Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent in combination with graft
Reexamination Certificate
1998-12-23
2001-11-13
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent in combination with graft
C623S001200, C623S001460
Reexamination Certificate
active
06315791
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to expandable intraluminal prostheses for use in body passages, and more particularly, to self-expanding intraluminal prostheses useful for the treatment of body passages, such as blood vessels, occluded by disease.
Self-expanding prostheses are commonly used to restore and maintain the patency of body passages, particularly blood vessels. Self-expanding prostheses include stents constructed from shape memory materials, such as Nitinol, stents constructed of conventional materials, such as stainless steel, in a configuration that exhibits self expansion characteristics, and other varieties of prostheses. Such self-expanding stents can be compressed into a reduced diameter state suitable for percutaneous insertion into the body passage through a catheter. The self-expanding stent is typically held in the reduced diameter state until delivery into the body passage, whereupon the self-expanding stent is released to an increased diameter state within the body passage to hold open the body passage.
Problems associated with such conventional self-expanding stents include the need for pre-dilation of the body vessel, typically with a catheter-deployed balloon, prior to deployment of the self-expanding stent. Pre-dilation of the body vessel is necessary because the self-expanding stent alone frequently lacks sufficient radial expansion strength to completely open the diseased body vessel. Additionally, post-dilation of the self-expanding stent can be necessary to ensure the self-expanding stent has deployed to a sufficient diameter to engage the walls of the blood vessel. The need for pre- and post-dilation increases the duration of the medical procedure and the risk to the patient.
Additionally, conventional self-expanding stents generally require a separate containment system, for example a delivery tube or sheath, that radially constrains the stent in the reduced diameter state during catheter delivery and until the stent is deployed within the body vessel. Frequently, the self-expanding stent moves within the body vessel as the containment system is removed, adversely effecting the accuracy of the deployment of the stent within the body vessel. Moreover, the removal of the delivery sheath once the stent is in place requires an additional step, prolonging the medical procedure and, thus, the risk to the patient.
SUMMARY OF THE INVENTION
The present invention provides an expandable prosthesis that includes a self-expanding stent deployable between a substantially radially compressed configuration and a substantially radially expanded configuration. A biocompatible coating is attached to at least a portion of the outer surface of the self-expanding stent in the radially compressed configuration to inhibit radial expansion of the self-expanding stent to the radially expanded configuration. The biocompatible material is preferably integrally mounted to the self-expanding stent thus eliminating the need for a separate, independent containment system, such as a delivery tube or sheath, for maintaining the self-expanding stent in the radially compressed configuration during delivery of the self-expanding stent into a body vessel.
The self-expanding stent is preferably constructed from a material having shape-memory properties such as an alloy of nickel and titanium, (e.g. Nitinol). The biocompatible coating is preferably expanded polytetrafluoroethylene (ePTFE) and can extend between the first and second ends of the self-expanding stent. In addition, the biocompatible coating can be folded-over the first end and/or the second end of the self-expanding stent and can be attached to at least a portion of the inner surface of the self-expanding stent. In a preferred embodiment, the biocompatible coating is attached to the inner and outer surfaces and extends between the first and second ends of the stent to encapsulate the self-expanding stent.
In accordance with an alternative embodiment of the present invention, the expandable prosthesis includes a self-expanding stent deployable between a substantially radially compressed configuration and a substantially radially expanded configuration and a plastically deformed, expanded biocompatible coating attached to the outer surface of the self-expanding stent.
In accordance with another embodiment of the present invention, the expandable prosthesis includes a self-expanding stent having a first diameter which permits delivery of the self-expanding stent into a body passage and a second, expanded diameter suitable for treatment of the body passage. A layer of biocompatible material is attached to at least a portion of the outer surface of the self-expanding stent that is deformable between a first state sized to restrain the self-expanding stent to the first diameter, and a second, expanded state, the layer deforming to the second, expanded state upon expansion of the self-expanding stent to the second diameter by a radially, outward extending force.
A method of forming the expandable prosthesis of the present invention includes the steps of providing a self-expanding stent that is deployable between a substantially radially compressed configuration and a substantially radially expanded configuration and coating the self-expanding stent in the radially compressed configuration with a biocompatible material to retain the stent in the radially compressed configuration. Preferably, at least a portion of the outer surface of self-expanding stent is coated with the biocompatible material. Additionally, at least a portion of the inner surface of the self-expanding stent can be coated with the biocompatible material.
A method of deploying an expandable prosthesis in a body passage in accordance with the teachings of the present invention includes the steps of providing an expandable prosthesis that includes a self-expanding stent that is deployable between a substantially radially compressed configuration and a substantially radially expanded configuration. A biocompatible coating is attached to at least a portion of the outer surface of the self-expanding stent. The prosthesis is disposed on a catheter and the prosthesis and the catheter are inserted within the body passageway. The biocompatible coating retains the self-expanding stent in the radially compressed configuration in the absence of an external, radially outward force on the self-expanding stent.
In accordance with one aspect of the present invention, the prosthesis is expanded at a desired location in the body passage by applying a radially outward force on the prosthesis to place the biocompatible material into contact with the body passage. The step of expanding the prosthesis radially deforms the biocompatible coating beyond its elastic limit. The radially outward force on the prosthesis can be provided by inflating a catheter-deployed balloon within the self-expanding stent.
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Gingras Peter H.
Goodwin Jonathan
Hamelin Susan
Karwoski Theodore
Atrium Medical Corporation
Koh Choon P.
Lahive & Cockfield LLP
McDermott Corrine
LandOfFree
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