Mammalian body conduit intralumenal device and lumen wall anchor assembly, components thereof and methods of implantation and explantation thereof

Abstract

Transcatheterly implantable mammalian body conduit intralumenal device and lumen wall anchor assembly. Anchor includes: wire network, connector positioning wires having a secured and a released position, and a connector disposed at end of each wire. Anchor has: a compact-secured-configuration, an expanded-secured-configuration, an expanded-released-configuration. When the anchor is in the expanded-secured-configuration, the wire network exerts a force on conduit lumen wall and the connector positioning wires are the in secured position. When the anchor is in the expanded-released-configuration, the connector positioning wires are in the released position, and do not obstruct fluid flow axially through conduit. Device includes an interconnector that allows for the releasable interconnector of the connectors thereto. Device and anchor assembly can be explanted from the conduit. Or, device can be released from the anchor at the implantation site and only the device explanted with the anchor remaining within the conduit.

1 . A mammalian body conduit intralumenal device and lumen wall anchor assembly, comprising:
 the mammalian body conduit intralumenal device configured to be deliverable to a delivery site within a lumen of a mammalian body conduit via a catheter; and   the anchor removably coupled to the intralumenal device via a control element, the control element configured to be removably coupled to the anchor, when the intralumenal device is located at the delivery site, such that an operator can manipulate the control element to transition the anchor between (1) a compact, secured configuration, in which the anchor is coupled to the intralumenal device and arranged to be delivered to the delivery site within the catheter, (2) a partially-expanded, secured configuration, in which the anchor is coupled to the intralumenal device and partially expanded to engage with and secure the intralumenal device to a wall of the lumen of the mammalian body conduit, and (3) an expanded, released configuration, in which the anchor is decoupled from the intralumenal device and expanded to engage with the wall of the lumen of the mammalian body conduit.   
     
     
         2 . The assembly of  claim 1 , wherein the anchor is formed of shape-memory material and biased towards the expanded, released configuration. 
     
     
         3 . The assembly of  claim 2 , wherein the anchor is configured to transition from the compact, secured configuration, to the partially-expanded, secured configuration as the anchor exits a lumen of the catheter but to remain coupled to the control element, and to transition from the partially-expanded, secured configuration, to the expanded, released configuration as the anchor is decoupled from the control element. 
     
     
         4 . The assembly of  claim 1 , wherein the control element includes a wire configured to be removably coupled to the anchor, removal of the wire from the anchor when the anchor is in the partially-expanded, secured configuration and engaged with the wall of the lumen of the mammalian body conduit allows the anchor to assume its expanded, released configuration. 
     
     
         5 . The assembly of  claim 4 , wherein a proximal end portion of the anchor includes three elongated elements, each defining at least one aperture configured to receive the wire of the control element to removably couple the wire to the anchor. 
     
     
         6 . The assembly of  claim 1 , wherein the control element includes three wires, and a proximal end portion of the anchor includes three elongated elements, each defining at least on aperture configured to receive one wire from the three wires to removably couple each respective wire to each respective aperture. 
     
     
         7 . The assembly of  claim 1 , wherein a proximal end portion of the anchor includes three elongated elements configured to be removably coupled to the control element, each elongate element movable from a position adjacent and circumferentially surrounding the intralumenal device when the anchor is in the partially-expanded, secured configuration, to a position spaced from the intralumenal device and approximating the wall of the lumen of the mammalian body conduit when the anchor is in the expanded, released configuration. 
     
     
         8 . The assembly of  claim 1 , wherein the mammalian body conduit intralumenal device is a blood pump. 
     
     
         9 . The assembly of  claim 8 , wherein the blood pump includes a dock and at least one functional unit housing an impeller, the functional unit being separably deliverable and dockable to the dock within the delivery site. 
     
     
         10 . The assembly of  claim 1 , wherein the anchor is configured to remain in the delivery site in its expanded, released configuration, with the intralumenal device removed from the mammalian body conduit, while permitting sufficient blood flow therethrough. 
     
     
         11 . The assembly of  claim 1 , wherein the control element is formed of an alloy, removal of the control element from the anchor when the anchor is in the partially-expanded, secured configuration and engaged with the wall of the lumen of the mammalian body allows the anchor to assume its expanded, released configuration. 
     
     
         12 . The assembly of  claim 1 , wherein the anchor is constrained into the partially-expanded, secured configuration by the control element when the control element is coupled to the anchor, the control element being configured to be released by an operator from the anchor to allow the anchor to self-transition from the partially-expanded, secured configuration to the expanded, released configuration. 
     
     
         13 . A body conduit intralumenal assembly, comprising:
 a lumen wall anchor including a connector element; and   an intralumenal device including an interconnector element releasably connectable to the connector element of the lumen wall anchor.   
     
