Systems and methods for attaching a prosthesis with a body lumen or hollow organ
Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.
1. A tool for applying an implantation force to a helical fastener sized and configured for penetration in tissue comprising:
a tool body comprising internal threads;
a driven member carried by the tool body and operable to apply the implantation force;
a carrier on the driven member configured to couple the fastener to the driven member to transfer the implantation force from the driven member to the fastener, the carrier comprising a distal portion wherein the distal portion remains within the tool body during implantation of the fastener; and
wherein the tool is configured to operate in phases including:
an initial phase operating the carrier to partially implant the fastener into tissue such that a proximal portion of the fastener remains coupled to the carrier, wherein the proximal portion of the fastener is retained within the internal threads of the tool body at the end of the initial phase;
a lull phase interrupting operation of the carrier, wherein the fastener may be removed; and
a final phase operating the carrier to release the fastener therefrom and implant the fastener in tissue.
2. A tool according to claim 1 , wherein the tool requires a final phase command to advance from the lull phase to the final phase.
3. A tool according to claim 2 , wherein the driven member is also operable to apply a removal force to withdraw the fastener from tissue, and wherein the tool includes a removal phase operating the carrier to transfer the removal force to the fastener, the tool requiring a removal phase command different from the final phase command to advance from the lull phase to the removal phase.
4. A tool according to claim 3 , wherein the carrier is rotated in one direction to apply the implantation force and rotated in an opposite direction to transfer the removal force.
5. A tool according to claim 1 , further including an element tethering the fastener to the tool body, the element including a frangible portion.
6. A tool according to claim 1 , wherein the driven member is rotated to apply the implantation force.
7. A tool according to claim 1 , wherein the carrier comprises a distal portion having a configuration that corresponds to a configuration of a proximal end of the fastener, such that the proximal end of the fastener engages with the distal portion of the carrier to couple the fastener to the carrier throughout the initial phase.
8. A tool according to claim 7 , wherein the proximal end of the fastener comprises a leg portion that engages with the distal portion of the carrier throughout the initial phase.
9. A tool according to claim 1 , wherein the tool is configured to carry and deploy a single helical fastener at a time.
10. A tool according to claim 1 , wherein the tool is configured to rotatably drive the fastener into tissue.
11. A method for implanting a helical fastener in tissue comprising:
providing a tool as defined in claim 1 ;
coupling a helical fastener to the carrier;
accessing a tissue region;
operating the tool in the initial phase to partially implant the fastener in the tissue region;
deciding during the lull phase to commence the final phase; and
entering a final phase command to advance the tool from the lull phase to the final phase, thereby completing the implantation of the fastener in the tissue region.
12. A tool for applying an implantation force to a helical fastener sized and configured for penetration in tissue comprising:
a tool body comprising a tubular member comprising internal threads;
a driven member, disposed within the tubular member of the tool body and operable to apply the implantation force;
a carrier disposed on the driven member and within the tubular member of the tool body, the carrier configured to couple the fastener to the driven member to transfer the implantation force from the driven member to the fastener, the carrier comprising a distal portion having a configuration that corresponds to a configuration of a proximal end of the fastener wherein the distal portion remains within the tool body during implantation of the fastener, and
wherein the tool is configured to operate in phases including:
an initial phase operating the carrier partially to implant the fastener into tissue such that a proximal portion of the fastener is retained within the internal threads of the tool body at the end of the initial phase, wherein the proximal end of the fastener engages with the distal portion of the carrier to couple the fastener to the carrier throughout the initial phase,
a lull phase interrupting operation of the carrier, wherein the fastener may be removed, and
a final phase operating the carrier to release the fastener therefrom and implant the fastener in tissue.
13. A tool according to claim 12 , wherein the proximal end of the fastener comprises a leg portion that engages with the distal portion of the carrier throughout the initial phase.