Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis
Reexamination Certificate
2001-03-20
2003-05-27
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
C606S108000, C604S508000
Reexamination Certificate
active
06569190
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for treating aneurysms in a mammalian patient.
REFERENCES
The following publications are cited in this application as superscript numbers:
1
Castaneda-Zuniga, et al.,
Interventional Radiology
, in Vascular Embolotherapy, Part 1, 1:9-32, Williams & Wilkins, Publishers (1992)
2
Greff, et al.,
Compositions for Use in Embolizing Blood Vessels
, U.S. Pat. No. 5,667,767, issued Sep. 16, 1997
3
Evans, et al.,
Cellulose Diacetate Compositions for Use in Embolizing Blood Vessels
, U.S. Pat. No. 5,580,568, issued Dec. 3, 1996
4
Evans, et al.,
Novel Embolizing Compositions
, U.S. Pat. No. 5,695,480, issued Dec. 9, 1997
5
Jones, et al.,
Methods for Embolizing Vascular Sites with an Embolizing Composition Comprising Dimethylsulfoxide
, U.S. Pat. No. 5,830,178, issued Nov. 3, 1998
6
Whalen, et al.,
Novel Embolizing Compositions Comprising High Polymer Concentrations
, U.S. patent application Ser. No. 09/574,379, filed May 19, 2000
7
Evans, et al.,
Methods for Embolizing Blood Vessels
, U.S. Pat. No. 5,702,361, issued Dec. 30, 1997
8
Evans, et al.,
Methods for Embolizing Blood Vessels
, U.S. Pat. No. 6,017,977, issued Jan. 25, 2000
9
Wallace, et al.,
Intracranial Stent and Method of Use
, U.S. Pat. No. 6,007,573, issued Dec. 28, 1999.
10
Racchini, et al.,
Porous Balloon For Selective Dilation and Drug Delivery
, U.S. Pat. No. 5,458,568, issued Oct. 17, 1995
11
Whalen, et al.,
Novel High Viscosity Embolizing Compositions
, U.S. patent application Ser. No. 09/574,379, May 19, 2000
12
Szikora, et al.,
Endovascular Treatment of Experimental Aneurysms with Liquid Polymers: The Protective Potential of Stents, Neurosurgery,
38(2):339-347 (1996)
13
Kinugasa, et al.,
Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer, Part II—Preliminary Clinical Experience
, J. Neurosurg., 77:501-507 (1992)
14
Kinugasa, et al.,
Cellulose Acetate Polymer Thrombosis for the emergency Treatment of Aneurysms: Angiographic Finding, Clinical Experience, and Histopathological Study
, Neurosurgery, 34:694-701 (1994)
15
Mandai, et al.,
Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer: Part I—Results of Thrombosis in Experimental Aneurysms
, J. Neurosurg., 77:497-500 (1992)
16
Talia, et al.,
Bioabsorbable and Biodegradable Stents in Urology
, J. Endourology, 11(6):391 (1997)
17
Wallace, et al., Intracranial Stent, U.S. Pat. No. 6,254,628, issued Jul. 3, 2001.
18
Dunn, et al., U.S. Pat. No. 4,938,763 for “Biodegradable In-Situ Forming Implants and Methods for Producing Same” issued Jul. 3, 1990.
19
“CANCER, Principles & Practice of Oncology”, 4
th
Ed., Volume 1, “Cancer Treatment”, pp. 545-548 (1993).
All of the above references are herein incorporated by reference in their entirety to the same extent as if each individual reference was specifically and individually indicated to be incorporated herein by reference in its entirety.
2. State of the Art
Aneurysms arise in mammalian subjects and, in particular, human subjects as a result of vascular disease wherein the arterial (wall) weakens and, under pressure due to blood flow, the arterial wall “balloons”. Continued growth and/or eventual rupture of the ballooned arterial wall is associated with high morbidity and mortality rates. Intracranial aneurysms are of particular concern because surgical procedures to treat these aneurysms before rupture are often not feasible and further because rupture of these aneurysms can have devastating results on the patient even if the patient survives rupture. Accordingly, treatment protocols for intracranial aneurysms may be prophylactic in nature, i.e., to inhibit rupture or rerupture of the aneurysm rather than to inhibit bleeding from the ruptured aneurysm.
