Patent US5474535A successfully refreshed from Google Patents.
US5474535A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Dosage and inserter for treatment of erectile dysfunction
Assignee: Vivus LLC
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Filing: 1993-07-19
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Granted: 1995-12-12
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Expires: 2013-07-19
Abstract
Abstract Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (40) having a shaft with a deformable distal end which forms a dose receiving cavity when an internal piston is retracted relative to the shaft.
Inventors
- 👤 Virgil A. Place
- 👤 Robert M. Gale
- 👤 Randall G. Berggren
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 23:40
CPC Classifications
A; A61; A61M; A61M31/00; A61F; A61F5/00; A61F5/41; A61K; A61K9/00; A61K9/0012; A61K9/0034; A61M31/002; A61M2210/00; A61M2210/16; A61M2210/167
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
117 words
A dosage form for treating an erectile dysfunction, said dosage form comprising, in combination: a) a shaft having a diameter that is receivable in the male urethra, said shaft having a proximal end and a blunted distal end; b) means to prevent complete insertion of said shaft into the urethra on the proximal end of said shaft; and c) a dose of a therapeutic composition for said erectile dysfunction carried in said shaft prior to insertion in the urethra, said therapeutic composition comprising a therapeutic agent for said erectile dysfunction, wherein said dose weighs less than about 100 mgs, is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.
Claim 2
Dependent Claim
117 words
A dosage form for treating an erectile dysfunction, said dosage form comprising, in combination: a) a shaft having a diameter that is receivable in the male urethra, said shaft having a proximal end and a blunted distal end; b) means to prevent complete insertion of said shaft into the urethra on the proximal end of said shaft; and c) a dose of a therapeutic composition for said erectile dysfunction carried in said shaft prior to insertion in the urethra, said therapeutic composition comprising a therapeutic agent for said erectile dysfunction, wherein said dose weighs less than about 100 mgs, is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.
Claim 3
Dependent Claim
23 words
The dosage form of claim 1 further comprising: d) a cavity containing said therapeutic composition at the blunted distal end of said shaft.
Claim 4
Dependent Claim
20 words
The dosage form of claim 2 further comprising: e) means for displacing said composition from said cavity into the urethra.
Claim 5
Dependent Claim
37 words
The dosage form of claim 1 wherein said therapeutic composition is positioned in said shaft to be deposited within the urethra between the proximal portion of the fossa navicularis and the distal position of the pendulous urethra.
Claim 6
Dependent Claim
17 words
The dosage form of claim 1 wherein said dose weighs not more than 50 mg of agent.
Claim 7
Dependent Claim
21 words
The dosage form of claim 1, 2, 3, 4, or 5 wherein said shaft is from about 2-5 cm in length.
Claim 8
Dependent Claim
22 words
The dosage form of claim 1, 2, 3, 4, or 5 wherein said composition comprises a urethral permeation enhancer for said agent.
Claim 9
Dependent Claim
25 words
The dosage form of claim 1, 2, 3, 4, or 5 wherein said erectile dysfunction is impotence and said agent comprises one or more vasodilators.
Claim 10
Dependent Claim
47 words
The dosage form of claim 8 wherein said vasodilators are selected from the group consisting of nitrates, long and short acting α-blockers, calcium blockers, ergot alkaloids, chlorpromazine, haloperidol, yohimbine, natural and synthetic vasoactive prostaglandins and their analogs, vasoactive intestinal peptides, dopamine agonists, opioid antagonists and mixtures thereof.
Claim 11
Dependent Claim
15 words
The dosage form of claim 8 wherein said agent comprises an α-blocker and a prostaglandin.
Claim 12
Dependent Claim
51 words
The dosage form of claim 8 wherein said agent is selected from the group consisting of about 10-2000 μg of a vasoactive prostaglandin, about 1-50 mg of papaverine, about 1-10 mg of phentolamine, about 50-2000 μg of prazosin, about 50-2000 μg of doxazosin about 50-2000 μg of terazosin and mixtures thereof.
Claim 13
Dependent Claim
23 words
The dosage form of claim 11 wherein said therapeutic composition further comprises polyethylene glycol and said agent comprises an α-blocker and a prostaglandin.
Claim 14
Dependent Claim
15 words
The dosage form of claim 11 wherein said agent consists essentially of alprostadil and prazosin.
Claim 15
Dependent Claim
24 words
The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is priapism and said agent comprises one or more vasoconstrictors.
Claim 16
Dependent Claim
37 words
The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is Peyronie's syndrome and said agent comprises a material selected from the group consisting of steroidal and nonsteroidal anti-inflammatory agents and mixtures thereof.
Claim 17
Dependent Claim
32 words
The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is priapism and said agent is selected from the group consisting of α-agonists and β-blockers and mixtures thereof.
Claim 18
Dependent Claim
20 words
The dosage form of claim 1, 2, 3, 4, 5 or 11 wherein said therapeutical composition further comprises polyethylene glycol.
Claim 19
Dependent Claim
133 words
A dosage form for treating erectile dysfunction, said dosage form comprising, in combination: a) an insert comprising: (i) a shaft having a proximal end and a distal end sized to be received within the male urethra; and (ii) a bore within said shaft; b) a piston slidably received within said bore and movable from a first position where said piston forms a dose receiving cavity proximate to the distal end of said shaft to a second position where said dose is displaced from said cavity; and c) a dose of a therapeutic composition for said erectile dysfunction comprising said therapeutic agent for said erectile dysfunction, said dose being received in said cavity, wherein said dose is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.
Claim 20
Dependent Claim
133 words
A dosage form for treating erectile dysfunction, said dosage form comprising, in combination: a) an insert comprising: (i) a shaft having a proximal end and a distal end sized to be received within the male urethra; and (ii) a bore within said shaft; b) a piston slidably received within said bore and movable from a first position where said piston forms a dose receiving cavity proximate to the distal end of said shaft to a second position where said dose is displaced from said cavity; and c) a dose of a therapeutic composition for said erectile dysfunction comprising said therapeutic agent for said erectile dysfunction, said dose being received in said cavity, wherein said dose is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.
Claim 21
Dependent Claim
69 words
The dosage form of claim 18 wherein: A. the shaft of said insert is closed at said distal end to form a flexible peripheral wall having an interior surface and an exterior surface; and B. said piston is attached to the interior surface of said peripheral wall, said piston in said first position being withdrawn within said shaft where said flexible peripheral wall forms said cavity enclosing said dose.
Claim 22
Dependent Claim
15 words
The dosage form of claim 18 wherein said dose weighs less than about 50 mg.
Claim 23
Dependent Claim
17 words
The dosage form of claim 20 wherein the length of said shaft potion is from 2-5 cm.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1998-12-11 | 1999-06-12 | 1999-12-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-12-11 | 2003-06-12 | 2003-12-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-12-11 | 2007-06-12 | 2007-12-12 | $7700.00 | Window Closed / Lapsed |