US5482039A
Expired / Lapsed
US
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Process for diagnosing erectile dysfunction, and related methods of treatment
Assignee: Vivus LLC
•
Filing: 1994-03-25
•
Granted: 1996-01-09
•
Expires: 2014-03-25
Abstract
Abstract A method for diagnosing vasculogenic erectile dysfunction, including vasculogenic impotence and Peyronie's syndrome, is provided. The method involves transurethral administration of a vasodilating agent to induce an erection, followed by hemodynamic evaluation using duplex ultrasonography, NMR, angiography, or the like. Kits for conducting the diagnostic method are provided as well, as are methods of treatment based on the diagnostic conclusion.
Inventors
- 👤 Virgil A. Place
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 12:53
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/43; A61B5/4375; A61B5/4393; A61F; A61F5/00; A61F5/41; A61K; A61K9/00; A61K9/0012; A61K9/0034; A61M; A61M31/00
Claims Analysis
Total Claims: 55
Claim 1
Independent Claim
94 words
A method for diagnosing erectile dysfunction in a male individual, comprising: (a) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis; (b) after erection has been induced, conducting penile hemodynamic measurements, wherein the hemodynamic measurements include evaluation of cavernosal artery peak systolic velocity, evaluation of cavernosal artery end diastolic velocity, or both; and (c) determining from the results in step (b) whether penile vascular insufficiency exists, such that it may be concluded that the erectile dysfunction is or is not a result of vasculogenic factors.
Claim 2
Independent Claim
94 words
A method for diagnosing erectile dysfunction in a male individual, comprising: (a) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis; (b) after erection has been induced, conducting penile hemodynamic measurements, wherein the hemodynamic measurements include evaluation of cavernosal artery peak systolic velocity, evaluation of cavernosal artery end diastolic velocity, or both; and (c) determining from the results in step (b) whether penile vascular insufficiency exists, such that it may be concluded that the erectile dysfunction is or is not a result of vasculogenic factors.
Claim 3
Dependent Claim
11 words
The method of claim 1, wherein the erectile dysfunction is impotence.
Claim 4
Dependent Claim
13 words
The method of claim 1, wherein the vasculogenic erectile dysfunction is Peyronie's syndrome.
Claim 5
Dependent Claim
54 words
The method of claim 1, wherein step (a) is carried out by placing the vasodilating agent in contact with the male urethra at a location between the proximal portion of the fossa navicularis and the distal portion of the pendulous urethra, such that the agent enters the individual's blood stream through the urethral wall.
Claim 6
Dependent Claim
55 words
The method of claim 4, wherein the agent is administered in a dispersant which releases the agent in the urethra at said depth at a weight ratio of dispersant to agent of about 1:1 to 10:1, wherein the dose of agent is selected so as not to exceed the dose retaining capacity of the urethra.
Claim 7
Dependent Claim
16 words
The method of claim 5, wherein approximately 50 mg of agent and dispersant are administered transurethrally.
Claim 8
Dependent Claim
16 words
The method of claim 1, wherein a transurethral permeation enhancer is administered with the vasodilating agent.
Claim 9
Dependent Claim
16 words
The method of claim 7, wherein the transurethral permeation enhancer and vasodilating agent are administered simultaneously.
Claim 10
Dependent Claim
20 words
The method of claim 8, wherein the transurethral permeation enhancer and vasodilating agent are administered in a single pharmaceutical composition.
Claim 11
Dependent Claim
16 words
The method of claim 7, wherein the transurethral permeation enhancer and vasodilating agent are administered sequentially.
Claim 12
Dependent Claim
46 words
The method of claim 1, wherein the vasodilating agent is 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 13
Dependent Claim
12 words
The method of claim 1, wherein step (b) is conducted using ultrasonography.
Claim 14
Dependent Claim
11 words
The method of claim 12, wherein the ultrasonography is duplex ultrasonography.
Claim 15
Dependent Claim
41 words
The method of claim 13, wherein step (b) is conducted by transmitting ultrasound to each cavernosal artery, detecting ultrasound reflected therefrom, detecting the frequency difference between the transmitted and reflected ultrasound, and calculating the velocity of blood from the frequency difference.
Claim 16
Dependent Claim
12 words
The method of claim 1, wherein step (b) is conducted using angiography.
Claim 17
Dependent Claim
14 words
The method of claim 1, wherein step (b) is conducted using a corpus cavernosagram.
Claim 18
Dependent Claim
15 words
The method of claim 1, wherein the hemodynamic measurements include evaluation of maximum arterial dilation.
