Prosthetic valve for transluminal delivery
First Claim
1. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:
- a valve having a plurality of resilient leaflets;
a valve support configured to be collapsible for transluminal delivery and comprising a first and a second portion, said first portion expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned, said second portion supporting the base and the commissure points of the valve; and
a radial restraint for controlling a diameter of the second portion.
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0 Petitions
Accused Products
Abstract
A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchors may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia. A radial restraint, comprising a wire, thread or cuff, may be used to ensure expansion does not exceed the preset diameter. The valve support may optionally comprise a drug elution component. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. A blood pump may be inserted into the catheter to ensure continued blood flow across the implantation site during implantation procedure. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand at the implantation site and the anchor engages the lumen wall. Insertion of the catheter may optionally be performed over a transseptally delivered guidewire that has been externalized through the arterial vasculature. Such a guidewire provide dual venous and arterial access to the implantation site and allows additional manipulation of the implantation site after arterial implantation of the prosthetic valve. Additional expansion stents may be delivered by venous access to the valve.
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Citations
78 Claims
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1. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:
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a valve having a plurality of resilient leaflets;
a valve support configured to be collapsible for transluminal delivery and comprising a first and a second portion, said first portion expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned, said second portion supporting the base and the commissure points of the valve; and
a radial restraint for controlling a diameter of the second portion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of replacing a deficient native valve comprising the steps of:
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providing a prosthetic valve assembly, the assembly comprising a valve, a valve support permitting attachment thereto of the base and the commissures of the valve, and an anchor for engaging the lumen wall when expanded for preventing substantial migration of the valve assembly when positioned in place;
collapsing the valve support to fit within a distally positioned sheath on a catheter;
inserting a guidewire into a vascular access site;
externalizing at least a portion of the guidewire through a second vascular access site;
advancing the catheter over the guidewire to the deficient native valve;
deploying the valve assembly; and
withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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- 31. A prosthetic valve assembly configured for endoluminal delivery to replace a deficient native valve, the valve assembly comprising an axial valve support portion configured to support a prosthetic valve having at least one leaflet and to prevent substantial interference with the positioning and/or operation of the prosthetic valve by any residual components of the native valve, including calcified native components, said support portion comprising at least one radial restraint at a first section of said support portion to preclude expansion when deployed in situ substantially no greater than a preset diameter to increase coaptivity of the prosthetic valve leaflets and to prevent significant regurgitation.
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48. A method of replacing a deficient native valve comprising the steps of:
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providing a prosthetic valve assembly, the assembly comprising a valve, a valve support comprising a first valve support section permitting attachment thereto of the base and the commissures of the valve, and a second valve support section configured to expand in situ to push the residual native valve components against the native annulus and surrounding tissue;
collapsing the valve support to fit within a distally positioned sheath on a catheter;
inserting a guidewire into a vascular access site;
externalizing at least a portion of the guidewire through a second vascular access site;
advancing the catheter over the guidewire to the deficient native valve;
deploying the valve assembly; and
withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve. - View Dependent Claims (49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61)
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62. A method of replacing a deficient native valve comprising the steps of:
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providing a prosthetic valve assembly, the assembly comprising a valve, a valve support permitting attachment thereto of the base and the commissures of the valve, and a radial restraint controlling a diameter of at least a portion of the valve assembly;
collapsing the valve support to fit within a distally positioned sheath on a catheter;
inserting a guidewire into a vascular access site;
externalizing at least a portion of the guidewire through a second vascular access site;
advancing the catheter over the guidewire to the deficient native valve;
deploying the valve assembly; and
withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve. - View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74)
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75. A prosthetic valve assembly configured for endoluminal delivery to replace a deficient native valve, the valve assembly comprising a non-cylindrical valve support and at least one anchor.
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76. A method of replacing a deficient heart valve comprising the steps of:
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delivering to a target native valve site a valve prosthesis comprising a first portion and a second portion, the first portion limited in its expansion diameter when compared to the second portion;
delivering a perfusion pump to the desired target site to pump blood through the target site during application of the valve prosthesis; and
deploying the valve prosthesis while pumping blood through the target site. - View Dependent Claims (77, 78)
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Specification