Methods well documented in the art to inhibit intracranial aneurysmal rupture include the delivery into the aneurysmal sac of non-particulate agents such as metal coils which are designed to induce thrombosis after delivery to the aneurysm thereby inhibiting blood flow into the aneurysm
1
; delivery of a fluid composition into the aneurysmal sac which composition solidifies in the sac to inhibit blood flow into the aneurysm
2-6
; or a delivery of a combination of non-particulate agents and a fluidic composition into the aneursymal sac to inhibit blood flow into the aneurysm.
7-8
In each case, the cranial aneurysm is treated by filling the aneurysmal sac in a manner which inhibits blood flow into the sac. This reduced blood flow correlates to reductions in aneurysmal pressure and, hence, a reduction in the likelihood of rupture. However, care must be taken to ensure against migration of non-particulate agents or fluid composition beyond the aneurysmal sac (which can occur, for example, by overfilling of the sac) because this can result in parent artery or distal embolization which, in turn, has its own high level of morbidity associated therewith.
12
Notwithstanding the benefits that these methods provide in inhibiting aneurysmal rupture, in a significant number of cases, the treatment protocol is only effective for a short period of time due to reformation of the aneurysmal sac or formation of a new aneurysmal sac at or adjacent the previously treated aneurysm in the treated patient.
13-15
Upon careful analysis, this invention is based upon the discovery that subsequent re-treatment arising after initial treatment of the aneurysm by filling the aneurysmal sac with non-particulate agents and/or fluidic compositions was necessitated because the initial treatment did not address all of the diseased tissue. Specifically, the aneurysmal sac in the parent artery often reflects only the most diseased and hence weakest portion of the arterial wall. However, regions proximal and distal to the aneurysmal sac are often diseased and prone to ballooning. Hence, when the aneurysmal sac is filled via the methods described above, other diseased portions of the arterial wall adjacent to the treated aneurysm become more likely to balloon and rupture. It is this latter phenomena that is believed to result in retreatment of the aneurysm.
While Szikora, et al.
12
discloses the use of a porous stent in combination with a fluid composition in treating an aneurysm, the stent employed is a porous stent and the amount of polymer employed is less than that necessary to completely fill the aneurysmal sac. Accordingly, the techniques disclosed therein do not isolate the parent artery proximal and distal to the aneurysmal sac from blood flow.
SUMMARY OF THE INVENTION
This invention is directed to methods for treating aneurysms wherein the aneurysmal sac is filled with a non-particulate agent or plurality of such agents and/or with a fluid composition which solidifies in situ. Filling of the aneurysmal sac employs sufficient amount of the non-particulate agent or plurality of such agents and/or the fluid composition to inhibit blood flow into the aneurysm sac. In addition, the methods of this invention also provide for non-endogenous isolation of the parent artery proximal and distal to the aneurysmal sac from systemic blood flow of the treated mammal. The combination of these features provides for treatment of the aneurysmal sac while, at the same time, inhibiting aneurysm formation and/or regrowth in the diseased portions of the arterial wall proximal and distal to the treated aneurysm.
Preferably, the aneurysm treated is an intracranial (cerebral) aneurysm.
Accordingly, in one of its method aspects, this invention is directed to a method for treating an aneurysm in a mammalian patient which method comprises:
(a) identifying the vascular site of an aneurysm in a mammalian patient wherein said aneurysm comprises an aneursymal sac formed from the vascular wall of a parent artery and further wherein said aneurysmal sac participates in the systemic blood flow of said patient;
(b) inhibiting systemic blood flow into said aneurysmal sac by filling at least a portion of said sac with a fluid composition and/or a non-particulate agent or plurality of said agents; and
Gilmartin Kevin P.
Greff Richard J.
Hayman Douglas Ray
Hewitt Todd J.
Olson Ed L.
Jackson Suzette J.
Micro Therapeutics Inc.
Willse David H.
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