Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – X-ray contrast imaging agent
Reexamination Certificate
2000-03-20
2002-11-05
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
X-ray contrast imaging agent
C424S009400, C424S009410, C424S009411, C424S009455, C424S001290, C424S001650, C424S422000, C424S426000, C424S423000, C514S546000, C514S057000, C514S708000, C604S264000, C604S041000, C604S502000
Reexamination Certificate
active
06475466
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for treating endoleaks arising from endovascular repair of abdominal aortic aneurysms. Specifically, the methods of this invention involve the in situ sealing of endoleaks after placement of an endovascular prostheses in the abdominal aorta. Sealing of endoleaks is achieved by injection of a biocompatible fluid composition at the site of the endoleak which composition in situ solidifies and adheres to the vascular and/or prosthetic wall to seal the leak. Preferably, the biocompatible fluid composition comprises a contrast agent to allow the clinician to visualize the sealing process.
2. References
The following publications, patent applications and patents are cited in this application as superscript numbers:
1 May, et al., “Concurrent Comparison of Endoluminal Versus Open Repair in the Treatment of Abdominal Aortic Aneurysms: Analysis of 303 Patients by Life Table Method”, J. Vasc. Surg. 27(2):213-221 (1998)
2 White, et al., J. Endovasc. Surg., 3:124-125 (1996)
3 Marty, et al., “Endoleak After Endovascular Graft Repair of Experimental Aortic Aneurysms: Does Coil Embolization with Angiographic “Seal” Lower Intraaneursymal Pressure”, J. Vasc. Surg., 22(3):454-462 (1998)
4 Money, et al., “Perioperative Charge Comparison and Endovascular Abdominal Aortic Aneurysm Repair”, JPV 1.1-1.2, Presented at the 6
th
Annual Symposium on Current Issues and New Techniques in Interventional Radiology at New York, New York in November, 1998
5 Beebe, et al., “Current Status of the United States Vanguard™ Endograft Trial”, JPVA 2.1-2.3, Presented at the 6
th
Annual Symposium on Current Issues and New Techniques in Interventional Radiology at New York, New York in November, 1998
6 Hopkinson, et al., “Current Critical Problems, New Horizons and Techniques in Vascular and Endovascular Surgery”, JPIII 4.1-4.2, Presented at the 6
th
Annual Symposium on Current Issues and New Techniques in Interventional Radiology at New York, New York in November, 1998
7 Kinugasa, et al., “Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer”, J. Neurosurg., 77:501-507 (1992)
8 Greff, et al., U.S. Pat. No. 5,667,767 for “Novel Compositions for Use in Embolizing Blood Vessels”, issued Sep. 16, 1997
9 Greff, et al., U.S. Pat. No. 5,580,568 for “Cellulose Diacetate Compositions for Use in Embolizing Blood Vessels”, issued Dec. 3, 1996
10 Kinugasa, et al., “Early Treatment of Subarachnoid Hemorrhage After Preventing Rerupture of an Aneurysm”, J. Neurosurg., 83:34-41 (1995)
11 Kinugasa, et al., “Prophylactic Thrombosis to Prevent New Bleeding and to Delay Aneurysm Surgery”, Neurosurg., 36:661 (1995)
12 Taki, et al., “Selection and Combination of Various Endovascular Techniques in the Treatment of Giant Aneurysms”, J. Neurosurg., 77:37-42 (1992)
13 Evans, et al., U.S. patent application Ser. No. 08/802,252 for “Novel Compositions for Use in Embolizing Blood Vessels”, filed Feb. 19, 1997.
