Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active...
Reexamination Certificate
2001-05-04
2003-04-29
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
C424S422000, C424S423000, C424S426000, C424S430000
Reexamination Certificate
active
06555104
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for treating urinary incontinence in mammals generally and humans in particular. In these methods, a composition comprising a biocompatible polymer, a biocompatible solvent, and a contrast agent is delivered to the periurethral tissue of a mammal.
The biocompatible polymer is selected to be soluble in the biocompatible solvent, but insoluble in the periurethral tissue. The biocompatible solvent is miscible or soluble in the fluids of this tissue and, upon contact with such fluids, the biocompatible solvent quickly diffuses away whereupon the biocompatible polymer precipitates to form an occlusion in the periurethral tissue which compresses the urethra thereby preventing or reducing the involuntary leakage of urine from the bladder.
References
The following publications are cited in this application as superscript numbers:
1
Murless, “The Injection Treatment of Stress Incontinence,”
J. Obstet. Gynaecol.,
45: 67-73 (1938).
2
Quackels, “Deux Incontinences Après Adénomecomie Guéries Par Injection de Paraffine Dans Le Périnée,”
Acta Urol. Belg.,
23: 259-262 (1955).
3
Sachse, “Treatment of Urinary Incontinence with Sclerosing Solutions: Indications, Results, Complications,”
Urol. Int.,
15: 225-244 (1963).
4
Politano, et al., “Periurethral Teflon Injection for Urinary Incontinence,”
J. Urol.,
111: 180-183 (1974).
5
Lim, et al., “Periurethral Teflon Injection: A Simple Treatment for Urinary Incontinence,”
Br. J. Urol.,
55: 208-210 (1983).
6
Schulman, et al., “Endoscopic Injection of Teflon to Treat Urinary Incontinence in Women,”
BMJ,
228: 192 (1984).
7
Rodriguez, “Late Results of the Endourethral Injection of Teflon in Stress Urinary Incontinence,”
J. Urol.
(
Paris
), 62: 39-41 (1987).
8
Vesey, et al., “Teflon Injection in Female Stress Incontinence. Effect on Urethral Pressure Profile and Flow Rate,”
Br. J. Urol.,
62: 39-41 (1988).
9
Smart, “Poltef Paste for Urinary Incontinence,”
Aust. N. Z. J. Surg.,
61: 663-666 (1991).
10
Malizia, et al., “Migration and Granulomatous Reaction After Periurethral Injection of Polytef (Teflon),”
JAMA,
251: 3227-3281 (1984).
11
Stricker, et al., “Injectable Collagen for Type 3 Female Stress Incontinence: The First 50 Australian Patients,”
Med. J. Aust.,
158: 89-91 (1993).
12
Moore, et al., “Periurethral Implantation of Glutaraldehyde Cross-Linked Collagen (Contigen®) in Women with Type I or III Stress Incontinence: Quantitative Outcome Measures,”
Br. J. Urol.,
75: 359-363 (1995).
13
Capozza, et al., “Endoscopic Treatment of Vesico-Ureteric Reflux and Urinary Incontinence: Technical Problems in the Pediatric Patient,”
Br. J. Urol.,
75: 538-542 (1995).
14
Atala, et al., “Injectable Alginate Seeded with Chondrocytes as a Potential Treatment for Vesicoureteral Reflux,”
J. Urol.,
150: 745-747 (1993).
15
Meriguerian, et al., “Submucosal Injection of Polyvinyl Alcohol Foam in Rabbit Bladder,”
J. Urol.,
144: 531-533 (1990).
16
Walker, et al., “Injectable Bioglass as a Potential Substitute for Injectable Polytetrafluoroethylene,”
J. Urol.,
148: 645 (1992).
17
Atala, et al., “Endoscopic Treatment of Vesicoureteral Reflux with a Self-Detachable Balloon System,”
J. Urol.,
148: 724-728 (1992).
18
Kinugasa, et al., “Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer”,
J. Neurosurg.,
77:501-507 (1992).
