by the surgeon at the proximal end unit 136.

Implantation, Operation & Explantation of the Device

[0168] Device 100 can be transcatheterly implanted and explanted using standard conventional techniques. (The WO '765 Publication provides a very detailed description of such techniques, and they are not repeated herein for the sake of brevity.).

[0169] As the skilled addressee would be aware, the implantation of device 100 typically starts with device 100 being inside a loader. Although FIG. 9 shows device 100 inside a delivery sheath 198 (being particular type of catheter), the device 100 when inside a loader would look essentially the same. In FIG. 9, the distal end of the loader (198) is on the right of the figure and the proximal end of the loader (198) is on the left of the figure. Closest to the distal end of the loader (198) is the second impeller vane module 110b. The second impeller vane module 110b has the same orientation in the loader (198) as the device 100 itself. Thus, the distal end 184b of the second impeller vane module 110b is closest to the distal end of the loader (198). When in the loader, the second impeller vane module 110b is in an unassembled configuration with respect to the impeller hub module 106.

[0170] Immediately proximal to the second impeller vane module 110b in the loader (198) is the first impeller vane module 110a. The first impeller vane module 110a has the same orientation in the loader (198) as the device 100 itself. Thus, the distal end 184a of the first impeller vane module 110a is adjacent the proximal end 182b of the second impeller vane module 110b. When in the loader (198), the second impeller vane module 110a is in an unassembled configuration with respect to the impeller hub module 106.

[0171] Immediately proximal to the first impeller vane module 110b is the single implantable unit 102, which combines the impeller hub module 106 and the drive unit 120. The single implantable unit 102 has the same orientation in the loader (198) as the device 100 itself. Thus, the distal end 148 of the impeller hub module 106 is adjacent the proximal end 182a of the first impeller vane module 110a. The proximal end 121 of the drive unit 120 is closest to the proximal end of the loader (198). The control cable 134 extends proximally from the proximal end 121 of the drive unit 120 to the proximal end unit 136. The wire network anchor 126 is in its collapsed configuration within the loader (198).

[0172] The second control wire 116b extends from the proximal end 182b of the second impeller vane module 110b, passes by the first impeller vane module 110a, passes into the channel 152b of the second impeller hub connector 150b of the impeller hub module 106, extends through the housing 122 of the drive unit 120, enters the lumen 172 of the control cable 134 and extends to the proximal end unit 136 of the device 100. Similarly, the first control wire 116a extends from the proximal end 182a of the first impeller vane module 110a, passes into the channel 152a of the first impeller hub connector 150a of the impeller hub module 106, extends through the housing 122 of the drive unit 120, enters the lumen 172 of the control cable 134 and extends to the proximal end unit 136 of the device 100.

[0173] As a non-limiting example, in a device 100 to be implanted in a patient to provide left heart support, the delivery site of the device 100 may be within thoracic descending aorta. Thus, at a high level and broadly speaking, the device 100 can be implanted by the surgeon in the following manner by: (1) Obtaining access to the femoral artery of the patient (e.g., via the well-known Seldinger technique). (2) Guiding a delivery sheath 198 to the delivery site (e.g., using a conventional guidewire and railing the delivery sheath 198 along the guidewire). (3) Inserting the impeller vane modules 110b, 110a in their unassembled configuration distal end 184b, 184a first into the delivery sheath 198 in series one after another (e.g., from a loader in which they are in the configuration described above). (4) Inserting the single implantable unit 102 (which includes impeller hub module 106) into the delivery sheath 198 (e.g., again from a loader in which the single implantable unit 102 is in the configuration described above). (5) Guiding the impeller vane modules 110b, 110a and the single implantable unit 102 within the delivery sheath 198 to the delivery site. (6) Promoting exit of the impeller vane modules 110b, 110a from the delivery sheath 198 at the delivery site (e.g., by partially withdrawing the delivery sheath 198 while keeping the impeller vane modules 110b, 110a in place (e.g., via their control wires 116b, 116a). (7) Promoting exit of the single implantable unit 102 from the delivery sheath 198 at the delivery site. In the embodiment of the device 100 described above, this causes the wire network anchor 126 to adopt its expanded configuration, anchoring the single implantable unit 102 (of which the impeller hub module 106 is a part) in place. (8) Withdrawing the delivery sheath 198 from the body.

[0174] In the next part of the implantation process, the impeller 104 of the device 100 is assembled in vivo at the delivery site. FIG. 10 illustrates the configuration of the device 100 just after delivery as described hereinabove. The surgeon then manipulates the first control wire 116a of the first impeller vane module 110a to bring the first impeller vane module 110a into its assembled configuration with respect to the impeller hub module 106. As can be well seen in FIGS. 20 & 21, when the wire network of the anchor 126 is in its expanded configuration gaps 170a, 170b are formed in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126. Thus, the surgeon pulls the first control wire 116a of the first impeller vane module 110a to move the first impeller vane module 110a from a position outside of and distal to the wire network of the anchor 126 to a position where the first impeller vane module 110a starts to move through the gap 170a and starts to slide into its assembled configuration. Specifically, the right circular cylinder portion 193a of the first impeller vane module connector 118a enters the opening 154a of the channel 152a of the first impeller hub module connector 150a. As the surgeon continues to pull the first control wire 116a, the first impeller vane module 110a continues to slide closer to the proximal end wall of 160a of the first impeller hub module connector 150a. Thus, the right circular cylinder portion 193a of the first impeller vane module connector 118a continues to travel within the channel 152a of the first impeller hub module connector 150a. Referring now to FIG. 15, eventually the detent 188a of the secondary connector 189a projecting from the proximal end wall 186a enters the cavity 162a of the secondary connector 189a and is releasably retained therein. At this point, the proximal end wall 186a of the proximal end 182a of the first impeller vane module 110a completely abuts the proximal end wall 160a of the first impeller hub connector 150a. At this point, first impeller vane module 110a is in its assembled configuration with respect to the impeller hub module 106. The first impeller vane module 110a is retained in its assembled configuration as a result of the dovetail joint formed by the right circular cylinder portion 193a of the first impeller vane module connector 118a and the channel 152a of the first impeller hub module connector 150a, and as a result of the detent 188a of the secondary connector 189a being retained in the cavity 162a.