Claim 19
Independent Claim
137 words
A method for treating erectile dysfunction in a male individual, comprising: (a) determining whether or not the erectile dysfunction is due to vasculogenic causes, comprising (i) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis, (ii) after erection has been induced, conducting penile hemodynamic measurements, wherein the hemodynamic measurements include evaluation of cavernosal artery peak systolic velocity, evaluation of cavernosal artery end diastolic velocity, or both, (iii) determining from the results in step (ii) whether penile vascular insufficiency exists, thereby making a diagnosis as to whether the erectile dysfunction is vasculogenic; (b) if the diagnosis in step (a) is that the erectile dysfunction is vasculogenic, transurethrally administering a vasodilating agent to the patient within the context of a treatment regimen which is effective to remedy the erectile dysfunction.
Claim 20
Independent Claim
137 words
A method for treating erectile dysfunction in a male individual, comprising: (a) determining whether or not the erectile dysfunction is due to vasculogenic causes, comprising (i) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis, (ii) after erection has been induced, conducting penile hemodynamic measurements, wherein the hemodynamic measurements include evaluation of cavernosal artery peak systolic velocity, evaluation of cavernosal artery end diastolic velocity, or both, (iii) determining from the results in step (ii) whether penile vascular insufficiency exists, thereby making a diagnosis as to whether the erectile dysfunction is vasculogenic; (b) if the diagnosis in step (a) is that the erectile dysfunction is vasculogenic, transurethrally administering a vasodilating agent to the patient within the context of a treatment regimen which is effective to remedy the erectile dysfunction.
Claim 21
Dependent Claim
54 words
The method of claim 18, wherein step (b) is carried out by placing the vasodilating agent in contact with the male urethra at a location between the proximal portion of the fossa navicularis and the distal portion of the pendulous urethra, such that the agent enters the individual's blood stream through the urethral wall.
Claim 22
Dependent Claim
55 words
The method of claim 19, wherein the agent is administered in a dispersant which releases the agent in the urethra at said depth at a weight ratio of dispersant to agent of about 1:1 to 10:1, wherein the dose of agent is selected so as not to exceed the dose retaining capacity of the urethra.
Claim 23
Dependent Claim
12 words
The method of claim 18, wherein step (a)(ii) is conducted using ultrasonography.
Claim 24
Dependent Claim
11 words
The method of claim 21, wherein the ultrasonography is duplex ultrasonography.
Claim 25
Dependent Claim
41 words
The method of claim 22, wherein step (a)(ii) is conducted by transmitting ultrasound to each cavernosal artery, detecting ultrasound reflected therefrom, detecting the frequency difference between the transmitted and reflected ultrasound, and calculating the velocity of blood from the frequency difference.
Claim 26
Dependent Claim
12 words
The method of claim 18, wherein step (a)(ii) is conducted using angiography.
Claim 27
Dependent Claim
15 words
The method of claim 18, wherein the hemodynamic measurements include evaluation of maximum arterial dilation.
Claim 28
Dependent Claim
11 words
The method of claim 18, wherein the erectile dysfunction is impotence.
Claim 29
Dependent Claim
13 words
The method of claim 18, wherein the vasculogenic erectile dysfunction is Peyronie's syndrome.
Claim 30
Dependent Claim
16 words
The method of claim 18, wherein approximately 50 mg of agent and dispersant are administered transurethrally.
Claim 31
Dependent Claim
16 words
The method of claim 18, wherein a transurethral permeation enhancer is administered with the vasodilating agent.
Claim 32
Dependent Claim
16 words
The method of claim 29, wherein the transurethral permeation enhancer and vasodilating agent are administered simultaneously.
Claim 33
Dependent Claim
20 words
The method of claim 30, wherein the transurethral permeation enhancer and vasodilating agent are administered in a single pharmaceutical composition.
Claim 34
Dependent Claim
16 words
The method of claim 29, wherein the transurethral permeation enhancer and vasodilating agent are administered sequentially.
Claim 35
Dependent Claim
46 words
The method of claim 18, wherein the vasodilating agent is 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 36
Independent Claim
76 words
A method for diagnosing erectile dysfunction in a male individual, comprising: (a) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis; (b) after erection has been induced, conducting penile hemodynamic measurements using NMR spectroscopy; and (c) determining from the results in step (b) whether penile vascular insufficiency exists, such that it may be concluded that the erectile dysfunction is or is not a result of vasculogenic factors.
