Percutaneous potts shunt devices and methods
AssigneeTransmural Systems LLC
InventorsNasser Rafiee, Alexis Balcom, Mai Le Diep
Life of this patent
Estimating the term…
Abstract
The disclosure provides various embodiments of prostheses and delivery systems to permit an interventional cardiologist to create shunts between various blood vessels. Moreover, the disclosed shunts can be used to shunt between various hollow organs, as set forth in the present disclosure.
Claims21
1-19. (canceled)
A method of implanting a transcatheter Potts shunt between a left pulmonary artery and a descending aorta, comprising:
- providing a delivery system including an elongate inner core member, an inflatable member on the inner core member, a retractable sheath, and a tubular prosthesis configured with a distal sealing flange and at least one laterally extending projection structurally distinct from the distal sealing flange;
- advancing a distal end of the delivery system to a target location and through an ostium formed in a concave wall of a first vessel;
- withdrawing the sheath proximally to expose a distal end of the prosthesis such that the distal sealing flange and the at least one laterally extending projection are positioned inside the first vessel and a tubular body of the prosthesis extends through the ostium;
- actuating the inflatable member to expand the distal end of the prosthesis and to shape the distal sealing flange to seat against the concave wall of the first vessel;
- and
- deploying a proximal end of the prosthesis within a second vessel to establish a shunt between the first vessel and the second vessel.
The method of claim 1, further comprising orienting two laterally extending projections approximately 180 degrees apart at a bottom of the concavity of the first vessel to resist pull-through during deployment.
The method of claim 1, wherein the proximal end of the prosthesis includes three evenly spaced laterally extending projections approximately 120 degrees apart to facilitate alignment with blood flow in the second vessel.
The method of claim 1, further comprising using radiopaque markers on at least one laterally extending projection to confirm projection position at the ostium during implantation.
The method of claim 1, wherein the prosthesis includes a membrane comprising a woven or non-woven fabric covering at least the tubular body and sealing flange.
The method of claim 1, further comprising adjusting an axial length of the prosthesis by allowing one or more tension coil springs coupled to the prosthesis to shorten the prosthesis when unconstrained while maintaining a substantially unchanged inside diameter.
The method of claim 1, further comprising routing at least one removable tether through openings at a proximal region of the prosthesis and maintaining tension on the tether to permit recapture of the prosthesis into the sheath if repositioning is required.
The method of claim 1, further comprising inflating the inflatable member positioned distal to the prosthesis to outwardly flare the distal end of the prosthesis for enhanced apposition to the vessel wall.
The method of claim 1, wherein the ostium in the first vessel is crossed from the descending aorta to the left pulmonary artery using an electrosurgical 0.014″ guidewire which is subsequently exchanged for a 0.035″ guidewire prior to delivery system advancement.
The method of claim 1, further comprising deploying the proximal sealing flange of the prosthesis inside a second concave vessel wall so that the tubular body extends outwardly through a second ostium formed in the second vessel wall.
The method of claim 1, wherein the prosthesis self-expands when unconstrained and is further expandable by the inflatable member.
The method of claim 1, further comprising using a first set of radiopaque markers at a distal atraumatic tip of the delivery system and a second set of external markers maintained in registration to indicate relative longitudinal position during deployment.
The method of claim 1, wherein the laterally extending projections extend radially outward beyond a distal flange defined at least in part by an undulating, star-shaped circumferential wire frame to supplement resistance to pull-through.
The method of claim 1, further comprising positioning the prosthesis such that the distal end exhibits greater rigidity to resist mural recoil at the ostium while a proximal region exhibits increased flexibility to accommodate vessel curvature.
The method of claim 1, further comprising:
- after initial implantation, performing late post-dilation of the prosthesis to larger diameters to accommodate patient growth and increase shunt flow.
A method for deploying a tubular prosthesis using a delivery system with a retractable sheath and an inflatable member, comprising:
- mounting at least a portion of the prosthesis over the inflatable member on an elongate inner core member and covering the prosthesis with the retractable sheath;
- advancing the covered prosthesis to an anastomosis site between adjacent vessels;
- retracting the sheath to allow partial self-expansion of the prosthesis and then inflating the inflatable member to radially expand a distal region of the prosthesis within an ostium of a first vessel wall to seat a distal sealing flange against the wall;
- and
- thereafter retracting the sheath further and expanding a proximal region of the prosthesis to seat a proximal sealing flange in a second vessel wall to complete a side-to-side shunt.
Dependencies are inferred from the claim text.