Biological replacement valve assembly
First Claim
1. A biological valvular prosthesis for percutaneous implantation within a desired body site that includes a stent having a plurality of circumferential ribbon sections each of which is fabricated of a fine wire strand that are interconnected to form a tubular member, each wire ribbon containing a periodic series of substantially sinusoidal shaped bends along the length of the ribbon strand such that each of said shaped bends includes an apex that is welded to an apex on an adjacent ribbon section, said stent being expanded to a desired outside diameter that is related to the contour of the body sites into which the valve is to be implanted, a length of vein that contains a biological venous valvular replacement, the vein section of the replacement having a circular wall that is reduced in thickness such that the outer diameter of the vein is about equal to the expanded inside diameter of the stent, means for attaching the vein to the inside of the expanded stent so that the vein is supported in a circular configuration within the expanded stent, whereby the stent and the attached venous valvular replacement can be collapsed tightly upon. A deflated balloon of a catheter to form a compact package for percutaneous implantation, and said welds formed between ribbons being weaker than the tensile strength of the fine wire whereby the weld will break before the ribbon wire thus preventing the stent from fragmenting.
1 Assignment
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Accused Products
Abstract
A prosthesis device for percutaneous implantation that includes an expandable stent and a biological venous valvular replacement for a defective valve mounted inside the expanded stent. The wall thickness of the vein is reduced to a diameter that is about equal to the inside diameter of the expanded stent and is sutured to the inside of the expanded stent so that the vein is supported in a fully opened circular configuration.
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Citations
17 Claims
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1. A biological valvular prosthesis for percutaneous implantation within a desired body site that includes
a stent having a plurality of circumferential ribbon sections each of which is fabricated of a fine wire strand that are interconnected to form a tubular member, each wire ribbon containing a periodic series of substantially sinusoidal shaped bends along the length of the ribbon strand such that each of said shaped bends includes an apex that is welded to an apex on an adjacent ribbon section, said stent being expanded to a desired outside diameter that is related to the contour of the body sites into which the valve is to be implanted, a length of vein that contains a biological venous valvular replacement, the vein section of the replacement having a circular wall that is reduced in thickness such that the outer diameter of the vein is about equal to the expanded inside diameter of the stent, means for attaching the vein to the inside of the expanded stent so that the vein is supported in a circular configuration within the expanded stent, whereby the stent and the attached venous valvular replacement can be collapsed tightly upon. A deflated balloon of a catheter to form a compact package for percutaneous implantation, and said welds formed between ribbons being weaker than the tensile strength of the fine wire whereby the weld will break before the ribbon wire thus preventing the stent from fragmenting.
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10. The method of preparing a biological venous valvular replacement for a human valve within a given implantation site, said method including the steps of
providing a stent that produces minimal axial deformation as the stent is expanded radially, expanding the stent to a diameter that is equal to or slightly greater than the opening in the implantation site, reducing the thickness of the vein wall of the valvular replacement to a size such that the outer diameter of the vein is about equal to the inside diameter of the expanded stent, and attaching the vein to the inside of the expanded stent so that the vein is supported within the stent in a fully opened cylindrical configuration whereby the stent and attached valvular replacement can be collapsed tightly against a balloon of a catheter to form a compact package for percutaneous implantation.
Specification