Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – Coated – impregnated – or colloidal particulate
Reexamination Certificate
1999-03-19
2001-10-16
Jones, Dameron L. (Department: 1619)
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
Coated, impregnated, or colloidal particulate
C424S001730, C424S001650, C424S009100
Reexamination Certificate
active
06303100
ABSTRACT:
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
This invention is directed to methods for inhibiting the formation of potential endoleaks associated with endovascular repair of abdominal aortic aneurysms. In one embodiment, this invention is directed to methods for inhibiting the formation of potential endoleaks arising either from retrograde bleeding from blood vessels associated with the aneurysmal sac such as the lumbar and inferior mesenteric arteries into the aneurysm sac or from potential defects within the endovascular prosthesis which permit blood flow through it after endovascular repair of abdominal aortic aneurysms. Specifically, the methods of this invention involve the in situ embolization of blood vessels associated with the aneurysmal sac prior to placement of an endovascular prostheses in the abdominal aorta. Embolization of the blood vessels is achieved by injection of either a biocompatible polymer or prepolymer fluid composition into these vessels in a sufficient amount such that upon in situ solidification of this composition, blood circulation through these blood vessels and the aneurysmal sac ceases. Preferably, the biocompatible fluid composition comprises a contrast agent to allow the clinician to visualize the embolization process.
In another embodiment, the methods of this invention further comprise sealing of endoleaks formed after placement of the endovascular prosthesis 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.
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., 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., 3:661 (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 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 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, retrograde 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 flo
Cragg Andrew H.
Dolmatch Bart
Greff Richard J.
Ricci Charlie
Burns Doane Swecker & Mathis
Jones Dameron L.
Micro Therapeutics Inc.
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