Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent in combination with graft
Reexamination Certificate
2001-09-28
2004-07-27
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent in combination with graft
C623S001360
Reexamination Certificate
active
06767359
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a prosthesis for the repair of thoracic or abdominal aortic aneurysms (AAA) and to a method for utilizing the prosthesis. Furthermore, the invention is also directed to the provision of an arrangement and method for the repair of aortic aneurysms incorporating a device for the placement of the prosthesis in the corporeal lumen or body vessel of a patient, and wherein the prosthesis comprises a graft facilitating the exclusion of the aneurysm, and also provides for anastomotic structure for the attachment of the prosthesis in a laparoscopic surgical procedure.
It is a well established medical fact that various fluid conducting body or corporeal lumens, such as veins and arteries, may deteriorate or suffer trauma over time so that repair thereof becomes necessary. For example, various types of aneurysms or other deteriorative diseases may affect the ability of the lumen to conduct fluids, such as adequate blood flow, and in turn may create life-threatening situations. In some cases, the damaged lumen is repairable only with the use of a prosthesis, such as an artificial vessel or graft constituting a replacement vessel or a bypass.
For example, an aneurysm is a localized dilatation or weak spot in a blood vessel, whereby abdominal aortic aneurysms (AAA) are one of the most common and serious types of aneurysms. They are deemed by physicians to be atherosclerotic in origin, in effect, related to a high fat diet, high blood pressure, and cigarette smoking, although genetic factors that control collagen and/or elastic tissue metabolism may also be involved in such conditions.
In the implementation of the repair of vital vessels, such as the aorta, surgical repair is significantly life-threatening. Surgical techniques which are presently known in the art involve major surgery in which a graft resembling the natural vessel is spliced into the diseased or obstructed section of the natural vessel. Known procedures include surgically bypassing the damaged or diseased portion of the vessel and inserting an artificial or donor graft which is attached to the native vessel by an anastomosis.
It is also known within the confines of the medical profession to provide a prosthesis for the intraluminal repair of a vessel, such as an abdominal aorta having an aneurysm. The art has taught it to be expedient to provide a prosthesis which is positioned in a vessel, and then securing the prosthesis within the vessel with hooks or staples that are mechanically extended by the user. The early prior art devices were large in diameter, mechanically complex and, in turn, were susceptible to mechanical failure. Prior intraluminal grafting systems have embodied capsule catheters or balloon catheters, but these were relatively stiff and of a relatively high profile. Similarly, the prior art systems were configured in such a way that the graft was relatively difficult to deploy in the correct position. In addition, prior systems having a capsule catheter assembly were usually configured such that the prostheses was disposed within a unitary capsule. Further, the prior prosthesis were sometimes ill suited to withstand the high pressures existing in the vessels and, consequently, experienced structural failures.
Conventional repair of abdominal aortic aneurysms (AAA) involves exclusion of the aneurysm by implantation of bifurcated or straight vascular prostheses via a full laparotomy. This procedure has a high morbidity and mortality rates of 1-3%. Recent advances in engineering have resulted in stent-graft “prosthesis”, delivered to the aneurysm via the femoral artery. This procedure requires a 18-24 F catheter to be placed in the femoral artery, then worked through the iliac artery to the aneursym, where the stent-graft is deployed. Problems associated with this technology include failure to exclude the aneurysm (“endoleak”), generation of microemboli as the device traverses calcified and tortuous peripheral arteries, device migration, and frequent emergency conversions to an open surgical procedure. Another difficulty associated with this technology is the need to have two devices placed, one for the aorta-iliac and one for the contralateral iliac. This requires two arterial access sites and may increase the likelihood of endoleak, since the junction of the aortoiliac and contralateral iliac is not a closed seal. There have also been attempts to repair AAA by laparoscopic techniques. This procedure may require up to 9 hours to complete, can result in paraplegia, and is also prone to emergency conversion to a laporotomy or open repair.
With regard to the prior art, although significant steps have been taken to provide methods and devices for deploying intralumenally grafts and the use of anastomotic means in order to bypass abdominal aortic aneurysms (AAA), many of these devices are still subject to difficulties due to utilizing catheters or extensive surgical procedures in contrast with laparoscopic surgery which replaces the highly invasive procedures of open surgery which are subjective to high mortality rates especially for elderly and seriously-ill patients.
2. Discussion of the Prior Art
Quiachon et al., U.S. Pat. No. 6,039,758 and U.S. Pat. No. 5,628,783 disclose bifurcated vessel grafts with spring-hook attachment structure at an end portion thereof, employed for a method of repairing an aneurysm in a vessel at a remote location. This necessitates the use of catheters and extensive surgery wherein a separate vessel engaging members are preattached to the graft but which do not contemplate the unique anastomotic devices attached to the graft prior to the emplacement of the prosthesis as described by the present invention.
Pierce, U.S. Pat. No. 6,152,956 discloses an endovascular prosthesis for repair of abdominal aortic aneurysms (AAA), and which includes a graft with an elastic wire means for connecting an end portion of the graft to the wall of the aorta.
McNamara et al., U.S. Pat. No. 6,004,347 discloses a fabric graft with a resilient anchor structure located at the end portions of the graft repairing an abdominal aortic aneurysm. A catheter-like a device which includes a dilator is provided to deploy the graft. This clearly precludes the utilization of laparoscopic surgery which also avoids the necessary for open surgery potentially leading to higher patient mortality rates.
Chin, U.S. Pat. No. 5,800,540 discloses a method and an apparatus for implementing endoscopic grafting; however, the patent does not disclose a graft including the novel anastomotic attachments at the ends of the graft and the unique system for the emplacement thereof.
Pinchuk et al., U.S. Pat. No. 5,700,269 discloses an endoluminal prosthesis deployment device which includes a dilator tip and a plunger. Again, as in the previously described publications, there is no disclosure of the unique prosthesis for the repair of thoracic or abdominal aorta aneurysms in a laparoscopic procedure and the unique device for the emplacement of the prosthesis.
Chuter, U.S. Pat. No. 5,456,713 discloses a graft prosthesis which is equipped with anchoring barbs on the end portions thereof, and incorporates apparatus for positioning the graft within a vessel lumen in order to repair an aneurysm. However, as in the previously described publications, there is no disclosure of the unique auastomotic structures which are attached to the opposite ends of the graft and which will enable the simple laproscopic emplacement thereof in the lumen of a patient for the repair of either a thoracic or abdominal aortic aneurysms.
European Patent Application Nos. EP 108666482; EP 1086663 A1; and EP 1086665 A1 are each directed to various types of apparatus or stents, wherein the apparatus is adapted to deliver and emplace a prosthesis, and wherein a tubular graft is formed over monofilament fibers having resilient portions for engaging the wall of the lumen.
In summation, none of the foregoing publications are adapted to provide the particular inventive prosthesis or system fo
Ethicon Inc.
McDermott Corrine
Sweet Thomas J
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