Claim 37
Independent Claim
76 words
A method for diagnosing erectile dysfunction in a male individual, comprising: (a) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis; (b) after erection has been induced, conducting penile hemodynamic measurements using NMR spectroscopy; and (c) determining from the results in step (b) whether penile vascular insufficiency exists, such that it may be concluded that the erectile dysfunction is or is not a result of vasculogenic factors.
Claim 38
Dependent Claim
11 words
The method of claim 34, wherein the erectile dysfunction is impotence.
Claim 39
Dependent Claim
13 words
The method of claim 34, wherein the vasculogenic erectile dysfunction is Peyronie's syndrome.
Claim 40
Dependent Claim
54 words
The method of claim 34, wherein step (a) is carried out by placing the vasodilating agent in contact with the male urethra at a location between the proximal portion of the fossa navicularis and the distal portion of the pendulous urethra, such that the agent enters the individual's blood stream through the urethral wall.
Claim 41
Dependent Claim
55 words
The method of claim 37, wherein the agent is administered in a dispersant which releases the agent in the urethra at said depth at a weight ratio of dispersant to agent of about 1:1 to 10:1, wherein the dose of agent is selected so as not to exceed the dose retaining capacity of the urethra.
Claim 42
Dependent Claim
16 words
The method of claim 38, wherein approximately 50 mg of agent and dispersant are administered transurethrally.
Claim 43
Dependent Claim
16 words
The method of claim 34, wherein a transurethral permeation enhancer is administered with the vasodilating agent.
Claim 44
Dependent Claim
16 words
The method of claim 40, wherein the transurethral permeation enhancer and vasodilating agent are administered simultaneously.
Claim 45
Dependent Claim
20 words
The method of claim 41, wherein the transurethral permeation enhancer and vasodilating agent are administered in a single pharmaceutical composition.
Claim 46
Dependent Claim
16 words
The method of claim 40, wherein the transurethral permeation enhancer and vasodilating agent are administered sequentially.
Claim 47
Dependent Claim
46 words
The method of claim 40, wherein the vasodilating agent is 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 48
Dependent Claim
46 words
The method of claim 34, wherein the vasodilating agent is 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 49
Independent Claim
117 words
A method for treating erectile dysfunction in a male individual, comprising: (a) determining whether or not the erectile dysfunction is due to vasculogenic causes, comprising (i) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis, (ii) after erection has been induced, conducting penile hemodynamic measurements using NMR spectroscopy, (iii) determining from the results in step (ii) whether penile vascular insufficiency exists, thereby making a diagnosis of the erectile dysfunction is vasculogenic; (b) if the diagnosis in step (a) is that the erectile dysfunction is vasculogenic, transurethrally administering a vasodilating agent to the patient within the context of a treatment regimen which is effective to remedy the erectile dysfunction.
Claim 50
Independent Claim
117 words
A method for treating erectile dysfunction in a male individual, comprising: (a) determining whether or not the erectile dysfunction is due to vasculogenic causes, comprising (i) transurethrally administering to the individual a vasodilating agent in an amount sufficient to induce erection of the penis, (ii) after erection has been induced, conducting penile hemodynamic measurements using NMR spectroscopy, (iii) determining from the results in step (ii) whether penile vascular insufficiency exists, thereby making a diagnosis of the erectile dysfunction is vasculogenic; (b) if the diagnosis in step (a) is that the erectile dysfunction is vasculogenic, transurethrally administering a vasodilating agent to the patient within the context of a treatment regimen which is effective to remedy the erectile dysfunction.
Claim 51
Dependent Claim
11 words
The method of claim 46, wherein the erectile dysfunction is impotence.
Claim 52
Dependent Claim
13 words
The method of claim 46, wherein the vasculogenic erectile dysfunction is Peyronie's syndrome.
Claim 53
Dependent Claim
54 words
The method of claim 46, wherein step (a) is carried out by placing the vasodilating agent in contact with the male urethra at a location between the proximal portion of the fossa navicularis and the distal portion of the pendulous urethra, such that the agent enters the individual's blood stream through the urethral wall.
Claim 54
Dependent Claim
50 words
The method of claim 49, wherein the agent is administered in a dispersant which releases the agent in the urethra at said depth at a weight ratio of dispersant to agent of about 1:1 to 10:1, the amount of said dose not exceeding the dose retaining capacity of the urethra.
Claim 55
Dependent Claim
20 words
The method of claim 50, wherein the amount of agent and dispersant that is administered transurethrally is approximately 50 mg.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-01-08 | 1999-07-10 | 2000-01-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-01-08 | 2003-07-10 | 2004-01-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-01-08 | 2007-07-10 | 2008-01-09 | $7700.00 | Window Closed / Lapsed |