Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Having marker
Reexamination Certificate
1999-10-15
2002-03-12
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Having marker
C604S103100
Reexamination Certificate
active
06355060
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to apparatus and methods for the endoluminal placement of resilient tubular prostheses, such as grafts, stents, stent-grafts, and other structures. More particularly, the present invention relates to a delivery catheter for the placing of such intraluminal tubular protheses in body lumens, including blood vessels, for the treatment of abdominal and other aneurysms.
Vascular aneurysms are the result of abnormal dilation of a blood vessel, usually resulting from disease and/or genetic predisposition which can weaken the arterial wall and allow it to expand. While aneurysms can occur in any blood vessel, most occur in the aorta and peripheral arteries, with the majority of aortic aneurysms occurring in the abdominal aorta, usually beginning below the renal arteries and often extending distally into one or both of the iliac arteries.
Aortic aneurysms are most commonly treated in open surgical procedures where the diseased vessel segment is bypassed and repaired with an artificial vascular graft. While considered to be an effective surgical technique, particularly considering the alternative of a usually fatal ruptured abdominal aortic aneurysm, conventional vascular graft surgery suffers from a number of disadvantages. The surgical procedure is complex and requires experienced surgeons and well equipped surgical facilities. Even with the best surgeons and equipment, however, patients being treated frequently are elderly and weakened from cardiovascular and other diseases, reducing the number of eligible patients. Even for eligible patients prior to rupture, conventional aneurysm repair has a relatively high mortality rate, usually from 3% to 10%. Morbidity related to the conventional surgery includes myocardial infarction, renal failure, impotence, paralysis, and other conditions. Additionally, even with successful surgery, recovery takes several weeks, and often requires a lengthy hospital stay.
In order to overcome some or all of these drawbacks, endovascular graft placement for the treatment of aneurysms has been proposed. Although very promising, many of the proposed methods and apparatus suffer from other problems. In particular, delivery and placement of the endovascular graft within the vasculature can be problematic. Proper positioning and sizing of the endovascular graft is critical to the successful treatment of an aneurysm. Grafts are often resilient, biased to expand and anchor the graft within the body lumen. These resiliently expanding grafts are tightly compressed within the catheter and impose significant forces against the surrounding catheter bodies, often leading to excess friction between the graft and the catheter wall. These forces complicate the loading of the graft into the catheter, as well as the accurate release of grafts and stents in body lumens. Moreover, the catheters must maneuver the graft within the vascular system. Thus, the catheters are required to have flexible, elongate bodies which are particularly susceptible to the expanding graft, often resulting in invagination of the graft in the soft material of the catheter wall.
For these reasons, it would be desirable to provide improved apparatus and methods for endovascular placement of intraluminal protheses, including grafts, stents, and stent-grafts, for treating aneurysms and other conditions. It would be particularly desirable to provide delivery catheters and methods for the placement of endoluminal tubular prostheses which would facilitate the controlled release of resilient tubular prostheses. It would be particularly desirable to provide delivery catheters and methods which reduce the frictional forces created by the resilient expansion against the catheter during loading and release of the prostheses.
2. Description of the Background Art
Vascular grafts and devices for their endoluminal placement are described in U.S. Pat. Nos. 5,282,824; 5,272,971; 5,242,399; 5,219,355; 5,211,658; 5,201,757; 5,192,297; 5,190,058; 5,158,548; 5,147,370; 5,104,399; 5,092,877; 5,078,726; 5,019,085; 4,990,151; 4,950,227; 4,913,141; 4,886,062; 4,820,298; 4,787,899; 4,617,932; 4,562,596; 4,577,631; and 4,140,126; and European Pat. Publications 539,237; 533,511; 518,839; 518,704; 508 473; 505,686; 466 518; and 461 791. Catheters for placing vascular stents are described in U.S. Pat. Nos. 5,192,297; 5,092,877; 5,089,005; 5,037,427; 4,969,890; and 4,886,062. Catheters carding a graft structure in a tube or capsule are described in U.S. Pat. Nos. 5,275,622; 5,104,399; and 4,787,899; and EP466518.
SUMMARY OF THE INVENTION
The present invention provides apparatus and methods for the endoluminal placement of intraluminal prostheses, including grafts, stents, and stent-grafts, for the treatment of disease conditions, particularly aneurysms. The intraluminal prostheses will typically comprise a resilient, radially compressible, tubular frame having a proximal end, a distal end, and an axial lumen therebetween. In the case of graft prostheses, a liner, typically a fabric, polymeric sheet, membrane, or the like, will line all or most of the luminal surface of the tubular frame, usually extending from a near-proximal location to a near-distal location. Suitable graft structures for placement using the catheters and methods of the present invention are described in copending application Ser. No. 08/255,681, the full disclosure of which is incorporated herein by reference.
The intraluminal prostheses of the present invention are suitable for a wide variety of therapeutic uses, including stenting of the ureter, urethra, biliary tract, and the like. The present devices and methods will also be useful for the creation of temporary or long term lumens, such as the formation of fistulas. The present invention will find its greatest use, however, in the placement of endovascular prostheses into blood vessels for the treatment of abdominal and other aneurysms, vascular stenoses, and the like.
According to the present invention, a delivery catheter for positioning a radially compressible prosthesis comprises an elongate flexible shaft structure having a proximal end and a distal end. The shaft structure includes a prosthesis receptacle near the distal end. A tubular cover is slidably disposed about the shaft with at least one runner disposed within the distal end of the cover, wherein the runner is formed of a harder material than is the cover. The prosthesis can slide against the hard runner material within the cover in response to a distal force applied from the shaft. Advantageously, the hardness of the runner material avoids invagination of the compressed prosthesis frame in the cover while allowing use of a softer, more flexible cover material to facilitate intraluminal maneuvering of the catheter. Additionally, reduced friction between the prosthesis and cover also facilitates the precise positioning of the prosthesis by reducing the forces input at the proximal end and transmitted through the catheter body. The reduced friction of the present delivery catheter is also beneficial when it is necessary to recapture a partially deployed prothesis.
As used herein, a “prosthesis receptacle” is a structure or region along a shaft in or over which a radially compressible tubular prosthesis is carried during maneuvering of the shaft and prosthesis within a body lumen. The prosthesis receptacle may include a structure or portion at or near the distal end of the shaft which engages the prosthesis to effect its release—for example, a distal force imparting structure on the shaft that restrains proximal movement of the prosthesis as the cover slides proximally. Although the devices and methods of the present invention are illustrated with continuous shafts and covers for clarity, the principles of the present invention are fully compatible with an attachable prosthesis cartridge, as described in parent application Ser. No. 08/255,681, previously incorporated by reference. Similarly, catheter diameters may be reduced proximally of the prosthesis
Evans Michael A.
Glynn Brian
Kim Steven W.
Lenker Jay A.
Watanabe Gwendolyn A.
Medtronic AVE Inc.
Milano Michael J.
Sterne Kessler Goldstein & Fox P.L.L.C.
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