19
Kinugasa, et al., “Early Treatment of Subarachnoid Hemorrhage After Preventing Rerupture of an Aneurysm”,
J. Neurosurg.,
83:34-41 (1995).
20
Kinugasa, et al., “Prophylactic Thrombosis to Prevent New Bleeding and to Delay Aneurysm Surgery”.
Neurosurg.,
36:661 (1995).
21
Greff, et al., U.S. patent application Ser. No. 08/508,248 for “Cellulose Diacetate Compositions for Use in Embolizing Blood Vessels”, filed Jul. 27, 1995.
22
Greff, et al., U.S. patent application Ser. No. 08/507,863 for “Novel Compositions for Use in Embolizing Blood Vessels”, filed Jul. 27, 1995.
23
Taki, et al., “Selection and Combination of Various Endovascular Techniques in the Treatment of Giant Aneurysms”,
J. Neurosurg.,
77:37-42 (1992).
24
Park, et al., “New Polymers for Therapeutic Embolization”, Poster #47, Meeting of Radiological Society of North America (1993)
25
Winters, et al., “Periurethral Injection of Collagen in the Treatment of Intrinsic Sphincteric Deficiency in the Female Patient”,
Urologic Clinics of North America,
22(3):473-478 (1995)
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
Urinary incontinence is an extremely common problem especially in women. In particular, many women suffer from incontinence including stress incontinence. In this condition, the pelvic-floor muscles which support the base of the bladder and close off the top of the urethra are weakened by, for example, childbirth or obesity. As a result, when pressure is exerted on these muscles by coughing, lifting, etc., urine is involuntarily discharged from the bladder through the urethra.
The initial treatment for stress incontinence typically consists of exercises to strengthen the pelvic-floor muscles. If these exercises are ineffective, open surgical repair of the bladder neck is often attempted. However, such surgical repair procedures are not successful for all patients. Moreover, there are always certain risks associated with open surgical procedures, such as trauma, infection, risks of anesthesia, etc.
As an alternative to surgical repair, urinary incontinence has been treated by injecting various substances into the tissue surrounding the urethra, i.e., the periurethral tissue, to add bulk to this tissue. The aim of this treatment is to compress the urethra at the level of the bladder neck thus impeding the involuntary flow of urine from the bladder. Many substances have been tried for this purpose with varying results.
For example, Murless has reported the use of sodium morrhuate for the treatment of stress incontinence.
1
However, this material was not successful in preventing incontinence and pulmonary infarction was observed as a complication. Similarly, paraffin
2
and other sclerosing solutions
3
have been tried with poor results.
More recently, polytetrafluoroethylene particles (TEFLON™, POLYTEF™) have been used as an injectable material for the correction of urinary incontinence with a success rate of from 30% to 86% in some studies.
4-9
However, these particles have subsequently been demonstrated to generate foreign body granulomas and to migrate to distant organs, such as the lungs, liver, spleen and brain.
10
Accordingly, the use of polytetrafluoroethylene particles is currently disfavored.
Another injectable material that has been used recently for the treatment of urinary incontinence is glutaraldehyde cross-linked bovine dermal collagen.
11-13
However, a major problem associated with the use of collagen materials is the tendency of the implant to decrease in volume over time thereby necessitating retreatment.
14
In addition, collagen has been associated with adverse immune responses and allergic reactions to bovine dermal collagen have been described.
12
Various other injectable substances have been reported or proposed as implant materials for the treatment of bladder conditions, such as vesicoureteral reflux. These substances include polyvinyl alcohol foam,
15
glass particles,
16
a chondrocyte-alginate suspension
14
and a detachable silicone balloon.
17
In addition to the various problems associated with many of the substances used to treat urinary incontinence, the methods currently employed for delivering injectable materials to the periurethral tissue have certain disadvantages. In particular, the amount of material necessary to compress the urethra must typically be estimated by observing the compression of the urethra wall using a cystoscope or endoscope. If an insufficient amount of material is
Greff Richard J.
Wallace George
Burns Doane Swecker & Mathis L.L.P.
Joynes Robert M.
Micro Therapeutics Inc.
Page Thurman K.
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