Patent foramen ovale closure device with steerable delivery system
View Patent ↗The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.
1. A delivery system for deploying a medical device used to close a passageway in a body comprising:
a catheter shaft having a proximal and distal end;
a deflectable tissue piercing structure slideably engaged within the catheter shaft, the deflectable tissue piercing structure having a tubular shape defining a longitudinal axis, with luminal and abluminal surfaces and an open distal tip, at least a portion of the tissue piercing structure being deflectable relative to the longitudinal axis, the deflectable tissue piercing structure further comprising:
a tubular needle body along the proximal end of the tissue piercing structure; a tubular needle tip along the distal end of the tissue piercing structure, the needle tip terminating with a chamfered end;
a first longitudinal member forming a needle tang that attaches to the distal end of the catheter shaft to form a tab such that the catheter shaft and the needle tang cannot move relative to on another;
a second longitudinal member forming a needle spine being directly attached between the proximal end of tubular needle tip and the distal end of the tubular needle body but not to the catheter shaft, such that the needle spine is free to move within the catheter shaft; and
a needle support tube covering at least a portion of the tissue piercing structure to constrain at least a portion of the first longitudinal member and the second longitudinal member during deflection of the tissue piercing structure;
and
an actuator slideably engaged within the catheter shaft and attached to the needle spine such that translational movement of the actuator relative to the catheter shaft causes deflection of the tissue piercing structure about the tab.
2. The delivery system of claim 1 further comprising a delivery mechanism for deploying the medical device, the delivery mechanism being slideably engaged within the tissue piercing structure.
3. The delivery system of claim 2 wherein the delivery mechanism is a plunger.
4. The delivery system of claim 1 further comprising a mechanism for imparting linear translational movement to the actuator.
5. The delivery system of claim 4 wherein the mechanism for imparting movement to the actuator is a handle attached to the proximal end of the actuator.
6. The delivery system of claim 1 further comprising a sheath coaxially disposed over the catheter shaft diametrically sized such that the catheter shaft is slideably engaged within the sheath.
7. The delivery system of claim 1 wherein the tissue piercing structure is 10 French or smaller in diameter.
8. The delivery system of claim 1 wherein the tissue piercing structure comprises nitinol.
9. The delivery system of claim 1 wherein the tissue piercing structure is between 3 and 7 millimeters long.
10. The delivery system of claim 1 further comprising a sheath coaxial with the catheter shaft and diametrically sized so the catheter shaft is slideably engaged within the sheath.
11. A delivery system for deploying a medical device used to close a passageway in a body comprising:
a catheter shaft having a proximal and distal end;
a deflectable tissue piercing structure slideably engaged within the catheter shaft, the deflectable tissue piercing structure having a tubular shape defining a longitudinal axis, with luminal and abluminal surfaces and a distal tip, at least a portion of the tissue piercing structure being deflectable relative to the longitudinal axis, the tissue piercing structure further comprising:
a tubular needle body along the proximal end of the tissue piercing structure;
a tubular needle tip along the distal end of the tissue piercing structure, the needle tip terminating with a chamfered end;
a first longitudinal member forming a needle tang that attaches to the distal end of the catheter shaft to form a tab such that the catheter shaft and the needle tang cannot move relative to one another;
a second longitudinal member forming a needle spine directly attached between the proximal end of tubular needle tip and the distal end of the tubular needle body but not to the catheter shaft, such that the needle spine is free to move within the catheter shaft; and
a needle support tube covering a least a portion of the tissue piercing structure to constrain at least a portion of the first longitudinal member and the second longitudinal member during deflection of the tissue piercing structure;
and
an actuator slideably engaged within the catheter shaft and attached to the needle spine such that translational movement of the actuator relative to the catheter shaft causes deflection of the tissue piercing structure about the tab.