14 Castaneda-Zuniga, et al., Interventional Radiology, in Vascular Embolotherapy, Part 1, 1:9-32, Williams & Wilkins, Publishers (1992)
15 Rabinowitz, et al., U.S. Pat. No. 3,527,224, for “Method of Surgically Bonding Tissue Together”, issued Sep. 8, 1970
16 Hawkins, et al., U.S. Pat. No. 3,591,676, for “Surgical Adhesive Compositions”, issued Jul. 6, 1971
17 Parodi, “Endovascular AAA Stent Grafts: Technology, Training and Proper Patient Selection, JPVA 1.1-1.2 Presented at the 6
th
Annual Symposium on Current Issues and New Techniques in Interventional Radiology at New York, New York in November, 1998
18 van Schie, et al., “Successful Embolization of Persistent Endoleak from a Patent Inferior Mesenteric Artery”, J. Endovasc. Surg., 4:312-315 (1997)
19 Walker, et al., “A Study of the Patency of the Inferior Mesenteric and Lumbar Arteries in the Incidence of Endoleak Following Endovascular Repair of Infra-renal Aortic Eneurysms”, Clinical Radiology, 53:593-595 (1998)
All of the above publications, patent applications and patents are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent application or patent was specifically and individually indicated to be incorporated by reference in its entirety.
STATE OF THE ART
Abdominal aortic aneurysms (AAA) represents a serious medical challenge and, when left untreated, eventual rupture of the aneurysm has significant morbidity associated therewith. When feasible, open surgery to repair the aortic aneurysm has been shown to be clinically successful.
1
However, open surgery is often not feasible especially in patients suffering from severe cardiac disease, renal disease or other conditions which contraindicate open surgery. For example, conventional exposure of the infrarenal aorta necessitates a large abdominal incision, mobilization of the abdominal viscera, and retroperitoneal dissection which are associated with complications such as renal failure, pseudoaneurysms and bleeding. Infrarenal aortic clamping is also associated with an increased cardiac demand including an increase in left ventricular end diastolic volume and may be related to cardiac mortality.
Less invasive methods for treating abdominal aortic aneurysms avoid many of these problems and additionally result in reduced patient discomfort, reduced hospital stays and reduced care intensity.
5
Endovascular grafts have ERG been investigated as one example of a less invasive method for the treatment of aneurysmal aortic disease. When compared to open surgery, endovascular grafting provides similar perioperative mortality rates notwithstanding the fact that endovascular grafting is often performed with individuals who are not candidates for open surgery due to one or more medical conditions which preclude such surgery.
1,4
One of the main concerns regarding endovascular grafting is the continued blood flow into the aneurysm after grafting which blood flow is termed in the art as an endoleak.
2
Endoleaks have been reported in from about 7 to about 37% of endovascular aortic aneurysm repairs
3
with some reports placing this number as high as 44%.
Specifically, endovascular grafting requires catheter placement of an endovascular prosthesis at the abdominal aortic aneurysm site. Endoleaks arising after such grafting may be caused by incomplete sealing between the endovascular prosthesis and the aortic wall or by defects within the endovascular prosthesis. In addition, back blending from patent lumbar and inferior mesenteric arteries following placement of the endovascular prostheses in the aorta has also been recited as a potential cause of endoleaks.
6
There is uniform agreement that large endoleaks that lead to aneurysm enlargement necessitate treatment in order to prevent aneurysm rupture. It is also reported that the size of the endoleak does not appear to be a relevant factor for pressure transmission into the aneurysm.
3
There are a variety of prophylactic and therapeutic treatment regimens for endoleaks reported in the literature. Prophylactic methods of inhibiting endoleaks by embolizing vasculature leading to the aneurysm, evidently with metallic coils, have been suggested and dismissed in an article by Walker, et al.
19
Therapeutic methods for endovascular repair include placement of additional stents within the prosthesis; insertion of metallic coils into the aneurysm space to induce thrombosis therein; and embolization of the inferior mesenteric artery using a prepolymer/water soluble contrast agent compositions.
18
The goal of such treatments is complete exclusion of the aneurysm from systemic blood flow. While complete exclusion is desirable, secondary goal is to reduce intraaneursymal pressure (IAP) from blood flow into the aneurysm to acceptable levels thereby inhibiting the likelihood of rupture. In cases where no endoleaks arose after endovascular grafting, the mean IAP has been reported to be reduced by about 65%. However, when endoleaks arise, it is reported that the mean LAP, while initially decreasing significantly, stabilized after a week at a reduction
Cragg Andrew H.
Dolmatch Bart
Greff Richard J.
Ricci Charlie
Burns, Doane, Swecker and Mathis, L.L.P.
Micro Therapeutics Inc.
Sharareh Shahnam
Travers Russell
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