Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – X-ray contrast imaging agent
Reexamination Certificate
1999-03-19
2001-03-20
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
X-ray contrast imaging agent
C424S009455, C424S009400, C424S009410, C424S009411, C604S041000, C604S058000, C604S058000, C604S502000, C604S508000, C524S916000, C523S113000, C523S115000, C523S117000, C523S118000, C514S546000, C514S057000
Reexamination Certificate
active
06203779
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 either a biocompatible polymer or prepolymer 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. Vase. 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., 27(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, N.Y. 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, N.Y. 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, N.Y. 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, N.Y. in November, 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 contra-indicate 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 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 about 7 and 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 prostheses 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 prostheses. In addition, back bleeding 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 treatment regimens for endoleaks reported in the literature including endovascular repair by placement of additional stents within the prostheses as well as insertion of metallic coils into the aneurysm space to induce thrombosis therein. The goal of such treatments is complete exclusion of the aneurysm from systemic blood flow. While complete exclusion is desirable, a 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 IAP, while initially decreasing significantly, stabilized after a week at a reduction of only 22%. Moreover, the use of coils to induce thrombosis and thereby reduce IAP did not have any significant impact on the IAP.
In view of existing problems associated with endovascular repair of endoleaks, the accepted treatment for these endoleaks is open surgery. However, the mortality rates for open surgery of endoleaks is higher than either initial open surgery for the abdominal aortic aneurysm or for the initial endovascular repair of the aneurysm.
In view of the above, reliable endovascular methods to inhibit endoleaks after endovascular graft repair of abdominal aortic aneurysms is desirable.
SUMMARY OF THE INVENTION
This invention is directed to methods for treati
Cragg Andrew H.
Dolmatch Bart
Greff Richard J.
Ricci Charlie
Burns Doane , Swecker, Mathis LLP
Dudash Diana
Sharareh S
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