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US 10,420,636 B2Granted
Stent graft devices having collagen coating
AssigneeCook Medical Technologies LLC
InventorsF. Joseph Obermiller, Clay D. Fette
Life of this patent
Estimating the term…
Abstract
Described are stent graft devices and methods for their preparation and use. Expandable stent graft devices of the invention include inner and/or outer coverings uniquely applied and associated with surfaces of the stent. In certain described embodiments, bioremodelable materials such as ECM materials are vacuum pressed onto and/or around elements of a stent in the manufacture of a stent graft device.
Claims28
A unitary, implantable stent graft device, comprising:
- a unitary graft body having an expanded configuration for deployment, and a collapsed configuration for delivery, said unitary graft body in said expanded configuration including:
- (i) a first graft segment defining a first inner lumen having a first diameter, the first graft segment having a first end;
- (ii) a second graft segment and a third graft segment branching from the first end of the first graft segment, the second graft segment defining a second inner lumen having a second diameter and the third graft segment defining a third inner lumen having a third diameter, wherein the second inner lumen and third inner lumen are in fluid communication with the first inner lumen, and wherein the second diameter and the third diameter are smaller than the first diameter;
- (iii) a plurality of discrete, spaced radially expandable stents positioned in said first graft segment;
- (iv) an exterior lyophilized collagenous covering situated to the exterior of said stents, said exterior lyophilized collagenous covering being comprised of an extracellular matrix material retaining growth factors from a source tissue for the extracellular matrix material, said exterior lyophilized collagenous covering promoting cellular invasion and ingrowth when implanted, and said exterior lyophilized collagenous covering forming a first continuous circumferential tube of material surrounding the exterior of said stents, the first continuous circumferential tube of material defining a continuous circumferential outer surface of said first graft segment;
- (v) an interior lyophilized collagenous covering situated to the interior of said stents, said interior lyophilized collagenous covering being comprised of an extracellular matrix material retaining growth factors from a source tissue for the extracellular matrix material, said interior lyophilized collagenous covering being a compressible material that includes an inwardly facing surface and an outwardly facing surface, said interior lyophilized collagenous covering promoting cellular invasion and ingrowth when implanted, and said interior lyophilized collagenous covering forming a second continuous circumferential tube of material surrounding the interior of said stents, the second continuous circumferential tube of material defining a continuous circumferential inner surface of said first graft segment and having been dehydrothermally bonded to said exterior lyophilized collagenous covering in the absence of other bonding agents;
- (vi) said exterior lyophilized collagenous covering having inwardly facing surface regions that face toward and are bonded to the outwardly facing surface of said interior lyophilized collagenous covering which includes bonding in areas between adjacent stents of said plurality of stents so as to entrap the stents between said first continuous circumferential tube of material and said second continuous circumferential tube of material;
- (vii) wherein strut elements of said stents are in contact with the outwardly facing surface of the interior lyophilized collagenous covering;
- and
- (viii) wherein the strut elements of the stents are compressed into the interior lyophilized collagenous covering such that said outwardly facing surface of said interior lyophilized collagenous covering has regions locally contoured to the strut elements, such that a wall thickness of said interior lyophilized collagenous covering is less where said interior lyophilized collagenous covering passes over the strut elements as compared to adjacent regions of the interior lyophilized collagenous covering occurring between the strut elements, and further such that the inwardly facing surface of the interior lyophilized collagenous covering has a smooth contour lacking protuberances in regions where the interior lyophilized collagenous covering passes over and between strut elements of the stents.
7 more elements
A stented graft construct, comprising:
- a unitary graft body having an expanded configuration for deployment, and a collapsed configuration for delivery, said unitary graft body in said expanded configuration including:
- (i) a plurality of discrete, spaced stents spaced to provide openings between the stents;
- and
- (ii) said discrete, spaced stents interconnected to one another by inner and outer layers of a bioremodelable covering material that promote cellular invasion and ingrowth when implanted, wherein the inner and outer layers of bioremodelable covering material are each comprised of an extracellular matrix material retaining growth factors from a source tissue for the extracellular matrix material, wherein the inner and outer layers of bioremodelable covering material each form a continuous circumferential tube of material, wherein the inner and outer layers of bioremodelable covering material are sufficiently dehydrothermally bonded to one another in the absence of other bonding agents including through said openings to entrap the stents and form a stable, unitary stented graft construct for subsequent implantation in a patient, and wherein said inner layer of bioremodelable covering material is a compressible material that includes an inwardly facing surface and an outwardly facing surface, said outwardly facing surface being in contact with strut elements of said stents that are compressed into the inner layer of bioremodelable covering material such that said outwardly facing surface is contoured to the strut elements, such that a thickness of said inner layer of bioremodelable covering material is less where said inner layer of bioremodelable covering material passes over the strut elements as compared to adjacent regions of the inner layer of bioremodelable covering material that span between the strut elements, and further such that said inwardly facing surface has a smooth contour lacking protuberances in regions where said inner layer of bioremodelable covering material passes over and spans between the strut elements of said stents.
1 more element
A stented graft construct, comprising:
- a unitary graft body having an expanded configuration for deployment, and a collapsed configuration for delivery, said unitary graft body in said expanded configuration including:
- (i) a plurality of discrete, spaced, serpentine stent elements in succession with openings between successive stent elements;
- (ii) said discrete, spaced stent elements interconnected to one another by being entrapped between inner and outer layers of a bioremodelable covering material that promotes cellular invasion and ingrowth when implanted, wherein the inner and outer layers of bioremodelable covering material are each comprised of an extracellular matrix material retaining growth factors from a source tissue for the extracellular matrix material, said inner and outer layers each forming a continuous circumferential tube of material, said inner and outer layers being dehydrothermally bonded to one another in the absence of other bonding agents including through said openings so as to provide a generally fixed association of said stent elements with the bioremodelable covering material, wherein the inner and outer layers are sufficiently bonded to one another to form a stable, unitary stented graft construct for subsequent implantation in a patient;
- and
- (iii) wherein said inner layer of bioremodelable covering material is a compressible material that includes an inwardly facing surface and an outwardly facing surface, said outwardly facing surface being in contact with strut elements of said stent elements that are compressed into the inner layer of bioremodelable covering material such that said outwardly facing surface is contoured to said strut elements, such that said inner layer of bioremodelable covering material has a wall thickness that is less where said inner layer of bioremodelable covering material passes over the strut elements as compared to adjacent regions of the inner layer of bioremodelable covering material that span between the strut elements, and further such that said inwardly facing surface has a smooth contour lacking protuberances in regions where said inner layer of bioremodelable covering material passes over and spans between the strut elements of said stent elements.
2 more elements
Dependencies are inferred from the claim text.