Trans-aortic delivery system with containment capsule centering device
Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly which can include a first control mechanism, a second control mechanism, and a decoupling mechanism. The delivery systems can also include a delivery catheter extending from the handle assembly. The delivery catheter can include an outer shaft, which can be controlled by the first control mechanism; a prosthesis containing capsule comprising a proximal capsule portion connected to the outer shaft, and a distal capsule portion releasably coupled to the proximal capsule portion. After deploying a valve prosthesis, the capsule can be closed by activating the decoupling mechanism in the handle to rapidly close the distal and proximal capsule portions together. The delivery system can also include a centering element to guide the distal and proximal capsule portions together.
1. A prosthesis delivery system comprising:
a handle assembly comprising:
a first control mechanism; and
a second control mechanism;
a delivery catheter extending from the handle assembly, the delivery catheter comprising:
an outer shaft controlled by the first control mechanism;
a prosthesis containing capsule comprising:
a proximal capsule portion connected to the outer shaft; and
a distal capsule portion releasably coupled to the proximal capsule portion comprising:
a distal tip; and
a prosthesis containment sleeve;
an intermediate shaft, having a prosthesis retainer located at a distal end;
an inner shaft controlled by the second control mechanism and connected to the distal capsule portion; and
a centering element attached to the intermediate shaft, the centering element located proximally from the prosthesis retainer and having a collapsed configuration and an expanded configuration configured to guide the distal capsule portion and the proximal capsule portion together when closing the prosthesis containing capsule; and
a heart valve prosthesis located within the prosthesis containing capsule in a radially collapsed configuration, wherein with the heart valve prosthesis located within the prosthesis containing capsule, the centering element is in the collapsed configuration under the heart valve prosthesis.
2. The prosthesis delivery system of claim 1 , further comprising a safety mechanism connected to the first control mechanism, and configured to prevent proximal retraction of the outer shaft beyond a predetermined distance.
3. The prosthesis delivery system of claim 1 , wherein the prosthesis retainer comprises a proximal portion connected to the intermediate shaft, and a distal portion configured to create a compressible interference fit with the prosthesis containment sleeve.
4. The prosthesis delivery system of claim 1 , wherein the intermediate shaft is stationary such that the centering element is longitudinally stationary in the collapsed configuration and the expanded configuration.
5. The prosthesis delivery system of claim 1 , wherein the first and second control mechanisms are rotatable control knobs.
6. The prosthesis delivery system of claim 1 , wherein the centering element comprises a self-expanding frame attached to the intermediate shaft at either a proximal end or a distal end of the frame.
7. The prosthesis delivery system of claim 6 , wherein the self-expanding frame comprises a shape memory alloy.
8. The prosthesis delivery system of claim 6 , wherein the self-expanding frame comprises a plurality of nitinol wires.
9. The prosthesis delivery system of claim 1 , wherein the heart valve prosthesis is self-expanding.
10. The prosthesis delivery system of claim 1 , wherein the handle assembly further comprises a decoupling mechanism configured to decouple a decoupling portion of the handle assembly from a remainder of the handle assembly such that the decoupling portion may be translated proximally to move the inner shaft proximally.