[0175] Next, the surgeon manipulates the second control wire 116b of the second impeller vane module 110b to bring the second impeller vane module 110b into its assembled configuration with respect to the impeller hub module 106. Referring again to FIGS. 20 & 21, when the wire network of the anchor 126 is in its expanded configuration gaps 170a, 170b are formed in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126. Thus, the surgeon pulls the second control wire 116b of the second impeller vane module 110b to move the second impeller vane module 110b from a position outside of and distal to the wire network of the anchor 126 to a position where the second impeller vane module 110b starts to move through the gap 170b and starts to slide into its assembled configuration. Specifically, the right circular cylinder portion 193b of the second impeller vane module connector 118b enters the opening 154b of the channel 152b of the second impeller hub module connector 150b. As the surgeon continues to pull the second control wire 116b, the second impeller vane module 110b continues to slide closer to the proximal end wall of 160b of the second impeller hub module connector 150b. Thus, the right circular cylinder portion 193b of the second impeller vane module connector 118b continues to travel within the channel 152b of the second impeller hub module connector 150b. Referring now to FIG. 15, eventually the detent 188b of the secondary connector 189b projecting from the proximal end wall 186b enters the cavity 162b of the secondary connector 189b and is releasably retained therein. At this point, the proximal end wall 186b of the proximal end 182b of the second impeller vane module 110b completely abuts the proximal end wall 160b of the second impeller hub connector 150b. At this point, second impeller vane module 110b is in its assembled configuration with respect to the impeller hub module 106. The second impeller vane module 110b is retained in its assembled configuration as a result of the dovetail joint formed by the right circular cylinder portion 193b of the second impeller vane module connector 118b and the channel 152b of the second impeller hub module connector 150b, and as a result of the detent 188b of the secondary connector 189b being retained in the cavity 162b.

[0176] As can be well seen in FIGS. 17 to 19, when each of the first impeller vane module 110a and the second impeller vane module 110b is retained in its assembled configuration, the impeller 104 is fully assembled. Further, the outer surface 140 of the impeller hub module 106 is complete such that the impeller hub 105 (but for the vanes 114a, 114b) has the shape of a right circular cylinder. The tapered portion 146 of the distal end 148 of the impeller hub module 106 is now complete as well.

[0177] The surgeon then pulls on the first control wire 116a with sufficient force to overcome the magnetic connection holding the first control wire 116a in place within the interior of the first impeller vane module 110a. Thus, magnet 200a becomes disconnected from magnet 202a. The surgeon continues to pull the first control wire 116a until the distal end 117a of the first control wire 116a including magnet 200a have exited the passage at the proximal end 166 of the impeller hub module 106. The distal end 117a of the first control wire 116a including magnet 200a are now within the housing 122 of the drive unit 120 at the distal end 123 of the drive unit 120. The distal end 117a of the first control wire 116a including magnet 200a remain in that position, completely clear of the impeller 104, during operation of the impeller 104. The impeller 104 is thus free to rotate without interference from the first control wire 116a and magnet 200a.

[0178] Finally, the surgeon pulls on the second control wire 116b with sufficient force to overcome the magnetic connection holding the second control wire 116a in place within the interior of the second impeller vane module 110b. Thus, magnet 200b becomes disconnected from magnet 202b. The surgeon continues to pull the second control wire 116b until the distal end 117b of the second control wire 116b including magnet 200b have exited the passage at the proximal end 166 of the impeller hub module 106. The distal end 117b of the second control wire 116b including magnet 200b are now within the housing 122 of the drive unit 120 at the distal end 123 of the drive unit 120. The distal end 117b of second the control wire 116b including magnet 200b remain in that position, completely clear of the impeller 104, during operation of the impeller 104. The impeller 104 is thus free to rotate without interference from the second control wire 116b and magnet 200b.

[0179] The impeller 104 and thus the device 100 are now operable. The operative of the device 100 is conventional.

[0180] In explanation of the device 100, the device 100 is first disassembled, by reversing the assembly process described above. Once the device has been disassembled it is conventionally retrieved using snare and a retrieval sheath as described in the WO '765 Publication.

MISCELLANEOUS

[0181] The present technology is not limited in its application to the details of construction and the arrangement of components set forth in the preceding description or illustrated in the drawings. The present technology is capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including”, “comprising”, or “having”, “containing”, “involving” and variations thereof herein, is meant to encompass the items listed thereafter as well as, optionally, additional items. In the description the same numerical references refer to similar elements.

[0182] It must be noted that, as used in this specification and the appended claims, the singular form “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0183] As used herein, the term “about” or “generally” or the like in the context of a given value or range (whether direct or indirect, e.g., “generally in line”, “generally aligned”, “generally parallel”, etc.) refers to a value or range that is within 20%, preferably within 10%, and more preferably within 5% of the given value or range.

[0184] As used herein, the term “and/or” is to be taken as specific disclosure of each of the two 10 specified features or components with or without the other. For example, “A and/or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0185] Modifications and improvements to the above-described implementations of the present technology may become apparent to those skilled in the art. The foregoing description is intended to be exemplary rather than limiting. The scope of the present technology is therefore intended to be limited solely by the scope of the appended claims.