     
         14 . The assembly of  claim 13 , wherein the connector element of the lumen wall anchor includes at least one connector positioner and at least one corresponding connector, the at least one connector positioner moveable between a secured position in which the at least one corresponding connector is releasably connected to the interconnector element of the intralumenal device and a released position in which the at least one corresponding connector is disconnected from the interconnector element of the intralumenal device. 
     
     
         15 . The assembly of  claim 14 , wherein the at least one connector positioner is overcomeably movably biased towards the released position. 
     
     
         16 . The assembly of  claim 14 , wherein the connector positioner is a connector positioning wire. 
     
     
         17 . The assembly of  claim 14 , wherein the interconnector element of the intralumenal device includes a body, an actuation rod longitudinally movable relative to the body, and a cap attached to the actuation rod, the cap longitudinally movable by the actuation rod relative to the body between a secured configuration in which the body and the cap are contiguous relative to one another and are releasably connected to the at least one corresponding connector when the at least one connector positioner is in the secured position, and a released configuration in which the body and the cap are spaced apart relative to one another and are disconnected from the at least one corresponding connector when the at least one connector positioner is in the released position. 
     
     
         18 . The assembly of  claim 17 , wherein the interconnector element of the intralumenal device further includes a hook in movable relationship with the cap,
 the at least one corresponding connector of the connector element of the lumen wall anchor including a loop releasably connectable with the hook.   
     
     
         19 . The assembly of  claim 14 , wherein the at least one corresponding connector of the connector element of the lumen wall anchor includes a hook, further wherein the interconnector element of the intralumenal device includes a body, an actuation rod longitudinally movable relative to the body, and a loop attached to the actuation rod, the loop longitudinally movable by the actuation rod relative to the body between a secured configuration in which the loop is disposed inside the body and is releasably connected to the hook when the at least one connector positioner is in the secured position, and a released configuration in which the loop is disposed outside the body and is disconnected from the hook when the at least one connector positioner is in the released position. 
     
     
         20 . The assembly of  claim 14 , wherein the at least one corresponding connector of the connector element of the lumen wall anchor includes a hole, further wherein the interconnector element of the intralumenal device includes a body and an interconnector wire longitudinally movable relative to the body between a secured configuration in which the interconnector wire is releasably connected to the hole when the at least one connector positioner is in the secured position, and a released configuration in which the interconnector wire is disconnected from the hole when the at least one connector positioner is in the released position. 
     
     
         21 . The assembly of  claim 13 , wherein the lumen wall anchor includes (i) a compact-secured configuration in which the lumen wall anchor is releasably connected to the intralumenal device and is configured for delivery to a delivery site within a lumen of a body conduit via at least one of a catheter procedure or a sheath procedure, (ii) an expanded-secured configuration in which the lumen wall anchor is releasably connected to the intralumenal device and is configured for anchoring to an implantation site within the lumen of the body conduit, and (iii) an expanded-released configuration in which the lumen wall anchor is configured for anchoring to the implantation site within the lumen of the body conduit, and the intralumenal device is released from the lumen wall anchor and is explantable from the implantation site. 
     
     
         22 . The assembly of  claim 13 , wherein the lumen wall anchor includes a 3D-shaped wire network. 
     
     
         23 . A body conduit intralumenal assembly, comprising:
 a lumen wall anchor including a first connector element and a second connector element; and   an intralumenal device including a first interconnector element releasably connectable to the first connector element of the lumen wall anchor and a second interconnector element releasably connectable to the second connector element of the lumen wall anchor.   
     
     
         24 . The assembly of  claim 23 , wherein the lumen wall anchor includes (i) a compact-secured configuration in which the first connector element of the lumen wall anchor is releasably connected to the first interconnector element of the intralumenal device and the second connector element of the lumen wall anchor is releasably connected to the second interconnector element of the intralumenal device such that the lumen wall anchor is configured for delivery to a delivery site within a lumen of a body conduit, (ii) an expanded-secured configuration in which the first connector element of the lumen wall anchor is releasably connected to the first interconnector element of the intralumenal device and the second connector element of the lumen wall anchor is disconnected from the second interconnector element of the intralumenal device such that the lumen wall anchor is configured for anchoring to an implantation site within the lumen of the body conduit; and (iii) an expanded-released configuration in which the first connector element of the lumen wall anchor is disconnected from the first interconnector element of the intralumenal device and the second connector element of the lumen wall anchor is disconnected from the second interconnector element of the intralumenal device such that the lumen wall anchor is configured for anchoring to the implantation site within the lumen of the body conduit, and the intralumenal device is released from the lumen wall anchor and is explantable from the implantation site.